Slide 1: Etrasimod ELEVATE UC 12 and 52 Results
Etrasimod ELEVATE UC 12 and 52 Results Exciting Investigational Asset: Potential Best In Class UC Therapy Breakthroughs that change patients’ lives 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation and our discussions during this conference call will include forward-looking statements that are subject to substantial risks and uncertainties, many of which are beyond our control, that could cause actual results to differ materially from those expresse
Slide 3: Today's Speakers
Today’s Speakers Mike Vincent Mike Gladstone Mike Corbo Sheldon Sloan I&I Chief Scientific I&I Global President I&I Chief Development Officer Arena VP Etrasimod UC Officer Team Lead Confidential 3 3
Slide 4: ELEVATE UC 12 and 52 Results
ELEVATE UC 12 and 52 Results Phase 3 trials show potential best-in-class efficacy Efficacy of etrasimod may be competitive with market leading biologics Safety profile in phase 3 was consistent with previous studies and the S1P class Overall results support proposed positioning of etrasimod as the 1
Slide 5: Ulcerative Colitis Disease Overview
Ulcerative Colitis Disease Overview Ulcerative Colitis (UC) is a chronic and often debilitating inflammatory bowel disease that affects an estimated 1 million people in the US Symptoms include chronic diarrhea with blood and mucus, abdominal pain & cramping, and weight loss, which can interfere with
Slide 6: Current Ulcerative Colitis (UC) Treatment Algorithm
Current Ulcerative Colitis (UC) Treatment Algorithm Significant Unmet Need UC Treatment Paradigm Follows a Fail-First Approach to Stepping Up Cyclosporine/Tacrolimus/Surgery JAKs JAKs Disease Severity Biologics/Biosimilars Biologics/Biosimilars Unmet Need Unmet Need Corticosteroids Thiopurines Induc
Slide 7: Sphingosine 1-Phosphate (S1P) Receptors
Sphingosine 1-Phosphate (S1P) Receptors Responsible for Regulating Multiple Biological Processes Receptor Subtype S1P1 S1P2 & S1P3 S1P4 S1P5 • Trafficking, localization & • Maintenance of barrier • Regulation of immune • Trafficking & function of immune cells function in blood vessels functions loca
Slide 8: Etrasimod: Potentially Differentiated Oral S1P Receptor Modulator
Etrasimod: Potentially Differentiated Oral S1P Receptor Modulator Differentiated Pharmacology vs Approved S1P Modulators Afferent Lymphatic S1P1 S1P5 S1P2 S1P3 S1P4 T cells etrasimod etrasimod etrasimod Ulcerative Efferent Lymphatic Colitis • Differentiation: Etrasimod is a potent S1P1 agonist & par
Slide 9: Etrasimod Phase 2 OASIS Study
Etrasimod Phase 2 OASIS Study Competitive Efficacy Observed in Ulcerative Colitis Clinical Remission – OASIS 12 Week Endoscopic Improvement – OASIS 12 Week 60% 60% p = 0.003* 3 Component Remission Endoscopic Improvement 50% 50% Patients Achieving 41.8% Patients Achieving p = 0.0002* p = 0.3059 40% 4
Slide 10: Etrasimod Phase 3 Clinical Data
Etrasimod Phase 3 Clinical Data ELEVATE UC 12 and 52 Results Investor Call 10
Slide 11: ELEVATE Utilized Treat-Through Design over a Traditional Re-Randomization
ELEVATE Utilized Treat-Through Design over a Traditional Re- Randomization TREAT-THROUGH TRIALS: All patients who enroll in the trial are counted in the week 52 analysis. Induction Phase Maintenance Phase MORE Placebo Placebo CLOSELY REFLECTS R REAL Active Treatment Active Treatment WORLD TREATMENT
Slide 12: ELEVATE Program: Etrasimod in UC Utilized a Treat-Through Design
ELEVATE Program: Etrasimod in UC Utilized a Treat-Through Design Treat-through* Endpoints 12-Week induction 40-Week Treatment Period Co-Primary Endpoints Clinical remission: Week 12; Week 52 Etrasimod, 2 mg R Key Secondary Endpoints: 52-Week Treat-Through 2:1 Placebo N=433 Endoscopic improvement
Slide 13: ELEVATE UC Primary Endpoint: Week 12 & Week 52 Clinical Remission
ELEVATE UC 52 Primary Endpoint: Week 12 & Week 52 Clinical Remission Baseline MMS 5 to 9 (N=409) 100% 90% 80% P < 0.001 P < 0.001 Subjects, % 70% 60% 50% 32.1% 40% 27.0% (88/274) 30% (74/274) 20% 7.4% 6.7% 10% (10/135) (9/135) 0% Placebo etrasimod 2mg Placebo etrasimod 2mg Week 12 Week 52 Clinical R
Slide 14: ELEVATE UC 52: Key Secondary and Secondary Efficacy Endpoints
ELEVATE UC 52: Key Secondary and Secondary Efficacy Endpoints at Weeks 12 and 52 Secondary Endpoint Baseline MMS 5 to 9 (N=409) Δ = 28.3% P < 0.001 Key Secondary Endpoints Δ = 24.9% 70% Δ = 24.6% Δ = 24.9% 62.4% P < 0.001 P < 0.001 (171/274) Δ = 26.7% P < 0.001 60% Δ = 21.2% P < 0.001 P < 0.001 48.2
Slide 15: ELEVATE UC 52: Sustained Clinical Remission and CS-Free Clinical Remission
ELEVATE UC 52: Sustained Clinical Remission and CS-Free Clinical Remission Key Secondary Endpoints Exploratory Endpoint Baseline MMS 5 to 9 (N=409) Baseline MMS 4 to 9 (N=433) 100% 90% 80% Δ = 25.4% Δ = 24.3% Subjects, % 70% P<.001 P<.001 60% Δ = 15.8% 50% P<.001 32.1% 31.2% 40% (88/274) (29/93) 30%
Slide 16: ELEVATE UC 12 Primary and Key Secondary Efficacy Endpoints at Week 12
ELEVATE UC 12 Primary and Key Secondary Efficacy Endpoints at Week 12 Baseline MMS 5 to 9 (N=334) Secondary 100% 100% Key Secondary Endpoints Endpoint 90% 90% Δ = 21.2% Primary Endpoint P = <0.001 80% 80% Δ = 17.5% 70% P = 0.0013 62.2% 70% Subjects, % 138/222 Subjects, % Δ = 12.1% 60% 60% P = 0.0092
Slide 17: Etrasimod Induction: Cross Trial Comparison (Not Head-to-Head)
Etrasimod Induction: Cross Trial Comparison (Not Head-to-Head) Efficacy May Compare Favorably Across Contemporary UC Trials, although no conclusions can be drawn Clinical Remission1,2 S1Ps 40% p=0.026 p<0.001 P<0.001 p<0.05 33% 30% 27% Percent of Subjects 26% 25% 20% 18% 18.5% 19% 18% 16.5% 17% 17%
Slide 18: Etrasimod Induction: Cross Trial Comparison (Not Head-to-Head)
Etrasimod Induction: Cross Trial Comparison (Not Head-to-Head) Efficacy May Compare Favorably Across Contemporary UC Trials, although no conclusions can be drawn = Injectable = oral Clinical Remission1,2 S1Ps Biologics JAKs 40% p=0.026 p<0.001 P<0.001 p<0.05 p<0.05 P=0.001 P<0.001 P<0.001 p<0.001 p<
Slide 19: Overall Summary of TEAEs and Serious Adverse Events
Overall Summary of TEAEs and Serious Adverse Events ELEVATE UC 52 ELEVATE UC 12 Safety Set (N=433) Safety Set (N=354) Subjects, n (%) [# of events]; Placebo Etrasimod 2 mg Placebo Etrasimod 2 mg NOTE: data are not exposure adjusted (n=144) (n=289) (n=116) (n=238) Participants with any TEAE 81 (56.3)
Slide 20: Summary of Most Frequently Reported TEAEs
Summary of Most Frequently Reported TEAEs ELEVATE UC 52 ELEVATE UC 12 Safety Set (N=433) Safety Set (N=354) Subjects, n (%) [# of events]; Placebo Etrasimod 2 mg Placebo Etrasimod 2 mg NOTE: data are not exposure adjusted (n=144) (n=289) (n=116) (n=238) Most frequently reported TEAEsa Headache 7 (4.
Slide 21: Potential Differentiation vs. Ozanimod
Potential Differentiation vs. Ozanimod Ulcerative Colitis (UC) Profile Comparison, Subject to Approval and Labeling etrasimod1 ozanimod 2,3 Onset of action • Day 3: 53% reduction in lymphocytes • Day 3: 15% Lymphocyte reduction 1st Dose Titration required • No – Therapeutic dose on day 1 • Yes
Slide 22: Etrasimod Commercial Outlook
Etrasimod Commercial Outlook ELEVATE UC 12 and 52 Results Investor Call 22
Slide 23: Key Dynamics in Ulcerative Colitis
Key Dynamics in Ulcerative Colitis Unmet need remains: Only ~14% 1M adults in US of patients achieve market with UC long-term remission with SoC Patients need Market projected to options with a grow ~2x by 2030 favorable benefit-risk profile ELEVATE UC 12 and 52 Results Investor Call 23
Slide 24: Diversity of Options benefits UC Patients
Diversity of Options benefits UC Patients: If approved, etrasimod has potential to fill a gap in treatment paradigm Emerging Etrasimod Profile • Potential for Best-in- Class Efficacy • Dosing and safety consistent with prior studies and S1P class • Overall benefit/risk shows a very competitive profi
Slide 25: Etrasimod has Potential to Grow in GI Indications
Etrasimod has Potential to Grow in GI Indications Next Steps for Etrasimod in GI Ulcerative Colitis Anticipate Filing Q3 2022 Crohn’s Ph2/3 Expected Readout Q4 2023 Eosinophilic Esophagitis (EoE) Ph2 Expected Readout Q4 2022 GI: gastroenterology All dates are projections and subject to change ELEVAT
Slide 26: Pfizer I&I
Leading in three core disease areas of high unmet need… Pfizer I&I Medical Gastroenterology Rheumatology Dermatology Cross-Disease Area Platform: Anti-fibrotics … delivering breakthroughs that enable patients to thrive in remission… To be the bold ones who won’t Targeting stop until Augmenting white
Slide 27: Question & Answer Session
Question & Answer Session Breakthroughs that change patients’ lives 27
Slide 28: Common Designs of Ulcerative Colitis Phase 3 Trials
Common Designs of Ulcerative Colitis Phase 3 Trials TREAT-THROUGH TRIALS: All patients who enroll in the trial are counted in the week 52 analysis. Induction Phase Maintenance Phase MORE Placebo Placebo CLOSELY REFLECTS R REAL Active Treatment Active Treatment WORLD TREATMENT RE-RANDOMIZATION OF RES