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Arcutis BIOTHERAPEUTICS Arcutis Announces Third Quarter 2021 Financial Results and Provides Business Update November 4 , 2021 • Submitted New Drug Application ( NDA ) for roflumilast cream for the treatment of plaque psoriasis across the full spectrum of disease • Initiated single pivotal Phase 3 trial of roflumilast foam in scalp and body psoriasis • • Enrolling pivotal Phase 3 trials of roflumilast cream in atopic dermatitis and roflumilast foam in seborrheic dermatitis Expanded patent portfolio with issuance of first pharmacokinetics patent covering both the cream and foam formulations of topical roflumilast • Strong financial position with approximately $ 370 million in cash , cash equivalents , and marketable securities , providing cash runway well into 2023 WESTLAKE VILLAGE , Calif . , Nov. 04 , 2021 ( GLOBE NEWSWIRE ) -- Arcutis Biotherapeutics , Inc. ( Nasdaq : ARQT ) , a late - stage biopharmaceutical company focused on developing meaningful innovations in immuno - dermatology to address the urgent needs of patients living with immune - mediated dermatological diseases and conditions , today reported financial results for the quarter ended September 30 , 2021 , and provided a business update . " The submission of our first NDA for roflumilast cream represents a pivotal milestone for the Arcutis team and for the millions of individuals struggling with plaque psoriasis . It also demonstrates Arcutis ' progress to simplify complex disease management and solve the most persistent challenges of treating chronic inflammatory diseases of the skin , " said Frank Watanabe , Arcutis ' President and Chief Executive Officer . " With our proven , experienced team , our strong financial position , and our expanded intellectual property estate , we continue to invest in our ability to maximize the potential of our medicines for patients , dermatologists , and shareholders . We look forward to a transformative 2022 for Arcutis , with a potential launch in plaque psoriasis and three additional Phase 3 clinical data readouts anticipated . " Pipeline Updates Roflumilast cream - a highly potent and selective phosphodiesterase - 4 ( PDE4 ) inhibitor in a cream formulation , being developed as a potential treatment for plaque psoriasis , including intertriginous psoriasis , and atopic dermatitis • In late September , Arcutis submitted an NDA for plaque psoriasis to the U.S. Food and Drug Administration ( FDA ) , supported by the positive results from two pivotal Phase 3 clinical trials ( DERMIS - 1 and DERMIS - 2 ) . • Patient enrollment continues in the pivotal Phase 3 trials in patients with atopic dermatitis ( INTEGUMENT - 1 , INTEGUMENT - 2 , and INTEGUMENT - PED ) , with topline data anticipated in the second half of 2022 . Roflumilast foam - an alternative formulation of topical roflumilast designed to overcome the challenges of delivering topical drugs in hair - bearing areas of the body , being developed as a potential treatment for seborrheic dermatitis and scalp and body psoriasis • In July , Arcutis announced the initiation of a single pivotal Phase 3 trial for the treatment of seborrheic dermatitis , with topline data anticipated in the second or third quarter of 2022. If positive , the Company expects the data to be sufficient basis for an NDA . • In August , Arcutis announced the initiation of a single pivotal Phase 3 trial for the treatment of scalp and body psoriasis , with topline data anticipated in the second half of 2022. If positive , the Company expects the data to be sufficient basis for an NDA . ARQ - 252 - a topical small molecule inhibitor of Janus kinase type 1 ( JAK1 ) , being developed as a potential treatment for chronic hand eczema , vitiligo , and other inflammatory dermatoses • In July , the Company announced the termination of the Phase 2a clinical trial evaluating ARQ - 252 as a potential treatment for vitiligo , after analyses of the previously announced Phase 2 chronic hand eczema study pointed to inadequate local drug delivery to the skin . • The Company continues its reformulation efforts to develop an enhanced formulation of ARQ - 252 that delivers more active drug to targets in the skin . ARQ - 255- an alternative topical formulation of ARQ - 252 designed to reach deeper into the skin in order to potentially treat alopecia areata • Formulation and preclinical efforts are continuing . Recent Corporate Highlights