WESTLAKE VILLAGE, CA / ACCESSWIRE / May 30, 2019 / Arcutis, Inc., a privately held immuno-dermatology drug development company addressing significant unmet needs in dermatology, today announced that Frank Watanabe, Arcutis’ President and Chief Executive Officer, will present at the Jefferies 2019 Global Healthcare Conference on Tuesday, June 4, 2019 at 9:00 am ET. The Company will host investor meetings during the conference.

About Arcutis – Bioscience, applied to the skin.

Arcutis is a clinical-stage biopharmaceutical company focused on developing and commercializing drugs that address significant unmet medical needs in immuno-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. For more information, please visit www.arcutis.com or follow the Company on LinkedIn.

Contact:

John W. Smither
Chief Financial Officer
jsmither@arcutis.com

Investors and Media:

Derek Cole
720.785.4497
derek.cole@IRadvisory.com

SOURCE: Arcutis, Inc.

WESTLAKE VILLAGE, CA / ACCESSWIRE / May 21, 2019 / Arcutis, Inc., a privately held immuno-dermatology drug development company addressing significant unmet needs in dermatology, today announced the appointment of John W. Smither as Chief Financial Officer (CFO). Mr. Smither will be responsible for all financial and administrative aspects of the company including financing, business planning and analysis, investor relations, tax, accounting, treasury, human resources, and information technology.

“We are delighted for John to join Arcutis as our Chief Financial Officer,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “John is an exceptionally experienced finance executive with more than 40 years of professional experience, over 20 years of which is in the life science industry, and an unsurpassed understanding of both private and public equity markets for biotechnology companies. John and I have previously worked together, and I look forward to his counsel and contributions as we continue to expand and advance Arcutis’ robust dermatology development pipeline, build company capabilities and prepare for our next round of funding and potentially accessing public markets in the future.”

Mr. Smither previously served as CFO for Sienna Biopharmaceuticals from January 2016 to March 2017 and again from March 2018 to April 2019. From October 2017 to April 2018, he was interim CFO for Kite Pharma during its integration with Gilead, and prior to that, was CFO at Unity Biotechnology from January 2016 to 2017. Earlier, he served as CFO of Kythera Biopharmaceuticals, Inc. from November 2007 until it was acquired by Allergan in October 2015 for $2.1 billion. In his various CFO positions, Mr. Smither oversaw multiple private and public financing rounds, including Kythera’s initial public offering, and initial IPO preparations at Unity and Sienna. He also serves on the Board of Directors of both eFFFECTOR Therapeutics and Achaogen, Inc.

From 1998 to 2007, Mr. Smither held various positions at Amgen. From 2001 to 2004, he served as vice president of finance and administration for Amgen’s European Division, where he was responsible for financial operations in 28 European countries. Prior to that, Mr. Smither served as head of internal audit, and following his time in Europe was executive director of corporate accounting. Prior to joining Amgen, he served as audit partner at Ernst & Young LLP, a public accounting firm, and following his time at Ernst & Young served as CFO of several early stage companies. He holds a Bachelor of Science in Business Administration from California State University, Los Angeles. Mr. Smither is a Certified Public Accountant (inactive) and a member of the American Institute of Certified Public Accountants, the California Society of Certified Public Accountants and Financial Executives International.

About Arcutis – Bioscience, applied to the skin.

Arcutis is a clinical-stage biopharmaceutical company focused on developing and commercializing drugs that address significant unmet medical needs in immuno-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. For more information, please visit www.arcutis.com or follow the Company on LinkedIn.

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.

• ARQ-151 Potential “Best in Class” Topical PDE4 inhibitor
• Phase 1 Study in Atopic Dermatitis Completed
• Phase 2 Study Initiation Anticipated June 2019

WESTLAKE VILLAGE, CA / ACCESSWIRE / May 16, 2019 / Arcutis, Inc., a privately held immuno-dermatology drug development company addressing significant unmet needs in dermatology today provided details on the ARQ-151 clinical development program for atopic dermatitis. ARQ-151, Arcutis’ lead product candidate, is a highly potent and selective phosphodiesterase type 4 inhibitor (“PDE4 inhibitor”) once-daily topical cream. The Company anticipates initiating a Phase 2 study evaluating the compound as a potential treatment for atopic dermatitis (AD) in June 2019.

Frank Watanabe, Arcutis’ President and Chief Executive Officer, commented: “In 2017, approximately ten million atopic dermatitis patients were diagnosed in the United States with approximately 5.5 million of those patients receiving topical therapy. We believe a substantial need exists for a therapy that offers greater efficacy, the ability to treat chronically, and good safety and tolerability, all of which we believe ARQ-151 may provide.”

ARQ-151 is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast) that has been approved for the systemic treatment of chronic obstructive pulmonary disease (COPD) since 2011 and that is many-fold more potent than any other disclosed PDE4 inhibitor. Phosphodiesterase type 4 (PDE4) is an intracellular enzyme that increases the production of proinflammatory mediators and decreases production of anti-inflammatory mediators, and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the U.S. Food and Drug Administration for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

Arcutis believes ARQ-151 has significant potential as an atopic dermatitis treatment given PDE4 is a proven mechanism to treat AD and that ARQ-151 is 50- to 300- fold more potent than the approved PDE4 inhibitors. Arcutis has completed a Phase 1 pharmacokinetic (PK) study of ARQ-151 in AD patients, which provided an early signal of efficacy with an approximate 50% reduction in AD lesion area after only 2 weeks of treatment. ARQ-151 causes little to no irritation on application, and has shown no signs of significant local skin reactions in clinical studies.

Based on the strength of the Phase 1 AD PK study data and the compound’s profile, Arcutis anticipates initiating a Phase 2 study of ARQ-151 in AD in June 2019.

About Atopic Dermatitis

Atopic dermatitis (AD) is the most common type of eczema, occurring in approximately six percent of the U.S. population. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more. The disease typically begins in early childhood and is chronic, but many sufferers outgrow it as they age, although it persists into adolescence and even adulthood in some individuals. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Since a large percentage of AD patients are very young children, safety is a particularly important consideration in treatment selection.

About Arcutis – Bioscience, applied to the skin.

Arcutis is a clinical-stage biopharmaceutical company focused on developing and commercializing drugs that address significant unmet medical needs in immuno-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. For more information, please visit www.arcutis.com or follow the Company on LinkedIn.

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.

WESTLAKE VILLAGE, CA / ACCESWIRE / May 9, 2019 / Arcutis, Inc., a privately held immuno-dermatology drug development company addressing significant unmet needs in dermatology, today announced that Frank Watanabe, Arcutis’ President and Chief Executive Officer, will present at the RBC Capital Markets 2019 Healthcare Conference on Wednesday, May 22, 2019 at 9:00am ET. The Company will host investor meetings during the conference.

About Arcutis

Arcutis is a clinical-stage biopharmaceutical company focused on developing and commercializing drugs that address significant unmet medical needs in immune-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. For more information, please visit www.arcutis.com or follow the Company on LinkedIn. 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.

• ARQ-151 Potential “Best in Class” Topical PDE4 inhibitor
• ARQ-151 Potentially Only Topical PDE4 inhibitor for Psoriasis
• Phase 2a Study in Plaque Psoriasis Completed
• Phase 2b Study Initiated, Data Anticipated Third Quarter 2019

WESTLAKE VILLAGE, CA / ACCESSWIRE / May 7, 2019 / Arcutis, Inc., a privately held immuno-dermatology drug development company addressing significant unmet needs in dermatology today provided details on the ARQ-151 clinical development program for plaque psoriasis. ARQ-151, Arcutis’ lead product candidate, is a highly potent and selective phosphodiesterase type 4 inhibitor (“PDE4 inhibitor”) once-daily topical cream. 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.

Frank Watanabe, Arcutis’ President and Chief Executive Officer, commented: “Psoriasis is a very challenging dermatosis to treat topically. Based on the clinical data generated to date, we believe ARQ-151 is uniquely suited to address the unmet needs in topical treatment of psoriasis, offering an ideal combination of efficacy comparable to a high potency steroid, the ability to use the drug chronically in any anatomic area, and an excellent safety and tolerability profile.”

ARQ-151 is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast) that has been approved globally for the systemic treatment of COPD since 2011 and that is many-fold more potent than any other disclosed PDE4 inhibitor. Phosphodiesterase type 4 (PDE4) is an intracellular enzyme that increases the production of proinflammatory mediators and decreases production of anti-inflammatory mediators, and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and chronic obstructive pulmonary disease (COPD). PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the U.S. Food and Drug Administration for the topical treatment of atopic dermatitis and the systemic treatment of plaque psoriasis.

Arcutis has completed an 89-patient randomized, double blind, vehicle-controlled multinational, multi-center Phase 2a study of ARQ-151 in plaque psoriasis. In the Phase 2a study, ARQ-151 produced statistically significant reductions in the signs of plaque psoriasis after only 2 weeks of once daily treatment, and produced a greater than 65% improvement from baseline after 4 weeks of daily treatment, while demonstrating excellent safety and tolerability in this population.

Based on the strength of the Phase 2a data, Arcutis initiated an on-going 332-patient randomized, double blind multinational, multi-center, 12-week Phase 2b study of ARQ-151 in plaque psoriasis. The primary endpoint of the study is the Investigator’s Global Assessment (IGA). The study is fully enrolled, and the Company currently anticipates topline data from the Phase 2b study in the third quarter of 2019.

About Psoriasis

Psoriasis is an immune disease that occurs in about two percent of adults in western countries. About 90% of psoriasis cases is plaque psoriasis, which is characterized by “plaques”, or raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and the plaques are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous areas (where two skin areas may touch or rub together).

About Arcutis

Arcutis is a clinical-stage biopharmaceutical company focused on developing and commercializing drugs that address significant unmet medical needs in immune-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. For more information, please visit www.arcutis.com or follow the Company on LinkedIn. 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.