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Gensight Biologics SA

GenSight Biologics S.A. is a clinical-stage biotechnology company that discovers, develops, and commercializes novel therapies for neurodegenerative retinal diseases and central nervous system disorders. Its products are based on gene therapy mitochondrial targeting sequence and optogenetics technology platforms. Lead candidates include LUMEVOQ, a recombinant AAV2-based gene therapy in Phase III trials for Leber hereditary optic neuropathy caused by a mutated ND4 gene, and GS030, in Phase I/II trials for retinitis pigmentosa and dry age-related macular degeneration. The company also has preclinical programs in ophthalmic and neurodegenerative diseases, and license agreements with institutions such as Sorbonne Université, CNRS, Inserm, Genethon, Harvard, MIT, and Novartis Pharma AG, as well as a non-exclusive agreement with Adverum Biotechnologies. Incorporated in 2012, it is headquartered in Paris, France.

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GenSight Biologics Reports H1 2026 Results, €6.5 Million Collected From Early Access

GenSight Biologics reported interim financial results for the first half of 2026, collecting €6.5 million in gross revenue from paid early access programs in France and Israel, though reported IFRS revenue came in at €(1.2) million after €3.4 million of accrued rebates and a €4.3 million one-off non-cash change in accounting estimate. Net cash used in operating activities fell 37% to €1.6 million, and the company said the technology transfer of GS010/LUMEVOQ manufacturing to Catalent has been successfully completed, with manufacturing of a new GMP batch for early access programs now started and full release expected in March 2027. The REVISE dose-ranging study remains on track, with the last patient scheduled for December 2026, while preparation of the RECOVER Phase III trial continues and is expected to start in the second half of 2027 subject to securing financing. GenSight reported a net loss of €10.3 million for the half, compared with €7.0 million a year earlier, and said its available financial resources are not sufficient to cover operating requirements over the next twelve months, with total cash requirements estimated at approximately €41 million through September 30, 2027 and a net funding requirement of approximately €16 million. The company said it needs either a short-term bridge financing of up to €2 million or additional early access treatments by the end of November 2026 to fund operations until late March 2027, when the first significant RECOVER trial payments fall due.
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SIGHT.PA · Capital · Negative H1 2026 net loss widened to €10.3M and available resources are insufficient for the next twelve months, requiring up to €2M bridge financing or extra early access treatments by end-November 2026.
Catalent, Inc. · Supply · Positive GenSight said the technology transfer of GS010/LUMEVOQ manufacturing to Catalent has been successfully completed, with a new GMP batch now in production.
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