Relief Therapeutics Hldg Ag Stock Price, News & Analysis

Relief Therapeutics Holding SA announced that the I-SPY COVID Trial involving its product aviptadil has been halted due to a lack of clinical benefit in critically ill COVID-19 patients. The Phase 2 trial, sponsored by Quantum Leap Healthcare Collaborative, aimed to evaluate potential agents that could improve recovery times. Relief's pipeline includes RLF-100 and a collaboration with Acer Therapeutics for ACER-001, with a new drug application accepted by the FDA. The future of aviptadil’s approval remains uncertain amid ongoing litigation.

Relief Therapeutics reported full-year 2021 results with a net loss of CHF 34.7 million, up from CHF 7.8 million in 2020. The company generated CHF 3.3 million in revenue from marketed products following the acquisition of APR Applied Pharma Research. Relief is positioned for potential growth with plans for U.S. commercialization of ACER-001, pending FDA approval by June 5, 2022. The company ended 2021 with a cash position of CHF 44.8 million, forecasting a cash runway into 2023. Notable acquisitions and product developments are set to enhance its commercial infrastructure.

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.