1. WESTLAKE VILLAGE, Calif., Sept. 09, 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 announced that Arcutis management will participate in two upcoming investor conferences in September.

    Details for the company's participation are as follows:

    • Morgan Stanley 19th Annual Global Healthcare Conference
      Fireside Chat Date: Wednesday, September 15, 2021
      Fireside Chat Time: 10:15 a.m. EDT
    • Cantor Virtual Global Healthcare Conference
      Fireside Chat Date: Monday, September 27, 2021
      Fireside Chat Time: 11:20…

    WESTLAKE VILLAGE, Calif., Sept. 09, 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 announced that Arcutis management will participate in two upcoming investor conferences in September.

    Details for the company's participation are as follows:

    • Morgan Stanley 19th Annual Global Healthcare Conference

      Fireside Chat Date: Wednesday, September 15, 2021

      Fireside Chat Time: 10:15 a.m. EDT
    • Cantor Virtual Global Healthcare Conference

      Fireside Chat Date: Monday, September 27, 2021

      Fireside Chat Time: 11:20 a.m. EDT

    Webcasts for these conferences may be accessed at the "Events & Presentations" section of the Company's Investor website at https://investors.arcutis.com/events-and-presentations. Additionally, a replay of the webcasts will be available on the Arcutis website following the conferences.

    About Arcutis

    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 late in the third quarter or early in the fourth quarter of 2021 and three more Phase 3 clinical data readouts anticipated by the end of 2022. 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 www.arcutis.com or follow Arcutis on LinkedIn and Twitter.

    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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:

    Media

    Amanda Sheldon, Head of Corporate Communications

    (805) 418-5006

    asheldon@arcutis.com

    Investors

    Eric McIntyre, Head of Investor Relations

    (805) 418-5006

    emcintyre@arcutis.com



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  2. WESTLAKE VILLAGE, Calif., Sept. 02, 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 announced that Keith R. Leonard Jr. has been appointed to the Arcutis Board of Directors effective September 2, 2021, replacing Ricky Sun, Ph.D., who has decided to step down from the Board for personal reasons.

    "We thank Ricky for his leadership over the past three years," commented Patrick Heron, Chairman of the Arcutis Board of Directors. "He made significant contributions to Arcutis as the company grew from a start-up…

    WESTLAKE VILLAGE, Calif., Sept. 02, 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 announced that Keith R. Leonard Jr. has been appointed to the Arcutis Board of Directors effective September 2, 2021, replacing Ricky Sun, Ph.D., who has decided to step down from the Board for personal reasons.

    "We thank Ricky for his leadership over the past three years," commented Patrick Heron, Chairman of the Arcutis Board of Directors. "He made significant contributions to Arcutis as the company grew from a start-up to a company with a robust pipeline of novel immuno-dermatology drug candidates on the cusp of its first NDA submission. We wish him all the best in his future endeavors."

    "We are delighted to welcome Keith to the Arcutis Board," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "Keith adds to the depth of our board with over 25 years of commercial, operational, and international leadership experience. As a sitting chair of a publicly listed biotechnology company, a former CEO of two public biotech companies, and someone who has launched products at both large and emerging biopharmaceutical companies, Keith's insights will be instrumental as we prepare for our first potential commercial launch of topical roflumilast."

    "I am thrilled to join the Arcutis board at this pivotal time," said Keith Leonard. "I am impressed with Arcutis' product candidates and the team's dedication to providing important and effective solutions for dermatology patients that do not require a tradeoff between safety, efficacy, and tolerability. I look forward to working with the Arcutis management team on its development and commercialization efforts, and to bringing value to patients, physicians, and shareholders."

    Keith Leonard is Chairman of the Board of UNITY Biotechnology, where he served as Chief Executive Officer from 2016 to 2020, and currently serves on the board of robotic surgery pioneer Intuitive Surgical and Spanish biotech SANIFIT S.A.. Previously, Keith served as the Chief Executive Officer of KYTHERA Biopharmaceuticals from its founding in 2005 to its acquisition by Allergan plc in 2015. Before KYTHERA, Keith spent 13 years at Amgen, ultimately as Senior Vice President and General Manager at Amgen Europe, where he ran all commercial operations in 28 countries. Prior to that position, Keith ran Amgen's manufacturing operations in Europe, established Amgen's presence in inflammation, served as Head of Information Management, and had leadership roles in sales and marketing, engineering, operations, and finance. Keith has been an Independent Director of Anacor Pharmaceuticals, Affymax, and ARYx Therapeutics, and was a venture partner with ARCH Venture Partners. He holds a Master of Business Administration from The Anderson School of Management, University of California, Los Angeles, a Master of Science in Mechanical Engineering from University of California, Berkeley, a Bachelor of Arts in History from University of Maryland, College Park, and a Bachelor of Science in Engineering from University of California, Los Angeles.



    About Arcutis

    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 by the end 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 www.arcutis.com or follow Arcutis on LinkedIn and Twitter.

    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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:

    Media

    Amanda Sheldon, Head of Corporate Communications

    (805) 418-5006

    asheldon@arcutis.com



    Investors

    Eric McIntyre, Head of Investor Relations

    (805) 418-5006

    emcintyre@arcutis.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e14992f0-879a-4428-9247-9ffd730d2ade



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    • Topical roflumilast potential "Best-in-Class" topical PDE4 inhibitor
    • Scalp and body psoriasis affects more than 8 million patients in the U.S.

    WESTLAKE VILLAGE, Calif., Aug. 25, 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 announced it had enrolled the first patient in its single Phase 3 clinical trial evaluating topical roflumilast foam (ARQ-154) as a potential treatment for scalp and body psoriasis. Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective…

    • Topical roflumilast potential "Best-in-Class" topical PDE4 inhibitor
    • Scalp and body psoriasis affects more than 8 million patients in the U.S.

    WESTLAKE VILLAGE, Calif., Aug. 25, 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 announced it had enrolled the first patient in its single Phase 3 clinical trial evaluating topical roflumilast foam (ARQ-154) as a potential treatment for scalp and body psoriasis. Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.

    "The symptoms of scalp and body psoriasis, including itch and pain, can negatively impact quality of life for the millions of Americans affected. One challenge for patients with scalp psoriasis is that they often require two or more medications for different areas of the body to manage their disease," said Patrick Burnett, Ph.D., M.D., FAAD, Chief Medical Officer of Arcutis. "In our previous Phase 2b trial, roflumilast foam was demonstrated to be a safe, well-tolerated, and effective potential treatment for scalp and body psoriasis. We are pleased to initiate this Phase 3 trial, as we believe roflumilast foam, if approved, may represent a much-needed, new standard of care for people with scalp and body psoriasis that is suitable for use in hair-bearing areas, unlike creams and ointments, and does not pose the safety concerns typically seen with topical steroids."

    The "A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis" (ARRECTOR) study is a parallel group, double blind, vehicle-controlled pivotal Phase 3 study of the safety and efficacy of ARQ-154 0.3% foam or a matching vehicle administered once-daily in approximately 420 subjects with scalp and body psoriasis ages 12 and older. The co-primary endpoints of the study include the proportion of subjects achieving Scalp-Investigator's Global Assessment (IGA) success and the proportion of subjects achieving Body-IGA success, with IGA success defined as an IGA score of ‘clear' or ‘almost clear' plus a 2-point improvement from baseline after eight weeks. Based on prior discussions with the U.S. Food and Drug Administration (FDA), the Company believes that, if successful, this trial will provide sufficient basis to file a supplemental NDA for ARQ-154 in scalp and body psoriasis.

    "Our aim at Arcutis is to rapidly innovate topical treatments for dermatological conditions where there has been little to no treatment advances for decades. The initiation of our Phase 3 trial of roflumilast foam for scalp and body psoriasis is an important step forward to addressing an urgent unmet need," said Frank Watanabe, President and Chief Executive Officer at Arcutis. "The initiation of our ARRECTOR trial is the third of three new Phase 3 programs initiated in 2021 with readouts expected in 2022 and highlights the robustness of our unique dermatology drug development platform."

    About Scalp and Body Psoriasis

    Scalp psoriasis is a manifestation of plaque psoriasis characterized by raised, red areas of skin ("plaques") covered with a silver or white scale that occurs in the hair-bearing area of the scalp and sometimes extending to the forehead, back of the neck, or behind or inside the ears. Patients with scalp psoriasis commonly have plaques on other areas of the body as well. Approximately 40 percent of the estimated 8.6 million Americans with psoriasis have involvement of the scalp, and over a lifetime, up to 80 percent of psoriasis patients may experience scalp involvement. Scalp psoriasis plaques are identical to psoriatic plaques on other areas of the body; however, topical treatment of scalp plaques is complicated by the difficulty of delivering topical drugs under the hair and onto the skin. As with psoriatic plaques on other parts of the body, psoriasis on the scalp is often itchy and is sometimes painful. Scalp psoriasis can also be associated with hair loss, likely due to damage to the hair from excessive scratching, rubbing, or combing of the affected area. Often, patients require two or more medications to manage their disease when they have scalp involvement.

    About Topical Roflumilast Foam

    Topical roflumilast foam is a once-daily, topical formulation of a highly potent and selective PDE4 inhibitor (roflumilast). The unique foam formulation is designed to penetrate and treat inflammatory dermatoses in hair-bearing areas of the body, such as the scalp, although it is usable on all areas of the body. Roflumilast has been approved by the FDA for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. In Phase 3 trials, topical roflumilast cream (ARQ-151) has previously been demonstrated to be a safe, well-tolerated, and effective potential treatment for plaque psoriasis, and Arcutis expects to file an NDA with the FDA for roflumilast cream in late Q3 or early Q4 2021. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors for dermatology. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, atopic dermatitis, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis and the systemic treatment of plaque psoriasis.

    About Arcutis

    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 by the end 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 www.arcutis.com or follow Arcutis on LinkedIn and Twitter.

    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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:

    Media

    Amanda Sheldon, Head of Corporate Communications

    1 805-418-5006

    asheldon@arcutis.com

    Investors

    Eric McIntyre, Head of Investor Relations

    1 805-418-5006

    emcintyre@arcutis.com



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  3. WESTLAKE VILLAGE, Calif., Aug. 23, 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 announced that Bruce Binkowitz has joined as Vice President of Biometrics. Dr. Binkowitz, who brings over 30 years of drug development experience, will lead all biometrics activities for the company including supporting late-stage clinical programs and regulatory submissions of topical roflumilast in psoriasis, atopic dermatitis, and seborrheic dermatitis.

    "We are pleased to welcome Bruce to Arcutis. He is an experienced…

    WESTLAKE VILLAGE, Calif., Aug. 23, 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 announced that Bruce Binkowitz has joined as Vice President of Biometrics. Dr. Binkowitz, who brings over 30 years of drug development experience, will lead all biometrics activities for the company including supporting late-stage clinical programs and regulatory submissions of topical roflumilast in psoriasis, atopic dermatitis, and seborrheic dermatitis.

    "We are pleased to welcome Bruce to Arcutis. He is an experienced leader who will play an instrumental role as we advance multiple pivotal clinical studies and our upcoming submission of our first New Drug Application for roflumilast cream," said Frank Watanabe Arcutis' President and Chief Executive Officer.

    "Arcutis is making a real difference by advancing novel treatments for serious skin disorders where little progress has been made in decades," Dr. Binkowitz said. "I am excited to join the experienced medical and regulatory team and further clinical programs across our seven therapeutic areas."

    Most recently, Dr. Binkowitz was the Vice President of Biometrics at Shionogi, Inc., after spending over 30 years at Merck and Co. He has worked across all phases of drug development and across many therapeutic areas including dermatology, oncology, respiratory, metabolism/diabetes, cardiovascular and ophthalmology. Dr. Binkowitz has presented at all the major statistics conferences and has publications spanning more than 30 years, including his contributions as a thought leader on the topic of multiregional clinical trials. Dr. Binkowitz is a Fellow of the American Statistical Association (ASA), and was the 2020 Chair and is current Past-Chair of the Biopharmaceutical Section of the ASA. Dr. Binkowitz has a Ph.D. in Quantitative Methodology from the Rutgers School of Public Health, and a Master's degree in Statistics from the University of Florida.

    About Arcutis

    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 by the end 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 www.arcutis.com or follow Arcutis on LinkedIn and Twitter.



    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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:
    Media
    Amanda Sheldon, Head of Corporate Communications
    805-418-5006
    asheldon@arcutis.com
    
    Investors
    Eric McIntyre, Head of Investor Relations
    805-418-5006
    emcintyre@arcutis.com

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    • Anticipates submission of a New Drug Application (NDA) for topical roflumilast cream as a potential treatment for plaque psoriasis late in the third quarter or early in the fourth quarter of 2021
    • Initiated single pivotal Phase 3 trial of topical roflumilast foam in seborrheic dermatitis, a disease that affects more than 10 million people in the U.S.
    • Anticipates initiation of single pivotal Phase 3 trial of topical roflumilast foam in scalp psoriasis in Q3 2021
    • Enrolling pivotal Phase 3 trials of topical roflumilast cream in atopic dermatitis
    • Strong financial position with over $400 million in cash, cash equivalents, and marketable securities providing cash runway well into 2023

    WESTLAKE VILLAGE, Calif., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Arcutis…

    • Anticipates submission of a New Drug Application (NDA) for topical roflumilast cream as a potential treatment for plaque psoriasis late in the third quarter or early in the fourth quarter of 2021

    • Initiated single pivotal Phase 3 trial of topical roflumilast foam in seborrheic dermatitis, a disease that affects more than 10 million people in the U.S.
    • Anticipates initiation of single pivotal Phase 3 trial of topical roflumilast foam in scalp psoriasis in Q3 2021
    • Enrolling pivotal Phase 3 trials of topical roflumilast cream in atopic dermatitis
    • Strong financial position with over $400 million in cash, cash equivalents, and marketable securities providing cash runway well into 2023

    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.

    • Arcutis anticipates submitting an NDA for plaque psoriasis to the U.S. Food and Drug Administration (FDA) late in the third quarter or early in the fourth quarter of 2021, based on the positive results from two pivotal Phase 3 clinical trials (DERMIS-1 and DERMIS-2).
    • Patient enrollment continues in the pivotal Phase 3 trials in patients with atopic dermatitis (INTEGUMENT-1, INTEGUMENT-2, and INTEGUMENT-PED), with topline data anticipated in the second half of 2022.

    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.

    • In July, Arcutis announced the initiation of a single pivotal Phase 3 trial for the treatment of seborrheic dermatitis, with topline data anticipated in the second or third quarter of 2022. If positive, the Company expects the data to be sufficient basis for an NDA.
    • The Company anticipates initiating a single pivotal Phase 3 trial for the treatment of scalp and body psoriasis in Q3 2021, with topline data anticipated in the second half of 2022. If positive, the Company expects the data to be sufficient basis for an NDA.

    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.

    • In May, Arcutis announced that 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. Further analyses of the study pointed toward inadequate local drug delivery to the skin as a key driver of the lack of efficacy. Importantly, no safety or tolerability issues were seen.
    • In July, the Company announced the termination of the Phase 2a clinical trial evaluating ARQ-252 as a potential treatment for vitiligo, based on the aforementioned analyses of the Phase 2 chronic hand eczema study.
    • 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.

    • Formulation and preclinical efforts are continuing.

    Recent Corporate Highlights 

    • Sue-Jean Lin was appointed to Arcutis' Board of Directors
    • Raj Madan was appointed Senior Vice President and Chief Digital and Information Officer
    • Greg Sukay joined the Company as Vice President of Manufacturing and Process Technologies

    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 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.

    Contacts:

    Media

    Amanda Sheldon, Head of Corporate Communications

    asheldon@arcutis.com

    Investors

    Eric McIntyre, Head of Investor Relations

    emcintyre@arcutis.com

     
     
    ARCUTIS BIOTHERAPEUTICS, INC.

    Condensed Balance Sheets

    (In thousands)
        
     June 30, December 31,
     2021 2020
     (Unaudited)  
    ASSETS   
    Current assets:   
    Cash and cash equivalents$89,128  $65,082 
    Restricted cash1,542  1,542 
    Marketable securities320,236  219,359 
    Prepaid expenses and other current assets16,648  6,843 
    Total current assets427,554  292,826 
    Property and equipment, net2,069  2,016 
    Operating lease right-of-use asset3,191  3,349 
    Other assets78  78 
    Total assets$432,892  $298,269 
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable$2,676  $7,140 
    Accrued liabilities10,565  15,462 
    Operating lease liability106   
    Total current liabilities13,347  22,602 
    Operating lease liability, noncurrent5,032  4,964 
    Other long-term liabilities25  82 
    Total liabilities18,404  27,648 
    Stockholders' equity:   
    Common stock5  4 
    Additional paid-in capital694,519  472,569 
    Accumulated other comprehensive loss(36) (2)
    Accumulated deficit(280,000) (201,950)
    Total stockholders' equity414,488  270,621 
    Total liabilities and stockholders' equity$432,892  $298,269 
            



    ARCUTIS BIOTHERAPEUTICS, INC.
     
    Condensed Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share data)

    (unaudited)
     
     Three Months Ended June 30, Six Months Ended June 30,
     2021 2020 2021 2020
    Operating expenses:       
    Research and development$30,765   $30,009   $52,396   $55,191  
    General and administrative11,315   5,618   25,769   9,087  
    Total operating expenses42,080   35,627   78,165   64,278  
    Loss from operations(42,080) (35,627) (78,165) (64,278)
    Other income, net72   215   115   853  
    Net loss$(42,008) $(35,412) $(78,050) $(63,425)
    Per share information:       
    Net loss per share, basic and diluted$(0.84) $(0.94) $(1.60) $(2.05)
    Weighted-average shares used in computing net loss

    per share, basic and diluted
    50,000,716   37,587,330   48,648,262   30,921,866  



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    • Eric McIntyre joins as Head of Investor Relations
    • Amanda Sheldon joins as Head of Corporate Communications

    WESTLAKE VILLAGE, Calif., Aug. 02, 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 announced leadership additions to investor relations and communications functions.

    "We are delighted to have Eric McIntyre joining us to lead our investor relations, and Amanda Shelton to head our communications function. Their appointments will be critical as we enter our next phase of growth, including our anticipated…

    • Eric McIntyre joins as Head of Investor Relations

    • Amanda Sheldon joins as Head of Corporate Communications

    WESTLAKE VILLAGE, Calif., Aug. 02, 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 announced leadership additions to investor relations and communications functions.

    "We are delighted to have Eric McIntyre joining us to lead our investor relations, and Amanda Shelton to head our communications function. Their appointments will be critical as we enter our next phase of growth, including our anticipated first New Drug Application and potential commercial launch, as well as the continued communication of our robust product pipeline," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "Their breadth of biopharmaceutical experience complements our experienced leadership team, which continues to be a key differentiator and driver of our strong execution."

    Eric McIntyre brings nearly 15 years of biopharmaceutical, finance, and investor relations experience. He will be responsible for directing all investor relations activities, including communicating business objectives and accomplishments to the broader investment community. Previously, Mr. McIntyre spent 10 years at Amgen in roles of increasing responsibility across investor relations, financial planning & analysis, and valuation, including experience in the inflammation and dermatology business.

    Amanda Sheldon brings over 20 years of healthcare communications experience including an extensive track record building advocacy and brand loyalty for Fortune 100 and start-up pharmaceutical and medical device companies. She will be responsible for leading the overall strategic direction and implementation of internal and external communications across the organization, including corporate positioning, branding and identity, product communications, social media strategy, and social responsibility. Previously, she was vice president of marketing and communications for the FH Foundation, responsible for improving awareness and diagnosis of genetic lipid disorders. In addition, Amanda held multiple communications and digital marketing roles at Medtronic, where she established a first-of-its-kind patient social community that increased brand awareness for diabetes therapies.

    About Arcutis

    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 www.arcutis.com or follow Arcutis on LinkedIn and Twitter.

    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for filing Arcutis's first New Drug Application and commercial launch of roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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:

    Media

    Amanda Sheldon, Head of Corporate Communications

    asheldon@arcutis.com

    Investors

    Eric McIntyre, Head of Investor Relations

    emcintyre@arcutis.com



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    • The majority of patients with psoriasis have mild or moderate levels of disease
    • The new method, PASI-high discrimination (PASI-HD), is designed for use in clinical trials evaluating novel topical treatment options for psoriasis
    • Details of new approach published in Dermatology and Therapy

    WESTLAKE VILLAGE, Calif., July 21, 2021 (GLOBE NEWSWIRE) -- In order to address a major limitation of today's most widely used method for gauging severity of plaque psoriasis (the PASI scale), Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), in conjunction with leading psoriasis experts, has developed a revised scale that offers greater precision for measuring disease extent and therapeutic effects in patients with mild-to-moderate disease. Arcutis, a late-stage…

    • The majority of patients with psoriasis have mild or moderate levels of disease

    • The new method, PASI-high discrimination (PASI-HD), is designed for use in clinical trials evaluating novel topical treatment options for psoriasis
    • Details of new approach published in Dermatology and Therapy

    WESTLAKE VILLAGE, Calif., July 21, 2021 (GLOBE NEWSWIRE) -- In order to address a major limitation of today's most widely used method for gauging severity of plaque psoriasis (the PASI scale), Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), in conjunction with leading psoriasis experts, has developed a revised scale that offers greater precision for measuring disease extent and therapeutic effects in patients with mild-to-moderate disease. Arcutis, a late-stage biopharmaceutical company that champions meaningful innovation to address immune-mediated dermatological diseases and conditions, shared details of the new approach in the peer-reviewed scientific journal Dermatology and Therapy.

    "The majority of people affected by plaque psoriasis experience mild or moderate disease, yet clinicians lack the best possible tools to provide an accurate measurement of severity for those individuals," said Robert Higham, MPAS, PA-C, Executive Director of Clinical Development for Arcutis and one of the authors of the article. "As we work toward bringing topical treatment innovations for psoriasis to dermatologists and patients, we believe innovations are likewise needed to improve the tools and methods to properly diagnose and track all levels of disease and treatment effects."

    The article notes that disease severity is an essential outcome measure in clinical trials of new treatments for plaque psoriasis. However, the most common clinical measure to assess disease severity—the Psoriasis Area and Severity Index (PASI)—is geared toward more-severe levels of disease. To determine a PASI score, the area of body region affected by psoriasis is estimated and given a number, but for body areas with less than 10 percent of disease, a non-granular score of 1 is applied regardless of the actual extent of disease, masking any changes in disease extent between 0 and 9 percent.

    To address this shortcoming, Arcutis has introduced a key modification to PASI that more accurately measures severity and evaluates treatment effectiveness for areas of the body with mild-to-moderate levels of disease. The new method, PASI-high discrimination (PASI-HD), is designed to be used in clinical trials among patients for whom the areas of affected body surface within the anatomical regions measured by PASI are less than 10 percent.

    "Other alternatives to the PASI have been proposed in the past, but no other option preserves the anatomical component of the index by assessing the severity and percentage of area affected in the four body regions: head and neck, upper extremities, trunk, and lower extremities," said co-author Kim Papp, M.D., Ph.D., a Fellow of the Royal College of Physicians of Canada and Founder and President of Probity Medical Research Inc. Papp, a scientific advisor for Arcutis, also co-authored the journal article.

    In addition, PASI-HD more precisely captures disease flaring from and within areas with less than 10 percent of disease involvement.

    "Even mild or moderate psoriasis significantly impacts quality of life, and deserves focused attention from the medical dermatology community," said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer of Arcutis. "As part of our mission to revitalize the standard of care for dermatological diseases, we believe it is necessary to remove the challenges that have traditionally hampered innovation for patients with skin diseases."

    In addition to Higham and Papp, authors of the article include colleagues at Arcutis and leading experts in the field of medical dermatology:

    • Mark Lebwohl, M.D., Professor and Chair of the Kimberly and Eric J. Waldman Department of Dermatology of the Icahn School of Medicine, Mount Sinai and Arcutis scientific advisor
    • Leon Kircik, M.D., Clinical Professor of Dermatology, Icahn School of Medicine, Mount Sinai, and Medical Director of DermResearch, PLLC, Physicians Skin Care, PLLC, and Skin Sciences
    • David Pariser, M.D., Senior Physician at Pariser Dermatology Specialists
    • Bruce Strober, M.D., Ph.D., Clinical Professor of Dermatology, Yale School of Medicine and Co-Founder of Central Connecticut Dermatology
    • Gerald Krueger, M.D., Dermatologist at University of Utah

    About Arcutis

    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 by the end 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 www.arcutis.com or follow Arcutis on LinkedIn and Twitter.



    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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.

    Investor Contact:

    ir@arcutis.com

    Media Contact:

    Amanda Sheldon

    805.418.5006 x7116

    asheldon@arcutis.com



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  4. Eleusis, a clinical-stage life science company dedicated to unlocking the full therapeutic potential of psychedelics, today announced the appointment of four highly experienced business leaders to its board of directors. The new directors' deep expertise building high-growth, high-impact life science companies complements Eleusis's world-class leadership team. The appointees include:

    • David Socks, former CEO of Phathom Pharmaceuticals, joining as Chair of the board
    • Robert Hershberg, M.D., Ph.D., former CBO and CSO of Celgene
    • John Tucker, CEO of SC Pharmaceuticals
    • Esther van den Boom, Managing Partner at van den Boom & Associates

    "We are delighted to welcome these four exceptional directors, who bring with them decades of experience…

    Eleusis, a clinical-stage life science company dedicated to unlocking the full therapeutic potential of psychedelics, today announced the appointment of four highly experienced business leaders to its board of directors. The new directors' deep expertise building high-growth, high-impact life science companies complements Eleusis's world-class leadership team. The appointees include:

    • David Socks, former CEO of Phathom Pharmaceuticals, joining as Chair of the board
    • Robert Hershberg, M.D., Ph.D., former CBO and CSO of Celgene
    • John Tucker, CEO of SC Pharmaceuticals
    • Esther van den Boom, Managing Partner at van den Boom & Associates

    "We are delighted to welcome these four exceptional directors, who bring with them decades of experience building successful therapeutics-focused life sciences companies," said Shlomi Raz, Eleusis's CEO and founder. "Our management team is thrilled to have these individuals help support and guide the company's effort to discover, develop, and deliver transformational psychedelic drug therapies to patients in urgent need of new treatment alternatives."

    "This is an opportune moment for Eleusis to push forward its vision of transforming psychedelics into modern medicines," said David Socks, Chair of the board. "On behalf of myself and my fellow directors, we are excited to be involved in a science-driven company that is pursuing a disciplined, thoughtful approach to transforming psychedelics into potential treatment options for patients with depression and other neuropsychiatric disorders, where there is significant unmet need."

    ELE-Psilo, the company's lead psychedelic drug candidate, is based on a proprietary, infusible form of psilocybin and is expected to enter clinical trials in early 2022. The company is also in the process of nationally scaling its innovative care delivery platform for psychedelic drug therapy to provide patients with affordable therapeutic alternatives for depression in a safe and caring environment.

    Board Appointments

    David Socks currently serves on the board of directors of Phathom Pharmaceuticals (NASDAQ:PHAT), where he was the founding CEO through the company's IPO. He also serves as a Venture Partner at Frazier Healthcare Partners, where he helps lead the firm's company creation efforts, co-founding companies such as Arcutis (NASDAQ:ARQT), Passage Bio (NASDAQ:PASG) and Scout Bio. Mr. Socks has also served as an advisor to Prometheus Bioscience (NASDAQ:RXDX) and PvP Biologics (acquired by Takeda). Previously, he was co-founder, President and COO of Incline Therapeutics (acquired by the Medicines Company) and co-founder and Senior Vice President, Corporate Development and Strategy of Cadence Pharmaceuticals (NASDAQ:CADX, acquired by Mallinckrodt))). Mr. Socks holds a B.S. from Georgetown University and an M.B.A from Stanford University.

    Robert Hershberg, M.D., Ph.D., is a Venture Partner on the life sciences team at Frazier Healthcare Partners. Dr. Hershberg previously served as President and Chief Executive Officer of VentiRx Pharmaceuticals, a Frazier-founded company that he led through its transformational partnership with Celgene. Mr. Hershberg then joined Celgene, where he was promoted to Chief Scientific Officer and subsequently to Chief Business Officer. Before VentiRx, he served as Senior Vice President and Chief Medical Officer of Dendreon Corporation and as Vice President of Medical Genetics at Corixa, a Frazier portfolio company. Earlier in his career, he was an Assistant Professor at Harvard Medical School and an Associate Physician at Brigham and Women's Hospital in Boston. Dr. Hershberg received his undergraduate and medical degrees from the University of California, Los Angeles, and his Ph.D. from the Salk Institute for Biological Studies.

    John H. Tucker is the Chief Executive Officer of scPharmaceuticals. Mr. Tucker previously served as Chief Executive Officer at Algal Scientific and Alcresta, where he led both companies through successful periods of strategic innovation and development. Throughout his career, he has held senior positions at multiple life sciences companies, including Incline Therapeutics, AMAG Pharmaceuticals, Basilea Pharmaceuticals and Indevus Pharmaceuticals. He also worked in a variety of hospital and retail-based sales and marketing roles at Ortho-McNeil Pharmaceuticals, ALZA Corporation, VIVUS and UCB Pharma. Mr. Tucker holds a B.A. from Plymouth State College and an M.B.A. from New Hampshire College.

    Esther van den Boom is Managing Partner of van den Boom & Associates and Chief Financial Officer of Tyra Biosciences. Ms. van den Boom has personally worked with over 50 life sciences companies throughout her career, partnering on various responsibilities including CFO, SOX 404 implementations, compliance and IPO assistance. Prior to founding van den Boom & Associates, she worked at Ernst & Young LLP as a Senior Manager in their San Diego office's audit practice. Ms. van den Boom received a B.A. in economics from the University of California, San Diego and an M.S. in accountancy from San Diego State University and is a licensed CPA.

    About Eleusis Ltd.

    Founded in 2013, Eleusis is a privately held, clinical-stage life science company dedicated to unlocking the full therapeutic potential of psychedelics, guided by science and enabled by drug discovery, clinical development and care delivery design. The company's comprehensive discovery, development and delivery capabilities enable it to target a broad spectrum of unmet needs within psychiatry, and beyond psychiatry. For more information, visit https://www.eleusisltd.com/.

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    • Topical roflumilast potential "Best-in-Class" topical PDE4 inhibitor
    • Seborrheic dermatitis affects 10 million patients in the U.S.
    • Potential first new topical treatment for seborrheic dermatitis in decades
    • The Company anticipates topline data in the second or third quarter of 2022

    WESTLAKE VILLAGE, Calif., July 12, 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 announced enrollment of the first patient in its single pivotal Phase 3 clinical trial evaluating topical roflumilast foam (ARQ-154) as a potential…

    • Topical roflumilast potential "Best-in-Class" topical PDE4 inhibitor

    • Seborrheic dermatitis affects 10 million patients in the U.S.
    • Potential first new topical treatment for seborrheic dermatitis in decades
    • The Company anticipates topline data in the second or third quarter of 2022

    WESTLAKE VILLAGE, Calif., July 12, 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 announced enrollment of the first patient in its single pivotal Phase 3 clinical trial evaluating topical roflumilast foam (ARQ-154) as a potential treatment for seborrheic dermatitis. Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for seborrheic dermatitis and scalp psoriasis.

    "The symptoms of seborrheic dermatitis can have a significant, negative influence on quality of life and can cause psychological distress for millions of affected Americans. Despite that, no novel treatments have been developed for this chronic skin condition in decades, and current topical treatments frequently provide inadequate efficacy or pose safety concerns that limit their use," said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer of Arcutis. "In our Phase 2 trial, roflumilast foam was demonstrated to be an effective, safe, and well-tolerated treatment for seborrheic dermatitis. We are now pleased to initiate this single Phase 3 pivotal trial, as we believe roflumilast foam, if approved, has the potential to become a much-needed new standard of care for people with seborrheic dermatitis. Unlike most treatments, roflumilast foam is suitable for all body areas, including hair-bearing areas and the face, and does not pose the safety concerns typically seen with topical steroids."

    The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) is a Phase 3, parallel group, double blind, vehicle-controlled study of the safety and efficacy of roflumilast 0.3% foam administered once-daily in approximately 450 subjects ages nine and older with moderate to severe seborrheic dermatitis. The primary endpoint of the study is the proportion of subjects achieving Investigator Global Assessment (IGA) success, defined as an IGA score of "clear" or "almost clear" plus a 2-point improvement at eight weeks. The Company announced in January 2021 that it had conducted a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and planned to initiate a single pivotal Phase 3 trial in seborrheic dermatitis.

    About Seborrheic Dermatitis

    Seborrheic dermatitis affects more than 10 million people in the U.S., and is a common, chronic, or recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often on the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back.



    About Topical Roflumilast Foam

    Roflumilast foam is a once-daily, topical formulation of a highly potent and selective PDE4 inhibitor (roflumilast). The foam formulation was designed to treat hair-bearing areas of the body, such as the scalp, although it is usable in all areas of the body, including the face. Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors for dermatology. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators; it has been implicated in a wide range of inflammatory diseases including psoriasis, atopic dermatitis, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis and the systemic treatment of plaque psoriasis.



    About Arcutis

    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 by the end 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 www.arcutis.com or follow Arcutis on LinkedIn and Twitter.



    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in seborrheic dermatitis and other inflammatory dermatological conditions. 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.

    Investor and Media Contact:

    ir@arcutis.com

     



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    • Formulation-related observations from ARQ-252 trial in chronic hand eczema informed early termination of Phase 2a ARQ-252 trial in vitiligo
    • Company progressing new formulation with goal of greater drug delivery to targets in the skin

    WESTLAKE VILLAGE, Calif., July 01, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), today announced its decision to terminate the recently initiated Phase 2a clinical trial evaluating ARQ-252, a topical small molecule inhibitor of Janus kinase type 1 (JAK1), as a potential treatment for vitiligo (ARQ-252-213). Arcutis' decision is based on further analyses of the ARQ-252 drug formulation used in both this vitiligo study and the recently completed Phase 2b study evaluating ARQ-252 for the treatment…

    • Formulation-related observations from ARQ-252 trial in chronic hand eczema informed early termination of Phase 2a ARQ-252 trial in vitiligo

    • Company progressing new formulation with goal of greater drug delivery to targets in the skin

    WESTLAKE VILLAGE, Calif., July 01, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), today announced its decision to terminate the recently initiated Phase 2a clinical trial evaluating ARQ-252, a topical small molecule inhibitor of Janus kinase type 1 (JAK1), as a potential treatment for vitiligo (ARQ-252-213). Arcutis' decision is based on further analyses of the ARQ-252 drug formulation used in both this vitiligo study and the recently completed Phase 2b study evaluating ARQ-252 for the treatment of chronic hand eczema (ARQ-252-205).

    As previously announced, the Phase 2b chronic hand eczema study did not meet its primary endpoint, with none of the ARQ-252 arms achieving statistical significance versus vehicle. Further analyses of that study pointed toward inadequate local drug delivery to the skin as a key driver of the lack of efficacy.

    "While we are disappointed to terminate this vitiligo study, we believe topical JAK inhibition remains a promising strategy for the treatment of both chronic hand eczema and vitiligo, and that ARQ-252 has potential as a new treatment for both diseases. Published clinical data for other topical JAK inhibitors have shown encouraging results in both indications. Furthermore, the active pharmaceutical ingredient in ARQ-252 -- SHR0302 -- is a potent and highly selective JAK1 inhibitor that has demonstrated efficacy and safety as an investigational oral formulation in other inflammatory conditions such as rheumatoid arthritis and atopic dermatitis," said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer of Arcutis. "We have already made good progress in reformulating ARQ-252 to potentially deliver much more active drug to targets in the skin and hope to re-enter the clinic with this reformulated version in the not-too-distant future. We want to thank the patients and investigators in the vitiligo study for their participation."

    The vitiligo study is not being terminated for any safety or tolerability reasons. ARQ-252 has been safe and well-tolerated, and no unexpected safety concerns have been identified.

    About ARQ-252

    ARQ-252 is a small molecule inhibitor of Janus kinase type 1 (JAK1). Many inflammatory cytokines and other signaling molecules rely on the JAK pathway, and specifically JAK1, which plays a central role in immune system function. Inhibition of JAK1 has been shown to treat a range of inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and atopic dermatitis. The Company believes that due to its high selectivity for JAK1 over JAK2, ARQ-252 has the potential to effectively treat inflammatory diseases without causing the hematopoietic adverse effects typically associated with JAK2 inhibition. In 2018, Arcutis exclusively licensed the active pharmaceutical ingredient in ARQ-252 for all topical dermatological uses in the United States, Europe, Japan and Canada from Jiangsu Hengrui Medicine Co., Ltd. of China. In mid-2019, Hengrui completed a Phase 2b study in rheumatoid arthritis that used the same active pharmaceutical ingredient as in ARQ-252 but dosed orally. The results confirmed that this active pharmaceutical ingredient is a highly potent inhibitor of JAK1 based on the drug's impact on rheumatoid arthritis, and was generally well tolerated at exposures well above those expected with topical administration of ARQ-252 in patients with chronic hand eczema. In 2020, Reistone Biopharma, a subsidiary of Hengrui, announced positive topline results from a Phase 2 clinical trial evaluating the oral version of the active ingredient in ARQ-252 for the treatment of moderate-to-severe atopic dermatitis. Reistone Biopharma is also studying the oral formulation as a potential treatment for alopecia areata, Crohn's disease, and ulcerative colitis.



    About Arcutis

    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 by the end 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 www.arcutis.com or follow Arcutis on LinkedIn and Twitter.



    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for Arcutis to conduct clinical trials with a reformulated ARQ-252 and for the reformulated product to treat chronic hand eczema and vitiligo. 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.

    Investor and Media Contact:

    ir@arcutis.com





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  5. WESTLAKE VILLAGE, Calif., June 23, 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 announced that Greg Sukay has joined the company as Vice President, Manufacturing and Process Technologies. Mr. Sukay, who brings more than 25 years of experience in biopharmaceutical operations, will oversee Arcutis' external manufacturing and process development for its pipeline of medical dermatology programs.

    "We welcome Greg at an exciting time for our company, as we advance closer than ever to bringing our novel products to patients with…

    WESTLAKE VILLAGE, Calif., June 23, 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 announced that Greg Sukay has joined the company as Vice President, Manufacturing and Process Technologies. Mr. Sukay, who brings more than 25 years of experience in biopharmaceutical operations, will oversee Arcutis' external manufacturing and process development for its pipeline of medical dermatology programs.

    "We welcome Greg at an exciting time for our company, as we advance closer than ever to bringing our novel products to patients with immune-driven skin disorders," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "With his extensive background in product development, operations, and manufacturing, Greg will be an integral leader as we scale our programs to a commercial stage, especially in preparation for the anticipated launch of topical roflumilast."

    Topical roflumilast, Arcutis' lead product candidate, is being studied in cream and foam formulations as a potential transformative treatment for chronic plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis.

    "I am honored to join Arcutis at such a significant stage and to play a role in bringing the company's vision to life," Mr. Sukay said. "Topical roflumilast is just the first example of how we are moving forward with our mission to revitalize the standard of care for dermatological diseases. Through state-of-the-art manufacturing and process development, I look forward to helping bring innovative new therapies to patients in need."

    Prior to joining Arcutis, Mr. Sukay spent more than 22 years at Amgen, where he most recently served as Executive Director of Amgen Contract Manufacturing, overseeing a global multi-million dollar contract manufacturing network. He also spent six years as Plant Manager and Executive Director of Amgen Singapore. He holds over 25 years of drug development experience in various roles, including director of process development and principal engineer. Greg earned his B.S. in Chemical Engineering from Purdue University.



    About Arcutis

    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.



    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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.

    Investor and Media Contact:

    ir@arcutis.com



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  6. WESTLAKE VILLAGE, Calif., June 09, 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 announced that Sue-Jean Lin has been appointed to the Arcutis Board of Directors effective June 9, 2021, and that Jonathan Silverstein, J.D. has decided to step down from the Board for personal reasons.

    "We thank Jonathan for his outstanding contributions to Arcutis," commented Patrick Heron, Chairman of the Arcutis Board of Directors. "His leadership was instrumental in driving the continued success of the company over the past 4 years, including…

    WESTLAKE VILLAGE, Calif., June 09, 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 announced that Sue-Jean Lin has been appointed to the Arcutis Board of Directors effective June 9, 2021, and that Jonathan Silverstein, J.D. has decided to step down from the Board for personal reasons.

    "We thank Jonathan for his outstanding contributions to Arcutis," commented Patrick Heron, Chairman of the Arcutis Board of Directors. "His leadership was instrumental in driving the continued success of the company over the past 4 years, including providing invaluable input to multiple successful private and public financings. We wish him all the best in his future endeavors, and we will deeply miss his intellect, humor and friendship."

    "We are pleased to welcome Sue-Jean to the Arcutis Board," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "She brings unique and very deep digital and information technology expertise to our board, as well as extensive executive experience in the life sciences industry. With 30 years of digital, operational, financial, and leadership experience in driving higher business performance for global pharmaceutical companies, Sue-Jean will play a critical role in guiding Arcutis as we expand and advance our pipeline of novel immuno-dermatology drug candidates and prepare for our first potential commercial launch."

    "I am thrilled to join the Arcutis board at this pivotal time," said Sue-Jean Lin. "The Company's lead product candidate, topical roflumilast, shows strong promise as an innovative treatment for skin diseases where there is currently significant unmet need. I look forward to supporting the company's growth trajectory with my insight and expertise, specifically in digital transformation, information technology, finance, risk management, and commercial operations."

    Ms. Lin is Senior Vice President and Chief Information Officer at Alcon (NYSE:ALC), a global leader in eye care where she played a key role during its journey to becoming an independent, publicly traded company. Prior to Alcon, she was a member of the Hill-Rom executive leadership team, serving in the capacity of Senior Vice President and Chief Information Officer. Here she was instrumental in developing a new business model that enabled patient engagement and improved the effectiveness of biomedical professionals. During her career she also served multiple roles at Allergan, including as the Senior Vice President and Chief Information Officer, and as the regional Chief Financial Officer for Allergan's Europe, Middle East, Africa, and Asia Pacific commercial operations. Ms. Lin holds a bachelor's degree in accounting and a master's degree in business administration from the University of Nevada, Reno.



    About Arcutis

    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.

    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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.

    Investor and Media Contact:

    ir@arcutis.com



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  7. WESTLAKE VILLAGE, Calif., June 01, 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 announced that Rajvir (Raj) Madan has joined the company as its first Chief Digital and Information Officer. In this role, Mr. Madan will be responsible for providing the vision, strategic direction and overall leadership of digital, data/analytics and information technology initiatives across Arcutis.

    "We are thrilled to welcome Raj to our executive team. He brings deep expertise in digital and technology transformation in the healthcare sector…

    WESTLAKE VILLAGE, Calif., June 01, 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 announced that Rajvir (Raj) Madan has joined the company as its first Chief Digital and Information Officer. In this role, Mr. Madan will be responsible for providing the vision, strategic direction and overall leadership of digital, data/analytics and information technology initiatives across Arcutis.

    "We are thrilled to welcome Raj to our executive team. He brings deep expertise in digital and technology transformation in the healthcare sector, and under his guidance, Arcutis will look to evolve our digital and analytics capabilities to transform critical business areas as we move toward our first potential commercial launch," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "We look forward to working with Raj and are excited to leverage his expertise in support of our efforts to elevate the standard of care for dermatological diseases through digital and technology innovations."

    "I am excited to join Arcutis, with its bold vision to address unmet patient needs in the medical dermatology sector," said Mr. Madan. "Arcutis' commitment to transforming their digital and data capabilities to drive value across their various platforms makes this an amazing opportunity, and I look forward to contributing to the company's continued growth."

    Mr. Madan brings over 20 years of digital transformation and innovation experience to the Arcutis team. Prior to joining Arcutis, Mr. Madan served as the Vice President of Digital, Data/Analytics and Innovation for Consumer Healthcare Technology at GlaxoSmithKline (GSK), where in partnership with the Chief Digital Officer, he was responsible for driving significant elements of their digital and tech transformation globally. Before GSK, Mr. Madan was with Novartis where he was responsible for managing and delivering global, regional and localized digital solutions and services across three business units and in more than 80 countries. In addition to healthcare, Mr. Madan has experience in the consumer goods sector, having spent 14 years at L'Oreal in various roles, including managing the Digital Tech function for L'Oreal Americas. Mr. Madan holds a bachelor's degree in computer engineering from the New Jersey Institute of Technology and master's degrees in both business administration and information systems from New York University Stern School of Business.



    About Arcutis

    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.

    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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.

    Investor and Media Contact:

    ir@arcutis.com



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    • Data show roflumilast produced robust efficacy compared to vehicle in both Phase 3 studies on the primary efficacy endpoint of IGA success at eight weeks
    • Roflumilast also demonstrated statistically significant improvements over vehicle in the key secondary endpoints of I-IGA success, PASI-75, and reduction in itch as measured by WI-NRS
    • Improvement in itch occurred as early as two weeks and improved consistently through week eight
    • Roflumilast safety and tolerability were similar to vehicle

    WESTLAKE VILLAGE, Calif., May 06, 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…

    • Data show roflumilast produced robust efficacy compared to vehicle in both Phase 3 studies on the primary efficacy endpoint of IGA success at eight weeks

    • Roflumilast also demonstrated statistically significant improvements over vehicle in the key secondary endpoints of I-IGA success, PASI-75, and reduction in itch as measured by WI-NRS
    • Improvement in itch occurred as early as two weeks and improved consistently through week eight
    • Roflumilast safety and tolerability were similar to vehicle

    WESTLAKE VILLAGE, Calif., May 06, 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 announced the presentation of new data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential once daily, topical treatment for chronic plaque psoriasis at the European Association of Dermatology and Venereology (EADV) Spring Symposium. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4).

    Both Phase 3 trials achieved the primary efficacy endpoint of Investigator Global Assessment (IGA) Success at week eight, with significantly more patients treated with roflumilast cream 0.3% reaching IGA success compared to the control group of vehicle-treated patients (DERMIS-1: 42.4% vs. 6.1%; DERMIS-2: 37.5% vs. 6.9%, respectively, P<0.001 for both). IGA success is defined as clear or almost clear with at least a 2-grade improvement from baseline.

    "While nearly 90 percent of people with plaque psoriasis rely upon topical therapies, unfortunately, existing options often have significant shortcomings that force these patients and their dermatologists to make trade-offs between efficacy, safety, and tolerability," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "We are excited to share these Phase 3 trial findings, which we believe reinforce roflumilast cream as a potential topical treatment that is uniquely suited to address this unmet need and help those who have been struggling to treat their condition."

    Roflumilast also demonstrated statistically significant improvements over vehicle in key secondary endpoints, including the treatment of psoriasis presenting in intertriginous areas (i.e., where two skin areas may touch or rub together), as measured by intertriginous-IGA (I-IGA) success (clear or almost clear with at least a 2-grade improvement from baseline). When plaque psoriasis presents in intertriginous areas, it can be particularly challenging to treat, with physicians often needing to prescribe a regimen of multiple medications for a single patient. In the Phase 3 trials, roflumilast was highly effective for intertriginous plaques, with significantly more roflumilast-treated patients reaching I-IGA success at week eight than vehicle-treated patients (DERMIS-1: 71.2% vs. 13.8%, P<0.0001; DERMIS-2: 68.1% vs 18.5%, P=0.0004), with the vast majority of these patients achieving I-IGA=0 (clear).

    "Historically, there has been a significant lack of innovation in the development of topical treatments for plaque psoriasis, with no novel nonsteroidal topical therapies approved in more than two decades," said Mark Lebwohl, MD, Professor and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and participant in the trial. "This needs to be remedied, as those who suffer from the burden of chronic plaque psoriasis and their doctors need and deserve better options. These data, which demonstrate a robust efficacy and safety profile for roflumilast cream, represent a hopeful sign for the possibility of advancing the care of this condition."

    Other key Phase 3 findings include:

    • Roflumilast was statistically superior to vehicle for improvement of psoriasis at all timepoints as measured by the Psoriasis Area Severity Index (PASI). Across both trials, approximately 40% of patients achieved a 75% reduction in PASI scores (PASI-75) by week eight (DERMIS-1: 41.6% vs 7.6%; DERMIS-2: 39.0% vs 5.3%, P<0.0001).
    • Patients with clinically significant itch, as measured by a baseline Worst Itch-Numeric Rating Scale (WI-NRS) ≥4, achieved a 4-point reduction in WI-NRS at week eight (DERMIS-1: 67.5% vs 26.8%; DERMIS-2: 69.4% vs 35.6%, P<0.0001). Itch improvement was notable by two weeks, the earliest timepoint measured (DERMIS-2: P=0.0026), with consistent improvements achieved through week eight.
    • Roflumilast safety and tolerability were similar to vehicle, including pooled rates of treatment-related treatment-emergent adverse events (AEs) (3.9% roflumilast vs. 3.6% vehicle), any AE leading to discontinuation (1.0% roflumilast vs 1.3% vehicle) and application site pain (1.0% roflumilast vs 0.3% vehicle). There were no treatment-related serious AEs, and local tolerability was highly favorable for roflumilast as reported by patient and investigator assessment of irritation, burning, and stinging.

    The "Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS" One and Two (or DERMIS-1 and DERMIS-2) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or matching vehicle cream were applied once daily for 8 weeks to subjects age 2 years and above with mild, moderate, or severe chronic plaque psoriasis involving between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442 subjects. The primary endpoint of the studies was Investigator Global Assessment (IGA) Success at week 8. Multiple secondary endpoints were also evaluated, including intertriginous-IGA (I-IGA) Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the WI-NRS and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD).

    For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter. Join the conversation with the hashtag #EADVSymposium.

    Disclosure: Dr. Lebwohl has been a paid consultant and researcher for Arcutis.

    About Plaque Psoriasis

    Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

    About Topical Roflumilast Cream

    Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    About Arcutis

    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 roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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.

    Investor and Media Contact:

    Heather Rowe Armstrong

    harmstrong@arcutis.com

    805-418-5006 ext. 740

    Media Contact:

    Erich Sandoval

    erich.sandoval@finnpartners.com

    917-497-2867



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    • 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…
    • 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.

    • Formulation and preclinical efforts are underway.

    Recent Corporate Highlights 

    • Scott Burrows, previously Vice President of Finance, was appointed Senior Vice President and Chief Financial Officer, following the retirement of John Smither
    • Courtney Barton joined the Company as Vice President, Chief Compliance Officer, and Chief of Staff
    • Corey Padovano joined the Company as Vice President of Sales
    • Sean Brugger joined the Company as Executive Director of Field Medical Affairs
    • Completed underwritten public offering of common stock in February 2021 with gross proceeds of $221.4 million and net proceeds of $207.5 million

    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 


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  8. Presentation will highlight efficacy and safety data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential topical once-daily treatment for chronic plaque psoriasis

    WESTLAKE VILLAGE, Calif., May 03, 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, will present efficacy and safety data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential once-daily topical treatment for chronic plaque psoriasis at the European Academy of Dermatology…

    Presentation will highlight efficacy and safety data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential topical once-daily treatment for chronic plaque psoriasis

    WESTLAKE VILLAGE, Calif., May 03, 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, will present efficacy and safety data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential once-daily topical treatment for chronic plaque psoriasis at the European Academy of Dermatology and Venereology (EADV) Spring Symposium May 6 - May 7, 2021.

    "The EADV symposium is an important and respected venue for exchanging information on the latest research and innovations in the field of dermatology," said Patrick Burnett,  M.D., Ph.D., FAAD, Chief Medical Officer, Arcutis. "We are thrilled the pivotal phase 3 data for roflumilast cream in the treatment of chronic plaque psoriasis has been accepted in the program as an oral presentation and look forward to sharing the findings with the dermatology community. We are also delighted that Dr. Mark Lebwohl, who participated in the study and is one of the world's leading authorities on psoriasis, will present the studies' results."

    The "Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS" One and Two (or DERMIS-1 and DERMIS-2) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or matching vehicle cream were applied once daily for 8 weeks to subjects age 2 years and above with mild, moderate, or severe chronic plaque psoriasis involving between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442 subjects. The primary endpoint of the studies was IGA Success at week 8. Multiple secondary endpoints were also evaluated, including I-IGA Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the WI-NRS and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD).

    Details of Arcutis' EADV Spring Symposium presentation is as follows:

    Roflumilast is a highly potent phosphodiesterase-4 (PDE4) inhibitor in development for plaque psoriasis (PsO). Arcutis is investigating roflumilast as a once-daily, nonsteroidal, topical treatment for plaque psoriasis, atopic dermatitis, seborrheic dermatitis, and scalp psoriasis.



    For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter. Join the conversation with the hashtag #EADVSymposium.

    About Psoriasis

    Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful.

    Scalp psoriasis is a manifestation of plaque psoriasis characterized by plaques in the hair-bearing area of the scalp and sometimes extending to the forehead, back of the neck, or behind or inside the ears. Patients with scalp psoriasis commonly have plaques on other areas of the body as well. Scalp psoriasis is present in nearly half of Americans with psoriasis. As with psoriatic plaques on other parts of the body, scalp psoriasis is often itchy and sometimes painful. It can also be associated with hair loss.

    About Topical Roflumilast Cream

    Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    About Arcutis

    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 roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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.

    Investor and Media Contact:

    Heather Rowe Armstrong

    harmstrong@arcutis.com

    805-418-5006 ext. 740



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  9. WESTLAKE VILLAGE, Calif., April 28, 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 announced that Arcutis management will participate in a virtual fireside chat during the 2021 Truist Securities Life Sciences Summit taking place May 4-5, 2021.

    Details for the presentation are as follows:
            2021 Truist Securities Life Sciences Summit
            Fireside Chat Date: Wednesday, May 5, 2021
            Fireside Chat Time: 1:00 p.m. ET

    The presentation will be webcast and may be accessed at the "Events & Presentations" section of…

    WESTLAKE VILLAGE, Calif., April 28, 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 announced that Arcutis management will participate in a virtual fireside chat during the 2021 Truist Securities Life Sciences Summit taking place May 4-5, 2021.

    Details for the presentation are as follows:

            2021 Truist Securities Life Sciences Summit

            Fireside Chat Date: Wednesday, May 5, 2021

            Fireside Chat Time: 1:00 p.m. ET

    The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company's website at https://investors.arcutis.com/events-and-presentations. Arcutis will maintain an archived replay of the webcast on its website for 30 days after the conference.

    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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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    • Detailed results from Phase 2b study of roflumilast foam in scalp and body psoriasis featured in late-breaking oral presentation
    • Data demonstrate roflumilast foam was well-tolerated and improved scalp and body psoriasis as early as two weeks after treatment initiation
    • Four additional posters feature data that support roflumilast foam for the treatment of seborrheic dermatitis and roflumilast cream for mild-to- severe chronic plaque psoriasis

    WESTLAKE VILLAGE, Calif., April 23, 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 announced…

    • Detailed results from Phase 2b study of roflumilast foam in scalp and body psoriasis featured in late-breaking oral presentation
    • Data demonstrate roflumilast foam was well-tolerated and improved scalp and body psoriasis as early as two weeks after treatment initiation
    • Four additional posters feature data that support roflumilast foam for the treatment of seborrheic dermatitis and roflumilast cream for mild-to- severe chronic plaque psoriasis

    WESTLAKE VILLAGE, Calif., April 23, 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 announced the presentation of new data demonstrating the safety and efficacy of roflumilast foam for the treatment of scalp and body psoriasis in a late-breaking oral presentation at the American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) held on April 23-25, 2021.

    The company is also showcasing data from four additional posters during the meeting, including a presentation on the safety and efficacy of roflumilast foam in the treatment of seborrheic dermatitis and three posters related to roflumilast cream in mild-to-severe chronic plaque psoriasis, including its impact on itch and use for steroid-sensitive areas. Roflumilast cream and foam are investigational once-daily, topical formulations of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.

    "Psoriasis and seborrheic dermatitis can significantly impact quality of life and are very challenging to treat, particularly long-term," said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer, Arcutis. "These new data add to the growing body of evidence supporting the potential of roflumilast, if approved, as an important, new treatment option for people affected by these chronic dermatological conditions."

    New findings from the late-breaking presentation demonstrate that roflumilast foam significantly improved both scalp and body psoriasis, with improvement as early as two weeks after treatment initiation. The primary endpoint of Scalp Investigator's Global Assessment (S-IGA) success (clear/almost clear and ≥2-grade reduction from baseline) at week eight was achieved by 59.1% of patients receiving roflumilast foam versus 11.4% of patients receiving vehicle (P<0.0001), with 34.3% of roflumilast foam-treated and 3.4% of vehicle-treated patients rated clear at week eight. Body IGA success at week eight was achieved by 40.3% and 6.8% of patients receiving roflumilast foam and vehicle, respectively (P<0.0001).



    Roflumilast foam was well-tolerated in the study. The incidence of treatment-related adverse events (TEAEs), application site adverse events (AEs), and discontinuations due to AEs were low and similar to vehicle. The most common TEAEs were application site pain (1.0% vs. 3.8%), diarrhea (1.5% vs. 0%), COVID-19 (1.5% vs. 1.9%), sinusitis (0.5% vs. 1.9%), psoriasis (0.5% vs. 1.9%), and hypertension (1.5% vs. 1.0%) for roflumilast foam and vehicle, respectively. Discontinuation due to AEs was 2.5% for roflumilast foam and 1.9% for vehicle. In the study, no patients in either group experienced any serious AEs.



    "Many current treatment options for psoriasis often carry significant limitations, particularly when being used to treat body areas covered with hair, which result in poor outcomes and additional patient burden," said lead investigator Leon Kircik, M.D., Clinical Professor of Dermatology, Icahn School of Medicine at Mount Sinai, Indiana University Medical Center, and Medical Director, Physicians Skin Care, DermResearch, and Skin Sciences, Louisville, KY. "Roflumilast once-daily foam, a novel formulation specifically designed for use on hair-bearing areas of the body like the scalp, but usable on all areas of the body, demonstrated significant benefit on both scalp and non-scalp areas. These positive results are encouraging for patients and clinicians who are desperate for new treatments that can simplify disease management, be used in all areas of the body, and ultimately improve the patient experience."



    Key findings from the other roflumilast foam and cream presentations include:

    • Efficacy and Safety of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis in a Randomized, Double-blind, Vehicle-controlled Phase 2 Study
      • Findings from this Phase 2 study demonstrated roflumilast foam is a safe, well-tolerated, and effective treatment in patients with seborrheic dermatitis. Treatment with roflumilast foam led to significant improvement in IGA Success, as well as erythema and scaling individually, and symptomatic improvement in itch in patients. Improvements in IGA Success were statistically significant at the first post-baseline visit at week two and continued through week eight. Rates of treatment-related AEs, discontinuations due to AEs, and application-site pain were low and similar to vehicle.
    • Correlation of Itch Response to Roflumilast Cream with Disease Severity and Patient-Reported Outcomes in Patients with Chronic Plaque Psoriasis
      • The Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey showed that the top factor contributing to disease severity in psoriasis according to patients was itch, but according to physicians, it was location/size of lesions. Consistent with these findings, the baseline data from this Phase 2b study in patients with chronic plaque psoriasis demonstrated that patient-reported itch was not always consistent with physician-assessed disease severity and that patients with mild disease can still experience considerable itch. In this Phase 2b study, treatment with roflumilast cream resulted in rapid and robust improvement in the severity of itch, itch-related sleep loss, and quality of life in patients with chronic plaque psoriasis.
    • Roflumilast Cream Significantly Improves Chronic Plaque Psoriasis in Patients with Steroid-Sensitive Area Involvement
      • Many patients with psoriasis have plaques on difficult to treat areas such as the face or intertriginous regions. Topical corticosteroids and vitamin D derivatives must be used with caution in these areas because they can cause side effects or tolerability problems, especially with long-term use. In this Phase 2b study, roflumilast cream was well-tolerated and provided significant improvements in investigator and patient‑assessed outcomes in participants with steroid-sensitive area involvement in a post-hoc analysis of the face, neck, or intertriginous areas in patients with chronic plaque psoriasis.
    • The PASI-HD Improved Precision in Measuring Disease Severity in Subjects with Mild-to-Moderate Plaque Psoriasis Treated with Roflumilast Cream, a PDE4 Inhibitor
      • The Psoriasis Area and Severity Index (PASI) is the gold standard measure in psoriasis clinical trials, but lacks sensitivity where the affected area is <10% body surface area. Most patients with chronic plaque psoriasis have mild-to-moderate disease, thus a higher level of discrimination for the assessment of disease severity is needed. PASI-HD is proposed as a modification to PASI to provide higher discrimination of the effects of treatment in areas with <10% involvement. This post-hoc analysis of the Phase 2b study of roflumilast cream in patients with mild-to-moderate plaque psoriasis, demonstrated that PASI-HD is more precise as compared to PASI for scoring disease severity in areas of disease involvement <10%.

    For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter. Join the conversation with the hashtag #AADVMX2021.

    About Scalp and Body Psoriasis

    Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the U.S. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful.

    Scalp psoriasis is a manifestation of plaque psoriasis characterized by plaques in the hair-bearing area of the scalp and sometimes extending to the forehead, back of the neck, or behind or inside the ears. Patients with scalp psoriasis commonly have plaques on other areas of the body as well. Scalp psoriasis is present in nearly half of Americans with psoriasis. As with psoriatic plaques on other parts of the body, scalp psoriasis is often itchy and sometimes painful. It can also be associated with hair loss.

    About Seborrheic Dermatitis

    Seborrheic dermatitis affects more than 10 million people in the U.S., and is a common, chronic, or recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often on the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back.

    About Topical Roflumilast Cream & Foam

    Roflumilast Cream and Foam are once-daily, topical formulations of a highly potent and selective PDE4 inhibitor (roflumilast). The foam formulation is to treat inflammatory dermatoses in hair-bearing areas of the body, such as the scalp, although it is usable in all areas of the body. Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors for dermatology. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, atopic dermatitis, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis and the systemic treatment of plaque psoriasis.

    About Arcutis

    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 roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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.

    Investor and Media Contact:

    Heather Rowe Armstrong

    harmstrong@arcutis.com

    805-418-5006 ext. 740



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  10. WESTLAKE VILLAGE, Calif., April 19, 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, will present new data from three studies evaluating the safety, efficacy, and tolerability of its once-daily, topical roflumilast cream and foam at the American Academy of Dermatology Virtual Meeting Experience (VMX) April 23 - 25, 2021.

    "Patients suffering from plaque psoriasis, scalp psoriasis, and seborrheic dermatitis have significant unmet needs given the lack of efficacious, safe, tolerable topical options for long-term use," said Patrick

    WESTLAKE VILLAGE, Calif., April 19, 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, will present new data from three studies evaluating the safety, efficacy, and tolerability of its once-daily, topical roflumilast cream and foam at the American Academy of Dermatology Virtual Meeting Experience (VMX) April 23 - 25, 2021.

    "Patients suffering from plaque psoriasis, scalp psoriasis, and seborrheic dermatitis have significant unmet needs given the lack of efficacious, safe, tolerable topical options for long-term use," said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer, Arcutis. "We are pleased to share these new data that further reinforce the potential of roflumilast cream and foam in various inflammatory skin diseases. If approved by the FDA, our therapies could change the treatment paradigm for patients and their providers in addressing challenging inflammatory dermatological conditions that can significantly impact quality of life."

    The data include positive results from a Phase 2b study of roflumilast foam for the treatment of scalp and body psoriasis, as well as a Phase 2 study of roflumilast foam in patients with seborrheic dermatitis.

    Two additional poster slide presentations will feature sub-analyses from the previously published Phase 2b study of roflumilast cream in the treatment of chronic, mild-to-severe plaque psoriasis: 1) the correlation of itch response to roflumilast cream with disease severity and patient-reported outcomes, and 2) the treatment of steroid-sensitive areas of the body including the face, neck, and intertriginous areas.

    Finally, Dr. Kim Papp will present results from a new measurement, PASI-HD, which he developed in conjunction with the Arcutis medical team and which was used in the Phase 2b study of roflumilast cream in plaque psoriasis. In areas where the affected body surface area is low (<10%), PASI-HD better distinguishes disease severity than the traditional Psoriasis Area and Severity Index (PASI), which is a gold standard measure in psoriasis clinical trials.

    Details of Arcutis' AAD Virtual Congress presentations include:

    • Late-breaking Oral Presentation (PSO 204): Once-daily Roflumilast Foam 0.3% for Scalp and Body Psoriasis: A Randomized, Double-blind, Vehicle-controlled Phase 2b Study

      Date: April 24, 2021



    • Poster Presentation Plus Recording (SebDerm 203): Efficacy and Safety of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis in a Randomized, Double-blind, Vehicle-controlled Phase 2 Study 

      Date: April 23, 2021



    • Poster Presentation (PSO 201): Correlation of Itch Response to Roflumilast Cream with Disease Severity and Patient-Reported Outcomes in Patients with Chronic Plaque Psoriasis 

      Date: April 23, 2021



    • Poster Presentation (PSO 201): Roflumilast Cream Significantly Improves Chronic Plaque Psoriasis in Patients with Steroid-Sensitive Area Involvement

      Date: April 23, 2021



    • Poster Presentation (PSO 201): The PASI-HD Improved Precision in Measuring Disease Severity in Subjects with Mild-to-Moderate Plaque Psoriasis Treated with Roflumilast Cream, a Phosphodiesterase-4 Inhibitor

      Date: April 23, 2021

    Roflumilast is a highly potent phosphodiesterase-4 (PDE4) inhibitor in development for plaque psoriasis (PsO). Arcutis is investigating roflumilast as a once-daily, nonsteroidal, topical treatment for plaque psoriasis, atopic dermatitis, seborrheic dermatitis, and scalp psoriasis.

    For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter. Join the conversation with the hashtag #AADVMX2021.

    About Psoriasis

    Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful.

    Scalp psoriasis is a manifestation of plaque psoriasis characterized by plaques in the hair-bearing area of the scalp and sometimes extending to the forehead, back of the neck, or behind or inside the ears. Patients with scalp psoriasis commonly have plaques on other areas of the body as well. Scalp psoriasis is present in nearly half of Americans with psoriasis. As with psoriatic plaques on other parts of the body, scalp psoriasis is often itchy and sometimes painful. It can also be associated with hair loss.

    About Seborrheic Dermatitis

    Seborrheic dermatitis affects more than 10 million people in the United States, and is a common, chronic, or recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often on the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back.

    About Topical Roflumilast Cream and Foam

    Roflumilast Cream and Foam are once-daily, topical formulations of a highly potent and selective PDE4 inhibitor (roflumilast). The foam formulation was developed to treat inflammatory dermatoses in hair-bearing areas of the body, such as the scalp, although it is usable in all areas of the body. Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors for dermatology. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, atopic dermatitis, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis and the systemic treatment of plaque psoriasis.

    About Arcutis

    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 roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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.

    Investor and Media Contact:

    Heather Rowe Armstrong

    harmstrong@arcutis.com

    805-418-5006 ext. 740



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    • Roflumilast cream potential "Best in Class" topical PDE4 inhibitor
    • Atopic dermatitis affects approximately 19 million patients in the U.S.
    • The Company anticipates topline data in the second half of 2022

    WESTLAKE VILLAGE, Calif., April 12, 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 announced it initiated a pivotal Phase 3 clinical trial evaluating topical roflumilast cream (ARQ-151) as a potential treatment for mild-to-moderate atopic dermatitis (AD) in patients between the ages of 2 and 5 years old. Roflumilast cream is a once…

    • Roflumilast cream potential "Best in Class" topical PDE4 inhibitor
    • Atopic dermatitis affects approximately 19 million patients in the U.S.
    • The Company anticipates topline data in the second half of 2022

    WESTLAKE VILLAGE, Calif., April 12, 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 announced it initiated a pivotal Phase 3 clinical trial evaluating topical roflumilast cream (ARQ-151) as a potential treatment for mild-to-moderate atopic dermatitis (AD) in patients between the ages of 2 and 5 years old. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is developing for plaque psoriasis and AD.

    "Young children suffering from atopic dermatitis often struggle with intense, persistent itching that can lead to damage caused by scratching, and that can negatively impact quality of life for both the child and the caregiver," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "Since the majority of atopic dermatitis patients are children, safety is particularly important. We are pleased to initiate this pivotal Phase 3 trial because we believe topical roflumilast has the potential to eliminate the need to compromise between safety, tolerability, and efficacy. In clinical trials, roflumilast cream has demonstrated a favorable safety and tolerability profile, and importantly, unlike steroids, it is safe to use chronically. In a previous Phase 2 trial, topical roflumilast has also shown encouraging efficacy in adult patients with atopic dermatitis. If approved, roflumilast cream may offer an additional treatment option to physicians and parents with otherwise limited choices."

    The "INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients" (or INTEGUMENT-PED) is a Phase 3, parallel group, double blind, vehicle-controlled trial in which roflumilast cream 0.05% or vehicle is applied once daily for 4 weeks to patients between the ages of 2 and 5 years old with mild-to-moderate AD involving ≥3% body surface area (excluding the scalp, palms, soles).

    In the trial, approximately 650 subjects will be randomized 2:1 to either roflumilast cream 0.05% or matching vehicle cream. The primary endpoint of the trial is Investigator Global Assessment (IGA) Success, defined as a Validated Investigator Global Assessment - Atopic Dermatitis (vIGA-AD) score of ‘clear' or ‘almost clear' plus a 2-grade improvement from baseline at Week 4. Multiple secondary endpoints will also be evaluated, including itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) as well as the proportion of subjects who attain at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4. The Company anticipates topline data from INTEGUMENT-PED in the second half of 2022.

    Arcutis recently initiated two other pivotal Phase 3 trials (INTEGUMENT-1 and -2), which are identical Phase 3, parallel group, double blind, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle is applied once daily for 4 weeks to subjects 6 years of age and older with mild to moderate AD involving ≥3% body surface area.

    About Atopic Dermatitis

    Atopic dermatitis (AD) is the most common type of eczema, occurring in approximately 6% of the U.S. population. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more. Disease onset is most common by 5 years of age, and the Company estimates that approximately 60% of patients suffering from AD are pediatric patients. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Given that most of the patients are pediatric, the safety and tolerability of AD therapies is paramount.

    About Topical Roflumilast Cream

    Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    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 become 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.

    Forward Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding roflumilast cream's potential as a treatment for atopic dermatitis; and expectations with regard to the timing of clinical data anticipated in the second half of 2022. 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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    • Scott Burrows to succeed John Smither as Chief Financial Officer (CFO) upon Mr. Smither's retirement

    • Corey Padovano named Vice President of Sales
    • Sean Brugger joins as Executive Director of Field Medical Affairs

    WESTLAKE VILLAGE, Calif., March 26, 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 announced several executive leadership updates, primarily as part of its continued preparations for the eventual launch and commercialization of its pipeline products.

    Scott Burrows, currently the company's Vice President of Finance, will…

    • Scott Burrows to succeed John Smither as Chief Financial Officer (CFO) upon Mr. Smither's retirement



    • Corey Padovano named Vice President of Sales
    • Sean Brugger joins as Executive Director of Field Medical Affairs

    WESTLAKE VILLAGE, Calif., March 26, 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 announced several executive leadership updates, primarily as part of its continued preparations for the eventual launch and commercialization of its pipeline products.

    Scott Burrows, currently the company's Vice President of Finance, will become CFO effective upon the retirement of John Smither, who has announced his intent to retire as Arcutis' CFO effective April 1, 2021, after two years with the company and a nearly 45-year career. Mr. Burrows brings almost 20 years of finance experience in the biopharmaceutical industry, including the last two years as a member of Arcutis' leadership team. As part of the transition, Mr. Smither will serve as an advisor to the company for at least two years post his retirement.

    The company also announced that Corey Padovano has joined Arcutis as Vice President of Sales. Mr. Padovano brings over 20 years of proven leadership experience in the biopharmaceutical industry and the military. Mr. Padovano will be responsible for recruiting and leading Arcutis' sales management and sales teams in preparation for the potential launch of topical roflumilast cream (ARQ-151).

    In addition, Sean Brugger, Ph.D., has joined the company as Executive Director of Field Medical Affairs. Dr. Brugger brings more than 16 years of biopharmaceutical industry experience across many disease states, including inflammatory disorders of the joints and skin. Dr. Brugger will be responsible for recruiting and leading Arcutis' field medical affairs team, which will be focused on scientific communications with health care professionals regarding Arcutis' product candidates.

    "As our first CFO, John has been an invaluable partner to me in building Arcutis into one of the pre-eminent medical dermatology companies. He played a central role in our successful IPO as well as two successful follow-on financings, leaving us well-capitalized and able to invest in the commercialization of topical roflumilast while continuing to progress our deep pipeline. While we will miss working with him daily, we are thrilled that he has agreed to stay on as an advisor, and I wish John all the best in his well-deserved retirement," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "Our thoughtful succession planning will allow us to have a smooth and seamless transition of the CFO responsibilities to Scott. Over the past two years, I and our executive team have worked closely with Scott, and I have complete confidence in his ability to take the reins as our CFO."

    Mr. Watanabe continued, "The unique depth of expertise across Arcutis' leadership team is a core element of our corporate strategy, and has enabled our operational excellence. The appointments of Corey and Sean will be critical in driving the next phase of growth for Arcutis as we prepare to file our first New Drug Application and prepare for potential commercial launch. We are excited to welcome these world-class executives to Arcutis and look forward to their leadership as we continue to advance our vision to become the preeminent innovation-driven company in medical dermatology."

    Mr. Burrows has served as Arcutis' Vice President of Finance since joining the Company in May 2019. He played key roles in the Company's private financing, initial public offering, and subsequent financings, in addition to overseeing the buildout of the financial planning and accounting functions. Prior to Arcutis, Mr. Burrows was the head of international investor relations for Shire, Plc. in Zug, Switzerland, where he played a key role in gathering European and Japanese investor support for Takeda's acquisition of Shire. Prior to Shire, he spent 15 years at Amgen in roles of increasing responsibility across financial planning and analysis, treasury, and investor relations. Mr. Burrows started his career as a consultant at Arthur Andersen. He earned both his B.A. and M.B.A. from the University of California, Los Angeles, and is a licensed CPA in California (inactive).

    Prior to joining Arcutis, Mr. Padovano was at Gilead Sciences, where he held roles of increasing responsibility, culminating in the role of Executive Director, Marketing Operations, where he was responsible for all aspects of the Marketing Operations department in support of the U.S. Commercial organization. Prior to Gilead, Mr. Padovano was Sales Director of Commercial Operations, Hospital Group, at Merck & Company, Inc., where he led the successful launch of DULERA®. Previously, he also held various roles of increasing responsibility at Schering-Plough Corporation, including Regional Sales Director for the New Jersey-Philadelphia Region. He began his biopharmaceutical career at Bayer Pharmaceuticals, where he was ultimately promoted to Division Manager of Northern New Jersey. Prior to that, he had a distinguished career in the United States Army, earning multiple personal commendations. Mr. Padovano earned his B.S. in History and Politics from Drexel University.

    Prior to joining Arcutis, Dr. Brugger spent nearly five years at Alexion Pharmaceuticals, culminating in the role of Regional Director, supporting their metabolic disorders portfolio and playing a major role in developing and implementing the broad medical strategy for the entire therapeutic area. Before Alexion, he spent nearly six years at Amgen where he held roles of increasing responsibility, culminating in the role of Director, Global Scientific Communications, Inflammation. While at Amgen, he led Scientific Affairs efforts for Enbrel® and the autoimmune diseases pipeline, including biosimilar adalimumab. Prior to that, he spent four years in Global Medical Affairs at Baxter BioScience supporting their hemophilia and clotting disorder therapies, as well as two years at Roche Bioscience as an inflammatory disease research scientist focused on TNF. Dr. Brugger earned a Ph.D. in Biochemistry and Molecular Biology from the University of Southern California and a B.S. in Genetics from the University of California, Davis.

    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 Arcutis to become the preeminent, innovation-driven medical dermatology company. 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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    • ARQ-252 is a potent and highly selective topical JAK1 inhibitor offering potential safety advantages over less selective JAK inhibitors
    • Topline data anticipated second half 2023
    • Vitiligo affects approximately 1.3 million patients in the U.S.

    WESTLAKE VILLAGE, Calif., March 18, 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 announced enrollment of the first patient in a Phase 2a clinical trial evaluating ARQ-252 as a potential treatment for vitiligo. ARQ-252 is a potent and highly selective topical small molecule inhibitor of Janus…

    • ARQ-252 is a potent and highly selective topical JAK1 inhibitor offering potential safety advantages over less selective JAK inhibitors

    • Topline data anticipated second half 2023
    • Vitiligo affects approximately 1.3 million patients in the U.S.

    WESTLAKE VILLAGE, Calif., March 18, 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 announced enrollment of the first patient in a Phase 2a clinical trial evaluating ARQ-252 as a potential treatment for vitiligo. ARQ-252 is a potent and highly selective topical small molecule inhibitor of Janus kinase type 1 (JAK1).

    "Initiation of this clinical trial marks an important milestone toward addressing the unmet need for new treatments for a chronic skin disease that can negatively impact a patient's quality of life," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "Approximately 1.3 million people in the U.S. suffer from vitiligo, and there is currently no FDA-approved treatment. Physicians typically use off-label combinations of older agents, but these options generally lead to only limited improvement, and most patients are dissatisfied with their treatment options. Early data with other topical JAK inhibitors suggest this target is effective in treating vitiligo, and ARQ-252 has demonstrated robust potency and high selectivity for JAK1 over JAK2, thereby giving it the potential to deliver efficacy without causing the side effects typical of other less selective JAK inhibitors. This Phase 2a study will evaluate ARQ-252 in combination with at-home narrowband UVB phototherapy, and it is our hope that this approach can provide meaningfully better efficacy to patients with this very challenging condition."

    This Phase 2a study is a parallel group, double blind, vehicle-controlled study of the safety and efficacy of ARQ-252 0.3% cream either with or without narrowband UVB (NB-UVB) phototherapy treatment in approximately 500 subjects with non-segmental facial vitiligo. The primary endpoint of the study is the proportion of subjects achieving Facial Vitiligo Area Scoring Index-75 (F-VASI-75), which is ≥ 75% improvement from baseline in F-VASI at week 24.

    Arcutis is also developing ARQ-252 0.3% cream as a potential treatment for chronic hand eczema and expects to report topline data from a Phase 1/2b study in mid-2021. In October 2020, Arcutis announced that enrollment had been completed in this Phase 1/2b study to assess the safety and efficacy of ARQ-252 0.1% cream once daily and ARQ-252 0.3% cream once daily or twice daily versus vehicle applied once daily or twice daily for 12 weeks to patients with chronic hand eczema.

    About Vitiligo

    Vitiligo is an auto-immune condition that occurs in as much as 1% of the U.S. population and is characterized by the loss of natural skin color or discolored patches on various parts of the body, including hair and mucous membranes. The cause of vitiligo is unknown but results when the skin's pigment producing cells (melanocytes) are targeted by the body's immune system. Vitiligo often starts on the hands, feet, or face and is typically progressive. It is a skin disease that affects people of all skin types but may be more noticeable in people with darker skin. Because of the effect on the person's appearance, vitiligo can be life-altering and can have a substantial negative impact on the psychological well-being of patients and reduce quality of life. Vitiligo can lead to a poor body image, causing individuals to feel embarrassed or anxious about their skin and withdraw from social activities.

    About ARQ-252

    ARQ-252 is a potent and highly selective topical, small molecule inhibitor of Janus kinase type 1 (JAK1). Many inflammatory cytokines and other signaling molecules rely on the JAK pathway, and specifically JAK1, which plays a central role in immune system function. Inhibition of JAK1 has been shown to treat a range of inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and atopic dermatitis. The Company believes that due to its high selectivity for JAK1 over JAK2, ARQ-252 has the potential to effectively treat inflammatory diseases without causing the hematopoietic adverse effects typically associated with JAK2 inhibition. In 2018, Arcutis exclusively licensed the active pharmaceutical ingredient in ARQ-252 for all topical dermatological uses in the United States, Europe, Japan and Canada from Jiangsu Hengrui Medicine Co., Ltd. of China. In mid-2019, Hengrui completed a Phase 2b study in rheumatoid arthritis that used the same active pharmaceutical ingredient as in ARQ-252 but dosed orally. The results confirmed that this active pharmaceutical ingredient is a highly potent inhibitor of JAK1 based on the drug's impact on rheumatoid arthritis, and was generally well tolerated at exposures well above those expected with topical administration of ARQ-252 in patients with chronic hand eczema. In 2020, Reistone Biopharma, a subsidiary of Hengrui, announced positive topline results from a Phase 2 clinical trial evaluating the oral version of the active ingredient in ARQ-252 for the treatment of moderate-to-severe atopic dermatitis. Reistone Biopharma is also studying the oral formulation as a potential treatment for alopecia areata, Crohn's disease, and ulcerative colitis.

    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 become 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.

    Forward Looking Statements



    This press release contains "forward-looking" statements, including, among others, statements regarding ARQ-252's potential as a treatment for vitiligo; and expectations with regard to the timing of the Phase 2 clinical trial. 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 November 5, 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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  11. WESTLAKE VILLAGE, Calif., March 17, 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, will present safety, efficacy, and patient-reported outcomes from its Phase 2 open-label long-term safety study investigating roflumilast 0.3% cream in adult patients with mild-to-severe chronic plaque psoriasis at the Innovations in Dermatology: Virtual Spring Conference 2021.

    "Psoriasis can significantly impact all aspects of a patient's life, including adverse physical, emotional, and social effects," said Dr. Linda Stein Gold, MD, Henry Ford Health…

    WESTLAKE VILLAGE, Calif., March 17, 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, will present safety, efficacy, and patient-reported outcomes from its Phase 2 open-label long-term safety study investigating roflumilast 0.3% cream in adult patients with mild-to-severe chronic plaque psoriasis at the Innovations in Dermatology: Virtual Spring Conference 2021.

    "Psoriasis can significantly impact all aspects of a patient's life, including adverse physical, emotional, and social effects," said Dr. Linda Stein Gold, MD, Henry Ford Health System and Chair, Innovations in Dermatology. "Current topical treatments for plaque psoriasis are often ineffective for long-term treatment, are not well tolerated, or are ill-suited for use in some areas of the body. We are excited to present data demonstrating that roflumilast addresses these limitations with the added benefit of a favorable long-term safety and efficacy profile."

    A poster presentation will feature new long-term efficacy and safety data on topical roflumilast 0.3% cream at 52- to 64-weeks (Dr. Linda Stein Gold). Additionally, two poster presentations will feature analyses of improved burden of signs and symptoms and improved itch severity (Dr. Leon Kircik), and itch-related sleep loss in adults with chronic plaque psoriasis (Dr. Linda Stein Gold) from the original Phase 2b study of roflumilast cream over a 12-week treatment period.

    Arcutis also recently released positive topline data from the pivotal Phase 3 studies of roflumilast cream in plaque psoriasis, and plans to present the full results of those studies in the near future, as well as submit a New Drug Application later this year.

    In addition to the plaque psoriasis presentations, Dr. Melinda Gooderham will present the results from the Phase 2 study of roflumilast cream 0.15% and 0.05% in patients with mild-to-moderate atopic dermatitis.

    "Existing topical treatments prescribed to psoriasis patients have significant shortcomings, which lead to difficult trade-offs between efficacy, safety, and tolerability," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "These data reinforce our conviction that topical roflumilast, if approved by the FDA, has the potential to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions by reducing the need to make such trade-offs."

    Arcutis is investigating roflumilast as a once-daily, nonsteroidal treatment for plaque psoriasis, atopic dermatitis, seborrheic dermatitis, and scalp psoriasis. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4). Based on results from the pivotal Phase 3 studies, topical roflumilast potentially delivers efficacy comparable to the results of published clinical studies of high-potency steroid/calcipotriene or high-potency steroid/tazarotene combination products, but with safety and tolerability that supports chronic use in all areas of the body, and little or none of the local tolerability issues associated with many competitive agents.

    For more information, visit the Innovations in Dermatology Spring Conference virtually and https://www.arcutis.com or follow the company on LinkedIn and Twitter.

    About Plaque Psoriasis

    Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

    About Atopic Dermatitis

    Atopic dermatitis (AD) is the most common type of eczema, occurring in approximately 6% of the U.S. population. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more. Disease onset is most common by 5 years of age, and the Company estimates that approximately 60% of patients suffering from AD are pediatric patients. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Given that most of the patients are pediatric, the safety and tolerability of AD therapies is paramount.

    About Topical Roflumilast Cream

    Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors for dermatology. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis and the systemic treatment of plaque psoriasis.

    About Arcutis

    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 roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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.

    Investor and Media Contact

    Heather Rowe Armstrong

    harmstrong@arcutis.com

    805-418-5006 ext. 740



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  12. WESTLAKE VILLAGE, Calif., Feb. 25, 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 announced that Arcutis management will participate in a virtual presentation during the Cowen 41st Annual Health Care Conference taking place March 1-4, 2021.

    Details for the presentation are as follows:
            Cowen 41st Annual Health Care Conference
            Presentation Date: Monday, March 1, 2021
            Presentation Time: 12:20 p.m. PT / 3:20 p.m. ET

    The presentation will be webcast and may be accessed at the "Events & Presentations" section…

    WESTLAKE VILLAGE, Calif., Feb. 25, 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 announced that Arcutis management will participate in a virtual presentation during the Cowen 41st Annual Health Care Conference taking place March 1-4, 2021.

    Details for the presentation are as follows:

            Cowen 41st Annual Health Care Conference

            Presentation Date: Monday, March 1, 2021

            Presentation Time: 12:20 p.m. PT / 3:20 p.m. ET

    The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company's website at https://investors.arcutis.com/events-and-presentations. Arcutis will maintain an archived replay of the webcast on its website for 30 days after the conference.

    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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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  13. WESTLAKE VILLAGE, Calif., Feb. 18, 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 announced that Courtney Barton has joined the company as Chief Compliance Officer and Chief of Staff. Ms. Barton will also serve as the company's Chief Privacy Officer.

    "Courtney's extensive corporate and healthcare compliance background and proven track record of leadership make her the right leader to assume this important role within our company," said Keith Klein, Arcutis' General Counsel. "Arcutis is committed to conducting our business with…

    WESTLAKE VILLAGE, Calif., Feb. 18, 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 announced that Courtney Barton has joined the company as Chief Compliance Officer and Chief of Staff. Ms. Barton will also serve as the company's Chief Privacy Officer.

    "Courtney's extensive corporate and healthcare compliance background and proven track record of leadership make her the right leader to assume this important role within our company," said Keith Klein, Arcutis' General Counsel. "Arcutis is committed to conducting our business with the highest level of integrity and in full compliance with the laws and regulations that govern our operations. Courtney is an accomplished compliance and data privacy leader with extensive global experience in pharmaceutical and medical device industries and a proven track record of success, and I am confident that she will be successful in leading our comprehensive companywide compliance program, in addition to her role as our Chief of Staff."

    "I am incredibly excited to be joining Arcutis at this pivotal time in the company's evolution and applaud Arcutis' continued investment in compliance and data privacy," said Ms. Barton. "Arcutis is progressing on its bold strategy to become the preeminent innovation-driven medical dermatology company. I look forward to leading our comprehensive compliance program and acting as Chief of Staff as the company continues its impressive growth trajectory."

    Ms. Barton brings over 17 years of corporate and healthcare compliance experience to Arcutis' growing team. Prior to joining Arcutis, Ms. Barton served as Vice President, Commercial Excellence & Chief Compliance Officer at Cipla Therapeutics, a division of Cipla, USA. Ms. Barton has broad, global compliance and ethics expertise, having begun her compliance and ethics career at Winn-Dixie Stores, Incorporated before transitioning to roles in the pharmaceutical and medical device sector with Bausch + Lomb, Allergan, KYTHERA, Anacor and MannKind Corporation. She has also held positions with Merrill Lynch and Janus, including an appointment overseas. A graduate of Syracuse University, Ms. Barton holds Bachelor's degrees in Political Science and International Relations, both magna cum laude, and is a Certified Compliance and Ethics Professional (CCEP) and Certified Information Privacy Professional (CIPP US/E).

    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 Arcutis to become the preeminent innovation-driven medical dermatology company. 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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    • NDA submission for topical roflumilast cream as a potential treatment for plaque psoriasis anticipated in the second half of 2021
    • Positive Phase 3 data on topical roflumilast cream in plaque psoriasis reported in February
    • Advancing topical roflumilast into Phase 3 programs for atopic dermatitis, seborrheic dermatitis, and scalp psoriasis during 2021
    • Robust pipeline addressing unmet medical needs of over 20 million patients
    • Strong financial position with over $470 million in cash, cash equivalents and marketable securities, including the proceeds from recent equity offering, providing cash runway into 2023

    WESTLAKE VILLAGE, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company…

    • NDA submission for topical roflumilast cream as a potential treatment for plaque psoriasis anticipated in the second half of 2021

    • Positive Phase 3 data on topical roflumilast cream in plaque psoriasis reported in February
    • Advancing topical roflumilast into Phase 3 programs for atopic dermatitis, seborrheic dermatitis, and scalp psoriasis during 2021
    • Robust pipeline addressing unmet medical needs of over 20 million patients
    • Strong financial position with over $470 million in cash, cash equivalents and marketable securities, including the proceeds from recent equity offering, providing cash runway into 2023

    WESTLAKE VILLAGE, Calif., Feb. 16, 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 and year ended December 31, 2020, and provided a business update.

    "2020 was a year of incredibly strong execution for Arcutis," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "From our initial public offering in February through implementation of 18 clinical trials with three different product candidates involving more than 3,200 patients, we made tremendous progress advancing our mission of addressing significant unmet needs in medical dermatology. I am unbelievably grateful to the patients and physicians participating in our clinical trials, and to our amazing Arcutis team. This effort culminated in multiple notable milestones, including our recently reported positive pivotal Phase 3 results in plaque psoriasis, positive Phase 2 results in atopic dermatitis, seborrheic dermatitis, and scalp psoriasis, and the landmark publication of plaque psoriasis Phase 2b data in the New England Journal of Medicine."

    Mr. Watanabe continued, "2021 will be a transformational year for Arcutis as we continue to rapidly advance our innovative and differentiated late-stage pipeline of potential best-in-class topical dermatology therapies. Based on positive Phase 3 data, we anticipate submitting a New Drug Application to the FDA for topical roflumilast cream as a potential once daily topical treatment for plaque psoriasis this year. We are excited to advance three additional programs into pivotal Phase 3 trials in 2021. Our focus on addressing the gap in dermatology drug development currently includes four product candidates in development for seven indications, with an addressable U.S. market of over 20 million patients, representing a potential revenue opportunity of between $3 billion and $8 billion."

    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; New Drug Application (NDA) submission to U.S. FDA anticipated in the second half of 2021.
    • Pivotal Phase 3 trials in patients with atopic dermatitis (INTEGUMENT-1 and INTEGUMENT-2) initiated in January 2021 with topline data anticipated in the second half of 2022.
    • Reported positive results from the Phase 2 long-term safety study as a potential once-daily chronic topical treatment for plaque psoriasis.

    ARQ-154 (topical roflumilast foam) - a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor in a foam formulation, 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.

    • Reported positive topline data from Phase 2b study in patients with scalp and body psoriasis which affects more than 2.5 million of the 6 million psoriasis patients in U.S with active disease.
    • Announced advancement of seborrheic dermatitis into Phase 3 development, anticipating initiation of a single pivotal Phase 3 study (STRATUM) in the second or third quarter of 2021, with topline data anticipated in the second or third quarter of 2022.
    • Pending discussions with regulators, the Company expects to initiate its Phase 3 program in scalp psoriasis in the second half of 2021, with topline data anticipated in the second half 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.

    • Completed enrollment of the ongoing Phase 1/2b study in chronic hand eczema, with topline data anticipated by mid-2021.
    • The Company anticipates initiating a Phase 2a study in vitiligo in the first quarter of 2021.

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

    • Formulation and preclinical efforts are underway.

    Recent Corporate Highlights 

    • Terrie Curran appointed to Arcutis' Board of Directors
    • Arcutis common stock (ARQT) added to the Nasdaq Biotechnology Index
    • Matthew Moore joined the Company as Chief Business Officer
    • Completed underwritten public offering of common stock in February 2021 with gross proceeds of $221.4 million and net proceeds of $207.4 million

    Fourth Quarter and Full Year 2020 Summary Financial Results

    Cash, cash equivalents, restricted cash and marketable securities were $286.0 million as of December 31, 2020, compared to $101.3 million as of December 31, 2019. Arcutis believes that its current cash, cash equivalents and marketable securities of over $470 million, including the $207.4 million net proceeds from its recent financing, will be sufficient to fund its operations into 2023.

    Research and development (R&D) expenses for the quarter ended December 31, 2020 were $27.4 million compared to $10.8 million for the corresponding period in 2019. R&D expenses for the year ended December 31, 2020 were $115.3 million compared to $36.5 million for the corresponding period in 2019. These year-over-year increases were primarily due to the initiation of multiple clinical trials during the last year.

    General and administrative (G&A) expenses for the quarter ended December 31, 2020 were $6.7 million compared to $2.2 million for the corresponding period in 2019. G&A expenses for the year ended December 31, 2020 were $21.3 million compared to $6.6 million for the corresponding period in 2019. These year-over-year increases were primarily due to higher headcount and professional services costs, including the costs associated with being a public company.

    Net loss was $34.0 million, or $0.79 per basic and diluted share, for the quarter ended December 31, 2020 compared to $12.6 million, or $6.13 per basic and diluted share, for the corresponding period in 2019. Net loss was $135.7 million, or $3.80 per basic and diluted share, for the year ended December 31, 2020 compared to $42.0 million, or $22.78 per basic and diluted share, for the corresponding period in 2019.

    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.

    Balance Sheets

    (In thousands)

     December 31,
     2020 2019
    ASSETS   
    Current assets:   
    Cash and cash equivalents$65,082   $63,336  
    Restricted cash1,542     
    Marketable securities219,359   37,929  
    Prepaid expenses and other current assets6,843   5,209  
    Total current assets292,826   106,474  
    Property and equipment, net2,016   227  
    Operating lease right-of-use asset3,349   264  
    Other assets78   47  
    Total assets$298,269   $107,012  
    LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)   
    Current liabilities:   
    Accounts payable$7,140   $1,405  
    Accrued liabilities15,462   3,654  
    Operating lease liability   178  
    Total current liabilities22,602   5,237  
    Operating lease liability, noncurrent4,964   129  
    Other long-term liabilities82   184  
    Total liabilities27,648   5,550  
    Convertible preferred stock   166,491  
    Stockholders' equity (deficit):   
    Preferred stock     
    Common stock4     
    Additional paid-in capital472,569   1,244  
    Accumulated other comprehensive loss(2)  (1) 
    Accumulated deficit(201,950)  (66,272) 
    Total stockholders' equity (deficit)270,621   (65,029) 
    Total liabilities, convertible preferred stock and stockholders' equity (deficit)$298,269   $107,012  





    ARCUTIS BIOTHERAPEUTICS, INC.

    Condensed Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share data)

     Three Months Ended December 31, Year Ended December 31,
     2020 2019 2020 2019
     (unaudited)    
    Operating expenses:       
    Research and development$27,374   $10,757   $115,308   $36,522  
    General and administrative6,690   2,237   21,337   6,610  
    Total operating expenses34,064   12,994   136,645   43,132  
    Loss from operations(34,064)  (12,994)  (136,645)  (43,132) 
    Other income, net15   426   967   1,136  
    Net loss$(34,049)  $(12,568)  $(135,678)  $(41,996) 
    Per share information:       
    Net loss per share, basic and diluted$(0.79)  $(6.13)  $(3.80)  $(22.78) 
    Weighted-average shares used in computing net loss per share, basic and diluted42,977,244   2,051,584   35,668,152   1,843,213  

     



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  14. WESTLAKE VILLAGE, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. ("Arcutis") (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, announced that it has completed the sale of an additional 825,000 shares of common stock, pursuant to the exercise in full of the overallotment option granted to the underwriters in connection with the Company's recently completed underwritten public offering of 5,500,000 shares of common stock, at the public offering price of $35.00 per share, less underwriting discounts and commissions. After giving effect to the sale of these additional…

    WESTLAKE VILLAGE, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. ("Arcutis") (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, announced that it has completed the sale of an additional 825,000 shares of common stock, pursuant to the exercise in full of the overallotment option granted to the underwriters in connection with the Company's recently completed underwritten public offering of 5,500,000 shares of common stock, at the public offering price of $35.00 per share, less underwriting discounts and commissions. After giving effect to the sale of these additional shares, a total of 6,325,000 shares of common stock were sold in the offering, for aggregate gross proceeds of approximately $221.4 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Arcutis.

    Morgan Stanley, Cowen, and Guggenheim Securities acted as bookrunning managers for the offering. Truist Securities and Cantor acted as lead managers for the offering.

    The public offering was made pursuant to an automatic shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission (the "SEC") on February 1, 2021 and automatically became effective upon filing. A final prospectus supplement and accompanying prospectus relating to and describing the final terms of the offering were filed with the SEC and are available on the SEC's website located at http://www.sec.gov or may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at prospectus@morganstanley.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, New York 10017, by telephone at (212) 518-9658, or by email at GSEquityProspectusDelivery@guggenheimpartners.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Forward Looking Statements

    This press release contains "forward-looking" statements. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause Arcutis' 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 Arcutis' actual results to differ include risks and uncertainties associated with the effect of changing economic conditions, risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and Arcutis' ability to defend its intellectual property. Arcutis' business could be affected by a number of other factors, including the risk factors discussed in the preliminary prospectus supplement relating to the offering and the documents incorporated by reference therein, which include Arcutis' Quarterly Reports on Form 10-Q and Annual Report on Form 10-K. The forward-looking statements contained in this press release speak only as of the date hereof and Arcutis cautions investors not to place undue reliance on these forward-looking statements. Except as required by law, Arcutis disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

    Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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  15. WESTLAKE VILLAGE, Calif,, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. ("Arcutis") (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 announced the pricing of its upsized underwritten public offering of 5,500,000 shares of its common stock at a public offering price of $35.00 per share. In addition, Arcutis has granted the underwriters a 30-day option to purchase up to an additional 825,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Arcutis from the offering are expected to be $192.5 million…

    WESTLAKE VILLAGE, Calif,, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. ("Arcutis") (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 announced the pricing of its upsized underwritten public offering of 5,500,000 shares of its common stock at a public offering price of $35.00 per share. In addition, Arcutis has granted the underwriters a 30-day option to purchase up to an additional 825,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Arcutis from the offering are expected to be $192.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Arcutis, and assuming no exercise of the underwriters' option to purchase additional shares. Subject to customary conditions, the offering is expected to close on February 5, 2021.

    Arcutis currently intends to use the net proceeds from the offering, together with its existing cash, cash equivalents, restricted cash, and marketable securities, to fund the continued development of its multiple programs, including ARQ-151, ARQ-154, ARQ-252 and ARQ-255 programs, filing of the NDA for ARQ-151 in psoriasis, approval and commercial launch for ARQ-151 in psoriasis, and the remainder for working capital and other general corporate purposes.

    Morgan Stanley, Cowen, and Guggenheim Securities are acting as bookrunning managers for the offering. Truist Securities and Cantor are acting as lead managers for the offering.

    The public offering is being made pursuant to an automatic shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission (the "SEC") on February 1, 2021 and automatically became effective upon filing. A final prospectus supplement and accompanying prospectus relating to and describing the final terms of the offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov or may be obtained, when available, from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at prospectus@morganstanley.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, New York 10017, by telephone at (212) 518-9658, or by email at GSEquityProspectusDelivery@guggenheimpartners.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Forward Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the timing, size and completion of the public offering. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause Arcutis' 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 Arcutis' actual results to differ include risks and uncertainties associated with the effect of changing economic conditions, risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and Arcutis' ability to defend its intellectual property. Arcutis' business could be affected by a number of other factors, including the risk factors discussed in the preliminary prospectus supplement relating to the offering and the documents incorporated by reference therein, which include Arcutis' Quarterly Reports on Form 10-Q and Annual Report on Form 10-K. The forward-looking statements contained in this press release speak only as of the date hereof and Arcutis cautions investors not to place undue reliance on these forward-looking statements. Except as required by law, Arcutis disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

    Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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  16. WESTLAKE VILLAGE, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. ("Arcutis") (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 announced the commencement of an underwritten public offering of $150.0 million of shares of its common stock. All of the shares in the offering are being sold by Arcutis. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering. In addition, Arcutis intends to grant the underwriters a…

    WESTLAKE VILLAGE, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. ("Arcutis") (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 announced the commencement of an underwritten public offering of $150.0 million of shares of its common stock. All of the shares in the offering are being sold by Arcutis. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering. In addition, Arcutis intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering at the public offering price.

    Morgan Stanley, Cowen, and Guggenheim Securities are acting as bookrunning managers for the proposed offering. Truist Securities and Cantor are acting as lead managers for the offering.

    The proposed offering will be made pursuant to an automatic shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission (the "SEC") on February 1, 2021 and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC's website located at http://www.sec.gov or may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at prospectus@morganstanley.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, New York 10017, by telephone at (212) 518-9658, or by email at GSEquityProspectusDelivery@guggenheimpartners.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Forward Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the timing, size and completion of the proposed public offering and the grant to the underwriters of an option to purchase additional shares. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause Arcutis' 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 Arcutis' actual results to differ include isks and uncertainties associated with the effect of changing economic conditions, risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and Arcutis' ability to defend its intellectual property. Arcutis' business could be affected by a number of other factors, including the risk factors discussed in the preliminary prospectus supplement relating to the offering and the documents incorporated by reference therein, which include Arcutis' Quarterly Reports on Form 10-Q and Annual Report on Form 10-K. The forward-looking statements contained in this press release speak only as of the date hereof and Arcutis cautions investors not to place undue reliance on these forward-looking statements. Except as required by law, Arcutis disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

    Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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    • Roflumilast cream demonstrated statistically significant superiority over vehicle on primary endpoint of IGA Success
    • Favorable safety and tolerability profile in this patient population
    • New Drug Application (NDA) submission anticipated in the second half of 2021
    • Roflumilast cream potential "Best in Class" topical PDE4 inhibitor, a non-steroidal treatment intended for chronic use
    • Plaque psoriasis affects approximately 8.6 million patients in the U.S.
    • Company to host a conference call today at 8:30 a.m. EST

    WESTLAKE VILLAGE, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today…

    • Roflumilast cream demonstrated statistically significant superiority over vehicle on primary endpoint of IGA Success

    • Favorable safety and tolerability profile in this patient population
    • New Drug Application (NDA) submission anticipated in the second half of 2021
    • Roflumilast cream potential "Best in Class" topical PDE4 inhibitor, a non-steroidal treatment intended for chronic use
    • Plaque psoriasis affects approximately 8.6 million patients in the U.S.
    • Company to host a conference call today at 8:30 a.m. EST

    WESTLAKE VILLAGE, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced positive topline results from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential topical treatment for plaque psoriasis. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4).

    On the studies' primary endpoint of Investigator Global Assessment (IGA) Success at week 8, roflumilast cream 0.3% had an ‘IGA Success' rate in DERMIS-1 of 42.4% compared to a vehicle rate of 6.1% (P<0.0001), and in DERMIS-2 an ‘IGA Success' rate of 37.5% compared to a vehicle rate of 6.9% (P<0.0001). IGA Success was defined as an IGA score of clear or almost clear and at least a 2-grade improvement from baseline. Roflumilast cream 0.3% also demonstrated statistically significant improvements over vehicle on key secondary endpoints, including on Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD).

    In DERMIS-1 and DERMIS-2, roflumilast cream was generally safe and well-tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate in severity. Overall, 90% of patients who were randomized to roflumilast cream in the studies completed the full 8 weeks. Among subjects receiving roflumilast cream, there were only 5 discontinuations in DERMIS-1 due to a TEAE (1.7% of subjects) and 1 discontinution in DERMIS-2 due to TEAE (0.3% of subjects), and there were no treatment-related Serious Adverse Events (SAEs).

    "We are delighted with the strength of these Phase 3 data, which surpassed the already positive results we saw in our Phase 2 studies," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "These data reinforce our conviction that topical roflumilast is exceptionally well suited to address the unmet needs in the topical treatment of psoriasis, offering an ideal combination of efficacy comparable to the results of published clinical studies of high-potency steroid/calcipotriene or high-potency steroid/tazarotene combination products, the ability to use the drug chronically in any anatomical area, and a very favorable safety and tolerability profile. Based on the strength of these Phase 3 data, we anticipate submission of our NDA to the U.S. FDA in the second half of 2021. Importantly, we want to express our appreciation to the trial participants and the clinical investigators for their commitment to this important research effort."

    "The impact of plaque psoriasis extends beyond the serious physical burdens of the disease, with many patients experiencing adverse psychological and social effects as well," said Mark Lebwohl, MD, Professor and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and participant in the trial. "The existing topical treatments prescribed to psoriasis patients have significant shortcomings, which lead to difficult trade-offs between efficacy, safety, and tolerability. These data demonstrate once-daily topical roflumilast cream was well-tolerated and achieved early and significant improvements in psoriasis signs and symptoms, including having a profound impact on itch."

    The "Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS" One and Two (or DERMIS-1 and DERMIS-2) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or matching vehicle cream were applied once daily for 8 weeks to subjects age 2 years and above with mild, moderate or severe chronic plaque psoriasis involving between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442 subjects. The primary endpoint of the studies was IGA Success at week 8. Multiple secondary endpoints were also evaluated, including I-IGA Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the WI-NRS and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). The Company anticipates submission of its NDA to the FDA in the second half of 2021.

    Management will host a conference call today at 8:30 a.m. EST to discuss these results. To access the call, please dial (833) 614-1393 (domestic) or (914) 987-7114 (international) prior to the scheduled conference call time and provide the conference ID 8079585. A live webcast of the call will be available on the "Investors" section of the company's website, www.arcutis.com. An archived version of the webcast will be available on the Arcutis website after the call.

    About Psoriasis

    Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

    About Topical Roflumilast Cream

    Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    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 become 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.

    Forward Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding roflumilast cream's potential as a treatment for plaque psoriasis; and expectations with regard to the timing of potential NDA submission in 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 November 5, 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740





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    • Phase 3 development to consist of single pivotal trial
    • Previously reported data demonstrated that roflumilast foam provided statistically significant improvement and a favorable safety and tolerability profile
    • Roflumilast foam potential "Best in Class" topical PDE4 inhibitor
    • Seborrheic dermatitis affects 10 million U.S. patients

    WESTLAKE VILLAGE, Calif., Jan. 20, 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 announced that it will advance its program to develop topical roflumilast foam (ARQ-154) as a treatment for seborrheic dermatitis

    • Phase 3 development to consist of single pivotal trial
    • Previously reported data demonstrated that roflumilast foam provided statistically significant improvement and a favorable safety and tolerability profile
    • Roflumilast foam potential "Best in Class" topical PDE4 inhibitor
    • Seborrheic dermatitis affects 10 million U.S. patients

    WESTLAKE VILLAGE, Calif., Jan. 20, 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 announced that it will advance its program to develop topical roflumilast foam (ARQ-154) as a treatment for seborrheic dermatitis into Phase 3 following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The Phase 3 program will consist of a single pivotal trial, which the Company anticipates initiating in the second or third quarter of 2021. Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor.

    "Following our interactions with the FDA, we are delighted to advance topical roflumilast foam into Phase 3 development for the treatment of seborrheic dermatitis, a disease that affects more than 10 million people in the U.S.," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "Results from our Phase 2 clinical trials with once-a-day topical roflumilast foam demonstrated that it provides statistically significant improvements in signs and symptoms of both seborrheic dermatitis and scalp psoriasis compared to a matching vehicle foam, while also being well tolerated. Unlike creams and ointments, roflumilast foam is suitable for use in hair-bearing areas; unlike steroids, it is expected to be suitable for long-term use, including on the face; and unlike shampoos, it is an elegant, quick drying, leave-in foam that doesn't need to be rinsed out. If successful in the Phase 3 clinical trial and approved for commercialization, roflumilast foam has the potential to become the standard of care in seborrheic dermatitis."

    "Patients are desperate to find new treatment options for seborrheic dermatitis, a common, chronic skin disease affecting the face and scalp that can profoundly affect patients' appearance and quality of life," said Matthew Zirwas, M.D., Founder of Bexley Dermatology Research Clinic and an investigator in the trial. "Dermatologists and patients face a real challenge, with current treatment options that are either safe or effective, but rarely both. Based on clinical results to date, topical roflumilast has shown to be safe and effective, rapidly improving both the appearance and the itch, dramatically improving patients' quality of life. Notably, it comes in a cosmetically-elegant foam that can be used chronically in multiple locations without the burning and stinging associated with other treatment options. If approved, topical roflumilast will be a revolutionary advancement in the treatment of seborrheic dermatitis."

    Roflumilast foam is a once-daily topical foam formulation of a highly potent and selective PDE4 inhibitor that Arcutis is developing particularly to treat inflammatory dermatoses in hair-bearing areas of the body such as the scalp, although it is usable in all areas of the body.

    Roflumilast has been approved by the FDA for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to-300 fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    Arcutis believes roflumilast foam has significant potential as a treatment for seborrheic dermatitis. In a recently completed Phase 2 study of roflumilast foam in seborrheic dermatitis, roflumilast foam demonstrated statistically significant improvement over the vehicle foam on the trial's primary endpoint, Investigator Global Assessment (IGA) success, and multiple secondary endpoints including the reduction of itch. Once-daily roflumilast foam also demonstrated a favorable safety and tolerability profile. Additionally, other than a very small change in the formulation, roflumilast foam is identical to roflumilast cream (ARQ-151), Arcutis' investigational topical cream PDE4 inhibitor, which has demonstrated symptomatic improvement and a favorable tolerability profile in clinical trials in plaque psoriasis, including chronic treatment of psoriasis, as well as encouraging results in atopic dermatitis.

    Arcutis is currently conducting a Phase 2 long-term safety study in seborrheic dermatitis. This is a multicenter, open-label study of roflumilast foam 0.3% applied once daily in adolescent and adult patients with seborrheic dermatitis and includes patients who were treated previously in the Phase 2 trial, as well as patients naïve to treatment with topical roflumilast foam. Periodic clinic visits include assessments for clinical safety, application site reactions, and disease improvement, or progression.

    About Seborrheic Dermatitis

    Seborrheic dermatitis affects more than 10 million people in the U.S., and is a common, chronic or recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often on the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back.

    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 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 of roflumilast foam to address the unmet needs in the topical treatment of seborrheic dermatitis; the potential safety and efficacy of roflumilast foam; and the initiation of a pivotal Phase 3 clinical trial in 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 November 5, 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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    • Roflumilast cream potential "Best in Class" topical PDE4 inhibitor
    • Atopic dermatitis affects approximately 19 million patients in the U.S.
    • The Company anticipates topline data in the second half of 2022

    WESTLAKE VILLAGE, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it has commenced pivotal Phase 3 clinical trials evaluating topical roflumilast cream (ARQ-151) as a potential treatment for atopic dermatitis (AD). Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4…

    • Roflumilast cream potential "Best in Class" topical PDE4 inhibitor

    • Atopic dermatitis affects approximately 19 million patients in the U.S.
    • The Company anticipates topline data in the second half of 2022

    WESTLAKE VILLAGE, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it has commenced pivotal Phase 3 clinical trials evaluating topical roflumilast cream (ARQ-151) as a potential treatment for atopic dermatitis (AD). Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is developing for plaque psoriasis and AD.

    "More than 19 million people in the U.S. suffer from atopic dermatitis, of which at least 60 percent are young children, thereby making safety and tolerability particularly important in this disease," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "Atopic dermatitis is characterized by a defect in the skin barrier, which results in a red, itchy rash that in many cases can cover significant areas of the body. Current treatments often fall short, resulting in patients, parents and physicians having to make trade-offs between efficacy, safety and tolerability."

    Dr. Burnett continued, "We are excited to begin our pivotal Phase 3 trials in patients with atopic dermatitis. If approved, roflumilast cream would be the first once-a-day topical nonsteroidal treatment for AD, and would also offer patients a cosmetically-elegant, non-greasy formulation. In clinical trials, roflumilast cream has demonstrated a benign safety and tolerability profile, without the local tolerability or safety issues associated with many other topical AD treatments, and importantly, unlike steroids, it can safely be used chronically. We believe topical roflumilast has the potential to eliminate the need to compromise between safety, efficacy, and tolerability, and we look forward to reporting topline data in the second half of 2022."

    The "INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis" 1 and 2 (or INTEGUMENT-1 and -2) are identical Phase 3, parallel group, double blind, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle is applied once daily for 4 weeks to subjects 6 years of age and older with mild to moderate AD involving ≥3% body surface area.

    In each trial, approximately 650 subjects are planned to be randomized 2:1 to either roflumilast cream 0.15% or matching vehicle cream. The primary endpoint of both trials is Investigator Global Assessment (IGA) Success, defined as a Validated Investigator Global Assessment - Atopic Dermatitis (vIGA-AD) score of ‘clear' or ‘almost clear' plus a 2-grade improvement from baseline at Week 4. Multiple secondary endpoints will also be evaluated, including itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) as well as the proportion of subjects who attain at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4. After completing INTEGUMENT-1 or -2, subjects may be eligible to enroll in a 12‑month, open label extension study (INTEGUMENT-OLE) evaluating once daily roflumilast cream. The Company anticipates topline data from INTEGUMENT-1 and -2 in the second half of 2022.

    Arcutis also plans to initiate a third pivotal Phase 3 study, the "INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients" (or INTEGUMENT-PED) shortly to evaluate roflumilast cream in subjects 2 to 5 years of age with mild to moderate AD.

    About Atopic Dermatitis

    Atopic dermatitis (AD) is the most common type of eczema, occurring in approximately 6% of the U.S. population. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more. Disease onset is most common by 5 years of age, and the Company estimates that approximately 60% of patients suffering from AD are pediatric patients. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Given that most of the patients are pediatric, the safety and tolerability of AD therapies is paramount.

    About Topical Roflumilast Cream

    Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    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 roflumilast cream's potential as a treatment for atopic dermatitis; and expectations with regard to the timing of clinical data anticipated in the second half of 2022. 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 November 5, 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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  17. WESTLAKE VILLAGE, Calif., Jan. 11, 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 announced that Matthew Moore has joined the company as Chief Business Officer. Mr. Moore brings to Arcutis over 20 years of strategy, transaction and operations experience in the biopharmaceutical industry. Most recently, he served as Vice President, Corporate Business Development and Alliance Management at Allergan, where he led worldwide strategy and business development for the company's $4B+ Medical Aesthetics business unit.

    "We are thrilled…

    WESTLAKE VILLAGE, Calif., Jan. 11, 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 announced that Matthew Moore has joined the company as Chief Business Officer. Mr. Moore brings to Arcutis over 20 years of strategy, transaction and operations experience in the biopharmaceutical industry. Most recently, he served as Vice President, Corporate Business Development and Alliance Management at Allergan, where he led worldwide strategy and business development for the company's $4B+ Medical Aesthetics business unit.

    "We are thrilled to add Matt to our executive team. Like the rest of our senior team, Matt brings a deep understanding of dermatology markets, and he adds important expertise in corporate strategy, business development, and alliance management. His extensive experience creating shareholder value through successful business development will be a key enabler as we continue to build Arcutis into one of the industry's leading dermatology companies," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "We at Arcutis are focused on elevating the standard of care for dermatological diseases, and his strategic insights and deal execution will play an important role in helping us to realize that goal."

    "I am delighted to join Arcutis at such an exciting time for the company," said Mr. Moore. "Arcutis has established itself as a leader in medical dermatology and is uniquely positioned to fill the innovation gap in this therapeutic area. I have been impressed by the pace of progress achieved to date, and look forward to working with the team to help make Arcutis the preeminent, innovation-driven medical dermatology company."

    During his tenure at Allergan and its predecessor companies, Actavis and Forest Labs, Mr. Moore was responsible for creating and executing business development growth strategies across multiple therapeutic areas including medical aesthetics, neuroscience, anti-infectives and hospital products. In addition, Mr. Moore served as a key deal team member in Actavis' transformational acquisition of Allergan and Allergan's ultimate sale to AbbVie. Prior to Allergan, Mr. Moore held executive roles at DOV Pharmaceutical and he started his career in the healthcare investment banking group at CIBC Oppenheimer. Mr. Moore earned his B.A. in Psychology from Trinity College.

    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 Arcutis to become the preeminent, innovation-driven medical dermatology company. 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 November 5, 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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  18. WESTLAKE VILLAGE, Calif., Dec. 21, 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 announced that it has been selected for inclusion in the NASDAQ Biotechnology Index (NASDAQ:NBI), based on the results of the annual reconstitution of the index announced by Nasdaq on December 11, 2020. The inclusion will become effective prior to the U.S. market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on the NASDAQ Stock Market that are classified as…

    WESTLAKE VILLAGE, Calif., Dec. 21, 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 announced that it has been selected for inclusion in the NASDAQ Biotechnology Index (NASDAQ:NBI), based on the results of the annual reconstitution of the index announced by Nasdaq on December 11, 2020. The inclusion will become effective prior to the U.S. market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on the NASDAQ Stock Market that are classified as either biotechnology or pharmaceutical companies, and is a modified market capitalization weighted index. According to NASDAQ, the NBI is reconstituted annually in December in accordance with a set of eligibility criteria including minimum market capitalization and average daily trading volume. The index currently has 198 securities as its components. For more information about the NBI, please visit https://indexes.nasdaqomx.com/index/overview/nbi.

    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 www.arcutis.com or follow the company on LinkedIn and Twitter.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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    • Broad and deep portfolio of highly differentiated product candidates aligned with needs of patients and doctors
    • Robust pipeline includes 4 development programs addressing 7 dermatological diseases, including 3 programs in Phase 2 or Phase 3 for 5 different indications
    • Pipeline has potential to generate sales of ~$3 billion to $8 billion by 2030 in the U.S. market alone
    • Live webcast and archived replay of Investor Day available in IR section of Arcutis website

    WESTLAKE VILLAGE, Calif., Dec. 09, 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…

    • Broad and deep portfolio of highly differentiated product candidates aligned with needs of patients and doctors
    • Robust pipeline includes 4 development programs addressing 7 dermatological diseases, including 3 programs in Phase 2 or Phase 3 for 5 different indications
    • Pipeline has potential to generate sales of ~$3 billion to $8 billion by 2030 in the U.S. market alone
    • Live webcast and archived replay of Investor Day available in IR section of Arcutis website

    WESTLAKE VILLAGE, Calif., Dec. 09, 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 announced continued progress and future growth drivers related to its immuno-dermatology platform and pipeline, which will be highlighted during today's Virtual Investor Day at 11:00 am ET.

    The Virtual Investor Day features presentations and a Q&A session led by Arcutis executives, Frank Watanabe, President and Chief Executive Officer, Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer, and Kenneth Lock, Chief Commercial Officer. In addition, there will be commentary and Q&A with Zoe Diana Draelos, M.D., FAAD, consulting professor of dermatology, Duke University School of Medicine, Durham, N.C., and an investigator, Dermatology Consulting Services, High Point, N.C.

    The Investor Day will highlight multiple programs and markets illustrating the significant opportunity in Arcutis' portfolio and its value-creating potential:

    Substantial Market Opportunity

    • Large pool of currently treated and readily addressable patients;
    • Strong Phase 2 data across multiple indications, including plaque psoriasis, atopic dermatitis, seborrheic dermatitis, scalp psoriasis, and long-term treatment of psoriasis;
    • Compelling and differentiated product profile for topical roflumilast with efficacy equivalent to high potency steroids, rapid relief from itch, ability to use on all body areas with excellent safety and tolerability and convenient, once-a-day dosing in a easy to use cream or foam formulation; and
    • Pipeline that could generate sales of $3 billion to $8 billion by 2030 in the U.S. market alone.

    ARQ-151 - Topical Roflumilast Cream

    • Psoriasis long-term safety data shows a strong durability of efficacy and favorable safety/tolerability over 52 to 64 weeks, with a high patient completion rate; and
    • Investigator Global Assessment (IGA) success in atopic dermatitis at 4 weeks similar to other topicals.

    ARQ-154 - Topical Roflumilast Foam

    • Potential to be the first topical treatment in decades to offer a novel mechanism of action for the treatment of seborrheic dermatitis;
    • Psoriasis Scalp Investigator Global Assessment (S-IGA) success at 8 weeks similar to high potency steroids; and
    • Roflumilast may possess anti-fungal in addition to anti-inflammatory effects.

    ARQ-252 Cream & ARQ-255 Suspension (JAK1 Inhibitors)

    • ARQ-252/255 is highly selective to JAK1 over JAK2;
    • Among topical JAK inhibitors, ARQ-252/255 is the only treatment that is specific to JAK1;
    • Quick enrollment in Phase 2 hand eczema study with data expected in mid 2021, and Phase 2 vitiligo study starting soon; and
    • Novel "4D" deep-penetrating vehicle allowing topical delivery deep in the dermis where other topicals cannot reach.

    "We have a unique strategy that affords speed, capital efficiency and reduced risk, which enables us to leverage our unrivalled product development capabilities and expertise in dermatology drug development to address the significant unmet needs in dermatology," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "Our team has built a broad and deep portfolio of unique and highly differentiated product candidates that we believe could generate as much as $8 billion in sales in the U.S. market alone. We are proud of this tremendous progress advancing and successfully executing on our strategy and positioning us to help dermatologists and their patients in the near future, and we look forward to providing updates on the upcoming flow of multiple Phase 2 and Phase 3 clinical catalysts expected in 2021 and 2022."

    Arcutis' virtual Investor Day is on Wednesday, Dec. 9, 2020, from 11:00 a.m.- 1:00 p.m. EST. A link to register for the event is available HERE. A live audio webcast and archived replay of the presentation will be available in the Investor Relations section of the Arcutis website.

    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 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 and initiation of clinical trials 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 into 2022. 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 November 5, 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.

    Investor Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

     



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    • Phase 3 trials' topline data anticipated in the first quarter of 2021 and potential New Drug Application (NDA) submission anticipated by the end of 2021
    • Roflumilast cream potential "Best in Class" topical PDE4 inhibitor
    • Plaque psoriasis affects approximately 8.6 million patients in the U.S.

    WESTLAKE VILLAGE, Calif., Dec. 07, 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 announced that the last participant has completed the 8-week treatment period in DERMIS-1 and DERMIS-2, the Company's pivotal Phase 3 clinical trials evaluating…

    • Phase 3 trials' topline data anticipated in the first quarter of 2021 and potential New Drug Application (NDA) submission anticipated by the end of 2021
    • Roflumilast cream potential "Best in Class" topical PDE4 inhibitor
    • Plaque psoriasis affects approximately 8.6 million patients in the U.S.

    WESTLAKE VILLAGE, Calif., Dec. 07, 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 announced that the last participant has completed the 8-week treatment period in DERMIS-1 and DERMIS-2, the Company's pivotal Phase 3 clinical trials evaluating ARQ-151 (topical roflumilast cream) as a potential topical treatment for plaque psoriasis.

    "Plaque psoriasis affects approximately 8.6 million patients in the U.S., many of whom are desperate for new topical options that don't require them to make trade-offs," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "We are delighted to complete DERMIS-1 and DERMIS-2, our pivotal phase 3 clinical trials evaluating roflumilast cream as a potential once daily topical treatment for plaque psoriasis. If approved, we believe roflumilast cream has the potential to eliminate the need for dermatologists and patients to compromise between efficacy and safety. We anticipate announcing topline data from these trials in the first quarter of 2021 and, if positive, anticipate submission of our NDA to the FDA by the end of 2021. We are immensely grateful to the trial participants and the clinical investigators for their time and commitment to this important research effort."

    Arcutis recently announced positive results from its Phase 2 long-term safety study in plaque psoriasis, which support chronic use of roflumilast cream. In addition, The New England Journal of Medicine published results from the double-blind, randomized Phase 2b study of roflumilast cream in plaque psoriasis.

    The "Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS" One and Two (or DERMIS-1 and DERMIS-2) are identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or vehicle cream are applied once daily for 8 weeks to subjects age 2 years and above with mild, moderate or severe chronic plaque psoriasis involving between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442 subjects. The primary endpoint of the studies is Investigator Global Assessment (IGA) Success, defined as an IGA score of clear or almost clear and at least a 2-grade improvement from baseline at week 8 on the IGA score. Multiple secondary endpoints will also be evaluated, including Intertriginous IGA (I-IGA) Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). The Company anticipates topline data from the Phase 3 studies in the first quarter of 2021 and, if positive, anticipates submission of its NDA to the FDA by the end of 2021.

    About Topical Roflumilast Cream

    Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    About Psoriasis

    Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

    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 roflumilast cream's potential as a psoriasis treatment; and expectations with regard to the timing of clinical data anticipated in the first quarter of 2021 and NDA submission by the end of 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 November 5, 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.

    Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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  19. WESTLAKE VILLAGE, Calif., Dec. 02, 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, will host a virtual Investor Day on Wednesday, Dec. 9, 2020, from 11:00 - 1:00 p.m. EST. The Company plans to showcase its unique immune-dermatology product development platform and  robust pipeline of novel drug candidates targeting multiple dermatologic indications. Presentations will be given by Arcutis' Senior Leadership Team in addition to Zoe Diana Draelos, M.D., consulting professor of dermatology, Duke University School of Medicine, Durham, N.C…

    WESTLAKE VILLAGE, Calif., Dec. 02, 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, will host a virtual Investor Day on Wednesday, Dec. 9, 2020, from 11:00 - 1:00 p.m. EST. The Company plans to showcase its unique immune-dermatology product development platform and  robust pipeline of novel drug candidates targeting multiple dermatologic indications. Presentations will be given by Arcutis' Senior Leadership Team in addition to Zoe Diana Draelos, M.D., consulting professor of dermatology, Duke University School of Medicine, Durham, N.C., and an investigator, Dermatology Consulting Services, High Point, N.C.

    A link to register for the event is available HERE. A live audio webcast and archived replay of the presentation will be available in the Investor Relations section of the Arcutis website.

    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 www.arcutis.com or follow the company on LinkedIn and Twitter.

    Investor Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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    • Once-daily roflumilast cream demonstrated favorable safety and tolerability over 52 to 64 weeks of treatment
    • At 52 to 64 weeks of treatment, over one-third of subjects demonstrated IGA Success and 45% of subjects had attained an IGA of clear or almost clear
    • Data further support the potential of roflumilast cream as a novel, once-daily, chronic topical treatment for plaque psoriasis, including intertriginous psoriasis
    • Pivotal Phase 3 data in plaque psoriasis are anticipated in first quarter of 2021

    WESTLAKE VILLAGE, Calif., Dec. 01, 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…

    • Once-daily roflumilast cream demonstrated favorable safety and tolerability over 52 to 64 weeks of treatment
    • At 52 to 64 weeks of treatment, over one-third of subjects demonstrated IGA Success and 45% of subjects had attained an IGA of clear or almost clear
    • Data further support the potential of roflumilast cream as a novel, once-daily, chronic topical treatment for plaque psoriasis, including intertriginous psoriasis
    • Pivotal Phase 3 data in plaque psoriasis are anticipated in first quarter of 2021

    WESTLAKE VILLAGE, Calif., Dec. 01, 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 announced positive results for the Phase 2 long-term safety study evaluating ARQ-151 (topical roflumilast cream) 0.3% as a potential once-daily chronic topical treatment for plaque psoriasis.

    The long-term safety study enrolled 332 patients, including one cohort (Cohort 1) of patients who elected to continue open-label treatment (n=230) following their participation in the double-blind, randomized Phase 2b study of roflumilast cream in plaque psoriasis, the results from which were published in the New England Journal of Medicine, and second cohort (Cohort 2) of treatment naïve patients (n=102). The maximum duration of treatment ranged from 52 weeks for naïve patients and those treated with vehicle in the randomized Phase 2b study, to 64 weeks for those treated with roflumilast cream for 12 weeks in the randomized Phase 2b study. In this open-label study, roflumilast cream 0.3% applied once daily for up to 52 weeks demonstrated favorable safety and tolerability over the long-term treatment period, consistent with what was seen in the randomized Phase 2b study, with only 3.6% of patients experiencing a treatment-related adverse event during 52 weeks of treatment. At week 52 of the long-term safety study, 44.8% of all subjects attained an Investigator Global Assessment (IGA) of clear or almost clear, with 34.8% of subjects in Cohort 1 and 39.5% of subjects in Cohort 2 achieving IGA Success, defined as a score of clear or almost clear plus a two-grade improvement from baseline. Additionally, of the subjects in the 12 week randomized Phase 2b study who were treated with roflumilast cream 0.3%, and who attained an IGA of clear or almost clear at 12 weeks in the first study, then continued on treatment in the long-term safety study, 66.7% had an IGA of clear or almost clear at the end of 64 weeks of treatment or their last visit. Of the 332 subjects in this study, 73.5% completed the full 52 weeks of open label treatment, with only 3.9% of subjects discontinuing the study due to an adverse event and less than 1% of subjects discontinuing due to lack of efficacy. There were no treatment related serious adverse events reported.

    "We are delighted with the results from this study of patients receiving long-term treatment with roflumilast cream, which support our belief that roflumilast cream, unlike high potency steroids, can be used chronically," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "We are encouraged that the efficacy and tolerability seen in this long-term study are consistent with the results seen in the double-blind Phase 2b study, and the unusually high proportion of patients who completed the full 52 weeks of treatment bodes well for real-world patient persistence. We believe there is a significant unmet need from patients and their dermatologists, who for too long have been forced to make trade-offs between efficacy, safety, and tolerability due to the significant shortcomings of existing topical treatments for psoriasis. Based on the strength of our clinical data to date, we believe that topical roflumilast has the potential to offer an ideal combination of efficacy comparable to a high potency steroid, the ability to use the drug chronically in any anatomical area, and a favorable safety and tolerability profile. We are hopeful that topical roflumilast, if approved, will help dermatologists and their patients to overcome these difficult clinical compromises. We look forward to the results from the ongoing DERMIS-1 and DERMIS-2 Phase 3 clinical trials of ARQ-151 in plaque psoriasis, which are anticipated in the first quarter of next year."

    The roflumilast cream long-term safety study was a Phase 2, multi-center, open label study of the long-term safety and efficacy of roflumilast cream 0.3% in adult subjects with chronic plaque psoriasis involving up to 25% total body surface area (BSA), evaluated in two cohorts: subjects who completed the ARQ-151-201 Phase 2b, randomized, controlled trial; and previously untreated subjects. Subjects applied roflumilast cream 0.3% once daily for 52 weeks at home. Approximately half (164 out of 332) of the subjects entered this long-term study after completing treatment with roflumilast cream 0.3% or 0.15% in the randomized Phase 2b study and therefore received up to 64 weeks of total treatment with topical roflumilast (12 weeks in the randomized Phase 2b study and 52 weeks in the long-term safety study). Periodic clinic visits included assessments for clinical safety, application site reactions, and disease improvement or progression. The primary outcome measures of this long-term safety study were the occurrence of treatment emergent adverse events and the occurrence of serious adverse events.

    Roflumilast cream is a once-daily topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25-to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    About Psoriasis

    Psoriasis is a common, non-contagious, immune disease that affects approximately 8.6 million patients in the United States and requires chronic treatment. About 90% of psoriasis cases are plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and the plaques are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

    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 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 of roflumilast cream to address the unmet needs in the topical treatment of psoriasis; the potential safety and efficacy of roflumilast cream; and the timing of clinical data readouts. 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 November 5, 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.

    Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740



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    • Roflumilast foam demonstrated statistically significant improvement on the trial's primary and multiple secondary endpoints
    • Once-daily roflumilast foam demonstrated a favorable safety and tolerability profile
    • Roflumilast foam potential "Best in Class" topical scalp and body psoriasis treatment
    • Scalp psoriasis affects more than 2.5 million of the 6 million psoriasis patients in U.S with active disease
    • Company to host a conference call today at 8:30 a.m. EST

    WESTLAKE VILLAGE, Calif., Nov. 23, 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…

    • Roflumilast foam demonstrated statistically significant improvement on the trial's primary and multiple secondary endpoints
    • Once-daily roflumilast foam demonstrated a favorable safety and tolerability profile
    • Roflumilast foam potential "Best in Class" topical scalp and body psoriasis treatment
    • Scalp psoriasis affects more than 2.5 million of the 6 million psoriasis patients in U.S with active disease
    • Company to host a conference call today at 8:30 a.m. EST

    WESTLAKE VILLAGE, Calif., Nov. 23, 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 announced positive top line data from its Phase 2b clinical trial evaluating ARQ-154 (topical roflumilast foam) as a potential treatment for scalp psoriasis.

    Roflumilast foam 0.3% administered once daily for 8 weeks demonstrated statistically significant improvements compared to a matching vehicle foam on key efficacy endpoints in 304 adult and adolescent patients with plaque psoriasis that included plaques on the scalp. On the study's primary endpoint of Scalp Investigator Global Assessment (S-IGA) success assessed at week 8, roflumilast foam 0.3% achieved a rate of 59.1% compared to a vehicle rate of 11.4% (p<0.0001). S-IGA success is defined as the achievement of an S-IGA score of 'clear' or 'almost clear' on a 5-grade scale plus at least a two-point change from baseline.   Onset was rapid, with significantly higher rates of S-IGA success noted as early as 2 weeks.

    Multiple secondary endpoints were also met. On the key secondary endpoint of Body Investigator Global Assessment (B-IGA) success assessed at week 8, roflumilast foam 0.3% achieved a rate of 40.3% compared to a vehicle rate of 6.8% (p<0.0001), with separation from vehicle on B-IGA success as early as 2 weeks. Symptomatic improvement was also demonstrated, with 71.0% of subjects treated with roflumilast foam 0.3% who had a baseline Scalp Itch Numeric Rating Scale (SI-NRS) score of 4 or greater achieving an itch reduction of at least 4 points at week 8 compared to 18.5% of vehicle treated subjects (p<0.0001). Consistent with other clinical trials of topical roflumilast, roflumilast foam was well-tolerated, as evidenced by subject-reported local tolerability and rates of application site adverse events, treatment-related adverse events, and discontinuations due to adverse events low and similar to vehicle. Only 5 out of 200 subjects (2.5%) in the roflumilast foam treated group discontinued the study due to an adverse event, compared to 2 out of 104 subjects (1.9%) treated with the vehicle.

    "Scalp psoriasis inflicts a high burden for patients, and current treatment options often carry significant treatment limitations that result in poor outcomes and can have a negative impact on patient quality of life," said Leon Kircik, MD, Clinical Professor of Dermatology, Icahn School of Medicine at Mount Sinai, Indiana University Medical Center, and Medical Director, Physicians Skin Care, DermResearch, and Skin Sciences. "Roflumilast once-daily foam demonstrated rapid and significant improvements in psoriasis signs and symptoms, including reducing itch in a meaningful way. These positive results are encouraging for patients and clinicians who are desperate for new treatments that can simplify disease management, can be used in all areas of the body, and can ultimately improve the patient experience."

    "Approximately 40 percent of the 6 million Americans afflicted with active, chronic psoriasis have scalp involvement, an area where treatment of scalp plaques is complicated by the difficulty of delivering topical drugs under the hair and to the surface of the skin," said Linda F. Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, as well as Division Head of Dermatology at Henry Ford Health System in West Bloomfield, Michigan. "Novel treatments are needed, particularly ones like topical roflumilast foam that have the potential to be safe for chronic use; that are appropriate for application in hair-bearing areas where a cream, lotion, or ointment is not suitable; and that have demonstrated symptomatic improvement similar to high-potency steroids while also maintaining a favorable safety and tolerability profile. I believe these data demonstrate that once daily roflumilast foam could offer patients the efficacy and tolerability that they need. In my opinion, if approved, topical roflumilast foam has the potential to become an important treatment option for plaque psoriasis patients, particularly those with scalp involvement."

    "We are delighted with these data, in which topical roflumilast foam demonstrated meaningful symptomatic improvement, alongside a favorable safety and tolerability profile that supports chronic use," said Patrick Burnett, M.D., Ph.D., FAAD, and Chief Medical Officer of Arcutis. "With once-a-day dosing, roflumilast foam potentially offers the convenience of a simple, single, non-steroidal solution for both scalp and non-scalp plaques. If successful in Phase 3 clinical trials and approved for commercialization, roflumilast foam will be the first novel mechanism of action for the treatment of scalp and body psoriasis in decades. We believe it has the potential to positively affect the symptoms and quality of life of the millions of patients who suffer from this distressing chronic skin condition."

    Management will host a conference call today at 8:30 a.m. EST to discuss these results. To access the call, please dial (833) 614-1393 (domestic) or (914) 987-7114 (international) prior to the scheduled conference call time and provide the conference ID 8960956. A live webcast of the call will be available on the "Investors" section of the company's website, www.arcutis.com. An archived version of the webcast will be available on the Arcutis website after the call.

    About Roflumilast Foam

    Roflumilast foam is a once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4 inhibitor) that Arcutis is developing particularly to treat inflammatory dermatoses in hair-bearing areas of the body such as the scalp.

    Roflumilast has been approved by the FDA for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to-300 fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    Arcutis believes roflumilast foam has significant potential as a treatment for scalp psoriasis and seborrheic dermatitis. Roflumilast foam is nearly identical to ARQ-151 (topical roflumilast cream), Arcutis' investigational topical cream PDE4 inhibitor that has demonstrated symptomatic improvement and a favorable tolerability profile in Arcutis' clinical trials in plaque psoriasis, as well as encouraging results in atopic dermatitis. Arcutis completed enrollment in DERMIS-1 and DERMIS-2, the Company's pivotal Phase 3 clinical trials evaluating topical roflumilast cream as a potential topical treatment for plaque psoriasis, and the Company expects to announce topline data in the first quarter of 2021 and to submit a New Drug Application (NDA) submission by the end of 2021. In addition, following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), Arcutis plans to advance its program to develop topical roflumilast cream for the treatment of atopic dermatitis into Phase 3 clinical trials beginning in early 2021.

    About Scalp Psoriasis

    Scalp psoriasis is a manifestation of plaque psoriasis characterized by raised, red areas of skin ("plaques") covered with a silver or white scale that occurs in the hair-bearing area of the scalp and sometimes extending to the forehead, back of the neck, or behind or inside the ears. Patients with scalp psoriasis commonly have plaques on other areas of the body as well. Approximately 40 percent of the estimated 8.6 million Americans with psoriasis have involvement of the scalp, and over a lifetime, up to 80 percent of psoriasis patients may experience scalp involvement. Scalp psoriasis plaques are identical to psoriatic plaques on other areas of the body; however, topical treatment of scalp plaques is complicated by the difficulty of delivering topical drugs under the hair and onto the skin. As with psoriatic plaques on other parts of the body, psoriasis on the scalp is often itchy and is sometimes painful. Scalp psoriasis can also be associated with hair loss, likely due to damage to the hair from excessive scratching, rubbing, or combing of the affected area. Often, patients require two or more medications to manage their disease when they have scalp involvement.

    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 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 roflumilast foam's potential as a scalp and body psoriasis treatment and whether roflumilast cream's Phase 2 results may be predictive of roflumilast foam's potential clinical outcomes. 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 November 5, 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.

    Investor Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740 

    A PDF accompanying this announcement is available at http://ml.globenewswire.com/Resource/Download/d3d13839-6109-4c6c-a20c-b9bb48d2c612



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  20. WESTLAKE VILLAGE, Calif., Nov. 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 announced that Frank Watanabe, President and CEO, will present a corporate overview during the Stifel 2020 Virtual Healthcare Conference taking place November 16-18, 2020.

    Details for the presentation are as follows:
            Stifel 2020 Virtual Healthcare Conference
            Presentation Date: Wednesday, November 18, 2020
            Presentation Time: 12:20 p.m. PST / 3:20 p.m. EST

    The presentation will be webcast and may be accessed at the "Events…

    WESTLAKE VILLAGE, Calif., Nov. 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 announced that Frank Watanabe, President and CEO, will present a corporate overview during the Stifel 2020 Virtual Healthcare Conference taking place November 16-18, 2020.

    Details for the presentation are as follows:

            Stifel 2020 Virtual Healthcare Conference

            Presentation Date: Wednesday, November 18, 2020

            Presentation Time: 12:20 p.m. PST / 3:20 p.m. EST

    The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company's website at https://investors.arcutis.com/events-and-presentations. Arcutis will maintain an archived replay of the webcast on its website for 30 days after the conference.

    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 www.arcutis.com or follow the company on LinkedIn and Twitter.

    Investor Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

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    • Pivotal Phase 3 data in plaque psoriasis anticipated in first quarter of 2021
    • Pivotal Phase 3 trials in atopic dermatitis anticipated to begin in late 2020 or early 2021
    • Recent positive Phase 2 data in seborrheic dermatitis supports pipeline advancement in indication that impacts 10 million patients in the U.S.
    • Strong financial position with over $300 million in cash, cash equivalents and marketable securities including the proceeds from our recent equity offering, providing cash runway into 2022

    WESTLAKE VILLAGE, Calif., Nov. 05, 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…

    • Pivotal Phase 3 data in plaque psoriasis anticipated in first quarter of 2021
    • Pivotal Phase 3 trials in atopic dermatitis anticipated to begin in late 2020 or early 2021
    • Recent positive Phase 2 data in seborrheic dermatitis supports pipeline advancement in indication that impacts 10 million patients in the U.S.
    • Strong financial position with over $300 million in cash, cash equivalents and marketable securities including the proceeds from our recent equity offering, providing cash runway into 2022

    WESTLAKE VILLAGE, Calif., Nov. 05, 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 September 30, 2020, and provided a business update.

    "Arcutis is rapidly advancing an innovative and differentiated late-stage pipeline of potential best-in-class topical dermatology therapies, with five important clinical data readouts anticipated by mid-2021," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "We expect to report topline data from our pivotal Phase 3 trials evaluating roflumilast cream as a potential once daily topical treatment for plaque psoriasis in the first quarter of next year and, if positive, anticipate submission of our New Drug Application to the U.S. Food and Drug Administration (FDA) by the end of 2021.  If approved, we believe roflumilast cream has the potential to eliminate the need for dermatologists and patients to compromise between efficacy and safety. Our focus on addressing the gap in dermatology drug development currently includes four product candidates in development for seven indications, with an addressable U.S. market of over 20 million patients."

    Pipeline Update

    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.

    • Completed enrollment in the two on-going pivotal Phase 3 clinical trials (DERMIS-1 and-2) in patients with plaque psoriasis, with topline data anticipated in the first quarter 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.  In July, the Company announced positive preliminary efficacy and safety data for the first patient cohort from this study.
    • Results from the positive Phase 1/2a trial of ARQ-151 for the treatment of chronic plaque psoriasis were published in the Journal of Drugs in Dermatology.
    • Based on FDA feedback from an End-of-Phase 2 meeting, the Company expects to begin pivotal Phase 3 trials of ARQ-151 in patients with atopic dermatitis in late 2020 or early 2021.

    ARQ-154 (topical roflumilast foam) - a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor in a foam formulation, 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.

    • Reported positive topline data from Phase 2 clinical trial in seborrheic dermatitis, supporting pipeline advancement in an indication that impacts 10 million patients in the U.S.
    • Ongoing Phase 2b study in scalp psoriasis has completed enrollment, with topline data anticipated by the end of 2020.

    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.

    • Completed enrollment of the ongoing Phase 1/2b study in chronic hand eczema, with topline data anticipated by mid-2021.
    • The Company anticipates initiating a Phase 2a study in vitiligo in late 2020 or early 2021.

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

    • Formulation and preclinical efforts are underway.

    Recent Corporate Highlights 

    • Bethany Dudek joined the Company as Vice President, Quality
    • Completed underwritten public offering and concurrent private placement of common stock with gross proceeds of $135 million.

    Third Quarter 2020 Summary Financial Results

    Cash, cash equivalents and marketable securities were $189.7 million as of September 30, 2020, compared to $101.3 million as of December 31, 2019. Arcutis believes that its current cash, cash equivalents and marketable securities at over $300 million, including the $128.4 million net proceeds from our recent financing, will be sufficient to fund its operations into 2022.

    Research and development (R&D) expenses for the quarter ended September 30, 2020 were $32.7 million compared to $12.3 million for the corresponding period in 2019. R&D expenses for the nine months ended September 30, 2020 were $87.9 million compared to $25.8 million for the corresponding period in 2019. These year-over-year increases were primarily due to the initiation of multiple clinical trials during the last year.

    General and administrative (G&A) expenses for the quarter ended September 30, 2020 were $5.6 million compared to $2.3 million for the corresponding period in 2019. G&A expenses for the nine months ended September 30, 2020 were $14.6 million compared to $4.4 million for the corresponding period in 2019. These year-over-year increases were primarily due to higher headcount and professional services costs, including the costs associated with being a public company.

    Net loss was $38.2 million, or $1.01 per basic and diluted share, for the quarter ended September 30, 2020 compared to $14.5 million, or $7.56 per basic and diluted share, for the corresponding period in 2019.  Net loss was $101.6 million, or $3.06 per basic and diluted share, for the nine months ended September 30, 2020 compared to $29.4 million, or $16.60 per basic and diluted share, for the corresponding period in 2019.

    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 become 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.

    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 and initiation of clinical trials 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 into 2022. 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 November 5, 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.

    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, except share and par value)

     September 30, December 31,
     2020 2019
     (Unaudited)  
    ASSETS   
    Current assets:   
    Cash and cash equivalents$45,707  $63,336 
    Marketable securities144,005  37,929 
    Prepaid expenses and other current assets4,409  5,209 
    Total current assets194,121  106,474 
    Property, plant, and equipment, net322  227 
    Operating lease right-of-use asset3,492  264 
    Other assets78  47 
    Total assets$198,013  $107,012 
    LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)   
    Current liabilities:   
    Accounts payable$5,039  $1,405 
    Accrued liabilities16,083  3,654 
    Operating lease liability32  178 
        Total current liabilities21,154  5,237 
    Operating lease liability, noncurrent3,675  129 
    Other long-term liabilities113  184 
    Total liabilities24,942  5,550 
      Convertible preferred stock  166,491 
    Stockholders' equity (deficit):   
      Preferred stock   
      Common stock4   
    Additional paid-in capital340,964  1,244 
    Accumulated other comprehensive income (loss)4  (1)
    Accumulated deficit(167,901) (66,272)
        Total stockholders' equity (deficit)173,071  (65,029)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit)$198,013  $107,012 



    ARCUTIS BIOTHERAPEUTICS, INC.

    Condensed Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share data)

    (unaudited)

     Three Months Ended September 30, Nine Months Ended September 30,
     2020 2019 2020 2019
    Operating expenses:       
    Research and development$32,743  $12,348  $87,934  $25,765 
    General and administrative5,560  2,300  14,647  4,373 
        Total operating expenses38,303  14,648  102,581  30,138 
    Loss from operations(38,303) (14,648) (102,581) (30,138)
    Other income, net99  168  952  710 
    Net loss$(38,204) $(14,480) $(101,629) $(29,428)
    Per share information:       
    Net loss per share, basic and diluted$(1.01) $(7.56) $(3.06) $(16.60)
    Weighted-average shares used in computing net loss per share, basic and diluted37,748,454  1,915,601  33,214,005  1,773,025 

     

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  21. WESTLAKE VILLAGE, Calif., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that Terrie Curran has been appointed to the Arcutis Board of Directors effective Nov. 2, 2020, and that Alexander Asam, Ph.D. has decided to step down from the Board.

    "We are tremendously grateful for Alexander's contributions to Arcutis," commented Patrick Heron, Chairman of the Arcutis Board of Directors. "His thoughtful counsel and leadership were instrumental in our recent progress, particularly our two recent very successful public financings. While we will miss his guidance, we…

    WESTLAKE VILLAGE, Calif., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that Terrie Curran has been appointed to the Arcutis Board of Directors effective Nov. 2, 2020, and that Alexander Asam, Ph.D. has decided to step down from the Board.

    "We are tremendously grateful for Alexander's contributions to Arcutis," commented Patrick Heron, Chairman of the Arcutis Board of Directors. "His thoughtful counsel and leadership were instrumental in our recent progress, particularly our two recent very successful public financings. While we will miss his guidance, we wish him well in his future endeavors."

    "We are absolutely delighted to welcome Terrie to the Arcutis Board," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "She is an exceptionally talented biopharmaceutical executive with over 20 years of industry experience in product commercialization. With her extensive experience launching and successfully commercializing innovative products in the dermatology segment, she is uniquely positioned to help Arcutis in its next stage of development, particularly in light of the upcoming data from our pivotal Phase 3 trials and potential NDA submission next year."

    "I am delighted to join the Arcutis board at this exciting time," said Terrie Curran. "The Company's lead product candidate, topical roflumilast, has the potential to become the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. I look forward to contributing my expertise, specifically with commercialization planning and execution, to help them build a leading dermatology company."

    Ms. Curran is CEO and President at Phathom Pharmaceuticals (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing new treatments for gastrointestinal diseases. Prior to this, she was the former President, Global Inflammation and Immunology (I&I) Franchise and member of the Executive Committee at Celgene. She joined Celgene in 2013 as the U.S. Commercial Head of the I&I Franchise and built the capabilities and recruited the teams that executed the successful launch of OTEZLA® for moderate-to-severe plaque psoriasis. Prior to joining Celgene, she served as Senior Vice President and General Manager, Global Women's Health at Merck & Co. Ms. Curran holds graduate and bachelor's degrees from the University of Technology Sydney.

    About Arcutis - Bioscience, applied to the skin.

    Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions. 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 become 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.

    Forward Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding data from the pivotal Phase 3 trials; the potential NDA submission next year; the potential for topical roflumilast to become the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis; and the potential for Arcutis to become a leading dermatology company. 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

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    • In Phase 2b study of patients with plaque psoriasis, roflumilast cream demonstrated rapid and clinically significant reduction in the severity and burden of itch and itch-related sleep loss as well as rapid improvement in patient-reported symptom burden
    • Phase 2 proof-of-concept study in atopic dermatitis underscores potential of roflumilast cream as once-daily treatment for this common condition
    • Roflumilast cream was safe and well-tolerated by psoriasis and atopic dermatitis patients in both Phase 2 studies, further highlighting its differentiated tolerability profile
    • Company highlights study results in presentations at the European Academy of Dermatology and Venereology Virtual Congress, Society of Dermatology Physician Assistants Digital 2020…
    • In Phase 2b study of patients with plaque psoriasis, roflumilast cream demonstrated rapid and clinically significant reduction in the severity and burden of itch and itch-related sleep loss as well as rapid improvement in patient-reported symptom burden
    • Phase 2 proof-of-concept study in atopic dermatitis underscores potential of roflumilast cream as once-daily treatment for this common condition
    • Roflumilast cream was safe and well-tolerated by psoriasis and atopic dermatitis patients in both Phase 2 studies, further highlighting its differentiated tolerability profile
    • Company highlights study results in presentations at the European Academy of Dermatology and Venereology Virtual Congress, Society of Dermatology Physician Assistants Digital 2020 conference, and virtual 2020 Fall Clinical Dermatology Conference

    WESTLAKE VILLAGE, Calif., Nov. 02, 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 new positive data from previously announced Phase 2 studies of ARQ-151 (topical roflumilast cream) in patients with chronic plaque psoriasis and atopic dermatitis. The data is being presented at the European Academy of Dermatology and Venereology (EADV) Virtual Congress (EADV Virtual), Society of Dermatology Physician Assistants (SPDA) Digital 2020 conference, and virtual 2020 Fall Clinical Dermatology Conference.

    Roflumilast cream, a potent phosphodiesterase-4 (PDE-4) inhibitor, is being investigated as a once-daily topical treatment for chronic plaque psoriasis and atopic dermatitis. In two virtual presentations, Arcutis shared data from a Phase 2b study on the efficacy of roflumilast cream on itch, a highly prevalent and frequently bothersome symptom of chronic plaque psoriasis, and on improving the burden of typical plaque psoriasis symptoms. In a third presentation, Arcutis highlighted results from a Phase 2 proof-of-concept study on the short-term safety and efficacy of roflumilast cream in patients with mild-to-moderate atopic dermatitis.

    "The results from our Phase 2 studies highlight the potential of roflumilast cream as a best-in-class topical PDE4 inhibitor for chronic plaque psoriasis and atopic dermatitis," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "The Phase 2b psoriasis study data provide clinical evidence of roflumilast cream's ability to reduce the burden of itch and improve typical symptoms in patients with plaque psoriasis. In addition, the encouraging efficacy results and safety profile in our Phase 2 proof-of-concept of roflumilast cream in atopic dermatitis provide a solid foundation for our upcoming pivotal Phase 3 studies."

    Results from the Phase 2b Study in Plaque Psoriasis

    In the Phase 2b study, 331 patients were randomized to roflumilast 0.3% (n=109), roflumilast 0.15% (n=113), or vehicle (n=109). At baseline, patients had to score ≥2 on the Investigator Global Assessment (IGA) scale and ≥2 on the modified Psoriasis Area and Severity Index. The primary endpoint was achievement of clear or almost clear skin based on IGA 0 or 1 at Week 6.

    Itch was assessed at baseline and throughout the 12-week trial using various patient-reported outcome measures, including itch severity and itch-related sleep loss. The study showed that treatment with roflumilast cream resulted in a rapid and clinically significant reduction in the severity and burden of itch compared to vehicle. In the roflumilast 0.3% group, significant itch reduction occurred by week 2 as compared with vehicle and continued through week 12 with 63% of patients achieving a clinically meaningful itch reduction. Reduction in itch also resulted in significant improvement in sleep loss by week 6 and continued through week 12.

    The Phase 2b study also assessed the efficacy of roflumilast cream in improving the burden of signs and symptoms of plaque psoriasis, including stinging, burning, skin cracking, pain, and scaling. Both doses of once-daily roflumilast cream led to rapid and robust improvements in symptom burden and quality of life in the patient population. The study results showed statistically significant improvements for both roflumilast doses compared with vehicle were seen in burden of individual patient-reported psoriasis-related signs and symptoms of scaling by Week 2; stinging, skin cracking, and pain by Week 4; and burning by Week 6. All reported improvements in individual psoriasis-related signs and symptoms were maintained through Week 12 with a mean decrease from baseline in the overall Patient Symptom Diary (PSD) Score of 42 and 44 in the roflumilast 0.3% and 0.15% groups, respectively.

    Roflumilast cream was well-tolerated by patients in the Phase 2b study. The rate of application site pain was low and similar to vehicle. 97% of adverse events were mild or moderate.

    Results from the Phase 2 Proof-of-Concept Study in Atopic Dermatitis

    In the Phase 2 proof-of-concept study in atopic dermatitis (AD), 136 patients were randomized to roflumilast 0.15%, roflumilast 0.05% or vehicle once-daily for 4 weeks. Patients had 1.5–35% body surface area (BSA) affected by AD, with a validated investigator global assessment AD (vIGA-AD) score of 2 (mild) or 3 (moderate), and eczema area and severity index (EASI) score of ≥5. The primary efficacy endpoint was absolute change from baseline in EASI score at Week 4.

    Study results showed that once-daily roflumilast cream demonstrated efficacy when compared to vehicle in AD. Although the primary endpoint in this proof of concept study showed a trend towards, but did not reach statistical significance, statistical significance for other efficacy endpoints was reached. Statistically significant improvements compared with vehicle were observed at Week 4, including 72.3% EASI improvement and >50% of patients achieving clear or almost clear skin on vIGA-AD for roflumilast cream 0.15%. Roflumilast cream was well tolerated, with a low rate of application site reactions, and no local irritation.

    The virtual presentations of Arcutis' Phase 2b and Phase 2 proof-of-concept studies of roflumilast cream given at the EADV Virtual Congress (October 29-31, 2020) and the 2020 Fall Clinical Dermatology Conference and SPDA DIGITAL 2020 (October 29 – November 1, 2020), are available for on-demand viewing using the links below and under Scientific Publications on the Arcutis website:

    • Roflumilast Cream (ARQ-151) Improved Itch Severity and Itch-related Sleep Loss in Adults With Chronic Plaque Psoriasis in a Phase 2b Study: EADV Virtual Congress; 2020 Fall Clinical; SPDA DIGITAL 2020
    • Roflumilast Cream (ARQ-151) 0.15% and 0.3% Improved Symptom Burden in Adults With Chronic Plaque Psoriasis in a Phase 2b Study: EADV Virtual Congress; 2020 Fall Clinical; SPDA DIGITAL 2020
    • The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Atopic Dermatitis: Phase 2 Proof-of-Concept Study: EADV Virtual Congress; 2020 Fall Clinical; SPDA DIGITAL 2020

    About Atopic Dermatitis

    Atopic dermatitis (AD) is the most common type of eczema, occurring in approximately six percent of the U.S. population. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more. Disease onset is most common by 5 years of age, and the Company estimates that approximately 60% of patients suffering from AD are pediatric patients. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Given that most of the patients are pediatric, the safety and tolerability of AD therapies are paramount.

    About Psoriasis

    Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

    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 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 ARQ-151's potential as a "Best-in-Class" PDE4 inhibitor, ARQ-151's potential as a treatment for atopic dermatitis, ARQ-151's potential as a treatment for plaque psoriasis and whether positive results in Phase 2 studies are indicative of potential outcomes in future studies. 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

    Primary Logo

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    • Data highlight potential of roflumilast cream as a "Best in Class" topical PDE4 inhibitor for the treatment of atopic dermatitis and plaque psoriasis
    • Two oral presentations and one poster at the European Academy of Dermatology and Venereology Virtual Congress
    • Data to also be featured in poster sessions at the Society of Dermatology Physician Assistants Digital 2020 and 2020 Fall Clinical Dermatology Conferences

    WESTLAKE VILLAGE, Calif., Oct. 29, 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 announced it will present new data from…

    • Data highlight potential of roflumilast cream as a "Best in Class" topical PDE4 inhibitor for the treatment of atopic dermatitis and plaque psoriasis
    • Two oral presentations and one poster at the European Academy of Dermatology and Venereology Virtual Congress
    • Data to also be featured in poster sessions at the Society of Dermatology Physician Assistants Digital 2020 and 2020 Fall Clinical Dermatology Conferences

    WESTLAKE VILLAGE, Calif., Oct. 29, 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 announced it will present new data from the previously announced Phase 2 studies of ARQ-151 (topical roflumilast cream) in chronic plaque psoriasis and atopic dermatitis at the European Academy of Dermatology and Venereology (EADV) Virtual Congress (EADV Virtual), the Society of Dermatology Physician Assistants (SPDA) Digital 2020 conference, and the virtual 2020 Fall Clinical Dermatology Conference.

    "Results from our ongoing clinical development program highlight the clinical benefit of roflumilast cream across multiple outcome measures associated with the treatment of atopic dermatitis and plaque psoriasis," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "We are pleased to share these significant new data with the medical community at each of this week's major conferences."

    At the EADV Virtual Congress, October 29-31, 2020, Arcutis will present positive results from a Phase 2 proof-of-concept study on the short-term safety and efficacy of roflumilast cream in patients with mild-to-moderate atopic dermatitis. In addition, the company will highlight data from a Phase 2b study on the impact of roflumilast cream on itch, a highly prevalent and frequently bothersome symptom of chronic plaque psoriasis, and symptom burden. Details of Arcutis' EADV Virtual Congress presentations include:

    • Oral Presentation (FC03.05): Roflumilast Cream (ARQ-151) Improved Itch Severity and Itch-related Sleep Loss in Adults With Chronic Plaque Psoriasis in a Phase 2b Study

      Date: October 29, 2020

    • Poster Presentation (P1450): Roflumilast Cream (ARQ-151) 0.15% and 0.3% Improved Symptom Burden in Adults With Chronic Plaque Psoriasis in a Phase 2b Study

      Date: October 29, 2020

    • Oral Presentation (FC08.07): The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Atopic Dermatitis: Phase 2 Proof-of-Concept Study

      Date: October 31, 2020

    EADV Virtual poster sessions will be available for on-demand viewing starting on October 29, 2020 and oral presentations (free communication) will be available starting on the day of the presentation.

    2020 Fall Clinical Dermatology Conference and Society of Dermatology Physician Assistants (SDPA) DIGITAL 2020

    Data presentations for roflumilast cream highlighted at the EADV Virtual Congress have also been accepted as poster sessions that will be available for on-demand viewing at the 2020 Fall Clinical Dermatology Conference and SPDA DIGITAL 2020, both of which will held virtually from October 29 – November 1, 2020.

    The virtual presentations will be available for on-demand viewing using the links below and under Scientific Publications on the Arcutis website:

    • Roflumilast Cream (ARQ-151) Improved Itch Severity and Itch-related Sleep Loss in Adults With Chronic Plaque Psoriasis in a Phase 2b Study: EADV Virtual Congress; 2020 Fall Clinical; SPDA DIGITAL 2020
    • Roflumilast Cream (ARQ-151) 0.15% and 0.3% Improved Symptom Burden in Adults With Chronic Plaque Psoriasis in a Phase 2b Study: EADV Virtual Congress; 2020 Fall Clinical; SPDA DIGITAL 2020
    • The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Atopic Dermatitis: Phase 2 Proof-of-Concept Study: EADV Virtual Congress; 2020 Fall Clinical; SPDA DIGITAL 2020

    About Atopic Dermatitis

    Atopic dermatitis (AD) is the most common type of eczema, occurring in approximately six percent of the U.S. population. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more. Disease onset is most common by 5 years of age, and the Company estimates that approximately 60% of patients suffering from AD are pediatric patients. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Given that most of the patients are pediatric, the safety and tolerability of AD therapies are paramount.

    About Psoriasis

    Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

    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 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 ARQ-151's potential as a "Best-in-Class" PDE4 inhibitor, ARQ-151's potential as a treatment for atopic dermatitis and ARQ-151's potential as a treatment for plaque psoriasis. 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

    Primary Logo

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    • ARQ-252 is a potent and highly selective topical JAK1 inhibitor offering potential safety advantages over less selective JAK inhibitors
    • Hand eczema is the most common skin disease affecting the hands, impacting more than 8 million Americans
    • Topline data now anticipated by mid-2021

    WESTLAKE VILLAGE, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it completed enrollment in its Phase 1/2b study of ARQ-252, a potent and highly selective topical small molecule inhibitor of Janus kinase type 1 (JAK1), in adult patients with chronic hand eczema. Arcutis has…

    • ARQ-252 is a potent and highly selective topical JAK1 inhibitor offering potential safety advantages over less selective JAK inhibitors

    • Hand eczema is the most common skin disease affecting the hands, impacting more than 8 million Americans
    • Topline data now anticipated by mid-2021

    WESTLAKE VILLAGE, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it completed enrollment in its Phase 1/2b study of ARQ-252, a potent and highly selective topical small molecule inhibitor of Janus kinase type 1 (JAK1), in adult patients with chronic hand eczema. Arcutis has updated its projections and now anticipates announcing topline data from this trial by mid-2021.

    "We were pleased with the speed with which this trial enrolled, underscoring the high unmet need for new treatments to treat this chronic skin disease that can cause significant skin irritation and discomfort and can have a negative impact on a patient's quality of life," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "More than eight million people in the U.S. suffer from hand eczema, and patients often have to make trade-offs between drug efficacy, safety, and tolerability with current available treatments. ARQ-252 has demonstrated robust potency and high selectivity for JAK1 over JAK2, thereby giving it the potential to deliver efficacy without causing the side effects typical of other less selective JAK inhibitors. Given this, we believe ARQ-252 has the potential to reduce the need to compromise between safety and efficacy."

    In April, Arcutis began the Phase 1 portion of this Phase 1/2b study to assess the safety, tolerability, and pharmacokinetics of once daily application of ARQ-252 cream 0.3% to both hands for two weeks in seven subjects with chronic hand eczema. In July, the Company began the Phase 2b portion of the study to assess the safety and efficacy of ARQ-252 cream 0.1% once daily and ARQ-252 cream 0.3% once daily or twice daily versus vehicle applied once daily or twice daily for 12 weeks to patients with chronic hand eczema. Enrollment of the Phase 2b portion is now complete with 223 subjects. The Company expects to report topline data by mid-2021.

    About Hand Eczema

    Hand eczema is a common inflammatory skin disease with prevalence estimated at up to 2.5% of the population, and is the most common skin disease affecting the hands. Symptoms of hand eczema can vary and include redness, fluid filled blisters or bumps, scaling, cracking, itching and pain occurring on the hands. It may occur in various forms, incorporating dyshidrotic eczema, an immune disease possibly related to atopic dermatitis; irritant contact dermatitis of the hands, which may be caused by occupational irritants; allergic contact dermatitis of the hands, which is caused by an allergic reaction; atopic hand dermatitis, which is atopic dermatitis occurring on the hands, and hyperkeratotic hand dermatitis, which are thickened, scaly, red plaques, similar to psoriasis, on the hands. The impact of hand eczema on patients can be significant, leading to work absences or disability, social stigmatization, and psychosocial distress.

    About ARQ-252

    ARQ-252 is a potent and highly selective topical, small molecule inhibitor of Janus kinase type 1 (JAK1). Many inflammatory cytokines and other signaling molecules rely on the JAK pathway, and specifically JAK1, which plays a central role in immune system function. Inhibition of JAK1 has been shown to treat a range of inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and atopic dermatitis. The Company believes that due to its high selectivity for JAK1 over JAK2, ARQ-252 has the potential to effectively treat inflammatory diseases without causing the hematopoietic adverse effects typically associated with JAK2 inhibition. In 2018, Arcutis exclusively licensed the active pharmaceutical ingredient in ARQ-252 for all topical dermatological uses in the United States, Europe, Japan and Canada from Jiangsu Hengrui Medicine Co., Ltd. of China. In mid-2019, Hengrui completed a Phase 2b study in rheumatoid arthritis that used the same active pharmaceutical ingredient as in ARQ-252 but dosed orally. The results confirmed that this active pharmaceutical ingredient is a highly potent inhibitor of JAK1 based on the drug's impact on rheumatoid arthritis, and was generally well tolerated at exposures well above those expected with topical administration of ARQ-252 in patients with chronic hand eczema. Reistone Biopharma, a subsidiary of Hengrui, is also studying the oral formulation as a potential treatment for alopecia areata, Crohn's disease, ulcerative colitis and atopic dermatitis.

    About Arcutis - Bioscience, applied to the skin.

    Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions. 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.

    Forward Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for ARQ-252 to treat hand eczema without causing the adverse effects associated with other JAK inhibitors; and the anticipated timing of the topline data of the Phase 2b portion of the study. 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

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  22. WESTLAKE VILLAGE, Calif., Oct. 06, 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 announced the closing of its underwritten public offering of 4,000,000 shares of its common stock at a public offering price of $25.00 per share, before underwriting discounts and commissions. All of the shares in the public offering were sold by Arcutis. The gross proceeds from the public offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Arcutis, were $100.0 million. In addition…

    WESTLAKE VILLAGE, Calif., Oct. 06, 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 announced the closing of its underwritten public offering of 4,000,000 shares of its common stock at a public offering price of $25.00 per share, before underwriting discounts and commissions. All of the shares in the public offering were sold by Arcutis. The gross proceeds from the public offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Arcutis, were $100.0 million. In addition, Arcutis has granted the underwriters a 30-day option to purchase up to an additional 600,000 shares of Arcutis' common stock at the public offering price less the underwriting discounts and commissions.

    Concurrent with the completion of the public offering, Arcutis sold to OrbiMed Advisors, LLC, an affiliate of one of the Company's directors, 1,400,000 shares of its common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, at a price per share equal to the public offering price. The gross proceeds from the private placement were $35.0 million.

    Goldman Sachs & Co. LLC, Cowen and Company, LLC, and Guggenheim Securities, LLC are acting as bookrunning managers for the public offering. Truist Securities, Inc. and Cantor Fitzgerald & Co. are acting as lead managers for the public offering.

    A registration statement on Form S-1 relating to the securities being sold in the public offering has been filed with the Securities and Exchange Commission (the "SEC") and became effective on October 1, 2020. The public offering was made only by means of a prospectus. Copies of the prospectus relating to the offering may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658, or by email at GSEquityProspectusDelivery@guggenheimpartners.com. You may also obtain these documents free of charge by visiting the SEC's website at www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

    Primary Logo

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  23. WESTLAKE VILLAGE, Calif., Oct. 01, 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 announced the pricing of its underwritten public offering of 4,000,000 shares of its common stock at a public offering price of $25.00 per share, before underwriting discounts and commissions. All of the shares in the offering are to be sold by Arcutis. In addition, Arcutis has granted the underwriters a 30-day option to purchase up to 600,000 additional shares of its common stock. The gross proceeds from the public offering, before deducting underwriting…

    WESTLAKE VILLAGE, Calif., Oct. 01, 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 announced the pricing of its underwritten public offering of 4,000,000 shares of its common stock at a public offering price of $25.00 per share, before underwriting discounts and commissions. All of the shares in the offering are to be sold by Arcutis. In addition, Arcutis has granted the underwriters a 30-day option to purchase up to 600,000 additional shares of its common stock. The gross proceeds from the public offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Arcutis, are expected to be $100.0 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on Oct. 6, 2020, subject to customary closing conditions.

    Concurrent with the completion of the public offering, Arcutis expects to sell to entities affiliated with OrbiMed Advisors, LLC, an affiliate of one of the Company's directors, 1,400,000 shares of its common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, at a price per share equal to the public offering price. The gross proceeds from the private placement are expected to be $35.0 million. The private placement will be contingent on the closing of the underwritten public offering and the satisfaction of customary closing conditions. The underwritten public offering is not contingent on the private placement.

    Goldman Sachs & Co. LLC, Cowen and Company, LLC, and Guggenheim Securities, LLC are acting as bookrunning managers for the public offering. Truist Securities, Inc. and Cantor Fitzgerald & Co. are acting as lead managers for the public offering.

    A registration statement on Form S-1 relating to the securities being sold in the public offering has been filed with the Securities and Exchange Commission (the "SEC") and became effective on October 1, 2020. The public offering is being made only by means of a prospectus. Copies of the prospectus relating to the offering may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658, or by email at GSEquityProspectusDelivery@guggenheimpartners.com. You may also obtain these documents free of charge by visiting the SEC's website at www.sec.gov.

    The securities in the public offering may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

    Primary Logo

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  24. WESTLAKE VILLAGE, Calif., Sept. 29, 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 announced the commencement of an underwritten public offering of 4,000,000 shares of its common stock. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to 600,000 additional shares of its common stock.

    Concurrent with the completion of the public offering, Arcutis expects to sell to OrbiMed Advisors, LLC, an affiliate of one of the Company's directors, $35.0 million of shares of its common stock in a private…

    WESTLAKE VILLAGE, Calif., Sept. 29, 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 announced the commencement of an underwritten public offering of 4,000,000 shares of its common stock. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to 600,000 additional shares of its common stock.

    Concurrent with the completion of the public offering, Arcutis expects to sell to OrbiMed Advisors, LLC, an affiliate of one of the Company's directors, $35.0 million of shares of its common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, at a price per share equal to the public offering price. The private placement will be contingent on the closing of the underwritten public offering and the satisfaction of customary closing conditions. The underwritten public offering is not contingent on the private placement.

    Goldman Sachs & Co. LLC, Cowen and Company, LLC, and Guggenheim Securities, LLC are acting as bookrunning managers for the offering. Truist Securities, Inc. and Cantor Fitzgerald & Co. are acting as lead managers for the offering.

    A registration statement on Form S-1 relating to the securities being sold in this offering has been filed with the Securities and Exchange Commission (the "SEC") but has not yet been declared effective.   The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the proposed offering may be obtained, when available, from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658, or by email at GSEquityProspectusDelivery@guggenheimpartners.com. You may also obtain these documents free of charge by visiting the SEC's website at www.sec.gov.

    These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Forward Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the timing, size and completion of the proposed public offering and concurrent private placement. 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 preliminary prospectus filed with the U.S. Securities and Exchange Commission (SEC) on September 29, 2020 and our other reports and filings filed 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

     

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    • Roflumilast foam demonstrated statistically significant improvement over the vehicle foam on the trial's primary and multiple secondary endpoints

    • Once-daily roflumilast foam demonstrated a favorable safety and tolerability profile
    • Roflumilast foam potential "Best in Class" topical PDE4 inhibitor
    • Seborrheic dermatitis affects 10 million U.S. patients
    • Company to host a conference call today at 8:30 a.m. EST

    WESTLAKE VILLAGE, Calif., Sept. 29, 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 announced positive topline data from its Phase

    • Roflumilast foam demonstrated statistically significant improvement over the vehicle foam on the trial's primary and multiple secondary endpoints



    • Once-daily roflumilast foam demonstrated a favorable safety and tolerability profile
    • Roflumilast foam potential "Best in Class" topical PDE4 inhibitor
    • Seborrheic dermatitis affects 10 million U.S. patients
    • Company to host a conference call today at 8:30 a.m. EST

    WESTLAKE VILLAGE, Calif., Sept. 29, 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 announced positive topline data from its Phase 2 clinical trial evaluating ARQ-154 (topical roflumilast foam) as a potential treatment for seborrheic dermatitis.

    Roflumilast foam 0.3% administered once daily for 8 weeks demonstrated statistically significant improvement compared to a matching vehicle foam on key efficacy endpoints in subjects with moderate-to-severe seborrheic dermatitis. On the study's primary endpoint assessed at week 8, roflumilast foam 0.3% achieved an Investigator Global Assessment (IGA) success rate of 73.8% compared to a vehicle rate of 40.9% (p<0.0001). IGA success is defined as the achievement of an IGA score of 'clear' or 'almost clear' on a 5-grade scale PLUS at least a two-point change from baseline. The onset of effect was rapid, with ARQ-154 statistically separating from vehicle as early as week 2, the first visit after baseline, on IGA success as well as multiple secondary endpoints. For example, at week 8, 64.6% of subjects treated with roflumilast foam who had a baseline Worst Itch Numeric Rating Scale (WI-NRS) score of 4 achieved an itch reduction of at least 4 points compared to 34.0% of vehicle treated subjects (p=0.0007). Other secondary endpoints included overall assessment of erythema and overall assessment of scaling, which also had positive outcomes. Importantly, roflumilast foam was well-tolerated, with rates of application site adverse events, treatment-related adverse events, and discontinuations due to adverse events low and similar to vehicle. Only 2 out of 154 subjects (1.3%) treated with roflumilast foam discontinued the study due to an adverse event, compared to 1 out of 72 subjects (1.4%) treated with the vehicle.

    "Seborrheic dermatitis is one of the most common skin conditions dermatologists deal with in adults, right up there with acne, rosacea, psoriasis and eczema. It has an enormous effect on patient's lives because it is so visible and often embarassing, with red, greasy, flaky areas on the face and scalp that are almost impossible to hide. Making it even worse, many of the more than 10 million sufferers in the U.S. may not know what it is, thereby contributing to the problem of under-treatment and inadequate treatment of the disease," said Matthew Zirwas, M.D., founder of the Bexley Dermatology Research Clinic and an investigator in the trial. "Current topical treatments for seborrheic dermatitis have major limitations, either having low efficacy, such as with topical antifungals, topical immunomodulators, low potency steroids and prescription shampoos, or high efficacy but unacceptable side effect profiles, such as with high potency topical steroids. Of the major dermatologic diseases, it has the greatest need for new treatment options. I believe these data demonstrate that once daily roflumilast foam is well-tolerated and effective. In my opinion, if approved, it has the potential to become the new standard of care in seborrheic dermatitis."

    "We are delighted with the robust signal for the efficacy of roflumilast foam in this relatively small, study. In this trial, topical roflumilast foam demonstrated meaningful symptomatic improvement, including a reduction in itch, alongside a favorable safety and tolerability profile that supports chronic use," said Patrick Burnett, M.D., Ph.D., FAAD, and Chief Medical Officer of Arcutis. "With once-a-day dosing, roflumilast foam potentially offers the convenience of a single, easy to use product to treat seborrheic dermatitis in all body locations where a patient might be affected. Unlike creams and ointments, roflumilast foam is suitable for use in hair-bearing areas; unlike steroids, it is expected to be suitable for long-term use on the face; and unlike shampoos, it is an elegant, quick drying, leave-in foam that doesn't need to be rinsed out. If successful in Phase 3 clinical trials and approved for commercialization, roflumilast foam will be the first topical drug treatment in decades to offer a novel mechanism of action for the treatment of seborrheic dermatitis, and has the potential to positively affect the symptoms and quality of life of patients who suffer from this distressing chronic skin condition."

    Between December 2019 and June 2020, the Phase 2 trial enrolled 226 adult subjects with moderate-to-severe seborrheic dermatitis. This 8-week, multi-center, multi-national, double blind, vehicle-controlled study evaluated the safety and efficacy of roflumilast foam 0.3% administered once-daily to affected areas on the scalp, face, and body. Topline efficacy data, including the primary endpoint, IGA success at week 8, were analyzed using the population of all randomized subjects with the exception of subjects who missed the week 8 IGA assessment specifically due to COVID-19 disruption. Importantly, only two subjects missed the week 8 IGA assessment due to concerns arising from COVID-19, and therefore the Intent-to-Treat (ITT) and modified ITT populations differed by only two subjects. Arcutis expects to present the full results from the trial at a future medical conference.

    Management will host a conference call today at 8:30 a.m. EST to discuss these results. To access the call, please dial (833) 614-1393 (domestic) or (914) 987-7114 (international) prior to the scheduled conference call time and provide the conference ID 7378204. A live webcast of the call will be available on the "Investors" section of the company's website, www.arcutis.com. An archived version of the webcast will be available on the Arcutis website after the call.

    Roflumilast foam is a once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4 inhibitor) that Arcutis is developing particularly to treat inflammatory dermatoses in hair-bearing areas of the body such as the scalp.

    Roflumilast has been approved by the FDA for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to-300 fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    Arcutis believes roflumilast foam has significant potential as a treatment for seborrheic dermatitis. Roflumilast foam is nearly identical to ARQ-151 (topical roflumilast cream), Arcutis' investigational topical cream PDE4 inhibitor that has demonstrated symptomatic improvement and a favorable tolerability profile in Arcutis' clinical trials in plaque psoriasis, as well as encouraging results in atopic dermatitis. Arcutis completed enrollment in DERMIS-1 and DERMIS-2, the Company's pivotal Phase 3 clinical trials evaluating topical roflumilast cream as a potential topical treatment for plaque psoriasis, and the Company expects to announce topline data in the first quarter of 2021 and to submit a New Drug Application (NDA) submission by the end of 2021. In addition, following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), Arcutis plans to advance its program to develop topical roflumilast cream for the treatment of atopic dermatitis into Phase 3 clinical trials beginning in late 2020 or early 2021.

    In addition to this Phase 2 trial, Arcutis is also conducting a Phase 2 long-term safety study

    in seborrheic dermatitis. This is a multicenter, open-label study of roflumilast foam 0.3% applied once daily in patients with seborrheic dermatitis and will include patients who were treated previously in the Phase 2 trial, as well as patients naïve to treatment with topical roflumilast foam. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement, or progression.

    About Seborrheic Dermatitis

    Seborrheic dermatitis affects more than 10 million people in the U.S., and is a common, chronic or recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often on the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest and back.

    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 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 ARQ-154's potential as a seborrheic dermatitis treatment; the Company's expectation to present the full results from the seborrheic dermatitis trial at a future medical conference; the Company's plan to announce ARQ-151 topline data for plaque psoriasis in the first quarter of 2021 and to submit a New Drug Application (NDA) submission by the end of 2021; the Company's plan to initiate pivotal Phase 3 clinical trials for ARQ-151 in atopic dermatitis in late 2020 or early 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.

    Investor Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

    Media Contact:

    Mike Beyer

    Sam Brown Inc. Healthcare Communications

    mikebeyer@sambrown.com

    312-961-2502 

    A PDF accompanying this announcement is available at http://ml.globenewswire.com/Resource/Download/630458c3-2f79-40cc-8260-2ef350559bbd

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    • Roflumilast cream potential "Best in Class" topical PDE4 inhibitor
    • Plaque psoriasis affects approximately 8.6 million patients in the U.S.
    • Phase 3 trials topline data now anticipated in the first quarter of 2021 and New Drug Application (NDA) submission anticipated by the end of 2021

    WESTLAKE VILLAGE, Calif., Sept. 16, 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 announced the completion of enrollment in DERMIS-1 and DERMIS-2, the Company's pivotal Phase 3 clinical trials evaluating ARQ-151 (topical roflumilast cream) as a…

    • Roflumilast cream potential "Best in Class" topical PDE4 inhibitor

    • Plaque psoriasis affects approximately 8.6 million patients in the U.S.
    • Phase 3 trials topline data now anticipated in the first quarter of 2021 and New Drug Application (NDA) submission anticipated by the end of 2021

    WESTLAKE VILLAGE, Calif., Sept. 16, 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 announced the completion of enrollment in DERMIS-1 and DERMIS-2, the Company's pivotal Phase 3 clinical trials evaluating ARQ-151 (topical roflumilast cream) as a potential topical treatment for plaque psoriasis.

    "Patients with plaque psoriasis, a common immune-mediated skin disease, are desperate for new topical options that, unlike existing treatments, don't require them to make trade-offs between efficacy, safety, and tolerability," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "We are delighted to complete enrollment in DERMIS-1 and DERMIS-2, our pivotal phase 3 clinical trials evaluating roflumilast cream as a potential once daily topical treatment for plaque psoriasis. If approved, we believe roflumilast cream has the potential to eliminate the need for dermatologists and patients to compromise between efficacy and safety. In two separate prior Phase 2 studies, roflumilast cream demonstrated statistically significant symptomatic improvements and a safety and tolerability profile that supports chronic use and the ability to use in all body areas. We are updating our guidance and now plan to announce topline data from these pivotal Phase 3 trials in the first quarter of 2021 and, if positive, anticipate submission of our NDA to the FDA by the end of 2021."

    Arcutis recently announced positive preliminary results from the first cohort in its ongoing Phase 2 long-term safety study in psoriasis, supporting its belief that roflumilast cream can be used chronically. In addition, The New England Journal of Medicine published results from the double-blind, randomized Phase 2b study of roflumilast cream in plaque psoriasis.

    The "Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS" One and Two (or DERMIS-1 and DERMIS-2) are identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or vehicle cream are applied once daily for 8 weeks to subjects age 2 years and above with mild, moderate or severe chronic plaque psoriasis involving between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442 subjects. The primary endpoint of the studies is Investigator Global Assessment (IGA) Success, defined as an IGA score of clear or almost clear and at least a 2-grade improvement from baseline at week 8 on the IGA score. Multiple secondary endpoints will also be evaluated, including Intertriginous IGA (I-IGA) Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). The Company anticipates topline data from the Phase 3 studies in the first quarter of 2021 and, if positive, anticipates submission of its NDA to the FDA by the end of 2021.

    About Topical Roflumilast Cream

    Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    About Psoriasis

    Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

    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 roflumilast cream's potential as a psoriasis treatment; and expectations with regard to the timing of clinical data anticipated in the first quarter of 2021 and NDA submission by the end of 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 May 12, 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.

    Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

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  25. WESTLAKE VILLAGE, Calif., Sept. 15, 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 announced that Arcutis management will participate in a fireside chat presentation during the Cantor Fitzgerald Global Healthcare Conference 2020 taking place Sept. 15-17, 2020.

    Details for the presentation are as follows:
             Cantor Fitzgerald Global Healthcare Conference 2020
             Presentation Date: Thursday, Sept. 17, 2020
             Presentation Time: 7:40 a.m. PT / 10:40 a.m. ET

    The presentation will be webcast and may be accessed at…

    WESTLAKE VILLAGE, Calif., Sept. 15, 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 announced that Arcutis management will participate in a fireside chat presentation during the Cantor Fitzgerald Global Healthcare Conference 2020 taking place Sept. 15-17, 2020.

    Details for the presentation are as follows:

             Cantor Fitzgerald Global Healthcare Conference 2020

             Presentation Date: Thursday, Sept. 17, 2020

             Presentation Time: 7:40 a.m. PT / 10:40 a.m. ET

    The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company's website at https://investors.arcutis.com/events-and-presentations . Arcutis will maintain an archived replay of the webcast on its website for 30 days after the conference.

    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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

     

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    • Progression to Phase 3 clinical trials represents significant acceleration of atopic dermatitis development program
    • Previously reported data demonstrated evidence that roflumilast cream provided symptomatic improvement and a favorable tolerability profile
    • Roflumilast cream is a novel PDE4 inhibitor being developed as a once-daily topical cream for atopic dermatitis and psoriasis

    WESTLAKE VILLAGE, Calif., Sept. 08, 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 announced plans to advance its program to develop ARQ-151 (topical roflumilast

    • Progression to Phase 3 clinical trials represents significant acceleration of atopic dermatitis development program

    • Previously reported data demonstrated evidence that roflumilast cream provided symptomatic improvement and a favorable tolerability profile
    • Roflumilast cream is a novel PDE4 inhibitor being developed as a once-daily topical cream for atopic dermatitis and psoriasis

    WESTLAKE VILLAGE, Calif., Sept. 08, 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 announced plans to advance its program to develop ARQ-151 (topical roflumilast cream) for the treatment of atopic dermatitis into Phase 3 clinical trials following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), without conducting the previously planned Phase 2b atopic dermatitis trial. The Company now anticipates initiating pivotal Phase 3 clinical trials in late 2020 or early 2021. ARQ-151 is a once-daily topical cream formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is developing for atopic dermatitis and psoriasis.

    "Following our interactions with the FDA, we are delighted to be able to accelerate the development of topical roflumilast cream into Phase 3 trials for the treatment of atopic dermatitis, a disease that affects almost 20 million people in the U.S., of which approximately 60% are children," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "Results from previous clinical trials have shown that our simple, easy-to-use, once-a-day topical roflumilast cream provided efficacy results similar to those seen with topical JAK inhibitors or mid-potency steroids while also being well tolerated, which is critical in children.  By delivering efficacy that enables meaningful symptomatic improvement and a favorable safety and tolerability profile that supports chronic use for patients with atopic dermatitis, topical roflumilast has the potential to overcome the significant shortcomings of existing therapies, which could mitigate the need for dermatologists and patients to make trade-offs  in efficacy, safety and tolerability."

    Roflumilast  cream is  a once-daily topical  cream  formulation of  a  highly  potent  and  selective  PDE4 inhibitor (roflumilast) that is under development for atopic dermatitis and psoriasis. Oral roflumilast has  been  approved by  the  U.S.  Food  and  Drug  Administration  (FDA) for treatment  to    reduce    the    risk    of    exacerbations  of    chronic    obstructive  pulmonary  disease (COPD) since 2011. Roflumilast has shown greater potency (25-to 300-fold) than the two other FDA-approved PDE4  inhibitors.  PDE4  is  an  intracellular  enzyme  that  increases  the  production    of    pro-inflammatory    mediators    and    decreases    production    of    anti-inflammatory  mediators  and  has  been implicated in a wide range of inflammatory diseases including psoriasis, eczema,  and  COPD.  PDE4  is  an  established  target  in  dermatology,  and  other  PDE4  inhibitors  have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.  Roflumilast cream is already undergoing Phase 3 clinical trials for the treatment of plaque psoriasis, with topline data expected in the first half of 2021.

    About Atopic Dermatitis

    Atopic dermatitis (AD) is the most common type of eczema, occurring in approximately six percent of the U.S. population.  AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation.  This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more.  Disease onset is most common by 5 years of age, and the Company estimates that approximately 60% of patients suffering from AD are pediatric patients.  The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing.  Given that most of the patients are pediatric, the safety and tolerability of AD therapies are paramount.

    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 of roflumilast cream to address the unmet needs in the topical treatment of atopic dermatitis; the potential safety and efficacy of roflumilast cream;  and the initiation of  pivotal Phase 3 clinical trials in late 2020 or in early 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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

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    • 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…

    • 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.

    "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."

    Pipeline Update

     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.

    • 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.

    ARQ-154 (Topical roflumilast foam) - a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor in a foam formulation, 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.

    • 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.

    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.

    • 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.

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

    • Formulation and preclinical efforts are underway.

    Recent Corporate Highlights 

    • 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.

    Second Quarter 2020 Summary Financial Results

    Cash, cash equivalents and marketable securities were $224.0 million as of June 30, 2020, compared to $101.3 million as of December 31, 2019. Arcutis believes that its current cash, cash equivalents, and marketable securities will be sufficient to fund its operations through 2021.

    Research and development (R&D) expenses for the quarter ended June 30, 2020 were $30.0 million compared to $7.2 million for the corresponding period in 2019. R&D expenses for the six months ended June 30, 2020 were $55.2 million compared to $13.4 million for the corresponding period in 2019. These year-over-year increases were primarily due to the initiation of multiple clinical trials during the last year.

    General and administrative (G&A) expenses for the quarter ended June 30, 2020 were $5.6 million compared to $1.3 million for the corresponding period in 2019. G&A expenses for the six months ended June 30, 2020 were $9.1 million compared to $2.1 million for the corresponding period in 2019. These year-over-year increases were primarily due to higher headcount and professional services costs, including the costs associated with being a public company.

    Net loss was $35.4 million, or $0.94 per basic and diluted share, for the quarter ended June 30, 2020 compared to $8.3 million, or $4.69 per basic and diluted share, for the corresponding period in 2019.  Net loss was $63.4 million, or $2.05 per basic and diluted share, for the six months ended June 30, 2020 compared to $14.9 million, or $8.79 per basic and diluted share, for the corresponding period in 2019.

    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 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 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.

    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, except share and par value)

     June 30, December 31,
     2020 2019
     (Unaudited)  
    ASSETS   
    Current assets:   
    Cash and cash equivalents$171,546  $63,336 
    Marketable securities52,429  37,929 
    Prepaid expenses and other current assets4,060  5,209 
    Total current assets228,035  106,474 
    Property, plant, and equipment, net228  227 
    Operating lease right-of-use asset3,629  264 
    Other assets78  47 
    Total assets$231,970  $107,012 
    LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)   
    Current liabilities:   
    Accounts payable$8,253  $1,405 
    Accrued liabilities10,948  3,654 
    Operating lease liability80  178 
    Total current liabilities19,281  5,237 
    Operating lease liability, noncurrent3,610  129 
    Other long-term liabilities156  184 
    Total liabilities23,047  5,550 
    Convertible preferred stock  166,491 
    Stockholders' equity (deficit):   
    Preferred stock     
    Common stock3   
    Additional paid-in capital338,617  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 
            

    ARCUTIS BIOTHERAPEUTICS, INC.

    Condensed Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share data)

    (unaudited)

     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  $13,417 
    General and administrative5,618  1,324  9,087  2,073 
    Total operating expenses35,627  8,538  64,278  15,490 
    Loss from operations(35,627) (8,538) (64,278) (15,490)
    Other income, net215  248  853  542 
    Net loss$(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 diluted37,587,330  1,767,658  30,921,866  1,700,549 

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  26. WESTLAKE VILLAGE, Calif., Aug. 10, 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 announced that Arcutis management will participate in a presentation during the Wedbush PacGrow Healthcare Conference Webcast taking place August 11 - 12, 2020.

    Details for the presentation are as follows:
             Wedbush PacGrow Healthcare Conference
             Presentation Date: Wednesday, August 12, 2020
             Presentation Time: 10:10 a.m. PT / 1:10 p.m. ET

    The presentation will be webcast and may be accessed at the "Events & Presentations…

    WESTLAKE VILLAGE, Calif., Aug. 10, 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 announced that Arcutis management will participate in a presentation during the Wedbush PacGrow Healthcare Conference Webcast taking place August 11 - 12, 2020.

    Details for the presentation are as follows:

             Wedbush PacGrow Healthcare Conference

             Presentation Date: Wednesday, August 12, 2020

             Presentation Time: 10:10 a.m. PT / 1:10 p.m. ET

    The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company's website at https://investors.arcutis.com/events-and-presentations. Arcutis will maintain an archived replay of the webcast on its website for 30 days after the conference.

    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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

    Primary Logo

    View Full Article Hide Full Article
  27. WESTLAKE VILLAGE, Calif., Aug. 04, 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 announced that Bethany Dudek has joined the company as Vice President of Quality. As the Arcutis Quality head, Ms. Dudek will be responsible for all aspects of quality as the Company prepares for the potential future commercialization of its product candidates.

    "Bethany brings more than 25 years of diverse experience in various technical operations and quality positions, and has demonstrated her leadership and effectiveness in commercializing…

    WESTLAKE VILLAGE, Calif., Aug. 04, 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 announced that Bethany Dudek has joined the company as Vice President of Quality. As the Arcutis Quality head, Ms. Dudek will be responsible for all aspects of quality as the Company prepares for the potential future commercialization of its product candidates.

    "Bethany brings more than 25 years of diverse experience in various technical operations and quality positions, and has demonstrated her leadership and effectiveness in commercializing new medicines and ensuring product quality within multiple organizations," said Patricia Turney, Senior Vice President of Operations. "At Arcutis, we are embarking on a bold strategy to become the preeminent innovation-driven medical dermatology company. As we prepare for potential commercialization, Bethany's extensive biopharmaceutical quality knowledge and compliance-driven mindset will be invaluable, and we look forward to her contributions to our future development."

    Prior to joining Arcutis, Ms. Dudek was at Kite Pharma, where she held roles of increasing responsibility, culminating in the role of Executive Director of Quality Europe, where she was  responsible for all aspects of quality to support supply and distribution of cell therapy products in EU and non-EU countries and was responsible for quality assurance and quality control for new clinical and commercial manufacturing sites for cell therapy products. Prior to Kite, Ms. Dudek was Senior Director of Quality Assurance at Kythera Biopharmaceuticals, where she was responsible for oversight of the Quality Assurance organization as it transitioned from development to commercial operations for KYBELLA®. Earlier in her career she was Technical Operations Head, Pediatrics and Specialty Franchise at Novartis Vaccines and Diagnostics. Previously, Ms. Dudek held various roles of increasing responsibility at Amgen, Inc., culminating in the role of Director, Global Operations Leader. Ms. Dudek received her B.A. in Biology Ithaca College.

    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.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

    Primary Logo

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    • Data demonstrate potential "Best in Class" topical PDE4 inhibitor roflumilast significantly improves signs and symptoms of chronic plaque psoriasis
    • Phase 3 topline data anticipated first half of 2021

    WESTLAKE VILLAGE, Calif., Aug. 03, 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, announced today that The Journal of Drugs in Dermatology has published positive results from a Phase 1/2a trial of its investigational drug topical roflumilast cream for the treatment of chronic plaque psoriasis. The article has been published in the August…

    • Data demonstrate potential "Best in Class" topical PDE4 inhibitor roflumilast significantly improves signs and symptoms of chronic plaque psoriasis

    • Phase 3 topline data anticipated first half of 2021

    WESTLAKE VILLAGE, Calif., Aug. 03, 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, announced today that The Journal of Drugs in Dermatology has published positive results from a Phase 1/2a trial of its investigational drug topical roflumilast cream for the treatment of chronic plaque psoriasis. The article has been published in the August 2020 issue of the journal. These results demonstrate that ARQ-151 (roflumilast cream) was safe and highly effective at doses of 0.5% and 0.15%, and represents a potential novel once-daily topical therapy for the treatment of chronic plaque psoriasis.

    "Psoriasis imposes a high burden for patients, and current standards of care to treat this skin disease often carry significant treatment limitations, resulting in poor outcomes. Poor outcomes often have a negative impact on patient quality of life," said Kim A. Papp, MD, PhD, of Probity Medical Research and K. Papp Clinical Research Inc., and lead author of the publication. "Roflumilast once-daily cream demonstrated significant improvements in psoriasis signs and symptoms. Notably, roflumilast cream demonstrated favorable tolerability, without any patient discontinuation due to adverse events. The positive results from this study are encouraging for patients and clinicians who are desperate for a new topical treatment solution that will simplify disease management and improve the patient experience. Enabling patients with more effective chronic treatment in all areas of the body is our hope."

    Roflumilast cream (ARQ-151) is a once-daily, highly potent, selective phosphodiesterase-4 (PDE-4) inhibitor being developed for chronic plaque psoriasis. Arcutis is currently conducting a Phase 3 clinical program with topical roflumilast cream, including two ongoing pivotal Phase 3 clinical trials (DERMIS-1 and -2). The company anticipates topline data from the Phase 3 studies in the first half of 2021.

    The Phase 1/2a study assessed the safety and efficacy of once-daily roflumilast cream 0.5% and 0.15% in patients with chronic plaque psoriasis. The study enrolled a single-dose, open-label Phase 1 cohort (0.5% cream applied to 25 cm2 psoriatic plaques), and a 28-day, double-blinded Phase 2a cohort (1:1:1 randomization to roflumilast cream 0.5%, 0.15%, or vehicle). Patients had chronic plaque psoriasis of > 6 months' duration with ≤5% body surface area involvement. Outcomes included safety (adverse events) and efficacy (percentage change in the product of Target Plaque Severity Score [TPSS] and Target Plaque Area [TPA]) at week 4.

    For Cohorts 1 (n=8) and 2 (n=89), adverse events (all mild/moderate; none serious or severe) were similar between active arms and vehicle. Treatment-related events were confined to the application site, with no difference between active and vehicle. No patient discontinued treatment due to adverse events. The primary efficacy endpoint was met for both roflumilast cream doses: TPSS×TPA improvement at week 4 was statistically significant for roflumilast 0.5% (P=0.0007) and 0.15% (P=0.0011) versus vehicle; significance was reached as early as 2 weeks. For both roflumilast cream doses, 66% to 67% improvement from baseline was observed at week 4, without reaching a plateau, versus 38% improvement for vehicle.

    "The results from this Phase 1/2a study provide further evidence of the potential of roflumilast cream as a once-daily treatment for patients with plaque psoriasis who currently lack suitable treatment options, and who often have to settle for trade-offs in drug efficacy, safety, and tolerability," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "We believe that topical roflumilast has the potential to deliver the efficacy that enables meaningful symptomatic improvement and a safety and tolerability profile that supports chronic use and the ability to use in all body areas."

    Please refer to the paper, "Roflumilast Cream Improves Signs and Symptoms of Plaque Psoriasis: Results from a Phase 1/2a Randomized, Controlled Study" for the full description of the design and results of this study.

    About ARQ-151 (Topical Roflumilast Cream)

    Topical roflumilast cream is a once-daily, topical cream formulation containing roflumilast, a PDE4 inhibitor, that Arcutis is developing to treat plaque psoriasis, including intertriginous psoriasis, and atopic dermatitis. PDE4 is an intracellular enzyme that regulates pro-inflammatory and anti-inflammatory cytokine production and cell proliferation. Roflumilast was approved by the FDA for systemic treatment to reduce risk of exacerbation of chronic obstructive pulmonary disease (COPD) in 2011, has shown greater potency (25 - 300 fold) than other two FDA-approved PDE4 inhibitors used in dermatology.

    About Psoriasis

    Psoriasis is an immune disease that occurs in about two percent of adults in western countries. About 90% of psoriasis cases is plaque psoriasis, which is characterized by "plaques", or raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and the plaques are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous areas (where two skin areas may touch or rub together).

    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.

    Contacts:

    Investor Relations:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

    Primary Logo

    View Full Article Hide Full Article
    • Once-daily roflumilast demonstrated favorable safety and tolerability over 52 to 64 weeks of treatment
    • At 52 to 64 weeks of treatment, 44% of subjects had attained an IGA of clear or almost clear
    • Preliminary data further support the potential of roflumilast as a novel, once-daily, chronic topical treatment for plaque psoriasis, including intertriginous psoriasis

    WESTLAKE VILLAGE, Calif., July 31, 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 announced preliminary results for the first cohort of 223 subjects from its ongoing Phase…

    • Once-daily roflumilast demonstrated favorable safety and tolerability over 52 to 64 weeks of treatment

    • At 52 to 64 weeks of treatment, 44% of subjects had attained an IGA of clear or almost clear
    • Preliminary data further support the potential of roflumilast as a novel, once-daily, chronic topical treatment for plaque psoriasis, including intertriginous psoriasis

    WESTLAKE VILLAGE, Calif., July 31, 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 announced preliminary results for the first cohort of 223 subjects from its ongoing Phase 2 long-term safety study evaluating ARQ-151 (topical roflumilast cream) 0.3% as a potential once-daily chronic topical treatment for plaque psoriasis. Arcutis now expects to have topline data for the full study population of 332 subjects from both cohorts in the first quarter of 2021.

    The first cohort of the long-term safety study includes subjects who elected to continue open-label treatment following their participation in the double-blind, randomized Phase 2b study of roflumilast cream in plaque psoriasis, the results from which were recently published in the New England Journal of Medicine.  In this group of subjects, roflumilast cream 0.3% applied once daily for up to a total of 52 to 64 weeks demonstrated favorable safety and tolerability over the long-term treatment period, consistent with what was seen in the parent Phase 2b study.  At 52 to 64 weeks of treatment, 44% of subjects had an Investigator Global Assessment (IGA) of clear or almost clear, compared to 38% of subjects at 12 weeks of treatment with ARQ-151 0.3% in the parent Phase 2b study.  Additionally, of the subjects in the parent Phase 2b study who received ARQ-151 0.3%, attained an IGA of clear or almost clear at 12 weeks, and continued on treatment in the long-term safety study, 68% had an IGA of clear or almost clear at the end of 64 weeks of treatment. Subjects who had received vehicle in the parent Phase 2b study but then received active treatment in the long-term safety study achieved IGA of clear or almost clear at a similar percentage and in a similar time course as subjects who received active treatment in the parent study.  Of the 223 subjects included in this analysis, 73% have completed the full 52 weeks of open label treatment.

    "While these data are preliminary, we are delighted with the results from this first group of subjects to receive long-term treatment with roflumilast cream, which support our belief that roflumilast cream, unlike high potency steroids, can be used chronically," said Frank Watanabe, Arcutis' President and Chief Executive Officer.  "While we are still awaiting the full results from this study, we are encouraged by these early indications that the long-term efficacy and tolerability seem to be consistent with the results seen in the parent study. For far too long, patients and their dermatologists have been forced to make trade-offs in efficacy, safety, and tolerability due to the significant shortcomings of existing topical treatments for psoriasis.  We continue to believe that topical roflumilast has the potential to offer an ideal combination of efficacy comparable to a high potency steroid, the ability to use the drug chronically in any anatomical area, and a favorable safety and tolerability profile. We are hopeful that topical roflumilast, if approved, will help dermatologists and their patients to overcome these difficult clinical compromises."

    The roflumilast cream long-term safety study is a Phase 2, multi-center, open label study of the long-term safety and efficacy of roflumilast cream 0.3% in adult subjects with chronic plaque psoriasis involving up to 25% total body surface area (BSA), evaluated in two ongoing cohorts: subjects who completed the ARQ-151-201 Phase 2b, randomized, controlled trial; and previously untreated subjects. The subjects apply roflumilast cream 0.3% once daily for 52 weeks at home. Some subjects who entered this long-term study after completing the parent Phase 2b study will therefore have received up to 64 weeks of total treatment with topical roflumilast (12 weeks in the parent Phase 2b study and 52 weeks in the long-term safety study). Periodic clinic visits include assessments for clinical safety, application site reactions, and disease improvement or progression.  The primary outcome measures of the study are the occurrence of treatment emergent adverse events and the occurrence of serious adverse events.  Full results from this study are expected in the first quarter of 2021.

    Roflumilast cream is a once-daily topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25-to 300-fold) than the two other FDA-approvedPDE4 inhibitors.  PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    About Psoriasis

    Psoriasis is a common, non-contagious, immune disease that affects approximately 8.6 million patients in the United States and requires chronic treatment.  About 90% of psoriasis cases are plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale.  Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and the plaques are often itchy and sometimes painful.  Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

    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 of roflumilast cream to address the unmet needs in the topical treatment of psoriasis; the potential safety and efficacy of roflumilast cream; and the timing of clinical data readouts. 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 May 12, 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.

    Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications

    harmstrong@arcutis.com

    805-418-5006, Ext. 740

    Primary Logo

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    • Experienced industry leader to head Arcutis' clinical development programs
    • Appointment aligns with Arcutis' strategy of building a team with deep dermatology expertise
    • Howard Welgus, M.D., FAAD to retire; elected to Arcutis' Board of Directors

    WESTLAKE VILLAGE, Calif., July 27, 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 announced the appointment of Patrick Burnett, M.D., Ph.D., FAAD, as Chief Medical Officer, effective August 1. Dr. Burnett replaces Howard Welgus, M.D., FAAD, who is retiring from Arcutis, but will continue…

    • Experienced industry leader to head Arcutis' clinical development programs

    • Appointment aligns with Arcutis' strategy of building a team with deep dermatology expertise
    • Howard Welgus, M.D., FAAD to retire; elected to Arcutis' Board of Directors

    WESTLAKE VILLAGE, Calif., July 27, 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 announced the appointment of Patrick Burnett, M.D., Ph.D., FAAD, as Chief Medical Officer, effective August 1. Dr. Burnett replaces Howard Welgus, M.D., FAAD, who is retiring from Arcutis, but will continue as a strategic advisor to the Company, and has been elected to the company's Board of Directors. 

    "We are delighted to welcome Patrick to the Arcutis team," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "His outstanding experience in the development and commercialization of innovative dermatology products will be invaluable to Arcutis as we advance our lead drug candidate through late-stage clinical trials and into regulatory approval to treat inflammatory dermatological conditions. We are fortunate to have his clinical leadership as we continue to execute upon our bold strategy to become the preeminent innovation-driven medical dermatology company."

    "I am excited to be joining Arcutis at this important point in the company's evolution," said Dr. Burnett.  "With a pipeline of four potentially best-in-class topical therapies, Arcutis is positioned to meaningfully advance patient care in dermatology." 

    Dr. Burnett joins Arcutis from Verrica Pharmaceuticals, where he was Chief Medical Officer from April 2018 to July 2020, and where he oversaw the Phase 3 program and new drug application (NDA) submission for VP-102.  He previously was Associate Vice President of Clinical Development at Sun Pharmaceuticals from September 2015 to March 2018, where he led the biologics license application (BLA) submission for Ilumya for psoriasis in the U.S. and Europe, and oversaw their dermatology and rheumatology pipeline. Prior to Sun, Dr. Burnett worked at Novartis from 2010 to August 2015, most recently as Global Program Medical Director, where he was involved in the approval of Cosentyx for psoriasis in the U.S.  He is a board certified dermatologist and was a member of the medical faculty at Vanderbilt University Medical Center as an Assistant Professor of Dermatology from 2004 to 2010. Dr. Burnett holds an M.D. and Ph.D. in neuroscience from Johns Hopkins School of Medicine and a B.S. in Biology and Biochemistry from the University of Iowa.

    Mr. Watanabe continued, "We are deeply indebted to Howard, a luminary in the field of dermatology for four decades, for his immense contributions to the formation of Arcutis and the development of our pipeline. Howard was the second employee at Arcutis and we consider him a core part of our DNA. His expertise, insight, humanity, and uncompromising commitment to serving patients have been instrumental in shaping Arcutis into the company it is today. Howard is a rare, upstanding example of a trusted colleague and a dear friend. While he plans to step back from day-to-day operations, we are delighted that we will continue to benefit from his ingenuity, as well as his wit and wisdom, as he helps share his incalculable insights as a member of our board and a strategic advisor to the company." 

    In addition, Dan Estes, Arcutis founder and General Partner at Frazier Life Sciences, will step down from the Board of Directors.

    "As we grow and evolve as a company, it's natural that the composition of our Board of Directors evolves as well," said Watanabe. "As an Arcutis founder, Dan's extensive knowledge, strategic insights, and wise counsel have been invaluable to our success to date. We have benefitted greatly from Dan's contributions and we thank him for helping build Arcutis into the company it is today."

    About Arcutis - Bioscience, applied to the skin.

    Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions. 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 and prospects of Arcutis and its product candidates, the timing of clinical data readouts and the expectation that Dr. Welgus will serve as a member of the Board of Directors and that Dr. Burnett will serve as Chief Medical Officer. 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