Equillium, Inc. · NASDAQ:EQ
Equillium — Investor Presentation (November 2018)
30 slides from Equillium's investor presentation, Nov 13, 2018
Slide 1: Harnessing Novel Immunobiology
Exhibit 99.1 Harnessing Novel Immunobiology November 2018Exhibit 99.1 Harnessing Novel Immunobiology November 2018
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: Executive Summary
Executive Summary First-in-class: Equillium is developing EQ001 (itolizumab) the first antibody targeting the novel immune checkpoint pathway CD6 – for the treatment of severe immuno-inflammatory disorders Pipeline-in-a-product: as a unique T cell modulator, EQ001 has potential broad, best-in-class,
Slide 4: CD6 Plays a Central Role in Immuno-inflammation
CD6 Plays a Central Role in Immuno-inflammationCD6 Plays a Central Role in Immuno-inflammation
Slide 5: Immuno-inflammation: Severe Disease, High Unmet Medical Need
Immuno-inflammation: Severe Disease, High Unmet Medical Need Acute Graft-Versus- Host Disease Solid Organ Chronic Graft-Versus- Rejection Host Disease Multiple Sclerosis Crohn’s Disease Neuromyelitis Optica Ulcerative Colitis Severe Asthma Vasculitis Lupus Interstitial Lung Diseases Scleroderma Chro
Slide 6: CD6 Plays a Central Role in Immuno-inflammatory Disease
CD6 Plays a Central Role in Immuno-inflammatory Disease T cell mediated diseases Acute Graft-Versus- Host Disease Solid Organ Chronic Graft-Versus- Rejection Effector T cells, or T , play an eff Host Disease important role in the pathogenesis of T cell mediated diseases driving Multiple Sclerosis Cr
Slide 7: The Basis of Immuno-inflammation
The Basis of Immuno-inflammation Immuno-inflammatory diseases can be fundamentally characterized by an imbalance between effector cell and immuno-regulatory activity Tolerance Autoimmunity T reg T T reg f ef T eff T eff T eff 7The Basis of Immuno-inflammation Immuno-inflammatory diseases can be fund
Slide 8: CD6 is Central to Immuno-inflammation
CD6 is Central to Immuno-inflammation Highest levels of CD6 are found on activated T effector cells (T ) and associated with eff amplification of the auto-reactive cascade Low/- CD6 CD6 + CD6 Hi T 1 h T 2 h T 17 h CD6 Immune Regulatory Autoreactive “Tolerance”“Autoimmunity” 8CD6 is Central to Immuno
Slide 9: CD6 Drives Pathogenic T Cell Activity & Trafficking
CD6 Drives Pathogenic T Cell Activity & Trafficking Co-stimulation = Activation Proliferation Differentiation / Survival Trafficking Suppression of regulatory pathways 9CD6 Drives Pathogenic T Cell Activity & Trafficking Co-stimulation = Activation Proliferation Differentiation / Survival Traffickin
Slide 10: EQ001 Inhibits Pathogenic T Cell Activity & Trafficking
EQ001 Inhibits Pathogenic T Cell Activity & Trafficking Inhibition = Activation Proliferation Differentiation / Survival Trafficking Restoration of regulatory pathways 10EQ001 Inhibits Pathogenic T Cell Activity & Trafficking Inhibition = Activation Proliferation Differentiation / Survival Trafficki
Slide 11: Upstream, Disease Modifying Immuno-inflammatory Mechanism
Upstream, Disease Modifying Immuno-inflammatory Mechanism EQ001 is designed to selectively target autoreactive effector T cell activity and trafficking, while sparing regulatory T cells to promote immune tolerance and durable disease remission Inhibition of T effector cells… Inhibition of traffickin
Slide 12: Clinical Strategy
Clinical StrategyClinical Strategy
Slide 13: Itolizumab is Clinically Validated in Autoimmune Disease
Itolizumab is Clinically Validated in Autoimmune Disease Phase 3 pivotal trial results: demonstrated efficacy & safety in psoriasis patients (n=223) Efficacious TREAT-PLAQ – Trial Results Safe & Tolerable Treatment Dosing Week 0-4 Dosing Week 5-12 PASI 75 Week 12 Dosing Week 12+ ALZUMAb Placebo Arm
Slide 14: Opportunity in Multiple Severe Autoimmune Indications
Opportunity in Multiple Severe Autoimmune Indications Scientific Rationale Translational Research Commercial Analysis Clinical Development ê Genetic data implicates CD6ê Bioinformaticsê High unmet medical needê Clear development path + ê Pathogenic CD6 cells ê Cell-based assaysê Steroid insensitive
Slide 15: GVHD Remains an Area of High Unmet Medical Need
GVHD Remains an Area of High Unmet Medical Need aGVHD ~50% of HSCT Steroids remain SOC for cGVHD first-line treatment of ~30-70% of HSCT aGVHD and cGVHD Bronchiolitis Obliterans Mortality from aGVHD as Advanced aGVHD skin Advanced aGVHD Gut of the Lung in cGVHD high as 95% in steroid refractory pati
Slide 16: GVHD is a Significant & Growing Market Opportunity
GVHD is a Significant & Growing Market Opportunity Projected US aGVHD incidence and GVHD prevalence by the year 2025 Ø Annual incidence of aGVHD up to 6,000 Ø Total prevalence of GVHD up to 35,000 Currently, limited available FDA approved therapies Ø Significant need for safe and effective therapies
Slide 17: CD6 Plays a Central Role in GVHD
CD6 Plays a Central Role in GVHD Ø Autoreactive T cells drive tissue damage in GVHD eff Ø T cells overexpress CD6 eff Ø CD6 co-stimulation results in increased T cell activation, eff proliferation and increased secretion of pro-inflammatory cytokines including IFN-γ, TNF-α, IL-6 and IL-17 Ø CD6 co-s
Slide 18: aGVHD Study Designed for Early POC
aGVHD Study Designed for Early POC Treatment Study Population • Patients at first presentation of aGVHD• Frontline therapy with 48 hours of • High risk patients enriched for Grade III/IV aGVHD presentation concomitant with steroids • Five doses administered Q2W who typically respond poorly to steroi
Slide 19: Severe Asthma: Significant Need in Severe Refractory Patients
Severe Asthma: Significant Need in Severe Refractory Patients Severe Asthma patients are characterized by: Poor symptom control Frequent severe exacerbations including related hospitalizations Decline in lung function (FEV1) Requires treatment with high dose inhaled corticosteroids, systemic cortico
Slide 20: T Cells Expressing CD6 Drive Severe Refractory Asthma
T 17 Cells Expressing CD6 Drive Severe Refractory Asthma h Reciprocally regulated T 2-High T 2-Low Non-T 2 h h h Eosinophils Low Eosinophils Neutrophils Response to steroids No approved Current therapies target downstream Current downstream therapies ineffective in therapies signaling of T 2-associa
Slide 21: CD6 is Upregulated in Severe Asthma Patients
CD6 is Upregulated in Severe Asthma Patients Analysis of gene expression in cells collected from lungs of healthy non-asthma, moderate asthma and severe asthma patients as part of two multi-center prospective observational studies Ø Analysis of gene expression datasets support the presence of increa
Slide 22: Asthma Next Steps
Asthma Next Steps We plan to initiate a proof-of-concept study in the first half of 2019 Trial will focus on studying non-eosinophilic severe asthma patients refractory to steroids Study objectives will include an assessment of PK/PD, dose finding, safety, and efficacy Subcutaneous dosing (supported
Slide 23: Corporate
CorporateCorporate
Slide 24: Partnership with a Leading Global Biopharma Company
Partnership with a Leading Global Biopharma Company Ø Leading global biologics manufacturer with FDA regulated cGMP facilities Ø World’s fourth largest insulin producer, and leading bio-similar developer: insulin glargine ® ® ® ® (Lantus ), adalimumab (Humira ), bevacizumab (Avastin ), etanercept (E
Slide 25: Partnership for U.S. & Canada
: Partnership for U.S. & Canada Equillium exclusive licensee to itolizumab for U.S. & Canada Ø Biocon is a significant minority shareholder in Equillium Biocon partnership provides clinical and commercial supply of our drug product: Ø Biocon has completed CMC & manufactures drug product at commercia
Slide 26: Intellectual Property & Market Exclusivity
Intellectual Property & Market Exclusivity Orphan Designation -7 years Projected FDA regulatory exclusivity Biologics Exclusivity If eligible, would be -12 years granted upon U.S. approval 2010 2020 2030 2040 Patent term 2005 2015 2025 2035 Method of Treating Severe Asthma Provisional Application (2
Slide 27: 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 Krishna Polu, MD Chief Medical Officer Jason Keyes Chief Financial Officer David Essayan, MD Head of Regulatory Affairs Christ
Slide 28: EQ001 Development Strategy
EQ001 Development Strategy We are leveraging our deep understanding of the CD6 pathway to develop EQ001 for multiple severe immuno-inflammatory disorders Therapeutic Indication Phase 1 Phase 1b / 2 Phase 3 Expected Milestones Area aGVHD IND open Phase 1b/2 aGVHD trial to initiate early 2019 Transpla
Slide 29: Executive Summary
Executive Summary First-in-class: Equillium is developing EQ001 (itolizumab) the first antibody targeting the novel immune checkpoint pathway CD6 – for the treatment of severe immuno-inflammatory disorders Pipeline-in-a-product: as a unique T cell modulator, EQ001 has potential broad, best-in-class,
Slide 30: Equillium, Inc.
Equillium, Inc. 2223 Avenida de la Playa / Suite 108 La Jolla, CA 92037 www.equilliumbio.comEquillium, Inc. 2223 Avenida de la Playa / Suite 108 La Jolla, CA 92037 www.equilliumbio.com