Operations funded until early June 2025 as a result of disciplined spending controls
Discussions with French agency ANSM regarding the early access program (AAC) for LUMEVOQ® progressing
Fundraising activities planned to extend runway, focusing on kicking off RECOVER Phase III trial and advancing MHRA marketing application
PARIS, April 07, 2025--(BUSINESS WIRE)--Regulatory News:
GenSight Biologics ("GenSight Biologics" or the "Company") (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 cash position as of March 31, 2025, and provided a business update.
"By maintaining disciplined spending controls and prioritizing expenses, we have been able to extend our financial horizon without compromising our core mission," commented Jan Eryk Umiastowski, CFO of GenSight Biologics. "Fundraising activities are planned to extend the cash runway. We are maintaining a forward-looking approach that demonstrates our commitment to responsible financial management while ensuring continued operational effectiveness."
Cash position as of March 31, 2025
GenSight Biologics’ cash and cash equivalents totaled €0.9 million as of March 31, 2025, compared to €2.5 million as of December 31, 2024. With the equity-with-warrants-attached financing announced in March 2025 (approximately €0.9 million) and the anticipated collection of approximately €1.1 million in Research Tax Credit (CIR) in April, and based on current operations, plans, and assumptions, this balance should fund operations until early June 2025.
The funds are insufficient to cover operational requirements for the next 12 months, so fundraising activities are underway to extend the cash runway and to initiate the RECOVER Phase III clinical trial and UK MHRA marketing application for LUMEVOQ®.
The Company expects that the French early access (AAC) program, once operational, now in Q2 2025, will also contribute to supporting clinical and regulatory activities and has secured a financial solution that eliminates payment delays, ensuring seamless cash flow between invoicing and payment.
Looking further ahead, the Company has planned for its November 2026 obligation to pay annual rebates amounting to up to 45% of the 2025 AAC program indemnities. In view of this financial commitment, it is taking proactive steps to secure its financial future by strategically exploring additional funding avenues. It is evaluating promising debt or equity financing opportunities, as well as potential partnering or M&A arrangements, well in advance of the second half of 2026.
Business update
The Company's discussions with the French medicines agency ANSM regarding the early access (AAC) dossier submitted for LUMEVOQ® are progressing. The Company expects to receive the final decision on the resumption of the AAC in France in the near future.
In parallel, the Company is continuing preparations to refine the RECOVER study design to incorporate feedback from the FDA and the EMA and thereby reach final alignment with regulatory agencies. It has adjusted its fundraising and other activities to minimize any risk to the timely initiation of the trial, which is targeted for H1 2026. This timeline incorporates ongoing activities to optimize the manufacturing process and enables the company to prepare the financing for the RECOVER study.
"Every day matters for patients waiting for a treatment," commented Laurence Rodriguez, CEO of GenSight Biologics. "Our singular focus is to bring this potentially life-changing therapy to those who need it, as quickly and safely as possible. With this as our guiding mission, we are maintaining the drive to launch the RECOVER study on time, as its results will unlock access for patients worldwide."
As previously announced, the existing clinical data package, not necessarily including data from the upcoming RECOVER trial data, may support a marketing authorization application in the UK. The Company plans to initiate interactions with MHRA in the course of H2 2025 to ensure the quickest path towards a regulatory submission.
Number of outstanding shares
As of March 31, 2025, GenSight Biologics’ number of outstanding shares was 131,206,495 ordinary shares.
Agenda
GenSight Biologics will hold its Annual General Meeting on May 13, 2025.
The Company will report its cash position as of June 30, 2025, on July 8, 2025.
Risk factors
Detailed information regarding the Company, including its business, financial information, results, perspectives and related risk factors are contained in the Company’s 2024 Universal Registration Document filed with the AMF on April 7, 2025. 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 chapter 3.1.1.
Note: The above statements contain forward-looking information subject to risks and uncertainties. While the Company is actively pursuing financing solutions, regulatory requirements necessitate disclosure that material uncertainty exists regarding the Company's ability to continue as a going concern if sufficient funding cannot be secured.
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. 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.
