The capital increase at the end of 2024 provides sufficient working capital until the expected resumption of the early access program in February.
Review of LUMEVOQ® file in progress, after submission of answers to questions by ASHSHK.
PARIS, January 23, 2025–(BUSINESS WIRE)–Regulatory news:
GenSight Biologics (“GenSight Biologics“or”company“) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on the development and commercialization of innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its position in cash on December 31, 2024, and provided a business update.
“Our recent bridge financing operations have provided us with operational flexibility as we await regulatory approval for the resumption of our early access program,” he noted Jan Eryk UmiastowskiChief Financial Officer of GenSight Biologics. “We remain focused on prudent cash management while working closely with ANSM to restart our program. The potential relaunch of the early access program represents an important milestone that would significantly strengthen our financial position and support our ongoing development efforts.“
Cash position at 31 December 2024
GenSight Biologics’ cash and cash equivalents amounted to €2.5 million on December 31, 2024, compared to €3.4 million on September 30, 2024.
The company completed successful offers in November and December 2024 through capital increases for gross amounts of approximately €2.8 million and €1.5 million, respectively, reserved for specialist investors. GenSight continues to work on optimizing cash management ensuring a sustainable future.
To date, the Company does not have sufficient net working capital to meet its obligations over the next 12 months, but only until the end of February 2025 when the first payments related to the possible resumption of the early access program (Autorisation d’Accès Compassionnel or CAA) are expected. With the potential indemnities generated by the resumption of SHKSH, the Company anticipates that it will have sufficient net working capital to meet its obligations over the next 12 months.
In November 2026, the Company will have to pay annual rebates for the CAA 2025 program, which will amount to approximately 50% of the CAA claims generated during the year. Consequently, the Company may need to seek other sources of debt or equity financing or to pursue partnership or M&A opportunities in order to meet its working capital requirements and fund its operating expenses prior to the second half of 2026 .
Regulatory Update
The French Agency for the Safety of Medicines ANSM (Agence Nationale de Sécurité des Medicaments et des produits de santé) is continuing the review of the LUMEVOQ® LUMEVOQ® quality file following the submission, on January 10, of the Company’s responses to questions received by the agency in late December. The GenSight teams, together with those of the 15-20 National Hospital treatment center, have been mobilized to act quickly on the next steps once the ANSM’s green light is received.
Preparations for the new RECOVER phase III trial and planned submission to the UK MHRA are ongoing.
Number of shares in circulation
As of December 31, 2024, the share capital of the Company consists of 124,774,445 shares.
Financial Calendar 2025
The Company’s financial calendar for 2025 is as follows:
: INFORMATION
Date*
Update and financial statements for 2024
March 19, 2025
2025 Q1 Cash Position
April 7, 2025
Annual General Meeting
May 12, 2025
2025 Q2 Cash Position
July 8, 2025
Update and financial statements for the six months of 2025
September 19, 2025
2025 Q3 Cash position
October 7, 2025
2025 Q4 Cash Position
January 8, 2026
*This financial calendar is provided for information only and may be subject to change. The updated financial calendar of the Company is available on the corporate website.
About GenSight Biologics
GenSight Biologics SA is a clinical-stage biopharma company focused on the development and commercialization of innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline uses two key technology platforms, Mitochondrial Targeting Sequencing (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, LUMEVOQ® (GS010; lenadogene nolparvovec), is an investigational compound and is not registered anywhere at this stage; an application for marketing authorization is currently under consideration by the EMA for the treatment of Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease affecting mainly adolescents and young adults that leads to irreversible blindness. 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 provide patients with durable visual functional 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 list and further description of the 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. Except as required by applicable law, GenSight Biologics undertakes no obligation to update or revise the information contained in this press release.
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contacts
GenSight Biologics Chief Financial Officer Jan Eryk Umiastowski jeumiastowski@gensight-biologics.com