Evelo Biosciences, Inc. · OTC:EVLO

Evelo Biosciences — Technical Presentation (September 2021)

33 slides from Evelo Biosciences's technical presentation, Sep 28, 2021

  1. Slide 1: Topline Results for Phase 2 Study of EDP1815 in Mild and Moderate Psoriasis

    Exhibit 99.1 Topline Results for Phase 2 Study of EDP1815 in Mild and Moderate Psoriasis September 27, 2021

  2. Slide 2: Legal Disclaimer

    Legal Disclaimer This presentation contains forward-looking statements within the meaning of the Private stockholders have the ability to control or significantly influence our business; costs and Securities Litigation Reform Act of 1995. All statements contained in this presentation resources of op

  3. Slide 3: Positive Phase 2 data of EDP1815 confirms ability to harness SINTAX

    Positive Phase 2 data of EDP1815 confirms ability to harness the small intestinal axis, SINTAX ™, to treat systemic inflammatory diseases Clinically and statistically significant improvement in PASI-50 score achieved Oral EDP1815 can drive potent effects with placebo-like safety and tolerability EDP

  4. Slide 4: PASI-50 response at week 16

    PASI-50 response at week 16 TREATMENT PERIOD FOLLOW UP Week 16 Baseline Week 8 Week 20 PASI-50 4 4PASI-50 response at week 16 TREATMENT PERIOD FOLLOW UP Week 16 Baseline Week 8 Week 20 PASI-50 4 4

  5. Slide 5: Majority of psoriasis sufferers have mild or moderate disease

    Majority of Psoriasis psoriasis sufferers have mild or moderate disease 55M 8.6M 6.7M Worldwide U.S. U.S. prevalence prevalence diagnosed 93% 71% 22% 7% 0.4M 4.8M 1.5M Mild Moderate Severe Source: Datamonitor Healthcare, Vanderpuyre-Orgle et al., J Am Acad Dermatol. 2015: 72:961–7 5Majority of Psori

  6. Slide 6: Mild and moderate psoriasis is a serious condition that significantly impacts patients

    Mild and moderate psoriasis is a serious condition that significantly impacts patients Burdensome Lesions Quality of Life Impact Psychosocial Impact • Painful, cracked skin 34% - 40% of mild and 65% of mild and 93% of moderate psoriasis moderate psoriasis • Itchy and irritating sufferers report mode

  7. Slide 7: Current therapies for psoriasis have limitations related to safety, tolerability, convenience, and price

    Current therapies for psoriasis have limitations related to safety, tolerability, convenience, and price 1 >50% of patients are dissatisfied with current treatment options Oral Immunosuppressant Topicals Traditional Systemics Injectable Biologics • Not convenient • Safety concerns • Apremilast: • No

  8. Slide 8: Apremilast is limited by tolerability

    Apremilast is limited by tolerability Significant High Tolerability Issues Discontinuation >30% >66% of patients with moderate PsO discontinued therapy in 1st 2,3 experienced one or more of: year ; majority of discontinuation attributed to diarrhea, nausea, vomiting, and 2,3,4 tolerability 1 headach

  9. Slide 9: EDP1815 Phase 2 study in mild and moderate psoriasis

    EDP1815 Phase 2 study in mild and moderate psoriasis 1 capsule Cohort 1: Screening Period: up to 4 weeks EDP1815 or Placebo Treatment Period: 16 weeks Cohort 2: 4 capsules Key Inclusion Criteria: EDP1815 or Placebo • BSA of ≥3% and ≤10% • PASI score of ≥6 and ≤15 • PGA score of 2 or 3 Follow-up Peri

  10. Slide 10: Primary Endpoint: PASI scores

    Primary Endpoint: PASI scores Mean treatment effect across all patients assessed by mean effect and response Result Measure: Mean % change in Bayesian probability (%) that EDP1815 is superior to rate PASI from baseline to placebo; threshold to proceed ≥ 80% week 16 vs. placebo Responder Endpoint: Pr

  11. Slide 11: Baseline characteristics are well-balanced across treatment groups

    Baseline characteristics are well-balanced across treatment groups Placebo Cohort 1 Cohort 2 Cohort 3 Parameter All (pooled) (1 capsule) (4 capsules) (10 capsules) Number 249 83 56 55 55 Age, mean years 44 44.4 44.5 41.2 45.5 Female (%) 36.9 39.8 39.3 43.6 23.6 2 BMI, mean kg/m 29.7 30.2 29.9 28.5 2

  12. Slide 12: EDP1815 is superior to placebo after 5 weeks of treatment

    EDP1815 is 0 superior to placebo after 16 -5 weeks of treatment -10 -15 -20 -25 04 8 12 16 Weeks All Placebo 1 Capsule 4 Capsules 10 Capsules Bayesian Analysis, modified intent to treat. 80-90% probability that EDP1815 is superior. 12 Posterior Mean Percentage Change from Baseline in PASI Score

  13. Slide 13: Robust PASI-50 responses with EDP1815 at week 16

    PASI-50 Robust PASI-50 35% responses with * * 31.9% 30% EDP1815 at week 16 29.7% 25% 25.0% Statistically significant p-value 20% (<0.05) for 2 of the 3 individual dose cohorts, and for all 3 cohorts when pooled 15% 12.1% 10% 5% 0% All Placebo Cohort 1: Cohort 2: Cohort 3: 1 Capsule 4 Capsules 10 Cap

  14. Slide 14: PASI-75 responses increase with time

    PASI-75 responses PASI-75 increase with time 15 Placebo 1 capsule 4 capsules 10 capsules 10 Studies of longer treatment with EDP1815 may lead to deeper responses 5 0 Week 16 Week 20 Follow-up period (off study drug) 14 Difference from placebo not statistically significant at week 16 Percent Responde

  15. Slide 15: Consistent improvements across multiple endpoints at week 16

    Consistent improvements across multiple endpoints at week 16 in active cohort: responder vs. non-responder* Patients with PASI-50 or greater: Mean PGA*BSA Mean PSI itch improvement improvement Standardized -63.6% -0.9 Score Active non-responders: -0.15 Active non-responders: +9.8% Mean PSI Mean DLQI

  16. Slide 16: EDP1815 demonstrates placebo-like safety and tolerability

    EDP1815 demonstrates placebo-like safety and tolerability • Oral drug candidate that should not require screening or laboratory monitoring • Gastrointestinal related Adverse Events (AEs) comparable to placebo with no meaningful difference All Placebo (N=83) % All EDP1815 (N=166) % Any Treatment Emer

  17. Slide 17: Photographs of EDP1815 treatment responders

    Photographs of EDP1815 treatment responders • Mild or moderate psoriasis • Illustrating PASI-50 and greater responses at week 16 (on daily EDP1815) • All maintained or improved response at week 20 (4 weeks after cessation of EDP1815) • No use of topical steroidsPhotographs of EDP1815 treatment respo

  18. Slide 18: MILD disease: PASI-50 responder

    MILD disease: PASI-50 responder PASI PGA DLQI PSI Baseline 7.2 2 3 4.1 Week 16 3.6 1 0 0.4 18MILD disease: PASI-50 responder PASI PGA DLQI PSI Baseline 7.2 2 3 4.1 Week 16 3.6 1 0 0.4 18

  19. Slide 19: PASI-50 response at week 16

    PASI-50 response at week 16 FOLLOW UP TREATMENT PERIOD Week 16 Baseline Week 8 Week 20 PASI-50 19 19PASI-50 response at week 16 FOLLOW UP TREATMENT PERIOD Week 16 Baseline Week 8 Week 20 PASI-50 19 19

  20. Slide 20: MODERATE disease: PASI-50 responder

    MODERATE disease: PASI-50 responder PASI PGA DLQI PSI Baseline 10.3 3 12 24.1 Week 16 3.1 1 1 1.6 20

  21. Slide 21: PASI-50 response at week 16

    PASI-50 response at week 16 TREATMENT PERIOD FOLLOW UP Week 16 Baseline Week 8 Week 20 PASI-50 21 21PASI-50 response at week 16 TREATMENT PERIOD FOLLOW UP Week 16 Baseline Week 8 Week 20 PASI-50 21 21

  22. Slide 22: MILD disease: PASI-90 responder

    MILD disease: PASI-90 responder PASI PGA DLQI PSI Baseline 6.2 2 15 27.1 Week 16 0.6 1 1 3 22MILD disease: PASI-90 responder PASI PGA DLQI PSI Baseline 6.2 2 15 27.1 Week 16 0.6 1 1 3 22

  23. Slide 23: PASI-90 response at week 16

    PASI-90 response at week 16 TREATMENT PERIOD FOLLOW UP Week 16 Baseline Week 8 Week 20 PASI-90 23 23PASI-90 response at week 16 TREATMENT PERIOD FOLLOW UP Week 16 Baseline Week 8 Week 20 PASI-90 23 23

  24. Slide 24: MODERATE disease: PASI-90 responder

    MODERATE disease: PASI-90 responder PASI PGA DLQI PSI Baseline 11.8 3 6 8.7 Week 16 1.1 0 2 n/a 24MODERATE disease: PASI-90 responder PASI PGA DLQI PSI Baseline 11.8 3 6 8.7 Week 16 1.1 0 2 n/a 24

  25. Slide 25: PASI-90 response at week 16

    PASI-90 response at week 16 TREATMENT PERIOD FOLLOW UP Week 16 Baseline Week 4 Week 20 PASI-90 25 25PASI-90 response at week 16 TREATMENT PERIOD FOLLOW UP Week 16 Baseline Week 4 Week 20 PASI-90 25 25

  26. Slide 26: MODERATE disease: Week 20 PASI-50 response

    MODERATE disease: Week 20 PASI-50 response PASI PGA DLQI PSI Baseline 10.5 3 3 4.9 Week 16 5.7* 2 0 2.0 26MODERATE disease: Week 20 PASI-50 response PASI PGA DLQI PSI Baseline 10.5 3 3 4.9 Week 16 5.7* 2 0 2.0 26

  27. Slide 27: PASI-50 response at week 20

    PASI-50 response at week 20 TREATMENT PERIOD FOLLOW UP Week 20 Baseline Week 8 Week 16 PASI-50 27 27PASI-50 response at week 20 TREATMENT PERIOD FOLLOW UP Week 20 Baseline Week 8 Week 16 PASI-50 27 27

  28. Slide 28: EDP1815 led to robust treatment responses demonstrating potential of SINTAX platform

    EDP1815 led to robust treatment responses à demonstrating potential of SINTAX platform Deepening responses over timeà Longer treatment may lead to greater activity PASI-50 PASI-50 PASI-90 PASI-90 PASI 7.2, PGA 2, DLQI 3, PSI 4.1 PASI 11.8, PGA 3, DLQI 6, PSI 8.7 PASI 10.3, PGA 3, DLQI 12, PSI 24.1 P

  29. Slide 29: Summary of additional Phase 1b studies

    Summary of additional Phase 1b studies • Mild and moderate psoriasis using EDP1815 capsule dosage form • Results from this 8-week study were consistent with the 8-week time point in Phase 2 • Successful bridge to future studies using the commercial manufacturing process • Human scintigraphy of capsu

  30. Slide 30: EDP1815 Phase 2 study in mild, moderate and severe atopic dermatitis

    EDP1815 Phase 2 study in mild, moderate and severe 1 capsule Cohort 1: once daily Screening Period: up to 4 weeks EDP1815 or Placebo atopic dermatitis 2 capsules Treatment Period: 16 weeks Cohort 2: Key Inclusion Criteria: once daily EDP1815 or Placebo • IGA of 2, 3 or 4 • BSA of ≥ 5% • EASI of ≥ 6

  31. Slide 31: Positive Phase 2 data of EDP1815 confirms ability to harness SINTAX

    Positive Phase 2 data of EDP1815 confirms ability to harness the small intestinal axis, SINTAX, to treat systemic inflammatory diseases Clinically and statistically significant improvement in PASI-50 score achieved Oral EDP1815 can drive potent effects with placebo-like safety and tolerability EDP18

  32. Slide 32: Multiple clinical catalysts

    Multiple clinical catalysts Time 3Q 2021 4Q 2021 4Q 2022 4Q 2022 Ongoing EDP1815 –TACTIC-E Readout EDP1815 EDP1867 EDP1815 EDP2939 • Phase 2/3 data in Psoriasis • Phase 1b data in Atopic Dermatitis •Phase 1 COVID-19 • Phase 2 data Atopic Dermatitis •Phase 2 data data in • Data from multiple inflamma

  33. Slide 33: Q&A

    Q&A Vii EVELO

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