Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT

Arcutis Biotherapeutics — Technical Presentation (April 2021)

12 slides from Arcutis Biotherapeutics's technical presentation, Apr 23, 2021

  1. Slide 1: Once-daily Roflumilast Foam 0.3% for Scalp and Body Psoriasis: Phase 2b Study

    Once-daily Roflumilast Foam 0.3% for Scalp and Body Psoriasis: A Randomized, Double-blind, Vehicle- controlled Phase 2b Study Leon H Kircik1, Angela Moore2, Neal Bhatia3, Alim R Devani4, Zoe D Draelos5, Janet DuBois6, Melinda J Gooderham7, Steven E Kempers8, Edward Lain9, Mark Lee10, Dedee F Murrell

  2. Slide 2: Disclosures

    Disclosures Leon H Kircik is a speaker for Galderma Laboratories, L.P., Genentech, Inc., Johnson & Johnson Consumer Products Company, Leo Pharma Inc, 3M Pharmaceuticals, Onset Dermatologics, Pharmaderm, Merck Serono, SkinMedica, Inc., Stiefel a GSK company, Triax Pharmaceuticals, LLC, Valeant Pharma

  3. Slide 3: Introduction

    Introduction • In patients with psoriasis, about 80% have scalp psoriasis (S-PsO)1 • S-PsO is often associated with itch, the most burdensome symptom of psoriasis2 • Itching, flaking, and appearance of plaques on the scalp can cause social embarrassment and adversely impact quality of life3 • Treatm

  4. Slide 4: Methods and Study Design

    Methods and Study Design Eligibility Endpoints • Aged ≥12y 2:1 Roflumilast foam • Diagnosis of scalp and 0.3% QD Primary body plaque psoriasis (n=200) Scalp-IGA (S-IGA) success (Clear or Almost Randomize • At least Mild severity* on Clear with at least a 2-grade both scalp (S-IGA) and improvement fr

  5. Slide 5: Subject Disposition

    Subject Disposition Roflumilast foam Vehicle foam Overall 0.3% (N=104) (N=304) (N=200) Completed 177 (88.5%) 87 (83.7%) 264 (86.8%) Prematurely discontinued 23 (11.5%) 17 (16.3%) 40 (13.2%) Reason for discontinuation Withdrawal by subject 9 (4.5%) 6 (5.8%) 15 (4.9%) Non-compliance 1 (0.5%) 0 1 (0.3%

  6. Slide 6: Baseline Disease Characteristics (ITT Population)

    Baseline Disease Characteristics (ITT Population) Roflumilast foam 0.3% Vehicle foam Overall (N=200)† (N=104) (N=304) BSA, mean % 8.0 7.6 7.9 Baseline S-IGA 2 – Mild 18 (9.0%) 14 (13.5%) 32 (10.5%) 3 – Moderate 151 (75.5%) 80 (76.9%) 231 (76.0%) 4 – Severe 29 (14.5%) 10 (9.6%) 39 (12.8%) Baseline B-

  7. Slide 7: Roflumilast Foam Significantly Increased Percentage of Patients with S-IGA Success at Week 8

    Roflumilast Foam Significantly Increased the Percentage of Patients with S-IGA Success at Week 8 (Primary Endpoint) Approx 60% of Patients Achieved S-IGA Success at Week 8 Significant Efficacy was Demonstrated as Early as Week 2 100% Percentage of Patients p < 0.0001 80% p < 0.0001 59.1% 60% 41.3% 4

  8. Slide 8: Significantly More Patients Treated with Roflumilast Foam Had B-IGA Success

    Significantly More Patients Treated with Roflumilast Foam Had B-IGA Success as Early as Week 2 40% of Patients Achieved B-IGA Success at Week 8 100% Percentage of Patients 80% p < 0.0001 60% 40.3% 40% p = 0.0011 p = 0.0079 21.3% 20% 9.5% 6.8% 5.6% 1.0% 0% Week 2 Week 4 Week 8 Roflumilast foam 0.3% V

  9. Slide 9: Significantly More Roflumilast-treated Patients Had SI-NRS 4-point Response

    Significantly More Roflumilast-treated Patients had SI-NRS 4-point Response as Early as Week 2 >70% of Patients Achieved a SI-NRS 4-point Response at Week 8 100% 90% p < 0.0001 80% p < 0.0001 71.0% Percentage of Patients 70% 62.0% 60% p < 0.0001 50% 44.6% 40% 30% 22.1% 18.5% 20% 15.6% 10% 0% Week 2

  10. Slide 10: Significantly More Roflumilast-treated Patients Achieved PSSI-75

    Significantly more Roflumilast-treated Patients Achieved a 75% Reduction in the Psoriasis Scalp Severity Index (PSSI-75) >50% of Patients Achieved PSSI-75 at Week 4 100% 90% p < 0.0001 80% Percentage of Patients p < 0.0001 70% 67.2% 60% 53.0% 50% p < 0.0001 40% 30% 26.3% 21.8% 20% 10.0% 10% 4.1% 0%

  11. Slide 11: Roflumilast Foam Had Safety and Tolerability Profile Similar to Vehicle

    Roflumilast Foam Had Safety and Tolerability Profile Similar to Vehicle Roflumilast foam Vehicle • Rates of AEs were low 0.3% foam • Few treatment-related AEs were N (%) (n=198) (n=104) reported Patients with any TEAE 46 (23.2) 20 (19.2) • Only 1 patient had a SAE (unrelated) Patients with any treat

  12. Slide 12: Conclusions

    Conclusions • Patients with scalp psoriasis need topical treatments that provide effective control of psoriasis with low incidence of side effects • In this Phase 2b study, once-daily roflumilast foam significantly improved both scalp and body psoriasis, apparent as early as 2 weeks after treatment

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