Biophytis SA American Depositary Share (0.01 Euro) Stock Price, News & Analysis

Biophytis announced that the independent DMC has recommended continuing patient recruitment for Part 2 of the COVA study without changes to the protocol after a safety review of the first 155 patients. Currently, 191 patients have been randomized across 36 centers in the USA, Brazil, France, and Belgium. The efficacy data from this cohort will be reviewed in Q3 2021, with top-line results from the full study of 310 patients expected in Q4 2021, subject to COVID-19 conditions. The study evaluates Sarconeos (BIO101) for severe respiratory issues due to COVID-19.

Biophytis has fulfilled its obligations from two Paris court judgments, involving a capital increase and share issuance to Negma Group. The company issued 4,950,000 new shares, leading to a 4.2% dilution of its capital, increasing its total shares to 122,145,455. This follows previous rulings which mandated Biophytis to pay fines totaling approximately €1.5 million and comply with share delivery orders. Biophytis intends to protect its interests regarding the legal processes involving Negma.

Biophytis has announced positive top line results from the SARA-INT phase 2 clinical trial of Sarconeos (BIO101) for age-related sarcopenia. The study demonstrated a statistically significant improvement in gait speed, measured by the 400-meter walk test, with a treatment effect of 0.09 m/s for the full analysis set and 0.10 m/s for the per-protocol population at the highest dose of 350 mg bid. Safety assessments showed a favorable profile with no serious adverse events attributed to the drug. The company plans to progress to a phase 3 study to further evaluate Sarconeos.

Biophytis SA (BPTS) announced the July 16, 2021 judgment from the Paris Court of Justice regarding its legal disputes with Negma Group Ltd. The court partially favored Negma, imposing a €1,500,000 penalty on Biophytis for non-performance and introducing a daily fine of €50,000 for further delays. The company intends to comply with the judgment while pursuing an appeal. Biophytis specializes in therapeutics that target age-related diseases, including their lead drug candidate Sarconeos (BIO101), which is undergoing multiple clinical trials.

Biophytis has released promising preclinical data for its drug Sarconeos (BIO101) against COVID-19, showing significant results in hamsters. The study indicated that daily treatment with BIO101 improved respiratory function and reduced distress indicators in infected animals. This breakthrough aligns with the ongoing Phase 2-3 COVA clinical study, which expects interim results in Q3 2021. The company is prepared to enhance production capacity upon regulatory approval.

Biophytis SA (Nasdaq: BPTS) announced key leadership changes aimed at enhancing its strategy in therapeutics for age-related diseases. Claude Allary joins as a new Board member, succeeding Jean Franchi, while Benoit Canolle is appointed Chief Business Officer. Jean Mariani will serve as interim Chief Medical Officer. Allary brings 40 years of healthcare experience, and Canolle has a strong background in pharma R&D. These appointments aim to advance the company’s clinical trials for Sarconeos (BIO101) targeting COVID-19 and sarcopenia.

Biophytis, a clinical-stage biotechnology company, is set to release topline results from its Phase 2 SARA-INT study of Sarconeos (BIO101) in August 2021. This study involves 233 patients aged over 65, focusing on sarcopenia and mobility disability, measured through a 400-meter walk test. The trial successfully completed despite challenges posed by the COVID-19 pandemic, with 196 participants finishing the study. Full results will be shared at the ICSFR conference on September 29-October 2, 2021.

Biophytis has entered into contracts with a major CDMO to manufacture registration batches of Sarconeos (BIO101) for potential Emergency Use Authorization from the FDA and Conditional Marketing Authorization from the EMA for COVID-19. The 155th patient in Part 2 of the COVA Phase 2-3 study has completed treatment, with interim analysis results expected in Q3 2021 and full results slated for Q4 2021. The company aims for commercialization to begin in early 2022, despite noting that new timelines do not affect Biophytis' overall strategy.

Biophytis SA (Nasdaq: BPTS) announces a €32 million financing agreement with Atlas to support the clinical development of Sarconeos (BIO101) for sarcopenia and COVID-19. This financing is through Bonds Redeemable in Cash and New and Existing Shares (ORNANE). Additionally, the company executed a €6 million drawdown from an existing convertible bond agreement with Atlas. The outcomes of upcoming clinical trials will be pivotal for further authorization in the U.S. and EU.