11 November 2021
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.
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.
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).
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.
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 Holding SA
Chief Financial Officer and Treasurer
Rx Communications Group
Rx Communications Group
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.