News Release Details

• Broad and deep portfolio of highly differentiated product candidates aligned with needs of patients and doctors
• Robust pipeline includes 4 development programs addressing 7 dermatological diseases, including 3 programs in Phase 2 or Phase 3 for 5 different indications
• Pipeline has potential to generate sales of ~$3 billion to $8 billion by 2030 in the U.S. market alone
• Live webcast and archived replay of Investor Day available in IR section of Arcutis website

WESTLAKE VILLAGE, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced continued progress and future growth drivers related to its immuno-dermatology platform and pipeline, which will be highlighted during today’s Virtual Investor Day at 11:00 am ET.

The Virtual Investor Day features presentations and a Q&A session led by Arcutis executives, Frank Watanabe, President and Chief Executive Officer, Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer, and Kenneth Lock, Chief Commercial Officer. In addition, there will be commentary and Q&A with Zoe Diana Draelos, M.D., FAAD, consulting professor of dermatology, Duke University School of Medicine, Durham, N.C., and an investigator, Dermatology Consulting Services, High Point, N.C.

The Investor Day will highlight multiple programs and markets illustrating the significant opportunity in Arcutis’ portfolio and its value-creating potential:

Substantial Market Opportunity

• Large pool of currently treated and readily addressable patients;
• Strong Phase 2 data across multiple indications, including plaque psoriasis, atopic dermatitis, seborrheic dermatitis, scalp psoriasis, and long-term treatment of psoriasis;
• Compelling and differentiated product profile for topical roflumilast with efficacy equivalent to high potency steroids, rapid relief from itch, ability to use on all body areas with excellent safety and tolerability and convenient, once-a-day dosing in a easy to use cream or foam formulation; and
• Pipeline that could generate sales of $3 billion to $8 billion by 2030 in the U.S. market alone.

ARQ-151 - Topical Roflumilast Cream

• Psoriasis long-term safety data shows a strong durability of efficacy and favorable safety/tolerability over 52 to 64 weeks, with a high patient completion rate; and
• Investigator Global Assessment (IGA) success in atopic dermatitis at 4 weeks similar to other topicals.

ARQ-154 - Topical Roflumilast Foam

• Potential to be the first topical treatment in decades to offer a novel mechanism of action for the treatment of seborrheic dermatitis;
• Psoriasis Scalp Investigator Global Assessment (S-IGA) success at 8 weeks similar to high potency steroids; and
• Roflumilast may possess anti-fungal in addition to anti-inflammatory effects.

ARQ-252 Cream & ARQ-255 Suspension (JAK1 Inhibitors)

• ARQ-252/255 is highly selective to JAK1 over JAK2;
• Among topical JAK inhibitors, ARQ-252/255 is the only treatment that is specific to JAK1;
• Quick enrollment in Phase 2 hand eczema study with data expected in mid 2021, and Phase 2 vitiligo study starting soon; and
• Novel “4D” deep-penetrating vehicle allowing topical delivery deep in the dermis where other topicals cannot reach.

“We have a unique strategy that affords speed, capital efficiency and reduced risk, which enables us to leverage our unrivalled product development capabilities and expertise in dermatology drug development to address the significant unmet needs in dermatology,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “Our team has built a broad and deep portfolio of unique and highly differentiated product candidates that we believe could generate as much as $8 billion in sales in the U.S. market alone. We are proud of this tremendous progress advancing and successfully executing on our strategy and positioning us to help dermatologists and their patients in the near future, and we look forward to providing updates on the upcoming flow of multiple Phase 2 and Phase 3 clinical catalysts expected in 2021 and 2022.”

Arcutis’ virtual Investor Day is on Wednesday, Dec. 9, 2020, from 11:00 a.m.- 1:00 p.m. EST. A link to register for the event is available HERE. A live audio webcast and archived replay of the presentation will be available in the Investor Relations section of the Arcutis website.

About Arcutis - Bioscience, applied to the skin.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis’ robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company’s lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow the company on LinkedIn and Twitter.

Forward Looking Statements

This press release contains "forward-looking" statements, including, among others, statements regarding the potential for its topical drugs in development to address large markets with significant unmet need; expectations with regard to the timing of data events and initiation of clinical trials anticipated during 2020/2021; and the Company’s belief that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations into 2022. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-Q filed with U.S. Securities and Exchange Commission (SEC) on November 5, 2020, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Investor Contact:
Heather Rowe Armstrong
Vice President, Investor Relations & Corporate Communications
harmstrong@arcutis.com
805-418-5006, Ext. 740