Tue, 21 May 2019

  • Robust pipeline of 'best-in-class' topical drugs
  • Leveraging recent advances in inflammation and immunology
  • Multiple clinically important Phase 3 and Phase 2 data events anticipated during 2019 and 2020
  • Leadership team members have successfully developed more than 20 FDA approved products
  • Strong institutional investor support in Series A and B financings

WESTLAKE VILLAGE, CA / ACCESSWIRE / April 23, 2019 / Arcutis, Inc., a privately held immuno-dermatology drug development company, was formed in 2016 to address significant unmet needs in dermatology. The Company applies recent innovations in inflammation and immunology to bring best-in-class molecules to bear against validated physiologic targets known to treat dermatologic diseases and disorders. Arcutis' leadership team has extensive expertise in the development and commercialization of dermatological products, having held key leadership roles at a number of leading dermatology companies and, collectively, has successfully developed more than 20 FDA-approved products.

Leading the company is Frank Watanabe, M.A. as President and CEO. He brings over 25 years of biotech and pharmaceutical leadership experience across U.S., international and global markets, including executive positions with Kythera Biopharmaceuticals, Amgen, Inc. and Eli Lilly and Company. HowardWelgus, M.D., FAAD, the company's Chief Medical Officer, was previously the Chief Medical Officer of Verrica Pharmaceuticals, Thesan Pharmaceuticals, Nycomed, and Head of Dermatology and Inflammation at Pfizer Global R&D. David Osborne, Ph. D, Arcutis' Chief Technical Officer, is an industry-leading expert in topical drug formulation, and was previously Chief Scientific Officer at Tolmar, and before that, Vice President of Product Development at Dow Pharmaceutical Sciences, and earlier, ViroTex/Atrix.

Arcutis' strategy is to identify, develop and commercialize best-in-class molecules against validated targets, which will enable the Company to develop differentiated products in less time, at lower cost, and at substantially lower risk than other approaches. This combination of vision, unmet medical need, experienced management and strategic approach has attracted support from leading investors in the life sciences sector, including: FrazierHealthcare Partners, BainCapital Life Sciences, OrbiMed,RA Capital Management,Hillhouse Capital Group, and Rainbow Group Capital Management. Arcutis has successfully completed Series A and Series B financings, the proceeds of which are funding its clinical development programs and corporate operations.

BhaskarChaudhuri, Ph.D., co-founder and Chairman of Arcutis' Board of Directors commented: 'Dermatological diseases affect tens of millions of people worldwide each year, impacting their quality of life, and physical, functional and emotional well-being. Despite this, and despite progress in the development of biologic therapies to treat dermatological diseases, the vast majority of dermatology patients continue to be treated by older therapies that offer inadequate efficacy, that do not target specific disease mediators, or that carry with them substantial safety and tolerability issues.' Mr. Watanabe added 'Dermatologists and patients badly need innovative topical treatments that directly target immunological mediators of inflammatory diseases with high local skin efficacy, low systemic safety risks, the ability to use them chronically, and a good risk/benefit ratio. Arcutis is focused on addressing these important needs.'

PIPELINE

Arcutis has built a robust pipeline with two best-in-class molecules, one of which also represents a 'pipeline-in-a-molecule' opportunity. The Company currently anticipates a steady stream of clinically important data events during 2019 and 2020, encompassing outcomes from multiple Phase 3 and Phase 2 studies.

Arcutis' lead product candidate, ARQ-151, is a potent phosphodiesterase type 4 inhibitor ('PDE4 inhibitor') topical cream for the treatment of plaque psoriasis, atopic dermatitis, and other inflammatory dermatoses. The Company is currently evaluating the compound in a Phase 2b study in plaque psoriasis with top line results anticipated in the third quarter of 2019. ARQ-151 has also been evaluated in a successful Phase 1 study in atopic dermatitis. The Company anticipates initiating a Phase 2 study in atopic dermatitis in the second quarter of 2019.

Arcutis' second drug candidate, ARQ-250, is a potent and highly selective topical janus kinase type 1 ('JAK1') inhibitor. The Company is currently in preclinical product development of ARQ-250.

About Arcutis

Arcutis is a clinical-stage biopharmaceutical company focused on developing and commercializing drugs that address significant unmet medical needs in dermatology. Arcutis exploits recent innovations in inflammation and immunology to develop best-in-class molecules against biologically validated targets, leveraging our industry-leading development expertise to bring to market novel dermatology treatments in less time, at lower cost and with lower risk than other approaches. Arcutis is currently developing two novel compounds (ARQ-151 and ARQ-250) for multiple indications including, psoriasis, atopic dermatitis, and eczema. Find more information at www.arcutis.com. Arcutis - Bioscience, applied to the skin.

Contact:

T. Frank Watanabe

Chief Executive Officer

tfw@arcutis.com

Investors and Media:

Derek Cole

720.785.4497

derek.cole@IRadvisory.com

SOURCE: Arcutis, Inc.

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