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.

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.

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.

ARQ-255 - an alternative topical formulation of ARQ-252 designed to reach deeper into the skin in order to potentially treat alopecia areata.

Recent Corporate Highlights 

First Quarter 2021 Summary Financial Results

Cash, cash equivalents, restricted cash and marketable securities were $446.5 million as of March 31, 2021, compared to $286.0 million as of December 31, 2020. Arcutis believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations well into 2023.

Research and development (R&D) expenses for the quarter ended March 31, 2021 were $21.6 million compared to $25.2 million for the corresponding period in 2020. The year-over-year decrease was primarily due to the completion of our Phase 3 studies of roflumilast cream in plaque psoriasis and Phase 2 studies of roflumilast foam in seborrheic dermatitis and scalp psoriasis, offset partially by increased clinical costs for our Phase 3 studies of roflumilast cream in atopic dermatitis and Phase 2 studies of ARQ-252 in hand eczema and vitiligo, as well as increased product development expenses.

General and administrative (G&A) expenses for the quarter ended March 31, 2021 were $14.5 million compared to $3.5 million for the corresponding period in 2020. The year-over-year increase was primarily due to higher headcount and professional services costs, as well as a one-time $5.3 million non-cash charge for modifications to previously granted stock awards in connection with an officer's retirement.

Net loss was $36.0 million, or $0.76 per basic and diluted share, for the quarter ended March 31, 2021 compared to $28.0 million, or $1.15 per basic and diluted share, for the corresponding period in 2020.

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 https://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 anticipated during 2021/2022; and the Company’s belief that its current cash, cash equivalents and marketable securities, including the net proceeds from its recent financing, will be sufficient to fund its operations into 2023. 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-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, 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.

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

 
ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Balance Sheets
(In thousands)
 
 March 31, December 31,
 2021 2020
 (Unaudited)  
ASSETS   
Current assets:   
Cash and cash equivalents$288,690  $65,082 
Restricted cash1,542  1,542 
Marketable securities156,237  219,359 
Prepaid expenses and other current assets19,506  6,843 
Total current assets465,975  292,826 
Property and equipment, net2,094  2,016 
Operating lease right-of-use asset3,269  3,349 
Other assets78  78 
Total assets$471,416  $298,269 
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY   
Current liabilities:   
Accounts payable$3,146  $7,140 
Accrued liabilities12,168  15,462 
Total current liabilities15,314  22,602 
Operating lease liability, noncurrent5,050  4,964 
Other long-term liabilities58  82 
Total liabilities20,422  27,648 
Stockholders’ equity:   
Common stock5  4 
Additional paid-in capital688,939  472,569 
Accumulated other comprehensive income (loss)42  (2)
Accumulated deficit(237,992) (201,950)
Total stockholders’ equity450,994  270,621 
Total liabilities, convertible preferred stock and stockholders’ equity$471,416  $298,269 
        


ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
 
 Three Months Ended March 31,
 2021 2020
 (unaudited)
Operating expenses:   
Research and development$21,631  $25,182 
General and administrative14,454  3,469 
Total operating expenses36,085  28,651 
Loss from operations(36,085) (28,651)
Other income, net43  638 
Net loss$(36,042) $(28,013)
Per share information:   
Net loss per share, basic and diluted$(0.76) $(1.15)
Weighted-average shares used in computing net loss per share, basic and diluted47,280,769  24,256,402