GenSight Biologics Announces the Filing of its 2022 Universal Registration Document and Reschedules its Annual General Meeting on June 21, 2023

PARIS--(BUSINESS WIRE)--Regulatory News:

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible) (Paris:SIGHT), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced the filing of its 2022 Universal Registration Document (URD) in English with the French market authority (Autorités des Marchés Financiers, or AMF) under the reference D.23-0406.

“We are actively preparing for a Scientific Advice meeting with the EMA expected in Q3 this year to agree on a clear and feasible pathway for LUMEVOQ to be approved in Europe as soon as possible,” commented Bernard Gilly, Chief Executive Officer and Co-Founder of GenSight Biologics. “In the meantime, we are also advancing a number of discussions with possible partners on strategic opportunities, including a merger or acquisition, assessed as one of the relevant options to move forward.”

“We have taken immediate measures to significantly reduce our cash burn and therefore our financing needs for 2023 and 2024,” added Thomas Gidoin, Chief Financial Officer of GenSight Biologics. “In order to immediately extend our cash runway beyond the end of June and be able to claim the €12 million EIB 2^nd Tranche in Q3, pending the validation campaign results for LUMEVOQ, we are moving forward with negotiations on a limited bridge financing with a few existing and new investors, aiming at closing in coming weeks.”

The universal registration document notably includes:

• the 2022 annual financial report;
• the management report;
• the report on corporate governance; and
• the description of the share buyback program.

This universal registration document may be consulted on the Company’s website (www.gensight-biologics.com), “Investors” section, and on the AMF’s website (www.amf-france.org).

As announced on April 20, 2023, GenSight Biologics decided to postpone its Annual General Meeting (AGM) initially scheduled on May 16, 2023. The AGM will now take place on June 21, 2023.

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.