Kowa Pharmaceuticals America, Inc.

Third quarter net product revenues for ZORYVE® (roflumilast) franchise of $44.8M, with $22.0M for ZORYVE cream 0.3%, $20.3M for ZORYVE topical foam 0.3%, and $2.5M for ZORYVE cream 0.15%; sales growth of 452% vs. Q3 '23 and 45% vs. Q2 '24Continued gross-to-net (GTN) improvement with blended GTN across products now in the low 50 percent range, improving from the high 50 percent range last quarterSustained growth in prescriptions for both cream and foam, with total U.S. franchise unit demand increase of 25% quarter over quarterSupplemental New Drug Application (sNDA) for ZORYVE foam accepted by Food & Drug Administration (FDA) for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over with Prescription Drug User Fee Act (PDUFA) action date of May 22, 2025Announced Health Canada approval of ZORYVE foam for seborrheic dermatitis on October 18 and plan to commercially launch by end of 2024 WESTLAKE VILLAGE, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended September 30, 2024, and provided a business update. “Arcutis continues to execute our strategy successfully, with 45% revenue growth this quarter, marking sequential quarter growth since January of 2023. Product revenue for the quarter was driven by strong demand growth, and product preference by both patients and providers for ZORYVE across our three approved indications, as well as continued improvements in GTN. We are in the early stages of our launch of ZORYVE cream in mild to moderate atopic dermatitis, which has been well received for its effective, safe, and well-tolerated profile,” said Frank Watanabe, president and chief executive officer. “We have a strong revenue trajectory for the future, with a large addressable market that will continue to expand with further Medicaid wins, expected Medicare coverage wins, expansion into pediatric and primary care practices, and an expected FDA approval next year of ZORYVE foam for scalp and body psoriasis. We also continue to progress our pipeline, with the last subject enrolled in our ARQ-255 alopecia areata phase 1 trial and steady progress towards an IND for ARQ-234. Our strong balance sheet positions us to fuel our growth.” Program Updates / Key Milestones ZORYVE cream - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a once-daily cream formulation, approved in the United States for the treatment of plaque psoriasis and atopic dermatitis U.S. demand for ZORYVE cream in plaque psoriasis continues to grow, with over 304,000 prescriptions filled to date since launch by over 14,000 unique prescribers, reflecting the high levels of patient and physician satisfaction with the ZORYVE cream clinical profile. ZORYVE cream is covered by the three largest Pharmacy Benefit Managers (PBMs) and multiple other commercial insurers, and the Company expanded its Medicaid coverage to four additional states, Michigan, Arizona, California and Indiana, and anticipates it will obtain Medicaid coverage in additional states during 2024. ZORYVE cream 0.3% saw some GTN improvement in the third quarter compared to Q2 '24, and is approaching its steady state GTN.The FDA approved ZORYVE cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children down to age 6 in early Q3, and the Company commenced the commercial launch at the end of July. ZORYVE cream 0.15% is already covered as a line extension by two of the largest national PBMs, and the company anticipates continued improvement in coverage through the remainder of 2024, which will translate into improving GTN for ZORYVE cream 0.15% and the portfolio. ZORYVE foam - a once-daily foam formulation of topical roflumilast designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, approved in the United States for the treatment of seborrheic dermatitis, and under FDA review for scalp and body psoriasis The launch of ZORYVE foam in seborrheic dermatitis continues to progress well, with over 168,000 prescriptions filled since launch, reflecting the high unmet need in this disease. ZORYVE foam is also covered by the three largest PBMs, and coverage for the foam is steadily improving, as evidenced by its favorable GTN, which is expected to approach steady state by the end of 2024.The Company submitted an sNDA for ZORYVE foam for scalp and body psoriasis to the FDA based on the positive results from the pivotal ARRECTOR Phase 3 trial and a Phase 2b trial, which was accepted by the FDA in September with a PDUFA action date set for May 22, 2025.The Company announced Health Canada approval of ZORYVE foam for seborrheic dermatitis on October 18, and anticipates making the foam commercially available in Canada prior to the end of 2024. ARQ-255 - a topical suspension formulation of ivarmacitinib, a potent and highly selective topical Janus kinase type 1 (JAK1) inhibitor, designed to preferentially deliver the drug deep into the hair follicle, in order to potentially treat alopecia areata at the site of inflammation In September 2024, Arcutis announced that it completed enrollment in a Phase 1b study evaluating ARQ-255 for the treatment of alopecia areata, with data expected in 1H '25. ARQ-234 - a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R), being developed as a potential biologic treatment in atopic dermatitis The Company has continued preclinical development efforts and is working towards submitting an Investigational New Drug Application (IND) in 2025. Recent Corporate Highlights In July, the Company announced a co-promotion agreement with Kowa Pharmaceuticals America, Inc., whereby Kowa markets and promotes ZORYVE cream and ZORYVE foam to primary care practitioners and pediatricians for all FDA approved indications in the United States. Kowa began promoting ZORYVE in the second half of September.Amended the $200 million term-loan with SLR Investment Corp., lowering the interest rate, extending the maturity to August 2029, and obtaining an option to prepay up to $100 million of the principal and re-draw it by the first half of 2026 at the Company’s discretion. The Company made a partial prepayment of the principal of $100 million on October 8, 2024.Obtained two new U.S. patents in Q3 2024 related to ZORYVE. These patents cover, in part, formulations and methods of treatment resulting in unexpected and beneficial properties of ZORYVE, including the beneficial pharmacokinetic profile of ZORYVE. Arcutis also obtained a new U.S. patent covering the novel formulation of ARQ-255. Published positive results from two pivotal Phase 3 studies (INTEGUMENT-1 and INTEGUMENT-2) evaluating the efficacy and safety of ZORYVE cream 0.15% as a once-daily, steroid-free treatment for mild to moderate atopic dermatitis in the Journal of American Medical Association Dermatology (JAMA Dermatology). ZORYVE nominated for the Prix Galien USA for "Best Biotechnology Product", the world's highest independent distinction that awards the most critical products approved by the FDA in the last five years that demonstrate tremendous potential to improve human health. Board of Directors (Board) unanimously elected Keith Leonard as chair of the Board effective November 4, 2024, succeeding Patrick Heron. Mr. Leonard has served on the Board since 2021 and has more than 30 years of biopharmaceutical experience, including multiple chair, board director, and chief executive officer roles at publicly listed companies, and deep expertise in pharmaceutical commercialization. Mr. Heron, who has served on the Board since its formation and chair of the Board since 2019, will continue to serve as an independent director. Third Quarter 2024 Summary Financial Results Product revenues for the quarter ended September 30, 2024 were $44.8 million compared to $8.1 million for the corresponding period in 2023. Revenues for the quarter were $22.0 million for ZORYVE cream 0.3%, $20.3 million for ZORYVE topical foam 0.3%, and $2.5 million for ZORYVE cream 0.15%. Year-over-year and quarter-over-quarter increases were due to strong unit demand as well as GTN improvements. Across ZORYVE cream and ZORYVE foam, blended GTN is now in the low 50s, driven by the high percentage of prescriptions being reimbursed. Cost of sales for the quarter ended September 30, 2024 were $5.5 million compared to $1.2 million for the corresponding period in 2023. Research and development (R&D) expenses for the quarter ended September 30, 2024 were $19.5 million compared to $26.2 million for the corresponding period in 2023. The year-over-year decrease was due to decreased clinical development costs related to our topical roflumilast program. Selling, general, and administrative (SG&A) expenses for the quarter ended September 30, 2024 were $58.8 million compared to $47.6 million for the corresponding period in 2023. The year-over-year increase was primarily due to sales and marketing expenses related to the launches of ZORYVE cream and foam. Net loss was $41.5 million, or $0.33 per basic and diluted share, for the quarter ended September 30, 2024 compared to $44.8 million, or $0.73 per basic and diluted share, for the corresponding period in 2023. Cash, cash equivalents, restricted cash, and marketable securities were $331.2 million as of September 30, 2024, compared to $272.8 million as of December 31, 2023. Net cash used in operating activities was $34.7 million during the third quarter, an improvement of 23% compared to Q2 '24. On October 8th, the Company made a partial prepayment of $100M of the outstanding debt under the SLR loan.Conference Call and Webcast Arcutis management will host a conference call and webcast today at 4:30 pm ET to discuss the financial results for the quarter and provide a business update. The webcast for this conference call may be accessed at the “Events” section of the Company’s website. The replay of the webcast will be available on the Arcutis website following the call. About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA approved products that harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit https://www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. Forward Looking Statements Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for its topical drugs in development to address large markets with significant unmet need; the development, approval and potential commercialization of Arcutis' product candidates; the potential continued commercial success and growth of ZORYVE cream 0.3% in plaque psoriasis, ZORYVE cream 0.15% in atopic dermatitis and ZORYVE foam 0.3% in seborrheic dermatitis, including market access and reimbursement, product demand growth and continued improvement in GTN; and the timing of regulatory filings and potential approvals for a number of dermatology indications for roflumilast in the United States and Canada. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, the timing, expenses, and success of our commercialization efforts, including uncertainty of future commercial sales and related items that can impact net sales, 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 27, 2024, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts: MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsLatha Vairavan, VP Finance and Corporate Controllerir@arcutis.com ARCUTIS BIOTHERAPEUTICS, INC.Condensed Consolidated Balance Sheets(In thousands) September 30,2024 December 31,2023 (unaudited) ASSETS Current assets: Cash and cash equivalents$134,851 $88,398 Restricted cash 617 925 Marketable securities 195,710 183,463 Trade receivable, net 60,119 25,807 Inventories 14,015 13,134 Prepaid expenses and other current assets 18,408 18,704 Total current assets 423,720 330,431 Property and equipment, net 1,186 1,539 Intangible assets, net 9,792 6,438 Operating lease right-of-use asset 2,060 2,361 Other assets 596 596 Total assets$437,354 $341,365 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$19,325 $11,992 Accrued liabilities 52,790 33,941 Current portion of long-term debt, net 99,513 — Operating lease liability 798 735 Total current liabilities 172,426 46,668 Operating lease liability, noncurrent 2,772 3,382 Long-term debt, net 105,095 201,799 Other long-term liabilities 420 849 Total liabilities 280,713 252,698 Stockholders’ equity: Common stock 12 9 Additional paid-in capital 1,267,251 1,070,558 Accumulated other comprehensive loss 533 4 Accumulated deficit (1,111,155) (981,904)Total stockholders’ equity 156,641 88,667 Total liabilities and stockholders’ equity$437,354 $341,365 ARCUTIS BIOTHERAPEUTICS, INC.Condensed Consolidated Statements of Operations(In thousands, except share and per share data)(unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenues: Product revenue, net$44,755 $8,109 $97,182 $15,660 Other revenue — 30,000 28,000 30,420 Total revenues 44,755 38,109 125,182 46,080 Operating expenses: Cost of sales 5,503 1,182 12,223 2,741 Research and development 19,501 26,236 61,940 86,800 Selling, general, and administrative 58,817 47,595 171,784 136,471 Total operating expenses 83,821 75,013 245,947 226,012 Loss from operations (39,066) (36,904) (120,765) (179,932) Other income (expense): Other income, net 4,182 2,721 13,455 9,114 Interest expense (6,653) (7,559) (21,617) (21,950) Loss before income taxes (41,537) (41,742) (128,927) (192,768) Provision for income taxes — 3,023 324 3,088 Net loss$ (41,537) $ (44,765) $ (129,251) $ (195,856) Per share information: Net loss per share, basic and diluted$ (0.33) $ (0.73) $ (1.08) $ (3.19)Weighted-average shares used in computing net loss per share, basic and diluted 124,302,317 61,727,278 119,627,687 61,462,025

Over 200-person sales force to promote ZORYVE (roflumilast) in primary care and pediatric practicesProvides access to a large portion of the 7.4 million individuals treated for plaque psoriasis, seborrheic dermatitis, and atopic dermatitis outside of dermatology officesZORYVE will be promoted in the primary position to maximize prescriber education WESTLAKE VILLAGE, Calif. and MONTGOMERY, Ala., July 29, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the signing of a co-promotion agreement with Kowa Pharmaceuticals America, Inc., a company committed to the development and commercialization of safe and effective healthcare solutions. Under the agreement, Kowa will leverage its primary care sales force to market and promote ZORYVE (roflumilast) cream and ZORYVE (roflumilast) foam to primary care practitioners and pediatricians for all FDA approved indications. Arcutis will maintain responsibility for the marketing and sales of ZORYVE to dermatologists, other dermatology clinicians, and related specialists. This partnership is expected to expand the total addressable market for ZORYVE, providing access to a large portion of the 7.4 million patients treated outside of dermatology offices. “This partnership is aligned with our strategy and significantly extends the reach of ZORYVE to primary care practitioners and pediatricians who treat millions of individuals each year suffering from atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE is well-suited to fit into the daily practice of these offices, as it simplifies disease management with a once-daily, steroid-free treatment option,” said Frank Watanabe, president and CEO of Arcutis. “Sales of ZORYVE continue to grow because it provides reliable efficacy and a safe and well-tolerated product profile, as well as Arcutis’ broad market access. With the new expansion into primary care and pediatrics through this partnership with Kowa, we will drive incremental revenue, while maintaining the focus of Arcutis’ sales force and its marketing efforts on dermatology clinicians and driving patient demand in the dermatology offices. Importantly, Kowa has established relationships in primary care and will promote ZORYVE as a core product throughout the term of the agreement.” “Kowa Pharmaceuticals America, Inc. has a long history of successfully co-promoting products within primary care, and this new partnership with Arcutis aligns closely with our focus and expertise in the primary care setting,” said Ben Stakely, chairman, CEO, and president of Kowa Pharmaceuticals America, Inc. “We remain committed to patients and healthcare professionals and to providing therapies that help address unmet needs. Adding ZORYVE to our product portfolio expands our offering and will enhance our ability to support patients.” Arcutis will recognize all revenue and will have sole responsibility for the manufacturing of ZORYVE during the 5-year term of the partnership. Kowa will have an exclusive agreement to promote ZORYVE in all approved formulations and dosage forms as commercialized by Arcutis to primary care clinicians, pediatricians, and certain collocated healthcare providers in the United States throughout the term of the agreement. Kowa will promote ZORYVE in priority position throughout the term of the partnership, and receive a commission on their sales. Financial terms of the agreement were not disclosed. INDICATIONSZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream. About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X. About Kowa Company, Ltd. Kowa Company, Ltd. (Kowa) is a privately held, multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various business fields, including the trading of textiles, machinery, and construction materials, in addition to the manufacturing and sales of pharmaceuticals, medical devices, vison units, energy-saving and energy-creating products. Kowa's pharmaceutical business is focused on research and development for three main activities in lifestyle-related diseases (dyslipidemia, type 2 diabetes, and atherosclerosis), ophthalmology, and anti-inflammatory agents. For more information, please see https://www.kowa.co.jp/eng/. About Kowa Pharmaceuticals America, Inc.Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, AL, is focused primarily in the area of primary care diseases. Established in September 2008, Kowa Pharmaceuticals America, Inc. focuses its efforts on the successful commercialization of its current and near-term portfolio of pharmaceutical products, and business development activities. For more information about Kowa Pharmaceuticals America, visit https://www.kowapharma.com/. Forward-Looking StatementsArcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for ZORYVE to simplify disease management for care of plaque psoriasis, atopic dermatitis and seborrheic dermatitis; the potential of real-world use results of roflumilast cream, the potential success of the co-promotion agreement with Kowa, the potential for and general ability to access patients treated outside of dermatology offices, as well as the commercial strategy and launches of ZORYVE. These statements are subject to 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. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, and the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsLatha Vairavan, Vice President, Finance and Investor Relationsir@arcutis.com

Additional ACTG Presentations Address Muscle Density and Area among People Living with HIV and COVID-19 TreatmentLOS ANGELES, July 23, 2024 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, will present an exploratory analysis from the REPRIEVE trial demonstrating that former and current use of abacavir was associated with a higher incidence of major adverse cardiovascular events at AIDS 2024 in Munich, Germany. The oral presentation will take place on July 26, 2024, as part of the session Comorbidities: The Heart of the Matter, from 10:30-11:30 am CEST at Hall B0b/Channel 5 and virtually. “This carefully constructed analysis adds to the body of evidence that abacavir use is associated with a higher risk of cardiovascular events like heart attacks and strokes,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles. “These data align with prior studies that had been considered somewhat controversial because no exact mechanism was clearly demonstrated and should be taken into account by clinicians when they evaluate treatment options for people living with HIV.” These are the latest findings from REPRIEVE, the first large-scale clinical trial to test a primary prevention strategy to reduce the increased risk of cardiovascular disease among people living with HIV. It found that participants who took pitavastatin calcium (a daily statin pill that lowers cholesterol) reduced their risk of major adverse cardiovascular events by 36 percent compared with those receiving a placebo over a median duration of five years of follow up. The analysis being presented at AIDS 2024 evaluated the role of prior and current use of select antiretroviral treatments (including abacavir, tenofovir, thymidine analogs, and protease inhibitors) on the development of major cardiovascular events. These antiretrovirals were selected based upon prior association with cardiovascular risk and kidney impairment (future analyses are planned to examine the role of other antiretrovirals). Among 7,769 participants, 31.3 percent were born female and 65.2 percent were not white. The median age was 50, LDL (low-density lipoprotein, a kind of cholesterol) was 108 mg/dL, CD4 count was 621 cell/mm3, and 88 percent had a viral load under 400 copies/mL. Participants had been taking HIV treatment for a median of 9.5 years. Researchers found that current or past use of abacavir increased the risk of major adverse cardiovascular events by 42 and 50 percent, respectively, while current or past use of other antiretroviral treatments caused no such increase. “This analysis is important as we seek to tease out the various factors that may help reduce cardiovascular risk in people living with HIV,” said lead study author Carl Fichtenbaum, M.D., University of Cincinnati. “While the association between abacavir and cardiovascular risk is disappointing, it is not a surprise. It is, however, reassuring that the other HIV therapies included in the analysis like tenofovir were not associated with a higher risk.” REPRIEVE had a number of unique aspects: study participants had no known prior history of cardiovascular disease, the global cohort from 12 countries had low-to-moderate risk for cardiovascular disease, and all study endpoints were independently vetted by the national study Thrombolysis in Myocardial Infarction (TIMI). REPRIEVE began in 2015 as cooperative agreements (HL12339, HL123336, HL164284, and HL164285) and was a collaborative effort between the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID), two of the largest NIH institutes. It received additional funding from the NIH Office of AIDS Research, Kowa Pharmaceuticals America, Inc. (providers of pitavastatin calcium and placebo), Gilead Sciences, Inc., and ViiV HealthCare. The trial is led by Steven Grinspoon, M.D. (Chair) and Pamela S. Douglas, M.D. (Co-chair), who led the Clinical Coordinating Center and Heather Ribaudo, Ph.D. (Lead Statistician) and Michael Lu, M.D., M.P.H. (Protocol Chair, Mechanistic Substudy of REPRIEVE), who led the Data Coordinating Center. To learn more, please visit www.reprievetrial.org. In addition to these data from REPRIEVE, ACTG will also make the following presentations at AIDS 2024: No Evidence of Pitavastatin Effect on Muscle Density or Area Among People with HIV (REPRIEVE; Poster Presentation: Tuesday, July 23rd, 12:00-1:00 pm CEST, Poster Exhibition Hall) Kristine Erlandson, et al. This analysis from the REPRIEVE mechanistic substudy found that statins did not reduce muscle density or area. This two-year study of middle-aged people living with HIV at low-to-moderate risk of cardiovascular disease, confirmed through imaging that statins were safe and did not cause significant muscle damage. This is reassuring to people who want to use statins to lower their risk of cardiovascular events like heart attacks and strokes. Efficacy and Safety of Ensitrelvir in Non-Hospitalized Adults at Standard or High-Risk of Progression to Severe COVID-19: the SCORPIO-HR Phase 3, Randomized, Double-Blind Placebo-Controlled Trial (ACTG 5407; Poster Presentation: Tuesday, July 23rd, 12:00-1:00 pm CEST, Poster Exhibition Hall) Kara Chew, et al. While the oral protease inhibitor ensitrelvir demonstrated anti-viral activity, safety, and a trend toward shorter time to symptom resolution compared to placebo, SCORPIO-HR (ACTG 5407) did not meet its primary endpoint of time to two or more days sustained resolution of 15 COVID-19 symptoms in outpatient participants at standard and higher risk for severe disease. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Jenna Conley, ACTGjenna@conleycommunications.net