Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (July 2021)
37 slides from Abivax Sa's investor presentation, July 2021
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 July 2021
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 Milestones Shareholder structure1 and market cap2 IPO (ABVX) on Euronext Paris in Founded in 2013 June 2015, Truffle Capital by Truffle Capital raising € 57.7m 35% 48% € 517m Sofinnova Sept. 2018: Focus Board & management ABX464 on chronic inflammation 12% Pub
Slide 4: 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 size* designed to modulate RNA biogenesis (>2,200 molecules); in inflammatory Collaboration with EVOTEC diseases Small molecule, administered as an oral capsule (o
Slide 5: Abivax: A late-stage biotech with a strong and diversified clinical pipeline
Abivax: A late-stage biotech with a strong and diversified clinical pipeline addressing major medical needs and markets Research Preclinical Phase 1 Phase 2 Phase 3 ABX464 Phase 2b completed – Phase 3 program in preparation Ulcerative colitis Inflammatory diseases ABX464 Pivotal Phase 2b study in pr
Slide 6: ABX464 novel mechanism of action: upregulation of miR-124
ABX464 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 target gene
Slide 7: ABX464: Clinical Development in IBD
ABX464: Clinical Development in IBD Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 7
Slide 8: Anti-inflammatory effect: ABX464 showed efficacy in the DSS mouse model
Anti-inflammatory effect: ABX464 showed efficacy in the DSS mouse model* ABX464 protects mice from death DSS without ABX464 leads ABX464 protects intestinal in the DSS mouse model to intestinal damage structure Relative weight (%) 120 Induction of inflammation by DSS ABX464 60 days 110 100 90 Days 8
Slide 9: ABX464 phase 2a POC induction study in ulcerative colitis
ABX464 phase 2a POC induction study in ulcerative colitis: Impressive efficacy achieved for all endpoints (induction and maintenance) Vermeire at al. Induction and long-term follow- ABX464 Placebo Study Design: up with ABX464 for moderate-to-severe p value*** ulcerative colitis: Results of phase 2a
Slide 10: ABX464 phase 2b clinical study in ulcerative colitis
ABX464 phase 2b clinical study in ulcerative colitis Ulcerative colitis phase 2b: • 254 patients in 15 European countries, US and Canada in 130 study sites • 4 study arms (placebo, 25, 50, 100mg QD) / Central blinded reading of endoscopies Study design: ABX464 phase 2b clinical study in ulcerative c
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 with recent published data 100mg 50mg 25 mg Placebo Statistic (N=64) (N=63) (N=61) (N=64) Age (years) Mean (SD) 42.2 (12.34) 40.2 (13.94) 41.5 (14.16) 41.1 (14.43) Male n (%
Slide 12: Top-Line week 8 Efficacy Results (ITT): Primary Endpoint met
Top-Line week 8 Efficacy Results (ITT): Primary Endpoint met - Efficacy confirmed Week 8 top-line 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 baseline Bio -1.0 -2.8 ** -2.9 ** -2.8 ** exposed
Slide 13: Top-Line week 8 Efficacy Results (ITT): Secondary endpoints
Top-Line week 8 Efficacy Results (ITT): Secondary endpoints - Efficacy confirmed Week 8 top-line 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 Improv
Slide 14: Top-Line week 8 Efficacy Results: Fecal calprotectin and Robarts Histopathology Index
Top-Line week 8 Efficacy Results (ITT): Fecal calprotectin (µg/g) and Robarts Histopathology Index Change from Baseline in FC Change from baseline in RHI Placebo 25 mg 50 mg 100 mg 0,00 -1,00 -2,00 -3,00 -4,00 -3.40 -5,00 -6,00 -5.90 -7,00 -8,00 -7.30 * -7.30 * *p-values of <0.05 versus placebo (MMR
Slide 15: Top-Line Efficacy Results (ITT): Fast onset of action
Top-Line 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 -1,6 -1.8 P<0.001 -2.2 -2.3 Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 15
Slide 16: Favorable safety results
Favorable safety results ✓ No new safety signal ✓ Low overall drop-out rate (8.7%) at week 8 despite Covid-19 ✓ Serious adverse events (SAEs) (related and non-related) • 6.2% (placebo), 1.6% (25mg), 6.3% (50mg), 6.2% (100mg) ✓ Severe (grade 3 or 4) treatment emergent adverse events (TEAEs) (related
Slide 17: Favorable ABX464 safety profile
Favorable ABX464 safety profile Most common (> 5%) Adverse Events (AE): Drug-related or non-drug-related Placebo ABX464 25mg ABX464 50mg ABX464 100mg (N=64) (N=63) (N=63) (N=64) System Organ Class Adverse effect n (%) of pts n (%) of pts n (%) of pts n (%) of pts Number Number Number Number with AE
Slide 18: Preliminary data from the maintenance study (ABX464-104)
Preliminary data from the maintenance study (ABX464-104): Further increased and durable efficacy at one year (Cut-off date: May 11, 2021) Preliminary data from the first 51 patients* enrolled and treated with once-daily 50mg ABX464 in the open-label maintenance study showed increased and durable cli
Slide 19: Complete resolution of UC lesions in an ABX464 treated patient
Complete resolution of UC lesions in an ABX464 treated (vedolizumab, infliximab and adalimumab resistant) patient Endoscopy before ABX464 Endoscopy after ABX464 Courtesy of Prof. Severine Vermeire, Leuven, Belgium Modulating the immune system to fight inflammatory and viral diseases, as well as canc
Slide 20: Following Phase 2b results, ABX464 is moving to phase 3 by end of year
Following Phase 2b results, ABX464 is moving to phase 3 by end of year Primary endpoint (statistically significant reduction of Modified Mayo Score ) was met with once-daily ABX464 (25mg, 50mg, 100mg) at week 8 in these 254 patients randomized, double- blind and placebo-controlled clinical trial (p<
Slide 21: 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 21
Slide 22: Phase 2a clinical study in RA – Topline results summary
Phase 2a clinical study in RA – Topline results summary Primary endpoint met with ABX464 demonstrating good safety and tolerability profile with 50mg once daily oral administration A statistically significant difference (p < 0.03) was met on key efficacy endpoint ACR20 in the PP population with 60%
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 4 C 2O 46 M H 2- X 2- B A A A B 2- B D D A B D Modu
Slide 24: 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 25: Phase 2a clinical study in RA – Topline results (ACR)
Phase 2a clinical study in RA – Topline 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 → Statistic
Slide 26: Phase 2a clinical study in RA – Topline results
Phase 2a clinical study in RA – Topline results Other efficacy endpoints and biomarkers Placebo 50 mg 100 mg PP ITT PP ITT PP (n=19) ITT (n=20) (n=16) (n=21) (n=7) (n=19) DAS28-CRP -0.63 -0.63 -1.78 -1.74 -1.95 -1.95 change from baseline Low Disease Activity 2 (11%) 2 (10%) 4 (25%) 4 (19%) 3 (43%) 3
Slide 27: 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 • 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 group (mainly GI),
Slide 28: ABX464 favourable safety profile
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 (In
Slide 29: Next steps for the clinical development of ABX464 in RA
Next steps for the clinical development of ABX464 in RA Complete the evaluation of the clinical phase 2a induction study in Q3 2021 Obtain one year phase 2a maintenance data in Q1 2022 Initiate clinical phase 2b studies in patients with inadequate response to conventional DMARDs as well as biologica
Slide 30: How to bring ABX464 to the finish line in chronic inflammation
How to bring ABX464 to the finish line in chronic inflammation Phase 1 TQT study: Ulcerative colitis phase 3 in preparation: • 120/120 subjects: enrollment completed • End of phase 2b meeting planned for Q3 2021 • Results expected in Q3 2021 • IQVIA involved in study preparation • ∼ 2 x 700 patients
Slide 31: ABX464: A potential blockbuster in IBD
ABX464: A potential blockbuster in IBD... Size of target market doubling in UC and increasing by nearly 25% in CD (2020 - 2026) 2020 In million cases UC Epidemiology Total Cases WW 12.8 Total Cases G7 3.5 Total moderate to severe cases G7 1.9 Moderate to severe cases G7 treated patients 1.5 Moderate
Slide 32: ABX464: As well as a potential blockbuster in RA
ABX464: As well as a potential blockbuster in RA 2020 In million cases Total Cases WW 26.5 Epidemiology Total Cases G7 3.8 RA Total moderate to severe cases G7 2.6 Moderate to severe cases G7 treated patients 1.0 Moderate to severe cases G7 patients treated with 2nd and 0.73 2026 0.80 3rd line thera
Slide 33: Newsflow through Q1 2022
Newsflow through Q1 2022 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Top-line results FPI Top-line results UC - Phase 2b (ABX464) (Induction and initial (One-year maintenance data) Phase 3 maintenance data) ✓ FPI CD - Phase 2b (ABX464) Phase 2b FPI Phase 2b Enrollment Top-line results RA - Phase 2a (ABX
Slide 34: EUR 85M new financing (as of July 2021)
EUR 85M new financing (as of July 2021) EUR 60M capital increase of and EUR 25M convertible bonds EUR 60M capital increase EUR 25M convertible bonds • Oversubscribed capital increase totaling EUR 60M • Convertible bonds issued for a total of EUR 25M • Subscription price set at EUR 30.55, i.e. with a
Slide 35: Abivax cash runway extended into Q2 2022
Abivax cash runway extended into Q2 2022 10/2021 06/2022 75% Funding Need ABX464 Project Plan 15% 8% ≥€ 30m UC Phase 3 I+M & Phase 2b M* CD pivotal Phase 2b I+M Abivax 2% RA Phase 2b I+M & Phase 2a M per quarter Manufacturing scale up R&D structure Loan ABX196 Regulatory clinical studies G&A reimbur
Slide 36: Abivax financing strategy
Abivax financing strategy Next strategic milestone to take place before end of 2021 Core strategic plan Alternative strategic plan Partnering Financing round (ranging from licensing to M&A) (on Euronext and/or Nasdaq) Modulating the immune system to fight inflammatory and viral diseases, as well as
Slide 37: Highly experienced Executive Committee
Highly experienced Executive Committee • Prof. Hartmut • Didier Blondel • Sophie Biguenet, • Alexandra Pearce, Ehrlich, M.D. M.D. Ph.D. • Chief Financial Officer • Chief Executive Officer & Board Secretary • Chief Medical • VP, Regulatory Affairs, Officer Quality, PV • Pierre Courteille • Paul Gines