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

Biophytis has signed a master service agreement with Intsel Chimos for the distribution of Sarconeos (BIO101) in France, specifically targeting hospitalized patients suffering from severe COVID-19. The early access program application submitted to the French National Authority for Health aims for treatment availability in the second half of 2023. The agreement marks a significant step for Biophytis, following positive results from its Phase 2-3 COVA study, illustrating the potential for Sarconeos as a therapeutic option in severe respiratory cases. Biophytis seeks to expand access to the drug in other countries, including Brazil.

Biophytis has initiated the early access application process in France for Sarconeos (BIO101), targeting severe COVID-19 treatment. A pre-filing meeting with the French National Authority for Health (HAS) is scheduled for March, aiming for authorization in Q2 2023. This initiative follows positive results from the phase 2-3 COVA trial, where Sarconeos reduced the risk of respiratory failure and early death by 44%. Additionally, Biophytis is preparing a conditional marketing authorization application in Europe and the US due to the ongoing health emergency.

Biophytis SA (NasdaqCM: BPTS), a biotech firm focused on anti-aging therapeutics, will hold an Extraordinary and Ordinary Shareholders' Meeting on March 30, 2023. The company seeks shareholder approval to reduce the nominal value of its shares to a minimum of €0.002 and regroup shares by a maximum factor of 400. These measures aim to enhance financial flexibility following positive results from the COVA study. Additionally, Biophytis requests the renewal of authorizations related to capital increases, initially granted at the June 2022 AGM.

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Biophytis announced positive final results from its phase 2-3 COVA clinical study, demonstrating a 44% significant reduction in the risk of respiratory failure or early death among hospitalized COVID-19 patients treated with Sarconeos (BIO101). The study involved 233 patients, showing statistical significance with a p-value of 0.043. The company is initiating Early Access Programs for Sarconeos in France and Brazil while preparing for Marketing Authorisation in Europe and Emergency Use Authorization in the USA. Biophytis aims to grant access to Sarconeos to at-risk patients in the second half of 2023, amid ongoing COVID-19 challenges.

Biophytis (NASDAQ: BPTS) reported its interim financial results for H1 2022, indicating a net loss of €12.4 million, down 8% from €13.2 million in H1 2021. Cash and cash equivalents decreased to €19.7 million from €23.9 million year-on-year. Research and development expenses fell to €6.9 million from €7.6 million, primarily due to the conclusion of the SARA-INT trial. General and administrative expenses rose to €5.1 million, reflecting increased legal and accounting fees following its Nasdaq listing. The company maintains that its cash reserves and credit lines can sustain operations for the next 12 months.

Biophytis (NasdaqCM:BPTS) announced that the Paris Court of Appeal confirmed the March 16, 2021 judgment against the company, ruling it must pay Negma Group Ltd €75,000. This decision, rendered on January 17, 2023, follows an agreement made on August 21, 2019. Biophytis noted that it had already complied with the initial judgment in 2021. The ruling has not yet been served, and the company retains the right to appeal to the French Supreme Court. Biophytis focuses on therapeutics for aging-related diseases, with leading drug candidate Sarconeos (BIO101) targeting sarcopenia and severe COVID-19 symptoms.

Biophytis (NasdaqCM:BPTS) has received a deficiency notice from Nasdaq for not filing its financial information for the six months ending June 30, 2022. The notice indicates non-compliance with Nasdaq's listing rules under Listing Rule 5250(c)(2). The company has until March 6, 2023 to submit a plan to regain compliance, which could extend the deadline to June 28, 2023 if accepted. Biophytis is working on this plan while continuing to develop its leading drug candidate, Sarconeos (BIO101), aimed at treating aging-related diseases.

Biophytis SA (NasdaqCM:BPTS) announced its participation in two key investor conferences in January 2023: the 41st JP Morgan Healthcare Conference from January 9-12 and the Invest Securities Biomed Event on January 24. These events will facilitate discussions on its clinical trial status and the results of the COVA trial for COVID-19. Biophytis focuses on therapies for aging-related diseases, with its lead candidate, Sarconeos (BIO101), undergoing Phase 2 trials aimed at sarcopenia and respiratory issues related to COVID-19.

Biophytis has presented positive post-hoc analysis results from the phase 2-3 COVA clinical study, showing significant therapeutic potential for Sarconeos (BIO101) in treating pneumonia in COVID-19 patients at risk of respiratory failure. The study revealed a 45% reduction in early death or respiratory failure risk at day 28 and a 43% decrease in death risk at day 90 in the Intent-To-Treat population. Biophytis is set to pursue regulatory approval for Sarconeos in 2023. An online event to discuss these findings will occur on December 1, 2022.