RELIEF THERAPEUTICS S/ADR - RLFTY STOCK NEWS

Relief Therapeutics (SIX:RLF, OTCQB:RLFTF, OTCQB:RLFTY) announced plans to file Form 15F with the SEC on December 17, 2024, to terminate its U.S. securities registration and reporting obligations. The company will maintain its primary listing on the SIX Swiss Exchange, continue its Level 1 ADR program, and maintain its OTCQB quotation.

The filing will immediately suspend SEC reporting requirements, including Forms 20-F and 6-K, with full termination expected 90 days after submission. This decision follows the company's previous choice not to pursue a U.S.-regulated exchange listing after filing Form 20-F in 2021. The move aims to reduce compliance costs while maintaining strategic flexibility.

Relief Therapeutics announced positive final results from its proof-of-concept clinical trial of RLF-TD011 for treating epidermolysis bullosa (EB), a rare genetic condition causing fragile skin and chronic wounds. The trial met its primary endpoint, showing a 24% decrease in S. aureus relative abundance (p=0.01) after eight weeks of treatment, correlating with wound size reduction. 78% of treated wounds closed during the treatment period. The treatment increased beneficial bacteria and microbiome diversity, with effects persisting through a four-week post-treatment period. The company plans to consult with the FDA to finalize development and regulatory plans.

Relief Therapeutics has signed a non-binding letter of intent for a reverse merger with Renexxion, a private U.S. biotech company focused on gastrointestinal disorders therapies. The proposed transaction values Relief's equity at USD 100 million and Renexxion's at USD 260 million, resulting in a 72.2% ownership for Renexxion shareholders and 27.8% for Relief shareholders. The combined entity would maintain listings on SIX Swiss Exchange and OTCQB. The deal includes a one-year post-closing reset mechanism and requires completion of due diligence, definitive agreement execution by December 31, 2024, Renexxion's private financing completion, and regulatory and shareholder approvals.

Relief Therapeutics announced the publication of a Plain Language Summary in Future Rare Diseases about PKU GOLIKE®, their treatment for phenylketonuria (PKU). The summary, co-authored by PKU specialists and patient associations, presents clinical study results comparing PKU GOLIKE® with standard amino acid formulations. The study showed that while both provide equal amino acid levels, PKU GOLIKE® delivers a more natural absorption pattern, similar to whole food proteins. This sustained absorption benefits PKU patients who need stable amino acid intake for metabolic balance. The publication aims to make complex scientific information more accessible to patients and caregivers.

Relief Therapeutics announced positive clinical study results for RLF-OD032, their investigational drug for phenylketonuria (PKU), and filed provisional patents in the United States. The study revealed that RLF-OD032, a liquid formulation of sapropterin dihydrochloride, showed superior absorption in fasted conditions compared to KUVAN®. Unlike KUVAN®, which requires food and water for optimal absorption, RLF-OD032 demonstrated effective absorption without these requirements. This breakthrough could offer PKU patients more flexible dosing options and improved convenience. The company plans to file a 505(b)(2) NDA in the U.S. by Q3/2025.

Relief Therapeutics has received a Notice of Allowance from the European Patent Office for its patent application covering RLF-TD011, a treatment for wounds caused by epidermolysis bullosa (EB). The patent, set to protect RLF-TD011 in key European countries until 2040, covers Relief's proprietary hypochlorous acid solutions. Corresponding applications are under review in other major markets, including the U.S. and China.

RLF-TD011 has previously received orphan drug designation from the U.S. FDA for EB, potentially providing incentives such as market exclusivity upon approval. Giorgio Reiner, Relief's chief scientific officer, stated that this patent grant validates their efforts to develop novel treatments for rare diseases and strengthens the protection of their innovation as they advance RLF-TD011's development.

Relief Therapeutics has announced promising preliminary results from its proof-of-concept clinical trial evaluating RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic condition. The study focused on the effects of RLF-TD011 on microbiome diversity in EB wounds.

Key findings include:

• Statistically significant reduction in Staphylococcus aureus
• Increase in beneficial bacteria in EB wounds
• Marked improvement in alpha microbiome diversity
• Notable correlation between wound healing and Staphylococcus aureus reduction

Prof. Amy Paller, Principal Investigator and Chair of Dermatology at Northwestern University, highlighted the importance of addressing Staphylococcus aureus overgrowth in EB patients. The preliminary results suggest RLF-TD011's potential to target a critical need in EB treatment, potentially improving patient outcomes.

Relief Therapeutics reported positive topline results from its proof-of-concept clinical study evaluating RLF-OD032, a concentrated liquid formulation of sapropterin dihydrochloride, for treating phenylketonuria (PKU). The four-way crossover pilot study compared RLF-OD032's pharmacokinetics with KUVAN® powder for oral solution. Topline data showed that RLF-OD032 administered under fed conditions, with or without water, achieved similar peak and total exposure of sapropterin dihydrochloride as KUVAN® under fed conditions with water, meeting FDA bioequivalence study requirements.

Relief plans to advance RLF-OD032 into a pivotal bioequivalence trial as part of the 505(b)(2) NDA submission process in the United States, following FDA pre-IND meeting guidance. The company believes RLF-OD032's potential for administration without water and low-volume dosage offers a unique, portable solution for PKU patients.

Relief Therapeutics (SIX:RLF, OTCQB:RLFTF, OTCQB:RLFTY) has completed the clinical phase of its proof-of-concept study for RLF-OD032, a treatment for phenylketonuria (PKU). The study aims to compare RLF-OD032 with an existing sapropterin dihydrochloride product, focusing on bioavailability under different conditions. Topline results are expected in October 2024, which will guide further development towards a pivotal trial and potential regulatory submission in the US.

RLF-OD032 is a highly concentrated liquid formulation of sapropterin dihydrochloride, designed to lower blood phenylalanine in PKU patients. It offers a more patient-friendly solution by reducing the required medication volume, potentially improving compliance, especially among pediatric patients. If approved, RLF-OD032 would be the first portable, ready-to-use liquid formulation of sapropterin dihydrochloride.