GenSight Biologics Reports €3.4 Million Cash Position as of September 30, 2024, and Business Update
GenSight Biologics (“GenSight” or the “Company”) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharmaceutical company dedicated to developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, has announced its cash position and provided a business update as of September 30, 2024.
- Cash Position and Financial Outlook
As of September 30, 2024, GenSight Biologics reported cash and cash equivalents totaling €3.4 million, down from €6.9 million as of June 30, 2024. The Company currently lacks sufficient net working capital to meet its obligations beyond mid-November 2024. However, it anticipates receiving indemnities from the resumption of the Early Access Program (AAC) between late December 2024 and early January 2025, which will extend its cash runway to Q4 2026.
In light of the delayed AAC program resumption, GenSight is actively seeking financing to support its operations until the expected AAC payments commence. The Company has secured waivers from existing creditors, including the European Investment Bank and Heights Capital Management, allowing it to explore additional financing options.
Jan Eryk Umiastowski, Chief Financial Officer of GenSight Biologics, stated, “We are pursuing bridge financing from existing and new investors to extend our cash runway to early January 2025, helping us navigate the delay in the AAC program. We are well-positioned to resume the program in the coming weeks, which will enhance our financial stability through Q4 2026.”
LUMEVOQ® Update
GenSight has completed the manufacture of the LUMEVOQ® drug product, which involved mixing two GMP drug substance batches produced in 2023. More than 100 vials have passed all quality control tests and are ready for human use, pending regulatory approval.
The Company is preparing Good Manufacturing Practice (GMP) documentation and plans to submit a dossier to the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) by mid-November 2024. Following this, healthcare professionals may submit requests for compassionate treatment to the ANSM. GenSight expects a review period for these applications and is committed to optimizing the assessment timeline.
The supply of the drug to the treatment center is now anticipated to begin in mid-December, with first patient injections projected by the end of December 2024.
Laurence Rodriguez, Chief Executive Officer of GenSight Biologics, remarked, “The successful production of a new GMP batch of LUMEVOQ® is a significant milestone in our effort to provide this innovative therapy to patients in need. We are prepared to collaborate with the ANSM to expedite treatment for those awaiting it.”
It’s important to note that GenSight has not initiated requests for compassionate treatment in Italy, as these are the responsibility of Italian physicians. The Italian medicines agency AIFA (Agenzia Italiana del Farmaco) rarely grants such requests, highlighting a significant unmet medical need in Leber Hereditary Optic Neuropathy (LHON). The paid AAC program is exclusive to France and does not affect initiatives in other countries.
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.
