Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (September 2022)
27 slides from Abivax Sa's investor presentation, September 2022
Slide 1: Modulating the Immune System to Fight Chronic Inflammatory Diseases
Modulating the Immune System to Fight Chronic Inflammatory Diseases Abivax, a Late-Stage Clinical Biotech Company September 2022
Slide 2: Disclaimer
Disclaimer This presentation contains information pertaining to Abivax S.A. (“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, comp
Slide 3: Abivax in a Nutshell: A Phase 3 Biotech
Abivax in a Nutshell: A Phase 3 Biotech Shareholder structure1 and market cap2 Milestones 24% Truffle Capital IPO (ABVX) on Founded in € 198M Sofinnova Partners Euronext Paris in 56% 2013 by Board & management June 2015, 11% Truffle Capital raising € 57.7m 2% Public Operations Key R&D and manufactur
Slide 4: Obefazimod Clinical Differentiation Factors and Positioning
Obefazimod Clinical Differentiation Factors and Positioning First-in-class small molecule with unique mechanism of action Easy, oral once-daily administration Obefazimod ...1st line therapy in has moderate to severe all necessary ulcerative colitis after Fast onset of action clinical failure of conv
Slide 5: Obefazimod: Mechanism of Action
Obefazimod: Mechanism of Action Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 5
Slide 6: 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 • First-in-class mechanism of action related to intracellular upregulation of miR-124. • microRNAs work by down-regulating the translation of their respective targe
Slide 7: Obefazimod: Clinical Development in IBD
Obefazimod: Clinical Development in IBD Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 7
Slide 8: 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 9: 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 Extension ≤ 4 weeks 16 weeks up to 4 years Central reading of endoscopy Placebo (N=64) Modified Mayo Score 5-9 After failure of R 25mg QD (N=61) conventional therapies and/or biol
Slide 10: Baseline Characteristics Well-Balanced Among the Treatment Groups
Baseline Characteristics Well-Balanced Among the Treatment Groups, Indicating a Moderate to Severe UC Population, very Similar to Data Published Recently 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)
Slide 11: Week 8 Efficacy Results (ITT): Primary Endpoint met
Week 8 Efficacy Results (ITT): Primary Endpoint met Efficacy Confirmed for all 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- refracto
Slide 12: Week 8 Efficacy Results (ITT): Secondary Endpoints
Week 8 Efficacy Results (ITT): Secondary Endpoints - Efficacy Confirmed 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 (34.5%) * 21 (39.6%) * 24 (44.4%) * Endoscopic Improvement a† Bio-refra
Slide 13: 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 14: 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 15: Phase 2a and 2b Open-Label Maintenance Study Results
Obefazimod Phase 2a and 2b Open-Label Maintenance Study Results – ITT Impressive Long-Term Efficacy Confirmed 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 16: Obefazimod well Positioned in the Competitive Landscape
Obefazimod well Positioned in the Competitive Landscape for both Induction and 1-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 ULTR
Slide 17: 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 18: Favorable Obefazimod Safety Profile
Favorable Obefazimod Safety Profile Safety in Phase 2b Study in UC Patients Confirms Profile Observed in the Phase 2a Study ➢ No new safety signal, no death, no malignancy ➢ Most frequently reported AEs are headaches (20% for 25mg and 8% for placebo), which occur early (first 10 days of treatment) a
Slide 19: Favorable Obefazimod Safety Profile across all Clinical Studies
Favorable Obefazimod Safety Profile across all Clinical Studies (UC, RA, HIV, Covid-19, Healthy Volunteers) • More than 1,000 subjects exposed to obefazimod (as of safety data cut-off Nov. 2021) → Subjects exposed at 25mg: 80 → Subjects exposed at 50mg: 830 (including 240 for longer than 6 months wi
Slide 20: Obefazimod in Ulcerative Colitis – Phase 3 Study Design
Obefazimod in Ulcerative Colitis – Phase 3 Study Design ➢ Final protocols submitted to FDA: June 22, 2022 ➢ Studies submitted to central IRBs (US): July 15, 2022 ➢ First Subject In (US) expected end of Sept. 2022 ➢ Key differences of phase 3 design from phase 2b Modulating the immune system to fight
Slide 21: How to Bring Obefazimod to the Market in Ulcerative Colitis
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 and Abivax is on track for FPI end of Sept. 2022 • 25mg and 50mg will be studied in the induction a
Slide 22: Obefazimod: Commercial Opportunity in IBD
Obefazimod: Commercial Opportunity in IBD Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 22
Slide 23: Obefazimod: A Potential Mega-Blockbuster in IBD
Obefazimod: A Potential Mega-Blockbuster in IBD Size of Target Market Increasing by 70% in UC and by Nearly 20% in CD (2021 - 2027) 2021 Total market size1 In million cases in inflammatory diseases > USD 90B UC Epidemiology Total Cases WW 13 Total Cases G7 3.6 Market size1,2 Obefazimod UC: USD 6.2B
Slide 24: Value Creation Continues
Value Creation Continues Q4 2021 Q1 2022 Q2 2022 Q3 2022 Top-line results Publication of UC - Phase 2b (One-year full-length phase (Obefazimod) maintenance data) ✓ 2b manuscript ✓ UC - Phase 3 FDA feedback EMA feedback ✓ FPI phase 3 study (Obefazimod) ✓ Top-line results Publication of RA - Phase 2a
Slide 25: Abivax Pipeline
Abivax Pipeline Priority Indication Research Preclinical Phase 1 Phase 2 Phase 3 Obefazimod Pivotal phase 3 study being initiated – FPI end of Sept. 2022 1 Ulcerative colitis Inflammatory diseases Obefazimod Pivotal phase 2b study planned 2 Crohn’s disease Obefazimod Phase 2b study planned 3 Rheumat
Slide 26: Financing Strategy – Multi-Pronged Approach
Financing Strategy – Multi-Pronged Approach September 2nd, 2022 Attracting Top Tier US Biotech investors with continued commitment from historical shareholders New US Shareholders Existing shareholders Cross-over Financing Equity & Royalty certificates Paris Santé Holding EUR 49,200,000 • The total
Slide 27: Highly Experienced Executive Committee
Highly Experienced Executive Committee • Prof. Hartmut • Didier Blondel • Bob Clay, • Mary Mantock, Ehrlich, M.D. MSc, MBA MSc • EVP, Chief Financial • Chief Executive Officer Officer & Board • Senior Regulatory • VP, Regulatory Affairs Secretary Strategy Advisor • Pierre Courteille • Laurence d’Aga