RELIEF THERAPEUTICS S/ADR - RLFTY STOCK NEWS

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.

Relief Therapeutics (OTCQB: RLFTF, RLFTY) announced that its collaboration partner, NRx Pharmaceuticals, reported on May 25, 2022, the Data Safety and Monitoring Board's (DSMB) review of the ACTIV-3b (TESICO) trial data. The DSMB determined that evaluation of aviptadil should cease due to futility after reviewing data from approximately 460 patients with Critical COVID-19 Respiratory Failure. This development raises concerns about the viability of aviptadil for treating this condition. Relief is also involved in the FDA filing of ACER-001, with a decision date set for June 5, 2022.

Relief Therapeutics Holding SA has announced the appointment of Tracy Truong and Kelli Powell as Regional Clinical Specialists for the West and Northeast Regions, effective May 23, 2022. Both specialists bring significant experience in pharmaceutical sales, particularly in rare diseases, having worked for top companies like Alexion and NPS Pharmaceuticals. Their expertise will support the anticipated rollout of PKU GOLIKE and the potential launch of ACER-001 for Urea Cycle Disorders, with a crucial PDUFA date set for June 5, 2022.

Relief Therapeutics Holding SA has submitted Amendment No. 2 to its Registration Statement on Form 20-F to the U.S. SEC, aiming to transition its Level 1 American Depositary Receipt (ADR) program to a Level 2 ADR program. This is part of Relief's goal to list its ADRs on the NASDAQ Stock Market. The effectiveness of the Registration Statement and the subsequent NASDAQ listing remain uncertain. Notably, there are no proceeds from this filing as it does not involve a securities offering.

Relief Therapeutics announced its participation in two significant conferences in May 2022, including Bio€quity Europe and the H.C. Wainwright Global Investment Conference. CFO Jack Weinstein will present at both events, with presentations scheduled for May 17 in Milan and May 24 virtually. Relief is advancing its drug candidate, RLF-100 (aviptadil), for treating respiratory issues linked to COVID-19, while also collaborating on ACER-001 for metabolic disorders. The company's ongoing efforts reflect a commitment to addressing unmet medical needs.

Acer Therapeutics (NASDAQ:ACER) and Relief Therapeutics (SIX:RLF, OTCQB:RLFTF, RLFTY) presented data on ACER-001 (sodium phenylbutyrate) at the GMDI Conference on May 5, 2022. The studies demonstrated that ACER-001 is bioequivalent to BUPHENYL under fasting and fed conditions, with no major safety concerns. The companies anticipate a decision from the FDA regarding the new drug application on June 5, 2022, and plan to submit a marketing application in the EU later this year. ACER-001 aims to address unmet needs in Urea Cycle Disorders.

Relief Therapeutics Holding SA has announced its Annual General Meeting (AGM) scheduled for May 31, 2022, which will be held without shareholder presence due to COVID-19. The Board recommends approval of key items including the Annual Report for 2021, carrying forward a loss of CHF 29,553,450, increasing authorized share capital to CHF 22 million, and approving compensation for the Board and Executive Committee totaling CHF 7.5 million. The meeting will also include re-elections for Board members and auditors.