Page 1

ArcutiS BIOTHERAPEUTICS Arcutis Announces First Quarter 2021 Financial Results and Provides Business Update May 4 , 2021 • New Drug Application ( NDA ) submission for topical roflumilast cream as a potential treatment for plaque psoriasis anticipated in the second half of 2021 • Positive Phase 3 results for topical roflumilast cream in plaque psoriasis announced in February • Advancing topical roflumilast foam into Phase 3 development for the treatment of scalp psoriasis with a single pivotal trial Progressing topical roflumilast foam into Phase 3 development in seborrheic dermatitis with a single pivotal trial • • Pivotal Phase 3 trials of topical roflumilast cream in atopic dermatitis initiated in January • Phase 1 / 2b study of ARQ - 252 in chronic hand eczema did not meet its primary endpoint • Strong financial position with over $ 440 million in cash , cash equivalents and marketable securities providing cash runway well into 2023 WESTLAKE VILLAGE , Calif . , May 04 , 2021 ( 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 reported financial results for the quarter ended March 31 , 2021 , and provided a business update . " Building on the foundation of last year's strong execution , the first quarter of 2021 was highly productive for Arcutis , " said Frank Watanabe , Arcutis ' President and Chief Executive Officer . " With the positive pivotal Phase 3 results in plaque psoriasis reported in February , we are on track to submit an NDA to the FDA in the second half of 2021 for topical roflumilast cream as a potential once daily topical treatment for plaque psoriasis . The robust Phase 3 data also reinforce our optimism for the multiple additional on - going development efforts with topical roflumilast cream and foam . We are also delighted that we were able to reach agreement with the FDA to advance roflumilast foam into Phase 3 development with a single pivotal study in scalp psoriasis . " Mr. Watanabe continued : " We are disappointed with the recent results of the ARQ - 252 Phase 1 / 2b study in chronic hand eczema , a difficult disease to treat , and are undertaking further analyses to understand the data . Looking forward , we believe 2021 will be a transformational year for Arcutis as we have begun our plaque psoriasis commercialization efforts in earnest , and continue to rapidly advance an innovative and differentiated late - stage pipeline of potential best - in - class topical dermatology therapies . " Pipeline Updates ARQ - 151 ( topical 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 . • Reported positive results from the two pivotal Phase 3 clinical trials ( DERMIS - 1 and DERMIS - 2 ) in patients with plaque psoriasis ; NDA submission to U.S. Food and Drug Administration ( FDA ) anticipated in the second half of 2021 . • Pivotal Phase 3 trials in patients with atopic dermatitis ( INTEGUMENT - 1 , INTEGUMENT - 2 , and INTEGUMENT - PED ) have been initiated , with topline data anticipated in the second half of 2022 . ARQ - 154 ( topical roflumilast foam ) - an alternative topical foam formulation of 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 . • Following a recent End - of - Phase 2 meeting with the FDA , the Company is advancing roflumilast foam into Phase 3 development for the treatment of scalp psoriasis in a single pivotal trial , with topline data anticipated in the second half of 2022 . • After a previous FDA End - of - Phase 2 meeting early in Q1 , announced advancement of roflumilast foam into Phase 3 development for the treatment of seborrheic dermatitis in a single pivotal trial , with topline data anticipated in the second or third quarter of 2022 . ARQ - 252 - a potent and highly selective topical small molecule inhibitor of Janus kinase type 1 ( JAK1 ) , being developed as a potential treatment for chronic hand eczema and other inflammatory dermatoses . • 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. In the study , none of the ARQ - 252 arms achieved statistical significance versus vehicle . Further analyses of the data are underway . ARQ - 252 was generally safe and well - tolerated . • Initiated a Phase 2a clinical trial evaluating ARQ - 252 as a potential treatment for vitiligo with topline data anticipated in the second half of 2023 . ARQ - 255 - an alternative topical formulation of ARQ - 252 designed to reach deeper into the skin in order to potentially treat alopecia areata .