Evelo Biosciences, Inc. · OTC:EVLO
Evelo Biosciences — Corporate Update (November 2019)
23 slides from Evelo Biosciences's corporate update, Nov 5, 2019
Slide 1: New Therapeutic Modality Supported by Positive Interim Clinical Data
New Therapeutic Modality Supported by Positive Interim Clinical Data EDP1815 Advancing into Phase 2 November 5, 2019
Slide 2: Legal Disclaimer
Legal Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including
Slide 3: Positive Interim Clinical Data Support Evelo's Platform Opportunity
Positive Interim Clinical Data Support Evelo’s Platform Opportunity • EDP1815 could address significant unmet need for mild to moderate psoriasis patients • EDP1815 continued to be well tolerated • Mean reduction in LSS at 28 days at high dose was consistent with low dose • High dose showed continue
Slide 4: Chronic Inflammation is a Central Driver of Society's Most Burdensome Diseases
Chronic Inflammation is a Central Driver of Society’s Most Burdensome Diseases Neurological diseases; 7M US DALYs, 111M WW “The contribution of inflammation in the pathogenesis of Alzheimer’s Disease has been appreciated only recently” Nat Rev Neuro, 2015 Chronic respiratory diseases; 6M US DALYs, 1
Slide 5: Significant Number of Patients with Psoriasis Go Untreated
Significant Number of Patients with Psoriasis Go Untreated Proportion of Patients Receiving No Treatment1 60 49.2 50 42.3 40 36.6 35.5 29.7 30 24.7 23.6 18.6 20 Respondents, % Respondents, 9.4 10 0 Mild Moderate Severe 2003-2005 2006-2009 2011 The primary reasons physicians do not initiate or mainta
Slide 6: Majority of Moderate Patients are Dissatisfied with Treatment Options
Majority of Moderate Patients are Dissatisfied with Treatment Options Treatment dissatisfaction by disease severity 60% In annual surveys conducted from 2003-2011 by the National Psoriasis Foundation, ~5,000 patients 50% were asked… 40% “How satisfied have you been with the treatment 30% you have re
Slide 7: EDP1815 High Dose Psoriasis Cohort
EDP1815 High Dose Psoriasis Cohort • 18 individuals with mild to moderate psoriasis • Randomized 2:1 (active:placebo) with 2.76g dose (enteric capsule formulation), daily oral administration • 28-day dosing period with follow up at day 42 • Primary endpoint of safety and tolerability 7
Slide 8: Secondary and Exploratory Endpoints Reported
Secondary and Exploratory Endpoints Reported • LSS • PASI • Cellular biomarkers from skin biopsies • Blood immune cell biomarkers of cytokine production 8
Slide 9: Lesion Severity Score and PASI
Lesion Severity Score and PASI Lesion Severity Score PASI 12-point severity score for a single lesion Severity score weighted for all lesions More sensitive in mild disease and Most appropriate for moderate to severe disease and short treatment periods longer treatment periods • 4 points – redness •
Slide 10: Mean LSS Reduction of 15% at Day 28; 24% at Day 42
Mean LSS Reduction of 15% at Day 28; 24% at Day 42 p= 0.173 p= 0.089 10% 0% −10% −20% Mean percentage +/ − SE change in LSS Group Placebo low dose + high dose (n=10) EDP1815 high dose (n=12) −30% 1 8 15 22 28 42 Day Dosing Period 10
Slide 11: LSS Reduction Consistent Between High and Low Dose Over Days
LSS Reduction Consistent Between High and Low Dose Over 28 Days; High Dose Better at Day 42 p= 0.173 p= 0.089 p= 0.101 p= 0.892 10% 0% • Continued reduction in LSS to day 42 at high dose may be indicative of potential −10% sustained effect and dose response −20% Mean percentage +/ − SE change in LSS
Slide 12: Reduction in LSS of up to 80% at High Dose
Reduction in LSS of up to 80% at Day 42 at High Dose 20% 10% 0% −10% −20% −30% −40% −50% −60% Percentage change in LSS from baseline Percentage Group Baseline LSS median (IQR) −70% Placebo low dose + high dose (n=10) 9 (6.25-11.75) −80% EDP1815 high dose (n=12) 8.5 (7.25-9.75) 3−6 4−3 4−6 4−8 3−10 4
Slide 13: High Dose Mean PASI Reduction Consistent with LSS
High Dose Mean PASI Reduction Consistent with LSS and Continued to Improve After End of Dosing 10% 0% • PASI reduction at high dose • 16% at day 28 versus −10% placebo of 1% • 21% at day 42 versus −20% placebo of 3% SE change in PASI SCORE Mean percentage +/ − SE change in PASI Group Placebo low dos
Slide 14: Reduction in PASI of up to 61% at High Dose
120% Reduction in PASI of up to 61% at Day 42 at High Dose 110% 100% 120%120%90% 110% 110% 100%80% 100%90%70% 80%60%90% 70%50%80% 60% 70% 50%40% 40%30%60% 30%20%50% 20% 10%40% 10% 30% 0%0% −−10%10%20% −−20%20%10% −30% −30%0% −40% Baseline PASI score Percentage change in PASI SCORE from baseline chan
Slide 15: Interim Clinical Data Summary
Interim Clinical Data Summary • Potential for EDP1815 to address significant needs of mild to moderate psoriasis patients • Encouraging early clinical activity • Mean LSS Reduction of 24% at Day 42 at high dose • Mean PASI Reduction of 21% at Day 42 at high dose 15
Slide 16: Planning for EDP1815 Phase 2 and Additional Indications
Planning for EDP1815 Phase 2 and Additional Indications Placebo-controlled dose and formulation optimization study in mild to moderate psoriasis planned for early 2020 initiation • Primary endpoint: change in PASI score at 16 weeks • Interim analysis for Part A expected in late 2020 Part A Part B Go
Slide 17: Evelo Platform Opportunity
Evelo Platform Opportunity 17
Slide 18: Summary
Summary 18
Slide 19: Evelo Strategy: Develop New Medicines for Millions of People
Evelo Strategy: Develop New Medicines for Millions of People Injectable First-line biologics/ therapy Mid-line specialty therapy drugs High unmet need Create new market as mid-line therapy and defer use of injectable biologics / specialty drugs Expand to front line treatment to become foundational t
Slide 20: EDP1815 Phase 2a 16-week Interim Data Expected in Late 2020
EDP1815 Phase 2a 16-week Interim Data Expected in Late 2020 Candidate 2020 Phase 1b Phase 2a 16-week interim Atopic Dermatitis Psoriasis EDP1815 New formulation Enteric capsule and new formulation 2Q 2020 Late 2020 Phase 1b Atopic Dermatitis EDP1066 New formulation 1Q 2020 Phase 1/2 MSS Colorectal C
Slide 21: Today's Highlights and Next Steps
Today’s Highlights and Next Steps • Positive interim clinical data supports validation of Evelo’s platform opportunity and vision • Oral biologics acting on cells in the small intestine have the potential to modulate systemic immunology • Potential to develop effective, safe, convenient, and afforda
Slide 22: New Therapeutic Modality Supported by Positive Interim Clinical Data
New Therapeutic Modality Supported by Positive Interim Clinical Data EDP1815 Advancing into Phase 2
Slide 23: Evelo
EVELO