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RELIEF THERAPEUTICS Holding SA, traded as RLFTF, is a biopharmaceutical company dedicated to providing innovative treatment options for select specialty, unmet, and rare diseases. The company focuses on advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit patients. Relief Therapeutics offers a diversified portfolio of marketed products, proprietary platform technologies, and a targeted clinical development pipeline. With a mission to provide therapeutic relief to those suffering from rare diseases, Relief Therapeutics is led by an experienced team of industry leaders. Headquartered in Geneva, the company is listed on the SIX Swiss Exchange and quoted on the OTCQB.
Relief Therapeutics announced its half-year results for 2022, reporting revenues of CHF 3.24 million from product sales, licensing fees, and royalties. The company anticipates the U.S. launch of PKU GOLIKE in Q4 2022, following the acquisition of commercialization rights for a new dosage form of a prescription drug for PKU. The FDA accepted the NDA for ACER-001 with a decision expected by January 15, 2023. However, the company incurred a net loss of CHF 26.5 million, driven by increased expenses and an impairment charge of CHF 8.2 million on intangible assets.
Relief Therapeutics, a Swiss biopharmaceutical company focused on rare diseases, announced participation in the 22nd Annual Biotech in Europe Forum on September 21-22, 2022, in Basel, Switzerland. CFO Jack Weinstein will lead a panel discussion titled Navigating Global Capital Markets in Current Times on September 21 at 1:35 pm CEST, followed by a company presentation at 3:20 pm CEST. The company engages with institutional investors and offers one-on-one meetings during the event. Relief develops innovative treatments for conditions like PKU and pulmonary disorders.
Relief Therapeutics announced that Jack Weinstein, the Chief Financial Officer, will present at the H.C. Wainwright 23rd Annual Global Investment Conference scheduled for September 13, 2022, at 1:30 PM ET. The event runs from September 12-14, 2022, where management will conduct one-on-one meetings with registered institutional investors. A live webcast of the presentation will be available on Relief’s website and archived for 90 days. Relief focuses on developing treatments for rare diseases and has ongoing collaborations and product pipelines addressing significant unmet medical needs.
Relief Therapeutics has filed a Registration Statement on Form F-1 with the U.S. SEC for a proposed offering of its ordinary shares as American Depositary Shares (ADSs). The details including the number of ADSs and pricing are yet to be determined. Relief aims to list its ADSs on the NASDAQ under the symbol RLFT. However, completion of the offering and listing success are uncertain. Relief operates in rare diseases and has a collaboration with Acer Therapeutics for metabolic disorders.
Relief Therapeutics Holding SA and NRx Pharmaceuticals announced a tentative settlement regarding their pending litigation. The parties will collaborate to finalize this settlement within 30 days and have agreed to a 60-day extension to negotiate the definitive settlement agreement. The settlement may involve a re-allocation of development rights and licensing for aviptadil, although success is not guaranteed. Investors are advised that uncertainties remain regarding the completion of the settlement.
Relief Therapeutics has appointed David McCullough as the Senior Director and Head of U.S. Market Access, effective August 22, 2022. This newly created role is aimed at enhancing market access strategies for the company's products. McCullough brings over 20 years of experience from various biopharmaceutical companies, including Mirum Pharmaceuticals and Novartis Gene Therapies. His expertise will be pivotal as Relief prepares for the October 2022 launch of PKU GOLIKE. This appointment signifies a milestone in Relief's growth and commitment to patient access.
Relief Therapeutics announced promising three-month stability data for a new formulation of RLF-100 (aviptadil), indicating it may have clinical use for rare lung diseases. The formulation shows potential for stability during shipping and long-term storage. Relief plans to file for additional patent protection and initiate a phase 2b study for pulmonary sarcoidosis in 2023. The FDA pre-IND meeting will confirm efficacy and safety. RLF-100 has a history of safe use in various conditions, with ongoing development for multiple lung diseases.
Relief Therapeutics announced that the U.S. SEC has declared effective its Registration Statement on Form 20-F, allowing the company to become a reporting entity under the Securities Exchange Act. This move is part of an effort to list its ADRs on the NASDAQ. While the company plans to file its application soon, success is contingent on meeting listing requirements and receiving NASDAQ approval. The company will not receive proceeds from the ADR program at this stage.
Relief Therapeutics announced that its partner, Acer Therapeutics, has resubmitted the New Drug Application (NDA) for ACER-001 to the FDA for treating urea cycle disorders (UCDs). This resubmission addresses issues raised in the previous Complete Response Letter (CRL) issued in June 2022, primarily concerning the inspection of a third-party contract packaging facility. Relief notes that Acer believes no other approvability issues remain. The FDA has already provided orphan drug designation for ACER-001, a sodium phenylbutyrate formulation under development for UCDs and Maple Syrup Urine Disease (MSUD).
Relief Therapeutics has appointed Serene Forte, Ph.D., MPH, as Senior Vice President, Head of Genetic Medicine, effective July 18, 2022. This strategic move aims to advance the company's initiatives in genetic medicine, particularly focusing on developing therapies for rare diseases. Dr. Forte's extensive experience in gene therapy, including leadership roles at Krystal Biotech and PTC Therapeutics, is expected to enhance Relief's commercial and medical strategies. The company aims to leverage Dr. Forte's expertise to evaluate prospective assets in this new field.
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