GenSight collects €6.5 million in the first half of 2026 but publishes negative revenue of €1.2 million
For the first time since 2022, GenSight Biologics has treated patients with its GS010/LUMEVOQ gene therapy under paid exceptional access programs, generating €6.5 million in cash receipts in the first half of 2026.
The gap between this cash reality and published IFRS revenue of negative €1.2 million structures the entire publication, against a backdrop of uncertainty flagged by the Statutory Auditors regarding the going concern assumption.
€6.5 million collected, €1.2 million negative published revenue
In the first half of 2026, GenSight generated €6.5 million in gross revenue from its paid exceptional access programs in France (at the price of €425,000 per injection from March 2026 onwards) and Israel. Under IFRS 15, this revenue is recognized net of anticipated future discounts, for €3.4 million, none of which was paid out in 2026.
In addition, there is a one-off and non-monetary accounting estimate change of €4.3 million, linked to the end of discounting the reimbursement liability of the former ATU program (2019-2022). In total, published revenue comes in at negative €1.2 million, compared to already negative revenue of €0.2 million in the first half of 2025.
Operating loss stands at €8.5 million, compared to €6.8 million a year earlier. Excluding the accounting estimate change, it would have been €4.2 million. Net loss reaches €10.3 million, compared to €7.0 million in the first half of 2025, with loss per share stable at €0.05.
Operational cash requirement reduced by 37%, manufacturing transfer completed
Receipts from exceptional access programs made it possible to reduce the net cash requirement linked to operational activities by 37%, brought down to €1.6 million in the first half of 2026, compared to a cash outflow of €2.5 million a year earlier. Cash and cash equivalents amount to €1.7 million as of 30 June 2026, compared to €2.4 million as of 31 December 2025.
On the industrial front, the technology transfer of GS010/LUMEVOQ manufacturing to Catalent has been completed, with test results received in late summer confirming the success of the process. Manufacturing of a new GMP batch has started and should be completed in January 2027, with full release of the finished product expected in March 2027. The company indicates it does not anticipate any supply disruption.
On the clinical side, all remaining patients to be enrolled in the REVISE dose escalation study, conducted at the request of the ANSM, have been identified, with the last patient scheduled for December 2026.
A net financing requirement of approximately €16 million and uncertainty regarding going concern
The limited review report of the Statutory Auditors includes an emphasis of matter paragraph drawing attention to significant uncertainty regarding the going concern assumption. The company indicates that its available financial resources are insufficient to cover its operational needs over the next twelve months.
Until 30 September 2027, total cash requirements are estimated at approximately €41 million. Revenue from exceptional access programs and Research Tax Credit should more than cover operating expenses, reducing the net financing requirement to approximately €16 million, corresponding primarily to the preparation of the RECOVER Phase III trial and associated manufacturing.
The company plans to start the RECOVER trial in the second half of 2027, subject to securing the necessary financing. Absent structural financing obtained by March 2027, this start would be postponed. As of 30 June 2026, financial debt amounts to €22.6 million in nominal amount (book value of €17.8 million), while the reimbursement liability reaches €13.2 million, compared to €5.0 million as of 31 December 2025.
