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

Regulatory News:

GenSight Biologics (Paris:SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of March 31, 2020, and provided an operational update.

“Following our pre-submission meeting with the European Medicines Agency (EMA), we are confirming our intention to submit LUMEVOQ for European approval in September 2020, as planned,” commented Bernard Gilly, co-founder and Chief Executive Officer of GenSight Biologics. “We are eager to collaborate with the EMA’s review team in this last mile to possible approval and commercialization of LUMEVOQ in Leber Hereditary Optic Neuropathy, the first asset developed from our leading Mitochondrial Targeting Sequence technology platform.”

Cash position and financing runway

GenSight Biologics’ cash and cash equivalents totaled €12.8 million as of March 31, 2020, compared to €19.2 million as of December 31, 2019.

The cash burn in the first quarter of 2020 principally reflects the conduct of all clinical trials of LUMEVOQ (GS010) in the treatment of Leber Hereditary Optic Neuropathy, mainly the REFLECT Phase III trial, as well as the PIONEER Phase I/II trial of GS030 in the treatment of Retinitis Pigmentosa. The Company also focused on final steps of pharmaceutical development for LUMEVOQ in preparation for a marketing authorization filing in Europe. These are mainly preparatory activities to ensure manufacturing readiness to commercialize under Good Manufacturing Practices (GMP).

The Company is financed until the end of 2020 and is investigating other financing options through debt or equity, focusing particularly on several non-dilutive financing initiatives promoted by the French government and Bpifrance in addition to existing commitments from Kreos Capital for up to €6 million. The Company also expects the reimbursement in 2020 of the 2019 Research Tax Credit for an amount of €4.2 million.

“We are now actively working on extending our financing runway to 2021, primarily investigating non-dilutive opportunities,” commented Thomas Gidoin, Chief Financial Officer of GenSight Biologics. “The additional tranches from the bond issuance with Kreos Capital, together with potential revenues from the Temporary Authorization for Use of LUMEVOQ in France, could also provide further resources and runway.”