Welcome to our dedicated page for Biophytis SA American Depositary Share (0.01 Euro) news (Ticker: BPTS), a resource for investors and traders seeking the latest updates and insights on Biophytis SA American Depositary Share (0.01 Euro) stock.
Biophytis SA (Symbol: BPTS) is a clinical-stage biotechnology company dedicated to developing drug candidates for age-related diseases. Founded in 2006 as a spin-off from Université Pierre et Marie Curie (Paris), Biophytis focuses on addressing conditions that become increasingly prevalent with aging, such as sarcopenia, dry age-related macular degeneration, and COVID-19-related respiratory issues.
The company's leading drug candidate, Ruvembri™ (20-hydroxyecdysone), has shown promising results in clinical trials. It is currently being evaluated in several rigorous studies, including the phase 3 SARA-31 study for sarcopenia and a phase 2-3 study for severe COVID-19. The SARA-INT phase 2 study demonstrated notable improvements in physical performance, evidenced by the 400 Meter Walking Test results.
Biophytis has also recently initiated the OBA clinical program, which aims to explore the efficacy of BIO101 (20-hydroxyecdysone) in treating obesity, especially in patients who are also being treated with GLP-1 receptor agonists. This program addresses the often-overlooked issue of muscle loss during obesity treatment, aiming to preserve muscle function while facilitating weight loss.
The company operates out of Paris, France, and Cambridge, Massachusetts, and is actively seeking partnerships to further develop and market its drug candidates. Biophytis' American Depositary Shares (ADS) are traded on the Nasdaq Capital Market under the ticker BPTS, while its ordinary shares are listed on Euronext Growth Paris under the ticker ALBPS.
In terms of financial health, Biophytis has successfully secured financing to sustain its activities until early 2025, despite a challenging financial environment for the biotech sector. This stable financial footing allows the company to continue its innovative work and expand its clinical programs.
Stay updated with the latest from Biophytis, including their groundbreaking research and strategic developments, by visiting their official website.
Biophytis (BPTS) has resumed patient recruitment in the US for its COVA study, following a recommendation from the Data Monitoring Committee (DMC) based on positive Interim Analysis 2 results regarding the efficacy of Sarconeos (BIO101). A total of 216 patients have been enrolled so far, with a target of 310 to 465 patients across 50 centers. The company anticipates final results in early 2022 and aims for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe by mid-2022. The ongoing study addresses severe respiratory complications related to COVID-19.
Biophytis (NASDAQ: BPTS) announced the restatement of financial statements for periods ending December 31, 2019, December 31, 2020, June 30, 2020, and June 30, 2021. This decision follows an independent accounting review to correct accounting treatments of convertible notes, impacting financial statement line items without affecting cash balances. Notably, the restatement reduced net loss for the six-month period ending June 30, 2021, by €2.7 million. Updated details are available in the company's 20-F/A report and on their website.
Biophytis (Nasdaq: BPTS) announced the restatement of its audited financial statements for FY 2019, FY 2020, and H1 2021 due to incorrect accounting practices regarding convertible notes. While the company is evaluating the impact on its financial statements, it asserts that these corrections won't affect its cash position. The firm will soon file the restated financials and publish a management report for H1 2021. Biophytis focuses on therapeutics for age-related diseases, including COVID-19 related respiratory failure.
Biophytis (Nasdaq: BPTS) has announced a virtual key opinion leader (KOL) event scheduled for October 6, 2021. The event will showcase discussions on two projects: Sarconeos (BIO101) for treating COVID-19 and Sarcopenia. The first session will focus on the COVA study involving prominent KOLs from the USA and Brazil, while the second will highlight the SARA study with experts from France and the USA. Sarconeos is under Phase 2 clinical trials in the US and Europe, targeting both severe respiratory issues due to COVID-19 and sarcopenia, a degenerative muscle condition.
Biophytis SA (NasdaqCM: BPTS) has issued 240 Bonds Redeemable in Cash and New and Existing Shares (ORNANE) amounting to €6 million under its convertible bond agreement with Atlas. This financing is part of a €24 million contract established in April 2020, allowing Biophytis to draw funds over three years. Following the recent draw, €3 million remains available. ORNANE do not bear interest and mature in 24 months, with conversion available at any time within that period, potentially affecting shareholder dilution.
Biophytis has announced promising results from the Phase 2 SARA-INT trial of Sarconeos (BIO101) for treating sarcopenia. The study demonstrated a significant improvement in the 400-Meter Walk Test at the highest dose of 350 mg bid after 6 months. Notably, Sarconeos displayed a strong safety profile with no serious adverse events reported. Biophytis is now preparing for a Phase 3 study targeting similar populations, aiming to position Sarconeos as the first approved treatment for sarcopenia. The study's execution was impacted by COVID-19 restrictions, affecting participant engagement.
Biophytis SA (NasdaqCM: BPTS) announced it will present full results from the SARA-INT Phase 2 trial of Sarconeos (BIO101) for sarcopenia at the International Congress on Frailty and Sarcopenia Research from September 29 to October 02, 2021. The results show a clinically meaningful improvement in the primary endpoint, the 400-meter walk test, with a good safety profile. Biophytis is now preparing for the Phase 3 program in response to these results, enhancing its potential in treating age-related diseases.
Biophytis SA (Nasdaq: BPTS) announced positive interim results from its Phase 2 SARA-INT trial, indicating that Sarconeos (BIO101) effectively improves functionality in sarcopenia patients. The company plans to advance into Phase 3 trials. Additionally, the Data Monitoring Committee supported continuing the COVA Phase 2/3 study for COVID-19, with expected results in Q1 2022. Biophytis has increased its cash reserves to €23 million following a successful IPO and secured €32 million in convertible bonds to support ongoing clinical developments.
Biophytis received a positive recommendation from the Data Monitoring Committee (DMC) to continue Part 2 of the Phase 2-3 COVA Study of Sarconeos (BIO101) without changes. The second Interim Analysis revealed efficacy results in a promising zone among 155 patients hospitalized with respiratory failure due to COVID-19. Currently, 200 patients are enrolled, with plans to open 15 additional recruitment sites across multiple countries. The company anticipates reporting top-line results in Q1 2022, targeting potential commercialization within the first half of 2022.
Biophytis SA (NasdaqCM: BPTS) announced its participation in several upcoming investor events, focusing on age-related therapeutics and severe respiratory failure treatments. Key events include the H. C. Wainwright 23rd Annual Global Investment Conference from September 13-15 (virtual), the Amsterdam MidCap Event from September 20-21 (virtual), and more through October and December. The company is advancing Sarconeos (BIO101) in Phase 2 clinical trials aimed at sarcopenia and COVID-19 respiratory distress. Biophytis operates out of Paris and Cambridge and trades on Nasdaq and Euronext Growth.
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