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 December 31, 2017, and provided a corporate update.
GS010 in Leber Hereditary Optic Neuropathy (LHON)
- Phase I/II follow-up continued to show promising pharmacodynamic trends after 2.5 years post-injection in subjects with < 2 years of onset of vision loss and relatively better baseline acuities (mirroring those enrolled in the ongoing Phase III trials).
- REVERSE and RESCUE Phase III clinical trials completed enrollment in February and July 2017, respectively.
- Topline results of REVERSE and RESCUE are expected in April and 3Q 2018, respectively.
- REFLECT, a bilateral confirmatory Phase III clinical trial, was initiated in 4Q 2017. First patient is expected to be treated in 1Q 2018 in the US.
GS030 in Retinitis Pigmentosa (RP)
- GS030 received orphan Drug Designation (ODD) in the US in January 2017, in addition to Europe.
- MHRA approved a CTA in the UK to initiate the PIONEER Phase I/II clinical trial, a first-in-man combination of a gene therapy based on optogenetics with a wearable optronic stimulation device. First patient is expected to be treated in 1Q 2018.
- GenSight raised €22.5 million in a private placement in June 2017.
- Barrett Katz, MD, MBA was appointed Chief Medical Officer in November 2017, strengthening the senior management team. He is based in New York, where the Company incorporated a US subsidiary.
- Julio Benedicto was appointed Vice President of Marketing, to roll-out the pre-commercialization strategy for GS010.
Cash and cash equivalents
GenSight Biologics’ cash and cash equivalents amounted to €55.4 million as of December 31, 2017, compared to €59.5 million as of September 30, 2017.
Number of outstanding shares
As of December 31, 2017, GenSight Biologics’ number of outstanding shares was 24,234,223 ordinary shares.
GenSight Biologics will report its 2017 full-year financial statements on February 28, 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.