Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (May 2023)
35 slides from Abivax Sa's investor presentation, May 2023
Slide 1: Modulating the Immune System to Fight Chronic Inflammatory Diseases
Modulating the Immune System to Fight Chronic Inflammatory Diseases Abivax, a Phase 3 Clinical Biotech Company May 2023
Slide 2: Disclaimer
Disclaimer This presentation contains information pertaining to Abivax SA (“Abivax” or the “Company”). Neither Abivax, nor its management, shareholders, directors, advisors, employees or representatives make any representation or warranty, express or implied, as to the fairness, the accuracy, comple
Slide 3: Abivax in a Nutshell: A Phase 3 Biotech Company
Abivax in a Nutshell: A Phase 3 Biotech Company Shareholder structure1 and market cap2 13% Truffle Capital Milestones TCGX 10% 41% Invus IPO (ABVX) on Founded in € 637M Sofinnova Partners Euronext Paris in 10% 2013 by Deeptrack June 2015, Venrock Truffle Capital 10% raising € 57.7m 3% Others* 6% 7%
Slide 4: Ulcerative colitis – A debilitating disease with significant societal burden
Ulcerative colitis – A debilitating disease with significant societal burden More than 2.5 million patients in the EU and over 1 million patients in the United States suffer from IBD The incidence rate is increasing in newly industrialized countries (Kaplan GG. The global burden of IBD: from 2015 to
Slide 5: Current Treatment Options in UC
Current Treatment Options in UC Conventional therapies 5-ASA, Corticosteroids, Immunosuppressants Advanced therapies (1st line) Biologics (anti-TNFα, anti-integrins, anti-IL-23) Small Molecules (S1P) Advanced therapies (2nd, 3rd, 4th, … lines ) Biologics (anti-TNFα, anti-integrins, anti-IL-23) Small
Slide 6: Obefazimod Clinical Differentiation Factors and Positioning
Obefazimod Clinical Differentiation Factors and Positioning Potential first-in-class small molecule with unique mechanism of action Easy, oral once-daily administration We believe obefazimod ...1st line therapy in has moderate to severe all necessary ulcerative colitis after Fast onset of action cli
Slide 7: Abivax Pipeline in Chronic Inflammatory Diseases
Abivax Pipeline in Chronic Inflammatory Diseases Drug Candidates Indication Research Nonclinical Phase 1 Phase 2 Phase 3 Anticipated Milestones • Topline data readout end of Pivotal Phase 3 program initiated 2024 (induction trials) Obefazimod Ulcerative colitis (UC) First-Patient-In in the US Oct. 1
Slide 8: Obefazimod: Mechanism of Action
Obefazimod: Mechanism of Action Modulating the immune system to fight chronic inflammatory diseases 8
Slide 9: Obefazimod's Novel Mechanism of Action: Upregulation of miR-124
Obefazimod’s Novel Mechanism of Action: Potent and Specific Upregulation of miR-124, Activating a “Physiological Brake” of Inflammation • Potential first-in-class mechanism of action related to intracellular upregulation of miR-124. • microRNAs work by down-regulating the translation of their respec
Slide 10: Obefazimod: Clinical Development in IBD
Obefazimod: Clinical Development in IBD Modulating the immune system to fight chronic inflammatory diseases 10
Slide 11: Obefazimod Phase 2a POC Study Results in Ulcerative Colitis
Obefazimod Phase 2a POC Study Results in Ulcerative Colitis Short-Term (Induction) and Long-Term (Maintenance) Efficacy Signal Observed • PI: Prof. Severine Vermeire, Leuven, BE • 32 patients with moderate to severe UC: randomized (2:1) 50mg obefazimod vs placebo, double blind, placebo controlled st
Slide 12: Obefazimod Phase 2b in Moderate-to-Severe Ulcerative Colitis: Study Design
Obefazimod Phase 2b in Moderate-to-Severe Ulcerative Colitis: Study Design Screening Induction phase Optional Open Label Maintenance ≤ 4 weeks 16 weeks up to 4 years Central reading of endoscopy Placebo (N=64) Modified Mayo Score 5-9 After failure of conventional R 25mg QD (N=61) therapies and/or 1:
Slide 13: Baseline Characteristics: Well-Balanced Among the Treatment Groups
Baseline Characteristics: Well-Balanced Among the Treatment Groups, Indicating a Moderate to Severe UC Population Placebo 25mg 50mg 100mg (n=64) (n=61) (n=63) (n=64) Age (years) Mean (SD) 41.1 (14.43) 41.5 (14.16) 40.2 (13.94) 42.2 (12.34) Male n (%) 40 (62.5) 40 (65.6) 27 ( 42.9) 41 ( 64.1) Modifie
Slide 14: Week 8 Efficacy Results (ITT): Primary Endpoint met
Week 8 Efficacy Results (ITT): Primary Endpoint met Clinical Activity observed in Patients and also for Subset of Bio-Refractory Patients Week 8 Results Placebo 25mg 50mg 100mg (ITT1 population / n=252) Modified Mayo Score All patients -1.9 -3.1 ** -3.2 ** -2.9 * Mean change from baseline Bio- refra
Slide 15: Week 8 Efficacy Results (ITT): Secondary Endpoints
Week 8 Efficacy Results (ITT): Secondary Endpoints – Clinical Activity observed Data presented as per final Clinical Study Report (Aug. 2021) Week 8 Results Placebo 25mg 50mg 100mg (ITT population / n=252) Key Secondary Endpoints (not powered for statistical significance) All patients 8 (13.6%) 20 (
Slide 16: Secondary Endpoints: Fecal Calprotectin and Robarts Histopathology Index
Secondary Endpoints: Fecal Calprotectin and Robarts Histopathology Index Mean Change from baseline in Fecal calprotectin (µg/g) Change from baseline in Robarts Histopathology Index 0 0 -1 -500 -2 -3 -1000 -1027.7 -3.40 -4 -1500 -5 -6 -2000 -5.90 -7 -2192.8 -7.30 -7.30 -2500 -2316.8 -2280.9 -8 Placeb
Slide 17: Week 8 Efficacy Results (ITT): Rapid Onset of Action
Week 8 Efficacy Results (ITT): Rapid Onset of Action Change from Baseline pMMS* change(least from baseline square mean) pMMS Day 8 Day29 Day57 0.0 Placebo mean mean -0.5 25 mg 50 mg square -1.0 square p<0.001 100 mg Least -1.5 least p<0.001 -2.0 -2.5 0 10 20 30 40 50 60 Day *pMMS is defined as RB= 0
Slide 18: Obefazimod upregulates miR-124 Expression in UC Phase 2b Patients
Obefazimod upregulates miR-124 Expression in UC Phase 2b Patients ➢ Blood: change from baseline in miR-124 ➢ Rectal tissue: change from baseline in miR-124 expression is statistically higher with expression is statistically higher with obefazimod compared with placebo after 1 week obefazimod compare
Slide 19: Obefazimod reduces IL17 & IL23 in UC Phase 2b Patients
Obefazimod reduces IL17 & IL 23 in UC Phase 2b Patients Blood Rectal tissue Obefazimod reduces statistically versus placebo plasma IL17 ns ✱ ✱✱✱✱ ✱✱✱✱ 3 Obefazimod reduces IL-17 % IL-17A positive area 2 n=254 1 Baseline values 0 8-week values Placebo 25mg 50mg 100mg ns ns ✱✱ ✱✱✱ 60 Obefazimod reduce
Slide 20: Obefazimod Phase 2b Open-Label Maintenance Study Results – ITT
Obefazimod Phase 2b Open-Label Maintenance Study Results – ITT Favorable Long-Term Clinical Activity observed Phase 2b study: 217/222 eligible patients enrolled into maintenance Patients with clinical Patients without clinical All patients 1 One-year results (ITT) response after induction response a
Slide 21: Obefazimod Phase 2a Open-Label Maintenance Study Results – ITT
Obefazimod Phase 2a Open-Label Maintenance Study Results – ITT Favorable Long-Term Clinical Activity observed Phase 2a study 1st year 2nd year 3rd year 4th year 1, 2, 3 and 4-year results (ITT) (n=22) (n=22) (n=22) (n=22) Clinical Remission1 n=12 | 54.5% n=11 | 50.0% n=11 | 50.0% n=9 | 41.0% 1 Irres
Slide 22: Obefazimod well-positioned in the Competitive Landscape
Obefazimod well-positioned in the Competitive Landscape for both Induction and One-Year Maintenance - Clinical Remission Rates Drug Study Active Placebo Delta Active Placebo Delta Results of Induction studies (ITT)* Results of Maintenance studies (ITT)* Induction All comers responders only Humira UL
Slide 23: Complete Resolution of UC Lesions in an Obefazimod Treated Patient
Complete Resolution of UC Lesions in an Obefazimod Treated Patient (Humira, Remicade and Entyvio Resistant) during 4 years of Open-Label Maintenance Treatment ➢ 52-year-old patient with severe UC, who had failed on Humira, Remicade and Entyvio ➢ Fall 2017: Patient was counseled for colectomy ➢ Nov.
Slide 24: Favorable Obefazimod Safety and Tolerability Profile
Favorable Obefazimod Safety and Tolerability Profile Phase 2b Study in UC Patients supported Profile observed in the Phase 2a Study ➢ No new safety signal, no death, no malignancy ➢ Most frequently reported AEs were headaches (20% for 25mg and 8% for placebo), which occurred early (first 10 days of
Slide 25: Favorable Obefazimod Safety and Tolerability Profile across all Clinical Studies
Favorable Obefazimod Safety and Tolerability Profile across all Clinical Studies (UC, RA, HIV, Covid-19, Healthy Volunteers) • 1,074 subjects exposed to obefazimod (as of safety data cut-off Nov. 2022) → Subjects exposed at 25mg: 80 → Subjects exposed at 50mg: 842 (including 209 patients treated for
Slide 26: Obefazimod in Ulcerative Colitis – Phase 3 Study Design
Obefazimod in Ulcerative Colitis – Phase 3 Study Design ABX464-107 Maintenance Study (n~450) ABX464-105 Induction Study (n=612) (obefazimod responders) W8 W44 Responders Obefazimod 50mg (n=306) Obefazimod 50mg (n~150) Obefazimod 25mg (n=153) Obefazimod 25mg (n~150) Placebo (n=153) Placebo (n~150) AB
Slide 27: Our Strategy how to bring Obefazimod to the Market in Ulcerative Colitis
Our Strategy how to bring Obefazimod to the Market in Ulcerative Colitis Ulcerative colitis Phase 3 preparation on track • Clinical protocols submitted to FDA on June 22 and approved by central US IRB in Aug. 2022 • First patient enrolled in the US on Oct. 11, 2022 • 25mg and 50mg will be studied in
Slide 28: Expected UC Program upcoming Milestones
Expected UC Program upcoming Milestones 2022 2023 2024 2025 Oct. 11, 2022 LPI Phase 3 FPI Phase 3 Top-line data of Obefazimod ✓ 2-year Phase 2b Phase 3 in UC maintenance Top-line data of Sept. 2022 maintenance study in study data Phase 3 Phase 2b publication ✓ induction studies in late 2025 in Lance
Slide 29: Obefazimod: Commercial Perspectives in IBD
Obefazimod: Commercial Perspectives in IBD Modulating the immune system to fight chronic inflammatory diseases 29
Slide 30: Obefazimod: Size of Target Market expected to Increase
Obefazimod: Size of Target Market expected to Increase by nearly 50% and more than 50% in CD (2022 - 2027) 2022 Total market size1 In million cases in inflammatory diseases > USD 120B UC Epidemiology Total Cases WW 13.1 Total Cases G7 3.6 Obefazimod Market size2 addresses a Total moderate to UC: USD
Slide 31: Obefazimod Patents
Obefazimod Patents Actual or Projected Projected Patent Patent Term US EP JP CN HK CA AU RU BR KR ZA MX IN Expiration Extensions Date Products Compound US 2034 Composition of matter 6/2030 * EU 2035 (product claim) Applications Disease treatment (use or method claims) US 2039 7/2035 * * EU 2040 Infl
Slide 32: Our Financing Strategy – Multi-Pronged Approach
Our Financing Strategy – Multi-Pronged Approach Attracting Top Tier US Biotech investors with continued commitment from historical shareholders for the cross-over financing of EUR 130M in Feb. 2022 New US Shareholders Existing shareholders Santé Holding • With EUR 130M gross financing (EUR 123M net
Slide 33: Oversubscribed EUR 130M Cross-Over Financing at Market Price
Oversubscribed EUR 130M Cross-Over Financing at Market Price EUR 130M Capital Increase Existing Investors • Oversubscribed capital increase totaling EUR 130M gross (EUR 123M net) • Subscription price at market closing price at EUR 6.5 (Feb. 22, 2023) Santé Holding • 20M newly-issued ordinary shares,
Slide 34: Highly Experienced Executive Committee
Highly Experienced Executive Committee • Marc de Garidel • Didier Blondel Sheldon Sloan, Michael Ferguson, MBA M.D., M. Bioethics B.S. and an M.B.A • EVP, Chief Financial • Chief Executive Officer Officer & Board Chief Medical Officer Chief Commercial Officer & Interim Board Chair Secretary • Mary M
Slide 35: Obefazimod – Major Peer-Reviewed Publications
Obefazimod – Major Peer-Reviewed Publications ABX464 (obefazimod) up-regulates miR-124 to reduce pro-inflammatory markers in inflammatory bowel diseases Cécile Apolit et al., Clinical and Translational Gastroenterology, published online Jan. 2023 ABX464 (obefazimod) for moderate-to-severe, active ul