GenSight Biologics Reports Cash Position as of March 31, 2024, and Provides Business Update - Seite 2

The Company is currently refining the RECOVER study design to incorporate feedback from regulatory agencies prior to the launch of the study, in order to both fulfil regulatory requirements and then support both US and EU regulatory submissions for registration. Additional consultations with regulatory agencies may be necessary to finalize the study design.

RECOVER will be able to begin recruiting once the design is finalized; the product is released for human use; and approval is obtained from local competent authorities and ethics committees. With the Company prioritizing the allocation of the next available LUMEVOQ vials to supply of the AAP/AAC program and considering the need of refining the RECOVER study design, the inclusion of the first patient in the trial is expected in H2 2025. The duration of the trial will depend on its final design currently being determined.

As previously announced, the existing clinical data package, not necessarily including the upcoming RECOVER trial data, could support a marketing authorization application in the UK. The Company plans further discussions with the MHRA to ensure the quickest path towards a regulatory submission.

Starting Q3 2024, the Company expects to provide treatment to patients in France through the AAC program.

Number of outstanding shares

As of March 31, 2024, GenSight Biologics’ number of outstanding shares was 78,370,724 ordinary shares.

Detailed information regarding the Company, including its business, financial information, results, perspectives and related risk factors are contained (i) in the Company’s 2022 Universal Registration Document filed with the AMF on May 10, 2023 under number D.23-0406 (the "2022 URD"), and (ii) the amendment to the 2022 URD filed with the AMF on November 21, 2023 under number D.23-0406-A01 (the "Amendment to the 2022 URD"). These documents, as well as other regulated information and all of the Company's press releases, can be accessed on the Company's website (www.gensight-biologics.com) and/or AMF (www.amf-france.org). Your attention is drawn to the risk factors related to the Company and its activities presented in chapter 3 of its 2022 URD and in chapter 2 of the Amendment to the 2022 URD, in particular the liquidity risk presented in the chapter 2.2.1 of the Amendment to the 2022 URD.