Biophytis announces the drawing of the last tranche of ORNANE under the 2020 Atlas Contract for €3 million Biophytis announces the issuance of the last 120 Bonds Redeemable in Cash and New and Existing Shares (ORNANE) for a total amount of €3 million under its existing convertible bond agreement with Atlas, a specialized investment fund based in New York (United States) for €24 million (the “2020 Atlas Contract”).
Biophytis to meet with FDA to advance Sarconeos (BIO101) development in Sarcopenia from Phase 2 to Phase 3 Following Phase2b/SARA-INT clinically meaningful results, Biophytis is starting first regulatory activities to advance from Phase 2 to Phase 3 development A Type B/End-of-Phase 2 meeting is planned with FDA (Food and Drug Administration) on January 24th, 2022, to discuss these results and the Phase 3 protocol design Assuming potential agreement and approval from US authorities Biophytis intends to initiate its Phase 3 program in Sarcopenia in H2 2022
Biophytis obtains a new 10M€ loan structure with Kreos Capital Biophytis announces that the Company entered into a new loan structure with Kreos Capital. Stanislas Veillet, CEO of BIOPHYTIS, stated: “This transaction allows us to fund the final steps of our COVA phase 2-3 study in COVID-19, mostly for registration under Emergency Use Authorization with the FDA and Conditional Use with the EMA, and the manufacturing of registration batches of the Sarconeos (BIO101). This new financing structure with Kreos Capital shows the good relationship both Parties are having since 2018”. The €10 million total loan was concluded on November 19,
Biophytis announces US centers to restart recruitment for the COVA phase 2-3 study with Sarconeos (BIO101) in COVID-19 Biophytis announces that patient recruitment in the United States, paused in May while waiting for results of the Interim Analysis 2, has restarted. The Data Monitoring Committee (DMC) had recommended in September from the Interim Analysis 2 the continuation of the COVA study unmodified based on results showing the efficacy of the treatment with Sarconeos (BIO101) in the promising zone and no futility of the study. The FDA confirmed that, as part of the protocol and following the DMC recommendation, the enrollment
Biophytis today reports the restated financial statements as per the Company’s previous announcement on October 7, 2021 for the periods ending December 31, 2019, December 31 2020, June 30 2020 and June 30 2021, with no impact on the Company’s cash and cash equivalent as of June 30 2021. Fullscreen Mode
Biophytis to Restate Previously Issued Financial Statements Biophytis today announced that the Company’s previously issued audited consolidated financial statements for the fiscal years ended December 31, 2019 and 2020 and unaudited consolidated financial statements for the six month periods ended June 30, 2021 and 2020 will be restated to correct the Company’s accounting treatment of its convertible notes. These technical corrections relate to the inappropriate historical accounting practices relating to notes convertible into ordinary shares and/or redeemable for cash with attached warrants issued to convertible noteholders. The Company is still in the process of evaluating the impact of these corrections
Biophytis to host virtual KOL event on Sarconeos (BIO101) on its lead projects in COVID-19 and Sarcopenia Biophytis today announces it will host a virtual key opinion leader (KOL) event on October 6th, 2021, on its lead projects, Sarconeos (BIO101) for the treatment of COVID-19 and Sarcopenia. The webinar will feature a presentation by four KOLs including: For the COVA study with Sarconeos (BIO101) in COVID-19: Professor Suzana Margareth Ajeje Lobo, MD, Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto, São Paulo State, Brazil Dr Girish Balachandran Nair, MD, Associate Professor of Medicine in the
Biophytis announces the drawing of 2 new tranches of ORNANE under the 2020 Atlas Contract for €6 million Biophytis today announces the issuance of 240 Bonds Redeemable in Cash and New and Existing Shares (ORNANE) for a total amount of €6 million under its existing convertible bond agreement with Atlas, a specialized investment fund based in New York (United States) for €24 million (the “2020 Atlas Contract”). Fullscreen Mode
Biophytis announces promising full results from the SARA-INT Phase 2b trial of Sarconeos (BIO101) in Sarcopenia at the 11th annual International Conference on Frailty and Sarcopenia Research (ICFSR) September 29 – October 2, 2021 Biophytis today announces the full results from the SARA-INT Phase 2 trial of Sarconeos (BIO101) in Sarcopenia that have been presented at the International Congress on Frailty and Sarcopenia Research (ICFSR) on September, 30th. ICFSR is the key international scientific event on Frailty and Sarcopenia and is attended by leading researchers, physicians and Biotech/Pharma in this field. Sarconeos (BIO101) at the highest dose (350 mg bid)
Biophytis to Present Full Results from the SARA-INT Phase 2b Trial of Sarconeos (BIO101) in Sarcopenia at the 11th annual International Conference on Frailty and Sarcopenia Research (ICFSR) September 29 – October 2, 2021 Biophytis today announces it will present full results from the SARA-INT Phase 2 trial of Sarconeos (BIO101) in Sarcopenia at the International Congress on Frailty and Sarcopenia Research (ICFSR) to be held virtually from September 29 to October 02, 2021 ICFSR is the key international scientific event on Frailty and Sarcopenia and is attended by leading researchers, physicians and Biotech/Pharma in this field. The results of