• Financial press releases
  • Ongoing communication with French medicines safety agency ANSM on early access dossier for LUMEVOQ®
  • First injections expected in January 2025
  • Advanced discussions to secure financing until first early access program (AAC) payment expected in late January 2025

Paris, France, December 18, 2024, 6:00 pm CEST – GenSight Biologics (“GenSight Biologics” or the “Company“) (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, today provided an update on its regulatory discussions with the French medicines safety agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé or the ANSM) and on its financial strategy.

Ongoing Discussions with the ANSM

The Company confirms the continuation of a constructive and collaborative communication with the ANSM on the updated regulatory file for LUMEVOQ® submitted in November. These discussions demonstrate mutual commitment to advancing toward the resumption of the Early Access Program in France (Autorisation d’Accès Compassionnel or AAC) for the Company’s gene therapy LUMEVOQ®.

Operational Readiness

GenSight Biologics has completed all preparations to supply LUMEVOQ® to the treatment center at the 15-20 National Hospital in Paris, which will optimize the time to the first injections after receipt of regulatory acceptance from the ANSM. Both the Company and the 15-20 National Hospital are aware of the acute need for treatment among eligible Leber Hereditary Optic Neuropathy (LHON) patients who have been waiting for the AAC program to resume. The first patient injections are now expected in January 2025, instead of late December as previously announced.

Financial Strategy

The Company does not have sufficient net working capital to meet its obligations over the next 12 months but only until early January 2025. The Company is currently engaged in advanced discussions to secure financing for its activities until the end of January 2025. The Company expects to receive the first payments from the resumption of the AAC Program at the end of January 2025, which would extend its cash runway beyond 12 months.

Share Information

As of today, the share capital of GenSight Biologics is composed of 117,517,544 ordinary shares.

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