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RELIEF THERAPEUTICS Holding SA, traded as RLFTF, is a biopharmaceutical company dedicated to providing innovative treatment options for select specialty, unmet, and rare diseases. The company focuses on advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit patients. Relief Therapeutics offers a diversified portfolio of marketed products, proprietary platform technologies, and a targeted clinical development pipeline. With a mission to provide therapeutic relief to those suffering from rare diseases, Relief Therapeutics is led by an experienced team of industry leaders. Headquartered in Geneva, the company is listed on the SIX Swiss Exchange and quoted on the OTCQB.
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.
Relief Therapeutics announced the results of its Annual General Meeting (AGM) on June 27, 2024, in Geneva. Key outcomes include approval of the 2023 annual report and financial statements, and the decision to carry forward the 2023 financial year loss. While the board of directors and executive committee were not granted discharge for the financial year 2023, all other resolutions were approved by a large majority. This includes the re-election of Dr. Raghuram Selvaraju as chairman, and the re-election of key board members and auditors. The company's efforts to address shareholder concerns continue, especially regarding the board's discharge.
Relief Therapeutics has announced several executive changes. Interim CEO Michelle Lock's contract expired on May 31, 2024, and she will not seek re-election to the Board of Directors. CFO Andrew Einhorn and CHRO Melinda Keegan have also departed. The Board of Directors will oversee the company's operations while evaluating options to optimize the senior management team. Jeremy Meinen will remain in a senior role. The Board is focused on maximizing the value of Relief Therapeutics' therapeutic product portfolio.
Relief Therapeutics has announced its Annual General Meeting (AGM) of shareholders, scheduled for June 27, 2024, at 11:00 a.m. CEST in Geneva, Switzerland. The agenda includes key items such as the adoption of the 2023 annual report and financial accounts, appropriation of the annual result, discharge of the board of directors and executive committee, approval of compensation for board members, re-election of existing board members and its chairman, and election of the nomination and compensation committee. Shareholders will also vote on the 2023 compensation report and re-elect the independent voting rights representative and auditors. The formal notice, including attendance details and registration requirements, will be sent to registered shareholders on June 5, 2024. The full agenda is available on the Relief website.
Relief Therapeutics, a biopharmaceutical company, announced a new executive leadership team, appointing a chief financial officer, chief human resources officer, and head of legal and compliance. The new team includes Andrew Einhorn as CFO, Melinda Keegan as chief human resources officer, Giorgio Reiner as chief scientific officer, Paolo Galfetti as chief business officer, and Vincenzo Gallo as head of legal and compliance. Jeremy Meinen will step down as CFO. The company aims to accelerate its future success in rare diseases with an expected cash runway into 2026.
Relief Therapeutics, a biopharmaceutical company, has published its Annual Report for 2023 and provided a corporate update. The company is focused on delivering innovative treatment options for rare diseases. The interim CEO, Michelle Lock, expressed confidence in the company's strategic approach and highlighted the potential of RLF-TD011 for epidermolysis bullosa and RLF-OD032 for phenylketonuria.
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