RELIEF THERAPEUTICS HLDG - RLFTF STOCK NEWS

Relief Therapeutics provided an update on ACER-001, a powder formulation of sodium phenylbutyrate for treating urea cycle disorders (UCDs). The company announced a Type B pre-NDA meeting with the FDA, aiming for an NDA submission in mid-2021. In Europe, Relief plans to engage with the European Medicines Agency regarding a Marketing Authorization Application later in 2021. If successful, ACER-001 could launch in both regions in 2022, targeting UCDs and Maple Syrup Urine Disease. Relief emphasizes the urgent need for better treatment options for UCD patients.

Relief Therapeutics (OTCQB: RLFTF) has expressed enthusiasm over the initiation of a pivotal clinical trial by APR Applied Pharma Research for its nasal spray targeting COVID-19. This development follows Relief's signing of a binding term sheet to acquire APR, which is set to enhance Relief's clinical pipeline with complementary late-stage candidates. The acquisition promises commercial revenues and access to established markets in Europe. Relief's lead product, RLF-100 (aviptadil), is also advancing in clinical trials aimed at treating lung injury caused by COVID-19.

Relief Therapeutics announced the signing of a binding term sheet to acquire APR Applied Pharma Research for CHF 22 million in cash and CHF 50 million in Relief shares. The acquisition is expected to diversify Relief's pipeline with both commercial and clinical-stage programs, enhancing revenue potential with APR's existing products. The deal aims for immediate earnings accretion and grants Relief access to APR's commercial infrastructure in Europe. Notably, APR's Sentinox has recently been cleared as a Class III medical device in the EU.

Relief Therapeutics announced that the first patient will be enrolled next week in a phase 2 trial for inhaled RLF-100 aimed at preventing COVID-19-related acute respiratory distress syndrome (ARDS). Conducted in Switzerland, the trial will include 80 patients and assess clinical improvement over 28 days. The company is also preparing a phase 2b/3 study for the intravenous formulation of RLF-100 and exploring further clinical development in non-COVID-19 indications. The completion of the trial is estimated between 6-12 months.

Relief Therapeutics Holding AG (OTCQB: RLFTF) has addressed disputes with partner NeuroRx, Inc. regarding the collaboration on RLF-100 (aviptadil). Key issues include NeuroRx's refusal to share clinical trial data, a claim of $4 million in unpaid invoices without valid documentation, and disputes over funding responsibilities for a new clinical trial for COVID-19 treatment. Relief believes these points may affect profit-sharing agreements outlined in their collaboration. Despite these challenges, Relief plans to take necessary actions to enforce its rights under the collaboration agreement.

Relief Therapeutics reported its 2020 financial results on April 15, 2021, highlighting a strong cash position of CHF 43.1 million, up from CHF 0.1 million in 2019. Key developments included advancement in the clinical trials for RLF-100 (aviptadil) for COVID-19 and a new collaboration for ACER-001 targeting orphan diseases. Despite a significant EBITDA loss of CHF 20.3 million, the company successfully raised CHF 58 million in equity financing throughout 2020. Looking ahead, Relief plans to expand its pipeline and pursue regulatory submissions for its lead projects.

Relief Therapeutics Holding AG has appointed J.J. Scherpbier as Manufacturing and Supply Chain Consultant, effective April 1, 2021. Mr. Scherpbier, with over 25 years of experience in pharmaceutical development, will focus on establishing a supply chain for ACER-001, a drug for Urea Cycle Disorders. The company aims to diversify its portfolio and enhance its development capabilities, particularly for RLF-100 (aviptadil), which is in late-stage testing for COVID-19 related respiratory issues. Relief is listed on the SIX Swiss Exchange (RLF) and OTCQB (RLFTF).

NeuroRx reported promising outcomes from its Phase 2b/3 trial of ZYESAMI™ (aviptadil acetate) for COVID-19-induced respiratory failure. The trial, involving 196 patients across 10 sites, met its primary endpoints at 28 days (P = .014) and 60 days (P = .013). Notably, patients treated with ZYESAMI™ had a 75% recovery rate by day 60, outperforming 55% in the placebo group (P = .036). The drug also significantly increased survival rates, particularly among patients receiving High Flow Nasal Cannula (P = .007). NeuroRx plans to submit an EUA application to the FDA and expand its trials further.

Relief Therapeutics Holding AG announces progress on its lead compound RLF-100(TM) (aviptadil) in collaboration with NeuroRx, Inc. They are evaluating the feasibility of formulating RLF-100(TM) as a dry powder using Thin-Film Freezing (TFF) technology. This method may enhance drug delivery, allowing up to 75% deposition in the lungs and eliminating cold chain shipping. The company is focused on advancing treatments for respiratory diseases, particularly related to COVID-19, with ongoing late-stage clinical trials. Relief holds a U.S. patent for RLF-100(TM).