As of mid-June 2025, GenSight Biologics has 131,466,495 outstanding shares and has acknowledged that its current funds are insufficient to meet operational requirements for the next year.

In May 2025, the company received €0.7 million from the Research Tax Credit, with an additional €0.4 million expected in July, but it still needs to extend its cash runway through planned financing initiatives.

To support its operations and regulatory milestones, GenSight is implementing a financing strategy that includes preparations for the upcoming AAC program and a global Phase III clinical trial.

GenSight has reached an agreement with the French medicines safety agency ANSM to consider opening the early access program for its treatment LUMEVOQ® following the approval of a dose-ranging study.

GenSight's CEO, Laurence Rodriguez, highlighted the significance of this agreement, which aims to provide urgent access to LUMEVOQ for patients suffering from Leber Hereditary Optic Neuropathy (LHON).

The design for the dose-ranging study has been submitted, with a clinical trial application anticipated in the third quarter of 2025.

Key value-creating events on the horizon include the clinical trial application in Q3 2025, the opening of the AAC program in Q4 2025, and the initiation of a global Phase III clinical trial in early H2 2026.

GenSight is preparing for regulatory consultations in both the US and EU, planning for the Phase III trial to commence in 2026, and is completing a transition to a new manufacturing partner.

The early access program (AAC) for LUMEVOQ® is targeted to open by the fourth quarter of 2025 at the latest.