Newsletter

Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Filing of New Drug Application for ACER-001 to Treat Urea Cycle Disorders

Year ordering: 2021
Media Contact:

 

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
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Acer Therapeutics Inc.
Jim DeNike
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+1 844-902-6100

Investor relations:

RELIEF THERAPEUTICS Holding SA:

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Acer Therapeutics:
Hans Vitzthum
LifeSci Advisors
This email address is being protected from spambots. You need JavaScript enabled to view it.
+1 617-430-7578

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the FDA will approve Acer’s NDA for ACER-001, (ii) whether Relief will be able to submit an application for approval of ACER-001 in Europe in Q2/Q3 2022 (or at all), (iii) whether any such application submitted to European authorities seeking marketing authorization for ACER-001 for the treatment of patient in Europe with UCDs will be approved, (iv) whether RLF-100 (aviptadil) will receive emergency use authorization in the United States, (v) whether RLF-100 (aviptadil) will ever be submitted for authorization in Europe, (vi) whether Relief’s ongoing disputes with its U.S. collaboration partner for RLF-100 (aviptadil) can be resolved amicably, and (vii) those other risks, uncertainties and factors described in Relief’s annual and periodic filings with the SIX Stock Exchange, all of which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 211006_Relief_ACER001 NDA accept
Attachment (PDF): 20211006_ad_hoc_Relief_ACER-001-NDA-Acceptance.pdf

Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Filing of New Drug Application for ACER-001 to Treat Urea Cycle Disorders

FDA sets PDUFA target action date of June 5, 2022

NEWTON, MA and GENEVA, SWITZERLAND – October 6, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for the treatment of patients with Urea Cycle Disorders (UCDs). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022.

Acer’s 505(b)(2) NDA is supported by results from two previously announced bioequivalence (BE) trials in which ACER-001 showed similar relative bioavailability for both phenylbutyrate (PBA) and phenylacetate (PAA), the active metabolite of sodium phenylbutyrate, compared to the reference listed drug, BUPHENYL® (sodium phenylbutyrate).

"With FDA commencing a substantive review of our NDA, ACER-001 is one step closer to potentially providing an alternative treatment option for patients with UCDs," said Chris Schelling, Chief Executive Officer and Founder of Acer. "We look forward to working with the FDA during their review of our application. In addition, we continue to collaborate with our partners to ensure we are well positioned to support a successful commercial launch of ACER-001, subject to FDA approval.”

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, added, “Our collaboration with Acer is thriving and we are pleased with the progress they have made in advancing ACER-001. In parallel with Acer’s activities, we continue to execute on our global commercial strategy for ACER-001 which includes our intended submission of a Marketing Authorization Application (MAA) for the treatment of patients with UCDs in Europe in Q2/Q3 2022.”

Parties interested in the ACER-001 program for UCDs may sign up for updates at:
https://www.acertx.com/rare-disease-research/acer-001-for-urea-cycle-disorders-ucds/

ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority. There is no guarantee that this product candidate will receive regulatory authority approval in any territory or become commercially available for the indications under investigation.

About UCDs

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2 The current treatment of patients with UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, frequency with which medication must be taken, required number of pills, and the high cost of the medication.3

About ACER-001

ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). The formulation is a multi-particulate dosage formulation for oral administration consisting of a core center, a layer of active drug, and a taste-masked coating designed to avoid the bitter taste of sodium phenylbutyrate in the mouth while quickly dissolving in the low pH of the stomach. Acer is also being developed for MSUD and has been granted orphan drug designation by the FDA for this indication. ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.

About Acer Therapeutics Inc.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief for development and commercialization of ACER-001. For more information, visit www.acertx.com.

About RELIEF THERAPEUTICS Holding SA

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs, a commercial infrastructure in selected European countries and an internal, R&D capability, which Relief hopes to leverage for both internal pipeline products as well as for third party product development on a fee for service basis.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit
www.relieftherapeutics.com. Follow Relief on LinkedIn.

References

1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

Acer Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

 

Acer Therapeutics and Relief Therapeutics Announce Issuance of U.S. Patent 11,154,521 Covering ACER-001 Formulation

Year ordering: 2021
Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Acer Therapeutics Inc.
Jim DeNike
This email address is being protected from spambots. You need JavaScript enabled to view it.
+1 844-902-6100

Investor relations:

RELIEF THERAPEUTICS Holding SA:

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Acer Therapeutics:
Hans Vitzthum
LifeSci Advisors
This email address is being protected from spambots. You need JavaScript enabled to view it.
+1 617-430-7578

Disclaimer:

Acer Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

Relief Forward-Looking Statements

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the FDA will approve Acer’s NDA for ACER-001, (ii) whether RELIEF THERAPEUTICS Holding SA will be able to submit an application for approval of ACER-001 in Europe in Q2/Q3 2022 or at all, (iii) whether any such application submitted to European authorities seeking marketing authorization for ACER-001 for the treatment of patients in Europe with UCDs will be approved, and (iv) those other risks, uncertainties and factors described in RELIEF THERAPEUTICS Holding SA’s annual and periodic filings with the SIX Stock Exchange, all of which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 211026_ACER001 patent issuance
Attachment (PDF): 20211026_ad_hoc_Relief_acer-001_patent_issuance.pdf

Acer Therapeutics and Relief Therapeutics Announce Issuance of U.S. Patent 11,154,521 Covering ACER-001 Formulation

Key ACER-001 formulation composition of matter patent strengthens proprietary position in U.S. until 2036

NEWTON, MA and GENEVA, SWITZERLAND – October 26, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced that the U.S. Patent and Trademark Office (USPTO) has issued a new U.S. patent to Acer for certain claims related to ACER-001 (sodium phenylbutyrate). Patent 11,154,521 covers pharmaceutical composition claims related to ACER-001’s taste-masked, multi-particulate dosage formulation for oral administration. The newly issued patent has an expiration date in 2036.

“We are extremely pleased that our ACER-001 formulation patent has been issued, adding key protection to our growing intellectual property portfolio for ACER-001 as we continue to advance its development to potentially treat patients with Urea Cycle Disorders (UCDs), Maple Syrup Urine Disease (MSUD) and other possible indications,” said Jeff Davis, Chief Business Officer at Acer. “This patent issuance is an important step in our pursuit of possible ACER-001 commercialization, and we intend to submit it for listing by the U.S. Food and Drug Administration (FDA) in its Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, should ACER-001 receive marketing approval.”

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, added, “In parallel to the patent application efforts in the U.S., Acer and Relief are pursuing similar claims in the European Patent Office to cover ACER-001 as we continue to execute on our plan to submit a Marketing Authorization Application for ACER-001 for the treatment of patients with UCDs in Europe in Q2/Q3 2022.”

Parties interested in the ACER-001 program for UCDs may sign up for updates at:
https://www.acertx.com/rare-disease-research/acer-001-for-urea-cycle-disorders-ucds/

ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority. There can be no assurance that this product candidate will receive regulatory authority approval for marketing in any territory or become commercially available for the indications under investigation.

About UCDs

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2 The current treatment of patients with UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, frequency with which medication must be taken, required number of pills, and the high cost of the medication.3

About ACER-001

ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). The formulation is a multi-particulate dosage formulation for oral administration consisting of a core center, a layer of active drug, and a taste-masked coating designed to avoid the bitter taste of sodium phenylbutyrate in the mouth while quickly dissolving in the low pH of the stomach. The ACER-001 NDA for UCDs is currently under FDA review with a PDUFA target action date of June 5, 2022. ACER-001 is also being developed for MSUD and has been granted orphan drug designation by the FDA for this indication. ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.

About Acer Therapeutics Inc.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief for development and commercialization of ACER-001. For more information, visit www.acertx.com.

About RELIEF THERAPEUTICS Holding SA

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit
www.relieftherapeutics.com. Follow Relief on LinkedIn.

References
1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

Acer Therapeutics and Relief Therapeutics Announce Presentation of ACER-001 Data at the Society for Inherited Metabolic Disorders Annual Meeting

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CORPORATE CONTACTS

Acer Therapeutics: Jim DeNike
Acer Therapeutics Inc. This email address is being protected from spambots. You need JavaScript enabled to view it. +1 844-902-6100

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

INVESTOR RELATIONS CONTACTS

Acer Therapeutics:
Hans Vitzthum
LifeSci Advisors This email address is being protected from spambots. You need JavaScript enabled to view it. +1 617-430-7578

Foot notes:
 
12 April 2022
Attachment Name: Ad Hoc_Relief_ACER-001 SIMD
Attachment (PDF): Ad_Hoc_Relief_ACER-001_SIMD.pdf

Acer Therapeutics and Relief Therapeutics Announce Presentation of ACER-001 Data at the Society for Inherited Metabolic Disorders Annual Meeting

NEWTON, MA and GENEVA, SWITZERLAND – April 12, 2022 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, Relief Therapeutics Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), today announced the presentation of data evaluating the bioavailability, bioequivalence and taste attributes of taste-masked sodium phenylbutyrate (ACER-001) compared to sodium phenylbutyrate (BUPHENYL®) powder during poster sessions at the recent Society for Inherited Metabolic Disorders (SIMD) Annual Meeting on April 10-13, 2022 in Orlando, Florida.

“These data further support our belief that, if approved, ACER-001 could offer an alternative to current therapies that may lead to meaningful clinical outcomes in UCDs patients,” said Adrian Quartel, MD, CMO of Acer. “We are pleased with the outcomes of these studies and look forward to presenting them at future conferences.”

“We are highly encouraged by the results of these bioavailability, bioequivalence and taste attribute studies of ACER-001,” added Raghuram (Ram) Selvaraju, Chairman of Relief. “We look forward to the U.S. Food and Drug Administration’s decision on the Prescription Drug User Fee Act (PDUFA) target action date on June 5, 2022.”

ACER-001 Data Presented at SIMD

A copy of each poster presentation from the SIMD Meeting is available on Acer’s website at:https://www.acertx.com/publications-and-presentations/

The Pharmacokinetics of Taste-Masked Sodium Phenylbutyrate (ACER-001) for the Treatment of Urea Cycle Disorders Under Fasting and Fed Conditions in Healthy Volunteers1
This poster summarizes results from two Phase 1 bridging studies that evaluated the bioavailability and bioequivalence of taste-masked sodium phenylbutyrate (ACER-001) compared to sodium phenylbutyrate (BUPHENYL®) powder. The objectives of the two studies were to determine the bioequivalence of taste-masked sodium phenylbutyrate (ACER-001) administered as a suspension relative to sodium phenylbutyrate (BUPHENYL®) powder administered as a solution in healthy adult volunteers after a single dose under fasting and fed conditions, and to assess the effect of a high-fat meal on the pharmacokinetics (PK) of taste-masked sodium phenylbutyrate (ACER-001).

The data presented concluded that taste-masked sodium phenylbutyrate (ACER-001) was bioequivalent to sodium phenylbutyrate (BUPHENYL®) powder under both fed and fasting conditions. Higher levels of phenylbutyrate (PBA) and phenylacetate (PAA), a conjugate base of phenylacetic acid, were observed when taste-masked sodium phenylbutyrate (ACER-001) was administered under fasting versus fed conditions. A similar reduction in the PK of sodium phenylbutyrate (BUPHENYL®) powder under fed conditions was observed between the fasted and fed studies. Adverse events in these studies showed no major safety signals and were similar to sodium phenylbutyrate (BUPHENYL®).
These studies suggest investigating administration of nitrogen scavengers under fasting conditions, which may ultimately provide lower dose options and increase dosing flexibility.

Taste-Masked Coating of Sodium Phenylbutyrate (ACER-001) Improves the Palatability of Sodium Phenylbutyrate for Treatment of Urea Cycle Disorders2
The second poster presented at SIMD details results from two Phase 1, open-label, repeated measures, taste assessment studies of taste-masked sodium phenylbutyrate (ACER-001) and sodium phenylbutyrate (BUPHENYL®) powder. The studies included healthy panelists who were required to complete a training program for a minimum of 6 months that educated panelists on the identification, description, and quantification of sensory attributes of products.

The objective of the two taste assessment studies was to identify and quantify the intensity of perceived flavor attributes of taste-masked sodium phenylbutyrate (ACER-001) relative to sodium phenylbutyrate (BUPHENYL®) powder. Results from both studies concluded that taste-masked sodium phenylbutyrate (ACER-001) was shown to have overall lower flavor intensity scores than sodium phenylbutyrate (BUPHENYL®) powder when administered within five minutes of preparation.

About UCDs

The urea cycle is a series of biochemical reactions that occur primarily in the liver, which converts toxic ammonia produced by the breakdown of protein and other nitrogen-containing molecules in the human body into urea for excretion. UCDs are a group of disorders caused by genetic mutations that result in a deficiency in any one of the six enzymes or two of the amino acid transporters, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.

Medications for UCDs are primarily comprised of nitrogen scavenger drugs, which are substances that provide alternative excretion pathways for nitrogen by bypassing the urea cycle. The use of these alternative pathways for nitrogen removal is important for the management of acute episodes of hyperammonemia and are also included as part of a long-term treatment regimen for UCDs patients. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports3, while nitrogen scavenging medications are effective in helping to manage UCDs, non- compliance with treatment is common. Reasons given for non-compliance include the unpleasant taste associated with some available medications, the frequency with which medication must be taken and the high cost of the medication.

About ACER-001

ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). ACER-001’s multi-particulate dosage formulation for oral administration is designed to minimize the aversive taste and odor4 of sodium phenylbutyrate while quickly dissolving in the stomach. The ACER-001 NDA for UCDs is currently under FDA review with a PDUFA target action date of June 5, 2022. ACER-001 is also being developed for MSUD and has been granted orphan drug designation by the FDA for this indication. ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.

About Acer Therapeutics Inc.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVOTM (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief for development and commercialization of ACER-001. For more information, visit www.acertx.com.

About RELIEF THERAPEUTICS Holding SA

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100® (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.

References
1. Steiner R, et al. The Pharmacokinetics of Taste-Masked Sodium Phenylbutyrate (ACER-001) for the Treatment of Urea Cycle Disorders Under Fasting and Fed Conditions in Healthy Volunteers. SIMD April 2022.
2. Cedarbaum S, et al. Taste-Masked Coating of Sodium Phenylbutyrate (ACER-001) Improves the Palatability of Sodium Phenylbutyrate for Treatment of Urea Cycle Disorders. SIMD April 2022.
3. Shchelochkov et al. Molecular Genetics & Metabolism Reports 8 (2016) 43-47.
4. Peña-Quintana L, et al. Profile of sodium phenylbutyrate granules for the treatment of urea-
cycle disorders: patient perspectives. Patient Prefer Adherence. 2017 Sep 6;11:1489-1496.

Acer Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines for clinical study enrollment or regulatory actions, or otherwise, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions for ACER-001, ACER-801, EDSIVOTM or our other products; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

Relief Forward-Looking Statements
This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the FDA will approve Acer’s NDA for ACER-001, (ii) whether RELIEF THERAPEUTICS Holding SA will be able to submit an application for approval of ACER-001 in Europe in Q2/Q3 2022 (or at all), (iii) whether any such application submitted to European authorities seeking marketing authorization for ACER-001 for the treatment of patient in Europe with UCDs will be approved, and (iv) those other risks, uncertainties and factors described in RELIEF THERAPEUTICS Holding SA’s press releases and filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission, all of which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Acer Therapeutics and Relief Therapeutics Announce Presentation of Four ACER-001 Posters at the Upcoming SIMD and GMDI Conferences

Year ordering: 2022
Media Contact:

 RELIEF THERAPEUTICS Holding SA

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Acer Therapeutics Inc.
Jim DeNike
This email address is being protected from spambots. You need JavaScript enabled to view it.
+1 844-902-6100

Investor relations:

RELIEF THERAPEUTICS Holding SA:

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Acer Therapeutics:
Hans Vitzthum
LifeSci Advisors
This email address is being protected from spambots. You need JavaScript enabled to view it.
+1 617-430-7578

Disclaimer:

Acer Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and 10-Q/A, and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

Relief Forward-Looking Statements

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the FDA will approve Acer’s NDA for ACER-001, (ii) whether RELIEF THERAPEUTICS Holding SA will be able to submit an application for approval of ACER-001 in Europe in Q2/Q3 2022 (or at all), (iii) whether any such application submitted to European authorities seeking marketing authorization for ACER-001 for the treatment of patient in Europe with UCDs will be approved, (iv) whether RLF-100 (aviptadil) will receive emergency use authorization in the United States, (v) whether RLF-100 (aviptadil) will ever be submitted for authorization in Europe, (vi) whether RELIEF THERAPEUTICS Holding SA’s ongoing disputes with its U.S. collaboration partner for RLF-100 (aviptadil) can be resolved amicably, and (vii) those other risks, uncertainties and factors described in RELIEF THERAPEUTICS Holding SA’s press releases, periodic filings with the SIX Stock Exchange, all of which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Foot notes:

References
1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.
4. Peña-Quintana L, et al. Profile of sodium phenylbutyrate granules for the treatment of urea-cycle disorders: patient perspectives. Patient Prefer Adherence. 2017 Sep 6;11:1489-1496.

Attachment Name: 220127_Relief_ACER001 posters
Attachment (PDF): 20220127_ad_hoc_Relief_Acer001_posters.pdf

Acer Therapeutics and Relief Therapeutics Announce Presentation of Four ACER-001 Posters at the Upcoming SIMD and GMDI Conferences

Data to be presented suggests ACER-001 could represent a potential alternative to sodium and glycerol phenylbutyrate for treatment of UCDs

NEWTON, MA and GENEVA, SWITZERLAND – Jan. 27, 2022 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced the acceptance of four ACER-001 abstracts for poster presentations at the upcoming Society for Inherited Metabolic Disorders (SIMD) Annual Meeting on April 10-13, 2022 in Orlando, Florida, and the Genetic Metabolic Dieticians International (GMDI) Conference on May 4-7, 2022, in Las Vegas, Nevada. The ACER-001 New Drug Application (NDA) for urea cycle disorders (UCDs) is currently under U.S. Food and Drug Administration (FDA) review with a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022.

“Many UCDs patients currently taking nitrogen scavengers may struggle with elevated ammonia levels potentially associated with consequences of treatment non-compliance,” said Chris Schelling, Chief Executive Officer and Founder of Acer. “The data from our bioequivalence and taste assessment studies accepted for presentations at the SIMD and GMDI conferences further support our belief that, if approved, ACER-001 could offer an alternative to current therapies that may lead to meaningful clinical outcomes in UCDs patients.”

Raghuram (Ram) Selvaraju, Chairman of Relief, added, “The acceptance of ACER-001 data at these prestigious industry conferences is another important milestone for this potential treatment for patients with UCDs. We are highly encouraged by the continued progress of the ACER-001 program and look forward to the FDA’s decision on the PDUFA target action date in June.”

Details of the presentations are as follows:

2022 SIMD 43rd Annual Meeting

Title: The Pharmacokinetics of Taste-Masked Sodium Phenylbutyrate (Acer-001) for the Treatment of Urea Cycle Disorders Under Fasting and Fed Conditions in Healthy Volunteers
Presenter: Dr. Robert Steiner
Poster #: 84
Date/Time: April 11, 2022; 7:00-8:00 pm ET

Title: Taste-Masked Coating of Sodium Phenylbutyrate (Acer-001) Improves the Palatability of Sodium Phenylbutyrate for Treatment of Urea Cycle Disorders
Presenter: Dr. Stephen Cederbaum
Poster #: 18
Date: April 11, 2022; 7:00-8:00 pm ET

Additionally, Acer is sponsoring a lunchtime symposium at SIMD on April 12th at 12:45 pm ET. The symposium, entitled: “Addressing Unmet Needs in Screening, Diagnosis, Therapeutics and Advocacy for Urea Cycle Disorders (UCDs),” will be hosted by Robert D Steiner, MD, FAAP, FACMG; Professor (Clinical) University of Wisconsin; Editor in Chief of Genetics in Medicine; Wisconsin Newborn Screening Program Medical Consultant; and Chief Medical Officer of PreventionGenetics.

2022 GMDI Conference

Title: ACER-001: a Potential Alternative to Sodium and Glycerol Phenylbutyrate for Treatment of Urea Cycle Disorders
Presenter: Dr. Robert Steiner
Poster #: 26
Date: May 5, 2022; 5:30-7:00 pm PT

Title: Taste-masked Coating of Sodium Phenylbutyrate (ACER-001) Improves the Palatability of Sodium Phenylbutyrate for Treatment of Urea Cycle Disorders
Presenter: Dr. Stephen Cederbaum
Poster #: 10
Date/Time: May 5, 2022; 5:30-7:00 pm PT

Additionally, Acer is sponsoring a breakfast symposium at GMDI on May 5th at 7:00 am PT. The symposium, entitled: “Energy and Protein Needs in UCD Patients: What We Know and What We Need to Know to Move Towards Personalized Care,” will be hosted by Deborah Geary Hook, MPH, RDN, FAND, PhDc. PhD Candidate, University of California, Davis.

Parties interested in the ACER-001 program for UCDs may sign up for updates at:
https://www.acertx.com/rare-disease-research/acer-001-for-urea-cycle-disorders-ucds/

About UCDs

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2 The current treatment of patients with UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports3, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include aversive taste and odor4, frequency with which medication must be taken, required number of pills, and the high cost of the medication.

About ACER-001

ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). ACER-001’s multi-particulate dosage formulation for oral administration is designed to minimize the aversive taste and odor4 of sodium phenylbutyrate while quickly dissolving in the stomach. The ACER-001 NDA for UCDs is currently under FDA review with a PDUFA target action date of June 5, 2022. ACER-001 is also being developed for MSUD and has been granted orphan drug designation by the FDA for this indication. ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.

About Acer Therapeutics Inc.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief for development and commercialization of ACER-001. For more information, visit www.acertx.com.

About RELIEF THERAPEUTICS Holding SA

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Finally, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

Acer Therapeutics and Relief Therapeutics Announce Submission of a New Drug Application to the U.S. FDA for ACER-001 for Treatment of Urea Cycle Disorders

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG and its businesses. The results reported herein may or may not be indicative of the results of future and larger clinical trials for ACER-001 for the treatment of UCDs and MSUD, nor whether the ongoing clinical trials of Relief’s lead compound, RLF-100™ (aviptadil) in advanced clinical development to treat respiratory deficiency due to COVID-19, will be successful. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 8.9.21 Relief and Acer announce submission of NDA
Attachment (PDF): 210809_Relief_Acer-001_NDA_Submission.pdf

Acer Therapeutics and Relief Therapeutics Announce Submission of a New Drug Application to the U.S. FDA for ACER-001 for Treatment of Urea Cycle Disorders

NEWTON, MA and GENEVA, SWITZERLAND – August 9, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, and RELIEF THERAPEUTICS Holding AG  (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ACER-001 (sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs).  ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).

Based on standard FDA review timelines, Acer expects to receive notification from FDA on the potential acceptance of the NDA for filing within 60 days of submission and subsequent substantive review.

The 505(b)(2) NDA submission is supported by results from two previously announced bioequivalence (BE) trials in which ACER-001 showed similar relative bioavailability for both phenylbutyrate (PBA) and phenylacetate (PAA), the active metabolite of sodium phenylbutyrate, compared to BUPHENYL® (sodium phenylbutyrate). Acer has also received an Agreement Letter from FDA in response to the Company’s initial Pediatric Study Plan (iPSP) which outlines an agreed upon approach that addresses the needs of pediatric patients with UCDs.

“The submission of our NDA for ACER-001 marks an important step toward bringing this potential alternative treatment option to patients with UCDs,” said Chris Schelling, Chief Executive Officer and Founder of Acer. “We look forward to working with the FDA through the review process and will continue advancing our preparations for a potential launch of ACER-001, while also assisting Relief toward regulatory submissions in Europe.”

Jack Weinstein, Chief Financial Officer and Treasurer of Relief Therapeutics, added, “We are excited about the progress made to date in support of a potential regulatory approval of ACER-001 for UCDs in the U.S. With the NDA now submitted, we will continue our efforts to back ACER-001’s development in Europe by targeting submission of a Marketing Authorization Application (MAA) for the treatment of UCDs in Europe by the end of 2021.”

ACER-001 is an investigational product candidate which has not been approved by FDA or the European Medicines Agency (EMA). There is no guarantee that this product candidate will be accepted for substantive review, or if accepted, receive regulatory authority approval in any territory, or become commercially available for the indications under investigation.

ABOUT UCDS

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms (1,2). The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate (GPB) and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, frequency with which medication must be taken, required number of pills, and the high cost of the medication (3).

ABOUT ACER-001

ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). The formulation is a multi-particulate dosage formulation for oral administration consisting of a core center, a layer of active drug, and a taste-masked coating designed to avoid the bitter taste in the mouth while quickly dissolving in the low pH of the stomach. ACER-001’s taste-masked formulation is aimed to improve the palatability of sodium phenylbutyrate. Acer is also being developed for Maple Syrup Urine Disease (MSUD) and has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is an investigational product candidate which has not been approved by FDA or the European Medicines Agency (EMA).

ABOUT ACER THERAPEUTICS INC.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief Therapeutics for development and commercialization of ACER-001. For more information, visit www.acertx.com.

ABOUT RELIEF THERAPEUTICS HOLDING AG

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.

REFERENCESREFERENCES

1.Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.

2.Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).

3.Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

ACER FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

Acer Therapeutics Receives Notice of Allowance of Key U.S. Patent Application Covering ACER-001 Formulation

Year ordering: 2021
Media Contact:

 

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
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Acer Therapeutics Inc.
Jim DeNike
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Investor relations:

RELIEF THERAPEUTICS Holding SA:

Rx Communications Group
Michael Miller
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Hans Vitzthum
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the FDA will approve Acer’s NDA for ACER-001, (ii) whether RELIEF THERAPEUTICS Holding SA will be able to submit an application for approval of ACER-001 in Europe in Q2/Q3 2022 (or at all), (iii) whether any such application submitted to European authorities seeking marketing authorization for ACER-001 for the treatment of patient in Europe with UCDs will be approved, (iv) whether RLF-100 (aviptadil) will receive emergency use authorization in the United States, (v) whether RLF-100 (aviptadil) will ever be submitted for authorization in Europe, (vi) whether RELIEF THERAPEUTICS Holding SA’s ongoing disputes with its U.S. collaboration partner for RLF-100 (aviptadil) can be resolved amicably, and (vii) those other risks, uncertainties and factors described in RELIEF THERAPEUTICS Holding SA’s annual and periodic filings with the SIX Stock Exchange, all of which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 211007_Relief_ACER001 Notice of Allowance
Attachment (PDF): 20211007_ad_hoc_Relief__ACER-001_ip-notice-allowance.pdf

Acer Therapeutics Receives Notice of Allowance of Key U.S. Patent Application Covering ACER-001 Formulation

Notice of allowance of ACER-001 formulation composition of matter patent application strengthens proprietary position in U.S. until 2036

NEWTON, MA and GENEVA, SWITZERLAND – October 7, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Acer’s patent application No. 17/196,416 for certain claims related to ACER-001 (sodium phenylbutyrate). The allowed patent claims in the application titled, “Palatable Compositions Including Sodium Phenylbutyrate and Uses Thereof,” include pharmaceutical composition claims covering ACER-001’s taste-masked, multi-particulate dosage formulation for oral administration.

The USPTO issues a patent Notice of Allowance after it determines a patent should be granted upon completion of any outstanding administrative requirements. Acer’s patent is expected to be issued in the fourth quarter of 2021 and expire in 2036. If it receives marketing approval for ACER-001, Acer intends to submit the patent for listing by the U.S. Food and Drug Administration (FDA) in its Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

“We are extremely pleased to have received this Notice of Allowance from the USPTO for our proprietary formulation of ACER-001 as we continue to advance its development to potentially treat patients with Urea Cycle Disorders (UCDs), Maple Syrup Urine Disease (MSUD) and other possible indications,” said Jeff Davis, Chief Business Officer at Acer. “This Notice marks another important milestone in our pursuit of possible ACER-001 commercialization while we prepare to bring this treatment to UCDs patients, subject to FDA’s approval of our ACER-001 New Drug Application.”

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, added, “In parallel to the patent application efforts in the U.S., Acer and Relief are pursuing similar claims in the European Patent Office to cover ACER-001 as we continue to execute on our plan to submit a Marketing Authorization Application for ACER-001 for the treatment of patients with UCDs in Europe in Q2/Q3 2022.”

Parties interested in the ACER-001 program for UCDs may sign up for updates at:
https://www.acertx.com/rare-disease-research/acer-001-for-urea-cycle-disorders-ucds/

ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority. There can be no assurance that this product candidate will receive regulatory authority approval for marketing in any territory or become commercially available for the indications under investigation.

About UCDs

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2 The current treatment of patients with UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, frequency with which medication must be taken, required number of pills, and the high cost of the medication.3

About ACER-001

ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). The formulation is a multi-particulate dosage formulation for oral administration consisting of a core center, a layer of active drug, and a taste-masked coating designed to avoid the bitter taste of sodium phenylbutyrate in the mouth while quickly dissolving in the low pH of the stomach. The ACER-001 NDA for UCDs is currently under FDA review with a PDUFA target action date of June 5, 2022. ACER-001 is also being developed for MSUD and has been granted orphan drug designation by the FDA for this indication. ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.

About Acer Therapeutics Inc.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief for development and commercialization of ACER-001. For more information, visit www.acertx.com.

About RELIEF THERAPEUTICS Holding SA

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs, a commercial infrastructure in selected European countries and an internal R&D capability, which Relief hopes to leverage for both internal pipeline products as well as for third party product development on a fee for service basis.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit
www.relieftherapeutics.com. Follow Relief on LinkedIn.

References
1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

Acer Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

Relief and AdVita Close Definitive Agreement for Relief to Acquire All Outstanding Shares of AdVita

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
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Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG and its business. There can be no assurance that Relief will successfully develop the inhaled formulation of aviptadil for any indication nor that aviptadil will ultimately be approved for marketing in any country. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 20210728_Relief and Advita Closing
Attachment (PDF): 210728_ad_hoc_Relief_AdVita_Closing.pdf

Relief and AdVita Close Definitive Agreement for Relief to Acquire All Outstanding Shares of AdVita

Acquisition Expands Scope of Development of Inhaled Formulation of Aviptadil

Geneva, Switzerland, July 28, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that it has closed a definitive agreement to acquire all outstanding shares of AdVita Lifescience GmbH ("AdVita"), a Germany-based, privately held pharmaceutical company developing effective products and strategies to improve the treatment and diagnosis of rare lung diseases.

With the acquisition, Relief has gained additional pending intellectual property rights that may cover RLF-100TM inhaled formulation specifications and the potential application of inhaled aviptadil for the treatment of lung diseases such as acute respiratory distress syndrome (ARDS), pulmonary sarcoidosis and checkpoint inhibitor-induced pneumonitis (CIP).

Under the terms of the agreement, Relief paid AdVita shareholders a total of 135,741,063 Relief common shares, representing EUR 25 million in value based on a 60-day Volume-Weighted Average Price (VWAP) of Relief’s common stock, to acquire all outstanding shares of AdVita. In addition, Relief will pay milestone payments of up to EUR 20 million in cash, contingent to achievement of certain regulatory milestones related to AdVita’s development programs.

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, said: "We are pleased to close this acquisition, which brings to Relief additional intellectual property concerning inhaled formulations of aviptadil.  In addition, the AdVita team has strong expertise with aviptadil that has already been extremely helpful as we advance our plans for the development of the inhaled formulation of RLF-100™ for the prevention of COVID-19-related ARDS, as well as other potential lung diseases."

Wolfgang Hoppe, Chief Executive Officer of AdVita, commented: "We are delighted to join the Relief team and are excited about working together to develop inhaled aviptadil with the goal of bringing it to patients with respiratory diseases where there is a need for better treatment options."

In April, Relief and AdVita initiated an investigator-sponsored phase 2 trial with inhaled aviptadil for the prevention of COVID-19-related acute respiratory distress syndrome. The study, “Inhaled aviptadil for the Prevention of COVID-19 Related ARDS” (NCT 04536350), is a randomized, double-blind, placebo-controlled phase 2 trial being conducted at major clinical sites in Switzerland.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Announces Issuance of Shares from Authorized Capital as Approved by 2021 Annual General Meeting

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding whether its collaboration partner’s application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Capital Increase
Attachment (PDF): 210722_ad_hoc_PR_share_capital_issuance_ENG.pdf

Relief Announces Issuance of Shares from Authorized Capital as Approved by 2021 Annual General Meeting

  • Shares being used in part for payments related to AdVita and APR acquisitions
  • Acquisitions are part of Relief’s transformation into a fully integrated diversified commercial-stage pharmaceutical company

Geneva, Switzerland, July 22, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief” or the “Company”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the Company will, on or around July 27, 2021, issue 1,000,000,000 additional registered shares out of the authorized share capital approved by the Annual General Meeting on June 18, 2021. The new shares are fully subscribed at par value by the Company’s wholly owned subsidiary, Relief Therapeutics International SA, and will be listed on the SIX Swiss Exchange on or around July 28, 2021. Some of the shares will be used for contractually agreed payments to the respective sellers of AdVita Lifescience GmbH (“AdVita”) and APR Applied Pharma Research SA (“APR”): approximately 140,000,000 shares and 206,786,784 shares, respectively. The remaining new shares will be held as treasury shares for possible future financing transactions, acquisitions, general corporate purposes, and the settlement of possible future contingent milestone payments to the APR and AdVita sellers. The APR sellers are generally subject to a 75-day lock-up period and a subsequent leak-out schedule.

Jack Weinstein, CFO and Treasurer of Relief, said: “During the course of 2021, we have taken several important steps to transform Relief into a multi-product, revenue-generating company. One critical component of that was the recently closed acquisition of APR, which brings us a diverse pipeline, including market-stage products, and provides a commercial springboard for future Relief product launches. We also are strengthening our intellectual property position with our lead candidate, RLF-100™ (aviptadil), through the planned acquisition of AdVita. We are also actively continuing to look for other opportunities as we build our business.”

The associated listing prospectus will be listed on the SIX Prospectus Office’s website and will be made available upon request once it has been approved by the SIX Swiss Exchange, which is expected on or around July 27, 2021.

###

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s acquisition of APR Applied Pharma Research brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Announces Receipt of U.S. FDA Orphan Drug Designation for the use of RLF-100 (aviptadil) in the Treatment of Sarcoidosis

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 8.3.21 Relief Therapeutics Sarcoidosis PR - FINAL
Attachment (PDF): 8.3.21_Relief_Therapeutics_Sarcoidosis_PR_-_FINAL.pdf

Relief Announces Receipt of U.S. FDA Orphan Drug Designation for the use of RLF-100 (aviptadil) in the Treatment of Sarcoidosis

Geneva, Switzerland, August 3, 2021 –RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief” or the "Company"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that, via its newly acquired subsidiary, AdVita Lifescience GmbH, the Company has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (“FDA”) for RLF-100 (aviptadil), an inhaled formulation in development for the treatment of sarcoidosis. RLF-100 is a synthetic form of vasoactive intestinal peptide. In open label exploratory clinical experience in sarcoidosis patients, RLF-100 has been shown to be well tolerated and safe, and to produce favorable immunoregulatory effects in the lungs that have been associated with symptom relief in a significant proportion of the patients.

“Receipt of our third Orphan Drug Designation is another important milestone for the Company, as it underscores the potential strength of our pipeline and the high need for better treatments for rare diseases such as sarcoidosis,” stated Raghuram (Ram) Selvaraju, Chairman of the Board of Directors of Relief. “The timing of this newest Orphan Drug Designation comes on the heels of our just closed acquisition of AdVita Lifescience GmbH and supplements those we have for our drug candidates for EB and PKU, which we added to our pipeline through our recent acquisition of APR Applied Pharma Research SA, consistent with our strategy to become a fully integrated diversified commercial-stage pharmaceutical company.”

Orphan Drug Designation is granted for products that are intended to treat life-threatening or chronically debilitating conditions affecting less than 200,000 patients in the U.S. and no more than five in 10,000 persons in the European Union. Further criteria include the potential of the product to provide significant patient benefit over available treatment, or to fill an unmet medical need where no treatment exists.

Orphan Drug Designation confers numerous benefits to the development of new products, including clinical protocol assistance and, upon marketing authorization, assures marketing exclusivity for a period of up to seven years in the U.S. and up to ten years in the EU once the medicine is on the market.

About Sarcoidosis

Sarcoidosis is a rare disease in which the inflammatory process involves the alveoli (air sacs), small bronchi, and small blood vessels. As the disease progresses, small lumps, or granulomas, appear in the affected tissues which tend to remain inflamed and become scarred (fibrotic). Granulomas are structured masses composed of activated immune cells (macrophages, lymphocytes, mast cells and fibroblasts). Many sarcoidosis patients are left with permanent lung damage as they undergo a chronic course where complications such as pulmonary fibrosis are common and irreversible. Currently there are about 140,000 sarcoidosis patients in the U.S.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and is quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Comments on Lawsuit Filed Against It by NeuroRx

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will be successful in its breach of contract action against NRx's subsidiary, NeuroRx, and NeuroRx's CEO, Jonathan Javitt, and in defending NeuroRx's recently filed lawsuit, (ii) whether the mediation will be successful, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NeuroRx lawsuit
Attachment (PDF): 20220112_ad_hoc_Relief_NeuroRx_Complaint.pdf

Relief Comments on Lawsuit Filed Against It by NeuroRx

Geneva, Switzerland, January 12, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that its collaboration partner with respect to aviptadil, NeuroRx, Inc. ("NeuroRx"), has filed a lawsuit against Relief in the Supreme Court of the State of New York, County of New York. NeuroRx's complaint alleges claims against Relief for breach of the collaboration agreement between the parties, for a declaration that the collaboration agreement has been cancelled, and for defamation. Relief believes that the collaboration agreement between the parties with respect to aviptadil remains in full force and effect, and that it is NeuroRx, and not Relief, that is in breach of that agreement.

Relief notes that NeuroRx's complaint includes numerous factual statements that Relief believes to be materially inaccurate. Relief also believes that the damages calculation alleged in NeuroRx's complaint is completely Illogical and unsupported. Relief reports that the allegations in NeuroRx's complaint will be responded to in an appropriate filing with the court after NeuroRx's complaint is served on Relief. While there can be no assurance, Relief remains confident in the validity of its claims against NeuroRx and Jonathan Javitt.

Finally, Relief reports that its previously announced mediation with NeuroRx, seeking to amicably resolve the litigation between the parties, remains scheduled for late February 2022 and that, notwithstanding the filing of the new complaint, Relief intends to participate in the upcoming mediation.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

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Relief Files Trademark Application for RLF-100TM With the U.S. Patent and Trademark Office

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Ad hoc_Relief_ RLF-100-TM
Attachment (PDF): Ad_hoc_Relief__RLF-100_TM.pdf

Relief Files Trademark Application for RLF-100TM With the U.S. Patent and Trademark Office

No Notice of Opposition or Extension Request has Been Received in Relation to the Application;
Certificate of Registration Expected by Late April

Geneva, Switzerland, February 8, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that it is has filed for a trademark for RLF-100TM with the United States Patent and Trademark Office (“USPTO”).

When the certificate of registration is received, the trademark will cover RLF-100 TM when used for pharmaceutical preparations and substances for the treatment of viral, metabolic, endocrine, musculoskeletal, cardiovascular, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmic, respiratory, neurological, gastrointestinal, hormonal, dermatological, psychiatric and immune system related diseases and disorders; pharmaceutical preparations for the treatment of viral diseases and; pharmaceutical preparations for the treatment of viral infections.

The trademark application (U.S. Serial Number 90141290) filed on August 27, 2020 was published for opposition on January 4, 2022. No party has filed an opposition or extension request with the USPTO within the required 30 days after the publication date. A certificate of registration is expected to be issued to Relief within 11 weeks from the publication date.

ABOUT RLF-100TM

RLF-100TM (aviptadil) is a synthetic form of Vasoactive Intestinal Peptide (“VIP”) consisting of 28 amino acids, which was first discovered in 1970. Although initially identified in the intestinal tract, human VIP is known to be produced throughout the body and to be primarily concentrated in the lungs where it has shown a multimodal mechanism of action: specifically, a decrease of inflammatory cytokines release leading to prevention of cytokine storm syndrome and viral replication, an immunomodulating effect, vasodilating and broncho-dilating effects, and prevention of surfactant depletion (surfactant coats the inside of the lungs, which can be lost during COVID-19 and lead to respiratory failure). Seventy percent of VIP in the body is bound to a less common type of cell in the lung, the alveolar type 2 cell, which is critical to the transmission of oxygen to the body.

RLF-100 TM has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, idiopathic pulmonary fibrosis, asthma, pulmonary arterial hypertension, and sepsis-induced acute respiratory distress syndrome. A combination of aviptadil with phentolamine is approved for the treatment of erectile dysfunction by intra-cavernous injections in countries outside the U.S.

RLF-100 TM is currently late-stage clinical testing in the U.S for acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) associated with the SARS-CoV-2 virus (COVID-19) through Relief’s collaboration partner in the U.S., NeuroRx, Inc. VIP has been granted Fast Track Designation by FDA for the treatment of critical COVID-19 patients with respiratory failure. Relief is also focused on RLF-100 TM for the treatment of, among other indications, COVID-19 non-acute lung injury, non-COVID-19 related ARDS, checkpoint inhibitor-induced pneumonitis and pulmonary sarcoidosis.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. In addition to RLF-100 TM , in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Finally, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

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Relief Provides Corporate Update and Outlines Plans to Advance its Diversified Portfolio of Pipeline Candidates, Including RLF-100™ (Aviptadil)

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
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Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA can obtain approval to market RLF-100™ (aviptadil) and the effect on its efforts in that regard of the pending lawsuit against NeuroRx and its CEO, (ii) whether ACER-001 will be approved for commercialization in the U.S. and successfully commercialized if approved, (iii) whether PKU GOLIKE® can be successfully marketed in the U.S., (iv) whether RELIEF THERAPEUTICS Holding SA has sufficient cash resources to fund its operations into late 2023 and whether RELIEF THERAPEUTICS Holding SA can become cash flow positive by 2024, (v) whether RELIEF THERAPEUTICS Holding SA will be able to transition its ADR program from a Level 1 program to a Level 2 or a Level 3 program and up list its ADRs to the NASDAQ Stock Market, and (vi) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief corporate update
Attachment (PDF): 20211111_ad_hoc_Relief_Corporate_Update.pdf

Relief Provides Corporate Update and Outlines Plans to Advance its Diversified Portfolio of Pipeline Candidates, Including RLF-100™ (Aviptadil)

Geneva, Switzerland, November 11, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today provided a corporate update detailing, among other matters, its ongoing clinical development and regulatory activities, as well as its plans to accelerate the maturation of its pipeline.

RLF-100™

Relief remains committed to the development of RLF-100™ (aviptadil) for the treatment of respiratory complications of COVID-19 infection. A clinical program remains under way in Europe for inhalation-based administration, while the ACTIVE-3b/TESICO study sponsored by the U.S. National Institutes of Health (“NIH”) assessing the intravenous formulation and the I-SPY trial sponsored by Quantum Leap testing the inhaled formulation also remain ongoing. Further, the parent company of Relief’s U.S. collaboration partner has publicly reported that they are continuing to conduct an investigational study of inhaled aviptadil in the U.S. as well. In addition, Relief continues to pursue aviptadil for the treatment of pulmonary sarcoidosis, and authorization to commence a phase 2 randomized, double-blinded, placebo-controlled clinical trial in this indication was recently granted by the German medical regulatory authorities. In August 2021, Relief announced the receipt of U.S. Orphan Drug Designation for the use of aviptadil in treatment of sarcoidosis. Relief also intends to explore the clinical utility of aviptadil in acute respiratory distress syndrome (“ARDS”) unrelated to COVID-19 infection, as well as in other pulmonary disorders, including chronic beryllium disease (“berylliosis”) and checkpoint inhibitor-induced pneumonitis (“CIP”), in which AdVita has filed pending patent claims. Finally, Relief is also working to optimize the formulation of aviptadil.

As previously reported, in October 2021 Relief filed a lawsuit against NeuroRx, Inc. ("NeuroRx") and its Chief Executive Officer, Dr. Jonathan Javitt, for multiple breaches of the Collaboration Agreement between Relief and NeuroRx relating to the development and commercialization of RLF-100™ (aviptadil). The complaint alleges, among other breaches of the Collaboration Agreement, that NeuroRx has failed to provide Relief with the full data set from NeuroRx's recently completed phase 2b/3 clinical trial evaluating IV RLF-100™ (aviptadil) for the treatment of acute respiratory failure due to COVID-19 (which data and information are required to be provided to Relief by NeuroRx under the Collaboration Agreement) and has failed to allow Relief to have input into NeuroRx's U.S. development program. Without doubt, Relief was disappointed that Emergency Use Authorization for aviptadil in the United States was denied. However, this decision by FDA does not affect Relief's commitment to the further development of this drug.

U.S. Commercial Initiatives

Relief is focused on establishing its U.S. commercial operations and initiating market rollout of its lead commercial product, PKU GOLIKE®, for the treatment of phenylketonuria (“PKU”). PKU GOLIKE® is a novel, proprietary next-generation prolonged-release amino acid mix for use as a mainstay of PKU therapy and is available in multiple formulations, including the innovative new PKU GOLIKE® KRUNCH™ tablets. Relief, through its wholly owned subsidiary, APR Applied Pharma Research SA ("APR"), currently markets this product in Europe. The initiative to market this product in the U.S. will be led by Relief's Head of U.S. Commercial Operations, Anthony M. Kim, who has a lengthy track record of successful commercialization of drugs aimed at rare and specialty disease indications in the U.S. market. Mr. Kim will be responsible for spearheading the creation of Relief’s U.S. commercial infrastructure and helping to optimize the introduction of the GOLIKE® product line.

Relief is also working closely with its collaboration partner Acer Therapeutics on the preparations for a potential launch of ACER-001, a proprietary, taste-masked formulation of sodium phenylbutyrate for the treatment of Urea Cycle Disorders (“UCDs”). ACER-001 is the subject of a New Drug Application (“NDA”) that has been accepted for review by the United States Food and Drug Administration (“FDA”) with a Prescription Drug User Fee Act (PDUFA) approval decision action date of June 5, 2022. Additionally, Relief is preparing to submit a Marketing Authorization Application (“MAA”) for ACER-001 to European and U.K. regulatory agencies, which is expected to be filed during the first half of 2022. Moreover, Relief intends to assess ACER-001 in a clinical program for Maple Syrup Urine Disease (“MSUD”) during 2022. Relief and Acer also continue to explore strategic options to advance the optimization of ACER-001’s commercial value in territories beyond the U.S., U.K. and Europe.

Other Initiatives

Relief intends to advance APR-TD011, a novel, proprietary, spray-based formulation of a hypotonic acid-oxidizing solution with established wound healing and anti-microbial properties, for epidermolysis bullosa (“EB”), a billion-dollar annual target market according to Knowledge Sourcing Intelligence. Relief believes that APR-TD011 could prove a transformative solution for EB patients, who suffer from debilitating pain due to large, chronic, constantly blistering skin wounds. APR-TD011 also inhibits the NF-kB pro-inflammatory pathway and by inactivating matrix metalloproteases, known to mediate wound inflammation. Relief believes that APR-TD011 could improve the quality of life of EB patients by accelerating wound healing and reducing the itching and pain linked to infections and inflammation.

Relief also possesses an array of other assets. These include SENTINOX, a novel nasal spray solution for upper airway infections with viral pathogens including the SARS-CoV-2 virus, the causal agent of COVID-19; Nexodyn AOS, an acid-oxidizing solution for treatment of chronic wounds (including foot ulcers); and the PHYSIOMIMIC platform-enabled amino acid-based product candidates for an array of rare metabolic disorders. Positive interim clinical data showing accelerated clearance of upper airway viral infection was recently reported for SENTINOX in a randomized, placebo-controlled clinical trial. SENTINOX was certified in Europe on February 16, 2021 as a Class III Medical Device (Certificate Nr. EPT 0477.MDD.21/4200.1).

Capital Resources

Relief currently has CHF45 million in cash, and, based on current financial current projections and available cash, expects that it has sufficient resources to fund operations into late 2023, assuming timely approval of ACER-001. Relief also expects that with a successful launch of ACER-001 and the potential expansion of its GOLIKE® franchise into the United States, Relief could achieve positive operating cash flow status during 2024. This could also be positively affected if Relief is successful in obtaining an approval to market RLF-100™.

Finally, in early November, Relief took the first step to establish a Level 1 American Depositary Receipt (ADR) program in the United States by filing a registration statement on Form F-6 with the U.S. Securities and Exchange Commission. It is expected that Relief's ADRs will begin trading in the over-the-counter (OTC) market at some point after its registration statement becomes effective. Relief's ADR program will complement its existing primary listing on the SIX Swiss Exchange. JPMorgan Chase Bank, N.A. has been appointed as the depositary bank for the Level 1 ADR program. This filing is the first step in a process through which Relief hopes to transition its ADR program from a Level 1 ADR program to a Level 2 or a Level 3 ADR program, with the ultimate goal of listing its ADRs on the NASDAQ Stock Market during the first half of 2022.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Receives Trademark Registration for RLF-100® From the U.S. Patent and Trademark Office

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Foot notes:
End of ad hoc announcement

show this
 
24 March 2022
Attachment Name: Ad hoc_Relief_ RLF-100 TM-1
Attachment (PDF): Ad_hoc_Relief__RLF-100_TM-1.pdf

Relief Receives Trademark Registration for RLF-100® From the U.S. Patent and Trademark Office

Geneva, Switzerland, March 24, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that, on March 22, 2022, it received the certificate of registration (Reg. No. 6,674,978) for a trademark for RLF-100®, from the United States Patent and Trademark Office (“USPTO”).

The trademark covers RLF-100 when used for pharmaceutical preparations and substances for the treatment of viral, metabolic, endocrine, musculoskeletal, cardiovascular, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmic, respiratory, neurological, gastrointestinal, hormonal, dermatological, psychiatric and immune system related diseases and disorders; pharmaceutical preparations for the treatment of viral diseases and; pharmaceutical preparations for the treatment of viral infections.

“Receipt of this trademark registration certificate for RLF-100, currently in late-stage development for a number of COVID-19 and non-COVID-19 related respiratory conditions, is very important to the company, in that it immediately strengthens, and will help to safeguard, our intellectual property position, globally,” stated Raghuram (Ram) Selvaraju, Chairman of Relief.

ABOUT RLF-100®

RLF-100® (aviptadil) is a synthetic form of Vasoactive Intestinal Peptide (“VIP”) consisting of 28 amino acids, which was first discovered in 1970. Although initially identified in the intestinal tract, human VIP is known to be produced throughout the body and to be primarily concentrated in the lungs where it has shown a multimodal mechanism of action: specifically, a decrease of inflammatory cytokines release leading to prevention of cytokine storm syndrome and viral replication, an immunomodulating effect, vasodilating and broncho-dilating effects, and prevention of surfactant depletion (surfactant coats the inside of the lungs, which can be lost during COVID-19 and lead to respiratory failure). Seventy percent of VIP in the body is bound to a less common type of cell in the lung, the alveolar type 2 cell, which is critical to the transmission of oxygen to the body.

RLF-100 has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, idiopathic pulmonary fibrosis, asthma, pulmonary arterial hypertension, and sepsis-induced acute respiratory distress syndrome. A combination of aviptadil with phentolamine is approved for the treatment of erectile dysfunction by intra-cavernous injections in countries outside the U.S.

RLF-100 is currently late-stage clinical testing in the U.S for acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) associated with the SARS-CoV-2 virus (COVID-19) through Relief’s collaboration partner in the U.S., NeuroRx, Inc. VIP has been granted Fast Track Designation by FDA for the treatment of critical COVID-19 patients with respiratory failure. Relief is also focused on RLF-100® for the treatment of, among other indications, COVID-19 non-acute lung injury, non-COVID-19 related ARDS, checkpoint inhibitor-induced pneumonitis and pulmonary sarcoidosis.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100® (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports Full-Year 2021 Results and Provides Corporate Update

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx will provide RELIEF THERAPEUTICS Holding SA with the data from its phase 2b/3 trial needed to seek approval of RLF-100 in the EU and UK, (ii) whether the phase 2 trial evaluating inhaled aviptadil for the treatment of sarcoidosis will be successful, (iii) whether RLF-100 will be granted EUA in the United States, (iv) whether the pending disputes between Relief and its U.S. collaboration partner, NeuroRx can be resolved, (v) whether inhaled aviptadil will ever be approved by the EU and/or the U.S. for the treatment of sarcoidosis or for any other indications, (vi) whether ACER-001 will be approved for commercialization by the FDA, and (vii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Foot notes:
End of ad hoc announcement

show this
 
31 March 2022
Attachment Name: Ad hoc_Relief_Full Year Results Release
Attachment (PDF): Ad_hoc_Relief_Full_Year_Results_Release.pdf

Relief Reports Full-Year 2021 Results and Provides Corporate Update

Geneva, Switzerland, March 31, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today reported its results for the full-year ended December 31, 2021 and provided a corporate update.

"2021 was a transformative year for Relief, marking a period during which we became a fully integrated, highly nimble, capital-efficient, commercial-stage biopharmaceutical company with operations in both Europe and the U.S. Importantly, we also launched a Level 1 ADR program in the U.S. and, in December, filed a Registration Statement to begin the process of moving to a Level 2 ADR program as part of our ongoing effort to up list to the Nasdaq Stock Market during the first half of 2022," stated Raghuram Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. "Operationally, our acquisition of APR Applied Pharma Research SA ("APR"), in June, immediately added a number of commercialized products, including PKU GOLIKE®, for the treatment of phenylketonuria ("PKU") and provided a European based commercial infrastructure that we will leverage for future product launches. We also plan to develop proprietary products, and third-party products on a fee for service basis under the APR umbrella and are confident that this strategy can generate meaningful additional revenue, going forward."

Dr. Selvaraju added, "Meanwhile, we continue to work closely with our partner, Acer Therapeutics Inc. ("Acer"), for a potential U.S. launch of ACER-001, a taste-masked, immediate-release, proprietary powder formulation of sodium phenylbutyrate (NaPB) to treat urea cycle disorders ("UCDs"). Acer has submitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") under the 505(b)(2) pathway for ACER-001 in UCDs, which was recently accepted for filing and with a Prescription Drug User Fee Act ("PDUFA") target action date of June 5, 2022. If approved, we anticipate U.S. commercialization in the second half of 2022. We also plan to submit a Marketing Authorization Application for approval of ACER-001 for the treatment of UCDs in the EU. Should we be granted approval, the drug will be marketed through APR’s commercial infrastructure. We also intend to assess ACER-001 in a clinical program for Maple Syrup Urine Disease ("MSUD") during 2022.

"Our 2021 acquisition of AdVita Lifescience GmbH ("AdVita") provided key pending intellectual property that may cover an improved inhaled formulation of RLF-100® (aviptadil), in development for several lung diseases, including acute respiratory distress syndrome (ARDS) and checkpoint inhibitor-induced pneumonitis (CIP), and, during the year, AdVita was granted Orphan Drug Designation ("ODD") by the FDA for inhaled RLF-100 for the treatment of pulmonary sarcoidosis. At the same time, an intravenous formulation of aviptadil continues to be evaluated as a treatment for severely ill COVID-19 patients in the ACTIVE-3b/TESICO study sponsored by the U.S. National Institutes of Health ("NIH"), while the inhaled formulation is in clinical trials for patients with critical COVID-19 and moderate and severe COVID-19 patients.

"The sheer growth of our pipeline and marketed products has necessitated the expansion of our management team and we were pleased to appoint Nermeen Varawalla, MD, PhD, to the position of Chief Medical Officer; Anthony M. Kim, as Senior Vice President and Head of U.S. Commercial Operations; and Christopher Wick, as Senior Director, Head of U.S. Sales. We ended the year on a strong financial footing with a cash position of CHF 44.8 million (U.S. $48.1 million) and a forecasted cash runway well into 2023. We expect that, with a successful launch of ACER-001 and the potential expansion of our PKU GOLIKE franchise into the U.S., Relief could achieve positive operating cash flow status during 2024. Today, we are a more mature, forward integrated, commercial-stage specialty drug company with a deep pipeline and multiple opportunities for growth and we will continue to evaluate in-licensing and acquisition opportunities to further expand and diversify our pipeline."

Key Clinical Development Highlights:

RLF-100® (aviptadil), IV

• In March 2021, the parent company, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx"), of Relief’s collaboration partner for RLF-100, NeuroRx, Inc. ("NeuroRx"), announced top-line 60-day results for the phase 2b/3 trial of RLF-100 (aviptadil) for the treatment of patients with critical COVID-19 respiratory failure. These findings formed the basis for NeuroRx’s Emergency Use Authorization ("EUA") application to the FDA, submitted in June 2021.
• In April 2021, NRx announced that RLF-100 had been selected for inclusion in ACTIV-3b/TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), an international, phase 3, multicenter clinical trial being sponsored by the NIH.
• In June 2021, NRx announced additional positive results from the RLF-100 U.S. Expanded Access Protocol ("EAP"). These EAP data were then submitted to the FDA and were characterized by NRx as "real world" evidence in support of the findings from the phase 2b/3 trial.
• In July 2021, NRx reported that it identified a statistically significant effect of RLF-100 in preventing the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. According to NRx, the data was collected as part of the ongoing U.S. phase 2b/3 trial and the findings were submitted to the FDA as a supplement to the pending EUA application.
• In July 2021, NRx announced the successful validation of the commercial formulation of RLF-100 for IV use, allowing for high volume manufacture, with an anticipated one year or greater stability, under appropriate storage conditions.
• In July 2021, NRx announced that the Nation of Georgia's Prime Minister and Minister of Health had issued an EUA for aviptadil.
• In August 2021, NRx provided a safety update on RLF-100 from the NIH sponsored ACTIV- 3b/TESICO study, noting that the study's Data Safety Monitoring Board ("DSMB") found no new safety concerns in the trial and recommended continued enrollment.
• In September 2021, Relief received scientific advice from the Medicines and Healthcare Products Regulatory Agency ("MHRA") in the United Kingdom relating to RLF-100, for the treatment of respiratory deficiency due to severe COVID-19. Relief also held discussions with the European Medicines Agency ("EMA") pertaining to the regulatory path forward for RLF-100 in the EU. Relief informed EMA that it would proceed with further dialogue with the MHRA once it has compiled critical information related to the study conduct, clinical data and the drug product.
• In September 2021, NRx announced top line data demonstrating improved outcomes at one year in highly comorbid patients with COVID-19, who were treated with RLF-100, providing a threefold, statistically significant increase in the likelihood of survival at one year. According to NRx, this was consistent with the increased odds of 60-day survival seen in the previously reported results from the phase 2b/3 randomized controlled trial of RLF-100.
• In October 2021, NRx announced that they had submitted a revised Investigational New Drug ("IND") module on the manufacturing of aviptadil to the FDA, containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply aviptadil on a commercial scale.
• In November 2021, NRx reported that it was declined its EUA by the FDA for the use of IV aviptadil for the treatment of acute respiratory failure due to critical COVID-19.
• In November 2021, NRx announced receipt of the FDA’s response to NRx’s October 8, 2021 submission of updated manufacturing information for aviptadil. According to NRx, the FDA review allowed for high volume production of aviptadil and also reported that the shelf life of aviptadil had been extended from 62 days to 150 days. In November 2021, NRx reported that the FDA had denied Breakthrough Therapy Designation for aviptadil.
• In November 2021, NRx reported that it had completed an analysis to identify clinical evidence that indicates a substantial improvement after treatment with aviptadil in patients with Critical COVID-19 and Respiratory Failure over existing therapies, such as remdesivir. Conducted by Prof. David Schoenfeld, who, according to NRx, is one of the world’s most widely published statisticians with unique expertise in life-threatening diseases of the lung, the analysis examined the subgroup of patients in the COVID-AIV trial (NCT 04311697) that remained in respiratory failure, despite treatment with remdesivir. According to NRx, the analysis identified a statistically significant (P=.03) 2.5-fold increased odds of being alive and free of respiratory failure at the 60 days primary endpoint and a statistically significant (P=.006) four-fold higher odds of being alive at day 60 among patients treated with aviptadil compared to those treated with placebo.
• In December 2021, NRx announced it had agreed with Hungarian Health Officials on a regulatory path for emergency use of aviptadil in the Central European region, beginning with a compassionate care program.
• In January 2022, NRx announced that it had submitted another application to the FDA seeking EUA for the use of aviptadil to treat patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy, including remdesivir, and who are ineligible for enrollment into the ACTIV-3b/TESICO NIH-sponsored trial.
• In January 2022, NRx announced enhancements to its Expanded Access and Right to Try programs. NRx stated that these programs enable patients with respiratory failure from COVID-19, who have tried all approved medicines, including remdesivir, and who are not able to participate in a clinical study, to receive aviptadil upon a physician’s prescription. NRx has also reported that it is making aviptadil available as an investigational medicine under the Federal Right to Try Act.
• In February 2022, NRx announced results of a review conducted by the DSMB of the National Institute of Allergy and Infectious Diseases of the NIH on February 14, 2022. According NRx, the DSMB reviewed data on 448 ICU patients with Critical COVID-19 Respiratory Failure who were enrolled in the ACTIV-3b/TESICO trial. NRx reported that no new safety concerns were identified and the study was cleared to continue enrollment to 640 patients. NRx also stated that the TESICO protocol was submitted by NIH and cleared by the FDA as a phase 3 trial that, if positive, may be used in the submission of a NDA for aviptadil.
• In March 2022, Relief received a certificate of registration (Reg. No. 6,674,978) for a trademark for RLF-100 from the United States Patent and Trademark Office ("USPTO"), covering RLF-100 for a broad range of diseases.
• In March 2022, NRx reported that, in light of their strategic focus and the ongoing hostilities in Eastern Europe, it is no longer pursuing opportunities in the Nation of Georgia or elsewhere in the Caucuses region or Europe. They further reported that they have not sold any doses under their previously reported EUA in Georgia.

RLF-100® (aviptadil), Inhaled

• In January 2021, a clinical trial participation agreement for the inclusion of an inhaled formulation of RLF-100 into the I-SPY COVID-19 clinical trial was signed between NeuroRx and Quantum Leap Healthcare CollaborativeTM of San Francisco, for a phase 2 adaptive platform trial (NCT04488081) aimed at improving treatment for severely and critically ill COVID-19 patients, which began treating patients in July 2021
• In January 2021, Relief and the former shareholders of AdVita signed a binding term sheet for Relief to acquire all shares of AdVita, giving Relief access to all of AdVita’s assets including further pending IP rights that may cover RLF-100 inhaled formulation specifications for its potential application in the treatment of lung diseases such as ARDS, pulmonary sarcoidosis and CIP. The acquisition closed in July 2021.
• In April 2021, Relief and AdVita announced the initiation of an investigator-sponsored, randomized, double-blind, placebo-controlled phase 2 trial (NCT 04536350) evaluating the inhaled formulation of RLF-100 for the prevention of COVID-19-related ARDS.
• In August 2021, Relief received ODD from the FDA for inhaled RLF-100, for the treatment of sarcoidosis, adding to existing ODD designations for APR-OD031 for PKU and APR-TD011 for epidermolysis bullosa.
• In September 2021, AdVita received regulatory clearance to commence a phase 2 clinical trial in Germany to evaluate inhaled aviptadil for the treatment of sarcoidosis.
• In December 2021, Relief reported that the Swiss Patent Office IPI had announced that it expected to conclude the patent application procedure by January 24, 2022 and to issue the patent entitled, "Vasoactive Intestinal Peptide (VIP) for the Use in the Treatment of Drug-induced Pneumonitis," as applied for by AdVita in 2020. In general, such patents are formally issued, at the earliest, one month after the conclusion of the patent examination procedure.

ACER-001

• In March 2021, Relief signed a Collaboration and License Agreement with Acer for the worldwide development and commercialization of ACER-001 for the treatment of UCDs and MSUD.
• In October 2021, the FDA accepted Acer’s NDA for ACER-001, submitted in August 2021 under the Section 505(b)(2) regulatory pathway, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022. Relief believes that, if approved, ACER-001 could be available commercially in the U.S. during 2022.
• In October 2021, Acer was issued patent No. 17/196,416 by the USPTO, for certain claims related to ACER-001, covering ACER-001’s taste-masked, multi-particulate dosage formulation for oral administration, providing intellectual property protection into 2036.

APR Applied Pharma Research SA

In May 2021, Relief and the former shareholders of APR signed a binding term sheet for Relief to acquire all of the outstanding shares of APR, a privately held Swiss pharmaceutical company with over 25 years' experience in identifying, developing and commercializing known molecules engineered with drug delivery systems in niche and rase diseases on a global basis. The transaction closed in June 2021.
• In September 2021, APR expanded its PKU GOLIKE product line with the launch, in Germany and Italy, of PKU GOLIKE KRUNCH®, a convenient chewable tablet for the dietary management of PKU.
• In October 2021, APR reported positive interim results from its clinical trial of Sentinox in SARS- CoV-2 infected patients, initiated in May 2021, suggesting that Sentinox could be effective in reducing the SARS-CoV-2 viral load in the upper respiratory tract. Final data was reported in March 2022, and, although the primary endpoint was not reached due to limited sample size, the results suggest the potential efficacy of Sentinox, with a better response in subjects dosed 3 times/day, versus the control group, in the reduction of the nasal viral load, negativization and infectivity and confirmed its safety and tolerability.
• In January 2022, APR received a Notice of Allowance from the USPTO for Patent Application No. 16/713,052 entitled, "Ready to Use Diclofenac Packs". Diclofenac potassium is an off-patent, potent non-steroidal anti-inflammatory drug widely used therapeutically for inflammatory conditions and pain management.
• In March 2022, APR announced the acquisition of the worldwide commercial rights (ex UK and Ireland) from the UK based company, Meta Healthcare Ltd., to a novel, differentiated dosage form of a prescription drug already approved by the FDA and intended for the treatment of patients with PKU.

Management and Board Additions

• As part of the acquisition of APR, Paolo Galfetti, Chief Executive Officer of APR, also assumed the position of President, Relief Europe, with overall responsibility for Relief’s activities in the EU and UK.
• Relief expanded the Board of Directors with highly experienced life science industry executives Patrice Jean, Ph.D., Tom Plitz, Ph.D., Paolo Galfetti and Michelle Lock.
• To match its fast pace of development, Relief has appointed Nermeen Varawalla, MD, as Chief Medical Officer; Anthony M. Kim, to the newly created position of Senior Vice President and Head of U.S. Commercial Operations; and Christopher Wick, to the newly created position of Senior Director, Head of U.S. Sales.
• Additionally, Jeremy Meinen, who serves as Relief’s Vice President of Finance and Administration, assumed the role of Chief Accounting Officer and Marco Marotta, who became part of Relief upon the acquisition of APR, was promoted to Chief Business Officer, responsible for business development activities across the entire company.

Business Update

• In November 2021, Relief filed a registration statement on Form F-6 with the U.S. Securities and Exchange Commission ("SEC"), taking the first step to establish a Level 1 American Depositary Receipt ("ADR") program in the U.S.
• In November 2021, the registration statement became effective, and Relief's ADRs began trading on the over-the-counter ("OTC") market on November 18, 2021; each ADR represents 150 of Relief's ordinary shares.
• In November 2021, Relief signed a collaboration agreement with InveniAI LLC, a U.S. based pioneer in the application of artificial intelligence and machine learning across biopharma and other industries, in order to identify promising drug candidates to treat rare and specialty diseases.
• In December 2021, Relief filed a Registration Statement on Form 20-F with the SEC to register Relief as a reporting company under the Securities Exchange Act of 1934.
• In March 2022, Relief filed Amendment No. 1 to its Registration Statement on Form 20-F with the SEC. The registration statement and Amendment were filed to begin the process of up-listing Relief's Level 1 ADR program in the U.S. to a Level 2 ADR program and is part of Relief's ongoing efforts to list its ADRs on the Nasdaq Stock Market during the first half of 2022. The Nasdaq listing will only occur after the registration statement has become effective, which is subject to an SEC review, and the filing by Relief of a listing application with the Nasdaq, which has not yet occurred.

Financial Highlights for the 12 Months Ended December 31, 2021

Results of Operation

• The Group's portfolio of marketed products generated CHF 3.3 million in revenue during the 6- month period from July to December 2021, following the acquisition of APR on June 28, 2021. Costs of sales incurred from third parties in the same period amounted to CHF 1.2 million. Prior to the acquisition of APR, the Group had no operating revenue.
• In 2021, the Group recognized other gains of CHF 1.2 million (2020: CHF 0.3 million), mainly in relation with the write-off of financial liabilities.
• Outsourced research and development expenses increased from CHF 13.7 million to CHF 19.0 million and were driven by development funding of ACER-001 in the U.S. and development activities for RLF-100. Furthermore, the Group invested in the development of APR's technology platforms.
• Personnel expenses increased from CHF 2.6 million to CHF 9.1 million. The business combinations with APR and AdVita increased the number of full-time equivalents and consultants from a dozen to six dozen, before organizational adjustments realized in the fourth quarter of 2021. As of December 31, 2021, the Group employed 55 full time equivalents and consultants.
• The addition of APR and AdVita, as well as increased needs of professional services for operations and financing activities, resulted in an increase of administrative expenses from CHF 3 million to CHF 6.8 million.
• In 2021, amortization and depreciation expenses amounted to CHF 2.0 million (2020: nil), mainly driven by the amortization of certain intangible assets acquired with APR.
• Net financial expenses were CHF 1.2 million (2020: CHF 0.5 million), mainly constituted by the Share Subscription Facility fee, by the effect of the passage of time in the fair value measurement of contingent liabilities, and by negative interests charged on the Group's Swiss francs deposits.
• Income tax gain of CHF 0.8 million resulted from variations of deferred tax assets and liabilities (2020: CHF 1.6 million loss). The Group did not have to pay or accrue income tax in jurisdictions where it is present.
• The Group incurred a net loss of CHF 34.7 million in 2021, compared to a net loss of CHF 7.8 million in 2020.

Balance sheet and cash flows

• In 2021, Relief acquired the two companies, APR and AdVita, and the ACER-001 license. On the asset side, the consolidation of the two subsidiaries and the capitalization of the acquisition cost of the license essentially resulted in an increase of intangible assets from CHF 30.8 million to CHF 192.3 million. On the liability side, the transactions essentially resulted in the recognition of provisions for contingent liabilities of CHF 30.8 million and deferred tax liabilities of CHF 21.5 million. Mainly as a result of the two acquisitions, the balance sheet of the Group increased by CHF 173.6 million to CHF 251.6 million.
• Other current assets increased from CHF 3.5 million to CHF 8.5 million and are primarily constituted by CHF 5.3 million unused advance payments made to Acer under the collaboration agreement.
• In 2021, the Group raised cash gross proceeds of CHF 75.9 million through private placements and sales of treasury shares. In addition, the issuances of shares for partial payments of the APR and AdVita acquisitions increased equity reserves by CHF 74.4 million. Overall, total shareholders' equity increased from CHF 67 million to CHF 215.8 million prior to the allocation of the 2021 comprehensive loss of CHF 34.3 million.
• Cash used by the Group in 2021 was primarily related to its operating activities and the acquisition of APR and ACER-001 license. The Group ended the year with a solid cash position of CHF 44.8 million (2020: CHF 43.2 million) and forecasted a cash runway well into 2023.

Further details are available in Relief’s 2021 Annual Report, which is available for download in the financial reports section of Relief's website.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100® (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

 

Relief Reports Half-Year 2021 Results and Provides Corporate Update

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
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CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx will provide RELIEF THERAPEUTICS Holding SA with the data from its phase 2b/3 trial needed to seek approval of RLF-100 in the EU and UK, (ii) whether the phase 2 trial evaluating inhaled aviptadil for the treatment of sarcoidosis will be successful, (iii) whether RLF-100 will be granted EUA in the United States, (iv) whether the pending disputes between Relief and its U.S. collaboration partner can be resolved, (v) whether inhaled aviptadil will ever be approved by the EU and/or the U.S. for the treatment of sarcoidosis or for any other indications, or (vi) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Half Year 2021 Results
Attachment (PDF): 210924_ad_hoc_Relief_Half_Yr_Release.pdf

Relief Reports Half-Year 2021 Results and Provides Corporate Update

Geneva, Switzerland, September 24, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today reported its results for the half-year ended June 30, 2021 and provided a corporate update.

“While we await the FDA’s decision on the Emergency Use Authorization (EUA) for IV RLF-100 (aviptadil), filed by our collaboration partner NeuroRx, Inc. (NeuroRx), we have successfully transformed Relief into a fully-integrated, multi-product, revenue-generating biopharmaceutical company,” stated Raghuram Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. “A critical component of our success so far this year was the acquisition of APR Applied Pharma Research SA (APR), which expanded and diversified our specialty drug pipeline, added a number of key commercialized products, including the PKU GOLIKE® family of products for the treatment of phenylketonuria (PKU), provided a European based commercial infrastructure that we hope to leverage for future product launches, including ACER-001, and offers an internal R&D capability that we plan to use for the development our own products as well as for third-party products on a fee for service basis.”

Dr. Selvaraju continued, “Through our collaboration with Acer Therapeutics, we recently filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for ACER-001, a proprietary powder formulation of sodium phenylbutyrate (NaPB), designed to be both taste-masked and immediate release, for the treatment of urea cycle disorders (UCDs) and maple syrup urine disease (MSUD). We look forward to the potential acceptance of the filing for regulatory review, which we expect to receive next month.”

“Also important was our recent acquisition of AdVita Lifescience GmbH (AdVita), from which we gained key pending intellectual property that may cover an improved inhaled formulation of RLF-100 (aviptadil), in development for a number of lung diseases, including acute respiratory distress syndrome (ARDS), and checkpoint inhibitor-induced pneumonitis (CIP). In parallel, IV RLF-100 continues to be evaluated as a treatment for severely ill COVID-19 patients, while the inhaled formulation is being tested in two clinical trials, one for patients with critical COVID-19 and another for moderate and severe COVID-19 patients. As we look ahead, and with a firm financial footing in place, we will maintain our commitment to pursuing additional strategic opportunities, both in-license and acquisition related, in order to aggressively expand and diversify our business.”

Clinical Development Highlights:
RLF-100 (aviptadil), IV

  • In March 2021, Relief’s collaboration partner, NeuroRx, Inc. (NeuroRx) announced top-line 60-day results for the phase 2b/3 trial of RLF-100™ for the treatment of patients with critical COVID-19 respiratory failure. These findings formed the basis for NeuroRx’s Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA).
  • In April 2021, NeuroRx announced that RLF-100 had been selected for inclusion in TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), an international, phase 3, multicenter clinical trial being sponsored by the U.S. National Institutes of Health (NIH).
  • In June 2021, NRx Pharmaceuticals Inc. (NRx), the parent company of NeuroRx, announced that NeuroRx had submitted its EUA application to the FDA for the use of RLF-100 in the treatment of critically ill COVID-19 in patients with respiratory failure. NeuroRx also reported that it plans to submit a New Drug Application (NDA) to the FDA.
  • In June 2021, NRx announced additional positive results from the RLF-100 U.S. Expanded Access Protocol (EAP). These EAP data were then submitted to the FDA and were characterized by NRx as “real world” evidence in support of the findings from the phase 2b/3 trial.
  • In July 2021, NRx reported that it identified a statistically significant effect of RLF-100 in preventing the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. The data was collected as part of the ongoing U.S. phase 2b/3 trial and NeuroRx reported that it had submitted these findings to the FDA as a supplement to the pending EUA application.
  • In July 2021, NRx announced the successful validation of the commercial formulation of RLF-100 for IV use, allowing for high volume manufacture, with an anticipated one year or greater stability, under appropriate storage conditions.
  • In July 2021, NRx announced that the Nation of Georgia's Prime Minister and Minister of Health had issued an EUA for RLF-100.
  • In August 2021, NRx provided a safety update on RLF-100 which is being tested in the ACTIV-3 Critical Care phase 3 study sponsored by the NIH, designed to evaluate RLF-100 and remdesivir in critical COVID-19 patients, as a monotherapy and in combination against placebo. They reported that the study's Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrollment.
  • In August 2021, NRx reported a new analysis showing that patients with acute respiratory failure due to Critical COVID-19 who were treated with aviptadil demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. NRx noted that this analysis appears to support its plan to submit an application for Breakthrough Therapy Designation to the FDA and that, if granted, could confer Priority Review to the aviptadil NDA, when submitted.

RLF-100 (aviptadil), Inhaled

  • In January 2021, a clinical trial participation agreement for the inclusion of an inhaled formulation of RLF-100 into the I-SPY COVID-19 clinical trial was signed between NeuroRx and Quantum Leap Healthcare Collaborative™ (Quantum Leap) of San Francisco.
  • In January 2021, Relief and the former shareholders of AdVita signed a binding term sheet for Relief to acquire all shares of AdVita, giving Relief access to all of AdVita’s assets including further pending IP rights that may cover RLF-100 inhaled formulation specifications for its potential application in the treatment of lung diseases such as ARDS, pulmonary sarcoidosis and CIP.
  • In April 2021, Relief and AdVita announced the initiation of an investigator-sponsored, randomized, double-blind, placebo-controlled phase 2 trial evaluating the inhaled formulation of RLF-100 for the prevention of COVID-19-related ARDS.
  • In July 2021, NeuroRx and Quantum Leap began treating patients with inhaled RLF-100 in the I-SPY COVID-19 Trial (NCT04488081), a phase 2 adaptive platform trial aimed at improving treatment for severely and critically ill COVID-19 patients.
  • In July 2021, Relief and the former shareholders of AdVita closed a definitive agreement for Relief to acquire all shares of AdVita, under which Relief paid the AdVita shareholders EUR 25 million in Relief common shares.
  • In August 2021, Relief received Orphan Drug Designation (ODD) from the FDA for inhaled RLF-100, for the treatment of sarcoidosis, adding to existing ODD designations for APR-OD031 for phenylketonuria (PKU) and APR-TD011 for epidermolysis bullosa (EB).
  • In September 2021, AdVita received regulatory clearance to commence a phase 2 clinical trial in Germany to evaluate inhaled aviptadil for the treatment of sarcoidosis.

ACER-001

  • In March 2021, Relief signed a Collaboration and License Agreement with Acer Therapeutics, Inc. (Acer) for the worldwide development and commercialization of ACER-001 for the treatment of Urea Cycle Disorders (UCDs) and Maple Syrup Urine Disease.
  • In May 2021, Acer announced the outcome of its Type B pre-NDA meeting with the FDA for ACER-001, for the treatment of UCDs. Based on the FDA’s feedback, both Relief and Acer noted that the proposed data package would likely be sufficient to support a Q3 2021 NDA submission under the Section 505(b)(2) regulatory pathway.
  • Subsequently, in August 2021, Relief and Acer announced the submission of the NDA to the FDA for ACER-001 for UCDs. Relief anticipates submitting a Marketing Authorization Application for approval of ACER-001 for UCDs in the European Union before the end of 2021. Pending a positive decision by regulators, management believes that ACER-001 could be launched in both the U.S. and Europe during 2022.

APR Applied Pharma Research SA

  • In May 2021, Relief and the former shareholders of APR signed a binding term sheet for Relief to acquire all of the outstanding shares of APR, a privately held Swiss pharmaceutical company with over 25 years' experience in identifying, developing and commercializing known molecules engineered with drug delivery systems in niche and rase diseases on a global basis. The transaction closed in June 2021.
  • In May 2021, APR initiated a pivotal clinical trial with its novel nasal spray, Sentinox, a Class III medical device, in patients with mild COVID-19.
  • In September 2021, APR expanded its PKU GOLIKE® product line with the launch, in Germany and Italy, of PKU GOLIKE® KRUNCH, giving patients a convenient chewable tablet for on-the-go dietary management of phenylketonuria, a rare, recessive metabolic genetic disorder affecting approximately 350,000 people, globally. Management hopes to announce its plans to market PKU GOLIKE® in the U.S. before year end 2021.

Management and Board Additions

  • As part of the acquisition of APR, Paolo Galfetti, Chief Executive Officer of APR, has also assumed the position of President, Relief Europe, with overall responsibility for Relief’s activities in the EU and UK.
  • The Board of Directors was expanded with the appointment of Patrice Jean, Ph.D., joining Raghuram (Ram) Selvaraju, MBA, Ph.D. (Relief’s Chairman of the Board), Tom Plitz, Ph.D. and Paolo Galfetti to round out Relief’s relevant life sciences Board level expertise.
  • Taneli Jouhikainen, M.D. was appointed to the newly created position of Chief Operating Officer.

Financial Highlights for the Six Months Ended June 30, 2021

  • The operating loss amounted to CHF 14.5 million with operating expenses of CHF 15.4 million and a one-time gain of CHF 0.9 million following a third-party debt write-off.
  • The period is marked by a significant growth in operating and administrative expenses. Service expenses of CHF 8.3 million (HY2020: CHF 2.9 million) were mainly driven by development activities for RLF-100 and ACER-001. Personnel expenses increased to CHF 3.4 million (HY2020: CHF 0.2 million) as the conduct and oversight of development and administrative projects required additional skilled professionals. Legal and administrative services reached CHF 3.2 million (HY2020: CHF 0.4 million), reflecting the company's need of legal and professional services in relation to its business activities, including the acquisition of APR and AdVita.
  • Cash used in operating activities has ramped up to CHF 17.7 million from CHF 3.2 million over the same period last year.
  • Net loss for the period was CHF 14.7 million (HY2020: CHF 8.3 million profit)
  • Relief acquired APR in exchange for CHF 21.5 million in cash and CHF 45 million in Relief shares. The sellers are also entitled to receive contingent milestone payments of up to CHF 35 million in a combination of cash and Relief shares upon completion of pre-agreed milestones. APR was consolidated in the balance sheet of the group on June 30, 2021, and will contribute to the group's income statement in the second semester 2021.

Jack Weinstein, Chief Financial Officer and Treasurer of Relief noted: “Relief remains well funded and, based on current programs, we believe we have sufficient reserves to support multiple clinical programs through key value inflection points. Since the beginning of the year to June 30, we bolstered our balance sheet with CHF 30 million in equity financings. We have also been able to take advantage of the flexibility provided by our additional share listing, giving the company, as of September 24, an available cash position of CHF 40 million.”

Post Reporting Period

  • On July 26, 2021, Relief announced that it had entered into a definitive agreement with two U.S. institutional investors to purchase in a private placement an aggregate of 71,428,572 shares of Relief common stock at a purchase price of CHF 0.21 per share, raising aggregate gross proceeds of CHF 15 million.
  • On July 27, 2021, the company issued and listed an additional 1 billion common shares. Relief used a total of 413,956,419 shares comprising 135,741,063, 206,786,784 and 71,428,572 shares, respectively, to meet its obligations to the AdVita sellers, the APR sellers and the provision of shares for the CHF 15 million private placement. The remaining shares can be used to support Relief’s current and future business development activities, and to provide additional working capital.
  • On July 27, 2021, Relief acquired AdVita in exchange of EUR 25 million in Relief shares and possible future contingent payments of EUR 20 million payable in cash.
    Further details are available in Relief’s Half Year 2021 Report, which is available for download at https://relieftherapeutics.com/investor-relations

###

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports Regulatory Clearance in Germany to Commence a Multicenter, Double-blind, Randomized Phase 2 Clinical Trial to Evaluate Inhaled Aviptadil for the Treatment of Sarcoidosis

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the phase 2 trial evaluating inhaled aviptadil for the treatment of sarcoidosis will be successful, (ii) whether inhaled aviptadil will ever be approved by the EU and/or the U.S. for the treatment of sarcoidosis or for any other indications, or (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Sarcoidosis_Germany
Attachment (PDF): 210902_Relief_Sarcoidosis_Phase_2_Trial_PR_-_FINAL.pdf

Relief Reports Regulatory Clearance in Germany to Commence a Multicenter, Double-blind, Randomized Phase 2 Clinical Trial to Evaluate Inhaled Aviptadil for the Treatment of Sarcoidosis

Geneva, Switzerland, September 2, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that its recently acquired German subsidiary, AdVita Lifescience GmbH (“AdVita”), has received regulatory clearance to commence a phase 2 clinical trial in Germany to evaluate inhaled aviptadil for the treatment of sarcoidosis.
Following a proof-of-concept trial in 20 sarcoidosis patients which demonstrated the suppression of inflammatory mechanisms of the lung in combination with amelioration of dry cough and exertional dyspnea, AdVita received clearance by the German medical regulatory authority Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) to conduct a randomized, double-blind, multicenter clinical trial in sarcoidosis patients.
Raghuram Selvaraju, Chairman of the Board of Relief, commented, “Receiving regulatory clearance to begin a phase 2 clinical trial of inhaled aviptadil marks another clinical milestone for Relief and our subsidiary, AdVita. Aviptadil is believed to be the only known experimental drug that could potentially suppress sarcoidosis-associated cough, one of the major symptoms reducing quality of life in this patient population. We look forward to initiating this trial and to further exploring the clinical utility of aviptadil across multiple pulmonary indications.”

ABOUT SARCOIDOSIS

Sarcoidosis is a rare disease in which the inflammatory process involves the alveoli (air sacs), small bronchi, and small blood vessels. As sarcoidosis progresses, small lumps, or granulomas, appear in the affected tissues which tend to remain inflamed and become scarred (fibrotic). Granulomas are structured masses composed of activated immunological cells (macrophages, lymphocytes, mast cells and fibroblasts). Many Sarcoidosis patients are left with permanent lung damage as they undergo a chronic course where complications such as pulmonary fibrosis are common and irreversible. Sarcoidosis affects up to about 100,000 people in the European Union, and a similar or higher amount in the U.S.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, brings to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Agreed with Hungarian Health Officials on a Pathway for Aviptadil

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
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Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx aviptadil Hungary
Attachment (PDF): 20211210_ad_hoc_Relief_aviptadil_Hungary.pdf

Relief Reports that its U.S. Collaboration Partner has Agreed with Hungarian Health Officials on a Pathway for Aviptadil

Geneva, Switzerland, December 10, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has announced it has agreed with Hungarian Health Officials on a regulatory path for emergency use of aviptadil in the Central European region, beginning with a compassionate care program, expected to begin by the end of 2021. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced a Favorable, New Safety Report for Aviptadil in the National Institutes of Health Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Foot notes:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx ACTIV3b new safety
Attachment (PDF): 20211103_ad_hoc_Relief_NRX_Favorable_Safety_Report.pdf

Relief Reports that its U.S. Collaboration Partner has Announced a Favorable, New Safety Report for Aviptadil in the National Institutes of Health Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

Geneva, Switzerland, November 3, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has issued a press release announcing a new safety update on aviptadil, which is being tested in the ACTIV-3b Critical Care Phase 3 study sponsored by the National Institutes of Health. According to the press release, in its third scheduled analysis, the study's Independent Data Safety Monitoring Board found no new safety concerns after reviewing a total of more than 300 patients and recommended continued enrollment to target 640 patients. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced a New Finding from the ZYESAMI™ (aviptadil) Phase 2b/3 Clinical Trial Demonstrating Clinically Significant Relief from Respiratory Distress in Critical COVID-19  

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NRx will provide Relief with the data from its Phase 2b/3 study, (ii) whether Relief can resolve its ongoing dispute with NRx without litigation, (iii) whether aviptadil will ever be approved in the U.S., UK or the EU for the treatment of respiratory failure in critically ill patients with COVID-19, and (iv) those risks discussed in Relief's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx_ADRS
Attachment (PDF): 210831_Relief_NRx_ADRS.pdf

Relief Reports that its U.S. Collaboration Partner has Announced a New Finding from the ZYESAMI™ (aviptadil) Phase 2b/3 Clinical Trial Demonstrating Clinically Significant Relief from Respiratory Distress in Critical COVID-19

Geneva, Switzerland, August 31, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release announcing an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI™ (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. According to the press release, the new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. This latest analysis also appears to support NRx's plan to submit an application for Breakthrough Therapy Designation to the U.S. Food and Drug Administration for this indication. Relief believes that, if granted, this could confer Priority Review to the aviptadil New Drug Application, when submitted. The related NRx press release can be accessed through the following link.

ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced a New, Favorable Safety Report for Aviptadil in the NIH Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx new safety ACTIV3b
Attachment (PDF): 20211215_ad_hoc_Relief__NRx_Zyesami_NIH_ACTIV-3b.pdf

Relief Reports that its U.S. Collaboration Partner has Announced a New, Favorable Safety Report for Aviptadil in the NIH Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

Geneva, Switzerland, December 15, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has announced a new safety update on aviptadil, which is being tested in the ACTIV-3b Critical Care Phase 3 study sponsored by the U.S. National Institutes of Health (NIH). According to the press release, in its third scheduled analysis, the study’s Independent Data Safety Monitoring Board found no new safety concerns after reviewing a total of 348 patients and recommended continued enrollment. The press release also reported that the study was cleared to continue enrollment to target 640 patients. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced a Positive Safety Report for ZYESAMI™ (aviptadil) in NIH Sponsored ACTIV-3 Critical Care Study in Patients with Life-Threatening COVID-19

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx will provide Relief with the data from its Phase 2b/3 study, (ii) whether aviptadil will ever be approved in the UK or the EU for the treatment of respiratory failure in critically ill patients with COVID-19, and (iii) those risks discussed in Relief's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 210819 Relief ACTIV-3 PR
Attachment (PDF): 210819_Relief_ACTIV-3_PR_FINAL.pdf

Relief Reports that its U.S. Collaboration Partner has Announced a Positive Safety Report for ZYESAMI™ (aviptadil) in NIH Sponsored ACTIV-3 Critical Care Study in Patients with Life-Threatening COVID-19

Geneva, Switzerland, August 19, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”) provided a safety update on ZYESAMI™ (aviptadil) which is being tested in the ACTIV-3 Critical Care Phase 3 study sponsored by the National Institutes of Health (NIH). The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and is quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced a Second Favorable Safety Report for ZYESAMI™ (RLF-100TM/aviptadil) in the NIH Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RLF-100TM (aviptadil) will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, (ii) whether RELIEF THERAPEUTICS Holding SA can satisfactorily resolve its ongoing disputes with NeuroRx without litigation, (iii) whether RELIEF THERAPEUTICS Holding SA will prevail in any litigation action with NeuroRx over the terms of the Collaboration Agreement, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx ACTIV3b safety
Attachment (PDF): 210930_ad_hoc_Relief_NRX_ACTIV-3b_2nd_Safety.pdf

Relief Reports that its U.S. Collaboration Partner has Announced a Second Favorable Safety Report for ZYESAMI™ (RLF-100TM/aviptadil) in the NIH Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

Geneva, Switzerland, September 30, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release providing a safety update on ZYESAMI™ (RLF-100TM/aviptadil) which is being tested in the ACTIV-3b/TESICO (Therapeutics for Severely Ill Inpatients with COVID-19) phase three study sponsored by the National Institutes of Health (NIH). According to the press release, in its second scheduled analysis, the study's Independent Data Safety Monitoring Board found no new safety concerns after reviewing a total of 231 patients and recommended continued enrollment. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced Emergency Use Authorization of Aviptadil in Nation of Georgia

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
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Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding whether its collaboration partner’s application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 20210728_Relief reports Collaboration partner Announced Emergency Use Authorization of Aviptadil in Nation of Georgia
Attachment (PDF): 270728_ad_hoc_Relief_confirms_RLF100_EUA_Nation_of_Georgia.pdf

Relief Reports that its U.S. Collaboration Partner has Announced Emergency Use Authorization of Aviptadil in Nation of Georgia

Geneva, Switzerland, July 28, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”) reported in a press release yesterday that the Nation of Georgia's Prime Minister and Minister of Health have issued an Emergency Use Authorization for intravenous aviptadil for the treatment of critical COVID-19.

NRx also reported that the first doses of aviptadil will arrive in the Nation of Georgia within 24 hours, and discussions are underway with the Ministry of Health to provide access to ZYESAMI™ to Georgians suffering with Critical COVID-19.

The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced Expansion of Aviptadil U.S. Expanded Access and Right to Try Programs for Patients With COVID-19 Respiratory Failure who Have Exhausted All Approved Therapies

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx's recently submitted application to the FDA seeking EUA for aviptadil to treat patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy including Remdesivir and who are ineligible for enrollment into the ACTIV-3b NIH-sponsored trial will be approved, (ii) whether RELIEF THERAPEUTICS Holding SA will be successful in its lawsuit against NRx's subsidiary, NeuroRx, and NeuroRx's CEO, Jonathan Javitt, and in defending NeuroRx’s recently filed lawsuit against Relief, (iii) whether the upcoming mediation between the parties to the disputes between Relief and NeuroRx will be successful, (iv) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 or any other disease, and (v) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx aviptadil EAP RTT
Attachment (PDF): 20220119_Ad_hoc_Relief__NRx_US_Expanded_Access.pdf

Relief Reports that its U.S. Collaboration Partner has Announced Expansion of Aviptadil U.S. Expanded Access and Right to Try Programs for Patients With COVID-19 Respiratory Failure who Have Exhausted All Approved Therapies

Geneva, Switzerland, January 19, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), of its collaboration partner with respect to aviptadil, NeuroRx, Inc. ("NeuroRx"), has announced enhancements to its Expanded Access and Right to Try programs. The press release states that these programs enable patients with respiratory failure from COVID-19, who have tried all approved medicines, including remdesivir, and who are not able to participate in a clinical study, to receive aviptadil upon a physician’s prescription. According to the press release, NRx will continue to provide aviptadil to hospitals enrolled in NRx’s Expanded Access Protocol under U.S. Food and Drug Administration guidelines. The press release also reported that NRx is also making aviptadil available as an investigational medicine under the Federal Right to Try Act. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Finally, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced Improved Survival at One Year in Highly Comorbid COVID-19 Patients Treated with ZYESAMITM (RLF-100TM/aviptadil)

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will be determined by regulatory authorities to be safe and effective as a treatment for highly comorbid patients with COVID-19, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 and (iii) those risks discussed in RELIEF THERAPEUTICS Holding AG's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Comorbid Survival
Attachment (PDF): 210928_ad_hoc_Relief_NRX_Comorbid_Survival.pdf

Relief Reports that its U.S. Collaboration Partner has Announced Improved Survival at One Year in Highly Comorbid COVID-19 Patients Treated with ZYESAMITM (RLF-100TM/aviptadil)

Geneva, Switzerland, September 28, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release announcing top line data demonstrating improved outcomes at one year in highly comorbid patients with COVID-19 who were treated with ZYESAMI™ (RLF-100 ™/aviptadil). According to NRx’s press release, in highly comorbid COVID-19 patients, ZYESAMI™ provided a threefold, statistically significant increase in the likelihood of survival at one year, consistent, according to NRx, with the increased odds of 60-day survival seen in the previously reported results from the phase 2b/3 randomized controlled trial of ZYESAMI™ (RLF-100 ™/aviptadil). The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced it has Filed a Breakthrough Therapy Designation Request for Aviptadil in Patients at Immediate Risk of Death from COVID-19 Despite Treatment with Remdesivir and Other Approved Therapies

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx breakthrough filing
Attachment (PDF): 20211230_ad_hoc_Relief__NRx_aviptadil_Filed_Breakthrough.pdf

Relief Reports that its U.S. Collaboration Partner has Announced it has Filed a Breakthrough Therapy Designation Request for Aviptadil in Patients at Immediate Risk of Death from COVID-19 Despite Treatment with Remdesivir and Other Approved Therapies

Geneva, Switzerland, December 30, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has announced it has filed for a new Breakthrough Therapy Designation (“BTD”) request with the U.S. Food and Drug Administration (“FDA”) focused on patients with Critical COVID-19 and respiratory failure who are at immediate risk of death despite treatment with Remdesivir and other approved therapies. According to the press release, the BTD request is based on an FDA request for clinical data on the effectiveness of aviptadil compared to Remdesivir and other approved therapies. The press release also reported patients treated with aviptadil vs. placebo demonstrated a statistically significant (P=.03) 2.8-fold increased odds of being alive and free of respiratory failure at day 28 and day 60 and a highly significant (P=.006) four-fold increased odds of survival is seen in these patients. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced it has Received a U.S. Food and Drug Administration Review of Aviptadil Manufacturing Information

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx_Manufacturing
Attachment (PDF): 20211112_ad_hoc_Relief_NRX_FDA_Review_Manufacturing_Info.pdf

Relief Reports that its U.S. Collaboration Partner has Announced it has Received a U.S. Food and Drug Administration Review of Aviptadil Manufacturing Information

Geneva, Switzerland, November 12, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has issued a press release announcing receipt of the U.S. Food and Drug Administration’s (FDA) response to NRx’s October 8, 2021 submission of updated manufacturing information for aviptadil. According to the press release, the FDA review allows for high volume production of aviptadil. The press release also reports that the shelf life of aviptadil has been extended from 62 days to 150 days. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced Progress on Worldwide Commercial Scale Development of ZYESAMI™ (aviptadil)

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx WW Commercial Dev
Attachment (PDF): 20211013_ad_hoc_Relief_NRX_WW_Commercial_Scale_Development_of_ZYESAMI.pdf

Relief Reports that its U.S. Collaboration Partner has Announced Progress on Worldwide Commercial Scale Development of ZYESAMI™ (aviptadil)

Geneva, Switzerland, October 13, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release announcing they have submitted a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) to the U.S. Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. According to the press release, NRx has also received notification that a European QP (Qualified Person) Auditor has completed an inspection at a separate manufacturing facility with no adverse findings. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced Receipt of Initial Report of Patient Safety and Survival from Right to Try Use of Aviptadil During Omicron Surge

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx's recently submitted application to the FDA seeking EUA for aviptadil to treat patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy including Remdesivir and who are ineligible for enrollment into the ACTIV-3b NIH-sponsored trial will be approved, (ii) whether RELIEF THERAPEUTICS Holding SA will be successful in its lawsuit against NRx's subsidiary, NeuroRx, and NeuroRx's CEO, Jonathan Javitt, and in defending NeuroRx’s recently filed lawsuit against Relief, (iii) whether the upcoming mediation between the parties to the disputes between Relief and NeuroRx will be successful, (iv) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 or any other disease, and (v) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx safety data
Attachment (PDF): 20220127_Ad_hoc_Relief__NRx_US_Safety_Data.pdf

Relief Reports that its U.S. Collaboration Partner has Announced Receipt of Initial Report of Patient Safety and Survival from Right to Try Use of Aviptadil During Omicron Surge

Geneva, Switzerland, January 27, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), of its collaboration partner with respect to aviptadil, NeuroRx, Inc. ("NeuroRx"), has announced receipt of a first safety report from a Southwestern hospital where physicians have administered aviptadil to patients with COVID-19 respiratory failure. According to the press release, the patients were treated under the Federal Right to Try Law that gives access to investigational medicines for patients who have been diagnosed with life-threatening diseases or conditions, who have tried all approved treatment options, and who are unable to participate in a clinical trial to access certain unapproved treatments. The press release stated that of the first 19 patients treated by December 31, 2021, three had died and 16 (84%) were reported to be alive by January 22, 2022. The release also reported that this Right to Try use of aviptadil occurred during the current Omicron surge, although patients were not necessarily tested for the specific COVID variant that caused their ICU admission. NRx reported that no serious adverse events were reported. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Finally, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced Successful Commercial Formulation for Aviptadil

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding whether its collaboration partner’s application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Stability Aviptadil
Attachment (PDF): 210723_ad_hoc_Relief_stability_data_aviptadil_EN.pdf

Relief Reports that its U.S. Collaboration Partner has Announced Successful Commercial Formulation for Aviptadil

Geneva, Switzerland, July 23, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release reporting that it has validated a commercial formulation of aviptadil for intravenous use, allowing for high volume manufacture, with an anticipated one year or greater stability, under appropriate storage conditions. NRx also reported in its press release that it had achieved a 30-to-50-fold increase in its manufactured lot size of aviptadil. The related NRx press release can be accessed through the following link.

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief, said: “We are pleased that our collaboration partner has reported that it has developed a formulation of aviptadil that it reports is suitable for commercial distribution. Despite the increase in the number of people being fully vaccinated against COVID-19, with emerging variants and disparities in vaccination rates, there remains a major need for effective therapeutic options for patients with respiratory failure. We are excited about the potential that aviptadil holds in helping critical COVID-19 patients and are hopeful that the drug candidate will soon be available to those who remain in need of better treatments.”

###

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has announced that it has Submitted an Application to the FDA seeking Emergency Use Authorization for Aviptadil to Treat Patients at Immediate Risk of Death from COVID-19 Despite Treatment with Remdesivir and Other Approved Therapies

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx's recently submitted application to the FDA seeking for EUA for aviptadil to treat patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy including Remdesivir and who are ineligible for enrollment into the ACTIV-3b NIH-sponsored trial will be approved, (ii) whether RELIEF THERAPEUTICS Holding SA will be successful in its lawsuit against NRx's subsidiary, NeuroRx, and NeuroRx's CEO, Jonathan Javitt, (iii) whether the mediation will be successful, (iv) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 or any other disease, and (v) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx aviptadil EUA2
Attachment (PDF): 20220106_Ad_hoc_Relief__NRx_files_application_for_EUA.pdf

Relief Reports that its U.S. Collaboration Partner has announced that it has Submitted an Application to the FDA seeking Emergency Use Authorization for Aviptadil to Treat Patients at Immediate Risk of Death from COVID-19 Despite Treatment with Remdesivir and Other Approved Therapies

Geneva, Switzerland, January 6, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), of its collaboration partner with respect to aviptadil, NeuroRx, Inc. ("NeuroRx") has announced that it has submitted an application to the FDA seeking emergency use authorization ("EUA") for the use of aviptadil to treat patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy including Remdesivir and who are ineligible for enrollment into the ACTIV-3b NIH-sponsored trial. The related NRx press release can be accessed through the following link.

Relief also updated the market on recent activities in its pending lawsuit against NeuroRx and NeuroRx's CEO, Jonathan Javitt (collectively, the "Defendants"), relating to the parties' collaboration agreement with respect to the development and commercialization of aviptadil. Relief reported that the Defendants have filed two motions with the Court: (i) a motion to dismiss seeking the dismissal of Jonathan Javitt from the case for lack of personal jurisdiction, or, in the alternative, on the merits, and (ii) a motion to strike certain statements made in Relief's complaint. Relief has begun its review of the defendants' filings and will respond at a future time in an appropriate filing with the Court. While there can be no assurance, Relief remains confident in the statements made in its complaint and in the validity of its claims against NeuroRx and Jonathan Javitt. Relief also reported that its previously announced mediation with the Defendants seeking to amicably resolve the litigation is currently scheduled for late February 2022.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY.  For more information, visit www.relieftherapeutics.com.  Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced that the I-SPY COVID Trial Sponsored by Quantum Leap Healthcare Collaborative Suggests No Clinical Benefit with Addition of Nebulized Aviptadil When Given by Mouth Inhalation in Critically Ill Patients with COVID-19

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx's recently submitted application to the FDA seeking EUA for aviptadil to treat patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy including Remdesivir and who are ineligible for enrollment into the ACTIV-3b NIH-sponsored trial will be approved, (ii) whether RELIEF THERAPEUTICS Holding SA will be successful in its lawsuit against NRx's subsidiary, NeuroRx, and NeuroRx's CEO, Jonathan Javitt, and in defending NeuroRx’s recently filed lawsuit against Relief, (iii) whether the upcoming mediation between the parties to the disputes between Relief and NeuroRx will be successful, (iv) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 or any other disease, and (v) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX and with the U.S. Securities and Exchange Commission, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Foot notes:
End of ad hoc announcement

show this
 
01 April 2022
Attachment Name: Ad hoc_Relief_ NRx I-Spy Results
Attachment (PDF): Ad_hoc_Relief__NRx_I-Spy_Results.pdf

Relief Reports that its U.S. Collaboration Partner has Announced that the I-SPY COVID Trial Sponsored by Quantum Leap Healthcare Collaborative Suggests No Clinical Benefit with Addition of Nebulized Aviptadil When Given by Mouth Inhalation in Critically Ill Patients with COVID-19

Geneva, Switzerland, April 1, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), of its collaboration partner with respect to aviptadil, NeuroRx, Inc. ("NeuroRx"), and Quantum Leap Healthcare Collaborative (“QLHC”), have announced that the nebulized form of aviptadil being used in the I-SPY COVID Trial of critical COVID-19 patients has been stopped. According to NRx and QLHC, the I-SPY COVID Trial (NCT04488081) is a phase 2, open label, adaptive platform trial designed to rapidly screen potential agents that could substantially improve treatment for severely and critically ill COVID-19 patients. QLHC is the sponsor of the I-SPY COVID Trial. NRx and QLHC reported that the trial is structured to identify those agents with a big impact, those that could have the potential to reduce the time to recovery (defined as reduction in oxygen demand) by approximately 50% or risk of mortality in critically ill COVID-19 patients. The related NRx and QLHC press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100® (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced that the Journal of Infectious Diseases and Treatment has Published Positive Trial Data of Aviptadil in High Comorbidity Patients Suffering from Critical COVID-19 with Respiratory Failure

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
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Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx Aviptadil Data Publication
Attachment (PDF): 20211015_ad_hoc_Relief_NRX_Publication_of_Data_on_Aviptadil.pdf

Relief Reports that its U.S. Collaboration Partner has Announced that the Journal of Infectious Diseases and Treatment has Published Positive Trial Data of Aviptadil in High Comorbidity Patients Suffering from Critical COVID-19 with Respiratory Failure

Geneva, Switzerland, October 15, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has issued a press release announcing that the peer-reviewed Journal of Infectious Diseases and Treatment has published positive trial data from a prospective, open label, administratively controlled trial of aviptadil in high comorbidity patients suffering from critical COVID-19 with respiratory failure. According to the press release, the study reported 60-day survival in 81% of those treated with aviptadil, compared to 21% survival among those who received standard of care treatment at the Houston Methodist Hospital (P<.0001). The press release also reports that a similar 9-fold advantage was seen in the cumulative probability of recovery from respiratory failure (P<.0001). The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced that the U.S. National Institutes of Health Study of Aviptadil in Critical COVID-19 is Cleared to Complete Full Enrollment

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx's recently submitted application to the FDA seeking EUA for aviptadil to treat patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy including Remdesivir and who are ineligible for enrollment into the ACTIV-3b NIH-sponsored trial will be approved, (ii) whether RELIEF THERAPEUTICS Holding SA will be successful in its lawsuit against NRx's subsidiary, NeuroRx, and NeuroRx's CEO, Jonathan Javitt, and in defending NeuroRx's recently filed lawsuit against Relief, (iii) whether the upcoming mediation between the parties to the disputes between Relief and NeuroRx will be successful, (iv) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 or any other disease, and (v) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Foot notes:
 

Additional features:


File: Ad hoc release

End of ad hoc announcement

show this
 
16 February 2022

Relief Reports that its U.S. Collaboration Partner has Announced that the U.S. National Institutes of Health Study of Aviptadil in Critical COVID-19 is Cleared to Complete Full Enrollment

No Notice of Opposition or Extension Request has Been Received in Relation to the Application;
Certificate of Registration Expected by Late April

Geneva, Switzerland, February 16, 2022 RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx"), of its collaboration partner with respect to aviptadil, NeuroRx, Inc. ("NeuroRx"), has announced results of a review conducted by the Therapeutics and Prevention Data Safety and Monitoring Board ("DSMB") of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health ("NIH") on February 14, 2022. According to the press release, the DSMB reviewed data on 448 ICU patients with Critical COVID-19 Respiratory Failure who were enrolled in the ACTIV-3b (TESICO) trial. The release reported that no new safety concerns were identified and the study is cleared to continue enrollment to 640 patients. The release also stated that the TESICO protocol was submitted by NIH and cleared by the United States Food and Drug Administration as a phase 3 trial that, if positive, may be used in the submission of a New Drug Application for aviptadil. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief's collaboration partner in the U.S., NeuroRx, Inc. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Finally, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced the Filing of a Provisional Patent for Stable Compositions of Aviptadil Suitable for Human Use

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the provisional application filed by NRx will result in the issuance of a patent, (ii) whether RELIEF THERAPEUTICS Holding SA will be successful in its breach of contract action against NRx's subsidiary, NeuroRx, and NeuroRx's CEO, Jonathan Javitt, (iii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 or any other disease, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx aviptadil provisional patent
Attachment (PDF): 20220104_ad_hoc_Relief__NRx_aviptadil_patent_final.pdf

Relief Reports that its U.S. Collaboration Partner has Announced the Filing of a Provisional Patent for Stable Compositions of Aviptadil Suitable for Human Use

Geneva, Switzerland, January 4, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), of its collaboration partner with respect to aviptadil, NeuroRx, Inc. ("NeuroRx") has announced that it has filed a provisional composition of matter patent application with the U.S. Patent and Trademark Office entitled, "Stable, Buffer-free Compositions of Vasoactive Intestinal Peptide (VIP)." According to the press release, the provisional application describes compositions of vasoactive intestinal peptide, the synthetic form of which is aviptadil, that are both shelf stable and biologically active when used to treat COVID-19 and other diseases. The related NRx press release can be accessed through the following link.

Relief notes, in response to a statement in NRx's press release that aviptadil is a 70-year old dormant drug, that aviptadil is an analog of vasoactive intestinal peptide (VIP) originally discovered in 1970, and that Relief and its predecessor companies have been working on the development of aviptadil for almost 20 years. Relief also notes that the formulation of aviptadil being used by NeuroRx, and any intellectual property that NeuroRx may obtain with respect to such formulation, is covered by the parties' collaboration agreement with respect to the development and commercialization of aviptadil, and that under such agreement, NeuroRx is obligated to cross-license such formulation, and all related intellectual property, to Relief. The failure of NeuroRx to cross-license its formulation of aviptadil to Relief is one of the alleged breaches of the collaboration agreement that is raised in Relief's previously filed breach of contract lawsuit against NeuroRx, and its CEO, Jonathan Javitt.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced the U.S. Food and Drug Administration has Denied Breakthrough Designation for Aviptadil

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx BTD denial
Attachment (PDF): 20211124_ad_hoc_Relief_NRx_BTD_Denial.pdf

Relief Reports that its U.S. Collaboration Partner has Announced the U.S. Food and Drug Administration has Denied Breakthrough Designation for Aviptadil

Geneva, Switzerland, November 24, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has issued a CEO Update announcing that the U.S. Food and Drug Administration (“FDA”) has denied Breakthrough Therapy Designation (“BTD”) for aviptadil. NRx noted that BTD is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel who may interact more frequently with the sponsor. Additionally, according to the CEO Update, the FDA has already granted priority and rolling review as part of the Fast Track Designation awarded in July 2020. Therefore, the denial does not impede NRx’s ability to seek drug approval, although it does identify areas where NRx needs to seek better scientific alignment with the FDA. The related NRx CEO Update can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Filed a New Breakthrough Therapy Designation Request for Aviptadil in a Subgroup of Patients with Critical COVID-19 with Respiratory Failure that were also Treated with Remdesivir and Continued to Progress

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx's recently submitted application to the FDA seeking Breakthrough Therapy Designation for aviptadil focused on a subgroup of patients with Critical COVID-19 that, in addition to aviptadil or placebo, were also treated with remdesivir, will be granted, (ii) whether RELIEF THERAPEUTICS Holding SA will be successful in its lawsuit against NRx's subsidiary, NeuroRx, and NeuroRx's former CEO, Jonathan Javitt, and in defending NeuroRx's recently filed lawsuit against Relief, (iii) whether the upcoming mediation between the parties to the disputes between Relief and NeuroRx will be successful, (iv) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 or any other disease, and (v) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Foot notes:
 
22 April 2022
Attachment Name: Ad hoc_Relief_ NRx Breakthrough Therapy Desig-Aviptadil-FINAL
Attachment (PDF): Ad_hoc_Relief__NRx_Breakthrough_Therapy_Desig-Aviptadil-FINAL.pdf

Relief Reports that its U.S. Collaboration Partner has Filed a New Breakthrough Therapy Designation Request for Aviptadil in a Subgroup of Patients with Critical COVID-19 with Respiratory Failure that were also Treated with Remdesivir and Continued to Progress

Geneva, Switzerland, April 22, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), of its collaboration partner with respect to aviptadil, NeuroRx, Inc. ("NeuroRx"), has announced that it
Relief Reports that its U.S. Collaboration Partner has Filed a New Breakthrough Therapy Designation Request for Aviptadil in a Subgroup of Patients with Critical COVID-19 with Respiratory Failure that were also Treated with Remdesivir and Continued to Progress has filed a new Breakthrough Therapy Designation request with the U.S. Food and Drug Administration ("FDA"). According to NRx, the request was based on a post-hoc analysis, focused on a subgroup of patients with Critical COVID-19 that, in addition to aviptadil or placebo, were also treated with remdesivir and whose respiratory failure due to Critical COVID-19 continued to progress. NRx also reported that the request includes cumulative safety data on approximately 750 patients treated with intravenous aviptadil for Critical COVID-19. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100® (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Identified a Significantly Higher Likelihood of Surviving and Recovering from Critical COVID-19 in Aviptadil Treated Patients Previously Administered Remdesivir

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
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Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx aviptadil data
Attachment (PDF): 20211129_ad_hoc_Relief__NRx_Zyesami_FINAL.pdf

Relief Reports that its U.S. Collaboration Partner has Identified a Significantly Higher Likelihood of Surviving and Recovering from Critical COVID-19 in Aviptadil Treated Patients Previously Administered Remdesivir

Geneva, Switzerland, November 29, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has announced it completed an analysis to identify clinical evidence that indicates a substantial improvement after treatment with aviptadil in patients with Critical COVID-19 and Respiratory Failure over existing therapies such as remdesivir. According to the press release, the analysis, conducted by Prof. David Schoenfeld, who they report is one of the world’s most widely published statisticians with unique expertise in life-threatening diseases of the lung, examined the subgroup of patients in the COVID-AIV trial (NCT 04311697) that remained in respiratory failure despite treatment with remdesivir. The press release also reported that the analysis identified a statistically significant (P=.03) 2.5-fold increased odds of being alive and free of respiratory failure at 60 days (the primary endpoint) and a statistically significant (P=.006) four-fold higher odds of being alive at day 60 among patients treated with aviptadil compared to those treated with placebo. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Presented Evidence that Aviptadil Helps to Prevent Cytokine Storm in Patients with COVID-19

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
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Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
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Disclaimer:

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding whether its collaboration partner’s application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Cytokine Storm
Attachment (PDF): 210720__ad_hoc_PR_confirm_RLF100_cytokine_storm_data_EN.pdf

Relief Reports that its U.S. Collaboration Partner has Presented Evidence that Aviptadil Helps to Prevent Cytokine Storm in Patients with COVID-19

Geneva, Switzerland, July 20, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”) reported in a press release yesterday that it has identified a statistically significant effect of aviptadil in preventing the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. They reported that the cytokine data were collected as part of the U.S. phase 2b/3 trial of aviptadil compared to placebo in critically ill patients with COVID-19 respiratory failure.
NRx also reported that it has submitted these findings to the U.S. Food and Drug Administration (FDA) as a supplement to its pending application for Emergency Use Authorization (EUA) and is submitting a biomarker letter of intent to the FDA as part of the FDA biomarker program, authorized under the 21st Century Cures Act.
NRx also reported that it continues to respond to FDA information requests for additional data in support of the currently pending EUA application for aviptadil in treating critically ill patients with COVID-19.
The related NRx press release can be accessed through the following link.

###

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.

Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner’s Emergency Use Authorization Request for ZYESAMI®/RLF-100™ (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure was Declined by the U.S. Food & Drug Administration

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
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Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Aviptadil EUA Denial
Attachment (PDF): 20211105_ad_hoc_Relief_EUA_Denial.pdf

Relief Reports that its U.S. Collaboration Partner’s Emergency Use Authorization Request for ZYESAMI®/RLF-100™ (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure was Declined by the U.S. Food & Drug Administration

Geneva, Switzerland, November 5, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release announcing that it was declined Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the use of IV aviptadil for the treatment of acute respiratory failure due to critical COVID-19. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics and InveniAI Sign a Strategic Collaboration Agreement to Identify New Product Development Opportunities using Artificial Intelligence

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
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Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether InveniAI will bring to RELIEF THERAPEUTICS Holding SA drug candidates that can be successfully developed by RELIEF THERAPEUTICS Holding SA, (ii) whether RELIEF THERAPEUTICS Holding SA will successfully develop and ultimately market any drug candidate identified by InveniAI, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_IveniAI
Attachment (PDF): 20211124_ad_hoc_Relief_InveniAI.pdf

Relief Therapeutics and InveniAI Sign a Strategic Collaboration Agreement to Identify New Product Development Opportunities using Artificial Intelligence

Geneva, Switzerland, November 24, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), announced today that it has signed a collaboration agreement (the “Collaboration”) with InveniAI LLC (“InveniAI”), a U.S. based company that has pioneered the application of artificial intelligence and machine learning across biopharma and other industries, in order to identify promising drug candidates to treat rare and specialty diseases.

Under the terms of the Collaboration, InveniAI will use its proprietary platform for the identification of potential pharmaceutical product opportunities using its Pharma Big Data Innovation Lab (“Platform”), consisting of (i) its proprietary AlphaMeld® platform, a cloud-based Artificial Intelligence (“AI”) platform that utilizes proprietary machine learning and deep learning based neural networks to identify product opportunities in therapeutic areas, (ii) its cross-functional teams at its Integrated Center of Excellence, and (iii) domain expertise, to generate novel pharmaceutical opportunities and the related development pathway for the development of such concepts.
In the Collaboration, it is expected that InveniAI will utilize its Platform to navigate the volume of data for all regulatory agency approved drugs and their associated active ingredients (Active Pharmaceutical Ingredient (“API”)) to identify potential rare and specialty disease indications for development and commercialization by Relief (“Product Concepts”). InveniAI will seek to prioritize top Product Concepts, associated diseases, scientific packages and evidence to support the potential drug development opportunities by Relief. Relief anticipates InveniAI’s Platform will complement its wholly owned subsidiary APR Applied Pharma Research SA’s existing capabilities in research and development and drug reformulation. Based on product leads developed by InveniAI, Relief hopes to develop proprietary versions of existing drugs, and to protect those drugs with long-lived intellectual property and defensible patent claims.

Under the terms of the Collaboration, Relief will pay InveniAI an initial up-front fee, success milestones and commercialization royalties for the full development program. Additional financial details were not disclosed.

“We believe that the addition of InveniAI’s AI-powered capabilities will meaningfully complement our existing drug development efforts. AI is becoming an increasingly important tool in identifying and screening new drug projects and Relief intends to fully leverage this promising technology,” stated Raghuram (Ram) Selvaraju, Chairman of Relief. “In partnering with InveniAI, we are accessing decades’ worth of expertise which has already led to successful drug re-innovation (e.g., vilazodone for treatment of depression and dexmedetomidine for treatment of agitation) and a proven platform that has been the basis of multiple partnerships with established companies. We believe that our work with InveniAI could generate multiple promising additions to our pipeline that may represent capital-efficient, cost-effective and risk-mitigated approaches to product development. In focusing on the optimization of existing approved APIs, we hope to ensure well-established clinical safety and tolerability for the product concepts identified at inception, giving us a running start in pursuing development of novel uses for these drugs. In our view, this approach will enable us to rapidly and efficiently execute innovation that brings relief to patients suffering from severe and debilitating conditions.”

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Announces CHF 15 Million Private Placement

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding whether its collaboration partner’s application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Private Placement
Attachment (PDF): 20210726_ad_hoc_Relief_PIPE_Final.pdf

Relief Therapeutics Announces CHF 15 Million Private Placement

Geneva, Switzerland, July 26, 2021 –RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that it has entered into a definitive agreement with two U.S. institutional investors to purchase in a private placement an aggregate of 71,428,572 shares of Relief common stock at a purchase price of CHF 0.21 per share. The aggregate gross proceeds from the private placement are expected to be approximately CHF 15 million, before deducting the placement agent fees and offering expenses payable by Relief. The private placement offering is expected to close on or about July 28, 2021, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

Relief plans to use the net proceeds from the private placement to acquire additional assets to expand and diversify its drug pipeline, meet its obligations to pay potential milestone payments and for general corporate purposes.

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, said: “This financing provides us with significant additional flexibility to both meet our potential future milestone payments for Acer Therapeutics Inc., APR Applied Pharma Research SA and AdVita Lifescience GmbH, while also expanding our ability to grow our pipeline. Chief among our priorities is moving ahead with our plan to further the development of RLF-100TM worldwide, as vaccine acceptance issues and new COVID-19 variants make the need for an effective therapy as great as ever.”

The private placement shares will be trading on the SIX Swiss Exchange and ranking pari passu (carrying the same rights) with Relief’s existing shares, and will be delivered from Relief’s treasury shares that were issued out of its authorized share capital under exclusion of the existing shareholders’ pre-emptive rights.

This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States absent registration under U.S. federal and state securities laws or an applicable exemption from such U.S. registration requirements.

###

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Announces Executive Changes

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_executive changes
Attachment (PDF): 20211130_ad_hoc_Relief_organizational_changes.pdf

Relief Therapeutics Announces Executive Changes

• Nermeen Varawalla, MD, PhD, MBA appointed Chief Medical Officer, replacing Gilles Della Corte, MD
• Jeremy Meinen promoted to Chief Accounting Officer
• Marco Marotta promoted to Chief Business Officer

Geneva, Switzerland, November 30, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, announced today a series of executive changes.

Nermeen Varawalla, MD, PhD, MBA has been appointed to the position of Chief Medical Officer, reporting to Raghuram (Ram) Selvaraju, PhD, MBA, Chairman of Relief. Dr. Varawalla will replace Gilles Della Corte, MD, who is leaving to pursue other opportunities. Nermeen brings to Relief deep expertise in clinical trials and medical affairs, having successfully led numerous international teams and clinical development programs for the global adoption of new pharmaceuticals and medical devices.

“Nermeen’s more than 30 years of international experience in the pharmaceutical sector, including her proven clinical development and regulatory expertise and experience within the rare disease space, is a major asset which we will immediately leverage as we seek to expand our clinical pipeline through our recently announced strategic collaboration with InveniAI, and as we progress our current proprietary and partnered product development programs,” stated Dr. Selvaraju. “Her contributions will be invaluable across the board including, of course, as it relates to the potential of RLF-100™ (for, among other respiratory issues, complications of COVID-19), the prospective launch of ACER-001 to treat Urea Cycle Disorders in 2022, and our other pipeline programs.”

Dr. Varawalla will join Relief from Atlantic Healthcare plc, a specialist pharmaceutical company with late-stage clinical assets for inflammatory bowel disease and gastrointestinal dysmotility in rare diseases, where she served as Chief Medical Officer and Head of Clinical Development. Before that, Dr. Varawalla was Managing Director of Clinstrat Ltd, a life science and healthcare business consultancy, where, among other projects, she worked with private equity firms to develop the investment thesis and business plan for the buy-out of BTG plc’s specialty pharmaceutical business unit, valued at approximately $1 billion. Before that, Dr. Varawalla was Senior Vice President and Head of Clinical Development at BTG International plc, where she led a global team responsible for clinical development of the company’s product portfolio across both pharmaceutical and medical device business units before it was acquired by Boston Scientific for $4.4 billion in 2019.

Earlier, Dr. Varawalla was Chief Medical Officer at Accord Healthcare UK, an international division of Intas Pharmaceuticals and Executive Vice President of Lambda Therapeutic Research, Intas’ full-service contract research organization. She began her career as a physician in obstetrics and gynecology at KEM Group of University Hospitals, Mumbai before continuing her specialist training at NHS University Hospitals in the United Kingdom. She is the current President of the INSEAD UK Alumni Association and is presently Chair, Medical Advisory Group, Atorvia Health Technologies and a Member of the International Advisory Council of the Oxford India Centre for Sustainable Development.

Dr. Varawalla received both her MBBS, Bachelor of Medicine and Surgery, and MD degree from the University of Mumbai; her PhD from the University of Oxford where she was a Rhodes Research Fellow and her MBA from INSEAD.

“I am honoured and delighted to accept the role of Chief Medical Officer with Relief,” said Dr. Varawalla. “I look forward to working with the company’s talented management team to develop and commercialize new medicines that will address important unmet medical needs for patients around the world.”

Relief also announced today that Jeremy Meinen, who currently serves as Relief’s Vice President of Finance and Administration, will also assume the role of Chief Accounting Officer. In that new role, he will continue to report to Jack Weinstein, Relief’s Chief Financial Officer and Treasurer.

Marco Marotta, who became part of Relief upon Relief’s acquisition of APR Applied Pharma Research SA (APR), has been promoted to Chief Business Officer, responsible for business development activities across the entire company, including strategic partnering, the management of the InveniAI collaboration and Relief’s various in-licensing and out-licensing initiatives. He will continue to report to Paolo Galfetti, President of Relief Europe. Mr. Marotta has deep expertise in operations, sales and business development in the pharmaceutical industry. During his tenure with APR, he has increased the organization’s presence in Asia and South America, executing multiple, key licensing and co-development deals. Mr. Marotta holds a Master of Science in Engineering from the University of Naples and an Executive MBA from Bocconi University.

Dr. Selvaraju added, “Today’s announced management appointments and changes reflect the expansion of Relief’s pipeline and expected future opportunities and will more strongly position the company for continued growth going forward. As I congratulate Nermeen, Jeremy and Marco on their new roles, I would like to extend our collective gratitude to Gilles for his significant contributions during what has been a truly transformative year for Relief and wish him the very best in his future endeavors.”

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Announces Filing of Lawsuit Against its U.S. Collaboration Partner, NeuroRx, Inc. and its CEO, Dr. Jonathan Javitt, for RLF-100™ (Aviptadil)

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
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Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including: (i) whether Relief's lawsuit will be successful, (ii) whether RLF-100™ (aviptadil) will ever be approved for commercialization in the United States or Europe, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_complaint filing
Attachment (PDF): 20211007_ad_hoc_Relief_Filing_Complaint.pdf

Relief Therapeutics Announces Filing of Lawsuit Against its U.S. Collaboration Partner, NeuroRx, Inc. and its CEO, Dr. Jonathan Javitt, for RLF-100™ (Aviptadil)

• Lawsuit alleges multiple breaches of Collaboration Agreement

Geneva, Switzerland, October 7, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced that it has filed a lawsuit against NeuroRx, Inc. and its Chief Executive Officer, Dr. Jonathan Javitt, for multiple breaches of the Collaboration Agreement between Relief and NeuroRx relating to the development and commercialization of RLF-100™ (aviptadil). The complaint was filed in the Supreme Court of the State of New York in Manhattan.

The complaint alleges that the defendants are in breach of numerous provisions of the Collaboration Agreement, including without limitation (i) by failing to provide Relief with the full data set from NeuroRx's recently completed phase 2b/3 clinical trial evaluating IV RLF-100™ (aviptadil) for the treatment of acute respiratory failure due to COVID-19, which data and information are required to be provided to Relief by NeuroRx under the Collaboration Agreement and which data and information are required for Relief to seek approval to commercialize the product in Europe, (ii) by failing to allow Relief, despite multiple requests, to conduct a forensic audit of NeuroRx's books and records to determine how the funds that Relief provided to NeuroRx were actually used, (iii) by entering into multiple agreements relating to the development of the product subject to the collaboration without Relief's consent, as required under the Collaboration Agreement, (iv) by engaging in commercialization efforts in territories outside the purview of NeuroRx's territory under the Collaboration Agreement, and (v) by developing additional COVID-19 treatments in violation of the exclusivity provisions of the Collaboration Agreement. The suit also alleges, among other matters, breaches of the covenant of good faith and fair dealing and tortious interference with prospective economic advantage. The Complaint, among other remedies, seeks damages, an order compelling defendants to comply with multiple provisions of the Collaboration Agreement, and a declaration directing NeuroRx to deliver the entire data set from the Phase 2b/3 clinical trial of intravenously-administering aviptadil to Relief.

"We are disappointed that NeuroRx has continued to refuse to ameliorate their breaches of the Collaboration Agreement," stated Jack Weinstein, Chief Financial Officer and Treasurer of Relief. "While we continue to hope to settle these matters with NeuroRx, we are compelled to bring this action to preserve our rights under the Collaboration Agreement and to allow us to continue to develop RLF-100™ (aviptadil) in a timely manner for the treatment of acute respiratory failure due to COVID-19 in our territories."

ABOUT RELIEF THERAPEUTICS


Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. On October 4, 2021, Acer's NDA for ACER-001 was accepted for filing by the FDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

 

Relief Therapeutics Announces Notice of Extraordinary General Meeting of RELIEF THERAPEUTICS Holding SA

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_EGM announce
Attachment (PDF): 20220103_ad_hoc_Relief_EGM_announcement_final.pdf

Relief Therapeutics Announces Notice of Extraordinary General Meeting of RELIEF THERAPEUTICS Holding SA

Geneva, Switzerland, January 3, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today gives notice of the Extraordinary General Meeting (“EGM”) of shareholders to be held on Friday, January 28, 2022.

Due to the ongoing COVID-19 pandemic, the Board of Directors decided that the meeting will be held without the presence of shareholders in accordance with the requirements of article 27 of Ordinance 3 issued by the Swiss Federal Council on Measures to Combat the Coronavirus. Guidelines on how to deliver voting instructions can be found in the EGM formal invitation, which is being sent out this week to registered shareholders and published in the Swiss Official Gazette of Commerce.

Agenda and Proposals of the Board of Directors:

1. Election of Michelle Lock as new member of the Board of Directors

The Board of Directors proposes the election of Michelle Lock as new member of the Board of Directors, for a term of office extending until completion of the upcoming Annual General Meeting.

Michelle Lock has over 25 years of strategic and operational experience in the life sciences with a strong track record of growth across multiple geographies, including the U.S., Europe, Japan, Australia, Southeast Asia and emerging markets. She is currently Senior Vice President and Head of International at Acceleron Pharmaceuticals, where she oversees its organizational build and commercial growth in countries and regions around the world. Prior to this, she was Senior Vice President and Head of Europe, Sage Therapeutics-Switzerland, where she built the company’s international business during a time of transformation. Ms. Lock also spent over 20 years with Bristol-Myers Squibb in positions of increasing responsibility in sales, commercial, general management, regional leadership and business strategy. In her final role at BMS, she served as Vice President and General Manager for EU Country Clusters & Global Capabilities Hub, Switzerland, driving the company’s leadership efforts in immuno-oncology. She has served as Honorary Ambassador between Switzerland and the U.S. since 2018 and has held several non-executive board positions.

2. Vote on the compensation of the members of the Board of Directors for the period from the Annual General Meeting 2021 until the Annual General Meeting 2022

The Board of Directors recommends that the General Meeting approves a maximum amount of CHF 2,500,000 (both fixed and variable compensation, including stock options and other benefits, but excluding employer's share of social benefit) for the members of the Board of Directors for the period from the Annual General Meeting 2021 until the Annual General Meeting 2022.

The Annual General Meeting held on June 18, 2021 previously accepted a maximum amount of CHF 1,500,000. With the proposed change in its composition, the Board of Directors recommends adjusting the compensation pool available for compensation of its members.

3. General revision of the Articles of Association

The Board of Directors proposes a general revision of the Articles of Association. The proposed revised Articles of Association are enclosed in the EGM invitation available here https://www.relieftherapeutics.com/images/EGM-invitation-2022-EN.pdf.

The Board of Directors intends, inter alia, to clarify certain existing articles and to selectively revise the following provisions, each to be submitted to a shareholders' vote:
3a. Amendment of article 2 'Purpose'
The scope of the Company's business activities is revised to ensure that the strategic plans of the Company are covered by the purpose;
3b. Amendment of article 3abis 'Authorised share capital'
The regime regarding subscription rights (including the exclusion of such rights) is clarified;
3c. Amendment of article 3b 'Conditional share capital'
The regime regarding subscription rights and preemptive rights (including the exclusion of such rights) is clarified;
3d. Amendment of article 15 'Important Decisions'
The wording of the article is clarified without change in substance;
3e. Amendment of other articles
Several revisions are proposed for clarity as well as for editorial reasons. In particular, provisions regarding circular resolutions of the Board of Directors, form of shares, and nominee regime are amended.

The agenda items 3a, 3b, 3c and 3d will be subject to the approval by two thirds of the votes represented and an absolute majority of the share par values represented.

Further details of the proposed changes to the Articles of Association can be found in the EGM invitation.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Announces Results of Extraordinary General Meeting of RELIEF THERAPEUTICS Holding SA

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_EGM results
Attachment (PDF): 220131_Ad_Hoc_Relief_EGM_Results.pdf

Relief Therapeutics Announces Results of Extraordinary General Meeting of RELIEF THERAPEUTICS Holding SA

Geneva, Switzerland, January 31, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that at its Extraordinary General Meeting (“EGM”) held on Friday, January 28, 2022, the proposed resolutions described in the EGM invitation and detailed below were approved by more than 85 percent of the represented votes.

1. Election of Michelle Lock as new member of the Board of Directors

Michelle Lock, who until recently, was Senior Vice President and Head of Europe and International at Acceleron Pharma Inc, was elected as a new member of the Board of Directors, for a term of office extending until completion of the 2022 Annual General Meeting. In addition to her tenure at Acceleron, Ms. Lock has built a wealth of strategic and operational expertise from prior positions at Sage Therapeutics and over 20 years at Bristol-Myers Squibb.

2. Approval of the compensation of the members of the Board of Directors for the period from the 2021 Annual General Meeting until the 2022 Annual General Meeting

The EGM approved a maximum amount of CHF 2,500,000 (both fixed and variable compensation, including stock options and other benefits but excluding employer's share of social benefit) for the members of the Board of Directors for the period from the 2021 Annual General Meeting until the 2022 Annual General Meeting.

3. Approval of a general revision of the Articles of Association

The EGM approved a general revision of Relief's Articles of Association. The approved revised Articles of Association were enclosed in the EGM invitation which is available here https://www.relieftherapeutics.com/images/EGM-invitation-2022-EN.pdf.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Finally, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Announces That Its Collaboration Partner, Acer Therapeutics, was Issued U.S. Patent 11,202,767 Covering ACER-001 Methods of Use for the Treatment of Urea Cycle Disorders and Maple Syrup Urine Disease

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the FDA will approve Acer’s NDA for ACER-001, (ii) whether RELIEF THERAPEUTICS Holding SA will be able to submit an application for approval of ACER-001 in Europe in the first half of 2022 (or at all), (iii) whether any such application submitted to European authorities seeking marketing authorization for ACER-001 for the treatment of patient in Europe with UCDs will be approved, and (iv) those other risks, uncertainties and factors described in RELIEF THERAPEUTICS Holding SA’s press releases and filings with the SIX Stock Exchange, all of which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_ACER001 patent
Attachment (PDF): 20220201_ad_hoc_Relief_ACER_Method_Patent_FINAL.pdf

Relief Therapeutics Announces That Its Collaboration Partner, Acer Therapeutics, was Issued U.S. Patent 11,202,767 Covering ACER-001 Methods of Use for the Treatment of Urea Cycle Disorders and Maple Syrup Urine Disease

Geneva, Switzerland, February 1, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its collaboration partner, Acer Therapeutics, has been issued a new patent from the U.S. Patent and Trademark Office (USPTO) for certain claims related to ACER-001 (sodium phenylbutyrate). Specifically, patent 11,202,767 covers methods of use claims related to ACER-001’s multi-particulate dosage formulation for oral administration as a potential treatment for Urea Cycle Disorders (UCDs) and Maple Syrup Urine Disease (MSUD). These claims are in addition to the previously reported issuance of patent 11,154,521, which covers pharmaceutical composition claims of ACER-001. Both patents have an expiration date in 2036. Acer Therapeutics’ New Drug Application (NDA) for ACER-001 to treat UCDs is currently under U.S. Food and Drug Administration (FDA) review, with a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022.

“Our collaboration partner, Acer Therapeutics, continues to solidify their intellectual property portfolio for ACER-001,” stated Raghuram (Ram) Selvaraju, Chairman of Relief. “We believe this coated formulation of sodium phenylbutyrate could be an important treatment for patients with UCDs and we hope to extend its use as a potential treatment for MSUD and other indications. In the meantime, Relief remains focused on submitting a Marketing Authorization Application for ACER-001 for the treatment of patients with UCDs in Europe.”

About UCDs

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2 The current treatment of patients with UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports3, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include aversive taste and odor4, frequency with which medication must be taken, required number of pills, and the high cost of the medication.

About ACER-001

ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). ACER-001’s multi-particulate dosage formulation for oral administration is designed to minimize the aversive taste and odor4 of sodium phenylbutyrate while quickly dissolving in the stomach. The ACER-001 NDA for UCDs is currently under FDA review with a PDUFA target action date of June 5, 2022. ACER-001 is also being developed for MSUD and has been granted orphan drug designation by the FDA for this indication. ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.

References

1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.
4. Peña-Quintana L, et al. Profile of sodium phenylbutyrate granules for the treatment of urea-cycle disorders: patient perspectives. Patient Prefer Adherence. 2017 Sep 6;11:1489-1496.

About RELIEF THERAPEUTICS Holding SA

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Finally, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

Follow us on LinkedIn.

Relief Therapeutics Announces that its Subsidiary, AdVita Lifescience GmbH, was Issued a Swiss Patent Entitled “Vasoactive Intestinal Peptide (VIP) for the Use in the Treatment of Drug-induced Pneumonitis”

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) when the patent will expire, (ii) the scope of protection from competition provided by the patent, (iii) whether aviptadil will prove useful as a treatment for checkpoint inhibitor drug-induced pneumonitis, (iv) whether aviptadil will ever be approved for commercialization for any use in any jurisdiction, and (v) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX and with the U.S. Securities and Exchange Commission, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Foot notes:
End of ad hoc announcement

show this
 
01 April 2022
Attachment Name: Ad hoc_Relief Advita Patent Issuance CIP
Attachment (PDF): Ad_hoc_Relief_Advita_Patent_Issuance_CIP.pdf

Relief Therapeutics Announces that its Subsidiary, AdVita Lifescience GmbH, was Issued a Swiss Patent Entitled “Vasoactive Intestinal Peptide (VIP) for the Use in the Treatment of Drug-induced Pneumonitis”

Geneva, Switzerland, April 1, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the Swiss Patent Office IPI has issued a patent WO2020/225246 entitled, “Vasoactive Intestinal Peptide (VIP) for the Use in the Treatment of Drug- induced Pneumonitis,” to Relief’s subsidiary, AdVita Lifescience GmbH. The patent will provide intellectual property protection for the inhaled formulation of RLF-100® (aviptadil) into at least 2039.

The patent generally relates to vasoactive intestinal peptide (VIP) for use in the treatment of drug-induced pneumonitis. In particular, it relates to VIP for use in the treatment of checkpoint inhibitor-related pulmonary pneumonitis (CIP) and methotrexate-induced pneumonitis.

“The granting of this Swiss patent for the inhaled version of RLF-100 serves to further strengthen our growing intellectual property portfolio for this highly promising drug candidate,” stated Raghuram (Ram) Selvaraju, Chairman of Relief. “Clinical studies to assess the potential advantages of RLF-100 remain ongoing, including a clinical program in Europe and the National Institutes of Health (“NIH”)-sponsored ACTIVE-3b/TESICO study.”

Immune checkpoint inhibitor therapy has become a new therapeutic option for several types of cancer, but immune related negative adverse events can limit their use. Outside of clinical studies, pneumonitis develops in as many as 10% to 20% of patients who are treated with immune checkpoint inhibitors, a complication that leads to discontinuation of treatment and to immunosuppressive therapy. Moreover, these patients suffer from recurrent pneumonitis even after immune checkpoint inhibitor treatment discontinuation and receipt of glucocorticoid treatment, according to current guidelines. Respiratory symptoms are demonstrated on computed tomography showing widespread consolidations and are denoted on Quality-of-Life Questionnaires. Patients experience severe lymphocytosis with a decreased number of regulatory T cells. As a result, there is an urgent need for an effective, safe treatment of checkpoint inhibitor-induced pneumonitis.

The unexpected finding that the synthetic form of Vasoactive Intestinal Peptide (aviptadil) administered via inhalation was well tolerated and led to dampening of alveolar inflammation, radiological and clinical improvement of pneumonitis resulting from a checkpoint inhibitor therapy for melanoma, was the basis for this issued patent.

Inhalation is the preferred route of aviptadil administration in that it, (1) acts quickly, minimizing potentially undesired negative side effects (2) avoids the hepatic first-pass metabolism, and (3) acts locally in the lungs. As the size variability among adult lungs is smaller than overall body size variability, the dosing reliability is also improved via inhalation.

This finding appeared in a Case Report Publication in the highly prestigious New England Journal of Medicine (Frye et al., 2020), a copy of which can be found here.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100® (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Announces Transitions in Commercial Organization to Implement Next Phase of Corporate Development

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_A Kim appointment
Attachment (PDF): 20211109_ad_hoc_Relief_Anthony_Kim.pdf

Relief Therapeutics Announces Transitions in Commercial Organization to Implement Next Phase of Corporate Development

• Anthony M. Kim Appointed Senior Vice President and Head of U.S. Commercial Operations – Seasoned Biotech Executive Brings Vast U.S. Commercial Launch Experience to Relief
• European and United Kingdom Commercial Operations Transitioned to Paolo Galfetti, President of Relief Europe
• Chris Stijnen to Depart Relief

Geneva, Switzerland, November 9, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, announced today the appointment, effective December 1, 2021, of Anthony M. Kim as Senior Vice President and Head of U.S. Commercial Operations. The company also reported that Chris Stijnen, Chief Commercial Officer since 2020, will be leaving to pursue other opportunities effective November 30, 2021. His duties regarding EU and UK commercial operations will be assumed by Paolo Galfetti, President of Relief Europe, and the commercial team at Relief’s subsidiary, APR Applied Pharma Research SA (“APR”).

“Our collaboration with Acer Therapeutics and strategic acquisitions of APR and AdVita Lifescience GmbH, all completed in 2021, have allowed us to significantly expand our intellectual property position and pipeline, while bringing, in-house, a number of already marketed products, such as APR’s flagship PKU GOLIKE®, for the treatment of phenylketonuria,” stated Raghuram Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. “Anthony’s appointment is a direct acknowledgement of our growing corporate needs, our commitment to our-long term growth, and our plans to expand availability of our product candidates in the U.S. including PKU GOLIKE®. Anthony will also be a key part of Relief’s plan to optimize the commercial success of ACER-001 in collaboration with our partner Acer Therapeutics. As a proven commercial leader with extensive launch experience gained during his tenures at Novocure, Alexion Pharmaceuticals, Inc. and Genentech, Anthony is an invaluable addition and we are delighted to welcome him to the Relief team.”

Dr. Selvaraju added, “I would also like to acknowledge Chris Stijnen’s extensive contributions during his time with the company. His efforts over the past year have been instrumental in helping to drive our strategy and identify key opportunities for growth. We wish him all the best in his future endeavors.”

“I am excited and honored to be joining Relief, and to help further their mission of developing innovative therapies for areas of great unmet medical need,” stated Mr. Kim. “I share the company’s vision for improving the lives of patients living with acute and rare medical conditions. I look forward to building Relief’s presence in the U.S., and to living the values of the organization with integrity, sensitivity, and humility each day.”

Prior to joining Relief, for the past three years, Mr. Kim was Vice President, Global Commercial Development at Novocure, where he led a 21-person team in the planning and U.S. marketing execution for that company’s Optune® and Optune Lua™, FDA-approved, therapeutic devices that deliver alternating electrical fields to treat patients with Glioblastoma Multiforme and Mesothelioma.

From 2017 to 2018, he was Executive Director of Marketing at Ignyta (subsequently acquired by Roche), during which time he led the development of the commercial launch plan for entrectinib, an oral, oncologic agent in pan-tumor clinical trials for patients with neurotrophic tyrosine receptor kinase (NTRK) and ROS1 fusion-positive disease. From 2012 to 2017, Mr. Kim held positions of increasing responsibility at Alexion Pharmaceuticals, Inc., most recently serving as Director, Head of U.S. Marketing, Hypophosphatasia, where he managed the U.S. marketing efforts for the launch of Strensiq, a novel, first-in-class enzyme replacement therapy for the treatment of hypophosphatasia, a rare inherited metabolic bone disorder. Earlier, from 2004 to 2012, Mr. Kim held various positions at Genentech, including Product Manager, Herceptin Marketing and Divisional Sales Manager, Rituxan Hematology.

Mr. Kim received his Bachelor of Arts Degree from Harvard University and a Master of Business Administration from The Wharton School.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Appoints Christopher Wick as Senior Director, Head of U.S. Sales

Year ordering: 2022
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This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

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16 February 2022
Attachment Name: Ad hoc_Relief_Christopher Wick
Attachment (PDF): Ad_hoc_Relief_Christopher_Wick.pdf

Relief Therapeutics Appoints Christopher Wick as Senior Director, Head of U.S. Sales

Proven Pharmaceutical Sales Professional Brings Big Pharma Experience to Relief’s U.S. Expansion Activities

Geneva, Switzerland, March 21, 2022 RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced the appointment of Christopher Wick to the newly created position of Senior Director, Head of U.S. Sales. In this position, Mr. Wick will be responsible for building out and leading the company’s U.S. sales team.

“The expansion of our pipeline and commercialized product portfolio, garnered as a result of our collaboration with Acer Therapeutics and the strategic acquisition, last year, of APR Applied Pharma Research SA, have allowed us to proactively plan for U.S. market penetration, initially, for APR’s currently marketed flagship PKU GOLIKE® to treat phenylketonuria and the potential launch of ACER-001 to treat Urea Cycle Disorders, which has a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022 ,” stated Raghuram (Ram) Selvaraju, Chairman of Relief. “In this new position, Christopher will work closely with our Head of U.S. Commercial Operations, Anthony Kim, to build our capabilities in this all important market, in order to ensure our commercial success. His highly impressive background, punctuated by extraordinary sales success during more than 20 years at ‘big pharma,’ including with Alexion Pharmaceuticals, GlaxoSmithKline and Novartis, makes Christopher a highly coveted addition to our team.”

Prior to joining Relief, Mr. Wick was, since 2018, Regional Sales Director for Alexion Pharmaceuticals, Inc., where he developed and led two high performing Excellence Award winning teams which achieved best in the nation sales for two product launches of Soliris®, for the treatment of neuromyelitis optica spectrum disorder (NOSD) and generalized myasthenia gravis (gMG). Earlier, from 2015 to 2018, he served as the company’s Southwest Regional Account Manager, where he cultivated a regional key opinion leader physician network while launching two of Alexion’s enzyme replacement therapies for ultra-rare disease.

From 2007 until 2015, Mr. Wick served in positions of increasing responsibility at GlaxoSmithKline, most recently, from 2012 to 2015, as Southwest Health Systems Account Manager helping to ensure early adoption of the company’s launch products as well as the entire pharmaceutical and biologic portfolio. In that role, he was responsible for Hospital System contracts, and collaborating with GlaxoSmithKline’s largest and most complex accounts in the Integrated Delivery Networks (IDN) and Hospital Customer Segment.

Earlier, from 1999 until 2007, Mr. Wick was an Executive Account Manager at Novartis. While there, he contributed to both Specialty and Hospital Sales, served as a National Training Leader and Regional Trainerand consistently achieved a top 15% sales ranking.

Mr. Wick attended Purdue University and earned a Bachelor of Arts in Business Administration from New Mexico State University.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Appoints Drew Cronin-Fine as Executive Director, Head of U.S. Marketing

Year ordering: 2033
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Michael Miller
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX and with the U.S. Securities and Exchange Commission, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

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26 April 2022
Attachment Name: Ad hoc_Relief_Drew Cronin-Fine
Attachment (PDF): Ad_hoc_Relief_Drew_Cronin-Fine.pdf

Proven Pharmaceutical Marketing Leader Brings Extensive Experience in Rare Diseases, Digital Innovation and New Product Launches to Relief’s U.S. Commercial Team

Geneva, Switzerland, April 26, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, announced today the appointment, effective May 3, 2022, of Drew Cronin-Fine as Executive Director, Head of U.S. Marketing. In this newly created position, Ms. Cronin-Fine will be responsible for building and leading the U.S. Marketing team. She will report to Anthony Kim, Senior Vice President and Head of U.S. Commercial Operations.

“Drew’s addition to the company reflects our continued commitment to building out our U.S. commercial team in anticipation of the rollout of PKU GOLIKE®, the flagship product line of our wholly owned subsidiary, APR Applied Pharma Research, SA (APR), and the upcoming June 5, 2022 Prescription Drug User Fee Act (PDUFA) date and potential launch of ACER-001 to treat Urea Cycle Disorders, in collaboration with Acer Therapeutics,” stated Mr. Kim. “Drew’s success in launching numerous products in the rare disease space, as well as her proven skills in digital technology and team building, gained from her tenures at Intercept Pharmaceuticals and Cubist Pharmaceuticals, make her a key member of the U.S. commercial team as we optimize our emerging rare disease pipeline.”

“My passion for improving the lives of patients with rare diseases, coupled with the opportunity to be part of the launch of potential new products in the U.S., were key factors that drew me to this exciting role at Relief Therapeutics,” added Ms. Cronin-Fine. “I look forward to joining the emerging commercial team at Relief and being an integral part of its mission to develop therapeutics for serious diseases with few or no existing treatment options.”

Prior to joining Relief, for the past seven years, Ms. Cronin-Fine held numerous positions of increasing responsibility in U.S. Marketing at Intercept Pharmaceuticals, Inc. As Executive Director, she led the U.S. Marketing department for OCALIVA®, indicated for use in primary biliary cholangitis, an orphan liver disease. While at Intercept, her responsibilities included overseeing the healthcare practitioner, patient, market access, and digital marketing strategies. From 2012 to 2015, Ms. Cronin-Fine worked at Cubist Pharmaceuticals (subsequently acquired by Merck), most recently serving as Associate Director, U.S. Marketing, where she managed the U.S. market research, market access, and forecasting budget plan for ZERBAXA®, a gram-negative anti-infective drug. Earlier in her career, from 2006 to 2011, Ms. Cronin-Fine was Co-founder and Chief Operating Officer of Zinuara Pharma, a company focused on the clinical development of Huperzine A, for the treatment of epilepsy and pain. She also served as a consultant and analyst at IMS Consulting (now IQVIA) in the pricing and reimbursement group.

Ms. Cronin-Fine earned a Bachelor of Science degree from Brown University, a Master of Business Administration degree from Harvard Business School, and a Master of Science from the Harvard-MIT Division of Health Sciences and Technology.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100® (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Comments on Certain Statements Made by NRx Pharmaceuticals in its Registration Statement on Form S-1 Filed on September 3, 2021

Year ordering: 2021
Media Contact:

 

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Michael Miller
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Jack Weinstein
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether Relief can satisfactorily resolve its ongoing disputes with NeuroRx without litigation, (ii) whether Relief will prevail in any litigation action with NeuroRx over the terms of the Collaboration Agreement, (iii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding AG's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx_S1_response
Attachment (PDF): 210907_Relief_S1_response_PR.pdf

 

Relief Therapeutics Comments on Certain Statements Made by NRx Pharmaceuticals in its Registration Statement on Form S-1 Filed on September 3, 2021

Geneva, Switzerland, September 07, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company"), commented today on statements made by NRx Pharmaceuticals, Inc. ("NRx"), the parent corporation of Relief's collaboration partner for RLF-100™ (aviptadil) in the United States, NeuroRx, Inc. ("NeuroRx"), in NRx's Registration Statement on Form S-1 filed on September 3, 2021 (the "Registration Statement"). In the Registration Statement, NRx makes several assertions that Relief believes require a public comment so that the marketplace has relevant information about the pending disputes between Relief and NeuroRx. Among other issues in dispute, based on currently available information, are the following:

  1. The Registration Statement includes numerous statements of purported fact setting forth NeuroRx's version of the history of the relationship between the companies that led to the signing of the Binding Collaboration Agreement, dated September 18, 2020 (the "Collaboration Agreement"). While Relief believes that many of the statements made by NRx in the Registration Statement on this topic are false or misleading, Relief does not believe that it is necessary to lay out that historical record in public reporting, since it has no application to the current and ongoing relationship between the parties. Relief notes that the Collaboration Agreement expressly states that it "supersedes any and all prior understandings or agreements, whether written or oral, and there are no promises, agreements, condition, undertakings, warranties or representations (whether oral or written, express or implied) between them other than as [herein set forth]." Therefore, the history of what discussions led up to the parties' entry into the Collaboration Agreement has no application to the parties' rights and responsibilities presently in force and effect.

  2. In the Registration Statement, NRx accuses Relief of misleading them and Relief's public shareholders about the stability of the formulation of aviptadil that Relief brought to the parties' collaboration. Relief reiterates, once again, that in its opinion, there is no truth to these allegations, and that NeuroRx was expressly tasked with developing a stable formulation of aviptadil under the Collaboration Agreement. Further, Relief reiterates, once again, that it never guaranteed that it already had an 18-month shelf stable product, and no such statements are made in the Collaboration Agreement, which contains the entire agreement between the parties. Finally, Relief once again reiterates its belief that the version of aviptadil that was and is being used by NeuroRx in its clinical trials is the drug version covered by the Collaboration Agreement.

  3. NRx continues to state in the Registration Statement that Relief has not paid certain amounts due to NeuroRx relating to the collaboration. While the amount allegedly owed by Relief to NeuroRx according to the Registration Statement has grown exponentially when compared to the amounts stated in NRx's earlier public filings, Relief reports, once again, that not only has it met all of its financial obligations under the Collaboration Agreement, but that it has not received invoices documenting amounts anywhere close to the amounts that NeuroRx claims are allegedly due. Relief continues to have no idea of how the amount allegedly owed that is set forth in the Registration Statement is calculated and has demanded that it be allowed to perform a forensic audit on NeuroRx's books and records to determine the accuracy of the financial information provided to Relief (which NeuroRx has, to date, refused to allow).

  4. In the Registration Statement, NRx states that Relief has "declined" to fund certain expenses relating to the development of the formulation of aviptadil and NeuroRx's clinical trial evaluating inhaled aviptadil for the treatment of patients with moderate to severe COVID-19. In fact, for some months, Relief has repeatedly requested information that is reasonably necessary to make a decision on whether or not to fund these expenses. Until sufficient information is provided so that Relief can make the decision whether or not to fund these expenses, the Collaboration Agreement does not allow NeuroRx to bring in another source to directly fund these expenses.

  5. NeuroRx continues to refuse, despite repeated demands by Relief requesting this information, to share with Relief the full clinical trial data set, including details on the statistical analysis performed, from its recently completed phase 2b/3 trial, which data and information is required to be provided to Relief by NeuroRx under the Collaboration Agreement. To date, Relief has only received a high-level summary of the clinical study report and has not been provided with, among other information, access to the 53,909 individual case reports, the raw data from the clinical trial, or the data on the multiple statistical analyses performed. NeuroRx has likewise refused to share with Relief any of the correspondence between NeuroRx and the FDA. Further, NeuroRx has refused to allow NeuroRx's contract partners dealing with issues relating to the development of aviptadil to share information with Relief that it requires to develop RLF-100™ (aviptadil) in its territories (including the European Union and the United Kingdom). The failure of NeuroRx to provide this information is seriously impairing Relief's ability to develop and execute a clinical and regulatory strategy for RLF-100™ (aviptadil) in its territories.

  6. Relief reminds NeuroRx that under Section 5.1 of the Collaboration Agreement, neither party may engage in any development activities for any drug or related product or treatment intended to be used to treat, combat, ameliorate, prevent or mitigate the effects of COVID-19 that can or may reasonably be expected to compete against or reduce sales (or other monetization) of aviptadil.

  7. Relief believes that it has satisfied all of its obligations under the Collaboration Agreement and that as a result, all revenue/profit splits set forth in the Collaboration Agreement remain in full force and effect.
    Relief intends to continue to seek an amicable resolution of its pending disputes with NeuroRx relating to the Collaboration Agreement. However, if such disputes are not resolved to Relief's satisfaction, Relief intends to take all actions necessary to enforce its rights under the Collaboration Agreement. While there can be no assurance, Relief believes that it will prevail in any such legal action to enforce its rights under the Collaboration Agreement.

ABOUT RELIEF THERAPEUTICS HOLDING AG

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol "RLF" and quoted in the U.S. on OTCQB under the symbol "RLFTF." For more information, visit www.relieftherapeutics.com.
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Relief Therapeutics Comments on NRx Pharmaceuticals' Press Release Reporting on its Recently Filed Lawsuit

Year ordering: 2022
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Michael Miller
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Michael Miller
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This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will be successful in its breach of contract action against NRx's subsidiary, NeuroRx, and NeuroRx's CEO, Jonathan Javitt, and in defending NeuroRx's recently filed lawsuit, (ii) whether the upcoming mediation will be successful, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx PR comment
Attachment (PDF): 20220114_ad_hoc_Relief_Response_to_NeuroRx.pdf

Relief Therapeutics Comments on NRx Pharmaceuticals' Press Release Reporting on its Recently Filed Lawsuit

Geneva, Switzerland, January 14, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, commented today on the press release that NRx Pharmaceuticals ("NRx") issued on Wednesday evening (the "NRx Press Release") reporting on the recently filed lawsuit that its subsidiary, NeuroRx, Inc. ("NeuroRx") filed against Relief earlier this week. In response to the NRx Press Release, Relief reported:

  • Notwithstanding the position taken by NRx in the NRx Press Release that the collaboration agreement between the parties has been cancelled, Relief continues to believe that the collaboration agreement between the parties with respect to aviptadil remains in full force and effect, and that NeuroRx, and not Relief, is in breach of that agreement.

  • The NRx Press Release includes numerous statements that Relief believes to be false and materially inaccurate. Among others, these include statements made in the NRx Press Release regarding the formulation of aviptadil that is the subject of the collaboration agreement, and statements made that suggest that Relief has not satisfied its financial obligations under the collaboration agreement (in a situation where Relief has advanced significant sums to NeuroRx up to the maximum amounts required to be paid under the collaboration agreement and that amounts that NeuroRx asserts are unpaid have not been paid as a direct result of NeuroRx failing to provide the required supporting documentation). Moreover, NeuroRx's egregious breaches of the collaboration agreement, as set forth in Relief's pleadings, excused any obligations that Relief might have had to fund additional amounts to NeuroRx under the circumstances. Finally, Relief asserts that the statements in the NRx Press Release to the effect that Relief is misleading the public and its shareholders in its public statements and regulatory filings are false and likely defamatory.

  • The NRx Press Release discusses a damages calculation that Relief believes to be completely Illogical and unsupported. The NRx Press Release also makes statements, which Relief believes are inaccurate and misleading, to the effect that Relief's conduct was so egregious as to warrant the imposition of punitive damages. If anything, NeuroRx's conduct, and not Relief's conduct, warrants the imposition of punitive damages.

  • Relief asserts that the statements made in the NRx Press Release regarding the Chairman of Relief, Ram Selvaraju, are false and likely defamatory. Relief expressly asserts that no members of Relief's board or management are criminals or have been incarcerated, and Relief believes that NeuroRx's statements in the NRx Press Release, and Jonathan Javitt's statements in his multiple posts on investor message boards regarding this topic, are false and likely defamatory as to Relief and its board and management.

Relief reports that the allegations in NeuroRx's complaint will be responded to in an appropriate filing with the court after NeuroRx's complaint is served on Relief. Further, in light of NeuroRx's claims in its recently filed lawsuit, and the statements made in the NRx Press Release, Relief is considering whether to file additional claims against NeuroRx and Jonathan Javitt. While there can be no assurance, Relief remains confident in the validity of its claims against NeuroRx and Jonathan Javitt.

Finally, Relief wishes to clarify the record regarding statements made in the NRx Press Release about the date of the mediation, so that the market has clarity as to what occurred. Following the filing of Relief's complaint on October 6, 2021, the parties agreed to engage in an effort to attempt to amicably resolve the litigation, which included an agreement by NeuroRx to produce certain financial records to Relief prior to the mediation. The original date set for the mediation was January 5, 2022. However, when NeuroRx failed to meet its own deadline for producing the agreed-upon financial documents, the parties agreed to reschedule the mediation date to February 22, 2022. Therefore, the statement made in the NRx Press Release that Relief has unilaterally delayed the mediation is misleading and does not reflect the fact that had NeuroRx provided the financial records it agreed to provide prior to the mediation on the timeline that it committed to meet, the mediation would likely have taken place in early January.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief's collaboration partner in the U.S., NeuroRx. Further, as part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Finally, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, have brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

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Relief Therapeutics Files Amendment No. 1 to its Registration Statement on Form 20-F with the U.S. Securities and Exchange Commission

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

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Jack Weinstein
Chief Financial Officer and Treasurer 
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the Registration Statement will become effective, (ii) whether a market will develop for Relief's ADRs, (iii) whether, if Relief's ADRs are traded in the U.S., they will become eligible to be listed on the Nasdaq Stock Market, and the timing of any such listing, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, press releases and filings with the SEC, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

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16 February 2022
Attachment Name: Ad hoc_Relief_20-F Amendment No. 1
Attachment (PDF): Ad_hoc_Relief_20-F_Amendment_No._1.pdf

Relief Therapeutics Files Amendment No. 1 to its Registration Statement on Form 20-F with the U.S. Securities and Exchange Commission

Geneva, Switzerland, March 21, 2022 RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) ("Relief"), announced today that it has filed Amendment No. 1 to its Registration Statement on Form 20-F ("Registration Statement") with the U.S. Securities and Exchange Commission ("SEC"). The Registration Statement is intended to register Relief as a reporting company under the Securities Exchange Act of 1934. The Registration Statement has been filed as part of an ongoing program to convert Relief's Level 1 American Depositary Receipt ("ADR") program in the United States to a Level 2 ADR program and is part of Relief's ongoing efforts to list its ADRs on the Nasdaq Stock Market. The Nasdaq listing will only occur after the Registration Statement has become effective, which is subject to a continuing review of the Registration Statement by the SEC, and the filing by Relief of a listing application with the Nasdaq (which has not yet occurred). There can be no assurance that the Registration Statement will become effective or that Relief will be successful in its efforts to list its ADRs to the Nasdaq Stock Market.

The filing of the Registration Statement is not part of an offering of securities. Therefore, Relief will receive no proceeds from its current ADR program.

This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy any securities in the United States or any other jurisdiction, nor shall there be any offer or sale of securities in the United States or any other jurisdiction in which such offer, solicitation, or sale would be unlawful unless registered and/or qualified under applicable securities laws. This press release does not constitute a prospectus according to art. 35 of the Swiss Financial Services Act dated 15 June 2018, as amended ("FinSA"), or art. 27 et seqq. of the SIX Swiss Exchange Listing Rules. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of Relief in or into Switzerland within the meaning of FinSA. Further, the ADRs have not been registered under the Securities Act of 1933, as amended (the "Act"), and no public offering of securities shall be made in the United States except by means of a prospectus meeting made available by Relief that contains detailed information about Relief and its management, as well as financial statements meeting the requirements of the Act.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief has also a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 was recently accepted for filing by the FDA with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, have brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Files Registration Statement on Form 20-F with the U.S. Securities and Exchange Commission

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
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Rx Communications Group

Michael Miller
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the registration statement will become effective, (ii) whether a market will develop for Relief's ADRs, (iii) whether, if Relief's ADRs are traded in the U.S., they will become eligible to be listed on the NASDAQ Stock Market, and the timing of any such listing, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases, filings with the SIX, and filings with the U.S. Securities and Exchange Commission, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_20F
Attachment (PDF): 20211216_ad_Hoc_Relief_FILING_OF_FORM_20-F.pdf

Relief Therapeutics Files Registration Statement on Form 20-F with the U.S. Securities and Exchange Commission

Geneva, Switzerland, December 16, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), announced today that it has filed a Registration Statement on Form 20-F with the U.S. Securities and Exchange Commission ("SEC") to register Relief as a reporting company under the Securities Exchange Act of 1934. The registration statement is being filed to begin the process of uplisting Relief's Level 1 American Depositary Receipt ("ADR") program in the United States to a Level 2 ADR program and is part of Relief's ongoing efforts to list its ADRs on the NASDAQ Stock Market during the first half of 2022. The NASDAQ listing will only occur after the registration statement has become effective, which is subject to an SEC review, and the filing by Relief of a listing application with the NASDAQ, which has not yet occurred. There can be no assurance that the registration statement will become effective or that Relief will be successful in its efforts to uplist its ADRs to the NASDAQ Stock Market.

Relief's ADR program complements its existing primary listing of its ordinary shares on the SIX Swiss Exchange. Relief's ordinary shares are listed on the SIX Swiss Exchange under the symbol "RLF" and are quoted in the U.S. on the OTCQB market under the symbol "RLFTF." Relief's ADRs, which represent one-hundred and fifty (150) of Relief's ordinary shares, presently trade in the U.S. over-the-counter market under the trading symbol "RLFTY."

The filing of the Registration Statement on Form 20-F by Relief is not part of an offering of securities. Therefore, Relief will receive no proceeds from its current ADR program.

This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy any securities in the United States or any other jurisdiction, nor shall there be any offer or sale of securities in the United States or any other jurisdiction in which such offer, solicitation, or sale would be unlawful unless registered and/or qualified under applicable securities laws. This press release does not constitute a prospectus according to art. 35 of the Swiss Financial Services Act dated 15 June 2018, as amended ("FinSA"), or art. 27 et seqq. of the SIX Swiss Exchange Listing Rules. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of Relief in or into Switzerland within the meaning of FinSA. Further, the ADRs have not been registered under the Securities Act of 1933, as amended (the "Act"), and no public offering of securities shall be made in the United States except by means of a prospectus meeting made available by Relief that contains detailed information about Relief and its management, as well as financial statements meeting the requirements of the Act.

Instructions for converting Relief ordinary shares into Relief ADRs are posted on Relief's website at https://www.relieftherapeutics.com/ADRInstructions.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Launches Level 1 ADR Program in the United States

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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RELIEF THERAPEUTICS Holding SA

Jack Weinstein
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Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether a market will develop for Relief's ADRs, (ii) whether, if Relief's ADRs are traded in the U.S., they will become eligible to be listed on the NASDAQ Stock Market, and the timing of any such listing, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_ADR Level 1 launch
Attachment (PDF): 20211118_ad_hoc_Relief_ADR_Level_1_Launch.pdf

Relief Therapeutics Launches Level 1 ADR Program in the United States

Geneva, Switzerland, November 18, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), announced today that its Form F-6 registration statement has become effective, and that Relief has launched its Level 1 American Depositary Receipt ("ADR") program in the United States (“U.S.”). It is expected that Relief's ADRs will begin trading on the over-the-counter ("OTC") market today, November 18, 2021, under the trading symbol ("RLFTY"). Relief's ADR program will complement its existing primary listing of ordinary shares on the SIX Swiss Exchange ("SIX"). J.P. Morgan has been appointed as the depositary bank for the Level 1 ADR program.

An ADR is a negotiable receipt, resembling a stock certificate, that is issued by a U.S. depositary bank appointed by a company to evidence one or more American Depositary Shares ("ADSs"). In the case of Relief's ADRs, each ADS will represent one hundred and fifty (150) of Relief's ordinary shares. ADRs allow U.S. investors to buy shares in foreign companies without the need for cross-border or cross-currency transactions. They are priced in U.S. dollars and can be traded like shares of U.S.-based companies listed on the OTC market.

Under the program, the owners and holders of ADSs will have the same rights to dividends and distributions and voting powers as the holders of Relief's ordinary shares subject, however, to enforcement procedures provided in the deposit agreement entered into by and among Relief, J.P. Morgan, as the depositary, and the owners and holders of ADSs.

The establishment of the program by Relief is not a new offering of securities, and the ADRs will be based on the Relief ordinary shares currently in issue. Therefore, Relief will receive no proceeds from the establishment of the program. However, Relief's goal is to take the necessary steps in the future to transition from a Level 1 ADR program to a Level 2 or a Level 3 ADR program, with the ultimate goal of listing its ADRs on the Nasdaq Stock Market during the first half of 2022. There can be no assurance that Relief will be successful in those efforts.

Instructions for converting Relief ordinary shares into ADRs are posted on Relief's website at https://www.relieftherapeutics.com/investor-relations or CLICK HERE.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide ("VIP"), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Provides Update on Regulatory Interactions in the United Kingdom and European Union Relating to Lead Drug Candidate, RLF-100 (Aviptadil)

Year ordering: 2021
Media Contact:

 

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
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Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx will provide Relief with the data from its Phase 2b/3 study, (ii) whether aviptadil will ever be approved in the UK or the EU for the treatment of respiratory failure in critically ill patients with COVID-19, and (iii) those risks discussed in Relief's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_MHRA
Attachment (PDF): 210913_Relief_MHRA_Regulatory_Guidance.pdf

Relief Therapeutics Provides Update on Regulatory Interactions in the United Kingdom and European Union Relating to Lead Drug Candidate, RLF-100 (Aviptadil)

Geneva, Switzerland, September 13, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that it has received scientific advice from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) relating to its lead investigational drug, RLF-100(TM) (aviptadil), for the treatment of respiratory deficiency due to severe COVID-19. The guidance, which was provided in the context of a recent meeting that Relief held with the MHRA, included advice on the appropriate pathway for submission of an application for conditional marketing approval (CMA)  for the intravenous formulation of RLF-100, subject to provision of all data from the U.S. Phase 2b/3 study conducted by Relief’s collaboration partner, NeuroRx, Inc. ("NeuroRx") According to the MHRA, a CMA through rolling review or expedited review process would be an appropriate pathway to ensure speedy access to beneficial treatments for patients infected with COVID-19. A rolling review allows the MHRA to start review of various sections of a submission as they are completed by Relief and provided to the MHRA.

Relief also reported today that it has held discussions with the European Medicines Agency (EMA) pertaining to the regulatory path forward for RLF-100 in the European Union.  Relief has informed EMA that it will proceed with further dialogue with the MHRA once it has compiled critical information related to the study conduct, clinical data and the drug product.

Relief also reported that, to date, NeuroRx has not provided it with all of the data from its U.S. Phase 2b/3 study evaluating intravenously administered aviptadil for the treatment of respiratory failure in critically ill patients with COVID-19. There can be no assurance that NeuroRx will provide the required information.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

1 In the interest of public health, a CMA may be granted for medicines on less comprehensive clinical data than normally required, where the benefit of immediate availability of the medicine outweighs the risk inherent in the fact that additional data are still required. Medicines for human use are eligible if they are intended for treating, preventing or diagnosing seriously debilitating or life-threatening diseases. This includes orphan medicines. Its use is also intended for a public health emergency (e.g., a pandemic).

Relief Therapeutics Reports Execution of Stipulation with NeuroRx and Jonathan Javitt to Continue Mediation Process

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the pending disputes between Relief, NeuroRx and Dr. Javitt can be resolved without further litigation, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, press releases and filings with the SEC, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Foot notes:
End of ad hoc announcement

show this
 
05 April 2022
Attachment Name: Ad hoc_Relief_Stipulation
Attachment (PDF): Ad_hoc_Relief_Stipulation.pdf

Relief Therapeutics Reports Execution of Stipulation with NeuroRx and Jonathan Javitt to Continue Mediation Process

Geneva, Switzerland, April 5, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) ("Relief"), today reported that it has entered into a stipulation to stay the proceedings in its pending litigation with NeuroRx, Inc. and Jonathan Javitt to allow the parties to attempt to seek to mediate their dispute. The parties have previously begun mediating their dispute and have made progress in said mediation. Under the stipulation, which has been approved by the court, the mediation has been stayed for 90 days to allow the parties to focus on these mediation efforts. The stipulation also extends the standstill period for additional periods of time under certain circumstances.

There can be no assurance that the parties will be able to successfully mediate their dispute.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief has also a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 was recently accepted for filing by the FDA with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, have brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Reports that Collaboration Partner, NRx Pharmaceuticals, and Quantum Leap Announce Treatment of Severely Ill COVID-19 Patients with Aviptadil in the I-SPY COVID Trial

Year ordering: 2021
Media Contact:

MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
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RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
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Disclaimer:

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding the timing or results of the I-SPY trial nor that NRx's application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_ISPY
Attachment (PDF): 20210713_ad_hoc_PR_confirm_RLF100_ISPY_first_patient_treated_EN.pdf

Relief Therapeutics Reports that Collaboration Partner, NRx Pharmaceuticals, and Quantum Leap Announce Treatment of Severely Ill COVID-19 Patients with Aviptadil in the I-SPY COVID Trial

Geneva, Switzerland, July 13, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that its collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”) and Quantum Leap Healthcare Collaborative™ (“Quantum Leap”) have announced that they have begun treating patients with inhaled aviptadil in the I-SPY COVID Trial (NCT04488081), a phase 2 adaptive platform trial aimed at improving treatment for severely and critically ill COVID-19 patients. The related NRx/Quantum Leap press release can be accessed through the following link.

###

 

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s acquisition of APR Applied Pharma Research brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Reports the Successful Conclusion of the Patent Examination Procedure for the Patent Application Entitled, “Vasoactive Intestinal Peptide (VIP) for the Use in the Treatment of Drug-induced Pneumonitis”

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
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Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) when the patent will be issued, (ii) when the patent, once issued, will expire, (iii) the scope of protection from competition provided by the patent, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX and with the U.S. Securities and Exchange Commission, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Advita patent
Attachment (PDF): 20211228_ad_hoc_Relief_Advita_Patent_pneumonitis.pdf

Relief Therapeutics Reports the Successful Conclusion of the Patent Examination Procedure for the Patent Application Entitled, “Vasoactive Intestinal Peptide (VIP) for the Use in the Treatment of Drug-induced Pneumonitis”

Geneva, Switzerland, December 28, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the Swiss Patent Office IPI has announced that it expects to conclude the patent application procedure by January 24, 2022 and to issue the patent entitled, “Vasoactive Intestinal Peptide (VIP) for the Use in the Treatment of Drug-induced Pneumonitis,” as applied for by Relief’s subsidiary, AdVita Lifescience GmbH, in 2020. The patent will be formally issued, at the earliest, one month after the conclusion of the patent examination procedure.

“The pending grant of this Swiss patent for the inhaled version of RLF-100™ (aviptadil) represents another important milestone for the Company and further solidifies our growing intellectual property portfolio,” stated Raghuram (Ram) Selvaraju, Chairman of Relief. “The potential benefits of this inhaled formulation of RLF-100™ are intriguing and a number of studies to assess its advantages remain ongoing, including a clinical program in Europe as well as the National Institutes of Health (“NIH”)-sponsored ACTIVE-3b/TESICO study and the I-SPY trial sponsored by Quantum Leap.”

Immune checkpoint inhibitor therapy has become a new therapeutic option for several types of cancer, but immune related negative adverse events can limit their use. Outside of clinical studies, pneumonitis develops in as many as 10% to 20% of patients who are treated with immune checkpoint inhibitors, a complication that leads to discontinuation of treatment and to immunosuppressive therapy. Moreover, these patients suffer from recurrent pneumonitis even after immune checkpoint inhibitor treatment discontinuation and receipt of glucocorticoid treatment, according to current guidelines. Respiratory symptoms are demonstrated on computed tomography showing widespread consolidations and are denoted on Quality of Life Questionnaires. Patients experience severe lymphocytosis with a decreased number of regulatory T cells. As a result, there is an urgent need for an effective, safe treatment of checkpoint inhibitor–induced pneumonitis.

The unexpected finding that the synthetic form of Vasoactive Intestinal Peptide (aviptadil) administered via inhalation was well tolerated and led to dampening of alveolar inflammation, radiological and clinical improvement of pneumonitis resulting from a checkpoint inhibitor therapy for melanoma, was the basis for this issued Patent.

Inhalation is the preferred route of aviptadil administration in that it, (1) acts quickly, minimizing potentially undesired negative side effects (2) avoids the hepatic first-pass metabolism, and (3) acts locally in the lungs. As the size variability among adult lungs is smaller than overall body size variability, the dosing reliability is also improved via inhalation.

This finding appeared in a Case Report Publication in the highly prestigious New England Journal of Medicine (Frye et al., 2020).

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Reports Two Publications of Positive Data on Nexodyn® AOS for Hard-to-Heal Ulcers

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Nexodyn publication
Attachment (PDF): 20211020_ad_hoc_Relief_Nexodyn_publication.pdf

Relief Therapeutics Reports Two Publications of Positive Data on Nexodyn® AOS for Hard-to-Heal Ulcers

A Prospective Series on Wound Bed Preparation with Nexodyn® AOS and Standard of Care and a 32-Week Follow-Up Study Published in the Peer Reviewed Journal of Wound Care

Geneva, Switzerland, October 20, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), reported two papers published in the peer reviewed Journal of Wound Care, concluding that the company’s Nexodyn® acid-oxidizing solution (AOS), developed with APR’s proprietary Tehclo® technology, may represent a valuable therapeutic addition to standard of care (SOC) for the management of hard-to-heal ulcers requiring long periods of treatment. The data also confirmed the safety of Nexodyn® AOS.

Conducted by Elia Ricci, M.D., Director of the Difficult Wound Healing Unit, St. Luca Clinic, Department of Surgery A, Pecetto Torinese (TO), Piedmont, Italy, the prospective case series evaluated the clinical impact of Nexodyn® AOS in addition to SOC. Between February 2015 and February 2017, a total of 60 patients with hard-to-heal ulcers of various etiologies took part in the study. Patients were treated for 70 days with Nexodyn® AOS and the usual SOC wound dressings. The follow-up study, also conducted by Dr. Ricci, included a subset of 31 patients (51.7%) whose wounds had not fully healed by day 70, who opted to continue with treatment for another 22 weeks (for a total treatment time of 32 weeks).

By day 70, 68.3% of wounds had healed or improved, and a significant mean wound size reduction of 21% from baseline was observed (p<0.001), despite a mean baseline wound duration of 20.6 months. 90% of patients were able to control signs of infection with a significant reduction versus baseline. Additionally, Bates–Jensen and wound bed preparation (WBP) scores improved with a significant increase of patients with 100% granulation tissue, and pain scores fell significantly over time. Overall, use of Nexodyn® AOS plus SOC allow a decreased number of dressing changes. In the follow-up study, by week 32, 35.5% (n=11) of wounds healed completely and 83.9% showed improvement. Additionally, all wounds were free of infection and colonization, the WBP score improved (100% A1–A2 at T196), and pain scores fell. This follow-up evaluation, coupled with the primary study, suggests that Nexodyn® AOS may represent a valuable and safe therapeutic option in addition to SOC for the management of hard-to-heal ulcers for long periods of treatment.

“The publication of additional data provides further evidence of the effectiveness of Nexodyn® AOS, developed with our proprietary, globally patented Tehclo® nanotechnology platform, in addition to SOC – in particular, its ability to reactivate the healing process in hard-to-heal lesions,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “Also of note, the study showed that Nexodyn® AOS, with its antimicrobial properties, can create an optimal microenvironment, reducing the bioburden, modulating inflammation by inactivating matrix metalloproteinases and increasing oxygenation. Additionally, clinical benefit was observed even in wounds with less favorable initial conditions, such as a large area and/or depth or long duration, adding further evidence that Nexodyn® AOS is an important treatment for hard-to-treat wounds.”

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief added, “These results reinforce the importance of Nexodyn® AOS as a critical wound healing treatment and provide additional real-world evidence to support our belief that an adaptation of Nexodyn® AOS may also become an effective therapeutic option for wound healing in patients suffering from epidermolysis bullosa (EB).”

About Nexodyn® Acid-Oxidizing Solution (AOS)

Nexodyn® Acid-Oxidizing Solution (AOS) is a Tehclo®-based product proven to restart wound healing in stalled wounds by creating the ideal microenvironment to sustain the physiological healing process. A wealth of evidence and real-world experience consistently show accelerated closure with reduced infection rates and less wound-associated pain.

Nexodyn® AOS is a solution with three main features: highly pure and stabilized hypochlorous acid (HClO >95% of free chlorine species), acidic pH (2.5 – 3.0) and high Reduction-Oxidation Potential (ORP 1.000 – 1.200 mV). The product is a sprayable solution with ancillary antimicrobial properties intended for use in the debridement, irrigation, cleansing and moistening of acute and chronic wounds (e.g., diabetic foot ulcers, pressure ulcers, and vascular ulcers), post-surgical wounds, burns and other lesions. The product is certified in the European Union as a Class III medical device.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Takes First Step to Create an ADR Program in the United States by filing a Form F-6 Registration Statement with the U.S. Securities and Exchange Commission

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
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Michael Miller
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This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether Relief's registration statement on Form F-6 will ever become effective, (ii) whether a market will develop for Relief's ADRs, (iii) whether, if Relief's ADRs are traded in the U.S., they will become eligible to be listed on the NASDAQ Stock Market, and the timing of any such listing, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_ADR program
Attachment (PDF): F-6_Filing_Press_Release_November_3J_2021_FINAL.pdf

Relief Therapeutics Takes First Step to Create an ADR Program in the United States by filing a Form F-6 Registration Statement with the U.S. Securities and Exchange Commission

Geneva, Switzerland, November 3, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), announced today that it has taken the first steps to establish a Level 1 American Depositary Receipt (ADR) program in the United States by filing a registration statement on Form F-6 with the U.S. Securities and Exchange Commission. It is expected that Relief's ADRs will begin trading in the over-the-counter (OTC) market at some point after its registration statement becomes effective, and Relief intends to issue a press release and announce the ticker symbol for its ADRs closer to the program's effective date. Relief's ADR program will complement its existing primary listing on the SIX Swiss Exchange ("SIX"). JPMorgan Chase Bank, N.A. ("JPMorgan") has been appointed as the depositary bank for the Level 1 ADR program.

An ADR is a negotiable receipt, resembling a stock certificate that is issued by a United States depositary bank appointed by a company to evidence one or more American Depositary Shares ("ADSs"). In the case of Relief's ADRs, each ADS will represent one hundred and fifty (150) of Relief's ordinary shares. ADRs allow U.S. investors to buy shares in foreign companies without the need for cross-border or cross-currency transactions. They are priced in US dollars and can be traded like shares of U.S.-based companies in the OTC market.

Under the program, the owners and holders of ADSs will be entitled to dividends and distributions and have voting powers with respect to Relief's ordinary shares represented by their ADSs subject, however, to the provisions and enforcement procedures provided in the deposit agreement to be entered into by and among Relief, JPMorgan as the depository, and all holders and beneficial owners from time to time of ADRs issued thereunder.

The establishment of the program by Relief is not an offering of new Relief ordinary shares, and the ADSs will be based on the Relief ordinary shares currently in issue. Therefore, Relief will receive no proceeds from the establishment of the program. However, Relief's goal is to take the necessary steps in the future to transition its ADR program from a Level 1 ADR program to a Level 2 or a Level 3 ADR program, with the ultimate goal of listing its ADRs on the NASDAQ Stock Market during the first half of 2022. There can be no assurance that Relief will be successful in those efforts.

This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy any securities in the United States or any other jurisdiction, nor shall there be any offer or sale of securities in the United States or any other jurisdiction in which such offer, solicitation, or sale would be unlawful unless registered and/or qualified under applicable securities laws. This document does not constitute a prospectus according to art. 35 of the Swiss Financial Services Act dated 15 June 2018, as amended ("FinSA"), or art. 27 et seqq. of the SIX Swiss Exchange Listing Rules. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of Relief in or into Switzerland within the meaning of FinSA. Further, the ADRs have not been registered under the Securities Act of 1933, as amended (the "Act"), and no public offering of securities shall be made in the United States except by means of a prospectus meeting made available by Relief that contains detailed information about Relief and its management, as well as financial statements meeting the requirements of the Act.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics' Wholly Owned Subsidiary, APR Applied Pharma Research Signs an Agreement To Acquire Rights to Commercialize a Novel Dosage Form for the Treatment of PKU

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Jack Weinstein
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the acquisition of commercialization right for the product will be completed, (ii) whenever GOLIKE (R) will ever be approved for commercialization in U.S., and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

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File: Ad hoc release

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15 March 2022

Relief Therapeutics' Wholly Owned Subsidiary, APR Applied Pharma Research Signs an Agreement To Acquire Rights to Commercialize a Novel Dosage Form for the Treatment of PKU

Relief Therapeutics Holding SA / Key word(s): Acquisition

Geneva, Switzerland, March 15, 2022 RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA ("APR"), has signed a binding term sheet with Meta Healthcare Ltd. ("Meta") to acquire the worldwide commercialization rights, except in the United Kingdom ("UK") and Ireland, for a novel dosage form of a prescription drug already approved by the U.S. Food and Drug Administration ("FDA") and intended for the treatment of patients with phenylketonuria ("PKU"). Financial terms of the agreement were not disclosed.

Meta has completed the product's galenical and technical development and, under the agreement, will provide the technology transfer package to APR. APR will be responsible for bioequivalence studies, industrial scale up, regulatory submission and commercialization in the U.S. and EU.

APR plans to file an Investigational New Drug Application in the U.S. as soon as possible and to file for FDA regulatory approval sometime in first half of 2023. Additionally, Meta has submitted a patent application in the UK and APR intends to seek a patent extension in all major territories including the U.S. and Europe.

"Acquiring the commercialization rights to this novel dosage form from Meta not only strengthens our relationship with our current UK distribution partner for the PKU GOLIKE(R) family of products, but also immediately expands our portfolio of effective and easy-to-use treatments for those with PKU, opening additional opportunities for market penetration," stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. "This portable, flavored, dosage form allows for precise dosing and can be stored at room temperature and is easily administered to both adults, newborns and children, making it a well differentiated, highly attractive alternative to the current formulations on the market. We look forward to a potential launch of the product in the U.S and Europe sometime during the first half of 2024."

"Relief continues to execute on its cost effective, capital efficient approach to drug development, and the acquisition of the commercialization rights to this PKU product is no exception," stated Raghuram (Ram) Selvaraju, Chairman of the Board of Relief. "This product fits perfectly into our existing line for the treatment of PKU and the distribution can be streamlined with our existing distribution platform. Our PKU GOLIKE product family has been granted Orphan Drug Designation in the U.S. and we are pursuing PKU GOLIKE(R) as a prescription product while, at the same time, focusing on commercial expansion and growth in Europe."

About Phenylketonuria or PKU

PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive levels of phenylalanine in the blood cause accumulation in the brain, which hampers proper brain development and results in neurophysiological dysfunction. Treatment of PKU is lifelong, requiring patients to follow a strict diet that severely limits phenylalanine (and, thus, protein) content. This necessitates supplementation of phenylalanine free-amino acid-mix to prevent protein deficiency and optimize metabolic control.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief's collaboration partner in the U.S., NeuroRx, Inc. Relief has also a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001,a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer's new drug application for ACER-001 was recently accepted by the FDA with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Launches PKU GOLIKE® KRUNCH in Germany and Italy

Year ordering: 2021
Media Contact:

 

MEDIA/INVESTOR INQUIRIES: 
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Michael Miller
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Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer 
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether APR can successfully market PKU GOLIKE® KRUNCH in Germany, Italy and other European countries, (ii) whether PKU GOLIKE® KRUNCH will ever be approved as a prescription product for PKU, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding AG's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Golike Krunch Launch
Attachment (PDF): 210909_Relief_Golike_Krunch_Launch_PR.pdf

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Launches PKU GOLIKE® KRUNCH in Germany and Italy

APR Expands PKU GOLIKE® Product Line with More Convenient, Chewable Tablet Option

Geneva, Switzerland, September 9, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), has launched, through its affiliates in Germany and Italy, PKU GOLIKE® KRUNCH, a convenient chewable tablet for the dietary management of phenylketonuria (“PKU”), a rare, recessive metabolic genetic disorder affecting approximately 350,000 people globally.

“With PKU GOLIKE® KRUNCH, we are directly addressing a critical patient need with a much more flexible and convenient option for the management of PKU. In particular, PKU GOLIKE® KRUNCH gives patients a ready to chew tablet allowing for ‘on-the-go’ administration of protein substitute. This new option is intended to substantially improve adherence to therapy, which is extremely difficult to maintain for these patients, leading to better outcome and quality of life,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “As important, PKU GOLIKE® KRUNCH is the result of how flexible is our patented Physiomimic Technology™, which allows to develop effective prolonged release, taste and odor masked products. We are pleased to begin sales in Germany and Italy, two key markets within the European Union, and in the coming months we plan to expand the distribution of PKU GOLIKE® KRUNCH to additional countries in Europe.”

The PKU GOLIKE® family of products are food for special medical purposes (“FSMP”) consisting of a phenylalanine-free amino acid mix in granules. Engineered with the APR’s Physiomimic Technology™, PKU GOLIKE® is the first prolonged-release amino acid product, characterized by a special coating that ensures a better physiological absorption of the amino acids, while also masking their unpleasant taste, odor and aftertaste.

“This newest launch by APR is a testament to the strength and adaptability of the Physiomimic Technology and is a key addition to our growing line of marketed products,” stated Raghuram (Ram) Selvaraju, Chairman of the Board of Relief. “Moving forward, we plan to expand our existing commercial infrastructure and refine marketing activities to accelerate the future growth of this product line. It is also important to note that, since PKU GOLIKE® has been granted Orphan Drug Designation, we intend to assess the pursuit of PKU GOLIKE® as a prescription product for PKU in the U.S., where the majority of patients have no access to reimbursed medical foods.”

ABOUT PHENYLKETONURIA OR PKU

PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive levels of phenylalanine in the blood cause accumulation in the brain, which hampers proper brain development and results in neurophysiological dysfunction. Treatment of PKU is lifelong, requiring patients to follow a strict diet that severely limits phenylalanine (and, thus, protein) content. This necessitates supplementation of amino acid-based foods for special medical purposes (FSMP) to prevent protein deficiency and optimize metabolic control.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Receives Notice of Allowance of Key U.S. Patent Application Covering PKU GOLIKE®

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether and when the new patent will issue, (ii) whether the new patent will be upheld, if challenged, (iii) the scope of the protection ultimately afforded by the new patent, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Foot notes:
 
27 April 2022
Attachment Name: Ad hoc_Relief APR Patent Allowance PKU GoLike
Attachment (PDF): Ad_hoc_Relief_APR_Patent_Allowance_PKU_GoLike.pdf

Notice of Allowance of Patent Application for Modified Release Orally Administered Amino Acid Formulations, Strengthens Proprietary Position in U.S. until 2036

Geneva, Switzerland, April 27, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), has received a Notice of Allowance from the U.S. Patent and Trademark Office (“USPTO”) for Patent Application No. 15/303,121 entitled, “Modified Release Orally Administered Amino Acid Formulations.”

The allowed claims cover certain PKU GOLIKE® formulations in APR’s product line, intended to enhance the dietary management of patients living with phenylketonuria (PKU). The PKU GOLIKE® family of products are a phenylalanine-free food for special medical purposes (FSMP), comprising amino acid granules engineered with APR’s Physiomimic TechnologyTM, a modified-release amino acid technology that ensures a prolonged physiological absorption of the amino acids, while also masking their unpleasant taste, odor and aftertaste.

The USPTO issues a patent Notice of Allowance after it determines a patent should be granted upon completion of any outstanding administrative requirements. The patent resulting from this application will have an expiration date of no earlier than September 27, 2036. When issued, the patent will supplement APR’s PKU GOLIKE® intellectual property portfolio, which currently includes U.S. Patent No. 10,500,180, which also expires no earlier than September 27, 2036.

“The receipt of this Notice of Allowance from the USPTO for PKU GOLIKE®, powered by our proprietary, PhysiomimicTM Technology, is another important milestone that helps strengthen our intellectual property position, which we will continue to build upon going forward. As we focus on increasing sales in the U.K. and Europe, we will continue our efforts in preparing for a potential U.S. launch,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “The novel formulation of each product within the PKU GOLIKE® family has proven to allow for the absorption of amino acids more closely resembling the natural protein in healthy humans, providing a distinct advantage for the treatment of patients suffering from PKU. As part of our commitment to expanding access to this important product, we are actively building out a U.S. commercial infrastructure, with the aim of launching PKU GOLIKE® as a treatment to PKU patients in the U.S. sometime in the second half of this year, assuming the product is approved for commercialization in the United States.”

About PKU GOLIKE®

The PKU GOLIKE® family of products are phenylalanine-free food for special medical purposes (FSMP) or medical formulas in the U.S. The products comprise a mixture of amino acids formulated in granules. Engineered with the Company’s patented PhysiomimicTM Technology platform, PKU GOLIKE® is the first prolonged-release amino acid product, characterized by a special coating that ensures a more physiological absorption of the amino acids, while also masking their unpleasant taste, odor and aftertaste.

About Phenylketonuria or PKU

PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive levels of phenylalanine in the blood cause accumulation in the brain, which hampers proper brain development and results in neurophysiological dysfunction. Treatment of PKU is lifelong, requiring patients to follow a strict diet that severely limits phenylalanine (and, thus, protein) content. This necessitates supplementation of phenylalanine free-amino acid-mix to prevent protein deficiency and optimize metabolic control.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100® (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Receives Notice of Allowance of Key U.S. Patent Application Covering Ready to Use Diclofenac Stick Packs

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

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Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether and when the new patent will issue, (ii) whether the new patent will be upheld, if challenged, (iii) the scope of the protection ultimately afforded by the new patent, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_APR patent allowance
Attachment (PDF): 20220124_ad_hoc_Relief_APR_Patent_Allowance.pdf

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Receives Notice of Allowance of Key U.S. Patent Application Covering Ready to Use Diclofenac Stick Packs

Notice of Allowance of Patent Application for a Non-Steroidal Anti-Inflammatory, Diclofenac Potassium, Strengthens Proprietary Position in U.S. until 2039

Geneva, Switzerland, January 24, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), has received a Notice of Allowance from the U.S. Patent and Trademark Office (“USPTO”) for Patent Application No. 16/713,052 entitled, “Ready to Use Diclofenac Packs.”

Diclofenac potassium is an off-patent, potent non-steroidal anti-inflammatory drug (“NSAID”) widely used therapeutically for inflammatory conditions and pain management. By applying the patented dynamic buffering technology (“DBT”), APR developed the first, and still the only, NSAID ever approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of acute migraine attacks in adults -- currently marketed as CAMBIA by Assertio Therapeutics Inc. in the U.S. and Miravo Healthcare (formerly Nuvo Pharmaceuticals Inc.) in Canada, under an exclusive, royalty bearing license agreement with APR.

DBT and CAMBIA are currently protected by a family of four patents listed in the FDA Orange Book, all expiring in 2026. CAMBIA is currently available in the form of a dry powder packed into a single dose sachet to be poured and dissolved in water before administration. APR, in order to offer a potential life cycle management option to its current commercial partners, has developed a liquid version of the same product packed into a portable stick pack in order to offer improved convenience to migraine patients; and this new dosage form is the subject matter of the new patent application just allowed by the USPTO.

The USPTO issues a patent Notice of Allowance after it determines a patent should be granted upon completion of any outstanding administrative requirements. The allowed claims are for a (i) single dose, ready to use oral solutions provided as liquid formulations in a stick pack containing diclofenac or a salt thereof, and (ii) methods of treating pain or migraine in a patient in need thereof comprising administering to said patient a therapeutically effective amount of the various diclofenac formulations. Once issued, the patent will have an expiration date of December 13, 2039.

“The receipt of this Notice of Allowance from the USPTO is another confirmation of our drug development and reformulation expertise,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “The new, user friendly, ready to use, liquid portable stick packs to deliver CAMBIA should improve patient compliance. We look forward to continue to identify, develop and commercialize innovative therapies for patients with niche and rare diseases.”

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Finally, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

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Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Data Published in the Peer Reviewed Journal of Wound Care, Indicating That Nexodyn® AOS Is a Highly Effective Treatment to Support Wound Healing of Hard-to-Heal Leg Ulcers

Year ordering: 2021
Media Contact:

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Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_APR Strohal study
Attachment (PDF): 20210930_ad_hoc_Relief_APR_Strohal_Study_Nexodyn.pdf

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Data Published in the Peer Reviewed Journal of Wound Care, Indicating That Nexodyn® AOS Is a Highly Effective Treatment to Support Wound Healing of Hard-to-Heal Leg Ulcers

As an Active Cleanser, Nexodyn® AOS Shows Superior Wound Healing Performance Compared to Standard of Care

Geneva, Switzerland, September 30, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), reported data published in the peer reviewed Journal of Wound Care, indicating that the company’s Nexodyn® acid-oxidizing solution (AOS), developed with APR’s proprietary Tehclo® technology, was found to be a highly effective treatment to support wound healing in infected or non-infected hard-to-heal leg ulcers. The data also confirmed the safety and tolerability of Nexodyn®.

Conducted by Robert Strohal, M.D., Professor and Department Head, Department of Dermatology, Federal Academic Teaching Hospital of Feldkirch, Austria, and colleagues, the open-label, randomized controlled MACAN study was conducted at two centers is Austria. A total of 50 patients were enrolled, with either infected or non-infected hard-to-heal leg ulcers of different etiology. Patients were treated for six weeks either with Nexodyn® AOS or standard of care (SOC) wound dressings.

In the patient group treated with Nexodyn® AOS, wounds exhibited a faster and more pronounced wound size reduction compared with wounds in the SOC group. Additionally, compared to SOC, the treatment group showed a markedly greater percentage of complete healing of hard-to-heal ulcers by the end of the study period (32% versus 8%, respectively). Furthermore, Nexodyn® demonstrated its ability to significantly reduce the wound pH (p<0.0001) and thus promote a faster healing process. In all patients with infected leg ulcers, local infection was overcome more rapidly with Nexodyn® AOS treatment. Overall, the efficacy of Nexodyn® AOS was found to be not only non-inferior but superior to SOC wound dressings.

“The publication of the MACAN study reconfirms the effectiveness of Nexodyn® AOS, developed with our proprietary, globally patented Tehclo® nanotechnology platform, versus SOC, providing further evidence of its unique ability to significantly reduce healing time, protect from risk of infection and reduce clinical signs of local infection,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “Importantly, the study showed that Nexodyn® AOS, with its antimicrobial properties, is able to control infection as a stand-alone treatment and that the reduction of the pH in the wound bed is directly associated with wound healing. Additionally, by restoring the prerequisites of the physiological healing process, use of Nexodyn® AOS can meaningfully help to reinitiate chronic wound closure. The published results show that Nexodyn® AOS is not only non-inferior, but is, in fact, superior to wound dressing standard of care, clearly establishing Nexodyn® AOS, as an important treatment for chronic hard-to-treat wounds.”

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief added, “The marked improvement in wound healing reported in the MACAN study also bodes well for APR-TD011, developed with the same Tehclo® platform as Nexodyn® AOS, which is designed as a complete treatment for epidermolysis bullosa (EB) patients to prevent or reduce skin lesion infections and inflammation through modulation of the wound microenvironment to support a faster physiological wound healing. APR TD-011 was granted Orphan Drug Designation and may become an important treatment option for the estimated 250,000 EB patients worldwide.”

About Nexodyn® Acid-Oxidizing Solution (AOS)

Nexodyn® Acid-Oxidizing Solution (AOS) is a Tehclo®-based product proven to restart wound healing in stalled wounds by creating the ideal microenvironment to sustain the physiological healing process.
A wealth of evidence and real-world experience consistently show accelerated closure with reduced infection rates and less wound-associated pain.

Nexodyn® AOS is a solution with three main features: highly pure and stabilized hypochlorous acid (HClO >95% of free chlorine species), acidic pH (2.5 – 3.0) and high Reduction-Oxidation Potential (ORP 1.000 – 1.200 mV). The product is a sprayable solution with ancillary antimicrobial properties intended for use in the debridement, irrigation, cleansing and moistening of acute and chronic wounds (e.g., diabetic foot ulcers, pressure ulcers, and vascular ulcers), post-surgical wounds, burns and other lesions. The product is certified in the European Union as a Class III medical device.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Data Published in the Peer Reviewed Journal, Nutrients, Indicating Additional Potential Benefits of Its Physiomimic™ Technology

Year ordering: 2021
Media Contact:

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Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
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RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx will provide Relief with the data from its Phase 2b/3 study, (ii) whether aviptadil will ever be approved in the UK or the EU for the treatment of respiratory failure in critically ill patients with COVID-19, and (iii) those risks discussed in Relief's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_APR publication PKU
Attachment (PDF): 210921_ad_hoc_Relief_APR_Publication_on_PKU.pdf

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Data Published in the Peer Reviewed Journal, Nutrients, Indicating Additional Potential Benefits of Its Physiomimic™ Technology

Data In Healthy Volunteers Suggests That APR’s Controlled Release Amino Acid Mix, PKU GOLIKE®, May Be Key To Reducing Catabolic Events In Patients With Phenylketonuria (“PKU”), Improving Utilization Of Amino Acids And Quality Of Life

Geneva, Switzerland, September 21, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), reported data published in the peer reviewed journal, Nutrients, indicating additional potential benefits of the company’s Physiomimic™ Technology to the management of patients suffering from phenylketonuria (“PKU”).

The paper, entitled, “Nitrogen Balance after the Administration of a Prolonged-Release Protein Substitute for Phenylketonuria as a Single Dose in Healthy Volunteers,” provides a further evaluation of published data from APR’s previously reported, randomized, controlled, single-dose crossover trial in healthy volunteers which showed that a prolonged-release amino acid (AA) mixture, formulated with Physiomimic Technology, significantly slowed down the release and reduced the peak plasma concentrations of essential AAs compared with a free AA mixture. Authors of the current paper, including Anita MacDonald, Ph.D. and Ania C. Muntau, M.D, renowned experts in the field of metabolic diseases, concluded that the controlled release amino acid mix (PKU GOLIKE®), given its ability to prolong the release of AAs, appears to be key to reducing catabolic events in patients with PKU, resulting in a more efficient utilization of AAs for protein synthesis and, therefore, an improved quality of life.

“The paper’s conclusions reaffirm our belief as to the benefits of our patented Physiomimic Technology, the distinct advantages of our PKU GOLIKE® family of products, and the potential additional advantages conferred by the product’s unique ability to prolong the release of AAs,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “The Physiomimic Technology allows for a formulation of AAs which we believe leads to a physiological absorption profile more closely resembling the absorption profile of natural proteins. Based on the results published in the paper, we plan to explore additional clinical assessments to support the benefits of AAs physiological absorption associated with PKU GOLIKE and the patented pharmaceutical Physiomimic Technology behind it.”

“The strong clinical results are a testament to the potential benefits of PKU GOLIKE® as compared to non-prolonged release AA supplementation,” stated Raghuram (Ram) Selvaraju, Chairman of the Board of Relief. “PKU GOLIKE® has been granted Orphan Drug Designation in the U.S. and further clinical studies on the benefits of the Physiomimic Technology will help as we pursue PKU GOLIKE® as a prescription product. In the meantime, we will focus on the commercial expansion and refinement of marketing activities to facilitate the growth of this product line in Europe.”

About PKU GOLIKE
The PKU GOLIKE family of products are food for special medical purposes (FSMP) consisting of a phenylalanine-free amino acid mix in granules. Engineered with the Company’s patented Physiomimic Technology platform, PKU GOLIKE® is the first prolonged-release amino acid product, characterized by a special coating that ensures a better physiological absorption of the amino acids, while also masking their unpleasant taste, odor and aftertaste.

About Phenylketonuria or PKU
PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive levels of phenylalanine in the blood cause accumulation in the brain, which hampers proper brain development and results in neurophysiological dysfunction. Treatment of PKU is lifelong, requiring patients to follow a strict diet that severely limits phenylalanine (and, thus, protein) content. This necessitates supplementation of amino acid-based foods for special medical purposes (FSMP) to prevent protein deficiency and optimize metabolic control.

ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Final Data from Its Clinical Trial of Novel Nasal Spray, Sentinox, in SARS- CoV-2 Infected Patients

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the final results from the study will be as positive as the interim data, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

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File: Ad hoc release

End of ad hoc announcement

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16 February 2022
Attachment Name: Ad_hoc_Relief__Sentinox_Results
Attachment (PDF): Ad_hoc_Relief__Sentinox_Results.pdf

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Final Data from Its Clinical Trial of Novel Nasal Spray, Sentinox, in SARS- CoV-2 Infected Patients

Despite Primary Endpoint not Being Met, Due to Small Sample Size, Results Show a Very Positive Trend in Efficacy Parameters with a Clean Safety and Tolerability Profile

Geneva, Switzerland, March 17, 2022 RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), reported final data from its clinical trial of nasal spray, Sentinox, in SARS-CoV-2 infected patients.

The post-market, interventional, randomized, controlled clinical study (NCT04909996, clinicaltrials.gov) enrolled 57 patients who were randomized to receive Sentinox treatment 0.5 ml into each nostril, performed 3 times/day or 5 times/day for 5 days as add-on to the standard therapy, vs. no Sentinox treatment group. The study was designed to assess the efficacy and safety of Sentinox spray in terms of viral load reduction, negativization and infectivity in recently infected SARS-CoV-2 individuals. It was conducted by the Hygiene Unit of IRCCS Policlinico San Martino Hospital in Genoa, Italy, and coordinated by Prof. Giancarlo Icardi.

Considering the small sample size and the high variability in the baseline viral load observed within study groups, the primary endpoint was not reached; however, the results of the study suggest the potential efficacy of Sentinox, with a better response for 3 times/day, versus the control group, in the reduction of the nasal viral load, negativization and infectivity.

The final analysis on the intention-to-treat (“ITT”) population of 54 patients who completed the study showed an about 90% (over 1.0 Log10) reduction of viral load after 5 days of treatment with Sentinox 3 times/day versus the control group.

Additional analyses have been conducted in patients stratified according to baseline value of RT-PCR cycles: in the subgroup with medium (Ct 20-30) viral load, the use of Sentinox significantly reduced the viral load of 1.9761 Log10 (p=0.0178) at day 5 compared to the control group, suggesting a positive trend in the treatment effect.

Further efficacy analyses on the ITT population showed that negativization in the Sentinox 3 times/day group started at day 4; at day 6 patients with negative swab were almost two-fold compared to the control group (47% in Sentinox group versus 22% in no treatment group) (p=0.0005). Similar results were obtained in the analysis conducted in the 20-30 RT PCR cycles subpopulation.

Analysis on infectivity data was conducted in the ITT population: patients were considered “not infectious” (patient likely not be able to spread virus to others) when the cycle threshold value of >35 cycles was achieved (Carrouel et al. 2021; Jang et al. 2021; Iwanami et al. 2021; Choudhuri et al. 2020).

In the 3 times/day Sentinox group, 71% of patients were non-infectious versus 44% in the control group at day 6 (p<0.0001).

Overall safety data monitored through clinical examination showed a good safety profile for Sentinox. This has been confirmed also by VAS and LIKERT scale results.

Prof. Giancarlo Icardi, head of the Hygiene Unit of IRCCS Policlinico San Martino Hospital in Genoa (Italy) and lead investigator, commented, “Globally our data suggest that Sentinox represents a promising and safe option in reducing the time for obtaining a negative result due to a significant reduction in the nasal viral load. Our findings are particularly encouraging and indicate that, by reducing the nasal viral load, Sentinox could also have the potential to reduce the chances of spreading the virus to others and to interfere with the spreading of the virus to the lungs, preventing a clinical deterioration. Further larger scale studies are suggested.”

Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe added, “We will continue to investigate the potential of Sentinox nasal spray to reduce nasal viral load and test the hypothesis that such reduction will interfere with the spreading of the virus to the lungs and, by doing so, prevent a clinical deterioration. We believe that further clinical studies can potentially confirm Sentinox as a preventive option, not only against SARS-CoV-2 infection, but as a treatment for a wide array of viruses and bacteria in the future.”

About Sentinox

Sentinox is an acid-oxidizing solution (AOS) containing hypochlorous acid at 0.005%, certified in Europe on February 16, 2021 as Class III Medical Device (Certificate Nr. EPT 0477.MDD.21/4200.2). The device is intended for irrigation, cleansing and moistening of the nasal cavities and is indicated for (i) reducing the risk of infections caused by bacteria and viruses, including SARS-CoV-2, by lowering the nasal microbial load, (ii) symptomatic nasal care and (iii) nasal care in case of minor lesions/alterations of the nasal mucosa.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, last summer brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports In Vivo Data Published in the Peer Reviewed, International Journal of Molecular Sciences, Indicating Prolonged Release of Amino Acids Using Its PhysiomimicTM Technology May Have Benefits for the Treatment of PKU

Year ordering: 2022
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including: (i) whether PKU GOLIKE® provides the benefits described in the paper published in Nutrients, (ii) whether PKU GOLIKE® will be approved as a prescription product in the United States, and (iii) those risks discussed in Relief's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Foot notes:
End of ad hoc announcement

show this
 
28 March 2022
Attachment Name: Ad hoc_Relief_Publication on PKU
Attachment (PDF): Ad_hoc_Relief_Publication_on_PKU.pdf

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports In Vivo Data Published in the Peer Reviewed, International Journal of Molecular Sciences, Indicating Prolonged Release of Amino Acids Using Its PhysiomimicTM Technology May Have Benefits for the Treatment of PKU

Data In Animal Models Suggest That APR’s Controlled Release Amino Acid (AA) Mix, Formulated With the PhysiomimicTM Technology, May Have Beneficial Effects on Both AA Oxidation and Catabolism With a Direct Impact on Muscle Mass, Strength And Glyceamia

Geneva, Switzerland, March 28, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), reported data published in the peer reviewed International Journal of Molecular Sciences, indicating that prolonged release of amino acids (“AA”) formulated with APR’s PhysiomimicTM Technology may have benefits for the dietary management of phenylketonuria (“PKU”). The full article can be accessed here.

The paper, entitled, “In Vivo Metabolic Responses to Different Formulations of Amino Acid Mixtures for the Treatment of Phenylketonuria (PKU),” evaluated the impact of a prolonged release of AA formulation on nitrogen balance, both in acute and long-term experimental studies to evaluate the impact on selected metabolic and functional parameters relative to the natural slow-release reference protein casein or free AA controls. Authors of the paper, including Prof. Dr. Júlio César Rocha, Assistant Professor at NOVA Medical School, Faculty of Medical Sciences, NOVA University of Lisbon Reference Centre for Inherited Metabolic Diseases – Centro Hospitalar Universitário de Lisboa Central, and CINTESIS Portugal, concluded that the prolonged release of an amino acid mix, found in PKU GOLIKE®, may have beneficial effects on both AA oxidation and catabolism, with a direct impact on muscle mass and muscle strength as well as on other metabolic pathways such as glycaemia, in normal rats. The results of this study also supported further studies in human subjects aimed at demonstrating the beneficial effects of the PhysiomimicTM Technology AA formulation for the dietary treatment of PKU.

“The paper’s conclusions confirm the advantages of prolonged AA absorption using our patented PhysiomimicTM Technology, which has already been demonstrated in humans,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “The prolonged release of AAs made possible through our PhysiomimicTM Technology and used in the currently commercialized PKU GOLIKE® family of products in Europe, we believe, leads to absorption of AAs more closely resembling the natural protein in healthy humans, providing a distinct advantage for the treatment of patients with PKU. We are relentlessly working to bring PKU GOLIKE® as a treatment to PKU patients in the U.S. within 2022 while we are in the process of generating further clinical evidence that will support PKU GOLIKE as a prescription product.”

About PKU GOLIKE®

The PKU GOLIKE® family of products are food for special medical purposes (FSMP) or medical formulas in the US consisting of a phenylalanine-free amino acid mix in granules. Engineered with the Company’s patented PhysiomimicTM Technology platform, PKU GOLIKE® is the first prolonged-release amino acid product, characterized by a special coating that ensures a more physiological absorption of the amino acids, while also masking their unpleasant taste, odor and aftertaste.

About Phenylketonuria or PKU

PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive levels of phenylalanine in the blood cause accumulation in the brain, which hampers proper brain development and results in neurophysiological dysfunction. Treatment of PKU is lifelong, requiring patients to follow a strict diet that severely limits phenylalanine (and, thus, protein) content. This necessitates supplementation of phenylalanine free-amino acid-mix) to prevent protein deficiency and optimize metabolic control.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Positive Interim Data from Its Clinical Trial of Novel Nasal Spray Sentinox in SARS-CoV-2 Infected Patients

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This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the final results from the study will be as positive as the interim data, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Sentinox interim data
Attachment (PDF): 20211027_ad_hoc_Relief_APR_Sentinox_Interim_Results.pdf

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Positive Interim Data from Its Clinical Trial of Novel Nasal Spray Sentinox in SARS-CoV-2 Infected Patients

Results Confirm the Safety and Tolerability of Sentinox and Suggest It Could Be Effective in Reducing Time to Negativization in SARS-CoV-2 Infected Patients

Geneva, Switzerland, October 27, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), reported positive interim results from its clinical trial of nasal spray Sentinox in SARS-CoV-2 infected patients, confirming its safety and tolerability. Relief also reported that data from the study suggest that Sentinox could be effective in reducing the SARS-CoV-2 viral load at the level of the nasal mucosa.

The post-market, confirmatory, interventional, randomized, placebo controlled clinical study is expected to enroll a total of 57 patients. The study is designed to assess the efficacy and safety of Sentinox spray in reducing viral load in the upper respiratory airways of recently infected SARS-CoV-2 individuals and is being conducted by the Hygiene Unit of IRCCS Policlinico San Martino Hospital in Genoa, Italy and coordinated by Prof. Giancarlo Icardi as lead investigator.

The interim analysis, based on 30 patients who have completed the study -- 10 patients for each treatment group (0.5 ml into each nostril, 3x/day, 5x/day or control group, for five days) -- showed that all patients treated with Sentinox tested negative for SARS-CoV-2 by the end of the study period (Day 21). By contrast, one out of 10 patients in the control group was still positive by Day 21. All subjects using Sentinox 3 times a day had already tested negative by visit number 7 (V7; Day 10) vs. 70% of subjects in the control group over the same study period. At visit 4, 5 and 6, a trend in favor of the 3 times a day treated group vs. control group was observed (10% of patients using Sentinox tested negative at V4 vs 0% of patients in the control arm; 40% of patients using Sentinox tested negative vs 20% in the control arm at V5; 70% of patients using Sentinox tested negative vs 40% at V6). For the purpose of this study, subjects are considered negative when their COVID-19 test becomes negative and remains negative throughout the study period.

Prof. Giancarlo Icardi, head of the Hygiene Unit of IRCCS Policlinico San Martino Hospital in Genoa and lead investigator, commented, “The interim analysis results are encouraging. Indeed, the preliminary efficacy data suggest that using Sentinox, in addition to standard of care, could accelerate the time to a negative SARS-CoV-2 test result, thereby allowing patients to resume their normal daily activities sooner. By lowering the viral load in the nasal mucosa, the use of Sentinox could help reduce the transmissibility of the virus and, consequentially, its spread. Moreover, it is possible that, by including a larger number of patients and clinical parameters, Sentinox will prove to be a helpful tool for improving clinical outcomes in patients with mild COVID-19 in addition to standard of care. In general, we expect that the positive data obtained so far will be confirmed by the end of the study.”

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief added, “These positive preliminary results serve to further illustrate the versatility of APR’s proprietary, globally patented Tehclo® nanotechnology platform. We are very encouraged by the data and remain committed to proactively progressing this program with the hope that we can eventually bring Sentinox to market as an important, additional, protective option for the treatment and spread of COVID-19.”

About Sentinox

Sentinox is an acid-oxidizing solution (AOS) containing hypochlorous acid at 0.005%, certified in Europe on February 16, 2021 as Class III Medical Device (Certificate Nr. EPT 0477.MDD.21/4200.1). The device is intended for irrigation, cleansing and moistening of the nasal cavities and is indicated for (i) reducing the risk of infections caused by bacteria and viruses, including SARS-CoV-2, by lowering the nasal microbial load, (ii) symptomatic nasal care and (iii) nasal care in case of minor lesions/alterations of the nasal mucosa.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.