Inventiva Sa · EURONEXT:IVA
Inventiva Sa — 43rd Annual J.P. Morgan Healthcare Conference 2025
24 slides from Inventiva Sa's conference presentation, January 2025
Slide 1: 43rd Annual J.P. Morgan Healthcare Conference
43rd Annual J.P. Morgan Healthcare Conference January 13-16, 2025
Slide 2: Disclaimer
Disclaimer This presentation contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this presentation are forward-looking statements. These
Slide 3: Lanifibranor: strong therapeutic profile for the MASH market
Lanifibranor: strong therapeutic profile for the MASH market Potential to be the second oral liver-targeted therapy to the market Best in Class Oral Efficacy Data Differentiated pan-PPAR Agonist Phase IIb demonstrated 18% fibrosis placebo-adjusted Balanced pan-PPAR agonist activity, once-daily dosin
Slide 4: The PPAR story has evolved: two novel agents are now approved in PBC
The PPAR story has evolved: two novel agents are now approved in PBC Regulatory authorities have shifted to a more positive stance on the class 1999 2004 2008 2009 2008 2014 2019 2024 1999 FDA Approval 2008 Rosiglitazone 2012 Rosiglitazone 2024 Approval of of Pioglitazone REMS Program REMS Removed t
Slide 5: Clinicians and industry have recognized the value of PPAR agonists
Clinicians and industry have recognized the value of PPAR agonists Prescriptions and M&A support the potential of this class of drugs Physicians continue to prescribe pioglitazone Gilead acquires Cymabay for with over 6M scrips written in 2023 in the U.S. $4.3B in February 2024 Pioglitazone U.S. Ann
Slide 6: Lanifibranor: a pan-PPAR agonist with differentiated profile
Lanifibranor: a pan-PPAR agonist with differentiated profile A new chemical entity: not a fibrate, not a TZD Moderate and balanced pan-PPAR agonist activity 150 PPARα Small molecule that activates all three PPAR isoforms in humans 125 hPPARα Balanced activity across the three human PPAR isoforms
Slide 7: Balanced PPAR activity with differential binding/target engagement
Balanced PPAR activity with differential binding/target engagement Lanifibranor did not lead to the adverse events and toxicity previously seen in single/dual PPAR agonists Moderate pan-PPAR agonist activity… … that engages PPARγ differently PPARα PPARδ PPARγ Compound EC50 (nM) EC50 (nM) EC50 (nM) L
Slide 8: The Phase IIb NATIVE trial published in NEJM
The Phase IIb NATIVE trial published in NEJM Evaluated 800 & 1200mg, oral, once-daily, 247 patients 24-week treatment + 4-week follow-up Screening Double blind, randomized, placebo-controlled End of treatment Liver biopsy ITT: 247 Patients Randomized Patients Liver biopsy Placebo • Randomization
Slide 9: Resolution of MASH and fibrosis improvement ≥ 1 stage
Resolution of MASH and fibrosis improvement ≥ least 1 stage Compares favourably to other oral and injectable compounds ORAL INJECTABLE PPARs THR-β FGF-21 GLP1-RA and GLP1-RA dual agonists Lanifibranor Resmetirom** Efruxifermin Pegozafermin Semaglutide Survodutide Tirzepatide Phase II Phase III Phase
Slide 10: Fibrosis improvement ≥ 1 stage with no worsening of MASH
Fibrosis improvement ≥ 1 stage with no worsening of MASH Compares favourably to other oral and injectable compounds ORAL INJECTABLE PPARs THR-β FGF-21 GLP1-RA and GLP1-RA dual agonists Lanifibranor Resmetirom** Efruxifermin Pegozafermin Semaglutide Survodutide Tirzepatide Phase II Phase III Phase II
Slide 11: MASH resolution with no worsening of fibrosis
MASH resolution with no worsening of fibrosis Compares favourably to other oral and injectable compounds ORAL INJECTABLE PPARs THR-β FGF-21 GLP1-RA and GLP1-RA dual agonists Lanifibranor Resmetirom** Efruxifermin Pegozafermin Semaglutide Survodutide Tirzepatide Phase II Phase III Phase IIb Phase IIb
Slide 12: Statistically significant decrease in liver enzymes
Statistically significant decrease in liver enzymes Liver biomarkers show rapid and sustained improvement Other secondary endpoints in ITT (N = 247) Absolute change from baseline in ALT Absolute change from baseline in AST 10 10 Mean absolute change (UI/L) Mean absolute change (UI/L) 0 0 -10 -10 -20
Slide 13: Statistically significant change in lipid profile
Statistically significant change in lipid profile Improvements in HDL-cholesterol & triglycerides without a change in LDL-cholesterol Other secondary endpoints in ITT (N = 247) * p<0.01 **p<0.001 Absolute change from baseline in HDL-C Absolute change from baseline in triglycerides SECONDARY ENDPOINT
Slide 14: Clear benefit in MASH patients with T2D, across multiple studies
Clear benefit in MASH patients with T2D, across multiple studies Significant reductions in HbA1c and fasting glucose Reduction in HbA1c in patients with MASH and T2D LS mean absolute change in hepatic insulin resistance index 0.5 Mean absolute change (%) -10 0 -9.5 -0.5 -30 * -30.1 ** **p<0.001 * **
Slide 15: Weight gain is observed in ~33% of patients
Weight gain is observed in ~33% of patients Weight gain comes with improvements in metabolic, cardiometabolic, or liver markers Mean absolute change at week 24 from baseline Weight changes at end of treatment (week 24) in Lanifibranor Placebo patients treated with lanifibranor versus placebo 4.0 Fas
Slide 16: Lanifibranor has a differentiated weight gain profile relative to pioglitazone
Lanifibranor has a differentiated weight gain profile relative to pioglitazone Weight gain plateaus with lanifibranor after 24-36 weeks Lanifibranor Pioglitazone 4.0 D Weight Abs Chg +/- 95%CI Weight (kg) mean 2.3 2.4 1.9 2.1 5.0 2.0 Change from baseline (kg) 1.0 Pioglitazone 0.4 0.0 0.0 2.5 Vitamin
Slide 17: SGLT2 inhibitor empagliflozin mitigates lanifibranor weight gain
SGLT2 inhibitor empagliflozin mitigates lanifibranor weight gain Meta-analysis data suggest that GLP-1s have a similar effect when combined with PPARs Lanifibranor + empagliflozin Pioglitazone + GLP1 or SGLT2i Baseline 63-137 kg Week 4 Week 12 Week 24 5 n=13/12/13 n=13/12/11 n=9/12/10 Placebo 3.6 3.
Slide 18: SGLT2 inhibitor empagliflozin mitigates lanifibranor weight gain
SGLT2 inhibitor empagliflozin mitigates lanifibranor weight gain Meta-analysis data suggest that GLP-1s have a similar effect when combined with PPARs Lanifibranor + empagliflozin Pioglitazone + GLP1 or SGLT2i Baseline 63-137 kg Week 4 Week 12 Week 24 5 n=13/12/13 n=13/12/11 n=9/12/10 Placebo 3.6 3.
Slide 19: Lanifibranor is well-positioned in the MASH market
Lanifibranor is well-positioned in the MASH market Multiple competitive advantages vs. other therapies pan-PPAR THR-β FGF-21 GLP-1 Route of administration Oral Oral Injectable Injectable Indirect Direct activity Indirect Direct activity seen with sema. after 18 Fibrosis improvement seen at 6 months
Slide 20: MASH with advanced fibrosis represents a high unmet medical need
MASH with advanced fibrosis represents a high unmet medical need Patients with MASH and type 2 diabetes are at higher risk MASH U.S. Prevalence and Progression Estimates by Fibrosis Stage Millions 30.0 (US, 2030) 27.0 3.1 25.0 ► 22% of patients with F3 fibrosis 9.0 liver-related mortality 20.0 progr
Slide 21: KOL discussions suggest that lanifibranor has significant potential
KOL discussions suggest that lanifibranor has significant potential Could play a key role in the highest unmet need segments in MASH Priority patient segment based on KOL feedback at time of lanifibranor launch F2 (~25%) F3 (~27%) F4cc (~10%) “Lean” Pan-PPAR agonists have strong MASH antifibrotic an
Slide 22: NATiV3 recruitment is nearly complete
NATiV3 recruitment is nearly complete Trial design mirrors the successful Phase IIb study Main Cohort Accelerated 72 weeks treatment Approval N~ 950 Lanifibranor: 1200 mg once daily Non-cirrhotic MASH & Lanifibranor: 800 mg once daily F2-F3 fibrosis Active Treatment Extension Trial Placebo: Once dai
Slide 23: NATiV3 data is expected in 2026
NATiV3 data is expected in 2026 Lanifibranor could be the second oral liver-directed agent for the treatment of MASH if approved Targeted timeline for anticipated catalysts 2025 2026 2027 2028 Lanifibranor H1 2025 H2 2026 2027 Last Patient Last Patient New Drug First Visit Last Visit and Approval fi
Slide 24: Contacts
Contacts Inventiva Brunswick Westwicke, an ICR Company Pascaline Clerc Tristan Roquet Montégon Patricia L. Bank Executive VP Aude Lepreux Investor relations Strategy and Corporate Affairs Julia Cailleteau Media relations pascaline.clerc@inventivapharma.com inventiva@brunswickgroup.com patti.bank@wes
Inventiva — 43rd Annual J.P. Morgan Healthcare Conference 2025 on 6ix