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 September 30, 2019, and
provided recent operational updates.
Cash and cash equivalents
GenSight Biologics’ cash and cash equivalents totaled €5.1
million as of September 30, 2019, compared to €14.3 million as of
June 30, 2019. This amount does not include a €4.3 million
reimbursement of the 2018 Research Tax Credit, expected in the
coming days. Including this impending reimbursement, cash and cash
equivalents would be €9.4 million as of September 30, 2019.
The cash burn in the first three quarters of 2019 principally
reflects the final steps of pharmaceutical development for GS010 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).
“In line with our expectations and including the impending
reimbursement of the 2018 Research Tax Credit, we are fully
financed until the end of the first quarter of 2020,” commented
Thomas Gidoin, Chief Financial Officer of GenSight
Biologics. “We have been actively working on a financing
transaction in the past weeks, favoring less dilutive options, and
expect to be able to announce a closing shortly.”
Clinical Development of GS010
Results at 96 weeks of the RESCUE Phase III clinical trial
evaluating the efficacy and safety of a single intravitreal
injection of GS010 in subjects with LHON due to the ND4 mutation
with an onset of vision loss up to 6 months were reported in
September 2019. This last set of results showed a durable bilateral
improvement in visual acuity of 25 ETDRS letters equivalent versus
nadir in GS010-treated eyes. These results from RESCUE show a
remarkable correspondence with those from the REVERSE trial, which
studied the treatment of subjects at 6 to 12 months after onset of
vision loss.
In a natural history study conducted by Santhera1, 28% of
subjects with the G11778A-ND4 mutation achieved a spontaneous
“clinically relevant recovery” (CRR) from nadir in at least one
eye. By comparison, 63% of RESCUE subjects achieved this definition
of CRR in at least one eye at Week 96, showing a clear superiority
to natural history. A similar comparison for REVERSE subjects
reveals a much higher rate of CRR (78%) from nadir compared to
natural history.
GenSight also reported results from a non-clinical study to
investigate the local biodistribution of GS010. In this study,
tissue samples from the non-injected eye of monkeys that had been
unilaterally injected with GS010 were found to contain GS010 DNA
three months after injection, indicating the expression of the
therapeutic gene in the uninjected contralateral eye. These
findings support the mechanism for bilateral visual improvement
with unilateral GS010 gene therapy, which was consistently observed
in LHON subjects in the REVERSE and RESCUE Phase III trials.
Regulatory Pathway of GS010
GenSight is planning to schedule a pre-submission meeting with
the EMA in early 2020 and expects to submit an application for
marketing approval in Europe in the third quarter of 2020.
An End of Phase II meeting with the U.S. Food and Drug
Administration (FDA) was requested as planned, which the agency has
now confirmed for December 19, 2019.
“We strongly believe that the remarkable results from REVERSE
and RESCUE, showing a clinically significant and durable bilateral
improvement of vision, and demonstrating clear superiority to
natural history, are a compelling core for our marketing
authorization application in Europe,” commented Bernard
Gilly, co-founder and Chief Executive Officer of GenSight
Biologics. “The demonstration of GS010 DNA presence in the
uninjected contralateral eye now provides a powerful scientific
rationale to support bilateral improvement. We are eager to meet
with regulatory agencies in the next few weeks to discuss these
major findings.”
Number of outstanding shares
As of September 30, 2019, GenSight Biologics’ number of
outstanding shares was 29,028,291 ordinary shares.
GenSight Biologics will report its cash position as of December
31, 2019 on January 21, 2020.
GenSight will host a conference call today, October 22, 2019, at
9:30am CEST in French, and at 2.30pm CEST (8.30am EST) in English,
to further discuss this operational update.
Conference call in French
Dial-in numbers:
France: +33 (0) 1 7037 7166 Password:
GenSight Français
Conference call in English
Dial-in numbers:
United States: +1 212 999 6659 France: +33
(0) 1 7037 7166 United Kingdom: +44 (0) 20 3003 2666 Password:
GenSight English
A replay of the calls will be available using the following
dial-in numbers:
France: +33 (0) 1 7037 7166 United Kingdom
(standard international access): +44 (0) 20 3003 2666 Code:
5645038#
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.
1 Magda et al (2019), “Natural History of Leber’s Hereditary
Optic Neuropathy (LHON): Findings from a Large Patient Cohort”,
Poster presented at NANOS March 16-21, 2019; Poster Session II:
Scientific Advancements; Poster: 163
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version on businesswire.com: https://www.businesswire.com/news/home/20191021005767/en/
GenSight Biologics Thomas Gidoin Chief Financial Officer
tgidoin@gensight-biologics.com +33 (0)1 76 21 72 20
RooneyPartners Media Relations Marion Janic
mjanic@rooneyco.com +1-212-223-4017
The Trout Group US Investor Relations Chad Rubin
crubin@troutgroup.com +1-646-378-2947
James Palmer Europe Investor Relations
j.palmer@orpheonfinance.com +33 7 60 92 77 74
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