Slide 1: EQ101: Phase 2 Topline Data in Alopecia Areata
EQ101: Phase 2 Topline Data in Alopecia Areata June 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: 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 3
Slide 4: EQ101: First-in-Class Tri-Specific Cytokine Inhibitor
EQ101: First-in-Class Tri-Specific Cytokine Inhibitor Inhibition of the key cytokines IL-2, IL-9 and IL-15 by EQ101 has shown an ability to translate from preclinical models into humans IL-2 IL-9 IL-15 • IL-2 & IL-15 are important • PEGylated peptide • As effective as ruxolitinib • Significant clini
Slide 5: 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 6: Large Unmet Need in Alopecia Areata
Large Unmet Need in Alopecia Areata EQ101 is positioned as a potentially well-tolerated and effective alternative to JAK inhibitors Currently approved and late-stage “I am concerned about the Blackbox warning ** pipeline drugs are all JAK inhibitors safety of oral JAK inhibitors There remains a chro
Slide 7: 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 8: EQ101 Reversed Immune-Mediated Hair Loss in a Mouse Model
EQ101 Reversed 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 9: SALT Response Varies by Baseline Severity & Dose
SALT Response Varies by Baseline Severity & Dose Patients with very severe disease have been shown to be slower to respond and need increased dosing and longer treatment Baricitinib 2-mg Baricitinib 4-mg SALT Score ≤20 Response Rate SALT Score ≤20 Response Rate * * Severea: baseline SALT score of 50
Slide 10: Comparative Data: SALT ≤20 at Week 24
Comparative Data: SALT ≤ 20 at 24 Weeks Consistently low placebo rates observed: average of 3.6% Dose-dependent drug activity observed: range of 11% - 33% in Phase 2 & 3 studies % Patients achieving SALT ≤ 20 50 SALT ≤ 20 at week 24 40 Therapeutic Signal High dose JAKi 30 Low dose JAKi Placebo 20 10
Slide 11: Comparative Data: SALT Change from Baseline at Week 24
Comparative Data: SALT Change from Baseline at 24 Weeks Consistently low placebo rates observed: average of 3.2% Dose-dependent drug activity observed: range of 17% - 45% in Phase 3 studies 50 SALT % change from baseline at week 24 % Change from Baseline 40 Therapeutic Signal High dose JAKi 30 Low d
Slide 12: EQ101 Data: Phase 2 Study in Alopecia Areata
EQ101 Data Phase 2 study in Alopecia Areata 12 Confidential (do not distribute)
Slide 13: Phase 2 Study of EQ101 in Adults With Moderate to Very Severe AA
Phase 2 Study of EQ101 in Adults With Moderate to Very Severe AA Phase 2 Open Label Study Design Potential Target Product Profile Screening Treatment Follow-Up 5 weeks 24 weeks 4 weeks Safer alternative to JAKi 2 mg/kg QW IV bolus push with comparable efficacy Patient-administered weekly/bi- Populat
Slide 14: Key Baseline Characteristics
Key Baseline Characteristics Baseline Characteristics Enrolled Population (N=36) Age: years Mean (SD) / Range 38.2 (13.5) / 18-60 Gender: n (%) Female: 19 (53%) Race: n (%) White: 24 (67%) Weight: kg Mean (SD) / Range 82 (21) / 49-128 Current AA Duration (months): Mean (SD) / Range 31 (20.6) / 6-82
Slide 15: Patient Disposition
Patient Disposition 48 subjects screened 36 subjects dosed across 5 sites (AUS/NZ) 11 subjects 25 subjects discontinued early completed treatment (weeks 0 to 19) (week 24) Predominantly due 1. Fatigue (related*) to logistical reasons, 6 not 5 2. Pyrexia and Urticaria (not related*), Swelling face (r
Slide 16: Subject Baseline SALT Scores
Subject Baseline SALT Scores Baseline SALT Score of Each Subject (N=36) Baseline SALT scores (Mean 76.0) Moderate Severe Very Severe (AU/AT) 18 100 90 16 80 14 70 12 Number of Subjects Baseline SALT score 60 10 50 8 40 6 30 4 20 2 10 0 0 Last Dose Week 14 16 17 21 19 0 26 2 20 22 24 29 34 18 0 36 30
Slide 17: Safety Summary: TEAEs
Safety Summary: TEAEs EQ101 exhibited a favorable safety and tolerability profile with no SAEs, similar to the safety profile observed in prior Phase 1 & 2 studies (SAD/MAD NHVs, LGLL and CTCL populations) SAFETY OVERVIEW Most TEAEs were Only 2 CTCAE Grade 3 TEAEs • >70% of subjects had a medical CT
Slide 18: Safety Summary: Study Treatment Discontinuation Attributed to AEs
Safety Summary: Study Treatment Discontinuation Attributed to AEs Prior EQ101 studies (>100 subjects), only 1 previous treatment discontinuation due to AE TEAE leading to discontinuation Last Dose Additional relevant details for each subject (PI assessment of relatedness to study treatment) 1) Blood
Slide 19: Mean SALT Scores Decline Over Time – All Subjects
Mean SALT Scores Decline Over Time – All Subjects 80 N=35 N=36 75 N=32 SALT (+/- SEM ) N=30 Mean Total SALT N=29 TotalSEM) 70 N=25 M ean(+/- N=26 65 All All Subjects Subjects Baseline 4 8 12 16 20 24 Baseline Study Study Week Week 19 All subjects (N=36), figure includes all data points including fol
Slide 20: Key SALT Response Data by Subgroup – Completed Subjects
Key SALT Response Data by Subgroup – Completed Subjects SALT responses exceed historical placebo rates: greater improvements in moderate and severe subjects (SALT 35 to <95) compared with those with very severe disease (SALT 95+) SALT ≤ 20 Mean SALT SALT Mean SALT @ n (%) @ W24 Improvement from Base
Slide 21: Percent of Subjects that Reach SALT ≤20 Over Time
Percent of Subjects that Reach SALT ≤ 20 Over Time – Completed Subjects 40 35 30 % of Completed Subjects 25 20 20 15 10 8 5 4 4 0 0 0 0 Baseline W4 W8 W12 W16 W20 W24 Week of Study 21 Completed subjects n=25 who completed the 24 weeks of treatment Abbreviations: SALT, severity of alopecia tool; W, w
Slide 22: Changes in SALT Score Over Time Vary by Baseline Severity
Changes in SALT Score Over Time Vary by Baseline Severity – Completed Subjects 100 80 Score (+/- SEM ) Mean Total SALT Score 60 SEM) (+/-SALT M ean Total 40 20 Baseline Baseline 4 8 12 16 20 24 Study Week Study Week Baseline SALT Baseline SALT:: ≥35 >=35toto<50 <50(n=3) (N=3) Baseline SALT Baseline
Slide 23: Mean % Reduction in SALT Greater in Moderate & Severe Subjects
Mean % Reduction in SALT Greater in Moderate & Severe Subjects – Completed Subjects Mean % Change in Total SALT Score 20 in Total Salt (+/- SEM ) 0 -20 SEM) % change M ean (+/- -40 -60 -80 Baseline Baseline 4 8 12 16 20 24 Study Study Week Week Baseline BaselineSALT: SALT≥35 to <50 : >=35 (n=3) to <
Slide 24: Mean Percent SALT Score Change – Responders
Mean Percent SALT Score Change – Responders* To better understand the depth of response in baseline SALT improvement, an analysis was performed of 21 subjects characterized as responders 0 Mean SALT SALT Baseline Improvement from by Subgroups Baseline @ W24 SALT Score (+/- SEM ) -20 n (%) Mean % Cha
Slide 25: Individual Total SALT Scores Over Time – Responders
Individual Total SALT Scores Over Time – Responders* 100 100 SUBJECTS WITH W24 SALT >20 80 80 SALT <=20 M ean (SEM ) Total SALT SALT SALT 60 60 ) Total Total M ean (SEM 40 Mean 40 20 20 0 0 Baseline Baseline 4 Baseline 8 4 12 8 16 12 20 16 24 20 24 Study Week Study Study Week Week 25 *Responders (n=
Slide 26: PROs and ClinROs for Scalp Hair and Eyebrow/Eyelashes
PROs and ClinROs for Scalp Hair and Eyebrow/Eyelashes Subjects and clinicians report improvements across scalp hair and eyebrow and eyelash hair regrowth among those that completed treatment Scalp hair PRO (0-4 scale with 4 being most severe) • 11 subjects (44%) improved 1 or more points on PRO Scal
Slide 27: Monitoring Drug Target Engagement
Monitoring Drug Target Engagement • CD132 (common-𝝲𝝲 chain) is a constitutively expressed and PBMC DERIVED CD8 T CELLS tightly regulated receptor1 INCUBATED WITH EQ101 FOR 72HRS EQ101 (72 hrs) • Elevated levels of CD132 are found on effector and memory 4000 T cells and positively correlate to…
Slide 28: Evidence of EQ101 Target Engagement
Evidence of EQ101 Target Engagement Preliminary data indicate reductions of cell surface CD132 on both CD8 and NK cells in peripheral blood consistent with EQ101 target engagement and pharmacodynamic response CD132 EXPRESSION ON NK CELLS OF COMPLETED SUBJECTS CD56lowCD16hi CD56lowCD16hi CD132 gMFI 7
Slide 29: EQ101 Study Summary
EQ101 Study Summary • EQ101 was well tolerated in AA subjects; Safety profile was consistent with that previously observed (>100 subjects in prior Phase 1 & 2 studies) • No SAEs; 2 subjects with grade 3 TEAEs (no CTCAE grade 4 or 5 TEAEs); most AEs were grade 1 and 2 • 11 subjects discontinued the s
Slide 30: EQ101 Study Conclusions & Next Steps
EQ101 Study Conclusions & Next Steps Conclusions: • Initial safety and efficacy data supports advancing EQ101 into further alopecia areata development to include dose regimen optimization • Study data and potential target product profile – safer alternative to JAKi with comparable efficacy – support
Slide 31: Thank you
Thank you www.equilliumbio.com