Slides
Page 1
June 2025 Corporate Presentation
Page 2
2 This presentation contains information pertaining to Abivax SA (“Abivax,” the “Company,” “we,” “our” or “us”). Certain statements included in this presentation that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “future,” “goals,” “intend,” “likely,” “may,” “might,” “ongoing,” “objective,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “strategy,” “will” and “would” or the negative of these terms, or other comparable terminology i ntended to identify statements about the future. These statements are based on the Company’s current strategy, plans, objectives, assumptions, estimates and projections. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax’s drug candidates, Abivax’s expectations regarding the availability of data as well as timing of enrollment and reporting results from its clinical trials, including its Phase 3 ABTECT induction and maintenance trials, obefazimod extension trials in UC, and obefazimod Phase 2b trial in CD, the availability and timing of preclinical data to support decision-making on therapy candidates for use in combination with obefazimod in UC, as well as the availability and timing of disclosure of preclinical data of any such combination therapy, the selection of an obefazimod follow-on drug candidate from Abivax’s miR-124 library, obefazimod’s potential to provide meaningful benefit to patients suffering from UC, CD, IBD or other indications the potential commercial opportunity for obefazimod and projections of market share, expectations for potential patent term extensions for obefazimod,, Abivax’s cash runway, and other statements that are not historical fact. Current results are not necessarily indicative of future results, including any clinical progress updates Abivax may provide from time to time. Readers are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are subject to inherent risks, contingencies and uncertainties beyond the Company’s control that could cause the Company’s actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. A description of the main risks, contingencies and uncertainties applicable to the Company can be found in the documents filed by the Company with the Autorité des marchés financiers (“AMF”) pursuant to its legal obligations, including the 2025 Universal Registration Document, as amended, available on the AMF website (www.amf-france.org/fr) and the Company’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the "SEC") on March 24, 2025 under the caption “Risk Factors” as well as other filings the Company makes with the SEC from time to time, available on the SEC’s website (www.sec.gov), as well as in the documents that may be published in the future by the Company. These documents are also available on Abivax’s website (www.abivax.com). If any of these risks materialize or Abivax’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that are presently unknown by the Company or that it currently believes are not material that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Abivax’s expectations, plans, or forecasts of future events and views as of the date of this presentation and are qualified in their entirety by reference to the cautionary statements herein. Abivax anticipates that subsequent events and developments will cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing Abivax’s assessments as of any date subsequent to the date of this presentation. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither Abivax nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as required by law. Furthermore, forward-looking statements, forecasts and estimates are made only as of the date of this presentation. The Company disclaims any obligation to update any forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. This presentation also contains estimates and other statistical data made by independent third parties and by us relating to market size and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data and estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. Neither we nor our affiliates, advisors or representatives makes any representation as to the accuracy or completeness of that data or undertake to update such data after the date of this presentation. Ongoing and future clinical development, including our Phase 3 clinical programs, trial design and initiation, is subject to assessment of clinical data of obefazimod by European Medicines Agency ("EMA"), U.S. Food and Drug Administration ("FDA") and other regulatory authorities. These authorities could request important modifications to the design of the ongoing and future clinical trials and/or request that additional studies or trials be conducted prior to their initiation. The FDA, EMA or other regulatory authorities may take decisions that would result in a delay or a clinical hold of Abivax’s clinical programs (including in particular its Phase 3 clinical trials for obefazimod in moderately to severely active ulcerative colitis or Phase 2b clinical trial for obefazimod in Crohn’s Disease. Certain data in this presentation are based on cross-study comparisons and are not based on any head-to-head clinical trials. Cross-study comparisons are inherently limited and may suggest misleading similarities or differences and you are cautioned not to place undue emphasis on these comparisons. Actual results may differ from these comparisons. This presentation contains trademarks, service marks, trade names, and copyrights of Abivax and other companies, which are the property of their respective owners. The use or display of third parties’ trademarks, service marks, trade name or products in this presentation is not intended to, and does not, imply a relationship with Abivax or an endorsement or sponsorship by or of Abivax. Solely for convenience, the trademarks, service marks and trade names referred to in this presentation may appear with the TM or SM symbols, but such references are not intended to indicate, in any way, that Abivax will not assert, to the fullest extent permitted under applicable law, their rights or the right of the applicable licensor to these trademarks, service marks and trade names. Forward Looking Statements
Page 3
3 Abivax Pipeline 1. Decision subject to results of the Phase 3 monotherapy induction trials Anticipated readout of ABTECT 8-Week Induction in Q3 2025 Drug Candidate Regimen Indication Research Nonclinical Phase 1 Phase 2 Phase 3 Achieved & Anticipated Milestones Obefazimod Monotherapy Moderately to Severely Active Ulcerative Colitis (UC) ▪ Enrollment completed April 2025 ▪ Induction trial topline data readout in Q3 2025 ▪ Maintenance trial topline data readout in Q2 2026 Monotherapy Crohn’s Disease (CD) ▪ IND filed Q4 2023 ▪ First patient enrolled Phase 2b trial in October in 2024 ▪ Phase 2b induction topline results expected in 2H 2026 Combination Therapy Moderately to Severely Active Ulcerative Colitis (UC) ▪ Encouraging preclinical combination data generated ▪ Decision on combination agent expected in 20251 miR-124 Follow On Monotherapy To be disclosed ▪ Selection of follow-on compound in 2025 Pivotal Phase 3 Program (ABTECT) Phase 2b
Page 4
4 ABTECT Ph 3 Enrollment Completed With 4% Over Enrollment *NDA submission is pending on positive results Total 1,275 patients randomized (104% target) First patient in 11-Oct-2022 Last patient in 28-Apr-2025 Induction data Q3 2025 Maintenance data 2Q 2026 NDA submission* 2H 2026 30 Months
Page 5
5 ABTECT Trial Blinded Baseline Participant Characteristics Closely Align with Phase 2b Trial ABTECT Phase 3 Phase 2b Study Participants 1,275 252 Baseline MMS (7-9) 65% 71% Prior Advanced Therapy Failure 48% 48% Corticosteroids 42% 52% Geographic Distribution North America 10% 1% Western/Central Europe 22% 33% Eastern Europe 38% 66% Asia 24% 0% ROW 6% 0%
Page 6
6 ABTECT Maintenance Trial and Safety Update To date, 597 of the 1,111 participants—comprising both completers of the induction study and those who were randomized but discontinued during the induction phase—have been enrolled in Part 1 (the 'responder arm') of the 44-week maintenance trial. This exceeds the minimum enrollment required to meet the statistical power assumptions. The Maintenance Study will continue to enroll participants through completion of induction study (end of June 2025). No new safety signals observed in the latest Data Safety Monitoring Board (DSMB) review conducted on April 25, 2025.
Page 7
7 1. UC Buying Process Market Research Results Aug 2023 2. IQVIA global pricing and market access landscape results Sept 2023. DURABLE Clinical Remission That Has Demonstrated Potential to Last SIMPLE Once-Daily Oral Without Pre-Initiation Burden SAFE The Potential of an Improved Safety Profile "Nothing is perfectly safe. We need highly effective, very safe, and oral. We don't have this now. “ – US Gastroenterologist1 “Route of Administration plays a very important role in young patients, which is the majority…to them it means a greater degree of freedom and flexibility.” – German Gastroenterologist1 “Currently available agents are ineffective in long- term clinical remission.” – US National Health Plan2 Provider and Payer Insights Highlight Significant Need for a Novel Oral Therapy Offering Durable Efficacy and Safety1,2
Page 8
8 Future UC Treatment Paradigm With Disease Progression Disease Severity Line of Therapy Aminosalicylate / Corticosteroids / Thiopurines Rinvoq, Xeljanz, Entyvio Relapse Maintenance Induction Simple, Safe, Durable Oral Therapy Conventional Therapy Advanced Therapy *Includes Biosimilars Patients often cycle through these advanced therapies • Bio-Similars (TNF, IL-12/23) or • IL-23 Cyclosporine / Tacrolimus / Surgery
Page 9
9 Significant Opportunity for a Simple, Safe, and Durable Therapy to Address Patient Concerns About Stepping up to Advanced Therapy Source: 1. Estimates based on IQVIA 2023 data analysis of advanced vs conventional therapy and census data. 2. Evaluate Pharm a US Ulcerative Colitis Sales Report Generated July 20, 2023. Conventional Therapy = 5-ASA, IM, Steroids; Advanced Therapy = Biologics/JAKis/S1P receptor modulators. 776K UC Patients Treated in the US in 12 Months Ended May 20231 Conventional Therapy 77% (594K) Advanced Therapy 23% (182K) 37% (285k) Maintained on Conventional Therapies 25% (193k) Steroids Only 15% (116k) Uncontrolled on Conventional Therapies 5% (43k) New to Advanced Therapy 7% (51k) Sub-Optimal (4%) or Recently Switched (1%) 11% (88k) Maintained on Advanced Therapy $5.3B In US UC Sales2 Intervention Opportunities For New Advanced Therapy 27% (210K) Patients A significant number of patients whose UC is uncontrolled on conventional therapies are not stepping up to advanced therapies due to limitations of available agents, leading to suboptimal disease management. Significant Unmet Need Additional Unmet Need
Page 10
10 Worldwide IBD Sales ($B)1 ~70% of Sales from US G7 2024 IBD Prevalence1 Steady Growth in US Global IBD Market Poised to Reach $30B by 2030, with the U.S. Driving 70% of Sales Source: 1. Evaluate Pharma, EU4 = Germany, Spain, Italy, France. $8.3 B $12.7 B $15.4 B $18.1 B $23.7 B $30.8 B 2024 2030UC CD 1.4 M 1.5 M 2.2 M 2.2 M 2024 2030 US EU4/UK/JP ↑0.4% IBD prevalence expecting modest 4% growth over the next 6 years in the US UC market growth driven by patients stepping up to advanced therapies earlier CAGR:7.5% CAGR:2.5% 3.6 M 3.7 M
Page 11
11 Mechanism of Action
Page 12
12 Clinical Development Transition to Inflammation Obefazimod Development Source: https://pubmed.ncbi.nlm.nih.gov/37129565/ ; Campos N, et al. Retrovirology. https://retrovirology.biomedcentral.com/articles/10.1186/s12977-015-0159-3. https://ard.bmj.com/content/81/8/1076.long An oral small molecule that enhances the expression of miR-124 Initial Development in HIV miR-124 Selectivity Pre-Clinical POC MOA Evidence in Humans UC Phase 3 Clinical Trial Program 2009 – 2015 2015 – 2017 2017 – Present Discovery Obefazimod Discovery ▪ Obefazimod was co- discovered with CNRS (French NIH) and Institut Curie ▪ Obefazimod was selected by functional screening on HIV replication from a chemical library of molecules designed to modulate RNA splicing ▪ Obefazimod was initially developed in HIV Abivax is using microRNA technology, a now Nobel Prize winning scientific discovery, to revolutionize the future treatment of IBD ▪ Among >1000 microRNAs, obefazimod found to enhance expression of only miR-124, a physiological miRNA and known anti- inflammatory ▪ Effective in DSS-induced colitis mouse model ▪ Consistent with known miR-124 profile, reduction of inflammatory cytokines and chemokines observed ▪ Enhanced expression of miR-124 in blood and colonic tissue of UC patients ▪ Reduction of inflammatory cytokines, including IL-23 & IL-17 in UC patients, and IL-6 in RA patients ▪ Initiation of ABTECT, global Phase 3 clinical trials for obefazimod in moderately to severely active UC, in Q4 2022
Page 13
13 3 Binding to specific miR-124 mRNA targets miR-124 binds to its specific mRNA targets in the cytoplasm, reducing the translation into their respective proteins miR-124 3 miR-124 Long non-coding RNA miR-124 Induces selective splicing of a single, long, non-coding RNA, leading to enhanced expression of miR-124 CYTOPLASM 2 2 Obefazimod CBC Obefazimod binds to cap binding complex (CBC) within the nucleus; demonstrated by cryo-electron microscopy* (CryoEM) NUCLEUS 1 1 *Cryo-electron microscopy is a technique to determine protein structure 1. Vermeire S, et al. J Crohns Colitis. 2023;jjad067; Data on file. Abivax 4 Reduced translation of MCP-1/CCL2 stabilizes macrophage activation and recruitment to the gut MCP-1/CCL2 Macrophage recruitment/activation IL-6, IL-23, IL-1, TNF-ɑ 4 IL-6, IL-23, IL-1, TNF-ɑ 5 Reduced translation of STAT3 and IL-6R stabilizes Th17 differentiation and related cytokines STAT3, IL6R Th17 cell differentiation 5IL-17 ◼ Immunosuppression ◼ Homeostasis ◼ Dysregulated Inflammation Obefazimod Enhances the Expression of miR-124, Resulting in Stabilization of the Dysregulated Inflammatory Response Present in UC
Page 14
14 Phase 2b OLE: Enhanced Expression of miR-124 in Rectal Tissue and Blood Sustained Out to Week 96 *p<0.001 for all timepoints vs baseline; each timepoint was compared using a Dunnett adjustment. Source: Santo J, et al. Long-term upregulation of mir-124 in blood and rectal biopsies of patients with moderate-to-severe ulcerative colitis receiving obefazimod 50 mg daily for 96-weeks. Poster presented at United European Gastroenterology Week; 2023; Copenhagen, Denmark. miR-124 Upregulation (fold increase, median) Rectal Tissue Blood
Page 15
15 Obefazimod Stabilizes Chemokines, Cytokines, and Th17/Th1 Cells Under Dysregulated Conditions Source: Data on file, Abivax. DSS= dextran sulphate sodium-Induced. Stabilized CCL2/MCP-1 and IL-6 to Homeostatic Levels No Impact on CCL2/MCP-1 in Normal Mice Effects of Obefazimod on Cytokine Secretion in Colonic Tissue in DSS and Normal Mice DSS Mice Normal Mice Effects of Obefazimod on CD4+ Subsets in Mesenteric Lymph Nodes in DSS and Normal Mice DSS Mice Normal Mice Stabilized Th17 and Th1 Cells to Homeostatic Levels No Impact on Th17 and Th1 Cells
Page 16
16 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 Strength of obefazimod Method of Use Patent Rigorously Assessed and Confirmed by Two Globally Renowned IP Law Firms Note: Applicable authorities in the US and EU may not agree with our assessment of whether such extensions to our patents are available or may grant more limited extensions than we request. Product: Compound Composition of matter (product claim (S2)) Application: Disease Treatment (method claim; inflammation (S9)) Projected Potential Extensions Projected Potential Extensions Granted Patent US Composition of matter patent or method of use patent (both granted) would extend the product patent protection until 2035 or the use patent until 2040. Granted Patent Patent Protection Expected to Extend from 2035 - 2039
Page 17
17 Clinical Trials
Page 18
18 Optional Open Label Maintenance (Up To 2 Years)Induction Phase 16 WeeksScreening Obefazimod Phase 2b Trial Design in Moderately to Severely Active Ulcerative Colitis Source: Vermeire S, et al. Lancet Gastroenterol Hepatol. 2022;7(11):1024-1034. Week 16 Randomization Up to Week 4 50 mg QD • Modified Mayo Score 5-9 • After failure of conventional therapies and/or biologics/JAKi • No restrictions on number of prior biologics/JAKi • Stable CS ≤ 20 mg • Stable dose of immunomodulators and/or 5ASA’s 25 mg QD (n=61) Placebo QD (n=64) 50 mg QD (n=63) 100 mg QD (n=64) Stratification on prior exposure to biologics /JAKi Central Reading of Endoscopy Week 8 252 Patients - 17 Countries - 130 Sites Phase 2b Ulcerative Colitis (UC) Trial Design Primary Endpoint: Mean change from baseline in Modified Mayo Score at week 8
Page 19
19 Baseline Characteristics *Percentages based on number of patients with previous exposure to biologics/JAK inhibitors. Source: Vermeire S, et al. Lancet Gastroenterol Hepatol. 2022;7(11):1024-1034. Phase 2b UC Clinical Trial 19 Placebo 25 mg 50 mg 100 mg (n=64) (n=61) (n=63) (n=64) Modified Mayo Score (MMS) Mean (SD) 7.0 (1.20) 7.1 (1.09) 7.1 (0.96) 7.0 (1.07) 7 to 9 n (%) 42 (65.6) 44 (72.1) 47 (74.6) 47 (73.4) Endoscopic Sub-Score = 3 % 75% 67% 75% 66% Duration of Disease (years) Mean (SD) 8.8 (6.8) 7.4 (6.8) 8.2 (7.8) 7.8 (7.3) Fecal Calprotectin (µg/g) Median 1558 1743 1671 1623 Previous Exposure to Biologics/JAKi n (%) 31 (48.4) 30 (49.2) 30 (47.6) 32 (50.0) Previous Exposure to 2 or More Biologics/JAKi* n (%) 28 (90.3) 27 (90.0) 29 (96.7) 31 (96.9) Primary Non-Response to Biologic/JAKi* n (%) 15 (48.4) 14 (46.7) 18 (60.0) 19 (59.4) Concomitant UC Medication Corticosteroids n (%) 29 (45.3) 32 (52.5) 33 (52.4) 37 (57.8) ~70% of patients had severely active disease (MMS 7-9) and ~45% had prior experience with 2 or more biologics/JAKis
Page 20
20 1. ANCOVA model for change from baseline MMS at Week 8 which includes baseline MMS as a covariate and treatment, previous exposure to biological drugs or JAK inhibitors as fixed effects and a random error term. 2. p-values are based on nonparametric ANCOVA using ranked data. 3. MMS is the sum of assessment scores (0-3) of mucosal appearance on endoscopy, stool frequency, and rectal bleeding 4. n = Number of patients in the category with data available for baseline and week 8 visit. Primary Endpoint Achieved Source: Vermeire S, et al. Lancet Gastroenterol Hepatol. 2022;7(11):1024-1034. Statistically significant improvements observed across all doses -1.9 -3.1 -3.2 -2.9 -4 -3.5 -3 -2.5 -2 -1.5 -1 -0.5 0 Placebo 25mg 50mg 100mg Modified Mayo Score Mean Change from Baseline ∆ -1.2 P=0.0012 ∆ -1.3 P<0.0012 ∆ -1.0 P=0.0042 n4 = 60 59 54 58 Change from Baseline in Modified Mayo Score (MMS3) at Week 8
Page 21
21 Secondary Efficacy Endpoints Positive trends observed across all doses 21 Secondary Efficacy Endpoints: Week 8* 12.5% 26.2% 17.5% 25.0% Placebo 25mg 50mg 100mg 34.4% 62.3% 58.7% 50.0% Placebo 25mg 50mg 100mg 13.6% 34.5% 39.6% 44.4% Placebo 25mg 50mg 100mg *Study not powered for statistical significance for secondary endpoints. % of Patients with Endoscopic Improvement % of Patients with Clinical Response % of Patients with Clinical Remission Clinical Remission1 Endoscopic Improvement3Clinical Response2 ∆ 14%6 ∆ 13%6 ∆ 5%6 ∆ 28%6 ∆ 24%6 ∆ 16%6 ∆ 21%6 ∆ 26%6 ∆ 31%6 Source: Vermeire S, et al. Lancet Gastroenterol Hepatol. 2022;7(11):1024-1034. 1. Clinical remission (per Modified Mayo Score) is defined as stool frequency subscore (SFS) ≤1, rectal bleeding subscore (RBS) of 0 and endoscopic subscore ≤1. 2. Clinical response (per Adapted Mayo Score) is defined as a decrease from baseline in the Modified Mayo Score ≥2 points and ≥30 percent from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1. 3. Endoscopic improvement is defined as endoscopic subscore ≤1 without friability. 4. n = Number of patients that met the respective endpoint. 5. N = Number of patients in the relevant analysis set. 6. Delta = arithmetic difference rounded to nearest full percentage. n/N4,5 = 8/64 16/61 11/63 16/64 n/N4,5 = 22/64 38/61 37/63 32/64 n/N4,5 = 8/59 20/58 21/53 24/54 Placebo response in naïve subgroup: ▪ 3 of 8 placebo clinical remitters from 1 site among 130 sites ▪ 8 total patients enrolled at this site
Page 22
22 Phase 2a & 2b Combined Baseline Characteristics Phase 2a+2b (N=284) Age (yr), mean (SD) 41.5 (14.0) Sex, Male (%) 168 (59.2) Duration of UC (yr), mean (SD) 8.3 (7.3) Baseline MMS, median 7.0 Baseline MMS, n (%) 0 to 4 5 to 6 7 to 9 4 (1.4) 84 (29.6) 196 (69.0) Baseline pMMS, median 4.0 Baseline C Reactive Protein, median (mg/L) 4.5 Baseline fecal calprotectin, median (µg/g) 1588 Source: ../ABX464/dryrun1/programs/statout/t2101.sas (Date: 2025-02-28 09:24:49) Note: CRP: C Reactive Protein, FCP: fecal calprotectin, MMS: modified Mayo score, pMMS: partial modified Mayo score. *Excluding site 7316 (Ukraine) from Phase 2b (ABX464-103).
Page 23
23 Phase 2a & 2b Combined: Prior and Concomitant Treatments for UC Source: ../ABX464/dryrun1/programs/statout/t2101.sas (Date: 2025-02-28 09:24:49) Phase 2a+2b (N=284) Prior Exposure to Biologics or JAKi Treatment, n (%) Exposed to >1 biologic/JAKi* Exposed to >2 biologics/JAKi** 136 (47.9) 112 (82.4) Concomitant UC Treatment at Baseline, n(%) Corticosteroids*** 5-ASA+ 142 (50.0) 218 (76.8) Note: 5-ASA: 5-aminosalicylic acid, JAKi: Janus Kinase inhibitor *: n1/n × 100. **: n2/n1 × 100. ***: Defined by ADSL.STRTGR1 = 'Corticosteroids = Yes' in study ABX464-101 and ADSL.CORT = Y in study ABX464-103. +: Defined by ATC code of A07EC. ‡ *Excluding site 7316 (Ukraine) from Phase 2b (ABX464-103).
Page 24
24 Phase 2a and 2b trials: Integrated Analysis of Efficacy Endpoints Clinical Remission2 Post-Hoc Analysis: Phase2a + Phase 2b at Week 8 Non-Responder Imputation; p-values are nominal 34.2% 62.3% 58.1% Clinical Response1 ∆ 28%7 ∆ 24%7 25/73 38/61 50/86 12.3% 32.8% 36.0% Endoscopic Improvement3 ∆ 21%7 ∆ 24%7 9/73 20/61 31/86 12.3% 26.2% 23.3% 0% 25% 50% 75% 100% Placebo 25mg 50mg % of Patients Achieving Endpoint ∆ 14%7 ∆ 11%7 n/N5,6 = 9/73 16/61 20/86 p=0.040 p=0.076 p=0.001 p=0.003 p<0.001 p=0.004 12.3% 26.2% 24.4% ∆ 14%7 ∆ 12%7 p=0.053 p=0.040 HEMI4 9/73 16/61 21/86 NRI: Non-responder imputation. Phase 2a + Phase 2b (ABX464-101 + ABX464-103) p-value: Nominal p-values using Mantel-Haenszel test. [1]: Clinical response: Change in Modified Mayo Score >=2 points and >=30% from baseline, plus a decrease in RBS >=1 or an ab solute RBS <=1. [2]: Clinical remission: SFS <=1, RBS = 0 and endoscopic sub -score (ES) <=1. [3]: Endoscopic improvement: ES <=1. [4]: Histo-endoscopic mucosal improvement (HEMI): Geboes histologic score <= 3.1 (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system) and ES <=1. [5].n = Number of patients that met the respective endpoint. [6].N = Number of patients in the relevant analysis set. [7].Delta = arithmetic difference rounded to nearest full percentage. Source: ../ABX464/dryrun1/programs/statout/t210201.sas (Date: 2025-03-10 08:28:33)
Page 25
25 Sub-Group Analysis Bio/JAKi-naïve and Bio/JAKi-experienced patients Endoscopic Improvement1 at Week 8* 25 3.7% 28.6% 30.4% 27.6% Endoscopic Improvement Placebo 25mg 50mg 100mg ∆ 25%4 ∆ 27%4 ∆ 24%4 % of Patients with Endoscopic Improvement Bio/JAKi-Naïve Patients Bio/JAKi-Experienced Patients Note: 93% (115/123) had experience with 2 or more Bio/JAKis 21.2% 38.7% 45.2% 55.2% Endoscopic Improvement50mg 100mg ∆ 18%4 ∆ 24%4 ∆ 34%4 % of Patients with Endoscopic Improvement Placebo 25mg Source: Data on File, Abivax. *Study not powered for statistical significance for sub-group analysis. 1. Endoscopic improvement is defined as endoscopic subscore ≤1 without friability. 2. n = Number of patients that met the respective endpoint. 3. N = Number of patients in the relevant analysis set. 4. Delta = arithmetic difference rounded to nearest full percentage. n/N2,3 = 7/33 12/31 14/31 16/29 n/N2,3 = 1/27 8/28 7/23 8/29
Page 26
26 5% 17% 7% 19% 15% 24% 8% 24% 8% 23% 8% 18% 4% 17% 15% 26% 4% 12% 5% 26% 4% 33% 6% 18% 15% 26% 7% 27% 13% 26% 0% 5% 10% 15% 20% 25% 30% 35% 40% Pbo N=149 Q8W N=225 Pbo N=319 Q8W N=322 Pbo N=267 Q4W N=795 Pbo N=320 Q4W N=646 Pbo N=280 Q4W N=421 Pbo N=122 10mg N=476 Pbo N=112 5mg N=429 Pbo N=137 200mg N=245 Pbo N=142 200mg N=262 Pbo N=154 45mg N=319 Pbo N=174 45mg N=341 Pbo N=216 1mg N=429 Pbo N=112 2mg N=221 Pbo N=134 2mg N=274 Pbo N=64 25mg N=61 1. FDA package inserts. TCMS = Clinical Remission on 4-Component Mayo Score (TCMS ≤2 with no individual score >1). MMS = Clinical Remission on 3-Component Mayo Score* (RB=0, SF≤1 with Improvement ≥1, Endo ≤1), MMS*Current FDA Required Endpoint. 2. All clinical remission efficacy numbers are rounded to the nearest whole number as reported in FDA prescribing information in package inserts. 3. 3. Reflects percentage of prior advanced tx population, not total population 4. Lancet 2022; 399: 2113-28; 5. Applies to TNF blockers; 6. Converted from percentage of total population reported in US PI; 7. Mean of 25 mg and placebo dose arms; Lancet Gastroenterol Hepatol 2022; 11, 1024-1035. 8. https://www.nejm.org/doi/full/10.1056/NEJMoa2207940#supplementary-materials. 9. EMA Product Characteristics. 10. Journal of Crohn’s and Colitis, 2025, 19(1), jjaf005. 11. Lancet 2024; 405: 10472, P33-49. Clinical Remission Induction Data of FDA Approved UC Products Entyvio®1 Week 6 TMCS Stelara®1 Week 8 TMCS Xeljanz®1 Week 8 TMCS Rinvoq®1 Week 8 MMS Omvoh®1 Week 12 MMS Velsipity1 Week 12 MMS Subjects (%) Clinical Remission Induction Efficacy2 of FDA/EMA Approved UC Products: 6-12 Weeks ∆ 12% ∆ 12% For illustrative purposes only. Not a head-to-head comparison. Differences exist between trial designs and subject characteristics, and caution should be exercised when comparing data across trials. ∆ 10% ∆ 13% ∆ 21% ∆ 10% ∆ 29% ∆ 11% ∆ 20% ∆ 16% Biologics Orals Prior Adv Treat. 39%1 51%1 41%1 52%1 52%1 51%1 52%1 0%9 100%9 53%4 51%4 33%1,5 34%1 30%1 48%7 >23 Prior Adv Treat. Not reported 32%1 49%8 54% 54% Not Reported Not Reported 0%9 43%9 66%4 62%4 63%1 50%1,6 47%1,6 90%7 Jyseleca®9 Week 10 TMCS ∆ 11% ∆ 8% Zeposia®1 Week 12 MMS Skyrizi®1 Week 12 MMS Tremfya®1 Week 12 MMS ∆ 15% ∆ 12% ∆ 13% Obefazimod Week 8 MMS Obe Ph2b Obefazimod’s Phase 2 induction data is competitive vs. approved UC products despite more refractory population
Page 27
27 Clinical Remission at weeks 64 and 112 (16-week induction period + 48wk or 96wk maintenance) 27 Clinical Remission Among All Patients and Week 8 Induction Responders (ITT Analysis) Source: Data on File, Abivax. 1. 217/222 eligible patients enrolled into open-label maintenance study. 2. Irrespective of the outcome at the end of the 8-week induction phase. 3. n = Number of patients that met the respective endpoint. 4. N = Number of patients in the relevant analysis set. 5. 124 patents achieved clinical response at end of the 8-week induction phase. 6. 93 patients did not achieve clinical response at end of the 8-week induction phase. 7. From week 48 to week 96, 19 patients began experiencing symptoms of UC again (i.e., were not in clinical remission anymore), and 14 patients achieved clinical remission. Open-Label Maintenance Study 119 patients in clinical remission at week 48 and 114 in clinical remission at week 967 Induction Non-Responders % of Patients with Clinical Remission 54.8% 52.5% 66.1% 59.7% 39.8% 43.0% Induction RespondersAll Patients2 n/N3,4 = 119/2171 48 Weeks 50mg 114/2171 96 Weeks 50mg 74/1245 96 Weeks 50mg 40/936 96 Weeks 50mg 82/1245 48 Weeks 50mg 37/936 48 Weeks 50mg
Page 28
28 Obe Ph2 OLE + Historic PBO Rate3 1. FDA package inserts. 2. Clinical remission among week 12 clinical responders; Vermeire et. al., ECCO 2023 Poster #582. 3. Historical placebo rate in maintenance ~18% as reported in a meta-analysis: Sedano R, et al. J Crohns Colitis. 2022;16(2):224-243; we did not run the open-label extension trial against a placebo arm, and such a comparison is provided for illustrative purposes only.* *All clinical remission efficacy numbers are rounded to the nearest whole number as reported in FDA prescribing information in package inserts. 4. EMA Product Summary Characteristics Clinical Remission Maintenance Data At 1 Year Obefazimod OLE data provides potential read-through to Phase 3 ABTECT maintenance data 16% 42% 26% 45% 27% 51% 26% 45% 19% 45% 11% 34% 11% 37% 12% 42% 19% 37% 17% 49% 18% 66% 0% 10% 20% 30% 40% 50% 60% 70% Pbo (N=126) 300mg Q8W (N=122) Pbo (N=175) 90mg Q8W (N=176) Pbo (N=169) 200mg Q4W (N=337) Pbo (N=182) 180mg Q8W (N=179) Pbo (N=190) 100mg Q8W (N=188) Pbo (N=198) 5mg (N=198) Pbo (N=98) 200mg (N=199) Pbo (N=149) 15mg (N=148) Pbo (N=227) 1mg (N=230) Pbo (N=46) 2mg (N=171) Pbo (N/A) 50mg (N=124) Entyvio®1 Week 52 TMCS Stelara®1 Week 52 TMCS Xeljanz®1 Week 52 TMCS Zeposia®1 Week 52 MMS Rinvoq®1 Week 52 MMS Obefazimod Week 48 OLE MMS Omvoh®1 Week 52 MMS Velsipity2 Week 52 MMS Subjects (%) Maintenance Efficacy of FDA/EMA Approved UC Products: Clinical Remission* at 52 Weeks Induction Responders Only ∆ 26% ∆ 19% ∆ 24% ∆ 18%∆ 30%∆ 23% ∆ 32% ∆ 48% For illustrative purposes only. Not a head-to-head comparison. Differences exist between trial designs and subject characteristics, and caution should be exercised when comparing data across trials. Skyrizi®1 Week 52 MMS Tremfya®1 Week 52 MMS ∆ 20% ∆ 25% Biologics Orals Jyseleca®4 Week 52 TMCS ∆ 26%
Page 29
29 Induction and Open-Label Maintenance in Phase 2b Obefazimod vs. Merck’s TL1A (tulisokibart) 29 26.2% 66.1% 26.4% 48.0% 1 % of Patients with Endoscopic Improvement % of Patients with Clinical Response % of Patients with Clinical Remission Clinical Remission Endoscopic ImprovementβClinical Response‡ 62.3% 86.3% 66.2% 68.0% 1 32.8% 70.2% 36.8% 48.0% 1 *250 mg is the high Tul Dose; 100 mg data not shown—lower efficacy rates were achieved †Induction responders were defined as patients who were treated with any obefazimod dose or placebo and achieved clinical response at week 8 of the obefazimod induction trial and entered the open-label maintenance study ◊Induction responders were defined as patients who were treated with the tulisokibart induction dosing regimen and achieved clinical response at week 8 of the tulisokibart induction trial and entered the open-label maintenance study α Clinical remission was defined with the modified Mayo Clinic Score; RB=0, ES=0 or 1, SF=0 or 1 € Clinical remission was defined with the modified Mayo Clinic Score; RB=0, ES=0 or 1, SF=0 or 1 with >1 pt improvement from baseline β Endoscopic improvement was defined as ES of 0 or 1 in both studies ‡Clinical response (per Adapted Mayo Score) is defined as a decrease from baseline in the Modified Mayo Score ≥2 points and ≥3 0 percent from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1 in both programs Link to UEGW 2024 Merck abstract:https://programme.ueg.eu/week2024/#/details/presentations/1076 obefazimod tulisokibart 8 wks 48 wks 12 wks 50 wks Obeα Obeα Tul€ Tul€ 25mg 50mg 250mg Induction Induction Responder† Induction Induction Responder◊ 16/61 82/124 18/68 12/25n/N = 8 wks 48 wks 12 wks 50 wks Obeα Obeα Tul€ Tul€ 25mg 50mg 250mg Induction Induction Responder† Induction Induction Responder◊ 38/61 107/124 45/68 17/25n/N = 8 wks 48 wks 12 wks 50 wks Obeα Obeα Tul€ Tul€ 25mg 50mg 250mg Induction Induction Responder† Induction Induction Responder◊ 20/61 87/124 25/68 12/25n/N = For illustrative purposes only. Not a head-to-head comparison. Differences exist between trial designs and subject characteristics, and caution should be exercised when comparing data across trials.
Page 30
30 Interim Efficacy Results at 3rd/4th Year (W48) or 5th/6th Year (W96) Data are reported in an as observed analysis Clinical remission was defined based on the modified Mayo Clinic Score: rectal bleeding subscore of 0, an endoscopic subscore of 0 or 1, and a stool frequency subscore of 0 or 1. Symptomatic remission was defined based on the modified partial Mayo Clinic Score: rectal bleeding subscore of 0 and a stool frequency subscore of 0 or 1 ABX464-108 Data on File 89.2% 84.1% 86.5% Baseline Week 48 Week 96 116/130 95/113 64/74 Clinical Remission Symptomatic Remission 91.5% 91.2% 91.9% 119/130 Week 96 103/113 68/74 Baseline Week 48
Page 31
31 Induction Maintenance Placebo (n=64) Obefazimod 25 mg (n=62) Obefazimod 50 mg (n=63) Obefazimod 100 mg (n=64) Obefazimod 50 mg (N=217) TEAEs Leading to Trial Discontinuation 5 (7.8%) 4 (6.5%) 9 (14.3%) 8 (12.5%) 17 (7.8%) Headache 5 (7.8%) 13 (21.0%) 19 (30.2%) 27 (42.2%) 25 (11.5%)a Discontinuation Due to Headache 0 (0%) 1 (1.6%) 3 (4.8%) 4 (6.3%) 1 (0.5%) SAEs 4 (6.3%) 1 (1.6%) 4 (6.3%) 4 (6.3%) 18 (8.3%) Serious Infections 0 (0%) 0 (0%) 1 (1.6%) 0 (0%) Safety and Tolerability Profile of Obefazimod: Long-term Results From Phase 2b Trial aAmong patients who experienced headaches, 10 had a dose escalation (eg, received placebo during induction and switched to 50 mg in maintenance; received 25 mg obefazimod during induction and 50 mg obefazimod during maintenance). bOne death was reported during the maintenance phase (car accident, not related to trial treatment). AE, adverse event; SAE, serious adverse event; TEAE, treatment-emergent adverse event; UC, ulcerative colitis. 1. Vermeire S, et al. Lancet Gastroenterol Hepatol. 2022;7(11):1024-1034. 2. Data on file. Abivax. • TEAEs were reported in 58% of patients in the induction trial 1 • AEs reported in ≥5% of patients in any treatment group: headache, nausea, infections, UC • In the maintenance trial, 14% of subjects reported TEAEs 2 • The most common TEAEs up to 2 years: COVID-19, headache, UC, nasopharyngitis, back pain, and arthralgia • The most common TEAE leading to trial discontinuation was headache in induction and colitis ulcerative in maintenance1,2 • There was one malignancy reported (meningioma malignant) and no signal for serious infections 1,2,b Most headaches TEAEs2: ▪ Occurred at treatment initiation ▪ Resolved within 7 days and did not recur ▪ Were mild to moderate in severity ▪ Managed with or without standard medications Safety Summary
Page 32
32 Exposure adjusted incidence rates of TEAEs were generally similar to or numerically lower for obefazimod relative to placebo across >440 PY of exposure • Exposure for all Obe- treated pts (N=274) was 440.1 PY including induction and maintenance periods • EAIR of TEAEs per PY was 1.40 in Obe-treated pts (N=274) and 2.40 in placebo-treated pts (N=73)
Page 33
33 First Patient Enrolled October 11, 2022 Induction Studies Maintenance Study ABTECT Phase 3 Program Design: 2 Induction Trials and 1 Maintenance Trial Source: ABX464-105, ABX464-106, ABX464-107 Obefazimod re-randomization of induction responders Assessment at Week 52 25 mg (n=153) Placebo (n=153) 50 mg (n=306) 25 mg (n=153) Placebo (n=153) 50 mg (n=306) RandomizationRandomization ABX464- 105 (n=612) ABX464- 106 (n=612) ABX464- 107 25 mg (n~150) Placebo (n~150) 50 mg (n~150) Randomization Ulcerative Colitis Program Design Week 8 Week 52 Treatment AssignmentAssessment at Week 8 Treatment Assignment Primary Endpoint: Clinical Remission Primary Endpoint: Clinical Remission RelapsersNon- Responders Non-responder Treatment Arm Induction Data Expected Q3 2025 Maintenance Data Expected Q2 2026 Responders Screening ❑ Moderately to severely active UC defined by: ▪ MMS 5-9, ES>2, RB>1 ❑ Prior failure of conventional and/or biologic/JAKi/S1P ❑ No limit on number of prior treatment failures ❑ Target ~60% bio/JAKi/S1P treatment failure patients Long-Term Extension Offered Up to 4 years or Until Commercialization
Page 34
34 *Upadacitnib- Phase 3 U-ACCOMPLISH and U-ACHIEVE Program, Upadacitinib Phase 2 https://www.gastrojournal.org/article/S0016-5085(20)30241-9/pdf Increase Clinical Trial Awareness and Education Minimize Placebo Response Drive Consistency of Results from Ph2 to Ph3 ▪ Deployed global team of medical science liaisons (MSLs) to engage and educate study sites ▪ Site engagement plan includes R&D Leadership visits with investigators and clinical research teams ▪ Accelerate ABTECT Phase 3 enrollment through expanded global GI congress presence ▪ Wide diversification of trial sites with no single region accounting for more than ~25% ▪ Unlike Phase 2b trial, Phase 3 protocol does not allow concurrent treatment with immunomodulators ▪ Concomitant corticosteroid dose limit reduced from 20 mg in Phase 2b trial to 15 mg in Phase 3 trial ▪ Dropoff in efficacy from Phase 2 to Phase 3 linked to studying more refractory patients in Phase 3 than Phase 2 ▪ Rinvoq’s* efficacy between Phase 2 and Phase 3 remained consistent by studying the same percentage of refractory patients in Phase 2 ▪ Abivax is targeting approximately the same percentage of refractory patients in Phase 3 as studied in Phase 2 ABTECT on pace to complete enrollment in Q2 2025 with top-line induction readout in Q3 2025 Multiple Initiatives Aimed At De-Risking Phase 3 Execution and Outcomes
Page 35
35 In the past 10 years, 9 out of 10 ulcerative colitis products that entered Phase 3 trials went on to gain FDA approval *Conducted Phase 2/3 Combined Studies for UC. Etrolizumab was an injectable monoclonoal antibody. InDex’s cobitolimod, a TLR9 agonist did fail a Phase 3 UC trial in 2023. Cobitolimod was delivered directly to the colon via an enema and was being studied for moderate-to-severe active left sided ulcerative colitis (CONCLUDE study) https://www.prnewswire.com/news-releases/index- pharmaceuticals-discontinues-cobitolimod-phase-iii-program-301995253.html. https://clinicaltrials.gov/study/NCT04985968?cond=ulcerative%20colitis&term=conclude&intr=cobitolimod&rank=1 Product Phase 2 Phase 3 FDA Approval ✓ ✓ ✓ - ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ - ✓ ✓ ✓ ✓ ✓ - ✓ ✘ ✓ ✘ ✘ etrolizumab (mab β7 inhibitor) Key Takeaways ▪ Gilead’s Jyseleca (filgotinib) was positive for its Phase 3 UC trials, but a CRL was received from the FDA due to safety concerns ▪ Genentech’s etrolizumab hit primary endpoints on 2 of its 3 Phase 3 UC induction trials, but failed in 1 induction trial and in both Phase 3 UC maintenance trials * * *
Page 36
36 ENHANCE CD: Phase 2b Trial Design Source: ABX-202 Obefazimod in Crohn’s Disease 36 40-Week Maintenance Phase12-Week Induction PhaseScreening Randomization Up to 4 weeks obefazimod 50 mg daily ❑ Moderately to severely active CD as defined by: ▪ 220 ≤ CDAI ≤ 450 ❑ SES-CD ≥ 6 for ileocolonic or colonic disease or SES-CD ≥ 4 for isolated ileal disease (per central reading) ❑ After failure of conventional therapies and/or biologics/JAK inhibitors Non-responders and loss of response in maintenance Responders Week 52 Total Study Duration: Up to 2 years Week 12 50 mg (n=53) Placebo (n=53) 25 mg (n=53) 12.5 mg (n=53) 50 mg Placebo 25 mg 12.5 mg obefazimod 25 mg Primary Endpoint: Change from baseline in CDAI score at Week 12 1st Patient Enrolled October 2024 Topline Induction Data Expected 2H 2026 Up to 48-Week Extension Phase
Page 37
37 Financial Planning
Page 38
38 2025 Q2 Q3 Anticipated Catalysts Over Next 6 Months Expected Ph 3 topline induction Data readout Q2 ‘25 Anticipated Completion of ABTECT enrollment Q3 ’25 Expected Phase 3 UC Induction Topline Data Last patient randomized in ABTECT Ph 3
Page 39
39 Cash Position Providing Runway Through Anticipated Induction Data and Into Q4 2025 Strategic Initiatives Organization / US Footprint Cash Runway ▪ Beyond current ABTECT program, UC Phase 3 long-term extension ▪ Execution of CD Phase 2b clinical trial ▪ Exploration of additional potential clinical development opportunities for obefazimod (combination therapies, etc.) ▪ Strengthening our organizational structure, notably in Clinical and Medical capabilities ▪ Expanding our US footprint, and opened a US office in Boston in Q4 2023 Cash Runway into Q4’25Existing and New Strategic Initiatives Require Significant R&D Spend Expansion of Clinical and Medical Capabilities, as well as US Footprint ▪ Cash (including financial assets) amounting to €103.6M as of March 31, 2025 ▪ Outstanding shares ~63.4M outstanding shares (Ordinary shares and ADS) as of March 31, 2025. ▪ Cash runway into Q4’25
Page 40
40 Thank You Nasdaq: ABVX / Euronext Paris: ABVX
Page 41
41 Appendix S T R I C T L Y C O N F I D E N T I A L
Page 42
42 Obefazimod returned pro-inflammatory cytokines IL-17 and IL-23 to homeostatic levels in UC patients Source: Apolit C, et al. Clin Transl Gastroenterol. 2023;14(4):e00560; ; ECCO 2023, abstract EC23-1425 IL-17 Levels in Blood at Weeks 1, 4 & 8 (relative change from baseline, %) IL-17 & IL-23 Levels in Rectal Tissues at Week 8 (mean difference from baseline, %) *p-value <0.01 for all 3 doses *p-value <0.01 for 25mg and 50mg only IL-17 IL-23 Solid Bars: Patients with a clinical response at week 8 Shaded Bars: Patients without a clinical response at week 8 *p<0.05; **p<0.01; ***p<0.001 IL-17 is statistically lower in obefazimod treated subjects at week 1, 4, and 8 Change from baseline in IL-17 is statistically significant with obefazimod 25 and 50 mg and in IL-23 with obefazimod 50 mg Relative Change From Baseline (%) % Mean Difference From Baseline %Mean Difference From Baseline * *
Page 43
43 Phase 3 Trial Design Considerations ▪ 25 mg and 50 mg had similar AE profiles in Phase 2b ▪ Induction data indicate dose response between 25 and 50 mg for selected endpoints in Phase 2b ▪ Long term efficacy and safety data for 50 mg, but not 25 mg, available from 2-year open-label maintenance ▪ Regulatory guidelines encourage studying lowest effective dose in maintenance 1. Vermeire S, et al. Lancet Gastroenterol Hepatol. 2022;7(11):1024-1034 *pMMS = partial modified Mayo Clinic Score is comprised of stool frequency sub-score plus rectal bleeding sub-score Dose Selection and Length of Induction Period Phase 2b Trial Indicates Vast Majority of Symptom Improvement Occurred by Week 8 1 Rationale for Inclusion of Two Doses in Phase 3 Program: Rationale for 8 Week Induction Period: ▪ Primary efficacy induction endpoint met at week 8 in Phase 2b trial for both 25 and 50 mg doses ▪ Positive efficacy trends observed in Phase 2a trial at week 8 ▪ pMMS* improvements leveled off by week 8 in Phase 2b ▪ Week 16 data from Phase 2b trial indicate potential for elevated placebo rate by week 16
Page 44
44 Obefazimod Pre-Clinical Combination Program Overview Objective: Evaluate combination treatment with obefazimod in mouse model to assess potential synergies to improve efficacy Process: 1- Identify appropriate preclinical model for each combination (T-cell transfer, acute DSS, chronic DSS) 2- Evaluate combination with Obefazimod and other IBD molecules (small molecules or antibodies) 3- Assess impact on key endpoints (weight loss protection, disease activity index, cytokines reduction) Significant progress with important preclinical data generated since January 2024 Preliminary data in initial combination planned for presentation at upcoming scientific congress
Page 45
45 Improved the response on body weight protection Synergistic and statistically significant reduction of several cytokines (TNFa, IL-17, IL-6, IFNg) in the blood 55 days Obefazimod Etrasimod Obefazimod + Etrasimod Assessment Improved the response on Disease Activity Index Results for the treatment of obefazimod + etrasimod compared to each drug alone Early Preclinical Combination Data of obefazimod and etrasimod in IBD Mouse Model Demonstrated Synergistic Effects