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

Biophytis, a clinical-stage biotechnology company, will present its Sarconeos (BIO101) development program at the 12th International Conference on Frailty and Sarcopenia Research in Boston, from April 20-22, 2022. The oral presentation on April 22, by key researchers, will focus on the Phase 2 SARA-INT trial results. Sarconeos demonstrated a safety profile and improved gait speed, meeting the Minimal Clinically Important Difference. The company aims for FDA discussions regarding further studies by Q3 2022, pending regulatory authorizations and potential delays.

Biophytis announced its 2021 financial results, reporting a net loss of €31.2 million, up from €25.5 million in 2020. The company had €23.9 million in cash by year-end and secured €42 million in financing, enhancing its financial visibility. Operationally, Biophytis achieved significant progress in its COVID-19 and sarcopenia clinical trials, with 237 patients recruited for the COVA study and promising results for Sarconeos (BIO101) in both programs. Early recruitment termination for COVA is planned, with trial results expected by Q3 2022.

Biophytis (NASDAQ:BPTS) announced key updates on its clinical trials for Sarconeos (BIO101), focusing on sarcopenia and COVID-19. Discussions with the FDA aim for a Phase 2-3 study to start by H2 2022, following a prior Phase 2 trial that showed promising gait speed improvements.

However, recruitment for the COVA study was halted at 237 patients due to declining COVID-19 cases, with results expected in Q3 2022. The company is preparing for further consultations with regulatory bodies to advance its trials.

Biophytis SA (NASDAQ:BPTS) has appointed Philippe Rousseau as Chief Financial Officer, succeeding Evelyne Nguyen, who leaves to pursue other projects. Rousseau brings nearly 25 years of experience in the biotech sector, previously serving as COO of Pherecydes Pharma and CFO of Therabron Therapeutics. His financial expertise will support Biophytis' strategic partnerships and investor relations, especially in the U.S. CEO Stanislas Veillet expressed confidence in Rousseau's ability to manage financial operations effectively.

Biophytis SA (NASDAQ:BPTS) announces its participation in a virtual workshop by the National Institute on Aging from March 20-22, 2022, focusing on therapies for the elderly. Dr. Waly Dioh will present on the progress of Sarconeos (BIO101), aimed at treating sarcopenia, and engage with potential partners and regulatory bodies. This follows a positive Phase 2 clinical trial for Sarconeos. The workshop addresses the public health need for therapies that promote functional health in aging populations.

Biophytis has received ANVISA approval for its Expanded Access Program (EAP) to provide Sarconeos (BIO101) treatment to a maximum of 80 hospitalized COVID-19 patients on mechanical ventilation in Brazilian ICUs. This program aims to evaluate the safety and potential effectiveness of Sarconeos in severe cases. Concurrently, Sarconeos is undergoing a Phase 2-3 study (COVA) in other regions for non-intubated patients. Brazil’s rising COVID-19 cases highlight the need for new treatment options, as current therapies are insufficient for critically ill patients.

Biophytis SA (NASDAQ:BPTS) announced the issuance of the final tranche of 120 Bonds Redeemable in Cash and New and Existing Shares (ORNANE) totaling €3 million under its convertible bond agreement with Atlas. This marks the last drawing from the €24 million agreement established on April 7, 2020. The ORNANE will not bear interest and have a 24-month maturity from issuance. If converted, this could dilute existing stakeholders, reducing a 1% stake's ownership to approximately 0.90%. The company focuses on COVID-19 and age-related disease therapeutics.

Biophytis announces the transition of its drug candidate Sarconeos (BIO101) from Phase 2 to Phase 3 clinical trials for sarcopenia. Following a successful Phase 2b/SARA-INT study, the company plans a Type B/End-of-Phase 2 meeting with the FDA on January 24, 2022 to discuss results and Phase 3 protocol design. If approved, the Phase 3 program could commence in H2 2022. The Phase 2 study showed a clinically significant improvement in mobility, with a good safety profile observed at high doses.

Biophytis (NASDAQ: BPTS) announced a €10 million loan agreement with Kreos Capital to fund the final phases of its COVA Phase 2-3 study targeting severe respiratory failure in COVID-19 patients. This loan comprises four tranches, with the first two already drawn. The loan features a fixed interest rate of 10% for straight bonds and 9.5% for convertible bonds, with repayment structured over 36 months. The agreement also includes share warrants allowing Kreos to convert bonds into shares at a fixed price, potentially diluting shareholder equity.