Arcutis Announces Second Quarter 2020 Financial Results and Provides Business Update

  • Robust pipeline anticipated to deliver two Phase 3 and four Phase 2 data events in 2020 and 2021
  • Arcutis currently expects no impact to its previously disclosed clinical timelines due to COVID-19
  • Arcutis development programs address dermatological diseases impacting over 20 million patients in the U.S.
  • Strong financial position with $224.0 million in cash, cash equivalents and marketable securities

WESTLAKE VILLAGE, Calif., Aug. 11, 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 reported financial results for the quarter ended June 30, 2020, and provided a business update.

Frank Watanabe, Arcutis’ President and Chief Executive Officer. “Dermatologists and patients are desperate for new topical options to treat serious diseases of the skin. We are focused on elevating the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and eliminate the need for patients to compromise between drug safety, efficacy, and tolerability. We appreciate the strong support from investigators across our development programs, which currently include four product candidates in development for seven indications, with an addressable U.S. market of over 20 million patients.”” data-reactid=”18″>“Arcutis is uniquely positioned to fill the innovation gap in the medical dermatology sector, and we anticipate six important clinical data readouts, including our pivotal Phase 3 clinical trials of topical roflumilast cream as a potential treatment for plaque psoriasis, between now and the end of 2021,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “Dermatologists and patients are desperate for new topical options to treat serious diseases of the skin. We are focused on elevating the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and eliminate the need for patients to compromise between drug safety, efficacy, and tolerability. We appreciate the strong support from investigators across our development programs, which currently include four product candidates in development for seven indications, with an addressable U.S. market of over 20 million patients.”

  • The New England Journal of Medicine published positive results from a Phase 2b trial, which demonstrated the compound significantly improves chronic plaque psoriasis.
  • Topline data from two on-going Phase 3 clinical trials (DERMIS-1 and-2) in patients with plaque psoriasis is anticipated in the first half of 2021.
  • On-going Phase 2 long-term safety study in plaque psoriasis has completed enrollment, with topline data anticipated in the first quarter of 2021.
  • The Company expects to begin a Phase 2b study in atopic dermatitis in the second half of 2020, with topline data anticipated in the second half of 2021.
  • In June, the Company completed enrollment in the on-going Phase 2 proof-of-concept study in seborrheic dermatitis, with topline data anticipated early in the fourth quarter of 2020.
  • In July, the Company completed enrollment in the ongoing Phase 2b study in scalp psoriasis, with topline data anticipated in the fourth quarter of 2020.
  • In July, the Company initiated enrollment in the Phase 2b portion of the ongoing Phase 1/2b study in chronic hand eczema, with topline data anticipated in the second half of 2021.
  • The Company anticipates initiating a Phase 2a study in vitiligo in the second half of 2020.
  • Formulation and preclinical efforts are underway.
  • Over the course of the second quarter, the Company announced that two senior executives had joined the Company:
  • Jay Ramsinghani, Vice President of Commercial Strategy and Operations.
  • Ayisha Jeter, Vice President of Market Access.
  • 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.” data-reactid=”52″>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.

    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 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  through 2021. 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 August 11, 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.

      June 30,   December 31,
      2020   2019
      (Unaudited)    
    ASSETS      
    Current assets:      
    Cash and cash equivalents $ 171,546     $ 63,336  
    Marketable securities 52,429     37,929  
    Prepaid expenses and other current assets 4,060     5,209  
    Total current assets 228,035     106,474  
    Property, plant, and equipment, net 228     227  
    Operating lease right-of-use asset 3,629     264  
    Other assets 78     47  
    Total assets $ 231,970     $ 107,012  
    LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)      
    Current liabilities:      
    Accounts payable $ 8,253     $ 1,405  
    Accrued liabilities 10,948     3,654  
    Operating lease liability 80     178  
    Total current liabilities 19,281     5,237  
    Operating lease liability, noncurrent 3,610     129  
    Other long-term liabilities 156     184  
    Total liabilities 23,047     5,550  
    Convertible preferred stock     166,491  
    Stockholders’ equity (deficit):      
    Preferred stock          
    Common stock 3      
    Additional paid-in capital 338,617     1,244  
    Accumulated other comprehensive income (loss)     (1 )
    Accumulated deficit (129,697 )   (66,272 )
    Total stockholders’ equity (deficit) 208,923     (65,029 )
    Total liabilities, convertible preferred stock and stockholders’ equity (deficit) $ 231,970     $ 107,012  
                   

      Three Months Ended June 30,   Six Months Ended June 30,
      2020   2019   2020   2019
    Operating expenses:              
    Research and development $ 30,009     $ 7,214     $ 55,191     $ 13,417  
    General and administrative 5,618     1,324     9,087     2,073  
    Total operating expenses 35,627     8,538     64,278     15,490  
    Loss from operations (35,627 )   (8,538 )   (64,278 )   (15,490 )
    Other income, net 215     248     853     542  
    Net loss $ (35,412 )   $ (8,290 )   $ (63,425 )   $ (14,948 )
    Per share information:              
    Net loss per share, basic and diluted $ (0.94 )   $ (4.69 )   $ (2.05 )   $ (8.79 )
    Weighted-average shares used in computing net loss per share, basic and diluted 37,587,330     1,767,658     30,921,866     1,700,549  

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