ISIN:US09076G1040

Biophytis announces receipt of Nasdaq Notice

Retrieved on: 
Jeudi, décembre 14, 2023

The Notification Letter has no immediate effect on the listing of the ADSs, and they will continue to trade on The Nasdaq Global Select Market under the symbol “BPTS”.

Key Points: 
  • The Notification Letter has no immediate effect on the listing of the ADSs, and they will continue to trade on The Nasdaq Global Select Market under the symbol “BPTS”.
  • Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the applicable grace period to regain compliance is 180 days, or until May 13, 2024.
  • Biophytis intends to regain compliance within the applicable compliance period and is currently evaluating its options to do so.
  • During this time, the Company’s ADSs will continue to be listed and trade on The Nasdaq Global Select Market and the Company’s business and operations are not affected by the receipt of the Notification Letter.

Biophytis and Innovation Solutions Pharma sign a partnership agreement to accelerate market access for Sarconeos (BIO101) in Brazil

Retrieved on: 
Mardi, novembre 7, 2023

As part of this partnership, Innovative Solutions Pharma will represent Biophytis in front of the Brazilian agency ANVISA to lift the suspension of the Early Access Program (EAP) authorized at the beginning of 2022.

Key Points: 
  • As part of this partnership, Innovative Solutions Pharma will represent Biophytis in front of the Brazilian agency ANVISA to lift the suspension of the Early Access Program (EAP) authorized at the beginning of 2022.
  • The aim is to offer a therapeutic alternative to prevent death of these patients.
  • Stanislas Veillet, Chief Executive Officer of Biophytis, stated: “Making Sarconeos (BIO101) available to Brazilian patients hospitalized in intensive care due to Covid-19 represents a key step towards bringing our treatment to market.
  • Biophytis aims to start this early access program in Brazil in the first quarter of 2024, and to continue expanding our early access program in France and in other countries.”

Biophytis receives notice of delisting from Nasdaq and announces it will request a hearing before the Nasdaq Hearings Panel

Retrieved on: 
Mardi, novembre 7, 2023

The Notice further states that unless the Company timely requests a hearing before a Nasdaq Hearings Panel, the Company’s securities would be subject to delisting.

Key Points: 
  • The Notice further states that unless the Company timely requests a hearing before a Nasdaq Hearings Panel, the Company’s securities would be subject to delisting.
  • The hearing request will automatically stay any suspension or delisting action pending the hearing.
  • Pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant the Company an additional extension not to exceed April 23, 2024.
  • At the hearing, the Company will present its plan for regaining and sustaining compliance with the Equity Requirement for continued listing.

Biophytis releases its half-yearly accounts as of 30 June 2023 and provides an update on its operations

Retrieved on: 
Mercredi, septembre 27, 2023

As in the previous year, Biophytis did not record any revenues in the first half of 2023.

Key Points: 
  • As in the previous year, Biophytis did not record any revenues in the first half of 2023.
  • The change in net financial expense is mainly due to the valuation of financial liabilities in accordance with IFRS 9.
  • As a result of the above, the half-year loss has been significantly reduced, from €12.4 million at 30 June 2022 to €7.8 million at 30 June 2023.
  • Continuing pre-clinical development work on Macuneos (BIO201) and its back-up BIO203 and preparing for clinical development in dry AMD.

Biophytis provides an update on its early access programs for Sarconeos (BIO101) in the treatment of severe forms of COVID-19

Retrieved on: 
Lundi, septembre 25, 2023

After examining the Early Access Authorization request file submitted at the end of May 2023, HAS considered that the Company had not provided sufficient data allowing it to evaluate precisely the benefit vs. risk ratio and to authorize the treatment of patients with severe forms of COVID-19, despite the statistically significant results of the phase 2-3 COVA study.

Key Points: 
  • After examining the Early Access Authorization request file submitted at the end of May 2023, HAS considered that the Company had not provided sufficient data allowing it to evaluate precisely the benefit vs. risk ratio and to authorize the treatment of patients with severe forms of COVID-19, despite the statistically significant results of the phase 2-3 COVA study.
  • At the same time, Biophytis is taking steps in Brazil to confirm the early access authorization obtained in early 2022 that was interrupted pending publication of the full results of the COVA study.
  • This new authorization is expected by the end of the year.
  • Finally, the Company is exploring the possibilities of launching early access programs in other key countries in Europe, in order to best respond to the medical need in a pathology that has become endemic.