Equillium, Inc. · NASDAQ:EQ
Equillium — Investor Presentation (May 2019)
33 slides from Equillium's investor presentation, May 1, 2019
Slide 1: Harnessing Novel Immunobiology
Harnessing Novel Immunobiology May 2019 www.equilliumbio.com Exhibit 99.1
Slide 2: Safe Harbor Statement
Safe Harbor Statement 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,” “continue” and “ongoing,” or
Slide 3: Delivering powerful new treatment approaches
Delivering powerful new treatment approaches Focused on immuno-inflammatory diseases with high unmet need Driven by an accomplished team rapidly delivering key milestones Our lead asset, itolizumab, is unique; modulating both the activity and trafficking of Teff cells Initial clinical programs are t
Slide 4: Accomplished Management Team
Accomplished Management Team Dan Bradbury Chairman & Chief Executive Officer Bruce Steel, CFA President & Chief Business Officer Steve Connelly, PhD Chief Scientific Officer Jason Keyes Chief Financial Officer Krishna Polu, MD Chief Medical Officer Christine Zedelmayer Vice-President of Operations
Slide 5: CD6/ALCAM Role in Immuno-inflammatory Disease
CD6/ALCAM Role in Immuno-inflammatory Disease Teff cells play an important role in the pathogenesis of T cell mediated diseases driving autoimmune and allergic inflammation Research implicates CD6/ALCAM pathway in disease pathogenesis Initial Indications Transplant Science Neuro- Inflammation System
Slide 6: Itolizumab (EQ001) – First-in-class Lead Program
Itolizumab (EQ001) – First-in-class Lead Program Equillium acquired exclusive rights to itolizumab for the U.S. & Canada from Biocon - partnership provides clinical & commercial product, commercial scale production at FDA regulated facility First-in-class anti-CD6 mAb that inhibits the activity and
Slide 7: Itolizumab Development Strategy
Itolizumab Development Strategy Equillium is well-capitalized and staffed to execute on key programs aGVHD uncontrolled asthma Indication Phase 1 Phase 1b / 2 Phase 3 Expected Milestones FDA Fast Track Orphan Drug Designation lupus nephritis Uncontrolled moderate to severe asthma proof-of-concept tr
Slide 8: The CD6/ALCAM Pathway
The CD6/ALCAM Pathway
Slide 9: CD6/ALCAM Pathway Central to Immuno-inflammation
CD6/ALCAM Pathway Central to Immuno-inflammation T CELL APC / TISSUE CD6 is a co-stimulatory receptor differentially expressed on T cells, subsets of innate lymphoid (ILC) and natural killer (NK) cells, but not on T regulatory cells (Treg) Activated leukocyte cell adhesion molecule (ALCAM), is expre
Slide 10: Itolizumab Modulates CD6/ALCAM Pathway
Itolizumab Humanized IgG1 Kappa Binds to domain 1 of human CD6 with 1.3 nM affinity Inhibits ALCAM binding to CD6 Non-depleting, modulatory action Manufacturing and formulation Manufactured in CHO cells at commercial scale IV and SC formulations available Dosing Half-life IV/SC @ 20/24 days respecti
Slide 11: CD6 – Central Role in Effector Cell Development
CD6 – Central Role in Effector Cell Development Highest levels of CD6 are found on activated T effector cells (Teff) and associated with amplification of the auto-reactive cascade Immune Regulatory “Tolerance” Autoreactive “Autoimmunity” CD6 Low/- CD6 + CD6 Hi CD6 Th1 Th2 Th17
Slide 12: CD6/ALCAM Pathway Central to Immuno-inflammation
CD6/ALCAM Pathway Central to Immuno-inflammation ACTIVITY TRAFFICKING Increased proinflammatory cytokine secretion Suppression of regulatory pathways Increased trafficking of Teff cells into target tissues Optimal immune synapse formation, activation and proliferation
Slide 13: Itolizumab Inhibits Pathogenic T Cell Activity & Trafficking
Itolizumab Inhibits Pathogenic T Cell Activity & Trafficking ACTIVITY TRAFFICKING Decreased proinflammatory cytokine secretion Restoration of regulatory pathways Decreased trafficking of Teff cells into target tissues Inhibits optimal synapse formation co-stimulation, activation and proliferation
Slide 14: Upstream, Disease Modifying Immuno-inflammatory Mechanism
Upstream, Disease Modifying Immuno-inflammatory Mechanism Restoration of immune regulation without immunosuppression Inhibition of Teff trafficking into key target organs Synergistic inhibition of multiple Teff cells and cytokines* Itolizumab acts upstream and selectively targets autoreactive effect
Slide 15: Clinical Strategy
Clinical Strategy
Slide 16: Acute graft-versus-host disease (aGVHD)
Acute graft-versus-host disease (aGVHD) 8,500 30-70% 53% 0 Allo-HSCT’s performed in 2016 4% procedural growth year-over-year Allo-HSCT patients will develop aGVHD Survival rate for steroid responders Number of approved treatments Number of products in development for first-line aGVHD 2 95% Mortality
Slide 17: Itolizumab is a Differentiated aGVHD Treatment Option
Itolizumab is a Differentiated aGVHD Treatment Option Cannabidiol ZEMAIRA® ENTYVIO® Itacitinib JAKAFI® T-Guard™ DEFITELIO® ORENCIA® GLASSIA® Prevention First-line Steroid-Refractory Itolizumab Phase 3 Phase 3 ready Phase 2b Phase 2 Phase 3 ready Phase 2 Phase 3 sNDA Phase 1b/2 Phase 3 ready BLA PROC
Slide 18: Strong Scientific Rationale for Itolizumab in aGVHD
Strong Scientific Rationale for Itolizumab in aGVHD Itolizumab shown to be effective in animal models of GVHD and inflammatory bowel disease (IBD) Ex vivo depletion of CD6+ Teff cells from donor bone marrow prior to allogeneic transplant effectively reduced GVHD incidence CD6+ T cells in drive Th1/T
Slide 19: EQUATE Study for First-line Treatment of aGVHD Patients
EQUATE Study for First-line Treatment of aGVHD Patients Assess the safety and tolerability of intravenous (IV) dosing of itolizumab Determine optimal IV dose level(s) of itolizumab Primary Objectives Secondary Objectives Characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of itolizumab
Slide 20: Uncontrolled moderate to severe asthma
Uncontrolled moderate to severe asthma 2.6mm 1.3mm ~50% 0 Severe asthma patients in the U.S. Patients uncontrolled by standard-of-care treatments (long-acting beta-agonists, inhaled corticosteroids, oral corticosteroids) Of uncontrolled patients do not respond to existing biologic treatments Approve
Slide 21: Itolizumab May Address The Full Spectrum of Uncontrolled Asthma
Itolizumab May Address The Full Spectrum of Uncontrolled Asthma Current therapies target downstream signaling of Th2-associated inflammation Current downstream therapies ineffective in patients with low levels of eosinophils No approved therapies anti-TSLP anti-IgE anti-IL-5 DP2 Agonist CINQAIR® ant
Slide 22: Itolizumab Targets both Th2 and Non-Th2 Asthma Pathogenesis
Itolizumab Targets both Th2 and Non-Th2 Asthma Pathogenesis Modulating CD6-ALCAM pathway attenuates activity and trafficking of Th1 (IFN-γ), Th2 (IL-4,5,13), Th17 (IL-17) cells and cytokines in multiple models of autoimmune and allergic inflammation Transcriptional and histological analyses support
Slide 23: CD6 Upregulation and ALCAM Expression in Severe Asthma Patients
CD6 Upregulation and ALCAM Expression in Severe Asthma Patients ***p<0.001, *p<0.05. Fatal asthma Non-asthma ALCAM CD6 overlay epithelium Lamina propria Lamina propria epithelium Examination of gene expression datasets and lung tissue support the presence of increased CD6, CD4 T cells, and ALCAM in
Slide 24: EQUIP Study in Uncontrolled Moderate to Severe Asthma
EQUIP Study in Uncontrolled Moderate to Severe Asthma Assess the safety and tolerability of subcutaneous dosing of itolizumab Determine optimal subcutaneous dose level(s) of itolizumab Primary Objectives Secondary Objectives Characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of itolizu
Slide 25: Lupus nephritis
Lupus nephritis 100,000 50%-75% 40% 0 9 Lupus nephritis patients in the U.S. Of patients do not respond to frontline treatments Of severe, proliferative patients will progress to end-stage renal disease Approved treatments Products in development Product in development that modulates both the activi
Slide 26: T Cell Directed Therapies Represent a Promising Approach
Current T cell approaches have demonstrated promising efficacy (MMF, Cytoxan), but have significant toxicities and a narrow therapeutic index B cell directed and single cytokine approaches have previously failed in lupus nephritis B cell T cells also secrete pro-inflammatory cytokines, help B cells
Slide 27: Itolizumab Targets Lupus Nephritis Pathogenesis
Itolizumab Targets Lupus Nephritis Pathogenesis Supportive preclinical models in lupus and lupus nephritis Kidney biopsy analysis reveal upregulation of CD6 and ALCAM expression on infiltrating T cells, innate immune cells, and resident renal cells Elevation in urinary ALCAM identifies patients with
Slide 28: Urine ALCAM Elevated in Active Lupus Nephritis
Unbiased screening of >1100 urinary proteins identified urinary ALCAM as a strong predictor of disease activity in lupus nephritis patients Elevations in urinary ALCAM and/or CD6 (Phase 1b) 1 2 3 Identify biomarker and differentiate responders (Phase 2 and 3) Companion diagnostic Commercialization U
Slide 29: Urinary Biomarkers May De-risk Lupus Nephritis Development
Urinary Biomarkers May De-risk Lupus Nephritis Development A number of therapies have been developed in lupus nephritis and SLE that have failed; Reasons include: Heterogeneity of patient population – differences in disease mechanisms by patient Safety / therapeutic index Trial design 1 2 3 Leveragi
Slide 30: Corporate
Corporate
Slide 31: Corporate
Corporate Robust IP portfolio and 12-year Biologics Exclusivity Biocon partnership provides risk-mitigated product supply on attractive terms CMC completed and itolizumab currently manufactured at commercial scale in FDA-regulated facility Drug product supplied at no cost for 3 concurrent orphan ind
Slide 32: Summary
Summary Focused Development: Strong scientific rationale and translational validation supporting initial indications in areas of unmet need; launching multiple clinical studies during 2019 Pipeline-in-a-product: Itolizumab has broad potential disease modifying therapeutic utility First-in-class: Ito
Slide 33: Equillium, Inc.
Equillium, Inc. 2223 Avenida de la Playa / Suite 105 La Jolla, CA 92037 www.equilliumbio.com ir@equilliumbio.com