Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (March 2021)
23 slides from Abivax Sa's investor presentation, March 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 March, 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 43% 38% € 301m Sofinnova Sept. 2018: Focus Board & management ABX464 on chronic inflammation 12% Pub
Slide 4: 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 recruitment completed – Phase 3 in preparation Ulcerative colitis Inflammatory diseases ABX464 Phase 2b/3 pivotal study
Slide 5: 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 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 phase 2a POC induction study in ulcerative colitis
ABX464 phase 2a POC induction study in ulcerative colitis: Impressive efficacy achieved for all endpoints (day 56) Study Design: Vermeire at al. Induction and long-term follow- ABX464 Placebo up with ABX464 for moderate-to-severe p value*** ulcerative colitis: Results of phase 2a trial. (n=20/23) (n
Slide 8: 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 9: ABX464 phase 2a UC induction study: fast onset of action
ABX464 phase 2a UC induction study: Fast onset of action and comparable efficacy in both biologics naïve and refractory patients Overall Patient Population Patients previously treated with biologics Change from Baseline Partial Mayo Score Change from Baseline Partial Mayo Score D0 D7 D14 D21 D28 D56
Slide 10: Confirmed durable and improved long-term efficacy in UC maintenance study
Confirmed durable and improved long-term efficacy in UC maintenance study: Several patients in 4th year of ABX464 continuous treatment 29/32 22/23 16/19 4/6 Patients Eligible patients enrolled in the 16 out of 19 patients Countries granted regulatory approval completed the maintenance study, 19 out
Slide 11: ABX464, Entyvio and Xeljanz efficacy in UC trials
ABX464, Entyvio® and Xeljanz® efficacy in UC induction and maintenance clinical trials Vedoluzimab* Phase 3 Tofacitinib** Phase 3 ABX464 Phase 2a*** Post Induction Active Placebo Delta Active Placebo Delta Active Placebo Delta Clinical Remission (%) 16.9 5.4 11.5 16.8-18.5 3.6-8.2 13.2-10.3 35 11 24
Slide 12: Changes of Partial Mayo Score and fecal calprotectin during maintenance
Changes of Partial Mayo Score and fecal calprotectin during the maintenance phase for all patients and patients previously on biologics Partial Mayo Score – Mean Fecal calprotectin µg/g – Median 4,0 350 3,5 300 3,0 250 2,5 200 2,0 150 1,5 100 1,0 0,5 50 0,0 0 Day 0 (OLE) M3 M6 M9 M12 Day 0 (OLE) M3
Slide 13: Completed studies: Favorable ABX464 safety profile
Completed studies: Favorable ABX464 safety profile Common (> 5%) adverse events (cut-off date Nov. 30, 2020) ABX464 (50mg QD) ABX464 (All doses) Placebo Adverse effect (N=115 subjects) (N=203 subjects) (N=33 subjects) System Organ Class n (%) of pts n (%) of pts n (%) of pts Number of Number of Numb
Slide 14: ABX464 phase 2b clinical study in ulcerative colitis
ABX464 phase 2b clinical study in ulcerative colitis Ulcerative colitis Phase 2b ongoing: • Enrollment completed with 254 patients in 15 European countries, US and Canada in 130+ study sites • 4 study arms (placebo, 25, 50, 100 mg QD) • Central blinded reading of endoscopies • Conducted with IQVIA a
Slide 15: Study design: ABX464 phase 2b clinical study in ulcerative colitis
Study design: ABX464 phase 2b clinical study in ulcerative colitis Screening Induction Phase Open Label Extension ≤4 weeks 16 weeks ABX464-196 Endoscopy Endoscopy Endoscopy Screening Week 8 Week 16 25mg QD 50mg QD Initial randomization 50mg 100mg QD Stratification factor: QD Patients without previou
Slide 16: How to bring ABX464 to the finish line
How to bring ABX464 to the finish line Phase 1 TQT study: Ulcerative colitis Phase 3 in preparation: • 66/120 subjects enrolled • End of Phase 2b meeting planned for Q3 2021 • Results expected in June 2021 • IQVIA involved in study preparation • App. 2x600 patients planned Phase 1 DDI study: • 24/42
Slide 17: ABX464: A future blockbuster in IBD
ABX464: A future blockbuster in IBD Size of targeted market doubling in UC and increasing by 34% in CD (2019 - 2025) 2019 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 to severe
Slide 18: ABX196: An iNKT agonist for checkpoint inhibitor refractory liver cancer
ABX196: An iNKT agonist for the treatment of checkpoint inhibitor refractory liver cancer patients Macroscopic liver tumor invasion on day 61 or at death in retrograde mouse hepatocellular carcinoma model (tumor invasion as % of liver) Licensed from Scripps Research, University of Chicago, Brigham-Y
Slide 19: ABX196 study design and recruitment status
ABX196 study design and recruitment status ✓ 3rd cohort: 1/3 patients dosed with 0.4 µg ABX196 ✓ 2nd cohort: 3/3 patients dosed with 0.2 µg ABX196 End of dose escalation phase expected for end 1st cohort: 3/3 patients of March 2021 dosed with 0.1 µg ABX196 Top-line results Q2 Dose Escalation Phase 2
Slide 20: Newsflow through end of 2021
Newsflow through end of 2021 Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Enrollment Top-line results FPI UC - Phase 2b (ABX464) (Induction and initial completed maintenance data) Phase 3 CD - Phase 2b/3 pivotal (ABX464) FPI Enrollment Top-line results RA - Phase 2a (ABX464) (Induction and initial comple
Slide 21: 2020 financing completed to extend cash runway until Q4 2021
2020 financing completed to extend cash runway until Q4 2021 2020 Financing Cash Runway Until Q4 2021 • Private Placement towards institutional investors € 28m • Financing to be used for: • Bpifrance funding € 36m ➢ ABX464 in ulcerative colitis (UC): Completion of the Phase 2b (to be tailored follow
Slide 22: Abivax analyst reports overview (after Covid-19 stop)
Abivax analyst reports overview (after Covid-19 stop) Analyst Country Last update Target Price Recommendation Bryan, Garnier & Co France 04/03/2021 € 39.40 Buy Degroof Petercam Belgium 08/03/2021 € 29.00 Buy goetzpartners securities UK/Germany 09/03/2021 € 43.00 Buy Kepler Cheuvreux France 08/03/202
Slide 23: Highly experienced Executive Committee
Highly experienced Executive Committee • Prof. Hartmut • Didier Blondel • Sophie Biguenet, • Jean-Marc Steens, Ehrlich, M.D. M.D. M.D. • Chief Financial Officer • Chief Executive Officer & Board Secretary • Chief Medical • Chief Medical Former Head of Global R&D, Officer Advisor Baxter BioScience •