Capital increases in late 2024 provide sufficient working capital until expected resumption of early access program in February.
Review of LUMEVOQ® dossier ongoing, following submission of responses to questions from the ANSM.
PARIS, January 23, 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 December 31, 2024, and provided a business update.
"Our recent bridge financing operations have provided us with operational flexibility as we await regulatory clearance for the resumption of our early access program," noted Jan Eryk Umiastowski, Chief Financial Officer of GenSight Biologics. "We remain focused on prudent cash management while working closely with ANSM to restart our program. The potential restart of the early access program represents an important milestone that would significantly strengthen our financial position and support our continued development efforts."
Cash Position as of December 31, 2024
GenSight Biologics’ cash and cash equivalents totaled €2.5 million as of December 31, 2024, compared to €3.4 million on September 30, 2024.
The Company completed successful offerings in November and December 2024, through capital increases for gross amounts of approximately €2.8 million and €1.5 million, respectively, reserved to specialized investors. GenSight continues to work on optimizing cash management while 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 late February 2025 when the first payments in connection with the potential resumption of the early access program (Autorisation d’Accès Compassionnel or AAC) are expected. With the potential indemnities generated by the resumption of AAC, the Company anticipates that it would have sufficient net working capital to meet its obligations over the next 12 months.
In November 2026, the Company will have to pay the annual rebates on the 2025 AAC program which will amount to around 50% of the AAC indemnities generated over the year. Consequently, the Company may need to seek other sources of debt or equity financing or achieve partnering or M&A opportunities, in order to supplement its working capital requirements and fund its operating expenses before the second half of 2026.
Regulatory Update
The French medicines safety agency ANSM (Agence Nationale de Sécurité des Médicaments et des produits de santé) is continuing its review of the LUMEVOQ® quality dossier LUMEVOQ® following the submission, on January 10, of the Company’s responses to the questions received from the agency in late December. GenSight teams, along with those of the treating center 15-20 National Hospital, are mobilized to act quickly on next steps once the ANSM’s green light is received.
Preparations for the new Phase III trial RECOVER and the planned submission to the UK’s MHRA are ongoing.
Number of outstanding shares
As of December 31, 2024, the Company’s share capital is composed of 124,774,445 shares.
Financial Calendar 2025
The Company’s financial calendar for 2025 is as follows:
Information
Date*
2024 Full-Year Financial Update and Statements
March 19, 2025
2025 Q1 Cash Position
April 7, 2025
Annual General Meeting
May 12, 2025
2025 Q2 Cash Position
July 8, 2025
2025 Half-Year Financial Update and Statements
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 changes. The Company’s updated financial calendar is available on the corporate website.
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, LUMEVOQ® (GS010; lenadogene nolparvovec), is an investigational compound and has not been registered in any country at this stage; a marketing authorization application is currently under review by the EMA for the treatment of Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease affecting primarily teens 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 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.
