07/04/2025 20:14
Inside Information / News release on accounts, results
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INFORMATION REGLEMENTEE

Press Release




GenSight Biologics Reports Cash Position as of
March 31, 2025, and Provides Business Update
• 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, France, April 7, 2025, 7:00 pm CEST – 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.




Contacts
GenSight Biologics
Chief Financial Officer
Jan Eryk Umiastowski
jeumiastowski@gensight-biologics.com



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.