-- 2025 was a turning point with key regulatory milestones providing a
solid foundation for 2026.
-- Cash runway is projected to extend through December 2026.
-- Preparation of the Phase III RECOVER study is ongoing, including
financing related to the trial.
Note: See paragraph on Estimated Full-Year 2025 Consolidated Financial Results at the end of this Press Release
PARIS--(BUSINESS WIRE)--March 27, 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 estimated full-year consolidated financial results for 2025,(1) as reviewed by the Audit Committee and the Board of Directors on March 25, 2026. The Board of Directors will approve the final accounts on April 3, 2026, and the certification by the statutory auditors will take place after completion of the required procedures for the filing of the universal registration document with the Autorité des Marchés Financiers (AMF).
"2025 served as a turning point for GenSight Biologics. We achieved key regulatory milestones of pressing importance to patients, namely the authorizations for early access programs in France, Israel and the USA, while also successfully completing multiple financing rounds in a challenging fundraising environment," commented Jan Eryk Umiastowski, CFO of GenSight Biologics. "Having extended our cash runway into the next phase of the Company's development, we enter 2026 with a strengthened financial foundation supporting a clear path forward."
Estimated Annual Consolidated Financial Statements (IFRS) for FY 2025(1)
In million euros As of December 31
---------------------------------------------
2025 2024
--------------------------------------------- --------- --------
Cash and cash equivalent 2.4 2.5
---------------------------------------------
Non-current assets 3.3 5.4
---------------------------------------------
Other Current assets 2.6 2.9
---------------------------------------------
Total assets 8.3 10.8
---------------------------------------------
Total shareholders' equity (24.9) (26.9)
---------------------------------------------
Non-current liabilities 20.5 15.1
---------------------------------------------
Current liabilities 12.7 22.6
---------------------------------------------
Total liabilities 33.2 37.7
Total Shareholders' equity and liabilities 8.3 10.8
--------------------------------------------- --------- --------
____________________
(1) See paragraph on Estimated Full-Year 2025 Consolidated Financial Results
at the end of this Press Release.
In million euros 2025 2024 % Change EUR Change
-------------------------------- ------ ------ -------- ----------
Operating income 0.7 2.6 (75.2)% (2.0)
--------------------------------
Research and development
expenses (6.4) (12.4) (47.9)% (5.9)
--------------------------------
Sales and marketing
expenses (0.6) (0.7) (18.9)% (0.1)
--------------------------------
General and administrative
expenses (4.7) (5.4) (12.5)% (0.7)
--------------------------------
Operating expenses (11.7) (18.4) (36.5)% (6.7)
--------------------------------
Operating profit (loss) (11.1) (15.8) (30.1)% (4.8)
--------------------------------
Financial profit (loss) (1.0) 1.8 n.m. (2.8)
--------------------------------
Net profit (loss) (12.0) (14.0) (14.0) (2.0)
--------------------------------
EPS (in EUR per share) (0.08) (0.15) (46.7)% 0.1
--------------------------------
Net cash flows from operating
activities (9.2) (12.9) (29.1)% 3.8
--------------------------------
Net cash flows from investing
activities 0.2 0.0 n.m. 0.2
--------------------------------
Net cash flows from financing
activities 8.9 13.5 (34.0)% (4.6)
--------------------------------
Increase (decrease) in cash
and cash equivalents (0.1) 0.6
--------------------------------
Cash and cash equivalents at
closing 2.4 2.5
-------------------------------- ------ ------ -------- ----------
Operating income decreased to EUR0.7 million from EUR2.6 million over the period. This EUR2.0 million decrease is primarily attributable to the decrease in the research tax credit (Crédit d'impôt recherche), amounting to EUR0.7 million at the end of 2025 from EUR1.1 million a year before, reflecting lower clinical development expenses for GS010 (LUMEVOQ$(R)$ ). The decrease is also explained by the change in the valuation of the refund liability and the potential rebate obligations arising from the ATU (early access) regulatory framework in 2024.
Research and development expenses decreased by 47.9%, or EUR5.9 million, to EUR6.4 million in 2025, compared with EUR12.4 million in the prior year. This decrease reflects the Company's continued focus on prioritizing its activities, with reduced R&D spending primarily related to the GS010 technology transfer to its new manufacturing partner, Catalent, Inc., and to essential activities supporting the preparation of the dose-ranging study requested by the ANSM in the context of the resumption of the AAC (early access program).
Sales and marketing expenses decreased by 19% in 2025 to EUR0.6 million, compared with EUR0.7 million in the prior year, reflecting continued cost discipline. These expenses remain limited, consistent with the Company's current stage of development and its focus on R&D activities rather than commercial operations.
General and administrative expenses decreased by 12.5% in 2025 to EUR4.7 million, compared with EUR5.4 million in the prior year, reflecting ongoing cost discipline. The increase in personnel expenses in 2025 is explained by the recruitment of a Chief Financial Officer in September 2024, a break from the previous outsourcing approach. This increase, however, was more than offset by a 45.5% decrease in professional fees, illustrating the Company's continued focus on cost control.
Operating loss decreased by 30.1%, or EUR4.8 million, in 2025, amounting to EUR(11.1) million compared to EUR(15.8) million a year earlier. This decrease reflects trends in Operating income, R&D expenses, Sales, medical, marketing and G&A expenses, which, as discussed above, was partially offset by the reduction in the research tax credit.
Financial result amounted to EUR(1.0) million compared to EUR1.8 million a year earlier. In 2024, the financial income is essentially explained by the renegotiation of our financial obligations and the change in derivative financial instrument fair value. In 2025, the financial result represents the interest expenses on our debt and the result in connection with our financial instrument.
Net loss amounted to EUR12.0 million in FY 2025 compared to a loss of EUR14.0 million in FY 2024, a decrease of EUR2.0million or 14.0%. The weighted average number of shares outstanding increased from 95.8 million in FY 2024 to 148.3 million in FY 2025, also contributing to a reduction in loss per share from EUR0.15 in FY 2023 to EUR0.08 in FY 2025.
Net cash flows from operating activities amounted to EUR(9.2) million in 2025, compared with EUR(12.9) million in 2024. The improvement mainly reflects the significant reduction in operating expenses, partially offset by a lower research tax credit $(CIR)$, which was the Company's sole source of revenue in 2025.
Net cash flows from investment activities remained limited, amounting to EUR0.2 million in 2025 compared with EUR0.02 million in 2024, reflecting the activity of the Company's liquidity contract and, in 2025, the refund of the security deposit related to the U.S. office premises following the termination of the lease in August 2025.
Net cash flows from financing activities amounted to EUR8.9 million in 2025, compared with EUR13.5 million in 2024. This change reflects capital increases of EUR10.4 million in 2025 versus EUR16.7 million in 2024, in line with the Company's financing strategy and the timing of fundraising activities. In addition, 2025 includes the repayment of the final installment of the French state-guaranteed loan (PGE) in October, whereas 2024 included the partial repayment of the PGE for EUR2.2 million.
Cash and cash equivalents totaled EUR2.4 million as of December 31, 2025, compared to EUR2.5 million as of December 31, 2024. The Company completed successful offerings in March, July, September, November and December 2025, corresponding to capital increases in gross amounts, excluding the convertible bond amortization rolled in of approximately EUR10.4 million in total, limited to specialized investors.
Cash runway
In December 2025, the ANSM granted Compassionate Use Authorization (Autorisation d'Accès Compassionnel, or AAC) for the GS010/LUMEVOQ(R) gene therapy in France. On March 9, 2026, the ANSM approved the first group of individual patient applications submitted under this AAC program. The first patients were treated on March 19, 2026, at 15--20 national hospital, with the first payments received on March 24, 2026.
Although the Group is unable to predict the precise number of treated patients and timing of treatments and related payments under its various paid early access programs (in particular in France and Israel) over the coming year, management currently expects that aggregate revenues from these programs in 2026 should be sufficient to cover the Group's operating expenses for that period, excluding costs associated with the new Phase III clinical trial including some of the manufacturing costs related to this study.
The revenues from these early access programs are not expected to be sufficient to fully fund the RECOVER Phase III clinical trial and the associated manufacturing costs. As a result, and in order to supplement its working capital and fund ongoing operating expenses, including preparations for and execution of the RECOVER Phase III clinical trial currently expected to start in the second quarter of 2027, the Company will need to obtain additional sources of financing (debt and/or equity), and/or expand international paid Early Access Programs beyond France and Israel, and/or enter into out-licensing deals outside the USA and Europe, and/or engage in partnering or M&A transactions within the going concern assessment period and, in any case, before the end of 2026, in order to avoid postponing the start of the Phase III study.
Accounting Principles for the Preparation of the Estimated Consolidated Financial Information
The estimated consolidated financial information has been prepared assuming the Company will continue as a going concern. No adjustments have been made to the financial statements relating to the recoverability and classification of asset carrying amounts or classification of liabilities that might be necessary, should the Company not be able to continue as a going concern.
The estimated consolidated financial information has been prepared on a going concern basis as of December 31, 2025, based on the following key assumptions:
-- The successful execution of the AAC program in France and other paid
early access programs, generating aggregate revenues in 2026 sufficient
to cover the Group's operating costs for that period (excluding costs
associated with the new Phase III clinical trial including some of the
manufacturing costs related to this study);
-- The Group's ability to timely initiate manufacturing campaigns with,
and provide adequate support to, its contract manufacturing organization
(CMO) so as to rebuild and maintain sufficient product inventories for
treatments expected to be performed in 2027 and 2028;
-- The availability, if required, of short--term bridge financing prior to
obtaining the structural funding required for the RECOVER Phase III
clinical trial;
-- The Group's ability to secure additional funds before the end of 2026,
with the structural financing required for the RECOVER Phase III clinical
trial expected to be obtained from one or more of the following sources:
(i) a new equity financing, (ii) the potential drawdown of the EUR12
million non--dilutive Tranche B under the existing EIB facility (subject
to the satisfaction of milestone--based conditions currently under
discussion), (iii) expansion of international paid Early Access Programs
beyond France and Israel, and (iii) potential out--licensing or
partnering arrangements or M&A transaction(s).
While management believes that it will be able to raise additional funds and/or realize partnering or M&A opportunities, there can be no assurance that such transactions will be completed on a timely basis, in sufficient amounts or on acceptable terms. Failure to secure adequate funding could require the Group to significantly curtail or delay its operating plans, impair its ability to realize its assets and settle its liabilities in the normal course of business, or could ultimately lead to insolvency proceedings or the cessation of its operations in whole or in part.
These events and conditions, together with the uncertainties above, indicate the existence of a material uncertainty that may cast significant doubt on the company's ability to continue as a going concern.
Financial Agenda
On April 7, 2026, GenSight Biologics will report its cash position as of March 31, 2026.
About GenSight Biologics
GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing 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 help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. GS010 is currently in clinical development, has not to date been granted marketing authorization in France or any other jurisdiction, and is therefore not available commercially. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding product development prospects and financial projections. These statements do not constitute guarantees of future performance and involve risks and uncertainties. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in GenSight Biologics' regulatory filings with the French Autorité des Marchés Financiers. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, GenSight Biologics undertakes no obligation to update or revise the information contained in this press release.
Estimated Full-Year 2025 Consolidated Financial Results
The Group's financial information relating to the financial year ended December 31, 2025 included in this document have been prepared using a process similar to that adopted for the preparation of the Group's annual consolidated financial statements. The estimated accounting and financial data are currently being audited by the Company's statutory auditors. Gensight has not yet obtained assurance from its auditors that the financial statements will be certified without qualification. The Board of Directors of Gensight has examined the Group's estimated financial information for the financial year ended December 31, 2025, at the meeting held on March 25, 2026, and has approved their communication. The Group's financial statements, which will be approved by the Board of Directors in the meeting to be held on April 3, 2026, shall include any material events previously unknown by the Group and of which it becomes aware or which may occur after March 25, 2026. Therefore, the financial information presented shall be qualified as estimated financial results.
Detailed information
Detailed information regarding the Company, including its business, financial information, results, perspectives and related risk factors are contained (i) in the Company's 2024 Universal Registration Document filed with the AMF on April 8, 2025, under number D.25-0234 (the "2024 URD"). This document, as well as other regulated information and all of the Company's press releases, can be accessed on the Company's website (www.gensight-biologics.com) and/or AMF (www.amf-france.org). Your attention is drawn to the risk factors related to the Company and its activities presented in chapter 3 of its 2024 URD, in particular the liquidity risk presented in the chapter 3.1.1.
Estimated Full-Year 2025 Consolidated Financial Results(2)
BALANCE SHEET
In thousands of Euros 2025 2024
ASSETS
Non-current assets
Intangible assets 0 57
Property, plant and equipment 427 933
Other non-current financial assets 2,847 4 424
Total non-current assets 3,274 5 413
Current assets
Trade accounts receivable 0 1
Other current assets 2 567 2 878
Cash and cash equivalents 2 415 2 464
Total current assets 4 982 5 343
TOTAL ASSETS 8 256 10 756
In thousands of Euros 2025 2024
LIABILITIES
Shareholders' equity
Share capital 5 522 3 119
Premiums related to the share capital 217 405 206 606
Reserves (235 833) (222 644)
Net income (loss) (12 036) (14 001)
Total shareholders' equity (24 942) (26 920)
Non-current liabilities
Convertible bonds--non-current portion 2 382 0
Derivative liabilities -- non-current portion 656 3 960
Borrowings from Banks--non-current portion 6 835 0
Conditional advances--non-current portion 4 565 4 700
Lease liability--non-current portion 4 514
Other liability -- non-current portion 4 983 4 718
Non-current provisions 1 104 1 166
Total non-current liabilities 20 529 15 058
Current liabilities
Convertible bonds--current portion 3 120 6 973
Derivative liabilities -- Current portion 0 0
Borrowings from Banks--current portion 176 6 341
Conditional advances--current portion 396 0
Lease liability--current portion 346 585
Trade accounts payable 5 922 6 357
Current provisions 0 0
Other current liabilities 2 708 2 362
Total current liabilities 12 669 22 618
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY 8 256 10 756
____________________
(2) See paragraph on Estimated Full-Year 2025 Consolidated Financial Results.
Estimated Full-Year 2025
Consolidated Financial
Results(3)
PROFIT & LOSS 2025
In thousands of Euros 2025 2024 VAR
Operating income
Revenues 1 1 500 (1 499) (99.9%)
Other income 651 1 125 (474) (42.2%)
Total operating income 652 2 625 (1 973) (75.2%)
Operating expenses
Research and development 6 440 12 368 (5 928) (47.9%)
General and administrative 4 711 5 386 (675) (12.5%)
Sales and marketing 555 685 (129) (18.9%)
Total operating expenses 11 706 18 438 (6 732) (36.5%)
Operating profit (loss) (11 054) (15 813) 4 759 (30.1%)
Financial income (loss) (987) 1 833 (2 820) (153.8%)
Income tax 5 (21) 26 -
Net income (loss) (12 036) (14 001) 1 965 (14.0%)
Basic and diluted earnings (loss)
per share (0.08) (0.15) 0.07 -
In thousands of Euros 2025 2024
Net income (loss) (12 036) (14 001)
Actuarial gains and losses on
employee benefits, net of income
tax 8 14
Foreign currency translation
differences, net of income tax 397 (184)
Total comprehensive income (loss) (11 631) (14 172)
____________________
(3) See paragraph on Estimated Full-Year 2025 Consolidated Financial Results.
Estimated Full-Year 2025 Consolidated Financial Results(4)
CASHFLOW STATEMENT
In thousands of Euros 2025 2024
Cash flows from operating activities
Net income (loss) (12 036) (14 001)
Operating activities
Amortization and depreciation 465 1 059
Retirement pension obligations 27 22
Expenses related to share-based payments 391 784
Income Tax (5)
Other financial items 630 (1 674)
Other non-monetary items (incl. change effect) 364
Operating cash flows before change in working capital (10 164) (13 810)
Accounts receivable 0 0
Accounts payable, net of prepayments (516) 155
Other receivables 890 2 028
Other current and non-current liabilities 620 (1 310)
Change in working capital 994 873
Net cash flows from operating activities (9 170) (12 937)
Net cash flows from investment activities 180 17
Net cash flows from financing activities 8 937 13 542
Increase/(decrease) in cash and cash equivalents (53) 623
Cash and cash equivalents at the beginning of the period 2 464 2 134
Effect of changes in exchange rates on Cash and cash
equivalent 5 (293)
Cash and cash equivalents at the close of the period 2 415 2 464
____________________
(4) See paragraph on Estimated Full-Year 2025 Consolidated Financial Results.
Estimated Full-Year 2025
Consolidated Financial Results(5)
CHANGE IN
EQUITY
In thousands Premium
of Euros, related
except for to Net Total
number of share income shareholders'
shares Share capital capital Reserves (loss) equity
Number of
shares Amount
At January 1,
2025 124 774 445 3 119 206 606 (222 644) (14 001) (26 920)
Net income
(loss) (12 036) (12 036)
Cumulative
translation
adjustment 397 397
Other
comprehensive
income 8 8
Total
comprehensive
income
(loss) 405 (12 036) (11 631)
Allocation of
prior period
net income
(loss) (14 001) 14 001 0
Allocation to
reserves
Capital
increase by
issuance of
ordinary
shares 93,253,258 2,331 5 550 7 881
Capital
increase
transaction
costs (932) (932)
Exercise and
subscription
of equity
instruments 2,862,695 72 6 181 6 252
Treasury
shares 16 16
Share-based
payments 391 391
At December
31, 2024 220,890,398 5 522 217 405 (235 833) (12 036) (24 942)
____________________
(5) See paragraph on Estimated Full-Year 2025 Consolidated Financial Results.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260326262732/en/
CONTACT: GenSight Biologics
Chief Financial Officer
Jan Eryk Umiastowski
jeumiastowski@gensight-biologics.com
(END) Dow Jones Newswires
March 27, 2026 02:30 ET (06:30 GMT)
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