RELIEF THERAPEUTICS HLDG - RLFTF STOCK NEWS

Relief Therapeutics' subsidiary, APR Applied Pharma Research, published promising in vivo data in the International Journal of Molecular Sciences. The study indicates that its Physiomimic^TM technology may provide prolonged release of amino acids (AAs), beneficial for managing phenylketonuria (PKU). Results show improved nitrogen balance, muscle mass, and strength in animal models. CEO Paolo Galfetti emphasized the potential of PKU GOLIKE(R), a product utilizing this technology, to mimic natural protein absorption. Relief aims for U.S. market entry of PKU GOLIKE(R) in 2022 while pursuing further clinical evidence.

Relief Therapeutics announced that it has received a trademark registration for RLF-100 from the USPTO. This certification is significant as it strengthens the company’s intellectual property position for RLF-100, a drug in late-stage development targeting respiratory issues related to COVID-19 and other conditions. RLF-100 is a synthetic form of Vasoactive Intestinal Peptide with a proven history of safe use in several trials. The company aims to leverage this trademark to enhance its market position as it navigates ongoing clinical testing.

Relief Therapeutics has appointed Christopher Wick as the Senior Director, Head of U.S. Sales, to strengthen its U.S. expansion efforts. Wick, with over 20 years in pharmaceutical sales, previously led successful teams at Alexion Pharmaceuticals and held key roles at GlaxoSmithKline and Novartis. His experience will support the planned launch of pharmaceutical treatments, including ACER-001 for Urea Cycle Disorders, with a PDUFA date of June 5, 2022. The company aims to boost its U.S. market presence driven by its recent acquisitions and strategic collaborations.

Relief Therapeutics announced the filing of Amendment No. 1 to its Registration Statement on Form 20-F with the SEC. This aims to register the company as a reporting entity under the Securities Exchange Act of 1934 and convert its Level 1 ADR program to Level 2, facilitating a future Nasdaq listing. However, there is no assurance that the registration will be effective or that the Nasdaq listing will occur. Notably, the filing does not involve any securities offering, hence no proceeds will be received from this ADR program.

Relief Therapeutics has reported results from its clinical trial of Sentinox, a nasal spray intended for SARS-CoV-2 infected patients. Although the primary endpoint was not met due to a small sample size, a positive trend in efficacy was observed, with a near 90% viral load reduction in patients treated three times daily. Negativization rates were significantly higher in the treatment group at day six. Overall, Sentinox demonstrated a favorable safety profile, suggesting its potential as a therapeutic option against viral infections.

Relief Therapeutics has signed a binding term sheet with Meta Healthcare Ltd. to acquire worldwide commercialization rights (excluding the UK and Ireland) for a novel dosage form of a prescription drug approved by the FDA for treating phenylketonuria (PKU). This agreement, expected to enhance Relief's PKU GOLIKE(R) product portfolio, includes responsibilities for bioequivalence studies and regulatory submissions. The product's launch in the U.S. and Europe is anticipated in the first half of 2024, following necessary regulatory approvals.

Relief Therapeutics announced that its collaboration partner, NRx Pharmaceuticals, received approval from the National Institutes of Health to continue the phase 3 trial of aviptadil for critical COVID-19 patients. The review by the Data Safety and Monitoring Board revealed no new safety concerns, allowing enrollment to expand from 448 to 640 patients. The trial's success could lead to a New Drug Application for aviptadil. Relief's diverse pipeline also includes partnerships for other treatments.

Relief Therapeutics has filed for a trademark of RLF-100 with the USPTO, expected to be registered by late April. This trademark will protect the drug's use in treating a variety of diseases, including respiratory and viral infections. The application faced no opposition, allowing for swift registration. RLF-100 is currently in late-stage clinical trials for COVID-19 related acute respiratory distress syndrome, having received FDA Fast Track Designation. This signifies progress in potential therapeutic applications amid ongoing health challenges.

Relief Therapeutics announces the appointment of Michelle Lock to its Board of Directors. Lock brings nearly 30 years of biopharmaceutical sales and commercialization experience from her roles at Covis Pharma, Acceleron Pharma, and Bristol-Myers Squibb. Her expertise aims to bolster Relief's growth strategy and advance its product pipeline, which includes RLF-100 for respiratory issues and ACER-001 for Urea Cycle Disorders. This addition increases the Board to five members, highlighting Relief's commitment to enhancing its operational leadership.