Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (July 2020)
29 slides from Abivax Sa's investor presentation, July 2020
Slide 1: Mobilizing the immune system to fight inflammatory and viral diseases, as well as cancer
Mobilizing the immune system to fight inflammatory and viral diseases, as well as cancer Abivax, a late-stage clinical biotech company July, 2020
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: Key company facts
Key company facts Milestones Shareholder structure1 and market cap2 Founded in 2013 Sept. 2018: Focus ABX464 on chronic inflammation 34% Truffle Capital by Truffle Capital Sofinnova € 250m 46% Board & management Abivax went May 2020: ABX464 to 2% Incubator & founders public in June 2015, treat acute
Slide 4: 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 ongoing Ulcerative colitis Inflammatory diseases ABX464 Phase 2b: FPI: H2, 2020 Crohn’s disease ABX464 Phase 2a ongoing Rheumatoid arthritis ABX464 Phase 2b/3 ongoing COVID-19 HIV A
Slide 5: ABX464: A promising candidate addressing attractive markets
ABX464: A promising candidate addressing attractive markets Coming from the proprietary Abivax library of compounds, Total market size* biased to modulate RNA biogenesis (>2200 molecules); in inflammatory Close collaboration with EVOTEC diseases greater than Small molecule (quinoline), administered
Slide 6: ABX464-101/102 study design: Phase 2a in ulcerative colitis
ABX464-101/102 study design: Phase 2a in ulcerative colitis • Randomized, double-blind, placebo controlled, multi-national study followed by an open-label maintenance study Induction study (ABX464-101) Open label extension (ABX464-102) 8 weeks of induction treatment (completed) First year completed,
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: Endosco
Slide 8: ABX464-101 Partial Mayo Score Results
ABX464-101 Partial Mayo Score Results Fast onset of action and clear responses in patients previously treated with biologics 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 D0
Slide 9: ABX464-102: Efficacy further amplified by 12-months maintenance study
ABX464-102: Efficacy further amplified by 12-months maintenance study 29/32 4/6 22/23 Patients completed Countries granted regulatory Eligible patients enrolled in the the induction study approval for maintenance study maintenance study, 19 completed first year Day 0 Month 12 Maintenance Clinical re
Slide 10: Changes of Partial Mayo Score and fecal calprotectin during the maintenance phase
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 11: ABX464, Vedolizumab, Tofacitinib and Filgotinib efficacy in induction and maintenance trials
ABX464, Vedolizumab, Tofacitinib and Filgotinib efficacy in induction and maintenance clinical trials Vedoluzimab Tofacitinib Filgotinib* ABX464 Phase 3 Phase 3 Phase 3 Phase 2a INDUCTION Active Placebo Delta Active Placebo Delta Active Placebo Delta Active Placebo Delta Clinical Remission (%) 16,9
Slide 12: ABX464 showed a good safety profile during clinical development of the 50 mg dosage form
ABX464 showed a good safety profile during clinical development of the 50 mg dosage form Safety profile consistent Overall: Generally well tolerated with no deaths, no malignancies, no severe infections, no significant changes in with previous and ongoing the laboratory parameters including blood ce
Slide 13: Conclusions
Conclusions Good safety and tolerability of chronic treatment with ABX464 50mg QD in patients with UC Conclusion is supported by safety analysis in more than 300 healthy volunteers and patients (no serious ABX464 oral 50mg QD adverse reactions, no severe infections, no lymphopenia, no neutropenia) d
Slide 14: ABX464 ongoing and planned studies
ABX464 ongoing and planned studies Phase 2b in ulcerative colitis: Phase 2b study in 232 patients with moderate to severe • Conducted with IQVIA as CRO ulcerative colitis is currently ongoing in Canada and Europe and the US (with FDA clearance of IND on • 232 patients, 17 countries, 150+ study sites
Slide 15: COVID-19 infection and pathology
COVID-19 infection and pathology Mild and moderate Recovery disease COVID-19 First Diagnosis infection symptoms (PCR) Acute Severe Respiratory Multi-Organ Distress Death 2 – 10 days disease Failure Syndrome Cytokine Storm ICU admission Syndrome Mostly in elderly and Hyper- other high-risk patients I
Slide 16: ABX464 COVID-19 Development Rationale
ABX464 COVID-19 Development Rationale Antiviral: ABX464 inhibits SARS-CoV-2 (COVID-19 virus) in vitro replication in human respiratory epithelium: Inhibition of COVID-19 viral replication comparable to Remdesivir Anti-inflammatory: ABX464 has demonstrated potent anti- inflammatory properties in seve
Slide 17: ABX464 rapidly upregulates miR-124 within hours in human PBMCs
ABX464 rapidly upregulates miR-124 (10-fold) within 24 hours in human PBMCs (in vitro results) miR-124 upregulation vs. time of ABX464 treatment 14 Mean fold-change compared to DMSO 12 ABX464 (5 µM) 10 8 6 4 2 0 2h 4h 8h 12h 24h Mobilizing the immune system to fight inflammatory and viral diseases,
Slide 18: ABX464 novel mechanism of action: upregulation of miR-124 reduces pro-inflammatory cytokines
ABX464 novel mechanism of action: Potent and specific upregulation of miR-124 leads to reduction of pro-inflammatory cytokines Both systemic and local inflammatory sites Established miR-124 targets: (translation ) Outcome ABX 464 MCP-1/ 1 CBC MCP-1/CCL2 CCL2 IL-6 STAT 3 IL-17 miR-124 TNFa JAK pathwa
Slide 19: Anti-inflammatory effect: ABX464 showed efficacy in the DSS mouse model
Anti-inflammatory effect: ABX464 showed efficacy in the 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 60 days 110 100 90 Days 8
Slide 20: Tissue repair in an ABX464 treated UC patient
Tissue repair in an ABX464 treated UC patient Courtesy of Prof. Severine Vermeire Before ABX464 After ABX464 Mobilizing the immune system to fight inflammatory and viral diseases, as well as cancer 20
Slide 21: Antiviral effect: Reduction of COVID-19 replication in an in vitro airway epithelial model
Antiviral effect: Reduction of COVID-19 replication in an in vitro reconstituted human airway epithelial model Infectious titrations TCID50 at 48 hours post infection Comparable efficacy between Remdesivir and ABX464 Mobilizing the immune system to fight inflammatory and viral diseases, as well as c
Slide 22: ABX464 showed a good safety profile during clinical development of the 50 mg dosage form
ABX464 showed a good safety profile during clinical development of the 50 mg dosage form Safety profile consistent Overall: Generally well tolerated with no deaths, no malignancies, no severe infections, no significant changes in with previous and ongoing the laboratory parameters including blood ce
Slide 23: Phase 2b/3 clinical trial miR-AGE: High-risk patients, PRIOR to respiratory distress
Phase 2b/3 clinical trial miR-AGE: High-risk patients, PRIOR to respiratory distress ➢ Early treatment of high-risk patients infected with COVID-19 ➢ Main objective: A Phase 2b/3, randomized, double blind, placebo-controlled study of ABX464 to treat inflammation and prevent acute respiratory failure
Slide 24: ABX464 supply available for COVID-19 clinical trials and scalable for commercialization
ABX464 supply available for COVID-19 clinical trials and scalable for commercialization French Manufacturers (Seqens / Delpharm / Creapharm) Supplies available for miR-AGE study Current drug supplies allow the treatment of around 2 500 patients during 4 weeks / 50 mg daily Current drug substance sup
Slide 25: Abivax Communication Plan until mid-2021
Abivax Communication Plan until mid-2021 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 UC 2-years Phase 2a (ABX464) maintenance data UC Enrollment Top line Phase 2b (ABX464) completed results RA Enrollment Top line Phase 2a (ABX464) completed results Crohn’s FPI Phase 2b (ABX464) COVID-19 Enrollment Top l
Slide 26: Abivax financial planning – Bpifrance € 36m funding first building block
Abivax financial planning – Bpifrance € 36m funding first building block The amount of € 36m will be paid within the next 12 months Total amount of € 36m is made of € 20,1m grant (non-refundable) and € 15,9m loan (refundable when ABX464 is reaching commercial stage) Total amount of € 36m is funding
Slide 27: Abivax Financing
Abivax Financing 07/2020 06/2021 ABX464 in UC: Phase 2a M & Phase 2b I+M* ABX464 ABX464 ABX464 in CD: Phase 2b I+M Manufacturing scale-up Preclinical Funding Need ABX464 in RA: Phase 2a I+M & Phase 2b I ABX464 Regulatory clinical Abivax New research Abivax G&A € 80m ABX464 in COVID-19: Phase 2b/3 st
Slide 28: Abivax Analyst Reports Overview
Abivax Analyst Reports Overview Analyst Country Last update Target Price Recommendation Bryan, Garnier & Co France 03/12/2019 € 37.50 Buy Degroof Petercam Belgium 13/12/2019 € 29.00 Buy goetzpartners securities UK/Germany 14/05/2020 € 40.00 Buy Kepler Cheuvreux France 18/05/2020 € 40.00 Buy LifeSci
Slide 29: Highly experienced Executive Committee
Highly experienced Executive Committee • Prof. Hartmut Ehrlich, M.D. • Chief Executive Officer Former 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 Commercia