Slide 1: First-Half 2021 Financial Results
First-Half 2021 Financial Results September 21, 2021
Slide 2: Disclaimer
DISCLAIMER This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, results of operations, business s
Slide 3: Today's speakers
Today’s speakers Frédéric Cren, MA/MBA, Chairman, CEO and Co-Founder Pierre Broqua, Ph.D., CSO and Co-Founder Michael Cooreman, MD, CMO Jean Volatier, MA, CFO H1 2021 Presentation Non-confidential – Property of Inventiva │ 3
Slide 4: Summary
Summary Highlights Pipeline update Financials Near-term catalysts H1 2021 Presentation Non-confidential – Property of Inventiva │ 4
Slide 5: Highlights
Highlights
Slide 6: First-Half 2021 Highlights
First-Half 2021 Highlights Lanifibranor in non-alcoholic steatohepatitis (NASH) Initiation of the NATiV3 Phase III clinical trial evaluating lanifibranor in adult patients with non-cirrhotic NASH and F2/F3 stage of liver fibrosis, with the activation of the first clinical sites in the United State
Slide 7: Pipeline update
Pipeline update
Slide 8: Lanifibranor in Nonalcoholic Steatohepatitis (NASH)
Lanifibranor in Nonalcoholic Steatohepatitis (NASH) A new generation pan-PPAR agonist for a safe and efficacious treatment of fibrotic conditions
Slide 9: Lanifibranor: a pan-PPAR agonist entering phase III development in NASH
Lanifibranor: a pan-PPAR agonist entering phase III development in NASH LANIFIBRANOR Moderate and balanced pan-PPAR agonist activity Small molecule that activates all three PPAR isoforms in humans PPARα Differentiated chemical structure: not a fibrate or a TZD Once daily oral administration
Slide 10: The overall development plan builds on the successful outcomes of the NATIVE Phase IIb trial
The overall development plan builds on the successful outcomes of the NATIVE Phase IIb trial CLINICAL DEVELOPMENT F2-F3 Phase III Registration Phase I Phase IIa Phase IIb (NATIVE) III OVERVIEW • 72 week Part 1 + Part IIb DESIGN 2 extension period • 24 weeks • Inclusion criteria and • 800 mg and 1200
Slide 11: Lanifibranor is the first candidate to achieve statistically significant results on the two Phase III primary endpoints
Lanifibranor is the first candidate to achieve statistically significant results on the two Phase III FDA and EMA primary endpoints PHASE IIb EFFICACY KEY ENDPOINTS xx Statistically significant xx Non-statistically significant Key Phase IIb results by endpoint N = 247 ITT population N = 197 PP popul
Slide 12: Lanifibranor is the only asset that addresses all key features of NASH
Compared to key competitors, lanifibranor is the only asset that addresses all key features of NASH EFFICACY Lanifibranor Ocaliva Resmetirom Aramchol Efruxifermin Semaglutide (PPAR) (FXR) (THR-β) (Other) (FGF) (GLP-1) ROUTE OF Oral Oral Oral Oral Injectable Injectable ADMINISTRATION INSULINO- RESIST
Slide 13: Lanifibranor compares favourably on fibrosis improvement and NASH resolution
Lanifibranor compares favourably in its ability to target both fibrosis improvement and NASH resolution EFFICACY Active Placebo xx Statistically significant xx Non-statistically significant Only drug achieving statistical significance on both endpoints Injectables Lanifibranor Ocaliva Resmetirom Ara
Slide 14: Physicians are positive about lanifibranor's value proposition
Physicians are positive about anifibranor's value proposition, noting its ability to target both fibrosis and NASH resolution EFFICACY The benefits of a pan-PPAR targeting multiple isoforms are clear to most physicians, who comment positively on lanifibranor's efficacy on fibrosis and NASH resolut
Slide 15: Physicians perceive weight gain due to lanifibranor as manageable
Physicians perceive weight gain due to lanifibranor as manageable, with the risk profile viewed positively SAFETY Physician express differing views on the importance of weight gain – the majority of physicians believed that given lanifibranor's efficacy profile the risk-benefit ratio was acceptabl
Slide 16: The F2-F3 Phase III consists of two parts
The F2-F3 Phase III consists of two parts, with inclusion criteria and patient profile in line with the NATIVE Phase IIb trial PHASE III F2 F3 Patients A randomized, double-blind, placebo-controlled, multicenter, Phase III study evaluating long-term efficacy and safety of lanifibranor in adult patie
Slide 17: The primary endpoint will help differentiate from key competitors
The primary endpoint combining NASH resolution and fibrosis improvement will help differentiate from key competitors PHASE III DESIGN The primary endpoint “resolution of NASH and improvement of fibrosis” addresses the major pathways of the disease: achieving both of these histological outcomes ref
Slide 18: Phase III patients randomised across approximately 300 sites worldwide
The Phase III patients will be randomised across approximately 300 sites worldwide PHASE III DESIGN SITE SELECTION Nativ3 countries 25 countries worldwide with more than 330 sites expected to participate H1 2021 Presentation Non-confidential – Property of Inventiva │ 18
Slide 19: Key milestones of the Phase III study in NASH (Part 1)
Key milestones of the Phase III study in NASH (Part 1) PHASE III MILESTONES 2021 2022 2023 2024 F2-F3 Phase III Q3 2021 H2 2022 H1 2024 Activation of Part 1: Last Patient Part 1: Last first clinical First Visit Patient Last Visit sites and start (c.900 patients) (c.900 patients) of screening H2 20
Slide 20: Save the Date
Inventiva ® SAVE THE DATE AASLD Nov. 12-15, 2021 The Liver e © Meeting KOL Meeting
Slide 21: Cedirogant - ABBV-157
Cedirogant - ABBV-157 Qobvie
Slide 22: Cedirogant: a clinical stage ROR inverse agonist (I)
Cedirogant: a clinical stage ROR inverse agonist co-discovered by Inventiva with potential in several auto-immune diseases (I) ROR is believed to be a master regulator of Th17 differentiation and IL-17 expression, an approach validated by several successful biologics Pharmacological inhibition o
Slide 23: Cedirogant: a clinical stage ROR inverse agonist (II)
Cedirogant: a clinical stage ROR inverse agonist co-discovered by Inventiva with potential in several auto-immune diseases (II) Cedirogant (ABBV-157) is targeting indications where competitors have reached block-buster status Brand Company Target Posology 2020 sales(1) Cedirogant Target Product P
Slide 24: Cedirogant Phase IIb in adults with moderate to severe psoriasis
Cedirogant Phase IIb in in adults with moderate to severe psoriasis A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Cedirogant (ABBV-157) in Adult Subjects With Moderate to Severe Psoriasis Status Primary outcome measu
Slide 25: Competitive landscape
Competitive landscape Development Product name Company Phase Cedirogant Phase 2 Bevurogant Phase 2 AUR-101 Phase 2 JTE-761 Phase 1 IMU-935 Phase 1 Selected ROR programs stopped Source: H1 2021 Presentation Non-confidential – Property of Inventiva │ 25
Slide 26: Financials
Financials
Slide 27: Key financials and shareholder base
Key financials and shareholder base Key financials Shareholder base Founders 25% Free Float 31% Employees ISIN code FR0013233012 / US46124U1079 & Others 2% Market Euronext Paris / Nasdaq GM Sofinnova 38,659,361 (incl. 7,478,261 shares of 8% Shares outstanding BVF the July 9 2020 Nasdaq IPO) NEA 13%
Slide 28: H1 2021 financial position
H1 2021 financial position Highlights Income Statement ► Revenues of €0.1 m, stable compared to H1 20 (in thousands of euros, except share and June 30, 2021 June 30, 2020 • Inventiva eligible to receive a milestone payment in Q4 upon the per share amounts) initiation by AbbVie of the Ph2b clinical t
Slide 29: Near-term catalysts
Near-term catalysts
Slide 30: Recent and anticipated key milestones
Recent and anticipated key milestones Lanifibranor Positive topline results of NATIVE Phase IIb trial in NASH Breakthrough Therapy Designation granted by FDA NATIVE Phase IIb meeting with FDA and EMA Scientific Advice Activation of first clinical sites and start of patient screening in phase
Slide 31: Q&A
Q&A
Slide 32: Contacts
Contacts Inventiva Brunswick Westwicke, an ICR Company Frédéric Cren Yannick Tetzlaff / Tristan Roquet Montégon Patricia L. Bank / Aude Lepreux CEO Investor relations Media relations info@inventivapharma.com inventiva@brunswickgroup.com patti.bank@westwicke.com +33 (0)3 80 44 75 00 + 33 1 53 96 83 8