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

Regulatory News:

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 reported its cash position as of March 31, 2024 and provided a business update.

“We are currently fully engaged in active discussions to secure funding for our operations until the resumption of our early access program, whose supply is our main immediate-term priority," commented Laurence Rodriguez, CEO of GenSight Biologics. "Simultaneously, we are actively working on refining the design of the RECOVER PIII study, in order to both fulfil regulatory requirements and support marketing authorization in both the United States and Europe.”

Cash position as of March 31, 2024

GenSight Biologics’ cash and cash equivalents totalled €2.2 million as of March 31, 2024, compared to €2.1 million as of December 31, 2023.

The Company completed a successful offering in February 2024 for a total gross amount of €5 million and has continued to work on cash preservation measures, notably additional savings and obtaining waivers from existing creditors¹.

The Company does not have sufficient net working capital to meet its obligations over the next 12 months but only until end of April 2024.

The Company is currently engaged in active discussions to secure financing for its activities from the end of April 2024 to Q3 2024, when the early access program in France (AAC - autorisation d’accès compassionnel, formerly known as ATU - autorisation temporaire d’utilisation) is expected to resume. Once the AAC/AAP program resumes, the Company estimates that the cash runway would be extended to the end of Q1 2025.

The net funding requirement for the next 12 months is estimated at €9 million (including the anticipated income from the resumption of the AAC/AAP program in France in Q3 2024), in view of the Company's need to finance its ongoing activities.

In parallel, the Company is also advancing on a number of discussions with potential partners on strategic opportunities, including a possible merger, acquisition or licensing deal, assessed as one of the relevant options to move forward.

Business update

GenSight successfully manufactured two Drug Substance (DS) batches of LUMEVOQ meeting Good Manufacturing Practice (GMP) standards in September and November 2023. To optimize vial availability for patients, the decision was made to mix these batches into one Drug Product (DP) batch, slated for release and inclusion in the EAP resumption in Q3 2024. In January 2024, GenSight received constructive feedback from the FDA regarding the design of the Phase III trial RECOVER, which had been previously shared with EMA (European Medicine Agency) and UK’s MHRA (Medicines and Healthcare products Regulatory Agency).