Biophytis SA American Depositary Share (0.01 Euro) - BPTS STOCK NEWS

Biophytis SA (Euronext Growth Paris:ALBPS) has announced the expansion of its partnership strategy in Asia by signing two contracts with local agents. One contract covers Japan and South Korea, while the other focuses on China and Southeast Asia. These agents will help Biophytis identify partners for its drug candidate BIO101 (20-hydroxyecdysone) in these markets.

This initiative aims to accelerate BIO101's deployment in Asia, the world's second-largest pharmaceutical market. Japan and China are strategic targets due to their high prevalence of sarcopenia and obesity, respectively. Following a recent exclusive license agreement with Blanver in Latin America, Biophytis now seeks co-development and commercialization agreements with partners in Asia and North America.

Biophytis has received FDA approval for its phase 2 OBA study in obesity using BIO101 (20-hydroxyecdysone). The study will evaluate muscle strength improvement in the lower limbs and secondary endpoints like mobility and body composition. The trial, led by obesity expert Marc-André Cornier, will start mid-2024 in the USA and may extend to Europe. Preliminary results are expected in 2025. Biophytis aims to attract funding and partnerships, emphasizing the growing obesity treatment market, projected to reach $100 billion by 2030.

Biophytis presented the results of its Phase 2/3 COVA study on severe COVID-19 at the World Congress on Infectious Diseases in Paris, held from June 24-26, 2024. The study focused on the efficacy of BIO101 (20-hydroxyecdysone) in hospitalized patients. Results showed a 43.8% reduction in the risk of early respiratory failure or death, and a 44.6% reduction in the death rate over 90 days. The study highlighted a good safety profile for BIO101. The presentation comes as COVID-19 cases rise, with a noted 52% increase in ER visits in France during mid-June. The results position BIO101 as a promising treatment for severe COVID-19, especially in elderly patients with comorbidities.

Biophytis has signed an exclusive license agreement with Blanver for the commercialization of BIO101 in Latin America, including countries such as Brazil, Mexico, Argentina, and Colombia. The deal is valued at up to €108 million, comprising upfront and milestone payments, along with double-digit royalties on future sales.

Blanver will handle the registration, marketing, and commercialization of BIO101 for various indications like obesity, respiratory infections due to Covid-19, sarcopenia, and Duchenne Muscular Dystrophy, contingent on successful clinical trials by Biophytis.

This partnership aims to leverage Blanver's extensive distribution network and expertise in infectious diseases and metabolic disorders, highlighting the promising potential of BIO101 based on positive clinical results.

Biophytis anticipates this collaboration will significantly contribute to its strategic goals, especially in addressing obesity in a rapidly growing pharmaceutical market like Brazil.

Biophytis has extended its bond financing agreement with Atlas, allowing for the issuance of convertible bonds up to €16 million over two years. This extension aims to fund Biophytis' clinical programs in obesity (OBA) and Duchenne Muscular Dystrophy (MYODA). However, the financing method may cause significant shareholder dilution and downward pressure on the stock price. Biophytis’ OBA Phase 2 study is set to start in mid-2024, and the MYODA trial has received FDA approval. The company is also seeking additional partners and funding to support these programs.

Biophytis, a clinical-stage biotechnology company, announced the successful industrial transfer of its drug candidate BIO101 (20-hydroxyecdysone) production to Seqens. Seqens has produced the first GMP-compliant batch at their Villeneuve La Garenne plant, which is now available for Biophytis' clinical development program aimed at treating respiratory deterioration in Duchenne Muscular Dystrophy (DMD) patients. DMD is a severe genetic disease causing progressive muscle degeneration. The company, which holds orphan drug designation in Europe and the US for this indication, aims to assess BIO101's pharmacokinetics, safety, and clinical efficacy in a planned phase 1-2 trial. Biophytis is currently seeking partners and funding for this clinical trial.

Biophytis has submitted an IND application to the FDA for its phase 2 OBA clinical study in obesity using BIO101 (20-hydroxyecdysone). The study will evaluate the efficacy and safety of BIO101 in obese and overweight patients with secondary comorbidities. Patients will be treated for 21 weeks with GLP-1 receptor agonists and a hypocaloric diet. Primary objectives include assessing muscle strength in lower limbs, with secondary endpoints like mobility and body composition. The international study is set to start mid-2024, with first patient treatments expected in the latter half of the year. Initial efficacy results are anticipated in 2025. The principal investigator is Professor Marc-André Cornier, a renowned expert in obesity. Biophytis aims to attract potential pharma partners and position itself in a growing market projected to treat 15 million U.S. adults by 2030, worth an estimated $100 billion.

Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company, has scheduled its Combined General Meeting (CGM) for June 24, 2024, at 2 pm at Sorbonne Université in Paris.

The meeting notice, agenda, draft resolutions, and attendance conditions were published on May 15, 2024. Shareholders can access preparatory documents, including voting forms and location maps, on Biophytis' website. Shareholders are encouraged to vote in advance by post, proxy, or online via VOTACCESS by June 21, 2024, or by June 23, 2024, for online votes.

Biophytis has announced the design of its Phase 2 OBA clinical study in obesity, focusing on BIO101 (20-hydroxyecdysone). The study will evaluate BIO101 in obese patients treated with GLP-1 RAs and a hypocaloric diet. CEO Stanislas Veillet highlighted the potential market for obesity treatments and the opportunity for BIO101 to preserve muscle function in these patients. The double-blind, placebo-controlled study will involve 164 patients and assess muscle strength, 6-minute walking distance, and various performance tests. The IND filing is expected soon, with the study starting mid-2024 and initial results in 2025.