RELIEF THERAPEUTICS S/ADR - RLFTY STOCK NEWS

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.

Relief Therapeutics announced that interim data from their clinical trial evaluating PKU GOLIKE® will be presented at the SSIEM 2024 Annual Symposium in Porto, Portugal. This study, carried out by the Inherited Metabolic Disorders Unit at Birmingham Children's Hospital, UK, focuses on controlling overnight phenylalanine (Phe) fluctuations in pediatric patients with phenylketonuria (PKU).

The study compares the benefits of PKU GOLIKE to standard amino acid protein substitutes. Preliminary results indicate that PKU GOLIKE reduces blood phenylalanine levels and increases blood tyrosine levels overnight, which could prevent toxic Phe accumulation during prolonged fasting periods. Final results will be reported after ongoing data analysis.

For more information, visit clinicaltrials.gov (NCT05487378).

Relief Therapeutics (SIX:RLF, OTCQB:RLFTF, OTCQB:RLFTY) reported strong financial results for H1 2024, with revenue up 85% and operating expenses down 45%. The company's cash reserves of CHF 15.1 million are expected to fund operations into at least 2026. Key developments include:

1. Anticipated results from the RLF-TD011 trial for epidermolysis bullosa wound treatment
2. Progress in the RLF-OD032 pilot PK study for phenylketonuria, with potential NDA filing by mid- to late 2025
3. Streamlined operations and cost-reduction initiatives
4. Stable R&D investments despite overall expense reduction

The company remains debt-free and expects continued revenue growth to support its development programs.

Relief Therapeutics has secured up to $11 million in non-dilutive funding through the sale of royalty interests to SWK Funding The deal includes $5.75 million upfront and $5.25 million in potential milestone payments. The funds will support the development of RLF-TD011, a topical spray for epidermolysis bullosa, and other pipeline advancements.

The agreement covers royalties from OLPRUVA, GOLIKE, and CAMBIA. Relief retains significant upside potential, with SWK returning 80% of OLPRUVA royalties over $2.25 million annually and all royalties over $4.5 million. For GOLIKE, SWK will return 80% of royalties over $1.32 million annually and all over $1.98 million. The deal terminates when SWK receives 2.75 times its invested capital.