Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (June 2019)
23 slides from Abivax Sa's investor presentation, June 2019
Slide 1: A Turning Story Towards Inflammatory Diseases
A Turning Story Towards Inflammatory Diseases Targeting the immune system to eliminate inflammatory and viral diseases as well as cancer June 2019
Slide 2: Forward looking statements
Forward looking statements This presentation contains information pertaining to Abivax S.A. (“Abivax”). 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, compl
Slide 3: ABX464: A promising candidate addressing attractive markets
ABX464: A promising candidate addressing attractive markets Total market size Coming from the proprietary Abivax library of compounds, in inflammatory biased to modulate RNA biogenesis (>2000 molecules) diseases greater than Small molecule (quinoline), administered as an oral capsule USD 70 B (once
Slide 4: ABX464 showed efficacy in DSS mouse model
ABX464 MC ABX464 showed efficacy in 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. 20 days ABX464. 60 days ABX464 110 MC 100 90
Slide 5: Study design: Randomized, double-blind, placebo controlled, multi-national study
Study design: Randomized, double-blind, placebo controlled, multi-national study Induction study (ABX464-101) Open label extension (ABX464-102) 8 weeks of treatment (completed) 52 weeks (ongoing), now extended for 2. year ABX464 ‒ Single dose 50mg o.d. Randomisation ABX464 ‒ Single dose 50mg o.d. 2:
Slide 6: ABX464-101: Good safety profile
ABX464-101: Good safety profile Very consistent with previous Patients with at least one treatment emergent adverse clinical studies events (>15%) regardless of causality No deaths, no malignancies, ABX-464 (n=23) Placebo (n=9) no opportunistic infections, no significant changes in the n (%) n (%) l
Slide 7: ABX464-101: Statistically significant efficacy achieved for major endpoints (day 56)
ABX464-101: Statistically significant efficacy achieved for major endpoints (day 56) Clinical remission: ABX464 Placebo p Total Mayo Score (TMS) equal or (n=20/23) (n=9/9) value lower than 2 + no sub-score >1 PP/ITT PP/ITT (PP) Clinical remission 35%/30% 11%/11% 0.16 Endoscopic improvement: Endoscop
Slide 8: ABX464-101: Impressive Mayo Score results
ABX464-101: Impressive Mayo Score results ABX464: Fast onset of action and clinical responses in patients who failed on biologics Change from baseline Total Mayo Score Total Mayo Score (biologic refractory pts) D0 D56 D0 D56 0 0 -0,5 -0,5 -1 -1,5 -1 -2 -14% -27% -1,5 -2,5 -3 -2 -3,5 P=0,03 -2,5 -4 -
Slide 9: ABX464-101: Statistically significant increase in miR-124 expression
ABX464-101: Statistically significant increase in miR-124 expression miR-124 expression in total blood miR-124 expression in rectal biopsies Fold induction (ratio) Fold induction (ratio) 900 10 • * * 9 7.69 800 * 700 8 7 600 6 500 5 400 4 300 3 1.46 200 2 1.00 100 1 0 0 Day 0 Day 28 Day 56 Day 0 Day
Slide 10: ABX464-102 maintenance phase: Month 9 interim analysis
ABX464-102 maintenance phase: Month 9 interim analysis 22/23 patients including 7 patients initially on placebo enrolled in the Cumulative exposure (in months) induction phase (2 countries did not grant regulatory clearance because as of May 20, 2019: of lack of efficacy data at the time of CTA subm
Slide 11: ABX464-102 maintenance phase: Month 9 interim-analysis confirms strong potential
ABX464-102 maintenance phase: Results presented at U.S. Digestive Disease Week Month 9 interim-analysis confirms strong potential (DDW) on May 21st Partial Mayo Score (n=19) All (n=19) Placebo induction (n=6) 5 ABX464 induction (n=13) 4 3 2 Safety profile remains very good with no 1 severe adverse r
Slide 12: ABX464 in Ulcerative colitis Summary
ABX464 in Ulcerative colitis Summary Good safety and tolerability of ABX464 in UC New mechanism of action patients and HIV program in more than 200 subjects ORAL drug ABX464 treated (no serious adverse reactions, no severe infections, no lymphopenia, no neutropenia) Promising preclinical Confirmed p
Slide 13: ABX464 development plan
ABX464 development plan Phase 2b study protocol in 232 patients with moderate 1 to severe ulcerative colitis was approved by regulatory agencies in first countries in EU and Canada Phase 2a studies are being submitted in Rheumatoid 2 Arthritis (CTA already fully approved in France) and Crohnʼs disea
Slide 14: ABX464 novel mechanism of action-1: Generation of miR-124
ABX464 novel mechanism of action-1: Generation of miR-124, a potent anti-inflammatory micro-RNA* Normal CBC Function ABX464 and CBC Function CBC binds to the majority of ABX ABX464 acts on the CBC to CBC 1 RNAs generated in the nucleus and recruits factors necessary for RNA processing CBC 464 1 incr
Slide 15: ABX464 novel mechanism of action-2: miR-124 suppresses pro-inflammatory cyto- and chemokines
ABX464 novel mechanism of action-2: miR-124 suppresses pro-inflammatory cyto‒ and chemokines miR-124 targets: (translation ) Outcome ABX 464 MCP-1/ 1 CBC MCP-1/CCL2 CCL2 IL-6 STAT 3 TNF-α miR-124 JAK pathway IL-6 IL-6R blocked TNF-α miR-124 TACE TNF-α (TNF-α converting enzyme - so far, observed in m
Slide 16: ABX196 - Background
ABX196 ‒ Background Mechanism of Action Synthetic glycolipid agonist of iNKT (invariant Natural Killer T) cells in liposomal formulation Licensed from Scripps Research, University of Chicago, Brigham-Young University © 2015 American Association for Cancer Research Phase 1 completed in volunteers: AB
Slide 17: ABX196 controls tumor growth in orthotopic HCC mouse model...
ABX196 controls tumor growth in orthotopic HCC mouse model... Sorafenib daily Hepa 1‒6 engraftment ABX196 Anti-PD-1 MRI Imaging Day 0 Survival Day 5 Day 7 Day 10 Day 14 Day 17 Day 19 Day 26 Day 61 All MRI Imaging Done Macroscopic Liver tumor invasion evaluation on day 61 on day 19 or at death of the
Slide 18: ... and increases survival
... and increases survival Percent survival Survival Day 60 100 ** * Vehicle 31% 80 ABX196 92% Sorafenib 39% 60 Anti-PD-1 92% 40 ABX196 + 100% Anti-PD-1 20 0 Days post tumor 0 20 40 60 challenge *p value <0.01; **p value <0.001 A Turning Story Towards Inflammatory Diseases 18
Slide 19: ABX196: Rationale for use in HCC therapy
ABX196: Rationale for use in HCC therapy The liver is a tolerogenic, HCC arises in the setting HCC is an immunogenic FDA accelerated approval immunosuppressed organ of chronic inflammation cancer obtained for nivolumab Very high exposure to gut-borne Inflamed microenvironment Strategies that overcom
Slide 20: Abivax: A strong and diversified pipeline
Abivax: A strong and diversified pipeline Lead generation Research Preclinical Phase 1 Phase 2 Phase 3 ABX464 Phase 2b FPI: Q2, 2019 Ulcerative colitis Inflammatory diseases ABX464 Phase 2a FPI: Q3, 2019 Crohnʼs disease x ABX464 Phase 2a FPI: Q2, 2019 Rheumatoid arthritis HIV ABX464 Phase 2b FPI: H2
Slide 21: Key company facts
Key company facts Overview Shareholder structure 2 (undiluted) Abivax went Founded in 2013 public in June 2015, by Truffle Capital raising EUR 57.7m Truffle Capital 45% 47% Board & management Primary listing: Euronext (Paris) Incubator & founders ABVX: FR0012333284 Liquidity: 27K shares/day in 20181
Slide 22: Actuals 2018: Key financial figures
Actuals 2018: Key financial figures 2018 FY m€ 2017 FY m€ Variation m€ / % Administrative Costs -4,1 -3,7 -0,4 -11% % of Oper. Costs 20% 25% R&D Costs -15,9 -10,8 -5,0 -46% % of Oper. Costs 80% 75% Costs Operating Costs -19,9 -14,5 -5,4 -37% Other Costs -0,9 -0,2 -0,7 -318% Revenues 5,0 3,5 1,5 42%
Slide 23: Highly experienced Executive Committee
Highly experienced Executive Committee • Prof. Hartmut Ehrlich, M.D. • Chief Executive Officer Ex-Head of Global R&D, Baxter BioScience • Didier Blondel • Pierre Courteille • Jérôme Denis • Alexandra Pearce • Chief Financial Officer & Pharmacist, MBA Ph.D. Ph.D. Board Secretary • Chief Commercial •