Inventiva SA · EURONEXT:IVA
Inventiva SA — FY2021 Earnings Presentation
43 slides from Inventiva SA's earnings presentation, Mar 8, 2022
Slide 1: Full Year 2021 Financial Results
Full Year 2021 Financial Results March 8, 2022
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 Full Year 2021 Presentation | 2022 Non-confidential – Property of Inventiva │ 3
Slide 4: Summary
Summary Full year 2021 highlights Clinical pipeline update Financials Near-term catalysts Full Year 2021 Presentation | 2022 Non-confidential – Property of Inventiva │ 4
Slide 5: Full Year 2021 Highlights
Full Year 2021 Highlights
Slide 6: Full Year 2021 Highlights
Full Year 2021 Highlights Lanifibranor program in non-alcoholic steatohepatitis (NASH) Initiation of NATiV3 Phase III clinical trial evaluating lanifibranor in NASH Design of LEGEND, a Phase IIa combination trial with lanifibranor and SGLT2 inhibitor empagliflozin in patients with NASH and type
Slide 7: Full Year 2021 Highlights
Full Year 2021 Highlights Odiparcil program in mucopolysaccharidoses (MPS) Preparation of a meting with FDA to validate the design of a pivotal trial in children with MPS VI Other Opening of Inventiva Inc. in the United States Several recruitments with solid track records and complementary pro
Slide 8: Clinical pipeline update
Clinical pipeline update
Slide 9: Lanifibranor
Lanifibranor A new generation pan-PPAR agonist potentially active across the entire spectrum of NASH disease biology
Slide 10: Lanifibranor: a pan-PPAR agonist in phase III development in NASH
Lanifibranor: a pan-PPAR agonist in 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 Positi
Slide 11: Lanifibranor overall development plan in NASH
Lanifibranor overall development plan in NASH CLINICAL DEVELOPMENT Phase III in patients with NASH Registration and F2-F3 fibrosis Phase I Phase IIa Phase IIb (NATIVE) III OVERVIEW • 72 week Part 1 + Part 2 extension IIb DESIGN period • 24 weeks • Inclusion criteria and patient profile in • 800 mg a
Slide 12: Lanifibranor overall development plan in NASH
Lanifibranor overall development plan in NASH CLINICAL DEVELOPMENT Phase III in patients with NASH H2 2024 and F2-F3 fibrosis Topline results Phase I Phase IIa Phase IIb (NATIVE) Phase II in NAFLD patients H2 2022 with T2D Topline results Lanifibranor + empagliflozine Phase II in NASH patients H2 20
Slide 13: Phase III NATiV3 clinical trial: design overview
Phase III NATiV3 clinical trial: design overview PHASE III OVERVIEW A randomized, double-blind, placebo-controlled, multicenter, Phase III study evaluating long-term efficacy and safety of lanifibranor in adult patients with NASH with liver fibrosis Part 1: 72 week treatment Part 2: Extension period
Slide 14: NATiV3 Part 1 interim analysis to seek accelerated approval
Phase III NATiV3 Part 1 interim histology analysis will enable to seek U.S. accelerated approval and E.U. conditional approval PHASE III OVERVIEW Part 1 F2-F3 Phase III Part 1: 72 week treatment Screening Placebo Biopsy Eligible for U.S. ACCELERATED Biopsy Part I lanifibranor, 800 mg once daily APPR
Slide 15: NATiV3 Part 2 extension study for broader full approval
Phase III NATiV3 Part 2 extension study will allow for a broader “full approval” PHASE III OVERVIEW Part 2 F2-F3 Phase III Part 2: Extension period Placebo Biopsy Part II Potential for FULL lanifibranor, 800 mg once daily APPROVAL in U.S. and EU lanifibranor, 1200 mg once daily KEY ENDPOINTS IN PART
Slide 16: Phase III patients randomised across 350 to 400 sites worldwide
The Phase III patients will be randomised across 350 to 400 sites worldwide PHASE III DESIGN SITE SELECTION Study conducted with our global partner ICON Addition of two clinical research networks in NATiV3 countries the US and Europe with recruitment objectives additive to those of ICON ones Rec
Slide 17: Pharmaceutical development: towards a successful commercial supply
Pharmaceutical development: towards a successful commercial supply Supply chain strategy Drug Substance Drug product Suppy chain strategy under development Characteristics of the « to be marketed » product Two CDMOs to be involved defined for the US and EU/ROW market Both FDA approved Industri
Slide 18: Development plan: Phase II in NAFLD patients with type 2 diabetes
Lanifibranor overall development plan in NASH: Phase II in NAFLD patients with type 2 diabetes CLINICAL DEVELOPMENT Phase III in patients with NASH and F2-F3 fibrosis Phase I Phase IIa Phase IIb (NATIVE) Phase II in NAFLD patients with T2D Lanifibranor + empagliflozine Phase II in NASH patients with
Slide 19: NASH and Type 2 Diabetes
NASH and Type 2 Diabetes Study aim: investigate the mechanism(s) of action of lanifibranor to reduce intrahepatic triglyceride accumulation (IHTG) in relation to changes in adipose tissue, hepatic and muscle insulin resistance, as well as improvement in the cardiometabolic risk profile of patients w
Slide 20: Lanifibranor Phase II study in Patients with Type 2 Diabetes and NAFLD
Lanifibranor Phase II study in Patients with Type 2 Diabetes and NAFLD Main inclusion criteria ► A total of 34 patients with type 2 diabetes (T2D) with a fasting plasma glucose (FPG) ≤ 250 mg/dL and HbA1c ≤ 9.5% (not on insulin or pioglitazone) with NAFLD. ► Hepatic steatosis (intrahepatic triglycer
Slide 21: Lanifibranor clinical trial in patients with T2D and NAFLD
Lanifibranor clinical trial in patients with T2D and NAFLD Objective: Establish the efficacy/safety and mechanism of action of lanifibranor in patients with T2D and NAFLD. Specifically determine if lanifibranor decreases IHTG, improves adipose tissue, hepatic and muscle insulin sensitivity, endogeno
Slide 22: Development plan: combination study of lanifibranor and empagliflozine
Lanifibranor overall development plan in NASH: combination study of lanifibranor and empagliflozine CLINICAL DEVELOPMENT Phase III in patients with NASH and F2-F3 fibrosis Phase I Phase IIa Phase IIb (NATIVE) Phase II in NAFLD patients with T2D Lanifibranor + empagliflozine Phase II in NASH patients
Slide 23: Background
Background A large portion of patients with T2D and NASH display typical features of Metabolic Syndrome including abdominal obesity, dyslipidemia, hypertension and insulin resistance.1 T2D accounts for 90 to 95% of all cases of diabetes and is an increasingly prevalent disease with an estimated
Slide 24: Lanifibranor and a SGLT2 inhibitor: rationale
Lanifibranor and a SGLT2 inhibitor (SGLT2i) : rationale Lanifibranor: balanced pan-PPAR agonist Empagliflozin: SGLT2i reduces proximal tubule (PPARα, PPARγ and PPARδ)1 reabsorption of sodium and glucose2 Lanifibranor shown to improve insulin sensitivity, Empagliflozin shown to improve glycaemia, bod
Slide 25: LEGEND trial: rationale
LEGEND trial: rationale Target biology Utilizing drug combinations targeting multiple aspects of the metabolic syndrome has the potential to address the clinical outcomes in both T2D and NASH Complex NASH pathophysiology requires targeting multiple mechanisms Potential for additive effects Bod
Slide 26: LEGEND trial: design
LEGEND trial: design Lanifibranor in Combination with the SGLT2 Inhibitor empagliflozin in patients with NASH and Type 2 Diabetes LEGEND Study Principal investigator Design Prof. M. Lai, gastroenterologist- Double-blind comparison of lanifibranor vs. placebo will allow controlled hepatologist, a
Slide 27: LEGEND trial: summary
LEGEND trial: summary Lanifibranor and empagliflozin is an attractive combination to study in patients with NASH and T2D LEGEND trial will develop important ‘Proof of Concept’ data on the combination : – Metabolic function : ⚫ Lanifibranor addresses disease pathways across the spectrum, from lip
Slide 28: Cedirogant (ABBV-157)
Cedirogant (ABBV-157)
Slide 29: Highlights
Highlights RORg is believed to be a master regulator of Th17 differentiation and IL-17 expression, an approach validated by several successful biologics Potential to more effectively inhibit IL-17 production than antagonist approaches RORg mechanism of action could prove efficacious in psorias
Slide 30: RORg controls Th17 cell differentiation and effector function
RORg controls Th17 cell differentiation and effector function The success of anti-IL17 or anti-IL23 biologics in the treatment of psoriasis validates the IL23-IL17 pathway as an important target for therapy Source: Jetten et al. Nature 2010 Full Year 2021 Presentation | 2022 Non-confidential – Pro
Slide 31: Cedirogant: a clinical stage RORg inverse agonist
Cedirogant: a clinical stage RORg inverse agonist with potential in several auto-immune diseases RORg is believed to be a master regulator of Th17 differentiation and IL-17 expression, an approach validated by several successful biologics Pharmacological inhibition of RORg by small molecules has b
Slide 32: Psoriasis: a $20b global market dominated by injectables
Psoriasis: a $20b global market dominated by injectables Psoriasis is a common skin condition that affects 2-4% of the population in western countries with global sales in 2020 of approx. $20b(1) The market is dominated by IL-12/23, IL-17 and TNFa which, despite being injectables, account for mo
Slide 33: Cedirogant currently evaluated in a Phase IIb trial in psoriasis
Cedirogant (ABBV-157) is currently evaluated in a Phase IIb trial in adults with moderate to severe psoriasis Single ascending dose and multiple ascending dose trials in healthy volunteers completed Phase Ib: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pha
Slide 34: Cedirogant Phase IIb in adults with moderate to severe psoriasis
Cedirogant Phase IIb 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 measures
Slide 35: RORg competitive landscape
RORg competitive landscape Development Product name Company Comments Phase Cedirogant Phase 2 Oral once daily Bevurogant Phase 2 Progam not mentioned anymore in BI annual report AUR-101 Phase 2 Twice daily Results posted on clinicaltrials.gov do not meet JTE-451 Phase 1 target product profile Once d
Slide 36: Cedirogant royalties potential source of revenues
Cedirogant royalties have the potential to be an important source of revenues Cedirogant potential profile: Humira (TNFa) in a pill + better safety Inventiva eligible to receive development, regulatory, commercial milestones and tiered royalties from the mid-single to low-double digits Composi
Slide 37: Financials
Financials
Slide 38: Key financials and shareholder base
Key financials and shareholder base Key financials Shareholder base(1) Sofinnova Employees 8,0% & Others… NEA 13,2% Free Float ISIN code FR0013233012 / US46124U1079 32,6% Market Euronext Paris / Nasdaq GM BVF 20,6% Shares outstanding 40 873 551 Founders 23,2% Market cap Euronext Paris: €413m / Nasda
Slide 39: Full year 2021: Key figures
Full year 2021: Key figures Highlights Income Statement ► Revenues of €4.2 m, compared to €0.4 m in 2020 Key figures • Inventiva has received early 2022 a milestone payment of €4.0 m 2021 2020 (in thousands of euros) upon the initiation in Nov. 2021 by AbbVie of the Ph2b clinical trial Revenues 4 19
Slide 40: Near-term catalysts
Near-term catalysts
Slide 41: Anticipated key milestones
Anticipated key milestones 2022 2023 2024 Lanifibranor H1 2022 H2 2023 H2 2024 • Activation of first clinical • Topline results • Topline results sites for the phase II of Phase II of of the phase III trial combining lanifibranor in trial in patients lanifibranor with SGLT2i combination with NASH em
Slide 42: Q&A
Q&A
Slide 43: Contacts
Contacts Inventiva Brunswick Westwicke, an ICR Company Frédéric Cren Laurence Frost / Tristan Roquet Montégon Patricia L. Bank / Aude Lepreux CEO Investor relations Media relations [email protected] [email protected] [email protected] +33 (0)3 80 44 75 00 + 33 1 53 96 83 83