Equillium, Inc. · NASDAQ:EQ
Equillium — Investor Day (October 2023)
53 slides from Equillium's investor day presentation, Oct 16, 2023
Slide 1: Analyst & Investor Day
Analyst & Investor Day With Dr. Arash Mostaghimi October 16, 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements about Equillium, Inc. (the Actual results or events could differ materially from the plans, intentions and “Company”). In some cases, you can identify forward-looking statements by expectations disclosed or implied in t
Slide 3: Today's Agenda and Speakers
Today’s Agenda Speakers Welcome: Pipeline Overview Guest Speaker Bruce Steel, CEO Arash Mostaghimi, M.D., M.P.A., M.P.H. Associate Professor of Dermatology Powerful Multi-Cytokine Platform Harvard Medical School Steve Connelly, CSO Director, Inpatient Consultation Service, Department of Dermatology
Slide 4: Equillium Snapshot & Investment Highlights
Equillium Snapshot & Investment Highlights First-in-Class Immunology Assets Leaders in Novel immunobiology Multi-Cytokine Partnership for Inhibitors Itolizumab Developing high-impact, novel therapeutics to treat autoimmune and Multiple Clinical Stage Multiple Near-term inflammatory disorders Program
Slide 5: Diversified Pipeline of First-In-Class Immunology Assets
Diversified Pipeline of First-In-Class Immunology Assets Drugs Indication Pre-Clinical Phase 1 Phase 2 Phase 3 Partners Anticipated Milestones EQ101 Q4 2023 initial data PoC data & FDA/EMA Orphan Worldwide IL-2/9/15 alopecia areata Drug Designations for CTCL rights Mid-2024 topline data inhibitor EQ
Slide 6: Anticipated Milestones
Anticipated Milestones EQ101 – Phase 2 Clinical Study Alopecia Areata – Initial Data Q4 2023 Alopecia Areata – Topline Data Mid-2024 EQ102 – Phase 1 Clinical Study SAD / MAD (healthy volunteers) – Data Q4 2023 Celiac Disease – Data 2024 Itolizumab – Phase 1b / Phase 3 Clinical Studies Lupus Nephriti
Slide 7: Itolizumab
Itolizumab First-in-Class immune- modifying mAb targeting the CD6-ALCAM signaling pathway 7
Slide 8: Ono Pharmaceutical: High Value Strategic Partnership
Ono Pharmaceutical: High Value Strategic Partnership Equillium receives upfront payment and full funding of itolizumab R&D in exchange for Ono exclusive option to purchase Equillium’s rights to itolizumab Closing payments*: $38.2M Option exercise payment**: $35.1M Milestone payments: $101.4M Option
Slide 9: Multi-Cytokine Platform & Therapeutic Candidates
Multi-Cytokine Platform & Therapeutic Candidates 9
Slide 10: The Multi-Cytokine Problem
The Multi-Cytokine Problem Cytokines leverage shared receptors exhibiting overlapping or synergistic biological activities which presents unique drug development challenges when treating disease Cytokines often exhibit… Cytokines signal via… Upstream shared receptor ‘Overlapping signaling’ signaling
Slide 11: Challenges in Targeting Cytokine Signaling
Challenges in Targeting Cytokine Signaling mAb JAK inhibitor Ideal Therapeutic Approach Inhibits Only One Cytokine Inhibits 50+ Cytokines Selective inhibition of disease driving cytokines Inhibiting the right Upstream combination of signaling cytokines is key for optimal therapeutic effect, balancin
Slide 12: Multi-Cytokine Platform
Multi-Cytokine Platform Modular platform generates products that modulate the natural biological redundancy or synergy of cytokines affording greater therapeutic benefit Validated Disease Targets • Technology originating from • Products can be flexibly the National Institutes of Health modified to o
Slide 13: Shared Receptors are Key Signaling Hubs
Shared Receptors are Key Signaling Hubs Shared receptors play a critical role in orchestrating important biological functions Auto-immune, inflammatory, and Wound healing anti-tumor responses & tissue regeneration IL2 / 15Rβ Inflammation IL-27 Suppression of IL-10 IL-6R & fibrosis R⍺ inflammation R⍺
Slide 14: Products of the Multi-Cytokine Platform
Products of the Multi-Cytokine Platform Shared receptors offer opportunity to more effectively modulate biology •MULTI-CYTOKINE ACTIVATOR (MCa) Engineered proteins that engage multiple signaling pathways to modulate biological function •MULTI-CYTOKINE INHIBITOR (MCi) Engineered peptides or proteins
Slide 15: γC Receptor: A Key Shared Cytokine Signaling Hub
γC Receptor: A Key Shared Cytokine Signaling Hub Cytokines of the γC receptor are critical regulators of immune responses thus, making it an attractive drug target for modulating T, NK and B cells Overlapping Signaling Synergistic signaling on CD8 cytotoxic T cells on CD8 & NK T cells α α β γ α γ α
Slide 16: IL-15 at the Apex of Tissue Specific Immuno-inflammation
IL-15 at the Apex of Tissue Specific Immuno-inflammation Approaches to Targeting IL-15 EQ101 & EQ102 • Initiates proinflammatory cascade preceding expression of TNFα and other key cytokines • IL-15 play pathogenic roles in diverse organ-specific autoimmune disorders • IL-15 stimulates generation of
Slide 17: Generation of Selective Multi-Cytokine Inhibitors (MCi)
Generation of Selective Multi-Cytokine Inhibitors (MCi) •CYTOKINE-RECEPTOR COMPLEX •CYTOKINE D-HELICES •FUNCTIONAL FUSIONS Cytokine Shared PK extension strategies receptor Private PEGylation receptor Lipidation FC-fused peptibodies native sequences Oral delivery Peptide Stapling proprietary composit
Slide 18: MCi MoA: Disrupting Assembly of the Receptor Complex
MCi MoA: Disrupting Assembly of the Receptor Complex Selective inhibition of cytokines A, D & F Cytokines E A F D C B A Multi-cytokine Inhibitor (MCi) % Inhibition A Private Shared No Signaling Receptors Receptor A B C D E F Cytokines E Control +MCi Cytokines first bind to private receptor MCi binds
Slide 19: The Multi-Cytokine Inhibitor Advantage
The Multi-Cytokine Inhibitor Advantage Addressing limitations of single-target biologics and broadly immunosuppressive kinase inhibitors by selectively inhibiting only those cytokines driving disease mAb JAK inhibitor MCi Improved Therapeutic Profile Inhibits One Cytokine Inhibits 50+ Cytokine Inhib
Slide 20: Differentiated Pipeline of First-In-Class Multi-Cytokine Agents
Differentiated Pipeline of First-in-Class Multi-cytokine Agents EQ101 EQ102 EQ302 EQ400 Series Phase 2/3 In Phase 1 Pre-clinical Pre-clinical PEGylated peptide inhibits: PEGylated peptide inhibits: Stabilized peptide inhibits: Protein activates: IL-2 + IL-9 + IL-15 IL-15 + IL-21 IL-15 + IL-21 IL-X +
Slide 21: EQ101 First-In-Class Tri-specific Inhibitor of IL-2/IL-9/IL-15
EQ101 First-in-Class Tri-specific Inhibitor of IL-2/IL-9/IL-15 21
Slide 22: EQ101: A First-In-Class Tri-Specific Cytokine Inhibitor
EQ101: A First-in-Class Tri-Specific Cytokine Inhibitor Inhibition of the key cytokines IL-2, IL-9 and IL-15 by EQ101 translates from preclinical models into humans IL-2 IL-9 IL-15 • IL-2 & IL-15 are important • PEGylated peptide • As effective as ruxolitinib • Significant clinical to CD8 and NK cel
Slide 23: EQ101: More Complete Downstream Signal Inhibition Versus JAKi
EQ101: More Complete Downstream Signal Inhibition Versus JAKi JAKi suppression of cytokine signaling is incomplete, while EQ101 inhibits the multiple downstream pathways for complete suppression of cytokine signaling Ruxolitinib blocks EQ101 blocks all JAK/STAT pathway only major pathways α +IL-2 -
Slide 24: EQ101 Performs Similarly to JAK Inhibition in IL-15 Driven ATL Model
EQ101 Performs Similarly to JAK Inhibition in IL-15 Driven ATL Model IL-2, IL-9 & IL-15 are overexpressed in adult T cell leukemia (ATL) and cutaneous T cell lymphoma (CTCL) where they drive cancer cell proliferation and increased inflammation in the skin1,2,3,4,5 Blocking IL-2 or IL-15 alone was in
Slide 25: EQ101: Summary of Historical Studies to Date
EQ101: Summary of Historical Studies to Date Study BNZ-CT-101, Phase 1 Study in Healthy Volunteers (n=18) First-in-Human study to investigate the safety, tolerability and PK of single ascending doses of BNZ132-1-40 • 3 subjects per treatment group • Single IV dose of 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg,
Slide 26: EQ101: Summary of Experience in Normal Healthy Volunteers
EQ101: Summary of Experience in Normal Healthy Volunteers Observed to be safe and No AE >= Grade 3, most common AE Dose proportional PK with well tolerated, no DLT and • SAD: mild headache in 3 of 18 subjects (17%) single dose half-life in • MAD: sore throat and headache in 4 of 24 no clinical
Slide 27: EQ101: Phase 1/2 Proof-of-Concept Study in CTCL
EQ101: Phase 1/2 Proof-of-Concept Study in CTCL Clinical validation and favorable safety profile positions EQ101 for further study Phase 1/2 MAD study in Cutaneous T Cell Lymphoma patients (n=30)1 • Heavily pre-treated population (median of 5 prior systemic treatments) • Dose-dependent PK/PD relatio
Slide 28: EQ101: Ready for Late-Stage Advancement in CTCL
EQ101: Ready for Late-Stage Advancement in CTCL EQ101 reduces IL-2 & IL-15 dependent cells and inflammation with improvements in skin lesions and ORR comparing favorably with benchmark drugs MAVORIC Phase 3 trial evaluating mogamulizumab and vorinostat provides the most recent and reliable estimates
Slide 29: EQ101: Positive Proof-of-Concept Opens Up Indication Expansion
EQ101: Positive Proof-of-Concept Opens Up Indication Expansion >100 subjects dosed, Compelling clinical activity Attractive target product demonstrated favorable observed in cutaneous T cell profile for the treatment of safety and tolerability lymphoma (CTCL) patients CTCL patients IND open
Slide 30: EQ101: Valuable Medical Dermatology Franchise
EQ101: Valuable Medical Dermatology Franchise Multi-Billion dollar market opportunity for EQ101 in medical dermatology Large need exists for safe and effective therapies 250,000 US 6.6M US 24,000 adult 1.5M+ US moderate-severe moderate- US Patients1 Patients3 Patients2 severe Patients4 Cutaneous T c
Slide 31: EQ101: Targeted Treatment Approach for Alopecia Areata
EQ101: Targeted Treatment Approach for Alopecia Areata IL-2, IL-9 and IL-15 are key drivers of disease in alopecia areata, promoting a cycle of increased IFN-γ production and immune cell attack of the hair follicle Hair follicle bulb IFN-γ CD4 IL-2 Drives inflammation IL-15 & hair loss IL-9 NK CD8 I
Slide 32: EQ101 Reverses Immune-Mediated Hair Loss in a Mouse Model
EQ101 Reverses Immune-Mediated Hair Loss in a Mouse Model EQ101 is more effective than ruxolitinib at hair regrowth and suppression of cytotoxic CD8+ T cells in humanized alopecia model EQ101 Improves Hair Regrowth EQ101 Reduces CD8+ Cytotoxic T-cell Activation Marker NKG2D 140 EQ101 2 mg/kg 120 IV
Slide 33: EQ101: Alopecia Areata Clinical Review
EQ101: Alopecia Areata Clinical Review
Slide 34: EQ101 in Adults With Moderate to Severe AA
EQ101 in Adults With Moderate to Severe AA Phase 2 Open Label Study Design Screening Treatment Follow-Up 5 weeks QW dosing for 24 weeks 4 weeks 2mg/kg Establish biologic IV bolus push activity and safety profile of EQ101 Population N~30 Study Objectives Next step: dose At least 35% scalp hair loss,
Slide 35: Alopecia Areata Trials Illustrate Efficacy Bar & Low Placebo Rates
Alopecia Areata Trials Illustrate Efficacy Bar & Low Placebo Rates Ritlecitinib results from Ph 2 and ALLEGRO-2b/3 studies: reduction in SALT scores in placebo subjects at 24 weeks was less than 6% Percent change from baseline in SALT Score baricitinib deuruxolitinib Results from BRAVE AA1 Results f
Slide 36: SALT Response Based on Baseline Severity in Baricitinib Studies
SALT Response Based on Baseline Severity in Baricitinib Studies SALT Score ≤20 Response Rate SALT Score ≤20 Response Rate baricitinib 2-mg baricitinib 4-mg EQ101 study EQ101 study 24 wk treatment 24 wk treatment Placebo response rates are very low for alopecia areata patients: at 36 weeks of treatme
Slide 37: Alopecia Areata Pipeline: Late-Stage Assets
Alopecia Areata Pipeline: Late-Stage Assets OLUMIANT® LITFULO® SOTYKTU® LY3009104 PF-06651600 CTP-543 SHR0302 BMS-986165 ASLAN003 ADX-914 HXN-7734 baricitinib ritlecitinib deuruxolitinib jaktinib ivarmacitinib deucravacitinib etrasimod farudostat bempikibart daxdilimab Approved Approved P3 Data: Key
Slide 38: Current Concerns in the Alopecia Areata Treatment Landscape
Current Concerns in the Alopecia Areata Treatment Landscape EQ101 is well positioned to be a better-tolerated and effective alternative to JAK inhibitors Currently approved and late-stage “I am concerned Blackbox warning ** pipeline drugs are all JAK inhibitors about the safety of WARNING: SERIOUS I
Slide 39: Dr. Arash Mostaghimi Alopecia Areata Fireside Chat
Dr. Arash Mostaghimi Alopecia Areata Fireside Chat Arash Mostaghimi, M.D., M.P.A., M.P.H. Associate Professor of Dermatology Harvard Medical School Director, Inpatient Consultation Service, Department of Dermatology Brigham and Women’s Hospital
Slide 40: Question 1
Question 1 How are you treating patients with alopecia areata of different severities (SALT scores), particularly given the approval of the JAKi for AA this past year? What treatments do patients prefer? 40
Slide 41: Alopecia Areata Treatment
ALOPECIA AREATA TREATMENT • Major problem: safe, effective, consistent drug delivery • Limited disease (95% of patients) • No treatment • Topical therapies (very limited efficacy) • Injectable steroids • Extensive disease • Systemic immunosuppressive agents (antimetabolites, prednisone) • Potential
Slide 42: Profound Dissatisfaction With Current Therapies
PROFOUND DISSATISFACTION WITH CURRENT THERAPIES DOI: 10.4103/ijt.ijt_53_17 42 Slides from Dr. Arash Mostaghimi, Associate Professor, Harvard Medical School
Slide 43: Patient Impact
PATIENT IMPACT • Variable, but often profound impact on quality of life • Higher rates of depression, anxiety, emotional behaviors, acute stress • Impacts performance in school, work, and relationships • Traumatic, unpredictable disease with 1/3 meeting PTSD criteria Source: DOI: 10.1007/s13555-021-
Slide 44: Question 2
Question 2 Does there remain an unmet need in the treatment of alopecia areata with the approval of JAKi? Are there concerns about long term use of JAKi? 44
Slide 45: Where We Are Today
WHERE WE ARE TODAY 45 Slides from Dr. Arash Mostaghimi, Associate Professor, Harvard Medical School
Slide 46: Next Step: Targeted Therapies
NEXT STEP: TARGETED THERAPIES • JAK inhibitors are a huge advance, but not enough • Targeted therapy designed for AA is critical • Better outcomes • Improve risk/benefit of treatment • Localized therapy is an unsolved problem! • Addresses need of 95% of those who do not have an FDA approved treatmen
Slide 47: Dermatologists Are Looking for Safer Alternatives to JAKi for AA
DERMATOLOGISTS ARE LOOKING FOR SAFER ALTERNATIVES TO JAKI FOR AA Unmet Needs for New Treatment Options Statement Agreement: % of respondents (n=103) I am concerned about the safety of oral JAK inhibitors for my AA patients % of respondents (n=101) 6.4 8.1 9.0 3.8 Remaining Unmet Needs for AA Treatme
Slide 48: Question 3
Question 3 Can you share your thoughts on EQ101’s MOA and the potential use in AA patients? What are you, as a clinician, hoping to observe in this study? 48
Slide 49: How Should We Measure Success?
HOW SHOULD WE MEASURE SUCCESS? • For a proof of concept study, would like to see early activity and then follow on studies to optimize dosing and administration • Not worried about taking an injectable treatment, but able to grow hair consistently and feel confident • Speed might be less important •
Slide 50: Final Thoughts
FINAL THOUGHTS • AA has unique properties as a disease—we cannot treat it the same way as psoriasis and atopic dermatitis • Need a safe chronic long term treatment, physicians and patients are looking beyond JAKI • Systemic treatment is in the early innings—please innovate in this space 50 Slides fr
Slide 51: Thank You Dr. Mostaghimi
THANK YOU DR. MOSTAGHIMI AVAILABLE FOR Q&A Arash Mostaghimi, M.D., M.P.A., M.P.H. Associate Professor of Dermatology Harvard Medical School Director, Inpatient Consultation Service, Department of Dermatology Brigham and Women’s Hospital
Slide 52: Equillium: Short Term Forecast
Equillium: Short Term Forecast 1. EQ101 initial data from alopecia areata study expected before end of year, followed by topline data expected mid-2024 2. EQ102 SAD/MAD data expected before end of year 3. Itolizumab: • lupus nephritis data from EQUALISE study to be presented at ASN & ACR in November
Slide 53: Thank you
Thank you www.equilliumbio.com