RELIEF THERAPEUTICS HLDG - RLFTF STOCK NEWS

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.

Relief Therapeutics has acquired the worldwide rights to a novel therapeutic product aimed at managing phenylketonuria (PKU), excluding the UK. This acquisition complements their existing PKU GOLIKE portfolio. Financial terms were undisclosed. The company plans to conduct clinical studies and submit an Investigational New Drug (IND) application for U.S. FDA approval, with a potential market launch in 2024. The product is expected to cater to the pediatric population by offering better dosage precision.

Relief Therapeutics has filed Amendment No. 4 to its Registration Statement on Form 20-F with the SEC to register as a reporting company under the Securities Exchange Act. This is part of its program to transition its Level 1 ADR to a Level 2 ADR and aims for a potential NASDAQ listing, although no assurance of success is provided. The filing does not involve an offering of securities, and Relief will not receive any proceeds from its current ADR program. The company's focus includes clinical-stage programs and partnerships for drug development.

Relief Therapeutics Holding SA reported on July 4, 2022, that the FDA has declined to issue an Emergency Use Authorization (EUA) for aviptadil concerning a subgroup of patients also receiving remdesivir. This decision impacts the company as it collaborates with NRx Pharmaceuticals, whose subsidiary, NeuroRx, is involved with aviptadil's development. Relief is involved in clinical-stage programs aimed at serious unmet medical needs, including various metabolic disorders. The firm has also expanded its pipeline through recent acquisitions.

Relief Therapeutics has filed Amendment No. 3 to its Registration Statement on Form 20-F with the SEC to transition its Level 1 American Depositary Receipt program to a Level 2 program, facilitating a potential listing on NASDAQ. The filing does not generate any proceeds for the company and is part of an ongoing effort to enhance its market presence. The effectiveness of the Registration Statement remains under review, and there is no guarantee of a successful listing. Relief continues focusing on clinical-stage programs, including collaborations for drug development.

Relief Therapeutics Holding SA announced that its parent company, NRx Pharmaceuticals, Inc., faced a setback as the FDA denied its application for Breakthrough Therapy designation for aviptadil. This rejection could have significant implications for the drug's further development, particularly in treating serious lung conditions, including COVID-19. Relief maintains its focus on clinical-stage programs and has a collaboration with Acer Therapeutics for developing ACER-001.

Relief Therapeutics Holding SA reported that its partner Acer Therapeutics has not received a decision from the FDA on the 505(b)(2) NDA for ACER-001 (sodium phenylbutyrate) aimed at treating urea cycle disorders. The NDA was accepted for review on October 5, 2021, with a PDUFA target action date of June 5, 2022. Currently, the FDA's review is ongoing without a set target date. Relief and Acer will issue a joint release once the FDA decision is made, impacting the prospects of their development and commercialization agreement for ACER-001.

Relief Therapeutics Holding SA announced the results of its Annual General Meeting (AGM) held on May 31, 2022, with over 85% approval for all proposed resolutions. Key outcomes include the approval of the 2021 financial statements, carrying forward a loss of CHF 29,553,450, and maintaining an authorized share capital of CHF 22,000,000. The AGM also approved maximum compensation of CHF 2,500,000 for the Board and CHF 5,000,000 for the Executive Committee. Re-elections for Board members and auditors were confirmed. This meeting underlines the company's ongoing efforts in its clinical-stage programs and collaborations.

Relief Therapeutics provided a corporate update on May 31, 2022, highlighting the discontinuation of the ACTIVE-3b/TESICO trial for COVID-19 due to futility. Despite this, the company is committed to pursuing RLF-100 for various pulmonary indications and initiating new clinical trials. Upcoming catalysts include potential FDA approval for ACER-001 on June 5, 2022, and launching its U.S. commercial operations for PKU GOLIKE. Relief has CHF 31 million in cash to fund operations into 2023 and aims for positive cash flow by late 2024.