Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (March 2022)
38 slides from Abivax Sa's investor presentation, March 2022
Slide 1: Modulating the immune system to fight inflammatory and viral diseases, as well as cancer
Modulating the immune system to fight inflammatory and viral diseases, as well as cancer Abivax, a late-stage clinical biotech company March 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 and ABX464 for chronic inflammatory diseases: Main take-home messages
Abivax and ABX464 for chronic inflammatory diseases: Main take-home messages ABX464 is a potent anti-inflammatory oral drug candidate with a novel first-in-class mechanism of 1 action: Upregulation of the physiological anti-inflammatory microRNA, miR-124 Good safety and efficacy demonstrated in phas
Slide 4: Abivax in a nutshell: A phase 3 biotech
Abivax in a nutshell: A phase 3 biotech Milestones Shareholder structure1 and market cap2 IPO (ABVX) on Euronext Paris in Founded in 2013 June 2015, Truffle Capital by Truffle Capital 33% raising € 57.7m 51% € 400M Sofinnova Partners Sept. 2018: Focus Board & management ABX464 on chronic inflammatio
Slide 5: ABX464: A promising candidate addressing large unmet medical needs
ABX464: A promising candidate addressing large unmet medical needs Coming from the proprietary Abivax library of compounds, Total market size1 designed to modulate RNA biogenesis (>2,200 molecules); in inflammatory Collaboration with EVOTEC diseases Small molecule, administered as an oral capsule (o
Slide 6: ABX464: Mechanism of Action
ABX464: Mechanism of Action Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 6
Slide 7: ABX464 novel mechanism of action: Potent and specific upregulation of miR-124
ABX464 novel mechanism of action: Potent and specific upregulation of miR-124, activating a “physiological brake” by reducing the expression of inflammatory cytokines and cells to normal levels • First-in-class mechanism of action related to intracellular upregulation of miR-124. • microRNAs work by
Slide 8: Pronounced anti-inflammatory effect in vivo: ABX464 showed efficacy in the DSS mouse model
Pronounced anti-inflammatory effect in vivo: ABX464 showed efficacy in the DSS mouse model* by preventing tissue damage and inflammation Colorectal tissue of mouse exposed Colorectal tissue of mouse exposed ABX464 protects mice from weight to DSS without ABX464 leads to to DSS with ABX464: Protectio
Slide 9: ABX464: Clinical Development in IBD
ABX464: Clinical Development in IBD Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 9
Slide 10: ABX464 phase 2a POC study results in Ulcerative Colitis
ABX464 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 ABX464 vs placebo, double blind, placebo controlled study • Mo
Slide 11: ABX464 phase 2a open-label maintenance study – long-term efficacy (3 years) confirmed
ABX464 phase 2a open-label maintenance study – impressive long-term efficacy (3 years) confirmed Phase 2a study 1 1st year 2nd year 3rd year Clinical remission (ITT) 12/22 (54.5%) 11/22 (50.0%) 11/22 (50.0%) 1 Irrespective of patient outcome at the end of the induction phase Only 1/19 patients on co
Slide 12: ABX464 phase 2b in moderate-to-severe ulcerative colitis: study design
ABX464 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 Modified Mayo Score 5-9 Placebo (N=64) After failure of conventional therapies R 25mg QD (N=61) and/or biologic
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, 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 14: 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) Primary Endpoint All -1.9 -3.1 ** -3.2 ** -2.9 * Modified Mayo Score patients Mean change from bas
Slide 15: Week 8 Efficacy Results (ITT): Secondary endpoints - Efficacy confirmed
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 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): Fast onset of action
Week 8 Efficacy Results (ITT): Fast onset of action Change from Baseline pMMS (least square mean) 0 -0.4 -0.7 -0.9 -0.8 P<0.001 Placebo -1,6 P<0.001 -1.8 100mg 50mg -2.2 -2.3 25mg Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 17
Slide 18: ABX464 phase 2b open-label maintenance study – one-year efficacy confirmed
ABX464 phase 2b open-label maintenance study – impressive one-year efficacy confirmed Phase 2b study: 217/222 eligible patients enrolled into maintenance The first 101 patients of the 217 were to complete 1st year of maintenance by Sept. 15, 2021: (12 patients were drop-outs, and no data available f
Slide 19: ABX464 well positioned in the competitive landscape for induction and 1-year maintenance
ABX464 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 Maintenance studies (ITT)* Results of Induction studies (ITT)* (Patients with clinical response at the end of the i
Slide 20: Complete resolution of UC lesions in an ABX464 treated patient
Complete resolution of UC lesions in an ABX464 treated patient (vedolizumab, infliximab and adalimumab resistant) during 4 years of open-label maintenance treatment Endoscopy before Endoscopy after Endoscopy after Endoscopy after ABX464 1st year of ABX464 2nd year of ABX464 3rd year of ABX464 ➢ 52-y
Slide 21: Favorable ABX464 safety profile
Favorable ABX464 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) and a
Slide 22: Favorable ABX464 safety profile across all clinical studies
Favorable ABX464 safety profile across all clinical studies • More than 1,000 subjects exposed to ABX464 as of November 2021 → Subjects exposed at 25mg: 80 → Subjects exposed at 50mg: 830 (including 240 for longer than 6 months with 197 patients more than a year) → Subjects exposed at 100mg: 95 • AB
Slide 23: How to bring ABX464 to the market in ulcerative colitis
How to bring ABX464 to the market in ulcerative colitis Ulcerative colitis phase 3 preparation on track • FDA end of phase 2 meeting feedback and EMA scientific advice with guidance and a path forward • 25mg and 50mg will be studied in the induction and maintenance trials • IQVIA and US and EU KOLs
Slide 24: ABX464 clinical differentiation factors and positioning
ABX464 clinical differentiation factors and positioning First-in-class small molecule with unique mechanism of action Easy, oral once-daily administration ABX464 has all necessary clinical ...2nd and 3rd line Fast onset of action differentiation therapy in moderate to factors to be severe ulcerative
Slide 25: ABX464: A potential mega-blockbuster in IBD
ABX464: 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 ABX464 UC: USD 6.2B addresse
Slide 26: ABX464: Clinical Development in rheumatoid arthritis
ABX464: Clinical Development in rheumatoid arthritis Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 26
Slide 27: ABX464 prevents joint swelling in the Collagen Induced Arthritis model
ABX464 prevents joint swelling in the Collagen Induced Arthritis model ABX464 joint swelling monitoring Age (week) 9 12 14 injection of collagen injection of collagen joint swelling (Averages of 4 legs) 2.6 P value 0,0015 * * 2.4 2.2 mm 2.0 1.8 1.6 64 C 2O M X4 H 2- 2- AB BA BA CIA CIA +ABX464 2- D
Slide 28: ABX464 study design for phase 2a in RA
ABX464 study design for phase 2a in RA following positive results in Collagen Induced Arthritis Model Phase 2a Randomized, double-blind, placebo controlled Primary objective Evaluate the safety profile of ABX464 given at two different doses (100mg and 50mg) vs placebo in combination with methotrexat
Slide 29: Phase 2a clinical study in RA – Study results (ACR)
Phase 2a clinical study in RA – Study results (ACR) Strong efficacy signal observed with 50mg o.d. → Patients’ characteristics well-balanced among the treatment arms → 70% (n=42) had inadequate response to methotrexate → 30% (n=18) had inadequate response/intolerance to TNFα inhibitors → Although no
Slide 30: Phase 2a clinical study in RA – Other efficacy endpoints
Phase 2a clinical study in RA – Study results Other efficacy endpoints and biomarkers Placebo 50mg 100mg PP ITT PP ITT PP ITT (n=19) (n=20) (n=16) (n=21) (n=7) (n=19) DAS28-CRP -0.63 -0.60 -1,79* -1,41* -1,94* -0,72 change from baseline Low Disease Activity 2 (11%) 2 (10%) 4 (25%) 4 (19%) 3 (43%) 3
Slide 31: ABX464 phase 2a open-label maintenance study – one-year efficacy confirmed
ABX464 phase 2a open-label maintenance study – impressive one-year efficacy confirmed 40/60 eligible patients enrolled into maintenance 23/40 patients complete 1st year of maintenance by Feb. 28, 2022 (17 patients dropped-out and were considered as treatment failures in ITT, incl. 10 for lack of eff
Slide 32: Phase 2a clinical study in RA – biomarkers miR-124 and IL-6
Phase 2a clinical study in RA – Study results Other efficacy endpoints and biomarkers miR-124 induction at week 8 IL-6 compared to baseline 300 *** Placebo 100000 ** Fold increase (with median) 50mg QD 10000 200 Percentage 100mg QD 1000 * 100 100 10 1 0 ** ** 0.1 0.01 ** p<0.01 -100 ** p<0.01 0 28 8
Slide 33: Phase 2a clinical study in RA – Topline safety results summary
Phase 2a clinical study in RA – Topline safety results summary No new safety signal reported with ABX464 + MTX ✓ Treatment emergent Serious Adverse Events: 1 (5%) placebo, 0 (0%) 50mg, 1 (5%) with 100mg ✓ No new safety signal reported. An increased incidence of AE was reported in the 100mg treatment
Slide 34: ABX464 favourable safety profile in RA phase 2a
ABX464 favourable safety profile Most frequent adverse events reported in the phase 2a clinical study in RA Placebo ABX464 50mg ABX464 100mg (N=20) (N=21) (N=19) System Organ Class Adverse effect Number n (%) of Pts. Number n (%) of Pts. Number n (%) of Pts. of with AE of with AE of with AE reports
Slide 35: Phase 2a clinical induction and maintenance studies in RA: Top-line results
Phase 2a clinical induction and maintenance studies in RA Top-line results allowing to move into phase 2b Baseline characteristics well balanced across all groups In the phase 2a induction study, primary endpoint met with ABX464 demonstrating good safety and tolerability profile with 50mg once daily
Slide 36: 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 (ABX464) maintenance data) 2b manuscript UC - Phase 3 (ABX464) FDA feedback ✓ EMA feedback ✓ FPI phase 3 study Top-line results Publication of RA - Phase 2a (ABX464) (O
Slide 37: Abivax financing strategy
Abivax financing strategy Current cash runway until the end of Q3 2022 Core strategic plan Partnering (ranging from licensing to M&A) Abivax to decide between two possible options: Option 1 Option 2 Partnering in 2022 before Partnering after UC phase 3 start, UC phase 3 start but before registration
Slide 38: 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 • Regulatory Strategy • VP, Regulatory Affairs Secretary Advisor • Pierre Courteille • Sophie Biguenet, • Pa