Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (May 2022)
37 slides from Abivax Sa's investor presentation, May 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 May 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% € 289M Sofinnova Partners Sept. 2018: Focus Board & management ABX464 on chronic inflammatio
Slide 5: ABX464: Mechanism of Action
ABX464: Mechanism of Action Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 5
Slide 6: 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 7: Pronounced anti-inflammatory effect in vivo: 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 8: ABX464: Clinical Development in IBD
ABX464: Clinical Development in IBD Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 8
Slide 9: 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 10: 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 Placebo (N=64) Modified Mayo Score 5-9 After failure of R 25mg QD (N=61) conventional therapies and/or biologic
Slide 11: 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 12: 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 13: 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 14: 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 15: Week 8 Efficacy Results (ITT): Fast onset of action
Week 8 Efficacy Results (ITT): Fast 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 16: ABX464 phase 2a and 2b open-label maintenance study results
ABX464 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 after
Slide 17: ABX464 well positioned in the competitive landscape: Clinical Remission Rates
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 Induction studies (ITT)* Results of Maintenance studies (ITT)* Induction All comers responders only Humira ULTRA I
Slide 18: Complete resolution of UC lesions in an ABX464 treated patient
Complete resolution of UC lesions in an ABX464 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. 2017
Slide 19: 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 20: Favorable ABX464 safety profile across all clinical studies
Favorable ABX464 safety profile across all clinical studies (UC, RA, HIV, Covid-19, healthy volunteers) • 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
Slide 21: 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 22: 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 22
Slide 23: 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 24: ABX464 phase 2a study design in rheumatoid arthritis
ABX464 phase 2b in moderate-to-severe ulcerative colitis: study design Phase 2a Randomized, double-blind, placebo controlled Screening period Study treatment period (12 weeks) Optional Open Label Extension ≤ 30 days Visit at day 0 (baseline randomization), week 1, week 2, week 4, week 8, week 12 Mat
Slide 25: 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 26: Phase 2a clinical study in RA – Other efficacy endpoints and biomarkers
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 27: 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 28: Phase 2a clinical study in RA – miR-124 and IL-6 biomarkers
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 29: 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 30: 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 31: 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 32: ABX464: Commercial opportunity in IBD
ABX464: Commercial opportunity in IBD Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 32
Slide 33: 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 34: 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 35: 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)
Slide 36: 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 37: 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 • Sophie Biguene