Equillium, Inc. · NASDAQ:EQ
Equillium — Corporate Update (October 2024)
23 slides from Equillium's corporate update, Oct 31, 2024
Slide 1: Itolizumab Update
Exhibit 99.1 Itolizumab Update October 31, 2024
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: Equillium Retains Rights to Itolizumab
Equillium Retains Rights to Itolizumab Ono provided substantial non-dilutive funding for itolizumab through two key milestones: 1. Positive interim data analysis in Phase 3 EQUATOR study of first-line aGVHD: • “Study should proceed” recommendation from the IDMC 2. Positive PoC data in Phase 1b EQUAL
Slide 4: Diversified Pipeline of Differentiated Immunology Assets
Diversified Pipeline of Differentiated Immunology Assets Indication Pre-Clinical Phase 1 Phase 2 Phase 3 Rights Status FDA Fast Track & Enrollment paused: Potential acceleration acute graft-versus-host disease of topline data to Q1 2025 Orphan Drug Designations US, CAN, EQ001 FDA Fast Track AUS & NZ
Slide 5: Itolizumab: Critical Mass of Safety Data and Positive Clinical Results
Itolizumab: Critical Mass of Safety Data and Positive Clinical Results Over 1,000 subjects dosed with itolizumab across numerous clinical studies Acute GVHD - Pivotal Phase 3 (ongoing) IDMC Interim Review @ 100 patients in July 2024; recommended study should proceed Acute GVHD - Phase 1b (completed)
Slide 6: Itolizumab: First-in-Class immune-modifying mAb targeting the CD6-ALCAM pathway
Itolizumab First-in-Class immune-modifying mAb targeting the CD6-ALCAM signaling pathway
Slide 7: CD6-ALCAM Pathway is Central to Immuno-Inflammation
CD6-ALCAM Pathway is Central to Immuno-Inflammation CD6 is a co-stimulatory receptor overexpressed on T eff T cell eff activation and down-regulated on T reg High CD6 cells exhibit greater pathogenic capacity Activated leukocyte cell adhesion molecule (ALCAM), is expressed on both antigen-presenting
Slide 8: High CD6 Cells Exhibit Greater Pathogenic Capacity
High CD6 Cells Exhibit Greater Pathogenic Capacity Highest levels of CD6 are found on activated T effector cells (T ) and associated with eff amplification of the auto-reactive cascade low/- high CD6 CD6 • Low proliferation• High Proliferation T • Regulatory phenotype• Pathogenic Phenotypes reg T ef
Slide 9: Itolizumab-induced Loss of Cell Surface CD6 Inhibits Teff Cells
Itolizumab-induced Loss of Cell Surface CD6 Inhibits T Cells eff Itolizumab leads to loss of CD6 in both a dose and time-dependent † manner resulting in T cells that are hyporesponsive to TCR stimulation Pathogenic hi CD6✱✱✱ ✱✱ T Cells 20000 500000 eff 1.2 400000 15000 0.9 1* 300000 10* 10000 0.6 It
Slide 10: 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 T Restoration of
Slide 11: Itolizumab Acute Graft-Versus-Host Disease
Itolizumab Acute Graft-Versus-Host Disease
Slide 12: Itolizumab in GVHD: Executive Summary
Itolizumab in GVHD: Executive Summary • Positive topline data from Phase 1b EQUATE study in acute graft-versus-host disease • Achieved CR and ORR at Day 29 of 61% and 67%, respectively* • Response at Day 29 was associated with improved progression-free survival through 1 year • Responders were able
Slide 13: GVHD Competitive Landscape
GVHD Competitive Landscape Growing strategic interest in GVHD with recently demonstrated market potential: JAKAFI: US sales in SR-aGVHD and 2L cGVHD estimated at $500M REZUROCK: US sales in 2L cGVHD estimated at $425M, ~3 years into launch (acquired by Sanofi $1.9B in 2021) Prophylaxis 1L acute GVHD
Slide 14: Standard of Care: High-Dose Steroids Achieve Poor CR Outcomes
Standard of Care: High-Dose Steroids Achieve Poor CR Outcomes MacMillan Steroids alone yield poor Complete Response rates et al. 2015 GRAVITAS-301 EQUATE (steroids alone) (steroids alone) (itolizumab + steroids) 100% Complete Reponses are associated with improved long-term clinical outcomes Standard
Slide 15: EQUATOR Study: First-line Treatment of High-Risk aGVHD
EQUATOR Study: First-line Treatment of High-Risk aGVHD Over 50 US clinical sites active, including 9 of top 10 U.S. allogeneic HSCT centers High exposure of itolizumab to key hospital systems and KOLs Phase 3 randomized, double-blind, global pivotal study of itolizumab in ~ 200 patients John Koreth,
Slide 16: Itolizumab Ulcerative Colitis
Itolizumab Ulcerative Colitis
Slide 17: Itolizumab in Ulcerative Colitis: Executive Summary
Itolizumab in Ulcerative Colitis: Executive Summary Strong mechanistic rationale Near term Phase 2 clinical data in GI disease read out high • CD6 T cells have greater • Itolizumab vs. placebo vs. adalimumab eff pathogenic potential and are study complete (n=90) associated with GI inflammation • Top
Slide 18: UC Phase 2 Study – Conducted by Biocon in India
UC Phase 2 Study – Conducted by Biocon in India Itolizumab Q2W + SoC + SoC (Fixed Dose 140 mg) ltolizumab Q2W + SoC N=3 n=30 Primary endpoint: Proportion of subjects who Biologics naive achieved clinical remission patients with Placebo + SoC per Total Mayo Score at moderate to severe Placebo + SoC W
Slide 19: Corporate
Equill equi uM Corporate
Slide 20: Itolizumab Intellectual Property & Regulatory Exclusivity
Itolizumab Intellectual Property & Regulatory Exclusivity Biologics Exclusivity 12 years Itolizumab Compositions / Methods 12 patent families Formulations 27 issued patents 34 applications pending Method of Treating MS and IBD (as of October 2024) Method of Inhibiting CD6 Method of Treating Lupus Me
Slide 21: Equillium Financial Overview
Equillium Financial Overview Key Financial Metrics $ Total Cash and Investments (as of June 30, 2024) 33.3 M $ Q2 2024: Net Cash Generated (as of June 30, 2024) 0.7 M Equillium funded * Shares Outstanding (as of August 5, 2024) 35.4 M into Q4 2025 $ Market Cap (as of close October 30, 2024) 48.9 M P
Slide 22: Equillium Summary
Equillium Summary Anticipated Major Milestones Itolizumab Derisked • Phase 3 aGVHD topline data – potential to • EQUATOR Phase 3 interim safety and efficacy review July 2024: accelerate to Q1 2025 (modified study) IDMC recommended study to proceed as planned • Phase 2 Ulcerative Colitis data expecte
Slide 23: Thank you
Thank you www.equilliumbio.com 23