GenSight Biologics Reports Estimated Full-Year Consolidated Financial Results for 2025

Note: See paragraph on Estimated Full-Year 2025 Consolidated Financial Results at the end of this Press Release

Paris, France, March 27, 2026, 7:30 am CET – 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 estimated full-year consolidated financial results for 2025,[1] as reviewed by the Audit Committee and the Board of Directors on March 25, 2026. The Board of Directors will approve the final accounts on April 3, 2026, and the certification by the statutory auditors will take place after completion of the required procedures for the filing of the universal registration document with the Autorité des Marchés Financiers (AMF).

“2025 served as a turning point for GenSight Biologics. We achieved key regulatory milestones of pressing importance to patients, namely the authorizations for early access programs in France, Israel and the USA, while also successfully completing multiple financing rounds in a challenging fundraising environment,” commented Jan Eryk Umiastowski, CFO of GenSight Biologics. “Having extended our cash runway into the next phase of the Company’s development, we enter 2026 with a strengthened financial foundation supporting a clear path forward.”

Estimated Annual Consolidated Financial Statements (IFRS) for FY 2025¹

Operating income decreased to €0.7 million from €2.6 million over the period. This €2.0 million decrease is primarily attributable to the decrease in the research tax credit (Crédit d’impôt recherche), amounting to €0.7 million at the end of 2025 from €1.1 million a year before, reflecting lower clinical development expenses for GS010 (LUMEVOQ^®). The decrease is also explained by the change in the valuation of the refund liability and the potential rebate obligations arising from the ATU (early access) regulatory framework in 2024.

Research and development expenses decreased by 47.9%, or €5.9 million, to €6.4 million in 2025, compared with €12.4 million in the prior year. This decrease reflects the Company’s continued focus on prioritizing its activities, with reduced R&D spending primarily related to the GS010 technology transfer to its new manufacturing partner, Catalent, Inc., and to essential activities supporting the preparation of the dose-ranging study requested by the ANSM in the context of the resumption of the AAC (early access program).

Sales and marketing expenses decreased by 19% in 2025 to €0.6 million, compared with €0.7 million in the prior year, reflecting continued cost discipline. These expenses remain limited, consistent with the Company’s current stage of development and its focus on R&D activities rather than commercial operations.

General and administrative expenses decreased by 12.5% in 2025 to €4.7 million, compared with €5.4 million in the prior year, reflecting ongoing cost discipline. The increase in personnel expenses in 2025 is explained by the recruitment of a Chief Financial Officer in September 2024, a break from the previous outsourcing approach. This increase, however, was more than offset by a 45.5% decrease in professional fees, illustrating the Company’s continued focus on cost control.

Operating loss decreased by 30.1%, or €4.8 million, in 2025, amounting to €(11.1) million compared to €(15.8) million a year earlier. This decrease reflects trends in Operating income, R&D expenses, Sales, medical, marketing and G&A expenses, which, as discussed above, was partially offset by the reduction in the research tax credit.

Financial result amounted to €(1.0) million compared to €1.8 million a year earlier. In 2024, the financial income is essentially explained by the renegotiation of our financial obligations and the change in derivative financial instrument fair value. In 2025, the financial result represents the interest expenses on our debt and the result in connection with our financial instrument.

Net loss amounted to €12.0 million in FY 2025 compared to a loss of €14.0 million in FY 2024, a decrease of €2.0million or 14.0%. The weighted average number of shares outstanding increased from 95.8 million in FY 2024 to 148.3 million in FY 2025, also contributing to a reduction in loss per share from €0.15 in FY 2023 to €0.08 in FY 2025.

Net cash flows from operating activities amounted to €(9.2) million in 2025, compared with €(12.9) million in 2024. The improvement mainly reflects the significant reduction in operating expenses, partially offset by a lower research tax credit (CIR), which was the Company’s sole source of revenue in 2025.

Net cash flows from investment activities remained limited, amounting to €0.2 million in 2025 compared with €0.02 million in 2024, reflecting the activity of the Company’s liquidity contract and, in 2025, the refund of the security deposit related to the U.S. office premises following the termination of the lease in August 2025.

Net cash flows from financing activities amounted to €8.9 million in 2025, compared with €13.5 million in 2024. This change reflects capital increases of €10.4 million in 2025 versus €16.7 million in 2024, in line with the Company’s financing strategy and the timing of fundraising activities. In addition, 2025 includes the repayment of the final installment of the French state-guaranteed loan (PGE) in October, whereas 2024 included the partial repayment of the PGE for €2.2 million.

Cash and cash equivalents totaled €2.4 million as of December 31, 2025, compared to €2.5 million as of December 31, 2024. The Company completed successful offerings in March, July, September, November and December 2025, corresponding to capital increases in gross amounts, excluding the convertible bond amortization rolled in of approximately €10.4 million in total, limited to specialized investors.

Cash runway

In December 2025, the ANSM granted Compassionate Use Authorization (Autorisation d’Accès Compassionnel, or AAC) for the GS010/LUMEVOQ^® gene therapy in France. On March 9, 2026, the ANSM approved the first group of individual patient applications submitted under this AAC program. The first patients were treated on March 19, 2026, at 15–20 national hospital, with the first payments received on March 24, 2026.

Although the Group is unable to predict the precise number of treated patients and timing of treatments and related 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 clinical trial including some of the manufacturing costs related to this study.

The revenues from these early access programs are not expected to be sufficient to fully fund the RECOVER Phase III clinical trial and the associated manufacturing costs. As a result, and in order to supplement its working capital and fund ongoing operating expenses, including preparations for and execution of the RECOVER Phase III clinical trial currently expected to start in the second quarter of 2027, the Company will need to obtain additional sources of financing (debt and/or equity), and/or expand international paid Early Access Programs beyond France and Israel, and/or enter into out-licensing deals outside the USA and Europe, and/or engage in partnering or M&A transactions within the going concern assessment period and, in any case, before the end of 2026, in order to avoid postponing the start of the Phase III study.

Accounting Principles for the Preparation of the Estimated Consolidated Financial Information

The estimated consolidated financial information has been prepared assuming the Company will continue as a going concern. No adjustments have been made to the financial statements relating to the recoverability and classification of asset carrying amounts or classification of liabilities that might be necessary, should the Company not be able to continue as a going concern.

The estimated consolidated financial information has been prepared on a going concern basis as of December 31, 2025, based on the following key assumptions:

• The successful execution of the AAC program in France and other paid early access programs, generating aggregate revenues in 2026 sufficient to cover the Group’s operating costs for that period (excluding costs associated with the new Phase III clinical trial including some of the manufacturing costs related to this study);
• The Group’s ability to timely initiate manufacturing campaigns with, and provide adequate support to, its contract manufacturing organization (CMO) so as to rebuild and maintain sufficient product inventories for treatments expected to be performed in 2027 and 2028;
• The availability, if required, of short‑term bridge financing prior to obtaining the structural funding required for the RECOVER Phase III clinical trial;
• The Group’s ability to secure additional funds before the end of 2026, with the structural financing required for the RECOVER Phase III clinical trial expected to be obtained from one or more of the following sources: (i) a new equity financing, (ii) the potential drawdown of the €12 million non‑dilutive Tranche B under the existing EIB facility (subject to the satisfaction of milestone‑based conditions currently under discussion), (iii) expansion of international paid Early Access Programs beyond France and Israel, and (iii) potential out‑licensing or partnering arrangements or M&A transaction(s).

While management believes that it will be able to raise additional funds and/or realize partnering or M&A opportunities, there can be no assurance that such transactions will be completed on a timely basis, in sufficient amounts or on acceptable terms. Failure to secure adequate funding could require the Group to significantly curtail or delay its operating plans, impair its ability to realize its assets and settle its liabilities in the normal course of business, or could ultimately lead to insolvency proceedings or the cessation of its operations in whole or in part.

These events and conditions, together with the uncertainties above, indicate the existence of a material uncertainty that may cast significant doubt on the company’s ability to continue as a going concern.

[1] See paragraph on Estimated Full-Year 2025 Consolidated Financial Results at the end of this Press Release.

[2] See paragraph on Estimated Full-Year 2025 Consolidated Financial Results.

[3] See paragraph on Estimated Full-Year 2025 Consolidated Financial Results.

[4] See paragraph on Estimated Full-Year 2025 Consolidated Financial Results.

[5] See paragraph on Estimated Full-Year 2025 Consolidated Financial Results.