Corporate Presentation
October 2023
A LEADING Gene Therapy BIOTECHNOLOGY COMPANY
GENSIGHT-BIOLOGICS.COM
2023-NPM-O-001 / October 2023 - Non-Confidential
Disclaimer
This document contains forward-looking statements and estimates made by the GenSight Biologics S.A. (the "Company"), including with respect to the anticipated future performance of the Company, its subsidiaries and affiliates, and the market in which they operate. They include all matters that are not historical facts. These forward-looking statements can be identified by the use of
forward-looking terminology including the terms "developments," "estimates," "expects," "intends," "may," "milestones," "potential," "value," "time to market," "targeting," "on track," "planned," "will," "move to," or other variations or comparable terminology, or by discussions of strategy and funding, as well as the Company's, its subsidiaries' and affiliates' technology, and
are based on financial and non-financial information, including projections as to the future regulatory situation and other information and assumptions. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may
depend upon factors that are beyond the Company's control. Therefore, actual results, the financial condition, performance or achievements of the Company, its subsidiaries and affiliates or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Forward-looking statements, forecasts and estimates only speak as of the date of this forward-looking statement, and no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. The Company, its subsidiaries and affiliates disclaim any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the
Company's expectations with regard thereto, or any events,
or changes in conditions or circumstances on which any such statement, forecast or estimate is based.
This document is proprietary communication from GenSight Biologics S.A.
2 October 2023 - Non-Confidential
Investment Case - Last Mile to LUMEVOQ® Approval
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Late-stage Biotech
company
Seasoned
management team / Solid investor base
LUMEVOQ®
Strong clinical data in
LHON
LUMEVOQ®
Defining registration
pathway
Cutting edge optogenetics in Retinitis Pigmentosa
Public company founded in 2012 dedicated to developing and commercializing gene therapies for neurodegenerative retinal diseases and diseases of the central nervous system.
Euronext Paris Listed SIGHT
Management team with strong and highly relevant Biotech experience in R&D and commercialization
Solid investor base of Healthcare specialist investors, including EU and US based investors.
LUMEVOQ® completed 3 Phase III studies in Leber Hereditary Optic Neuropathy (ND4 LHON), a rare and highly debilitating genetic ophthalmic disease leading to sudden loss of central vision and affecting c. 1,200 - 1,500 new patients / year in Europe and the US. Overall design of new Phase III RECOVER endorsed by EMA.
Available in France through paid Early Access at €700,000 for a bilateral injection (currently paused pending product availability in Q1 2024). Manufacturing issues successfully remediated.
Ongoing discussion with EMA, UK MHRA and US FDA to confirm registration pathway
GS030 outstanding early findings reporting blind patients to precisely identify objects (published in Nature Medicine in May 21) ; 1-yr data from PIONEER Phase I/II Clinical Trial reported in Feb 2023
Extension cohort currently being recruited, expected to be completed by year end 2023
3 October 2023 - Non-Confidential
Seasoned Executive Team
Bernard Gilly
Chief Executive Officer
PIXIUM VISION (Since 2011)
FOVEA PHARMA (2005-2009)
SOFINNOVA PARTNERS (2000-2005)
TRANSGENE (1992-2000)
Ph.D. in biology and bio-economics
Scott Jeffers
Chief Technical Officer
REDPIN THERAPEUTICS (2021-2022)
UNIQURE (2019-2021)
SELECTA BIOSCIENCES (2018-2019)
BRAMMER BIO (2015-2018)
Ph.D. in virology
4 October 2023 - Non-Confidential
Thomas Gidoin
Chief Financial Officer
DBV TECHNOLOGIES(2012-2015) IPSEN (2008-2011)
ERNST & YOUNG (2007-2008)
Magali Taiel
Chief Medical Officer
ProQR THERAPEUTICS (2016-2018)
ELI LILLY (2004-2016)
PFIZER (2001-2004)
SERVIER (1999-2001)
M.D., Board-certified ophthalmologist
Philippe Motté
SVP, Regulatory & Quality
GENFIT (2020-2022)
MEDDAY (2019-2020)
ABBVIE (2013-2018)
IPSEN (2004-2013)
ROCHE (1998-2004)
GSK (1991-1998)
SANOFI (1989-1991)
Pharm.D. & Ph.D. in human biology
Pipeline: solid and advanced product portfolio in ophthalmic Gene Therapy
MTS Platform
LHON ND4 (EU)
EMA Orphan Drug Designation
LHON ND4 (US)
FDA Orphan Drug Designation
GS011 LHON ND1
New Undisclosed
Optogenetics
Expected | |||||
Preclinical | Phase I / II | Phase III | Registration | Approval | Market Opportunity |
* | ~ 450 new patients per year |
~ 250 new patients per year
~ 100 new patients per year
~ 1,500 new patients per year
* Following the withdrawal of the EMA application in April 2023, GenSight is assessing next steps with the EMA
GS030
GS030
Retinitis Pigmentosa (RP) | 2025 | ~ 15-20,000 new patients per year |
EMA & FDA Orphan Drug Designation | ||
Dry AMD & | ~ 350-400,000 new patients per year | |
Geographic Atrophy | ||
5 October 2023 - Non-Confidential
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Gensight Biologics SA published this content on 04 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 October 2023 07:55:14 UTC.