Equillium, Inc. · NASDAQ:EQ
Equillium — Investor Presentation (March 2021)
40 slides from Equillium's investor presentation, Mar 9, 2021
Slide 1: Harnessing Novel Immunobiology
Harnessing Novel Immunobiology March 2021 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: Novel Treatments for Severe Immuno-inflammatory Disorders
Our mission is to dramatically improve the lives of patients through the development of novel immunotherapies Leaders in CD6 biology developing itolizumab, a first-in-class anti-CD6 antibody targeting the CD6-ALCAM pathway Itolizumab is a validated therapeutic with differentiated mechanism of action
Slide 4: Pipeline in a Product: Broad Therapeutic Potential of Itolizumab
Pipeline in a Product: Broad Therapeutic Potential of Itolizumab T Cell Mediated Immuno-inflammatory Diseases 4
Slide 5: Accomplished Management Team
Accomplished Management Team Bruce Steel, CFA Chief Executive Officer Steve Connelly, PhD Chief Scientific Officer Jason Keyes Chief Financial Officer Dolca Thomas, MD EVP Research & Development, Chief Medical Officer Christine Zedelmayer Chief Operating Officer Joel Rothman Chief Development Office
Slide 6: Itolizumab Development Strategy
Highly differentiated mechanism of action with potential broad therapeutic utility Itolizumab Development Strategy 6
Slide 7: Our Journey to Improve Patient Lives
Strategic partnership with Biocon Limited (Biocon): exclusive rights to commercialize itolizumab in the U.S., Canada, Australia, New Zealand Includes commercial-scale manufacturing drug product supply agreement Three clinical development programs ongoing; initial data promising Strong cash balance a
Slide 8: Itolizumab & CD6-ALCAM Pathway
Itolizumab & CD6-ALCAM Pathway
Slide 9: CD6-ALCAM Pathway Central to Immuno-inflammation
CD6 is a co-stimulatory receptor expressed on T cells, differentially expressed on subsets of innate lymphoid (ILC) and natural killer (NK) cells, but not on T regulatory cells (Treg) Activated leukocyte cell adhesion molecule (ALCAM), is expressed on both antigen-presenting cells and endothelial/ep
Slide 10: CD6 Expression Associated with T Cell Function
CD6 Expression Associated with T Cell Function Highest levels of CD6 are found on activated T effector cells (Teff) and associated with amplification of the auto-reactive cascade CD6 Low/- CD6 + CD6 Hi CD6 Th1 Th2 Th17 10
Slide 11: 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 11
Slide 12: CD6High Cells Exhibit Greater Pathogenic Capacity
CD6high High Proliferation Pathogenic Phenotypes Pro-inflammatory cytokines CD6low/- Low proliferation Regulatory phenotype Anti-inflammatory cytokines CD6High Cells Exhibit Greater Pathogenic Capacity Consuegra-Fernandez et al., Cell Mol Immunol 2018; Ma et al., J Crohns & Colitis 2019 12
Slide 13: Extensive Evidence Supports targeting CD6-ALCAM Pathway
Extensive Evidence Supports targeting CD6-ALCAM Pathway 13 13
Slide 14: Itolizumab Reduces Levels of Cell Surface CD6
Itolizumab Reduces Levels of Cell Surface CD6 Levels of CD6 on itolizumab treated cells normalized to isotype treated cells* *3 independent experiments on Donor 1041 (unstimulated PBMCs) IgG binds to domain-1 of CD6 Dose-dependent loss of CD6 resulting in hyporesponsive T cells Pharmacodynamic marke
Slide 15: 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 16: Clinical Strategy
Clinical Strategy
Slide 17: Acute graft-versus-host disease (aGVHD)
Acute graft-versus-host disease (aGVHD) 10,000 30-70% 53% 0 Allogeneic HSCTs performed in 2020, with incidence increasing Allogeneic HSCT patients will develop aGVHD Reported 5 year survival rate for responders to first-line treatment with corticosteroids Number of approved treatments for first-line
Slide 18: Itolizumab has Potential to be a First-line aGVHD Treatment
Itolizumab has Potential to be a First-line aGVHD Treatment JAKAFI® First-line Steroid-refractory Itolizumab Phase 1b/2 CRL Remestemcel-L Acute GVHD 0-100 days post-transplant Dual mode of action inhibits the activity and trafficking of Teff cells We believe itolizumab, if approved, has the potentia
Slide 19: EQUATE Study for First-line Treatment in aGVHD
EQUATE Study for First-line Treatment in aGVHD Assess the safety and tolerability of 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 Assess the clinical act
Slide 20: Interim Data Assessing EQUATE aGVHD Response Rates
Interim Data Assessing EQUATE aGVHD Response Rates Responses observed have been rapid and durable, with a majority of patients achieving a CR within the first 15 days and maintaining responses through Day 85 Adverse events reported with the EQUATE trial have been consistent with the safety profile p
Slide 21: Itolizumab: Interim Responses Higher Than Published Rates in aGVHD
Itolizumab: Interim Responses Higher Than Published Rates in First-line Treatment of High-Risk aGVHD 80% ORR 61% ORR 27% 16% partial response very good partial response complete response Response Rate at Day 29 Response rates in high risk aGVHD patients MacMillan: steroids alone ORR / CR: 43% / 27%
Slide 22: Itolizumab Associated with Dose Reduction in Systemic Steroid Use
Protocol specified steroid use of 2mg/kg of methylprednisolone or equivalent at initiation Steroid tapering was not mandated as part of the protocol; investigators could titrate as clinically indicated and per institutional protocols Data presented as mean (SD); Equivalent prednisone dose was calcul
Slide 23: Dose Responsive Reduction of CD6 with Itolizumab Treatment
Dose Responsive Reduction of CD6 with Itolizumab Treatment * Data from 9 patients, 3 per cohort. Study ongoing – data subject to change Interim PD data from 1st three cohorts suggests optimal dose range at 0.8 to 1.6 mg/kg 23 Pre 3rd dose
Slide 24: Clinical Regulatory Strategy and Lifecycle Considerations
Equillium plans to engage with FDA in 1H 2021 with goal to discuss: Dosing and design for pivotal program Potential of conducting a single pivotal trial to support a biologics license application (BLA) submission for an indication of first-line treatment of aGVHD Potential Development Timeline to BL
Slide 25: Lupus nephritis
Lupus nephritis 100,000 50%-75% 40% 2 13 1 A heterogeneous disease that is the most frequent and serious manifestation of systemic lupus erythematosus (SLE) All numbers are approximate and based on published reports Product in development designed to modulate both the activity and trafficking of Tef
Slide 26: T Cell Directed Therapies Represent a Promising Approach to Treat Lupus Nephritis
LUPKYNIS ® Teff 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 in Phase 3 trials B cell T cells also secrete pro-inf
Slide 27: Therapies Hitting a Ceiling in Achieving Complete Responses
Therapies Hitting a Ceiling in Achieving Complete Reponses Renal Survival by Response Rates – Highlights the Importance of Achieving Complete Remission (CR) * Study ongoing – data subject to change Exploring combinations of novel and complementary targeted therapies and/or precision medicine approac
Slide 28: CD6 & ALCAM-expressing Cells are Elevated in LN Patients
CD6 & ALCAM-expressing Cells are Elevated in LN Patients Renal Epithelial Renal Leukocytes Urine Leukocytes CD6 ALCAM 9x 16x 11x Dataset derived from AMP (Arazi et al., 2019). Analysis by Dr. Chaim Putterman. 28
Slide 29: ALCAM has been shown to be a Predictive Biomarker in Lupus Nephritis
Stanley et al., 2016. Comprehensive Aptamer-Based Screening of 1129 Proteins Reveals Novel Urinary Biomarkers of Lupus Nephritis. ACR/ARHP Annual Meeting. ALCAM has been shown to be a Predictive Biomarker in Patients with Active Lupus Nephritis Unbiased screening of >1100 urinary proteins identified
Slide 30: Lupus Phase 1b Study Design: Type A and B Cohorts
Type A Cohort and B Cohorts Assess the safety and tolerability of itolizumab in subjects with SLE with and without active proliferative lupus nephritis Determine optimal subcutaneous dose level(s) of itolizumab Secondary Objectives Type A Cohort and B Cohorts Characterize the pharmacokinetics (PK) a
Slide 31: Uncontrolled moderate to severe asthma
Uncontrolled moderate to severe asthma 2.6M 1.3M ~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 Approved
Slide 32: Itolizumab under Development to Address the Full Spectrum of Uncontrolled Asthma
Itolizumab under Development to 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 CINQAIR
Slide 33: CD6-ALCAM Pathway is Elevated in Patients with Severe Asthma
Upregulation of CD6 & ALCAM in Severe Asthma Patients ***p<0.001, *p<0.05. Examination of gene expression datasets support the presence of increased CD6, CD4 T cells, and ALCAM in the lungs of severe asthma patients Study of the Mechanisms of Asthma (MAST; NCT00595153); Bronchoscopic Exploratory Res
Slide 34: CD6-ALCAM Pathway is Elevated in Patients with Severe Asthma (lung tissue)
Upregulation of CD6 & ALCAM in Severe Asthma Patients Examination of lung tissue demonstrates the presence of increased CD6, T cells, and ALCAM in the lungs of severe asthma patients Fatal asthma patients – lung tissue staining suggests increased numbers of CD6+ cells, upregulation of ALCAM in the l
Slide 35: EQUIP Study in Uncontrolled Asthma
EQUIP Study in Uncontrolled 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 itolizumab Assess the clin
Slide 36: Corporate
Corporate
Slide 37: Strong Intellectual Property Portfolio / Regulatory Exclusivity
Strong Intellectual Property Portfolio / Regulatory Exclusivity Orphan Designation 7 years Biologics Exclusivity 12 years in US 2006 2014 2022 2030 2010 2018 2026 2034 2038 2042 Compositions / Methods - U.S. Patent No. 8,524,233 Patent term ~ 2028 Method of Treating Lupus – U.S. Application 16/343,1
Slide 38: Equillium Financial Overview
Equillium Financial Overview Lean operating model and disciplined control of spending Well capitalized to reach near-term catalysts Key Financial Metrics Please refer to the Form 10-Q filed on November 10, 2020, for the complete financials of the company as of September 30, 2020 38 * Closed $30M fin
Slide 39: Multiple Catalysts in 2021
Multiple Catalysts in 2021 Financed through completion of ongoing clinical trials with funding in place to advance itolizumab into later-stage trials 39 *Proposed protocol & timeline for site initiation contingent on regulatory review
Slide 40: Equillium, Inc.
Equillium, Inc. 2223 Avenida de la Playa / Suite 105 La Jolla, CA 92037 www.equilliumbio.com ir@equilliumbio.com