Slide 1: 2017 Full Year Results
2017 Full Year Results March 7 2018
Slide 2: Disclaimer
DISCLAIMER This document has been prepared by Inventiva (the "Company") solely for use at this presentation. By attending the meeting where this presentation is made, or by reading the following presentation slides, you agree to be bound by the following limitations, qualifications and restrictions:
Slide 3: Today's speakers
Today’s speakers Frédéric Cren, MA/MBA, CEO and Co‐Founder Pierre Broqua, Ph.D., CSO and Co‐Founder Jean Volatier, MA, CFO Full Year 2017 Presentation Property of Inventiva │ 3
Slide 4: Summary
Summary Full Year 2017 Highlights Update on pipeline Financials Conclusion Full Year 2017 Presentation Property of Inventiva │ 4
Slide 5: FY 2017 Highlights
FY 2017 Highlights Continued recruitment of patients in NASH Phase IIb NATIVE study evaluating lanifibranor in NASH Enrollment completed for the Phase IIb FASST study evaluating lanifibranor in systemic scleroderma Inclusion of the first patient in the Phase IIa study (iMProveS) with odiparcil
Slide 6: Large pipeline reaching major inflection points
Large pipeline reaching major inflection points Pre Candidate Indication Discovery Phase I Phase II Phase III Commercial Rights clinical Lanifibranor NASH Lanifibranor SSc Odiparcil MPS VI ROR Moderate to severe psoriasis Sales Royalties for Inventiva YAP/TEAD Malignant Mesothelioma, Lung
Slide 7: Lanifibranor NASH and SSc
Lanifibranor NASH and SSc A new generation pan-PPAR agonist for a safe and efficacious treatment of fibrotic conditions
Slide 8: Lanifibranor: a next generation panPPAR agonist for fibrotic conditions
Lanifibranor: a next generation panPPAR agonist for a safe and efficacious treatment of fibrotic conditions Unprecedented chemical structure with moderate and balanced panPPAR agonist activity (PPAR, PPAR and PPAR Oral administration Efficacy demonstrated on insulin resistance, dyslipidemi
Slide 9: Lanifibranor: a mechanism of action addressing all the key features of NASH
Lanifibranor: a mechanism of action addressing all the key features of NASH PPAR PPAR, Metabolism Steatosis Insulin sensitivity FA uptake HDLc FA catabolism Lanifibranor TG Lipogenesis Moderate and balanced panPPAR agonist activity regulating genes in: • PPAR: hepatocytes • PPAR: kuppfer cell
Slide 10: NATIVE Phase IIb in NASH
NATIVE Phase IIb in NASH Trial design Status Inclusion criteria Trial enrolling Liver biopsy Randomisation Moderate to severe patients with a inflammation and 1/1/1, stratification on T2DM patients ballooning score of 3 or 4 Study powered with 75 patients per group Steatosis score ≥ 1 an
Slide 11: NATIVE: Phase IIb in NASH countries worldwide
NATIVE: Phase IIb in NASH 16 countries worldwide ► 13 in EU Principal investigator: Pr Sven Francque, Belgium ► Canada ► Australia ► Mauritius 14 countries approved 76 sites involved 45 sites activated 42 sites screening Results expected second-half 2019 Full Year 2017 Presentation Property of Inven
Slide 12: Lanifibranor could address all the relevant clinical features of systemic sclerosis
Lanifibranor could address all the relevant clinical features of systemic sclerosis Lanifibranor reduces vasculopathy and inflammatory driven lung fibrosis Lanifibranor reduces Lung Skin established skin fibrosis Lanifibranor restores lung Lanifibranor reduces right ventricular functional capacity H
Slide 13: FASST Phase IIb in SSc
FASST Phase IIb in SSc Trial design Status Inclusion criteria Last patient recruited in October 2017. MRSS (Modified Rodnan Skin Score) between 10 and 25 SSc diagnosed from less than 3 years Clinicaltrials.gov identifier: NCT02503644 Primary endpoint Mean change of the MRSS from baseline t
Slide 14: FASST: 100% of patients randomized and close to 50% have completed
FASST: 100% of patients randomized and close to 50% of patients have already completed the trial 180 160 140 120 100 80 161 145 60 (100%) 102 40 72 (49%) 20 0 # of patients screened # of patients randomised # of patients with 6 months # of patients having of treatement completed the trial (12 month
Slide 15: Lanifibranor: a phase III ready program in both SSc and NASH by 2019
Lanifibranor: a phase III ready program in both SSc and NASH by 2019 2015 2016 2017 2018 2019 H2 H1 H2 H1 H2 H1 H2 H1 H2 EMA conditional marketing authorisation Systemic sclerosis submission Phase IIb FDA potential breakthrough therapy status FDA preIND Results FDA IND Start of pivotal Phase III stu
Slide 16: Odiparcil
Odiparcil The first oral therapy to treat five forms of mucopolysaccharidosis (MPS): MPS I, II, IV, VI and VII
Slide 17: Odiparcil, the first orally available therapy to treat several forms of MPS
Odiparcil, the first orally available therapy to treat several forms of MPS Mechanism of action via modulation of GAG synthesis which accumulation triggers MPS Oral administration Odiparcil reduction of GAG intracellular accumulation demonstrated in in vitro and in vivo relevant models Activit
Slide 18: Inventiva's observational study to evaluate intracellular GAG in leukocytes
Inventiva’s observational study to evaluate intracellular GAG in leukocytes Leukocytes are promising cells ► Low invasiveness of collection procedure ► GAG intracellular levels are increased in animal model of MPS ► Odiparcil decreases intra-cellular GAG level Objectives of Inventiva’s non-intervent
Slide 19: Study confirms promising biomarker for MPS VI and limited ERT efficacy
Study confirms Inventiva has developed a promising biomarker for MPS VI and the limited ERT efficacy in reducing leukoGAGs ARSB activity in leukocytes is MPS VI patients treated with MPS VI patients treated with ERT have increased by 8 fold after ERT ERT have increased CS (and DS increased CS and DS
Slide 20: Odiparcil iMProveS phase IIa study in MPS VI patients
Odiparcil iMProveS phase IIa study in MPS VI patients Trial design ► Inclusion criteria: MPS VI patients (≥ 16 year-old) ► Status: First patient recruited December 2017. 18 patients double blind + 6 patients open label 6 weeks 4 weeks 26 week treatment 10 weeks Screening Placebo + ERT, 6 patients Sc
Slide 21: Odiparcil overall development plan in MPS VI
Odiparcil overall development plan in MPS VI 2016 2017 2018 2019 2020 2021 2022 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 Biomarker study Phase IIa Clinic Results Phase Ib (MPS VI Pivotal Phase III children) EMA Scientific Regulatory EU ODD EMA PIP EMA SA PIII Advice Dev Plan US ODD Rare paediatric FDA Eo
Slide 22: Two collaborations with leading pharma companies
Two collaborations with leading pharma companies
Slide 23: Two successful collaborations in place with AbbVie and Boehringer Ingelheim
Two successful collaborations in place with AbbVie and Boehringer Ingelheim RORγ collaboration Collaboration in fibrosis RORγ program addresses large markets currently Multi-year R&D collaboration and licensing partnership dominated by biologics Joint team until pre-CC stage. BI to take full
Slide 24: Financials
Financials
Slide 25: Strong cash position and shareholder base
Strong cash position and shareholder base Key financials Shareholder base ~18,5% Free Float(1) ISIN code FR0013233012 ~11,0% BVF Market Euronext Paris Founders ~60,5% Shares outstanding 16 444 477 ~7,0% Novo Ventures Market cap €99,32m (28 February 2018) ~3,0% Employees €59m (including €45m raised a
Slide 26: FY 2017: a sound financial position
FY 2017: a sound financial position Income Statement ► Revenues of €6.5m compared to €9.4m in 2016 • Decrease in non-recurring income vs 2016: As of 31 December 2017 Key figures 2016: Two milestone payments from AbbVie totaling €4.5m (in thousands euros) 2017 2016 2017: Payment of €2.5m from Boe
Slide 27: Conclusion
Conclusion
Slide 28: Key 2017 achievements and near-term catalysts
Key 2017 achievements and near-term catalysts 2017 2018 2019 12 month monkey study finalized Last patient phase IIb NASH Results Phase IIb SSc Lanifibranor Lanifibranor INN name from WHO 2 year carcinogenicity study results Results Phase IIb NASH Last patient phase IIb SSc SSc IND
Slide 29: Q&A
Q&A
Slide 30: Contacts
Contacts Inventiva Brunswick LifeSci Advisors Frédéric Cren Julien Trosdorf / Yannick Tetzlaff Chris Maggos CEO Media relations Investor relations info@inventivapharma.com inventiva@brunswickgroup.com chris@lifesciadvisors.com +33 (0)3 80 44 75 00 + 33 1 53 96 83 83