Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (April 2019)
21 slides from Abivax Sa's investor presentation, April 2019
Slide 1: A Turning Story Towards Inflammatory Diseases
TARGETING THE IMMUNE SYSTEM TO ELIMINATE INFLAMMATORY AND VIRAL DISEASE A Turning Story Towards Inflammatory Diseases April 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 - Background
ABX464 - Background • Coming from the proprietary Abivax library of compounds, biased to modulate RNA biogenesis (>2000 molecules) • Small molecule (quinoline), administered as an oral capsule (once a day) • First-in-Class, novel mechanism of action: Selective upregulation of anti- inflammatory micr
Slide 4: ABX464 showed efficacy in DSS Mice Model
ABX464 showed efficacy in DSS Mice Model* ABX464 protects mice from death in the DSS mouse model DSS without treatment leads to ABX464 protects intestinal damage intestinal Structure Induction of inflammation by DSS ABX464. 20 days ABX464. 60 days ABX464. 20 days (n=8) ABX464. 60 days (n=8) No treat
Slide 5: Study Design
Study Design Randomized, double-blind, placebo controlled, multi-national study Induction Study (ABX464-101) Open Label Extension (ABX464-102) 8 weeks of treatment 52 weeks (Ongoing) ABX464 – Single Dose 50mg o.d. Randomisation ABX464 – Single Dose 50mg o.d. 2:1 Matching Placebo • Study Population =
Slide 6: Good Safety Profile
Good Safety Profile • Very consistent with previous clinical studies • No deaths, no malignancies, no opportunistic infections, no significant changes in the laboratory parameters including WBC • No Serious Adverse Reaction, all AE’s of mild to moderate intensity Patients with at least one Treatment
Slide 7: Efficacy data (Day 56)
Efficacy data (Day 56) ABX464 (n=20/23) Placebo( n=9/9) p value (PP) PP/ITT PP/ITT Clinical Remission 35% / 30% 11% / 11% 0.16 Endoscopic Improvement 50% / 43% 11% / 11% 0.03 Clinical response 70% / 61% 33% / 33% 0.06 Total Mayo Score Reduction -53% -27% 0.03 Partial Mayo score Reduction -62% -32% 0
Slide 8: Mayo Score Results
Mayo Score Results ABX464: Fast onset of action and clinical responses in patients who failed on biologics 8
Slide 9: Statistically significant increase in miR-124 expression
Statistically significant increase in miR-124 expression Total blood and Rectal tissue miR-124 expression in Rectal Biopsies 10 * * 9 7,69 * 8 Fold induction (Ratio) Fold Induction (ratio) 7 6 5 4 3 1,46 2 1,00 1 0 Day 0 Day 56 placebo Day 56 ABX464 * p value < 0.05 (Treatment and time point) 9
Slide 10: Maintenance Phase: 6-months interim analysis
Maintenance Phase: 6-months interim analysis • 22/23 patients including 7 patients initially on placebo enrolled in the induction phase (2 countries did not grant regulatory clearance because of lack of efficacy data at the time of submission) • 3 patients dropped out • One Lack of Efficacy at M1, i
Slide 11: ABX464 - Maintenance Phase
ABX464 - 102 Maintenance Phase Month 6 interim analysis Maintenance Phase • Safety profile remains very good with no severe adverse reactions. • Further improvement of Partial Mayo Score ( down by 76 % ) in patients who received ABX464 during induction study • 68 % reduction of Partial Mayo Score in
Slide 12: Summary
Summary • New mechanism of action ORAL drug ABX464 • Promising preclinical data in IBD model • Good Safety and tolerability of ABX464 in UC patients and HIV program in more than 200 subjects treated (No Serious Adverse Reactions, no severe infections, no lymphopenia, no neutropenia) • Confirmed prel
Slide 13: ABX464 next steps
ABX464 current activities • Phase 2b study protocol in 232 patients with moderate to severe ulcerative colitis was submitted to regulatory agencies in first countries in EU and Canada • Phase 2a studies are being submitted in Rheumatoid Arthritis and Crohn’s disease • Pre-clinical models in Multiple
Slide 14: 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) 14
Slide 15: High unmet medical need in HCC
High unmet medical need in HCC: Response Rates with Nivolumab (Checkmate 040 Study) Uninfected Untreated/ Uninfected Sorafenib HCV HBV All Intolerant Progressors (N=50) (N=51) (N=214) (N=56) (N=57) ORR 21% 20% 20% 14% 20% Med DOR 8.4 mo NR 9.9 mo NR 9.9 mo ORR: Objective Response Rate; DOR: Duration
Slide 16: ABX196 shows anti-cancer effects in mouse models
ABX196 shows anti-cancer effects in mouse models Liver cancer is a devastating disease with rapid mortality ABX196 shows to be a potent immune response activator • Reduces tumor progression in Hepatocellular Carcinoma (HCC) and B16 melanoma models 2017 HCC 2017 HCC new 2017 HCC • Shows survival bene
Slide 17: 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 start in Q2, 2019 Crohn’s Disease ABX464 Phase 2a start in Q3, 2019 Rheumatoid Arthritis ABX464 Phase 2a start in Q2, 2019 HIV ABX464 Phase 2b start in H2, 2019 L
Slide 18: Key company facts
Key company facts Overview Shareholder Structure 2 (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: 27K shares/day in 20181 Incub
Slide 19: Actuals 2018 - Key Figures
Actuals 2018 - Key Figures 2018 2017 Variation FY FY m€ m€ 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% Net Income
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 Didier Blondel Pierre Courteille Jérôme Denis, Alexandra Pearce Chief Financial Pharmacist, MBA Ph.D. Ph.D. Officer & Board Chief Commercial VP, Process Dev. VP, Regula
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