Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (February 2019)
21 slides from Abivax Sa's investor presentation, February 2019
Slide 1: Reprioritizing towards Inflammatory Diseases
TARGETING THE IMMUNE SYSTEM TO ELIMINATE INFLAMMATORY AND VIRAL DISEASE Reprioritizing towards Inflammatory Diseases February 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: The path towards inflammatory disease
0 1 2 3 4 5 6 7 8 9 1 ABX464: The path towards inflammatory disease gavage ABX464 Robust preclinical data from the IBD animal model B submucosa A induction of inflammation analysis Invention ABX464 Preclinical validation in Ulcerative Colitis (UC) mouse model DSSof compelling water • July 2017: Natu
Slide 4: Phase IIa Study Design (ABX464-101)
Phase IIa Study Design (ABX464-101) Randomized, double-blind, placebo controlled, multi-national study Induction Study (ABX464-101) – 8 weeks of treatment Maintenance Study (ABX464-102) – 52 weeks (On-going) ABX464 – Single Dose 50mg o.d. Randomisation ABX464 – Single Dose 50mg o.d. 2:1 Matching Pla
Slide 5: Patient demographics and baseline disease characteristics
Patient demographics and baseline disease characteristics Groups well-balanced ABX-464 Placebo Total N = 23 N=9 N = 32 Age (years) Mean (Min-Max) 42.96 (20.0 – 73.0) 44.11 (20.0 – 64.0) 43.28 (20.0 -73.0) Sex Male 12 (52.2%) 8 (88.9%) 20 (62.5%) BMI (kg/m2) at Screening Mean 25.63 (17.6 - 38.6) 25.9
Slide 6: Strong efficacy signal observed
Strong efficacy signal observed • Clinical Remission rate § 35.0 % of ABX464 patients in Clinical Remission (Placebo = 11.1%, consistent with literature in UC studies) defined as Total Mayo Score being less than or equal to two, with no individual sub- score greater than one. § 35.0 % of ABX464 pati
Slide 7: Mucosal healing in an ABX464 treated patient
Mucosal healing in an ABX464 treated patient Courtesy of Prof. Severine Vermeire Before ABX464 After ABX464 7
Slide 8: Mayo Score Results
Mayo Score Results Statistically significant signal observed in TMS and PMS ABX464: Fast onset of action and clinical responses in patients who failed on biologics 8
Slide 9: Calprotectin level
Calprotectin level Trend of greater reduction despite high placebo response – Consistent with TMS results % of patients with at least a 50% reduction from Baseline in Fecal Calprotectin ABX464 (n=20) 75.0% Placebo (n=8) 50.0% 9
Slide 10: Statistically significant increase in miR-124 expression
Statistically significant increase in miR-124 expression during ABX464 treatment Total blood and Rectal tissue miR-124 Expression in Total Blood miR-124 expression in Rectal Biopsies 900 853.2 ± 2.0 * 729.5 ± 2.4 * 10 800 9 * 7.69 700 8 Fold induction (Ratio) Fold Induction (ratio) 600 7 6 500 Treat
Slide 11: Safety Profile
Safety Profile Good safety profile – Consistent with previous studies Patients experiencing at least one TEAEs (Treatment Emergent Adverse Events) by ABX-464 Placebo SOC and PT (>5%) regardless of causality (N=23) (N=9) N (%) N (%) Any Treatment-Emergent Adverse Events 18 (78.3%) 5 (55.6%) Gastroint
Slide 12: ABX464-102: one year open-label extension study
ABX464 – 102: one year open-label extension study Second year of open label extension already approved in Belgium • 22 patients enrolled in the 52-week maintenance phase (including 7 previously placebo treated patients), dosed with ABX464 50mg once daily. • Safety profile is good with no severe adve
Slide 13: Phase 2a results support continuation of ABX464 in UC
Phase 2a results support continuation of ABX464 in UC as well as clinical exploration in other inflammatory indications • Clinical results warrant the conduct of Phase 2b Study – clinical study ABX464-103 • Patients with moderate to severe Ulcerative Colitis refractory to conventional and/or biologi
Slide 14: ABX464: Mechanism of Action
ABX464: Mechanism of Action* Cryo-EM of the CBC and the ABX464-CBC complex structure 1. ABX464 binds to its molecular target, the cap binding complex (CBC) that is present on the 5’ end of every human RNA 2. This binding induces a conformational change of the CBC that leads to enhanced RNA splicing
Slide 15: CBC-mediated effects of ABX464 on inflammation
CBC-mediated effects of ABX464 on inflammation* Source: Goetzpartners Securities Research *Vautrin et al., Nature Scientific Reports 9 (2019) 15
Slide 16: ABX464 in Inflammatory Diseases: Summary
ABX464 in Inflammatory Diseases: Summary • ABX464 is a small molecule from ABIVAX’s proprietary RNA biogenesis platform with a novel mode of action through its binding to a nuclear cellular protein complex (Cap Binding Complex) involved in the biogenesis of RNAs. • Binding of ABX464/N-Glu ABX464 to
Slide 17: Abivax has three key core pillars of value
Abivax has three key core pillars of value ABX464 ABX196 Targets CBC 80/20 complex, thereby Targets and activates invariant inducing enhanced RNA splicing natural killer T immune cells 1 Ulcerative Colitis 2 HIV 3 Hepatocellular Carcinoma What: • Upregulation of miRNA124 resulting in • Long-lasting
Slide 18: Abivax: A strong and diversified pipeline
Abivax: A strong and diversified pipeline Lead generation Research Preclinical Phase 1 Phase 2 Phase 3 Ulcerative Colitis ABX464 Phase 2b to start Q1, 2019 Crohn’s Disease ABX464 Phase 2a to start Q1, 2019 Rheumatoid Arthritis ABX464 Phase 2a to start Q1, 2019 HIV ABX464 Lasting viral remission Phas
Slide 19: Key company facts
Key company facts Overview Shareholder Structure 3 (undiluted) Founded in 2013 by Truffle Capital 45.0% 47.0% Abivax went public in June 2015, raising EUR 57.7m Primary listing: Euronext (Paris) Truffle Capital 1.0% 7.0% Board & Management ABVX : FR0012333284 Liquidity: 30K shares/day in 20181 Incub
Slide 20: Highly experienced Executive Committee
Highly experienced Executive Committee Prof. Hartmut Ex-Head of Global R&D, Baxter BioScience Ehrlich, M.D. Chief Executive Officer Pierre Courteille Jérôme Denis, Alexandra Pearce Didier Blondel Pharmacist, MBA Ph.D. Ph.D. Chief Financial Officer & Board Chief Commercial VP, Process Dev. VP, Regula
Slide 21: Abivax Investment Opportunity
Abivax Investment Opportunity • ABX464’s mode of action represents a potential first-in-class approach to treating inflammatory diseases as well as HIV infection • ABX464 has potent anti-inflammatory effects • Already confirmed in multiple Phase 2a trials in UC and HIV patients • Mechanism and precl