-- EUR6.5 million collected from paid early access programs; after
recognition of rebates and a EUR4.3 million non-cash change in accounting
estimate, reported IFRS revenue amounted to EUR(1.2) million.
-- Net cash used in operating activities was reduced by 37% to EUR1.6
million.
-- GS010/LUMEVOQ(R) manufacturing technology transfer to Catalent
successfully completed; manufacturing of a new GMP batch for early access
programs has started.
-- REVISE dose-ranging study is on track, with the last patient scheduled
for December 2026.
PARIS--(BUSINESS WIRE)--September 29, 2026--
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 interim financial results for the first half of 2026 and provided business updates.
The 2026 half-year condensed consolidated financial statements were subject to a limited review by the Company's statutory auditors and approved by the Board of Directors on September 29, 2026. The statutory auditors' review report includes an emphasis of matter paragraph drawing attention to the material uncertainty related to going concern described in Note 3.4 of the condensed consolidated financial statements. The full half-year financial report will be available on the Company's website in the Investors section.
"The first half of 2026 marked a turning point for GenSight: for the first time since 2022, patients received GS010/LUMEVOQ(R) under authorized paid early access programs, and as a result, we collected EUR6.5 million over the period," noted Jan Eryk Umiastowski, Chief Financial Officer of GenSight Biologics. "The negative revenue reported for the first half reflects future rebates and a one-off non-cash change in accounting estimate and so does not capture the stronger cash collection the company actually achieved. Early access revenues enabled us to reduce our operating cash burn by 37% to EUR1.6 million in the first half. With the successful transfer of our manufacturing process to Catalent, our priority now is to secure the structural financing for the RECOVER Phase III trial."
Business Updates
Manufacturing
The technology transfer to Catalent has been completed, with both the upstream and downstream stages successful. As announced on September 8, 2026, the viral genome (vg) titer of the engineering batch drug substance was within target specifications, and its reproducibility indicated that the transferred process would have repeatable yields. The full battery of drug substance test results, received at the end of the summer, has now confirmed the successful transfer of the process.
Manufacturing of a new GMP batch to sustain product supply for the Company's early access programs has started.(1) This manufacturing run is expected to be completed in January 2027, with full release of the drug product batch expected in March 2027.
With twice the number of vials needed to satisfy early access needs until release of the new GMP batch, the Company does not currently anticipate a supply interruption.
Clinical Activities
All remaining patients planned for REVISE, the dose-ranging study conducted in France at the request of the French health agency ANSM, have been identified. The last patient is scheduled for December 2026.
RECOVER Phase III Trial
Preparation of the RECOVER Phase III trial is ongoing. The trial is currently expected to start in the second half of 2027, subject to the Company securing the necessary financing.
From a clinical operations standpoint, the Company initiated the selection process for the contract research organization (CRO) in July 2026 and expects to reach the final decision by the end of October 2026. The potential clinical sites are currently being assessed.
From a regulatory standpoint, the next meeting with the U.S. Food and Drug Administration (FDA) to finalize the RECOVER protocol is expected to take place before the end of 2026.
Early Access Programs
In France, patient screening under the authorized named patient early access program (AAC) resumed after the summer break, during which applications had been paused. Treatments have resumed and the related payments, amounting to EUR1.7 million, were received in early September 2026.
First-half revenue includes the first sale to our partner in Israel, invoiced and collected in June 2026, ahead of the patient's treatment in July. Treatments under paid early access programs in other countries are expected to be carried out in the remainder of 2026.
2026 Half-Year Financial Results (IFRS)
EUR6.5 million cash collected, EUR(1.2) million reported revenue
In the first half of 2026, the Company generated EUR6.5 million of gross revenue under its paid early access programs in France (AAC, from March 2026, at a price of EUR425,000 per injection) and Israel.
Under IFRS 15, revenue under the French early access framework must be recognized net of the rebates that the Company expects to pay in the future, even though none of these rebates is payable in 2026. Reported revenue therefore amounted to EUR(1.2) million:
In million euros H1 2026 Cash impact
------------------------------- ------- -------------------------------
Gross revenue from paid
early access programs
(France, Israel) 6.5 Collected
------------------------------- ------- -------------------------------
Rebates accrued on 2026
revenue (3.4) No cash outflow in 2026
------------------------------- ------- -------------------------------
o/w statutory AAC
rebate (1.9) Payable in November 2027
------------------------------- ------- -------------------------------
Payable after marketing
o/w estimated CEPS authorization and final price
settlement rebate (1.5) negotiation
------------------------------- ------- -------------------------------
Net revenue before change in
estimate 3.1
-------------------------------- ------- -------------------------------
Change in accounting
estimate (end of
discounting of the legacy
ATU refund liability) (4.3) One-off, non-cash
------------------------------- ------- -------------------------------
Reported revenues (1.2)
-------------------------------- ------- -------------------------------
Figures are rounded; totals may not add up.
Rebates accrued on 2026 revenue (EUR3.4 million, no cash outflow in 2026). They comprise (i) the statutory AAC rebate, calculated on a progressive scale set by the French authorities on the revenue of the previous year, estimated at EUR1.9 million for the first half of 2026 and payable in November 2027; and (ii) the estimated CEPS settlement rebate, i.e. the amount the Company may have to repay when the provisional indemnities received under early access are reconciled with the final price negotiated with the French Economic Committee for Health Products (CEPS). This reconciliation can only take place after marketing authorization and completion of price negotiations. It is based on management's estimate of the final price and may ultimately result in an additional payment or a credit.
One-off, non-cash change in accounting estimate (EUR(4.3) million). The refund liability relating to indemnities received under the former ATU program (2019--2022) was previously measured on a discounted basis. At June 30, 2026, in light of the resumption of material early access revenue and of the uncertainty surrounding the timing of the final price reconciliation, which depends on the completion of development, financing, the regulatory review of a marketing authorization application and subsequent price negotiations, the Company concluded that the CEPS settlement rebate should be measured at its nominal amount, without discounting. In accordance with IAS 8, this change in accounting estimate was recognized prospectively: the reversal of the discount previously recognized reduced revenue by EUR4.3 million. It has no impact on cash and does not change management's estimate of the nominal amount ultimately payable; it increased the carrying amount of the refund liability. It also means that no discount unwinding will be charged to revenue in future periods.
Refund liability. As a result, the refund liability amounted to EUR13.2 million as of June 30, 2026, compared to EUR5.0 million as of December 31, 2025. It comprises EUR11.3 million for the CEPS settlement rebate, presented as due in more than five years and not expected to be paid before the conclusion of the price negotiation, and EUR1.9 million for the statutory AAC rebate payable in November 2027. The refund liability is not financial debt.