GenSight Biologics: Cash Position of €0.7M at End of September, €16M Needed for Recover

€1.7M Collected in Third Quarter, €8.2M Since March 2026

During the third quarter of 2026, GenSight Biologics collected €1.7 million through the compassionate access program (AAC) in France. At the publication of the half-year results on September 30, 2026, the company had reported €6.5 million in proceeds generated by paid compassionate access programs in the first half. The cumulative total since the start of treatments in March 2026 now stands at €8.2 million. These amounts are presented before deducting rebates. This clarification explains the possible difference between collections and accounting revenue: in the first half of 2026, the company had published negative revenue of €1.2 million, despite €6.5 million collected. The product in question, GS010/Lumevoq, remains an experimental gene therapy that has not obtained marketing authorization in any country. Treatments are provided under compassionate use frameworks, with the pace dependent on the schedule of patient administrations, as illustrated by the July and August pause.

Compassionate Access and R&D Tax Credits Expected to Cover Operations, €16M to Finance

As announced on September 29, 2026, the company indicated that its available financial resources are insufficient to cover its operational needs over the next twelve months. However, it noted that proceeds from compassionate access programs and the Research Tax Credit should more than cover its operational expenses. Net financing needs are estimated at approximately €16 million. This primarily corresponds to the costs of preparing the Phase III Recover trial and associated manufacturing. The mechanism is therefore as follows: compassionate access programs finance current operations, while the pivotal study constitutes the main item to be financed. On the industrial front, the transfer of manufacturing technology to Catalent was completed at the end of September 2026. Furthermore, the company indicates that treatments should take place in new countries in the fourth quarter of 2026, under paid compassionate access programs.

End of March 2027 Horizon Conditional on a Bridge Facility of No More Than €2M

The company detailed a conditional scenario. If by the end of November 2026 it obtains either a short-term bridge financing of a maximum amount of €2 million, or proceeds from additional treatments compared to those included in its projections, its cash reserves would be sufficient until the end of March 2027. This date corresponds to the first significant payments expected for the preparation of the Recover trial. If structural financing were not obtained by March 2027, GenSight Biologics would postpone the launch of the trial. In this case, proceeds from compassionate access programs would continue to cover operating expenses, subject to the treatment schedule and continuation of these programs. As described in note 3.4 of the condensed consolidated financial statements, these financing needs indicate the existence of significant uncertainty that may raise substantial doubt about the company's ability to continue operations. On October 8, 2026, the company announced that two of its existing shareholders, Heights Capital and Invus, had subscribed to the entire transaction for net proceeds of approximately €0.95 million. The most significant element of the announcement remains the net financing need of approximately €16 million, on which the launch of the Phase III Recover trial depends, with a deadline set for March 2027 for structural financing.