Slide 1: Phase 3 EQUATOR Data Presentation
Phase 3 EQUATOR Data Presentation March 27, 2025
Slide 2: Forward-Looking Statements and Other Disclaimers
Forward-Looking Statements and Other Disclaimers This presentation contains forward-looking statements about Equillium, Inc. (the “Company”). In some cases, you can identify forward-looking statements by the words “will,” “expect,” “intend,” “plan,” “objective,” “believe,” “estimate,” “potential,” “
Slide 3: A Differentiated Approach to Treating Immuno-Inflammatory Disease
A Differentiated Approach to Treating Immuno-Inflammatory Disease Selectively targets auto-reactive effector T cells, while sparing regulatory T cells to promote immune tolerance and homeostasis, resulting in durable disease remission Synergistic inhibition of multiple Inhibition of Teff Restoration
Slide 4: aGVHD: No Drugs Approved in First-line Treatment
aGVHD: No Drugs Approved in First-line Treatment Growing strategic interest in GVHD with recently demonstrated market potential: JAKAFI: US sales estimated at $500M REZUROCK: US sales estimated at $425M (acquired by Sanofi $1.9B in 2021) 1L aGVHD 2L SR aGVHD 1L cGVHD 2L/3L cGVHD No approvals No appr
Slide 5: Itolizumab
Itolizumab First-in-Class immune-modifying mAb targeting the CD6-ALCAM Phase 3 EQUATOR Study signaling pathway Efficacy & Safety Data
Slide 6: EQUATOR Study: First-line Treatment of aGVHD
EQUATOR Study: First-line Treatment of aGVHD Phase 3 randomized, double-blind, global pivotal study of itolizumab in 158 patients John Koreth, MD, Dana-Farber Cancer Institute, Principal Investigator 9 of top 10 U.S. allogeneic HSCT centers High exposure of itolizumab to key hospital systems and KOL
Slide 7: Baseline Demographics & Characteristics (ITT population)
Baseline Demographics & Characteristics (ITT population) Itolizumab (n=79) Placebo (n=79) TOTAL* (n=158) Age (years), median (range) 60 (21-73) 58 (18-75) 59 (18-75) Sex, n (%) Male 44 (55.7) 39 (49.4) 83 (52.5) Female 35 (44.3) 40 (50.6) 75 (47.5) Region, n (%) Europe 41 (51.9) 38 (48.1) 79 (50.0)
Slide 8: Summary of Safety Results
Summary of Safety Results Itolizumab demonstrated favorable safety and tolerability Did not increase the risk of clinical sequelae, including rates of infection and sepsis Treatment Emergent Adverse Events (Safety Population / mITT) Itolizumab Placebo Total Event, n (%) N=78 N=77 N=155 Subjects with
Slide 9: Steroid Tapering
Steroid Tapering Median initial dose on Day 1 was 1.79 and 1.80 mg/kg MPE or equivalent for itolizumab and placebo, respectively (mITT) Topline data with a cut-off date of 11-Dec-2024 and subject to change. Data presented as mean (SD) 9 Abbreviations: mITT, modified intent-to-treat; MPE, methylpredn
Slide 10: aGVHD Response Durable Complete Response
Primary and Key Secondary Outcomes Day 29 CR and ORR (ITT) Durable CR* Day 29-99 (ITT) (Key Secondary Endpoint) CR ORR (Primary Endpoint) (Key Secondary Endpoint) All Subjects Subjects with Day 29 CRs* p-value=0.005 80.0% 80.0% Durable Complete Response 67.6% 62.0% aGVHD Response 60.0% 54.4% 60.0% n
Slide 11: CR at Day 99: Achieved Statistical Significance
CR at Day 99: Achieved Statistical Significance Itolizumab maintains durable response through drug exposure window compared to placebo Number of Subjects 0 10 20 30 40 50 60 70 80 Day 8 Itolizumab 26 26 19 Placebo 21 28 24 Itolizumab 32 19 17 Day 15 Placebo 24 10 22 Day 29 Itolizumab 34 15 12 Placeb
Slide 12: Duration of Complete Response: Achieved Statistical Significance
Duration of Complete Response: Achieved Statistical Significance Itolizumab Complete Responders had statistically significant DOCR1 with a median 336 days vs. 72 days observed on placebo Itolizumab Placebo DOCR1 (ITT) (n=34) (n=38) Total Subjects with Events, n 12 22 Death 5 4 Received new anti-GVHD
Slide 13: Failure Free Survival: Achieved Statistical Significance
Failure Free Survival: Achieved Statistical Significance Itolizumab demonstrated statistically significant Failure Free Survival with a median 154 days vs. 70 days observed on Placebo Failure Free Survival Itolizumab Placebo (mITT) (n=78) (n=77) Event, n 40 52 Death 7 7 Primary disease relapse 6 7 R
Slide 14: Overall Survival: Demonstrated Positive Trend
Overall Survival: Demonstrated Positive Trend Itolizumab demonstrated positive trend in Overall Survival with mortality at 24.4% vs. 32.5% observed on placebo Overall Survival Itolizumab Placebo (mITT) (n=78) (n=77) Deaths, n 19 (24.4%) 25 (32.5%) Subjects Censored*, n 59 52 KM Rate (95% CI) At Day
Slide 15: Summary of Efficacy Results
Summary of Efficacy Results Achieved statistically significant and clinically meaningful longer-term outcomes Endpoint, n (%) Itolizumab Placebo p-value ITT (N=79) / mITT (N=78) ITT (N=79) / mITT (N=77) CR at Day 29 (ITT), n (%) (Primary Endpoint) 34 (43.0) 38 (48.1) NSS ORR at Day 29 (ITT), n (%) (
Slide 16: Itolizumab: Executive Summary
Itolizumab: Executive Summary Breakthrough Therapy designation submitted and FDA has granted a meeting to review potential for Accelerated Approval, with outcome expected May 2025 (Orphan Drug & Fast Track designations previously granted) Itolizumab Phase 3 EQUATOR study in first-line acute graft-ve
Slide 17: Thank you
Thank you www.equilliumbio.com