Inventiva Sa · EURONEXT:IVA
Inventiva Sa — FY2019 Earnings Presentation
44 slides from Inventiva Sa's earnings presentation, Mar 10, 2020
Slide 1: Full Year 2019 Financial Results
Full Year 2019 Financial Results March 10, 2020
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 Full Year 2019 Presentation | 2020 Property of Inventiva │ 3
Slide 4: Summary
Summary Full year 2019 highlights Clinical pipeline update Financials Near-term catalysts Full Year 2019 Presentation | 2020 Property of Inventiva │ 4
Slide 5: Full Year 2019 Highlights
Full Year 2019 Highlights
Slide 6: Full year 2019 highlights
Full year 2019 highlights Lanifibranor program Completion of patient recruitment in the NATIVE Phase IIb clinical study in NASH Fourth positive recommendation by the Data Safety Monitoring Board of the NATIVE clinical study Lifting of the target class clinical hold applying to PPAR agonists fo
Slide 7: Clinical pipeline update
Clinical pipeline update
Slide 8: Lanifibranor
Lanifibranor A new generation pan-PPAR agonist for a safe and efficacious treatment of fibrotic conditions
Slide 9: All three PPAR isoforms are needed for an optimal activity in NASH and for fibrosis improvement
All three PPAR isoforms are needed for an optimal activity in NASH and for fibrosis improvement PPARα Steatosis Insulin resistance TG synthesis Obesity ROS PPARδ Lipoprotein Ballooning Insulin β-oxydation Glucose Hepatocyte Inflammation FFAs PPARγ Adipokines TNF-α Il-1β Adiponectin ROS Macrophages T
Slide 10: Lanifibranor's mechanism of action addresses all key features of NASH
Lanifibranor’s mechanism of action addresses all key features of NASH Metabolism Steatosis Insulin sensitivity FA uptake PPARa,d,g HDLc PPARg FA catabolism TG Lipogenesis Inflammation and Ballooning Fibrosis NFkB-dependent gene Stellate cell proliferation PPARa,d,g activation PPARg and activation In
Slide 11: NATIVE: a Phase III enabling study in NASH
NATIVE: a Phase III enabling study in NASH Trial design Principal investigators Prof. Francque (Antwerp University, Belgium) Prof. Abdelmalek (Duke University, USA) Inclusion criteria Biopsy confirmed NASH patients with an inflammation and ballooning score of 3 or 4 Steatosis score ≥ 1 and f
Slide 12: Primary efficacy endpoint
Primary efficacy endpoint Primary endpoint Decrease from baseline to week 24 of at least 2 points of the inflammation and ballooning score without worsening of fibrosis Main analysis: evaluation of treatment effect – 1200mg versus placebo – 800mg versus placebo Analyses by sub-groups − Diabetic
Slide 13: Secondary endpoints
Secondary endpoints Key secondary endpoints NASH resolution with no worsening of fibrosis Improvement of fibrosis by at least 1 stage without no worsening of NASH NASH improvers − Decrease from baseline to week 24 of at least 2 points of the NAS CRN score with no worsening of fibrosis Other se
Slide 14: 247 patients randomized exceeding the initial target of 225 patients
247 patients randomized exceeding the initial target of 225 patients Patients Country randomized Europe 183 (74%) US 36 (15%) Australia 13 (5%) Canada 8 (3%) 14 sites in the United States >70 sites Mauritius 7 (3%) recruited 17 countries worldwide patients ►13 in EU Total 247 (100%) ►United States ►
Slide 15: The screening strategy has successfully led to the recruitment of severe patients (I/II)
The screening strategy has successfully led to the recruitment of severe patients (I/II) Patients without Patients with Total Parameters diabetes diabetes (N = 247 ; 100%) (N = 147 ; 60%) (N = 100 ; 40%) Female 58% 59% 58% Gender Male 42% 41% 42% Mean ± SD 51.8 ± 13.5 56.2 ± 10.4 53.6 ± 12.5 Age Med
Slide 16: The screening strategy has successfully led to the recruitment of severe patients (II/II)
The screening strategy has successfully led to the recruitment of severe patients (II/II) Patient distribution according to the NAS score 140 123 120 100 80 60 50% 44 40 40 22 20 18% 15 16% 9% 2 6% 0 NAS = 3 NAS = 4 NAS = 5 NAS = 6 NAS = 7 NAS = 8 Full Year 2019 Presentation | 2020 Property of Inven
Slide 17: NATIVE trial: confirmation of lanifibranor's good safety profile by four positive DSMBs
NATIVE trial: confirmation of lanifibranor’s good safety profile by four positive DSMBs Parameters DSMB # 1 DSMB # 2 DSMB # 3 DSMB # 4 Date of DSMB meeting June 2018 October 2018 March 2019 September 2019 # patients reviewed / % of 52 / 21% 94 / 38% 156 / 63% 227 / 92% total patients in the study #
Slide 18: NATIVE: key milestones
NATIVE: key milestones Activity Date Last Patient First Visit September 2019 Last Patient Last Visit Q1 2020 Database hard lock Q2 2020 Headline results publication Q2 2020 Full Year 2019 Presentation | 2020 Property of Inventiva │ 18
Slide 19: Inventiva Pharma to host a KOL Breakfast at EASL 2020
Inventiva Pharma to host a KOL Breakfast at the International Liver Congress (EASL) 2020 Annual Meeting The meeting will feature presentations by KOLs Pierre Bedossa, M.D., University Paris- Diderot, France and Sven Francque, M.D., University Hospital Antwerp who will discuss the NATIVE clinical stu
Slide 20: Odiparcil
Odiparcil An orally available small molecule GAG clearance therapy to treat several forms of MPS
Slide 21: Odiparcil: an orally available small molecule substrate reduction therapy to treat several forms of MPS
Odiparcil: an orally available small molecule substrate reduction therapy to treat several forms of MPS Decreases lysosomal accumulation of GAGs by promoting formation of soluble chondroitin sulfate (CS) and dermatan sulfate (DS) which can be excreted in the urine Oral administration and distrib
Slide 22: Odiparcil: a unique mechanism of action potentially synergistic with ERT
Odiparcil: a unique mechanism of action potentially synergistic with ERT Odiparcil diverts endogenous protein-bound GAG synthesis to soluble odiparcil-bound chondroitin sulfate (CS) and dermatan sulfate (DS) synthesis Galactosyl transferase I (GTI) Galactosyl transferase I (GTI) Synthesis of proteog
Slide 23: Odiparcil: potential to address several types of MPS
Odiparcil: potential to address several types of MPS by its capacity to produce soluble dermatan and chondroitin sulfates MPS Type Frequency DS CS HS KS MPS I-H ✓ ✓ MPS I-S 1/100,000 ✓ MPS I-H/S ✓ ✓ MPS II Types A & B 1/100,000 ✓ ✓ 1/40,000 to MPS IV Type A 1/200,000 ✓ ✓ 1/240,000 to MPS VI 1/400,00
Slide 24: Odiparcil penetrates hard-to-reach tissues
Odiparcil penetrates hard-to-reach tissues Odiparcil is well distributed in tissues and organs that are poorly penetrated by recombinant enzymes, poorly vascularized or protected by a barrier Heart Bone Cornea Cartilage Odiparcil(1) rhASB(2) Not tested Not detected Not detected Source: (1) Odiparcil
Slide 25: Odiparcil: GAG clearance mechanism of action observed in MPS VI mice
Odiparcil: GAG clearance mechanism of action observed in MPS VI mice Odiparcil decreases GAG accumulation in tissues Soluble GAGs produced from 40 odiparcil are excreted in urine GAG in liver [Area * Index] p<0.001 p<0.001 30 Sulfated GAG (µg/mg of creatinine) 6000 p<0.0001 20 10 4000 0 WT MPS VI MP
Slide 26: Odiparcil: preliminary data also indicate activity in MPS I mice
Odiparcil: preliminary data also indicate activity in MPS I mice Total GAG reduction in liver and eye(1) Reduction in the thickening of cartilage as measured in distal femoral growth plate (males and females data pooled together) Positive changes in the morphology of the growth plate (in MPS I
Slide 27: iMProveS Phase IIa trial with odiparcil in MPS VI
iMProveS Phase IIa trial with odiparcil in MPS VI Phase IIa Population ► Phase III enabling study 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 treatm
Slide 28: Safety
Safety The clinical study met its safety primary objective further supporting the good overall safety profile of odiparcil already observed in previous Phase I and Phase II clinical studies All 4 European investigators of the iMProveS study reported positive experience with odiparcil in terms of
Slide 29: Odiparcil pharmacodynamics: total GAG levels in urine and PK/PD correlation
Odiparcil pharmacodynamics: total GAG levels in urine and PK/PD correlation A dose-dependent urinary GAGs clearance, used as an activity biomarker, was clearly demonstrated in the entire odiparcil treated patient population 3000 Total urinary GAG 2000 µg/mg creatinine 1500 iMProveS Placebo 2000 1000
Slide 30: Efficacy
Efficacy 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 shoulders (S-ROM)
Slide 31: Efficacy: trends of improvement on 6MWT and FVC
Efficacy: trends of improvement on 6MWT and FVC 6MWT FVC ERT-PLB ERT-PLB ERT-250 BID ERT-250 BID ERT-500 BID ERT-500 BID non-ERT-500 BID non-ERT-500 BID -150 -100 -50 0 50 -150 -100 -50 0 50 100 worsening improvement worsening improvement change from reference (m) change from reference (mL) Trends f
Slide 32: Efficacy: several patients treated by ERT and odiparcil demonstrated improvements
Efficacy: several patients treated by ERT and odiparcil demonstrated improvements in one or several parameters Treatment Respiratory Ophthalmology Cardiology (N=10) (FVC) (COM left eye, right eye) 1 1 (slightly improved) (slightly improved) Placebo + ERT 0 Patient A: +4, +11 - (N=4) - Patient B: ↓ 3
Slide 33: Efficacy: signals of efficacy in patients only treated with odiparcil
Efficacy: signals of efficacy were also detected in patients only treated with odiparcil Odiparcil Respiratory 500mg Bid Ophthalmology Cardiology Range of Motion Other (FVC) (N=3) Improved range of Improved FVC motion on both Patient H NA Stable Pain improved by +18% shoulders (+17,8%/+21,0%) Improv
Slide 34: Odiparcil: clinical development path for approval in MPS VI
Odiparcil: clinical development path for approval in MPS VI Non-interventional Non-interventional BM6 and BM6Ext Biomarker Study Biomarker Study BM (leukoGAG) – BM6 MPS VI patients (7y to adult) MPS VI patients (7y to adult) BM (leukoGAG & skinGAG) – BM6Ext - Add on to ERT, n=12 - Add on to ERT,
Slide 35: Inventiva Pharma to present and host a Satellite Session at the MPS Symposium
Inventiva Pharma to present and host a Satellite Session at the 16th international Symposium on MPS and Related Disease (Barcelona, July 31, 2020 – August 2, 2020) The presentation of the iMProveS results, upon organizer’s invitation, will be given by Pr. Nathalie Guffon (Centre de Référence des Mal
Slide 36: Collaboration with AbbVie: ABBV-157
Collaboration with AbbVie: ABBV-157
Slide 37: ABBV-157, a clinical compound co-discovered by Inventiva, has block-buster potential
ABBV-157, a clinical compound co-discovered by Inventiva, has block-buster potential in several auto-immune diseases RORg is a master regulator of Th17 IL-17 / 23 approach has been validated by differentiation and IL-17 expression several successful biologics RORgt = Retinoic acid-related Orphan Sal
Slide 38: Financials
Financials
Slide 39: Key financials and shareholder base
Key financials and shareholder base Key financials A strong and diversified shareholder base Free float* Founders 15,8% 31,2% * Including Perceptive Advisors ISIN code FR0013233012 BVF Market Euronext Paris 22,4% Employees & others 2,0% Shares outstanding 30.687.750 Sofinnova 7,2% Market cap €95m NE
Slide 40: Full year 2019: a solid financial position with an extended cash runway
Full year 2019: a solid financial position with an extended cash runway Income Statement Highlights Key figures 2019 2018 ► 2019 revenues more than doubled at €7.0m, compared to (in thousands of euro, except share and per share amounts) €3.2m in 2018, including a €3.5m milestone payment from Revenue
Slide 41: Near-term catalysts
Near-term catalysts
Slide 42: Recent and upcoming key milestones
Recent and upcoming key milestones Lanifibranor Headline results: Phase IIb NATIVE clinical study in NASH - H1 2020 Odiparcil Positive results of the Phase IIa iMProveS clinical study in MPS VI Launch of Phase I/II SAFE-KIDDs clinical study (pediatric study) in MPS VI – by the end of 2020 ABBV
Slide 43: Q&A
Q&A
Slide 44: Contacts
Contacts Inventiva Brunswick Frédéric Cren Yannick Tetzlaff / Tristan Roquet Montégon / Aude Lepreux CEO Media relations info@inventivapharma.com inventiva@brunswickgroup.com +33 (0)3 80 44 75 00 + 33 1 53 96 83 83