Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (January 2021)
21 slides from Abivax Sa's investor presentation, January 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 January 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 39% raising € 57.7m 41% € 480m Sofinnova Sept. 2018: Focus ABX464 on May 2020: ABX464 to Board & management chronic
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 ongoing – Phase 3 in preparation Ulcerative colitis Inflammatory ABX464 Phase 2b/3 pivotal study in preparation Crohn’s
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: Potent and specific 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: ABX464 Placebo p value (n=20/23) (n=9/9) PI: Prof. Severine Vermeire, Leuven, BE (PP) PP/ITT** PP/ITT 32 patients with moderate to severe UC: randomized (2:1), double blin
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 induction and maintenance 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 En
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: How to bring ABX464 to the finish line
How to bring ABX464 to the finish line Ulcerative colitis Phase 2b ongoing: Crohn’s disease Phase 2b/3 pivotal study in preparation: • Enrollment completed with 254 patients in • 900 patients 15 European countries, US and Canada in • FPI expected for Q3 2021 130+ study sites • 4 study arms (placebo,
Slide 15: 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 16: Covid-19 infection and pathology
Covid-19 infection and pathology ABX464 to be administered to prevent severe disease and death in high-risk patients Mild and moderate Recovery disease First symptoms Covid-19 ABX464 infection Diagnosis (PCR) Acute Severe Respiratory Multi-Organ Distress Death 2 – 10 days disease Failure Syndrome Cy
Slide 17: ABX464 miR-AGE phase 2b/3 clinical trial in Covid-19
ABX464 miR-AGE phase 2b/3 clinical trial: Fully powered and placebo controlled to establish safety and efficacy in preventing severe Covid-19 disease Early treatment of high-risk Covid-19 patients to prevent excessive inflammation and Main objective acute respiratory failure / death Patients aged ≥6
Slide 18: ABX196: An iNKT agonist for the treatment of liver cancer
ABX196: An iNKT agonist for the treatment of liver cancer 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-Young University Synthetic glycolipid agon
Slide 19: 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 20: 2016-2020: Positive and durable increase in shareholder value
2016-2020: Positive and durable increase in shareholder value Share Price Performance Market Cap Performance 40 600 In million € 30 400 In € 20 200 10 0 0 2016 2017 2018 2019 2020 2016 2017 2018 2019 2020 Variance Share Price & Market Cap 1000 In % 500 x 5.4 x 8.0 x 5.4 x 8.0 0 2016/2017 2017/2018 2
Slide 21: Highly experienced Executive Committee
Highly experienced Executive Committee • Prof. Hartmut • Didier Blondel • Pierre Courteille • Jean-Marc Ehrlich, M.D. Pharmacist, MBA Steens, M.D. • Chief Financial Officer • Chief Executive Officer & Board Secretary • Chief Commercial • Chief Medical Former Head of Global R&D, Officer & VP, BD Offi