GenSight Biologics Provides 2021 Operations Update in the Context of COVID-19

Regulatory News:

GenSight Biologics (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 provides an update on the impact of COVID-19 on its operations in 2021.

“It has been slightly over a year since we had to adjust our operations to the COVID-19 situation and provided you with an update on our activities. Although conditions have improved in many regions, the burden of the COVID-19 crisis continues to impact the medical and regulatory ecosystems. GenSight is preparing for the commercialization of LUMEVOQ first in Europe in 2022, then in North America a year later, despite the US Defense Production Act introducing a slight delay in manufacturing our validation batches,” said Bernard Gilly, Co-founder and Chief Executive Officer of GenSight Biologics. “Our team will be ready in due time to deliver LUMEVOQ to patients affected with this highly debilitating disease and continue to work tirelessly to develop alternative strategies to minimize the impact of COVID-19 on our operations.”

LUMEVOQ Commercial Launch in Europe Still Expected in H1 2022

The REVERSE and RESCUE Phase III trials of LUMEVOQ (GS010) for the treatment of Leber Hereditary Optic Neuropathy (LHON) are completed, and patients have been transferred to long-term follow-up, the RESTORE study, for an additional three-year period. The sustained efficacy of LUMEVOQ three years after injection was previously reported. Patients are now followed-up annually, and given the follow-up nature of these visits and the stability of patients with no safety concern, delaying some of these visits has been an acceptable precautionary measure, which should have no impact on the conduct of the trial, and will be properly documented and reported to regulators.

The strategic manufacturing partner (CDMO) for LUMEVOQ, ThermoFischer Scientific (TFS) in Boston, USA, is maintaining its operations and is due to manufacture three validation batches to support the MAA filing with the European Medicines Agency (EMA) in Europe. TFS informed the Company that, as a consequence of the US Defense Production Act (DPA), American suppliers have had to redirect certain consumables towards the manufacture of COVID vaccines in the US. It is our understanding that this is an Industry issue impacting many manufacturers, biotech and pharmaceutical companies in particular. This has resulted in extended timelines for the availability of some items required for manufacturing LUMEVOQ. Accordingly, the Company anticipated delays in providing data from the planned validation batches to the EMA and, after discussions with the European Agency, agreed upon an extended clock-stop period. Responses to the Agency D120 questions are therefore now due by January 2022 instead of the previously anticipated August 2021. Based on this new timeline the Company now expects EMA approval for LUMEVOQ to shift from Q4 2021 to H1 2022. The revised timeline will be confirmed as soon as there is greater clarity from TFS on material availability. The timing for commercialization remains unchanged and the Company will continue to build the European commercial platform during 2021 to prepare the commercial launch of LUMEVOQ in Europe, still expected in H1 2022.