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.”
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
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
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
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
Third Quarter 2021 Summary Financial Results
Cash, cash equivalents, restricted cash, and marketable securities were $368.8 million as of September 30, 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 September 30, 2021 were $40.6 million compared to $32.7 million for the corresponding period in 2020. R&D expenses for the nine months ended September 30, 2021 were $93.0 million compared to $87.9 million for the corresponding period in 2020. The year-over-year increase for the quarter ended September 30, 2021 was primarily due to higher headcount and professional services expenses. The year-over-year increase for the nine months ended September 30, 2021 was primarily due to higher headcount and professional services expenses, mostly offset by the completion of several clinical studies.
General and administrative (G&A) expenses for the quarter ended September 30, 2021 were $16.5 million compared to $5.6 million for the corresponding period in 2020. G&A expenses for the nine months ended September 30, 2021 were $42.2 million compared to $14.6 million for the corresponding period in 2020. These year-over-year increases were primarily due to higher headcount and professional services expenses.
Net loss was $57.0 million, or $1.14 per basic and diluted share, for the quarter ended September 30, 2021 compared to $38.2 million, or $1.01 per basic and diluted share, for the corresponding period in 2020. Net loss was $135.0 million, or $2.75 per basic and diluted share, for the nine months ended September 30, 2021 compared to $101.6 million, or $3.06 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 medical dermatology company that champions meaningful innovation to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions, with one NDA submission filed with the FDA and three Phase 3 clinical data readouts anticipated by the end of 2022. The company’s lead program, topical roflumilast, has the potential to advance 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 well 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.
Amanda Sheldon, Head of Corporate Communications
Eric McIntyre, Head of Investor Relations
ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Balance Sheets
|September 30,||December 31,|
|Cash and cash equivalents||$||51,778||$||65,082|
|Prepaid expenses and other current assets||12,958||6,843|
|Total current assets||381,770||292,826|
|Property and equipment, net||2,045||2,016|
|Operating lease right-of-use asset||3,115||3,349|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Operating lease liability||306||—|
|Total current liabilities||19,058||22,602|
|Operating lease liability, noncurrent||4,924||4,964|
|Other long-term liabilities||31||82|
|Additional paid-in capital||699,988||472,569|
|Accumulated other comprehensive loss||(18||)||(2||)|
|Total stockholders’ equity||362,995||270,621|
|Total liabilities and stockholders’ equity||$||387,008||$||298,269|
ARCUTIS BIOTHERAPEUTICS, INC.
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||$||40,604||$||32,743||$||93,000||$||87,934|
|General and administrative||16,474||5,560||42,243||14,647|
|Total operating expenses||57,078||38,303||135,243||102,581|
|Loss from operations||(57,078||)||(38,303||)||(135,243||)||(102,581||)|
|Other income, net||98||99||213||952|
|Per share information:|
|Net loss per share, basic and diluted||$||(1.14||)||$||(1.01||)||$||(2.75||)||$||(3.06||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||50,097,851||37,748,454||49,136,768||33,214,005|