PARIS--(BUSINESS WIRE)--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, 2018, and provided a corporate update on GS010.
Corporate update on GS010 in Leber Hereditary Optic Neuropathy (LHON)
On April 3, 2018, GenSight Biologics reported the topline results from REVERSE Phase III clinical trial of GS010 in patients with Leber Hereditary Optic Neuropathy (LHON). At 48 weeks, the study demonstrated a clinically meaningful improvement of +11 ETDRS letters in GS010-treated eyes and similar improvement in sham-treated eyes across the 37 subjects enrolled, suggesting an unexpected bilateral treatment effect. In addition, SD-OCT demonstrated statistically significant relative preservation of both retinal ganglion cell volume and nerve fiber layer thickness in treated eyes while untreated eyes continued to deteriorate.
Following these topline results, GenSight Biologics is further investigating the full set of data, as well as running multiple post hoc analyses, to better understand the observed treatment effect and responder profiles. The Company is also engaging with Key Opinion Leaders, investigators and clinical experts to assess whether the ongoing RESCUE and REFLECT Phase III clinical trials could be optimized in light of lessons learned from REVERSE.
GenSight Biologics expects to complete these analyses and discussions by the end of May, and will host an R&D Day in New York on June 5, 2018 (tentative date, venue and time to be confirmed). At this event, Management and internationally renowned Key Opinion Leaders will present additional data from REVERSE, discuss the findings and expectations from the patients and medical communities, and provide an update on clinical and regulatory strategies for GS010 going forward. The event will be webcasted live.
Cash and cash equivalents
GenSight Biologics’ cash and cash equivalents amounted to €49.2 million as of March 31, 2018, compared to €55.4 million as of December 31, 2017.
Number of outstanding shares
As of March 31, 2018, GenSight Biologics’ number of outstanding shares was 24,234,223 ordinary shares.
GenSight Biologics will report its 2018 half-year interim financial statements on July 25, 2018.
About GenSight Biologics
GenSight Biologics S.A. is a clinical-stage biopharma company focused on discovering and developing 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, GS010, is in Phase III trials in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. 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.