GENSIGHT BIOLOGICS S.A. Corporate Presentation
June 2021
A LEADING Gene Therapy BIOTECHNOLOGY COMPANY
GENSIGHT-BIOLOGICS.COM
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.
2 June 2021 - non confidential
Corporate Overview - Transitioning from R&D to Commercial Organization
GenSight at the forefront of Gene Therapy in Ophthalmology
- Publicly traded Biotech company
- Seasoned management team with strong BioPharma and Financial markets experience
-
Differentiated gene therapy approach forming a technology platform leveraging disruptive gene therapies in ophthalmology and broader
o Lead product (LUMEVOQ) targets mitochondrial disease o Second compound (GS030) uses optogenetic technology
LUMEVOQ® - Filed for Approval in Europe in September 2020 and preparing for commercial launch in H1 2022
- Market: High unmet medical need; 1,200 - 1,500 new patients / yr EU + US
- Efficacy: Unparalleled clinical benefit demonstrated in two Phase III studies
- +28/+26 ETDRS letters (i.e. over 5 lines on visual scale) improvement vs nadir(1)
- Durability & Safety: Excellent tolerability; Visual improvement maintained at least 3 years post- treatment
- Clinically meaningful improvement on all Quality of Life parameters at week 96
- Disease modifying: Stark difference from Natural History
Commercial strategy and manufacturing capabilities close to completion
- Bilateral injection priced at €700,000 / patient in French named patient Temporary Authorization for Use
-
Nadir: worst visual acuity from baseline
3 June 2021 - non confidential
Established in 2012 / IPO in 2016 | |
EuroNext Paris: | SIGHT |
Market Cap (May 3, 2021): | € 423m |
Avg 30-day Daily volume: | 1.0% of O/S |
Cash (March 31, 2021): | € 61.1m |
Improvement vs nadir in
REVERSE and RESCUE
+5
Lines
Considered clinically meaningful
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
Thomas Gidoin
Chief Financial Officer
DBV TECHNOLOGIES (2012-2015) IPSEN (2008-2011)
ERNST & YOUNG (2007-2008)
Magali Taiel | Leigh Shaw |
Chief Medical Officer | VP of Regulatory Affairs |
ProQR THERAPEUTICS (2016-2018) | UNITED NEUROSCIENCE (2017-2020) |
ELI LILLY (2004-2016) | NIGHTSTARX (2015-2017) |
PFIZER (2001-2004) | GREGORY FRYER ASSOCIATES (2005-2015) |
SERVIER (1999-2001) | HUNTINGDON LIFE SCIENCES (2002-2005) |
M.D., Board-certified ophthalmologist | CANTAB PHARMACEUTICALS (1995-2001) |
Catherine Cancian
VP of Pharmaceutical Operations
Julio Benedicto | Marie-Claude Holtz | Isabelle Scarabin |
VP of Marketing | VP of Quality | Director, Business Development |
GENETHON (2015-2017)
SANOFI PASTEUR (1998-2014)
4 June 2021 - non confidential
IMS CONSULTING (2011-2017) BOOZ & COMPANY (2010-2011) MONITOR GROUP (1994-2009)
EXELTIS SANTE (2016-2019) | LYONBIOPOLE (2006-2013) | |
PFIZER (2015-2016) | GREATER LYON (2002-2006) | |
ABBVIE (2014-2015) | RESSOURCES EN INNOVATION (1999-2002) | |
GALDERMA (2012-2013) | SANOFI PASTEUR MSD (1998-1999) | |
LABORATOIRE LAFON (TEVA) (1993-2012) | ||
Pharm.D. | ||
Pipeline: solid and advanced product portfolio in ophthalmic Gene Therapy
Product | Expected | ||||||||
Technology | Candidate | Indication | Research | Preclinical | Phase I/II | Phase III | Registration | Approval | |
REVERSE: Phase III top-line data | |||||||||
LHON ND4 | H1 2022 | reported in Apr (48w) & Oct (72w) | |||||||
2018 and in May 2019 (96w) | |||||||||
LUMEVOQ® | (EU) | ||||||||
RESCUE: Phase III top-line data | |||||||||
(FDA & EMA | |||||||||
reported in Feb (48w), Apr (72w) and | |||||||||
Orphan Drug | |||||||||
Sep (96w) 2019 | |||||||||
Designation) | LHON ND4 | Q2 2022 | |||||||
REFLECT*: Phase III recruitment | |||||||||
MTS platform | (US) | ||||||||
completed in July 2019, top-line data | |||||||||
expected in June 2021 | |||||||||
GS011 | LHON ND1 | Initiate preclinical studies following | |||||||
GS010 Phase III clinical data | |||||||||
Undisclosed | |||||||||
Mitochondrial | Undisclosed | ||||||||
Target | |||||||||
GS030 | Retinitis | PIONEER: Extension cohort in | |||||||
(FDA & EMA | PIONEER Phase I/II clinical trial to be | ||||||||
Pigmentosa | |||||||||
Orphan Drug | completed by end 2021. | ||||||||
(RP) | |||||||||
Optogenetics | Designation) | Early findings in Q2 2021 | |||||||
Dry AMD & | |||||||||
GS030 | Geographic | ||||||||
Atrophy | |||||||||
*Conducting this trial under a special protocol assessment with the FDA |
LUMEVOQ® commercial launch in Europe expected in H1 2022
5 June 2021 - non confidential
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Gensight Biologics SA published this content on 11 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 June 2021 09:49:06 UTC.
