Corporate presentation
A P R I L 5 , 2 0 2 4
Disclaimer
IMPORTANT NOTICE - YOU MUST READ THE FOLLOWING BEFORE CONTINUING. THIS PRESENTATION HAS BEEN PREPARED BY GENFIT AND IS FOR INFORMATION PURPOSES ONLY.
CERTAIN OF THE INFORMATION CONTAINED HEREIN CONCERNING ECONOMIC TRENDS AND PERFORMANCE IS BASED UPON OR DERIVED FROM INFORMATION PROVIDED BY THIRD-PARTY CONSULTANTS AND OTHER INDUSTRY SOURCES. WHILE GENFIT BELIEVES THAT SUCH INFORMATION IS ACCURATE AND THAT THE SOURCES FROM WHICH IT HAS BEEN OBTAINED ARE RELIABLE, GENFIT HAS NOT INDEPENDENTLY VERIFIED THE ASSUMPTIONS ON WHICH PROJECTIONS OF FUTURE TRENDS AND PERFORMANCE ARE BASED. IT MAKES NO GUARANTEE, EXPRESS OR IMPLIED, AS TO THE ACCURACY AND COMPLETENESS OF SUCH INFORMATION.
This presentation contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GENFIT, including, but not limited to statements about GENFIT's corporate strategy and objectives, the potential of elafibranor to receive marketing authorization in the United States, Europe and United Kingdom for PBC, expected milestone and royalty payments for elafibranor in PBC, Ipsen's expectations regarding global peak sales for elafibranor in PBC, Ipsen's ability to effectively maximize commercialization of elafibranor, the potential scope and size of the market for ACLF, commercial certainty within that market, development plans for our pipeline programs and expected timing for potential regulatory approvals and clinical milestones for our drug candidates, as well as projections regarding our cash runway and sources of funding of our research and development. The use of certain words, including "believe, "potential," "expect" and "will" and similar expressions, is intended to identify forward- looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company's management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, potential commercial success of elafibranor if approved, exchange rate fluctuations, our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company's public filings with the AMF, including those listed in Chapter 2 "Main Risks and Uncertainties" of the Company's 2022 Universal Registration Document filed with the AMF on April 18, 2023, which is available on the Company's website (www.genfit.com) and on the website of the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission ("SEC") including the Company's 2022 Annual Report on Form 20-F filed with the SEC on April 18, 2023 and subsequent filings and reports filed with the AMF or SEC, including the Half-Year Business and Financial Report at June 30, 2023 or otherwise made public, by the Company.
In addition, even if the Company's results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.
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Towards a new GENFIT
ACLF disease state
GENFIT's approach to ACLF
ACLF market opportunity
Highlights on newsflow
French biopharmaceutical company Dual-listed on EURONEXT & NASDAQ (GNFT)
Improving the life of patients with liver diseases
Specific focus on rare and severe liver diseases with high unmet medical need
Expertise bringing early-stageassets
to commercial readiness
Lille & Paris
Zurich
Cambridge, MA
GENFIT Highlights
Our
Pipeline
Who we are
Financial elements
Worldwide Offices
VS-01 (Phase 2) | |
5 assets in ACLF & | NTZ (Phase 2 ready) |
its complications | SRT-015 (preclinical) |
CLM-022 (preclinical) | |
VS-02-HE (preclinical)
Other conditions | GNS561 CCA (Phase 2) |
VS-01-HAC UCD/OA (preclinical) | |
ELAFIBRANOR in PBC (Positive Phase 3) | |
Diagnostic programs | NIS4/NIS2+® ('at risk' MASH) |
TS-01 (ammonia) | |
€77.8M as of December 31, 2023 Cash until 4Q25*
Potential milestones related to elafibranor in 2024 extending cash runway Royalties will help finance operations
*We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements until approximately the fourth quarter of 2025. This is based on current assumptions and programs and does not include exceptional events. This estimation includes our expectations to receive future milestone revenue in 2024, subject to approval by applicable regulatory authorities and US and European commercial launches of elafibranor in PBC by Ipsen, representing a total of approximately €75.2 million.
4
Inception
& early years
1999
Towards a new GENFIT
Strategic | |
Shift | |
Clinical development | Focus on rare and life-threatening liver |
in chronic liver diseases | diseases with high unmet needs |
2023 |
Development of Research
- Development know-howvia collaborations with
Big Pharma
In-house discovery of elafibranor (GFT505)
Development of elafibranor in NASH/MASH1
up to Phase 3 included
Positive 52-week ELATIVE Phase 3 trial
evaluating elafibranor in PBC
Know-how and experience in liver diseases
- Research (collaborations with academia, liver disease models, spheroids, etc.)
- Clinical (large international trials, KOL networks, patient engagement, etc.)
- Regulatory (FDA/EMA interactions, etc.)
A diversified pipeline in ACLF (5 programs) and other life-threatening diseases (2 programs)
- Acute on Chronic Liver Failure (ACLF)
▪ | VS-01 (Phase 2 initiated) | ▪ | SRT-015 (preclinical) |
▪ | NTZ (Phase 2 under preparation) | ▪ | CLM-O22 (preclinical) |
▪ | VS-02-HE (preclinical) |
- Other life-threatening liver diseases
▪ GNS561 (Phase 2 initiated) | ▪ VS-01-HAC (preclinical) |
Potential future milestone payments and royalties from PBC2 to partially fund pipeline development
- Cash position: $77.8M as of Dec 31, 2023
- Eligible for up to $360 million in milestone payments and tiered double-digit royalties under Ipsen agreement2
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1: NASH now called MASH, standing for metabolic dysfunction-associated steatohepatitis | 2: https://ir.genfit.com/news-releases/news-release-details/genfit-ipsen-and-genfit-enter-exclusive-licensing-agreement |
2024 Outlook Following Acceptance of Elafibranor Filings in PBC in U.S./EU
▪ Regulatory filings U.S. and Europe
- <6 months after topline data
▪ Expected launch of elafibranor in the U.S.
- Priority Review granted by U.S. FDA
- FDA PDUFA set to June 10, 2024
▪ Financial implications for GENFIT
- Expected milestones of approx. 89M€ by the end of 2024
▪ PBC market
- $1.5bn by 2030 (source Ipsen Capital Market Day December 7, 2023)
▪ Global annual peak sales of elafibranor
- Expected to exceed >500M$ (source Ipsen
Capital Market Day December 7, 2023)
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Pipeline
Preclinical | Phase 1 | Phase 2 | Phase 3 | Next expected/targeted steps2 |
ACLF | VS-01 | ||
franchise | NTZ3 | ||
SRT-0154 | |||
1 | CLM-0225 | ||
Therapeutics | |||
VS-02 in HE | |||
GNS5616 in CCA | |||
VS-01-HAC for | |||
UCDs/OAs | |||
ELAFIBRANOR7 in PBC | |||
NISH4/NIS2+® | |||
Diagnostics | |||
in MASH | |||
TS-01 for blood ammonia levels
Orphan Drug Designation (ODD) FDA & EMA
Orphan Drug Designation (ODD) FDA
Rare Pediatric Disease
Designation FDA8 ; ODD FDA
Ph2 UNVEIL-IT® Interim analysis 2H24
Ph2a POC initiation targeted for 1H25
First-in-Human study targeted for 1Q25
Preclinical Proof of Concept in 2024 IND enabling studies completion in 2025
Phase 1b interim data end of 2024
IND enabling studies completion in 2024
U.S. FDA PDUFA action date June 10, 20242
Commercialization by Labcorp as NASHNext®
Prototype
1. | All drugs under development are investigational compounds that have not been reviewed nor been approved by a regulatory authority in targeted indications | 5. | In-licensed from Celloram | 7 |
6. | In-licensedfromGenoscience Pharma | |||
2. https://ir.genfit.com/news-releases/news-release-details/ipsen-confirms-us-fda-grants-priority-review-new-drug | ||||
7. | Out-licensedtoTerns PharmaceuticalsandIpsen Pharmaceuticals | |||
3. | Repositioned molecule (Nitazoxanide) | |||
8. | Potentially eligible for priority review voucher upon approval by the FDA | |||
4. In-licensedfromSeal Rock Therapeutics | ||||
Towards a new GENFIT
ACLF Disease state - PART I
Pr . R . Moreau, MD, Senior Scientist (Outstanding Grade), INSERM
GENFIT's approach to ACLF
ACLF market opportunity
Highlights on newsflow
Professeur Richard Moreau, Founding Member of EF-CLIF
and Worldwide Leader in ACLF
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ACLF Day
December 12, 2023
Acute-on-Chronic Liver Failure
(ACLF)
Richard Moreau, MD, FAASLD,1,2,3
1European Foundation for the Study of Chronic Liver Failure (EF CLIF),
Barcelona, Spain;
2Centre de Recherche sur l'Inflammation (CRI),
INSERM, Université Paris Cité, CNRS, Paris, France;
3Service d'hépatologie, Hôpital Beaujon, APHP, Cichy, France.
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Genfit SA published this content on 04 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 April 2024 10:37:04 UTC.