GenSight Biologics Reports Cash Position as of December 31, 2020 and Provides Operational Update
GenSight Biologics (Paris:SIGHT) (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 reported its cash position as of December 31, 2020, and provided an operational update.
“Following the filing of the Market Authorisation Application of LUMEVOQ with the European Medicines Agency, our team is focused on taking GenSight forward to a new chapter in our development and growth. The European sales and marketing infrastructure is being put in place to be ready for commercial launch as early as the beginning of 2022. At the same time, we continue to prepare for the filing of the Biologics License Application with the U.S. Food and Drug Administration during the second half of 2021,” commented Bernard Gilly, Chief Executive Officer of GenSight Biologics.
Cash position and financing runway
GenSight Biologics’ cash and cash equivalents totaled €37.9 million as of December 31, 2020, compared to €18.1 million as of September 30, 2020.
The operating cash burn in the fourth quarter of 2020 mainly reflects the conduct of the REFLECT Phase III clinical trial of LUMEVOQ in the treatment of Leber Hereditary Optic Neuropathy, as well as the PIONEER Phase I/II trial of GS030 in the treatment of Retinitis Pigmentosa. The Company also focused on the final pharmaceutical development steps for LUMEVOQ in preparation for the European marketing authorization filed in September 2020. These were mainly preparatory activities to ensure manufacturing readiness to commercialize under Good Manufacturing Practices (GMP).
The operating cash burn was more than offset by the net proceeds from the €25 million private placement in October led by Arix Bioscience, Invus and Sofinnova Partners. The Company also recorded revenues from the sale of LUMEVOQ under a Temporary Authorization for Use (ATU) in France amounting to €2.1 million in the fourth quarter of 2020, and to a total of €5.6 million in 2020 despite a very limited access of patients to hospitals due to the COVID-19 crisis.
“We have been able to secure significant financing this year with minimal dilution to shareholders, in addition to revenues generated by ATUs in France, extending the runway to at least the end of Q1 2022,” commented Thomas Gidoin, Chief Financial Officer of GenSight Biologics. “We will continue to be opportunistic and seek optimal conditions to finance the commercial launch of LUMEVOQ through 2022.”