GenSight Biologics Reports Cash Position and Revenue from Early Access Program as of March 31, 2026

PARIS--(BUSINESS WIRE)--Regulatory News:

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, today reported its cash position and the revenues from its Named Patient Early Access Program as of March 31, 2026.

Cash position as of March 31, 2026

GenSight Biologics’ cash and cash equivalents totaled €3.2 million as of March 31, 2026, compared to €2.4 million as of December 31, 2025.

The operating cash burn in the first quarter of 2026 mainly reflects the preparation and management of GS010 Early Access Programs, primarily in France, as well as the preparation of the Phase III RECOVER study for GS010/LUMEVOQ^®, GenSight’s gene therapy for Leber Hereditary Optic Neuropathy (LHON).¹

On March 10, 2026, the Company raised nearly €1.7 million in the form of shares and warrants, including pre-funded warrants. The purpose of this fundraising was to provide the Company with a cash buffer to absorb any delays in payments from the French hospital system.

Proceeds from Early Access Program

Following the authorization in March of the first named patient requests in France, an initial group of patients in the GS010 Named Patient Program (AAC) were treated at the 15-20 National Hospital in Paris in later in the same month.

The first proceeds from the AAC Program were recorded in March 2026 and amounted to €2.6 million.

Following the July 2021 reform in France (Decree No. 2021-869 of June 30, 2021 on early access authorizations), companies are required to make payments based on compensation received in over a calendar year according to a progressive rebate scale, with such payments due in November of the following year. Accordingly, the Company will be required to pay a rebate in November 2027 based on proceeds received from the 2026 French Early Access Program only, which is expected to range from 10% to 35%.

Revenues to be recorded in the Company’s financial statements are also subject to a potential rebate payable upon commercialization of the drug.

The price of the treatment under the French Named Patient Early Access Program (AAC) for GS010/LUMEVOQ^® has been set at €425,000 per injection.

Additional treatments are scheduled for April 2026, and the Company also expects to initiate the Paid Named Patient Program in Israel in Q2 2026.

Cash runway

Although the Company is unable to predict the precise timing of treatments and associated payments under its various paid early access programs (in particular in France and Israel) over the coming year, management currently expects that aggregate revenues from these programs in 2026 should be sufficient to cover the Group’s operating expenses for that period, excluding costs associated with the new Phase III RECOVER clinical trial, including certain manufacturing costs related to the study.

Financial Agenda

GenSight Biologics will hold its Annual General Meeting on May 19, 2026.

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. GS010 is currently in clinical development, has not to date been granted marketing authorization in France or any other jurisdiction, and is therefore not available commercially. 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.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding product development prospects and financial projections. These statements do not constitute guarantees of future performance and involve risks and uncertainties. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in GenSight Biologics’ regulatory filings with the French Autorité des Marchés Financiers. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, GenSight Biologics undertakes no obligation to update or revise the information contained in this press release.

Detailed information

Detailed information regarding the Company, including its business, financial information, results, perspectives and related risk factors are contained (i) in the Company’s 2024 Universal Registration Document filed with the AMF on April 8, 2025, under number D.25-0234 (the "2024 URD"). This document, 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 2024 URD, in particular the liquidity risk presented in the chapter 3.1.1.

¹ GS010/LUMEVOQ^® has not received marketing authorization in any jurisdiction and is not available commercially.