Inventiva Sa · EURONEXT:IVA
Inventiva Sa — H1 2020 Earnings Presentation
42 slides from Inventiva Sa's earnings presentation, Sep 17, 2020
Slide 1: First-Half 2020 Financial Results
First-Half 2020 Financial Results September 17, 2020
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 Jean Volatier, MA, CFO H1 2020 Presentation Property of Inventiva │ 3
Slide 4: Summary
Summary Highlights Pipeline update Financials Near-term catalysts H1 2020 Presentation Property of Inventiva │ 4
Slide 5: Highlights
Highlights
Slide 6: Inventiva in a nutshell
Inventiva in a nutshell Clinical stage biotech with focus on oral small molecules for the treatment of NASH, MPS, and other diseases with high unmet medical needs Two unencumbered late stage assets – Lanifibranor – only pan-PPAR agonist in clinical development for NASH; positive Phase IIb topline da
Slide 7: First-Half 2020 Highlights
First-Half 2020 Highlights Lanifibranor in non-alcoholic steatohepatitis (NASH) Phase IIb NATIVE trial positive topline results: lanifibranor is the first drug candidate to achieve statistically significant effects on NASH resolution with no worsening of fibrosis and improvement of fibrosis with n
Slide 8: First-Half 2020 Highlights
First-Half 2020 Highlights ABBV-157 Pursuit by AbbVie of a second Phase I clinical trial in patients with moderate to severe psoriasis and confirmation of trial results publication for Q4 2020 Financials / Other Successful IPO on NASDAQ of approx. 7.5 million American Depositary Shares (ADSs) fo
Slide 9: Pipeline update
Pipeline update
Slide 10: 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 11: Lanifibranor: the only pan-PPAR agonist in clinical development for NASH
Lanifibranor: the only pan-PPAR agonist in clinical development for the treatment of NASH Moderate and balanced pan-PPAR agonist activity PPAR PPAR PPAR Differentiated Compound EC50 (nM) EC50 (nM) EC50 (nM) chemical structure Once daily oral Lanifibranor(1) 1630 850 230 administration Fen
Slide 12: NATIVE Phase III enabling trial: design
NATIVE Phase III enabling trial: design Clinicaltrials.gov identifier: NCT03008070 24-week treatment + 4-week follow-up Screening Double blind, randomized, placebo-controlled End of treatment Liver biopsy Liver biopsy Placebo Lanifibranor, 800 mg once daily • Randomisation 1/1/1 • Stratification
Slide 13: Lanifibranor first to achieve significance on the two Phase III FDA and EMA endpoints
Lanifibranor is the first drug candidate to achieve statistically significant results on the two Phase III FDA and EMA primary endpoints Intention to Treat Population Per Protocol Population Statistically significant in accordance to the xx statistical analysis plan (SAP) Lanifibranor Lanifibranor x
Slide 14: Statistically significant decrease in liver enzymes
Statistically significant decrease in liver enzymes 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 ** * ** ** * ** ‐30 ** * ** ** ‐20 * ** 00 4 W4 8 12
Slide 15: Circulating biomarkers in NATIVE: significant decrease under lanifibranor
Circulating biomarkers in NATIVE: significant decrease under lanifibranor treatment after 24-weeks Median relative change (%) lanifibranor placebo Pvalue Pro-C3 -13.9% -4.1% p= 0.005* Pro-C3 >14 µg/mL(1) at Fibrosis -20.5% -12.8% p= 0.017* baseline Ratio TIMP-1/MMP-2 -22.5% -4.6% p < 0.001* Apoptosi
Slide 16: Significant changes in HDL-cholesterol, triglycerides, glucose, insulin and HbA1c
Statistically significant changes in HDL-cholesterol, triglycerides, fasting glucose, insulin and HbA1c Absolute change from baseline in HDL-C Absolute change from baseline in triglycerides 0,25 * p<0.01 **p<0.001 0,2 Mean absolute change (mmol/L) Mean absolute change (mmol/L) 0,15 ** 0 ** ** ** * ‐
Slide 17: Lanifibranor: a continued favorable tolerability profile
Lanifibranor: a continued favorable tolerability profile Safety population N = 247 Placebo 800 mg 1200 mg N (%) patients reporting Adverse Event (AE) (N = 81) (N = 83) (N = 83) Any Treatment-Emergent AE (TEAE) 50 (61.7%) 59 (71.1%) 62 (74.7%) - Drug-related TEAE 19 (23.5%) 25 (30.1%) 23 (27.7%) Any
Slide 18: Lanifibranor: modest weight increase with no impact on efficacy
Lanifibranor: modest weight increase with no impact on efficacy Consistent with known insulin sensitizing pharmacology, a mean weight increase from baseline of 2.4 kg (2.6%) at the 800 mg/day dose and 2.7 kg (3.1%) at the 1200 mg/day dose was observed According to a six month study with pioglita
Slide 19: Lanifibranor: TEAEs oedema peripheral reported in NATIVE trial
Lanifibranor: TEAEs oedema peripheral reported in NATIVE trial Treatment Verbatim of AE Action taken or Corrective Relationship # Intensity group Oedema peripheral treatment to treatment 1 oedema in the lower leg and knees Moderate IMP interrupted + Meloxicam Unlikely Placebo 2 bilateral lower extre
Slide 20: Lanifibranor results viewed very positively by physicians
Lanifibranor results viewed very positively by physicians, especially its ability to target both fibrosis improvement and NASH resolution Physicians valued lanifibranor's efficacy on fibrosis and NASH resolution The benefits of a pan-PPAR compound targeting multiple isoforms are clear to most phys
Slide 21: Lanifibranor tolerability profile and other oral NASH drug candidates
Lanifibranor tolerability profile characteristics and other oral NASH drug candidates NATIVE FLINT REGENERATE ARREST Phase IIb trial Phase IIb trial Phase IIb trial Phase III trial Phase II trial Deaths None 2 3 None None 9% placebo 11% placebo 12.5% placebo Trial 7% placebo 5% placebo 7% 800mg 11%
Slide 22: Lanifibranor NATIVE results and other oral NASH drug candidates
Lanifibranor NATIVE results and other oral NASH drug candidates NASH resolution with no worsening of fibrosis <0.001 xx Statistically significant in accordance to the statistical analysis plan (SAP) Placebo Active xx Non- statistically significant 0.03 0.045 0.0659 45% 0.051 0.1268 25% 19% 17% 19% 1
Slide 23: 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 liver triglycerides Trial design Principal investigator Primary endpoint Prof. Kenneth Cusi (University of Florida) Change from baseline to week 24 in IHTG Randomisation Key secondary endpoints
Slide 24: Lanifibranor: next key milestones in NASH
Lanifibranor: next key milestones in NASH Finalization of Phase III synopsis and protocol: ongoing End of Phase IIb meeting with FDA: scheduled in Q4 2020 Scientific advice meeting with EMA: scheduled in Q4 2020 Finalization of Phase II trial in NAFLD patients with TD2M conducted by Pr. Cusi
Slide 25: Save the Date
SAVE THE DATE KOL Meeting Abstract presentations …
Slide 26: Odiparcil
Odiparcil The first oral therapy to treat five forms of mucopolysaccharidosis (MPS): MPS I, II, IV, VI and VII
Slide 27: Odiparcil: an orally available small molecule GAG reduction therapy
Odiparcil: an orally available small molecule GAG reduction therapy designed to treat several forms of MPS Acts to decrease lysosomal accumulation of GAGs by promoting formation of soluble DS / CS which can be excreted in the urine Oral administration and distribution in tissues that are poorly pene
Slide 28: iMProveS Phase IIa trial of odiparcil in MPS VI
iMProveS Phase IIa trial of odiparcil in MPS VI Phase IIa Population ► Safety and efficacy trial with evidence for dose selection and PK / PD response characterization ≥ 16yo ► Clinicaltrials.gov identifier: NCT03370653 15 patients double blind + 5 patients open label 6 weeks 4 weeks 26 week treatme
Slide 29: Efficacy endpoints
Efficacy endpoints Not addressed by ERT (hard-to-reach Partially addressed by ERT tissues) Endurance and mobility Cardiac and vascular system 6-minute walk test (6MWT) ECG, Echocardiogram 9 hole peg test (9HPT) Carotid intima media thickness (CIMT) Range of motion of left and right shoulde
Slide 30: iMProveS: key conclusions
iMProveS: key conclusions Safety primary objective further supports the good overall safety profile of odiparcil already observed in previous Phase I and Phase II clinical studies • No new safety findings were observed Positive results regarding the efficacy after 6 months of odiparcil in advanc
Slide 31: Odiparcil: anticipated clinical development path for approval in MPS VI
Odiparcil: anticipated clinical development path for approval in MPS VI Phase IIa (6-m treatment) MPS VI adults (16y+) Safety - Add on to ERT, n=15 PK, PD (uGAG) and BM (leukoGAG, skinGAG) - Not receiving ERT, n=5 Exploratory assessment of efficacy Open-label (iMProveS Extension) extension Com
Slide 32: ABBV-157
ABBV-157 Qobvie
Slide 33: ABBV-157, a clinical compound co-discovered by Inventiva
ABBV-157, a clinical compound co-discovered by Inventiva, with potential in several auto-immune diseases ABBV-157: clinical proof of concept in patients with psoriasis expected in Q4 2020 ABBV-157, a potent ROR clinical candidate coming from the partnership with AbbVie, addresses large markets do
Slide 34: Financials
Financials
Slide 35: Key financials and shareholder base
Key financials and shareholder base Key financials Shareholder base(1) Founders 25% Free Float 31% Employees ISIN code FR0013233012 / US46124U1079 & Others 1% Market Euronext Paris / Nasdaq GM Sofinnova 38,393,011 (incl. 7,478,261 shares 8% Shares outstanding of the July 9 Nasdaq IPO) NEA BVF Market
Slide 36: H1 2020: financial position
H1 2020: financial position Highlights ► Revenues of €0.2 m compared to €1.3 m in H1 19 Income Statement ► 36% decrease in R&D investment, €12.6 m vs €19.6 m in H1 19 (in thousands of euros, except June 30, June 30, • Continued efforts dedicated to the development of lanifibranor share and per share
Slide 37: Near-term catalysts
Near-term catalysts
Slide 38: Recent and anticipated upcoming key milestones
Recent and anticipated upcoming key milestones Lanifibranor Positive topline results of NATIVE Phase IIb trial in NASH – June 2020 End of NATIVE Phase IIb meeting with FDA and Scientific Advice meeting with EMA – Q4 2020 Odiparcil Positive results of the iMProveS Phase IIa trial in MPS VI – De
Slide 39: Q&A
Q&A
Slide 40: 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
Slide 41: 247 patients randomized in 71 sites worldwide
247 patients randomized in 71 sites worldwide 4 sites in 49 sites in Canada Europe Patients Country randomized Europe 183 (74%) US 36 (15%) Australia 13 (5%) 12 sites in the Canada 8 (3%) United States Mauritius 7 (3%) 1 site in 5 sites in Total 247 (100%) Mauritius Australia 16 countries worldwide
Slide 42: Patient disposition (N = 247)
Patient disposition (N = 247) 247 patients randomized and treated Placebo Lanifibranor 800 mg/day Lanifibranor 1200 mg/day N = 81 N = 83 N = 83 74 (91%) patients completed 77 (93%) patients completed 77 ( 93%) patients completed the 24-week treatment the 24-week treatment the 24-week treatment 7 (9%