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ArcutisS BIOTHERAPEUTICS Arcutis Announces Second Quarter 2021 Financial Results and Provides Business Update August 5 , 2021 • Anticipates submission of a New Drug Application ( NDA ) for topical roflumilast cream as a potential treatment for plaque psoriasis late in the third quarter or early in the fourth quarter of 2021 • Initiated single pivotal Phase 3 trial of topical roflumilast foam in seborrheic dermatitis , a disease that affects more than 10 million people in the U.S. • Anticipates initiation of single pivotal Phase 3 trial of topical roflumilast foam in scalp psoriasis in Q3 2021 • Enrolling pivotal Phase 3 trials of topical roflumilast cream in atopic dermatitis • Strong financial position with over $ 400 million in cash , cash equivalents , and marketable securities providing cash runway well into 2023 WESTLAKE VILLAGE , Calif . , Aug. 05 , 2021 ( GLOBE NEWSWIRE ) -- Arcutis Biotherapeutics , Inc. ( Nasdaq : ARQT ) , a late - stage biopharmaceutical company focused on developing meaningful innovations to address the urgent needs of patients living with immune - mediated dermatological diseases and conditions , or immuno - dermatology , today reported financial results for the quarter ended June 30 , 2021 , and provided a business update . " We are on track to submit our plaque psoriasis NDA to the FDA soon , based on the strongly positive pivotal Phase 3 results reported in February . We have also initiated , or are on the cusp of initiating , three more Phase 3 programs of topical roflumilast , with multiple top - line readouts in 2022 , " said Frank Watanabe , Arcutis ' President and Chief Executive Officer . " We continue to add top talent to our team , as our strong financial position allows us to build out key capabilities to ensure we are ready to launch topical roflumilast , pending FDA approval , and to maximize the potential of our medicines for patients , dermatologists , and shareholders . The significant progress made at Arcutis in the first half of 2021 positions us well for an exciting next 18 months . " Pipeline Updates Roflumilast cream - a highly potent and selective phosphodiesterase type 4 ( PDE4 ) inhibitor in a cream formulation , being developed as a potential treatment for plaque psoriasis , including intertriginous psoriasis , and atopic dermatitis . • Arcutis anticipates submitting an NDA for plaque psoriasis to the U.S. Food and Drug Administration ( FDA ) late in the third quarter or early in the fourth quarter of 2021 , based on 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 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 . • The Company anticipates initiating a single pivotal Phase 3 trial for the treatment of scalp and body psoriasis in Q3 2021 , 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 May , Arcutis announced that the Phase 2 study of ARQ - 252 in chronic hand eczema did not meet its primary endpoint of Investigator Global Assessment ( IGA ) of clear or almost clear at week 12. Further analyses of the study pointed toward inadequate local drug delivery to the skin as a key driver of the lack of efficacy . Importantly , no safety or tolerability issues were seen . • In July , the Company announced the termination of the Phase 2a clinical trial evaluating ARQ - 252 as a potential treatment for vitiligo , based on the aforementioned analyses of the Phase 2 chronic hand eczema study . • 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 .