Inventiva Sa · EURONEXT:IVA
Inventiva Sa — H1 2019 Earnings Presentation
40 slides from Inventiva Sa's earnings presentation, Sep 27, 2019
Slide 1: First-Half 2019 Financial Results
First-Half 2019 Financial Results September 27, 2019
Slide 2: Disclaimer
DISCLAIMER This document has been prepared by Inventiva (the "Company") solely for the purpose of this presentation. This presentation includes only summary information and does not purport to be comprehensive. Any information in this presentation, whether from internal or from external sources, is
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 Jean Volatier, MA, CFO H1 2019 Presentation Property of Inventiva │ 3
Slide 4: Summary
Summary First-Half 2019 highlights Pipeline update Financials Near-term catalysts H1 2019 Presentation Property of Inventiva │ 4
Slide 5: First-Half 2019 Highlights
First-Half 2019 Highlights
Slide 6: Inventiva: highlights
Inventiva: highlights Clinical stage biotech with focus on oral small molecules for high unmet need in fibrosis, lysosomal storage disorders and oncology Two unencumbered late stage assets in two high value indications Lanifibranor: Phase IIb data due H1 2020 Odiparcil: Phase IIa data due H2 2019 Tw
Slide 7: Deep pipeline approaching major near term value inflection points
Deep pipeline approaching major near term value inflection points Candidate / IND Commercial Indication Discovery Phase I Phase II Phase III Program Enabling Rights Phase IIb Lanifibranor NASH Pan-PPAR results: H1 2020 Phase IIa Odiparcil MPS VI GAG clearance results: H2 2019 Moderate to RORߛ
Slide 8: First-Half 2019 Highlights
First-Half 2019 Highlights Lanifibranor Successful end of recruitment of the Phase IIb study in NASH: headline-results confirmed for H1 2020 Confirmation of lanifibranor good safety profile with the fourth and last positive DSMB recommendation Positive FDA feedback on the carcinogenicity studi
Slide 9: First-Half 2019 Highlights
First-Half 2019 Highlights YAP-TEAD Pursuit of the development of the program and generation of new data showing the relevance of the approach in mesothelioma, in association with other drugs of reference and in drug resistant cancers Positive preliminary toxicology data and ongoing selection of
Slide 10: Pipeline update
Pipeline update
Slide 11: 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 12: Lanifibranor: only pan-PPAR agonist in clinical development for NASH
Lanifibranor: only pan-PPAR agonist in clinical development for the treatment of NASH Orally available. New chemical entity and differentiated mechanism of action Composition of matter patent delivered in 59 countries and method of use patent granted in the US and in the EU: limit of exclusivity 203
Slide 13: Lanifibranor achievements: increased and extended protection
Lanifibranor achievements: increased and extended protection Previous IP Composition of matter patent protecting lanifibranor in 59 countries including US, Europe, Japan , China,… – Limit of exclusivity August 2031 including 5-year extension Use patent granted in the United States countries prot
Slide 14: Lanifibranor achievements: a strengthened safety profile and positive FDA interactions
Lanifibranor achievements: a strengthened safety profile and positive FDA interactions Safety package 6 month tox in rodents 6 month tox data in primates 12 month tox data in primates 2 year carcinogenicity studies in rats and mice 100 healthy volunteers treated in Phase I trials and 56 pa
Slide 15: Phase IIa study demonstrated beneficial effects on key metabolic markers in T2D patients
Phase IIa(1) clinical study demonstrated beneficial effects on key metabolic markers in T2D patients Lanifibranor has beneficial effects on key metabolic markers in type II diabetic patients Adiponectin (PPAR) HDL Cholesterol (PPAR) Triglycerides (PPAR) 300 p=0.05 40 0 baseline baseline basel
Slide 16: Lanifibranor achievements: NATIVE trial in NASH patients fully recruited (I/II)
Lanifibranor achievements: NATIVE trial in NASH patients fully recruited (I/II) Trial design Principal investigators Inclusion criteria Prof. Sven Francque (Antwerp University, Belgium) Liver biopsy Prof. Manal Abdelmalek (Duke University, USA) Severe patients with an inflammation and Random
Slide 17: Lanifibranor achievements: NATIVE trial in NASH patients fully recruited (II/II)
Lanifibranor achievements: NATIVE trial in NASH patients fully recruited (II/II) Parameter Total Female 144 (58%) Gender Male 103 (42%) Mean 53.6 ± 12.5 Age Median 55.0 Min ; Max 20 ; 77 Mean ± SD 93.3 ± 18.9 14 sites in the Weight Median 91.0 United-States >70 sites 17 countries Min ; Max 51 ; 145
Slide 18: Ongoing Phase II trial in type 2 diabetes patients with NAFLD
Ongoing Phase II trial in type 2 diabetes patients with NAFLD evaluating the effect of lanifibranor on hepatic insulin sensitivity Trial design Principal investigator Primary endpoint Prof. Kenneth Cusi (University of Florida) Change from baseline to week 24 in IHTG Randomisation Key secondary e
Slide 19: New data showing lanifibranor reduces fibrosis and portal pressure in cirrhotic rat model
Lanifibranor achievements: new data showing lanifibranor reduces fibrosis and portal pressure in a preclinical cirrhotic rat model Lanifibranor reduces established fibrosis Lanifibranor inhibits HSC activation Lanifibranor reduces portal pressure Lani Portal Pressure Vehicle 100 -SMA GAPDH Vehicle
Slide 20: Property of Inventiva │ 20
H1 2019 Presentation Property of Inventiva │ 20
Slide 21: PanNASH Initiative: highlights
PanNASH Initiative: highlights Recent achievements Launch of the PanNASH website: https://pannash.org/ Natural History of NASH and PPAR role paper available online NASH Slide Kit available online Key articles selected by the PanNASH experts on NASH available online Expert videos available
Slide 22: Odiparcil
Odiparcil The first oral therapy to treat five forms of mucopolysaccharidosis (MPS): MPS I, II, IV, VI and VII
Slide 23: Odiparcil: an orally available small molecule as GAG clearance therapy
Odiparcil: an orally available small molecule as GAG clearance therapy to treat several forms of MPS Oral medication with a large number of Phase I and Phase II studies completed Efficacy in tissues and organs not treated by current standard of care (enzyme replacement therapies) supported by precli
Slide 24: Odiparcil: a GAG clearance therapy in MPS
Odiparcil: a GAG clearance therapy in MPS in which dermatan and chondroitin sulfates (DS, CS) accumulate Odiparcil diverts endogenous protein-bound GAG synthesis to soluble odiparcil-bound chondroitin sulfate (CS) and dermatan sulfate (DS) synthesis Galactosyl transferase I (GTI) Galactosyl transfer
Slide 25: Odiparcil decreases GAG accumulation and restores mobility in MPS VI mouse model
Odiparcil decreases GAG accumulation and restores mobility in a mouse model of established MPS VI disease Odiparcil decreases GAG accumulation in tissues Liver Whole eye Sulfated GAG (µg/mg of wet tisues) 20 GAG in liver [Area * Index] p<0.001 p<0.05 * 5 *** p<0.001 p<0.001 Age at treatment onset: 1
Slide 26: Odiparcil decreases GAG accumulation in leukocytes excreted through the urine
Odiparcil decreases GAG accumulation in leukocytes which are excreted through the urine Soluble GAG produced from Odiparcil are excreted in urine Sulfated GAG (µg/mg of creatinine) 6000 p<0.0001 4000 Odiparcil decreases intracellular GAG levels in leukocytes 80 2000 %cells with > 10 GAG granules p<0
Slide 27: LeukoGAG biomarker for MPS VI demonstrates incomplete impact of ERT
LeukoGAG biomarker for MPS VI demonstrates the incomplete impact of ERT and opportunity for odiparcil Leukocytes intracellular GAG levels are increased in MPS vivo models and odiparcil decreases intra-cellular GAG content Objectives of Inventiva’s non-interventional study: develop a robust quant
Slide 28: Odiparcil achievements: iMProveS Phase IIa trial fully recruited
Odiparcil achievements: iMProveS Phase IIa trial fully recruited Phase IIa Population ► Phase III enabling study with evidence for dose selection ► Receiving ERT (N=15) and PK / PD response characterization ► Not receiving ERT (N=5) ► Clinicaltrials.gov identifier: NCT03370653 ≥ 16yo 15 patients dou
Slide 29: Odiparcil achievements: orphan status complemented by rare paediatric designation in MPS VI
Odiparcil achievements: orphan status complemented in the US by rare paediatric designation in MPS VI Rare pediatric designation The FDA granted Rare Pediatric Disease Designation to odiparcil for the treatment of MPS VI – Inventiva eligible to receive Priority Review Voucher upon approval of odip
Slide 30: ABBV-157 and BI collaboration
ABBV-157 and BI collaboration
Slide 31: Key validating collaborations with AbbVie and Boehringer Ingelheim
Key validating collaborations with AbbVie and Boehringer Ingelheim Successful first Phase I and launch of a clinical study ABBV-157, a potent ROR clinical candidate coming from the partnership with AbbVie, addresses large markets dominated by biologics and could prove to be superior to biologics
Slide 32: Yap-Tead program
Yap-Tead program
Slide 33: YAP-TEAD achievements
YAP-TEAD achievements The Hippo pathway: a newly discovered oncogenic signaling pathway, where Inventiva has established a leading position The program addresses both rare cancers (malignant mesothelioma, uveal melanoma, …) as well as large cancers (NSCLC, TNBC, hepatoblastoma, hepatocellular carc
Slide 34: Financials
Financials
Slide 35: Cash position and shareholder base
Cash position and shareholder base Key financials Shareholder base ISIN code FR0013233012 Market Euronext Paris Shares outstanding 26.532.176 Market cap €55m (September 26, 2018) €37,1m compared to €56,7m end of December 2018. Cash position Successful €48.5m Euronext IPO *Including Perceptive Adviso
Slide 36: H1 2019: financial position
H1 2019: financial position Highlights Income Statement ► Revenues of €1.3m compared to €1.4m in H1 18 (in thousands of euros, except share June 30, 2019 June 30, and per share amounts) 2018 ► 23% increase in R&D investment, €19.6m vs €15.9m in H1 18 restated (1) Revenue 1,333 1,403 • Continued effo
Slide 37: Near-term catalysts
Near-term catalysts
Slide 38: Three transformational clinical outcomes expected in the short-term
Three transformational clinical outcomes expected in the short-term Lanifibranor Results: phase IIb NASH - H1 2020 Odiparcil Results phase IIa in MPS VI - H2 2019 ABBV-157 ABBV-157 milestone when first psoriatic patient is treated - H1 2020 H1 2019 Presentation Property of Inventiva │ 38
Slide 39: Q&A
Q&A
Slide 40: Contacts
Contacts Inventiva Brunswick LifeSci Advisors Frédéric Cren Yannick Tetzlaff / Tristan Roquet Monique Kosse Montegon / Aude Lepreux CEO Investor relations Media relations info@inventivapharma.com monique@lifesciadvisors.com inventiva@brunswickgroup.com +33 (0)3 80 44 75 00 + 33 1 53 96 83 83