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 as of September 30, 2026.
Cash Position and Early Access Programs as of September 30, 2026
GenSight Biologics’ cash and cash equivalents amounted to €0.7 million as of September 30, 2026, compared with €1.7 million as of June 30, 2026.
In the third quarter of 2026, the Company collected €1.7 million from the French named patient early access program (AAC). Total gross cash collections from paid early access programs reached €8.2 million since the start of treatments in March 2026.
The decrease in cash and cash equivalents over the quarter mainly reflects the summer pause in treatments under the AAC program in July and August, the continuation of the manufacturing technology transfer to Catalent, which was successfully completed at the end of September 2026, and the ongoing preparation of the RECOVER Phase III study.
Paid early access programs for GS010/LUMEVOQ®1 continue to generate cash inflows, supporting the Company’s operating activities. Treatments under paid early access programs in new countries are expected in Q4 2026. Collections are presented gross of rebates.
Funding Needs and Cash Runway
As previously disclosed on September 29, 2026, based on its current cash position and projected cash flows, the Company’s available financial resources are not sufficient to cover its operating requirements over the next twelve months. Early access collections and the research tax credit are expected to more than cover the Company’s operating expenses, and the net funding requirement is estimated at approximately €16 million, mainly corresponding to the costs of preparing the RECOVER Phase III trial and the associated manufacturing.
Assuming the Company secures, by the end of November 2026, either a short-term bridge financing of up to €2 million or cash inflows from additional early access treatments beyond those assumed in its projections, its cash resources would be sufficient until late March 2027, when the first significant payments for the preparation of the RECOVER trial fall due. Should the structural financing not be obtained by March 2027, the Company would postpone the start of the RECOVER trial; in that case, early access collections would continue to cover the Company’s operating expenses, subject to the timing of treatments and the continuation of the early access programs.
The Company’s funding requirements indicate the existence of a material uncertainty that may cast significant doubt on its ability to continue as a going concern, as described in Note 3.4 to the condensed half-year consolidated financial statements.
About GenSight Biologics
GenSight Biologics S.A. is a clinical-stage biopharma company focused on discovering and developing 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 develop novel approaches for restoring vision in patients with inherited retinal neurodegenerative diseases. GenSight Biologics’ lead product candidate, GS010, is in Phase III clinical development in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. The company’s second product candidate, GS030, is in Phase 1/2 clinical development as a mutation-agnostic optogenetic candidate therapy for late-stage Retinitis Pigmentosa, a leading cause of blindness in the world. Using gene therapy-based approaches, GenSight Biologics’ product candidates are designed to be administered as one-time intravitreal injections with the potential to provide sustained functional visual recovery.
Forward-Looking Statements
This press release contains forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the Company’s cash runway and funding requirements, its financing plans, including the bridge financing and the structural financing, the progress of its early access programs and the related collections and rebates, the preparation and timing of the RECOVER Phase III trial, and the future expectations, plans and prospects of the Company. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions, many of which are beyond the control of the Company, including, without limitation, the Company’s ability to secure financing, the timing and number of treatments under early access programs, the outcome of price negotiations with the French authorities, manufacturing and regulatory risks, market conditions and the risk factors and other matters set forth in the filings the Company makes with the AMF from time to time, including its 2025 Universal Registration Document. The Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law.
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1 GS010/LUMEVOQ is an investigational gene therapy that has not received marketing authorization in any country. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20261007442702/en/
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