Relief Therapeut Stock Price, News & Analysis

Relief Therapeutics provided an update on its potential reverse merger with Renexxion, a private U.S. clinical-stage biotech company focused on gastrointestinal disorders therapies. Following their earlier non-binding letter of intent, both companies have made significant progress in transaction structuring and integration planning. The parties expect to sign a definitive merger agreement in Q1 2025.

Dr. Raghuram Selvaraju, Relief's board chairman, emphasized their focus on leveraging complementary strengths to maximize shareholder value. However, the company noted that there's no assurance of reaching a definitive agreement or completing the proposed transaction as planned.

Relief Therapeutics (RLFTY) announced final results from a clinical trial evaluating PKU GOLIKE for treating phenylketonuria (PKU). The study demonstrated superior metabolic control during prolonged fasting periods compared to standard amino acid protein substitutes. Key findings showed PKU GOLIKE achieved:

- 17.8% reduction in blood phenylalanine (Phe) levels (P=0.0484)
- 33.8% increase in blood tyrosine (Tyr) levels (P=0.0008)

The randomized, crossover, controlled trial was conducted at Birmingham Children's Hospital, UK, on pediatric patients with classical PKU. The results will be presented at the 2025 ACMG Annual Clinical Genetics Meeting in Los Angeles.

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.