WESTLAKE VILLAGE, CA / ACCESSWIRE / January 30, 2020 / Arcutis Biotherapeutics, Inc. (Arcutis), 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 initial public offering of 9,375,000 shares of its common stock at a price to the public of $17.00 per share. The shares are expected to begin trading on The Nasdaq Global Select Market on January 31, 2020 under the symbol “ARQT.” The offering is expected to close on February 4, 2020, subject to customary closing conditions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Arcutis, are expected to be approximately $159.4 million. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 1,406,250 shares of common stock.

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

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became effective on January 30, 2020. The offering is being made only by means of a prospectus. A copy of the final prospectus relating to the offering, when available, may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at 866-471-2526, or by email at prospectus-ny@ny.email.gs.com; or Cowen and Company, LLC at Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, or 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, 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 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. Arcutis exploits recent innovations in inflammation and immunology to develop potential best-in-class therapies against validated biological targets, leveraging our deep development, formulation and commercialization expertise to bring to market novel dermatology treatments, while maximizing our probability of technical success and financial resources. Arcutis is currently developing three novel compounds (ARQ-151, ARQ-154 and ARQ-252) for multiple indications, including psoriasis, atopic dermatitis, seborrheic dermatitis and eczema.

Contact:

John W. Smither
Chief Financial Officer
jsmither@arcutis.com

Investors and Media:

Derek Cole, President
Investor Relations Advisory Solutions
720.785.4497
derek.cole@IRadvisory.com

SOURCE: Arcutis Biotherapeutics, Inc.

WESTLAKE VILLAGE, CA / ACCESSWIRE / January 15, 2020 / Arcutis Biotherapeutics, Inc. (Arcutis), a privately held 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 Patricia Turney as Senior Vice President, Manufacturing.

“We are delighted for Patricia to join Arcutis as our head of manufacturing,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “Patricia is the ideal candidate to lead our manufacturing operations, bringing broad and deep expertise across product commercialization, manufacturing, engineering, and end-to-end supply chain management in the biopharmaceutical industry, in addition to exceptional leadership. I look forward to working closely with her to build out our manufacturing operations as we continue to advance Arcutis’ pipeline of potential best-in-class product candidates.”

Ms. Turney previously worked at Amgen, Inc. from 1996 to 2019 in roles of increasing responsibility, most recently as Vice President, External Supply, when she managed more than 50 contract manufacturing sites supporting clinical programs and commercial products. Prior Amgen roles included: Executive Director, Medical Device and Direct Materials; Site Operations Head for Amgen’s Netherlands Site; Executive Director, Global Facilities Operations; and, Director, R&D Strategic Operations. Prior to joining Amgen, Ms. Turney was a Federal Aviation Administration Certified Instructor, and earlier, a Naval Aviator in the United States Navy. She holds a Bachelor of Science in Mathematics from the United States Naval Academy and a Master of Business Administration from the Anderson School, University of California, Los Angeles.

About Arcutis – Bioscience, applied to the skin.

Arcutis 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. Arcutis exploits recent innovations in inflammation and immunology to develop potential best-in-class therapies against validated biological targets, leveraging our deep development, formulation and commercialization expertise to bring to market novel dermatology treatments, while maximizing our probability of technical success and financial resources. Arcutis is currently developing three novel compounds (ARQ-151, ARQ-154 and ARQ-252) for multiple indications, including psoriasis, atopic dermatitis, seborrheic dermatitis and eczema. For more information, please visit www.arcutis.com or follow the Company on LinkedIn.

Contact:

John W. Smither
Chief Financial Officer
jsmither@arcutis.com

Investors and Media:

Derek Cole, President
Investor Relations Advisory Solutions
720.785.4497
derek.cole@IRadvisory.com

SOURCE: Arcutis Biotherapeutics, Inc.

  • ARQ-252 potential to offer “Best in Class” topical JAK therapy
  • Phase 2b study in adult patients with hand eczema anticipated to start in the first half of 2020

WESTLAKE VILLAGE, CA / ACCESSWIRE / January 13, 2020 / Arcutis Biotherapeutics, Inc. (Arcutis), a privately held 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 in December 2019, it exercised its option under a 2018 License Agreement with Jiangsu Hengrui Medicine Co., Ltd. of China (Hengrui) for an exclusive license to the active pharmaceutical ingredient in ARQ-252, a potent and highly selective inhibitor of janus kinase type 1 (JAK1), for all topical dermatological uses in the United States, Canada, Europe and Japan. Arcutis plans to develop ARQ-252 for hand eczema and other inflammatory dermatoses.

Frank Watanabe, Arcutis’ President and Chief Executive Officer, commented: “We greatly appreciate our collaborative interaction with Hengrui. JAK1 inhibition is a promising approach to inflammatory dermatologic diseases, and Hengrui’s JAK inhibitor appears to be an ideal candidate for use in dermatology. The key to JAK inhibition for dermatology is effective JAK1 inhibition with little or no JAK2 inhibition, which, based on data to date, we believe ARQ-252 has the potential to deliver. We look forward to initiating our Phase 2b study in hand eczema in the first half of 2020.”

Hengrui is developing SHR0302, the active ingredient in ARQ-252, for the oral treatment of various inflammatory and immunological disorders, and has already completed a Phase 2 study in rheumatoid arthritis with oral SHR0302. Under the agreement, Arcutis has the exclusive rights to SHR0302 for all topical dermatological uses in its territory, as well as a right of reference to Hengrui safety data, along with the systemic toxicology data supporting their program. Hengrui has built strong intellectual property protection around the active ingredient in ARQ-252 and holds U.S. composition of matter patents. Arcutis anticipates initiating a Phase 2b study in the first half of 2020 to evaluate the compound as a potential treatment for hand eczema. Arcutis also anticipates initiating a Phase 2a study in vitiligo in the second half of 2020.

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, psoriasis, Crohn’s disease, and eczema. Arcutis believes that, due to its high selectivity for JAK1 over JAK2, ARQ-252 has the potential to treat inflammatory diseases without causing the hematopoietic adverse effects typically associated with JAK2 inhibition.

About Arcutis – Bioscience, applied to the skin.

Arcutis 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. Arcutis exploits recent innovations in inflammation and immunology to develop potential best-in-class therapies against validated biological targets, leveraging our deep development, formulation and commercialization expertise to bring to market novel dermatology treatments, while maximizing our probability of technical success and financial resources. Arcutis is currently developing three novel compounds (ARQ-151, ARQ-154 and ARQ-252) for multiple indications, including psoriasis, atopic dermatitis, seborrheic dermatitis and eczema. For more information, please visit www.arcutis.com or follow the Company on LinkedIn.

Contact:

John W. Smither
Chief Financial Officer
jsmither@arcutis.com

Investors and Media:

Derek Cole, President
Investor Relations Advisory Solutions
720.785.4497
derek.cole@IRadvisory.com

SOURCE: Arcutis Biotherapeutics, Inc.

  • ARQ-151 potential “Best in Class” topical PDE4 inhibitor
  • Plaque psoriasis affects approximately 8.6 million patients in the U.S.
  • Phase 3 trials topline data anticipated first half 2021

WESTLAKE VILLAGE, CA / ACCESSWIRE / January 8, 2020 / Arcutis Biotherapeutics, Inc. (Arcutis), a privately held 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 patients in both of the Company’s pivotal Phase 3 clinical trials evaluating ARQ-151 as a potential topical treatment for plaque psoriasis.

Frank Watanabe, Arcutis’ President and Chief Executive Officer, commented: “We are very excited to be enrolling the pivotal trials of ARQ-151 in plaque psoriasis. Based on our clinical data to date, we believe ARQ-151 has the potential to be both the best-in-class topical PDE4 inhibitor and the only topical PDE4 inhibitor approved for plaque psoriasis. Our Phase 3 clinical trials build on our prior clinical development in which ARQ-151 demonstrated statistically significant improvements of psoriasis symptoms and a favorable safety and tolerability profile in two separate Phase 2 studies. With these Phase 3 clinical trials, we hope to advance a potential new once daily treatment for patients who currently do not have adequate treatment options.”

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 ARQ-151 0.3% cream or vehicle cream are applied once daily for 8 weeks to subjects aged 12 and above with mild, moderate or severe chronic plaque psoriasis involving between 2% and 20% body surface area. The studies will each enroll approximately 400 patients. 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 half of 2021.

About ARQ-151

ARQ-151 is a 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, and has shown greater potency based on IC50 values (a non-clinical measure of a drug’s potency) than other PDE4 inhibitors.

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 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. Arcutis exploits recent innovations in inflammation and immunology to develop potential best-in-class therapies against validated biological targets, leveraging our deep development, formulation and commercialization expertise to bring to market novel dermatology treatments, while maximizing our probability of technical success and financial resources. Arcutis is currently developing three novel compounds (ARQ-151, ARQ-154 and ARQ-252) for multiple indications, including psoriasis, atopic dermatitis, seborrheic dermatitis and eczema. For more information, please visit www.arcutis.com or follow the Company on LinkedIn.

Contact:

John W. Smither

Chief Financial Officer

jsmither@arcutis.com

Investors and Media:

Derek Cole, President

Investor Relations Advisory Solutions

720.785.4497

derek.cole@IRadvisory.com

SOURCE: Arcutis Biotherapeutics, Inc.

WESTLAKE VILLAGE, CA / ACCESSWIRE / January 6, 2020 Arcutis Biotherapeutics, Inc. (Arcutis), 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 filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to the proposed initial public offering of shares of Arcutis’ common stock. The number of shares of common stock to be offered and the price range for the proposed offering have not yet been determined. Arcutis has applied to list its common stock on the Nasdaq Global Market under the symbol “ARQT”.

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

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, or by telephone at 866-471-2526, or by email at prospectus-ny@ny.email.gs.com; or Cowen and Company, LLC at Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, or 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, or 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.

A registration statement relating to the proposed sale of these securities has been filed with the SEC but has not yet become effective. 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 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. Arcutis exploits recent innovations in inflammation and immunology to develop potential best-in-class therapies against validated biological targets, leveraging our deep development, formulation and commercialization expertise to bring to market novel dermatology treatments, while maximizing our probability of technical success and financial resources. Arcutis is currently developing three novel compounds (ARQ-151, ARQ-154 and ARQ-252) for multiple indications, including psoriasis, atopic dermatitis, seborrheic dermatitis and eczema.

Contact:

John W. Smither
Chief Financial Officer
jsmither@arcutis.com

Investors and Media:

Derek Cole, President
Investor Relations Advisory Solutions
720.785.4497
derek.cole@IRadvisory.com

SOURCE: Arcutis Biotherapeutics, Inc.

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