GenSight Biologics Reports Cash Position as of March 31, 2020 and Provides Operational Update - Seite 2

Temporary Authorization for Use (ATU) of LUMEVOQ

A patient was treated with LUMEVOQ under a first Temporary Authorization for Use (ATU) granted by the French National Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM) in December 2019. A second patient was treated early 2020, and several additional ATUs have been requested and are being reviewed by the ANSM.

GenSight Biologics has committed to provide the drug for potential additional requests, limited to available stock. These bilateral injections are priced at €700,000 per patient and are expected to generate revenues in 2020. Hospitals focusing their resources on the current COVID-19 situation may delay requesting additional ATUs as well as the treatment of patients in the next few weeks. GenSight Biologics expects any delays to be overcome as soon as patients regain normal access to their treatment site, with no material impact on the related revenues expected in 2020; this will be more precisely assessed as soon as the situation improves.

In addition, the Company is discussing with the ANSM the possibility to broaden individual named patient ATUs to a cohort ATU as soon as feasible to further facilitate access to LUMEVOQ for patients in Europe.

European Submission of LUMEVOQ on track for September 2020

GenSight Biologics met with the EMA on March 19, 2020, at the pre-submission meeting for LUMEVOQ. During this meeting, the EMA confirmed the information needed for the Company’s September regulatory submission. The agency also provided updated guidance on various administrative topics, as well as advice on topics to be discussed in the meetings between the Company and the Rapporteurs and Co-rapporteurs planned for June 2020.

Based on this meeting with the EMA, GenSight Biologics confirmed its intention to submit the MAA for LUMEVOQ in September 2020, as planned.

PIONEER Phase I/II clinical trial of GS030 – DSMB confirmed moving to maximal dose

The independent Data Safety Monitoring Board (DSMB) completed its second planned safety review of the ongoing PIONEER Phase I/II clinical trial of GS030, GenSight’s novel product combining gene therapy and optogenetics for the treatment of Retinitis Pigmentosa. The DSMB confirmed the absence of any safety issues for the second cohort of three subjects who received the dose of 1.5e11 vg, and recommended moving forward as planned without any modification in the protocol and recruiting the third cohort of three subjects who are to receive the maximal dose of 5e11 vg.