Regulatory News:
The Combined General Meeting of shareholders of GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, took place on May 13, 2025, at 2:00 pm CEST at the Company’s headquarters, 74 rue du Faubourg Saint-Antoine, 75012 Paris, France. The General Meeting was chaired by Laurence Rodriguez, Chief Executive Officer of the Company.
All resolutions recommended by the Board of Directors and submitted to the Combined General Meeting were adopted, with the exception of Resolution A, which was rejected, in accordance with the recommendations of the Board. The quorum on first convening amounted to 56.51%.
During the General Meeting, the Chief Executive Officer reviewed the key achievements of 2024, a year marked by careful cash management, strengthened financial structure with the participation of new investors and renewed support from historical shareholders, as well as the renegotiation of the Company’s financial obligations. She also highlighted progress in manufacturing, including the optimization of GenSight’s technology, preparation for technology transfer to a new manufacturing partner, and the successful mixing and pharmaceutical release of two active substance batches. On the regulatory and clinical fronts, the year saw the preparation of the Phase III RECOVER protocol, the planned submission of the Early Access Program (AAC) application in November 2024, and the continuation of strong scientific communication through international congresses and high-impact journal publications.
Looking ahead to 2025, the Company will maintain strict spending discipline while actively pursuing refinancing opportunities. Strategic priorities include the finalization of the Phase III RECOVER protocol in alignment with health authorities, the submission of the LUMEVOQ® registration dossier to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and the resumption of the Early Access Program in France through continued engagement with the French agency ANSM. On the manufacturing side, efforts will focus on successfully completing the technology transfer initiated at the end of 2024, optimizing LUMEVOQ® production yields, and finalizing the quality control plan. In parallel, the Company will continue to explore strategic options through discussions already underway.
The results of the vote by resolution and the videocast of the Annual General Meeting will be available on the Company's website in the Investors section (www.gensight-biologics.com/investors-media).
About GenSight Biologics
GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.
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Contacts
GenSight Biologics
Chief Financial Officer
Jan Eryk Umiastowski
jeumiastowski@gensight-biologics.com
