Eczema, Dyshidrotic

Received U.S. Food and Drug Administration (FDA) approval for ZORYVE™ (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous psoriasis, in individuals 12 years of age and olderAnnounced positive topline results from pivotal Phase 3 trial of roflumilast foam in seborrheic dermatitis, with anticipated New Drug Application (NDA) submission in the first quarter of 2023Completed enrollment in INTEGUMENT-1, the first of two pivotal Phase 3 trials in subjects with atopic dermatitis six years of age and olderStrengthened balance sheet with over $285 million from recent financings WESTLAKE VILLAGE, Calif., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended June 30, 2022, and provided a business update. “The FDA approval of ZORYVE for the treatment of plaque psoriasis is a pivotal milestone for the Arcutis organization, and for dermatologists and people suffering from psoriasis, who have long-awaited an innovative, steroid-free treatment option for chronic use on all affected areas of the body,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “Our organization is well prepared and excited to launch ZORYVE in the coming weeks and we have bolstered our financial strength on the back of this approval. At the same time, we continue to execute on each of our Phase 3 development programs, progressing towards topline clinical data readouts in atopic dermatitis and scalp and body psoriasis later this year, as well as the NDA submission for seborrheic dermatitis early in 2023.” Program Updates ZORYVE (roflumilast cream) - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a once-daily cream formulation, approved in the U.S. for the treatment of plaque psoriasis and under development for atopic dermatitis On July 29, 2022, the FDA approved ZORYVE for the treatment of plaque psoriasis, including intertriginous psoriasis, in individuals 12 years of age and older. ZORYVE is approved for once-daily treatment in mild, moderate, and severe plaque psoriasis with no restrictions on location or duration of useIn August 2022, Arcutis announced the completion of enrollment in INTEGUMENT-1, the first of two pivotal Phase 3 trials for the treatment of atopic dermatitis in subjects six years of age or older. Patient enrollment continues in the other pivotal Phase 3 trials in patients with atopic dermatitis (INTEGUMENT-2 and INTEGUMENT-PED). Topline data from each of INTEGUMENT-1 and INTEGUMENT-2, in subjects six years of age or older, are anticipated by the end of 2022. Topline data from INTEGUMENT-PED are expected in 2023.In July 2022, Arcutis announced that Health Canada accepted for review the New Drug Submission (NDS) for roflumilast cream for adults and adolescents with plaque psoriasis, with a target action date of April 30, 2023. Arcutis has established operations in Canada and is building a strong team to support the approval and launch. Roflumilast foam - a once-daily foam 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 In June 2022, Arcutis announced positive topline results from the STRATUM pivotal Phase 3 trial for the treatment of moderate to severe seborrheic dermatitis. The Company anticipates submitting an NDA to the FDA in the first quarter of 2023.In April 2022, Arcutis announced the completion of enrollment of the sole pivotal Phase 3 trial (ARRECTOR) for the treatment of scalp and body psoriasis, with topline data anticipated late in the third quarter or early in the fourth quarter of 2022. If positive, the Company expects the data to be sufficient basis for a supplemental New Drug Application (sNDA) submission. 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 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 The Company continues its Investigational New Drug application (IND)-enabling efforts, and expects to enter the clinic in 2022. Recent Corporate Highlights In August 2022, the Company priced an underwritten public offering of common stock with expected gross proceeds of $173 million and expected net proceeds of $162 million, inclusive of the underwriters' option.In August 2022, the Company drew an additional $125 million from its debt facility with SLR Capital Partners.In July 2022, Great Place to Work® and Fortune magazine named the Company one of the 2022 Best Workplaces for Millenials™. Second Quarter 2022 Summary Financial Results Cash, cash equivalents, restricted cash, and marketable securities were $283.4 million as of June 30, 2022, compared to $388.6 million as of December 31, 2021. These resources, combined with the expected $162 million in net proceeds from its August 2022 equity financing and the $125 million drawn from its existing loan facility, will provide for capital resources of approximately $570 million to support the launch and commercialization efforts for ZORYVE, as well as continue to advance the Company’s pipeline development initiatives. Research and development (R&D) expenses for the quarter ended June 30, 2022 were $38.2 million compared to $30.8 million for the corresponding period in 2021. The year-over-year increase was primarily due to higher headcount and professional services expenses. General and administrative (G&A) expenses for the quarter ended June 30, 2022 were $27.6 million compared to $11.3 million for the corresponding period in 2021. The year-over-year increase was primarily due to higher headcount and professional services expenses as we prepare for commercialization. Net loss was $67.4 million, or $1.31 per basic and diluted share, for the quarter ended June 30, 2022 compared to $42.0 million, or $0.84 per basic and diluted share, for the corresponding period in 2021. 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 including plaque psoriasis, atopic dermatitis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, 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 clinical trial results and regulatory events anticipated during 2022; the anticipated successful commercial launch of ZORYVE in plaquepsoriasis; and the Company’s belief that its current cash, cash equivalents, and marketable securities, including the net proceeds from its recent debt financing, will be sufficient to fund its operations into 2024. 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, the timing, expenses and success of our commercialization efforts, 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 22, 2022, 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. Contacts: MediaAmanda Sheldon, Head of Corporate Communicationsasheldon@arcutis.com InvestorsEric McIntyre, Head of Investor Relationsemcintyre@arcutis.com ARCUTIS BIOTHERAPEUTICS, INC.Condensed Balance Sheets(In thousands) June 30, December 31, 2022 2021 (unaudited) ASSETS Current assets: Cash and cash equivalents$61,512 $96,449 Restricted cash 1,233 1,542 Marketable securities 220,657 290,610 Prepaid expenses and other current assets 12,024 14,172 Total current assets 295,426 402,773 Property and equipment, net 2,078 2,261 Operating lease right-of-use asset 2,882 3,040 Other assets 78 78 Total assets$300,464 $408,152 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$8,437 $7,353 Accrued liabilities 18,463 25,540 Operating lease liability 582 433 Total current liabilities 27,482 33,326 Operating lease liability, noncurrent 4,450 4,774 Long-term debt, net 73,138 72,350 Other long-term liabilities 12 25 Total liabilities 105,082 110,475 Stockholders’ equity: Common stock 5 5 Additional paid-in capital 736,665 706,233 Accumulated other comprehensive loss (1,252) (255)Accumulated deficit (540,036) (408,306) Total stockholders’ equity 195,382 297,677 Total liabilities and stockholders’ equity$300,464 $408,152 ARCUTIS BIOTHERAPEUTICS, INC. Condensed Statements of Operations(In thousands, except share and per share data)(unaudited) Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Operating expenses: Research and development $38,205 $30,765 $78,827 $52,396 General and administrative 27,622 11,315 49,628 25,769 Total operating expenses 65,827 42,080 128,455 78,165 Loss from operations (65,827) (42,080) (128,455) (78,165) Other income (expense): Other income, net 421 72 563 115 Interest expense (2,000) — (3,838) — Total other income (expense) (1,579) 72 $(3,275) $115 Net loss $(67,406) $(42,008) $(131,730) $(78,050) Per share information: Net loss per share, basic and diluted $(1.31) $(0.84) $(2.58) $(1.60)Weighted-average shares used in computing net loss per share, basic and diluted 51,422,386 50,000,716 50,970,465 48,648,262

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. 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. 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 Second Quarter 2021 Summary Financial Results Cash, cash equivalents, restricted cash, and marketable securities were $410.9 million as of June 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 June 30, 2021 were $30.8 million compared to $30.0 million for the corresponding period in 2020. R&D expenses for the six months ended June 30, 2021 were $52.4 million compared to $55.2 million for the corresponding period in 2020. The year-over-year increase for the quarter ended June 30, 2021 was primarily due to increased clinical costs for the Phase 3 studies of topical roflumilast in atopic dermatitis, seborrheic dermatitis, and scalp psoriasis and the Phase 2 study of ARQ-252 in vitiligo, mostly offset by completion of the Phase 3 studies of roflumilast cream in plaque psoriasis and Phase 2 studies of roflumilast foam in seborrheic dermatitis and scalp psoriasis. The year-over-year decrease for the six months ended June 30, 2021 was primarily due to the completion of the 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 the Phase 3 studies of topical roflumilast in atopic dermatitis, seborrheic dermatitis, and scalp psoriasis, and the Phase 2 study of ARQ-252 in vitiligo. General and administrative (G&A) expenses for the quarter ended June 30, 2021 were $11.3 million compared to $5.6 million for the corresponding period in 2020. G&A expenses for the six months ended June 30, 2021 were $25.8 million compared to $9.1 million for the corresponding period in 2020. These year-over-year increases were primarily due to higher headcount and professional services costs. First half 2021 G&A expenses were also impacted by 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 $42.0 million, or $0.84 per basic and diluted share, for the quarter ended June 30, 2021 compared to $35.4 million, or $0.94 per basic and diluted share, for the corresponding period in 2020. Net loss was $78.1 million, or $1.60 per basic and diluted share, for the six months ended June 30, 2021 compared to $63.4 million, or $2.05 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 seven clinical programs for a range of inflammatory dermatological conditions, with our first NDA submission anticipated late in the third quarter or early in the fourth quarter of 2021 and three more Phase 3 clinical data readouts anticipated over the next 18 months. The company’s lead product candidate, 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 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. Contacts: MediaAmanda Sheldon, Head of Corporate Communicationsasheldon@arcutis.com InvestorsEric McIntyre, Head of Investor Relationsemcintyre@arcutis.com

Los Angeles, June 08, 2021 (GLOBE NEWSWIRE) -- A Comprehensive Analysis of 18+ Key Companies Strengthening Chronic Spontaneous Urticaria Pipeline | Insights by DelveInsight For the treatment of Chronic Spontaneous Urticaria, there are several drugs being developed by different pharmaceutical industries with different routes of administration like oral, subcutaneous, intravenous which could be chosen according to the affordability and feasibility of an individual. DelveInsight’s ‘Chronic Spontaneous Urticaria Pipeline Insights’ report offers a holistic coverage of the current treatments and pipeline therapies and landscape in different stages of development from pre-clinical till late-stage, along with dormant, inactive and abandoned therapeutic agents. Some of the key pointers from the Chronic Spontaneous Urticaria Pipeline report: Request for Sample to know more about the key pharma company and therapy expected to grab maximum share @ Chronic Spontaneous Urticaria Emerging Therapies and Forecast Chronic Spontaneous Urticaria: Overview Chronic Urticaria (CU) is a condition of the skin caused by a plenitude of factors such as environmental irritants, your immune system, genetics, or in response to a bacterial, fungal, or viral infection. Based on the cause, it can be of two types Chronic Idiopathic Urticaria (also called chronic spontaneous urticaria) and Chronic Inducible Urticaria (also called physical urticaria). Chronic Spontaneous Urticaria was previously referred to as Chronic Idiopathic Urticaria, however, the term is no longer used as many cases have an autoimmune basis. For more information on emerging drugs, visit Chronic Spontaneous Urticaria Pipeline Analysis Chronic Spontaneous Urticaria Drug Pipeline Assessment Request for Sample to know more @ Chronic Spontaneous Urticaria Pipeline Analysis, Key Companies and Futuristic Trends Chronic Spontaneous Urticaria Therapeutics Assessment The Chronic Spontaneous Urticaria Pipeline report proffers comprehensive coverage of the active pipeline candidates segmented by Stage, Product Type, Route of Administration, Molecule Type, Target, and Mechanism of Action. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets Connect with our Business Executive for Asset Prioritization Services and Consulting Solutions Scope of the Chronic Spontaneous Urticaria Pipeline Report Coverage: GlobalKey Players: Allakos, AstraZeneca, Biosana, Celldex Therapeutics, Celltrion, Eli Lilly and Company, Genentech, GI Innovation/Yuhan, GlaxoSmithKline, Glenmark Pharmaceuticals, Gossamer Bio, Kiniksa Pharmaceuticals, Mycenax Biotech, Novartis, Regeneron, Synermore Biologics, UCB Biopharma, United BioPharma, Amgen, and others. Key Chronic Spontaneous Urticaria Pipeline Therapies: UB-221, GBR 310, Ligelizumab, UCB8600, Antolimab, Dupilumab, GI-301, CDX-0159, LY3454738, Fenebrutinib, GS-4059, Nucala, SYN008, BP001, Tezepelumab and others. Reach out @ Chronic Spontaneous Urticaria Pipeline: Novel therapies and Emerging technologies Table of Contents Learn more about the report offerings @ Chronic Spontaneous Urticaria Emerging Therapies, Treatments and Ongoing Clinical Trials Related Reports Chronic Spontaneous Urticaria MarketDelveInsight’s ‘Chronic spontaneous urticaria (CSU) – Market Insights, Epidemiology, and Market Forecast—2030’ report. Chronic Inducible Urticaria Market ForecastDelveInsight’s ‘Chronic Inducible Urticaria Market Insights, Epidemiology, and Market Forecast-2030’ report. Scleroderma MarketDelveInsight's " Scleroderma Market Insights, Epidemiology, and Market Forecast-2030" report. Skin Neoplasms MarketDelveInsight's "Skin Neoplasms - Market Insights, Epidemiology, and Market Forecast-2030" report. Soft Tissue Defect MarketDelveInsight's "Soft Tissue Defect - Market Insights, Epidemiology, and Market Forecast-2030" report. Uremic Pruritus MarketDelveInsight's "Uremic Pruritus (UP) - Market Insights, Epidemiology, and Market Forecast-2030" report. Warts MarketDelveInsight's "Warts Market Insights, Epidemiology, and Market Forecast-2030" report. Related Posts Highlights from ASCO20218 most common allergensDeadliest infectious diseasesChronic Hand Eczema Market Analysis and Forecast About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.  Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News