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Gilead’s Investigational Lenacapavir Demonstrates Sustained Long-Acting Efficacy Through Week 26 in Data Presented at CROI

– Lenacapavir Maintained High Rates of Virologic Suppression Among Heavily Treatment-Experienced People with Multi-Drug Resistant HIV –

– Late-Breaking Preclinical Data Support Further Study of Lenacapavir as a Long-Acting Agent for HIV Prevention –

FOSTER CITY, Calif.–(BUSINESS WIRE)–
Gilead Sciences, Inc. (Nasdaq: GILD) today presented additional results from the Phase 2/3 CAPELLA trial evaluating the company’s investigational, long-acting HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The data build on the positive primary endpoint results announced previously. The new interim efficacy results demonstrate that lenacapavir administered subcutaneously every six months maintained high rates of virologic suppression through 26 weeks in a difficult-to-treat patient population with limited therapy options and high unmet medical need. In this analysis of the ongoing maintenance period of CAPELLA, which evaluated lenacapavir in combination with an optimized background regimen, 73% (n=19/26) of participants who reached Week 26 since the first dose of subcutaneous lenacapavir achieved undetectable viral load (<50 copies/mL). The data were presented at the 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021).

“Some heavily treatment-experienced people with multi-drug resistant HIV are unable to maintain viral suppression with currently available treatment regimens. The CAPELLA trial enrolled people who were failing their regimens with a detectable viral load and had very few remaining options due to multi-drug resistance, which presents a formidable barrier to treatment,” noted Diana Brainard, MD, Senior Vice President, Virology Therapeutic Area, Gilead Sciences. “When treated with lenacapavir plus an optimized background regimen in this study, the majority of participants achieved virologic suppression at 26 weeks of treatment. These interim results from the CAPELLA trial demonstrate lenacapavir’s potential to be a foundational, long-acting agent of future HIV treatment regimens.”

Lenacapavir is being developed as the foundation of a long-acting regimen in combination with other antiretroviral agents for the treatment of HIV-1 infection. Lenacapavir is a potential first-in-class capsid inhibitor that is designed to inhibit HIV replication as it interferes with the disassembly of the HIV capsid core, inhibits the role of capsid proteins during viral RNA/DNA translocation to the nucleus, and disrupts assembly of the capsid core. If approved, lenacapavir would be the first HIV capsid inhibitor available for the treatment of HIV-1 infection. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs.

“Significant advances in antiretroviral therapy have enabled many people living with HIV to achieve viral suppression if adherent to their medications. However, in my practice I still see some people struggle with adherence to a complex regimen, which may lead to difficulty maintaining viral suppression and eventual drug resistance,” said Sorana Segal-Maurer, MD, Director of the Dr. James J. Rahal Jr. Division of Infectious Diseases at NewYork-Presbyterian Queens and the Site Principal Investigator for the CAPELLA study. “These challenges highlight a true unmet need and underscore the importance of new treatment options for heavily treatment‐experienced people living with multi-drug resistant HIV, for whom it is otherwise not possible to construct a suppressive antiviral regimen. The CAPELLA results show lenacapavir’s potential value as a long-acting option that can be administered subcutaneously every six months, and as part of a complete treatment regimen to provide viral suppression and overcome resistance for many patients in this important population.”

In addition to the new interim findings from the CAPELLA trial, Gilead also presented the results of a preclinical non-human primate study with GS-CA1, a close lenacapavir analog, for HIV pre-exposure prophylaxis (PrEP). In the study, one injection of low (150 mg/kg) or high dose (300 mg/kg) GS-CA1 or placebo (n=8 each) was given, followed by weekly escalating titer of rectal SHIV challenges for up to 15 weeks and then monitored to Week 24. Overall, 8/8 animals became infected in the placebo group, whereas 2/8 and 5/8 animals remained protected in the low and high dose GS-CA1 groups, resulting in an 86% (p=0.0061) and 96% (p=0.0002) infection risk reduction, respectively. Notably, treatment group infections occurred only after marked drug washout. These preclinical data demonstrate the potential utility of a long-acting capsid inhibitor to prevent HIV infection and may help advance clinical research evaluating lenacapavir as a potential future monotherapy option for HIV prevention.

Gilead previously announced plans to evaluate the use of lenacapavir as an injectable PrEP option administered every six months for cisgender adolescent girls and young women. An additional lenacapavir for PrEP study in cisgender men, persons of trans experience and gender non-binary individuals who have sex with men is planned. Both trials have projected initiation dates in 2021.

Additional lenacapavir data presented at virtual CROI 2021 provide insight into the investigational agent’s drug interaction potential, dosing response among people living with HIV with mild to moderate hepatic impairment, and resistance profile. Additional data from the CAPELLA study will be presented at a future scientific conference.

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not known. There is no cure for HIV or AIDS.

About CAPELLA (NCT04150068)

CAPELLA is a Phase 2/3 randomized, double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of Gilead’s investigational, long-acting HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. CAPELLA includes men and women living with HIV and is being conducted at research centers in North America, Europe and Asia.

In CAPELLA, 36 participants with multi-class HIV drug resistance and a detectable viral load while on a failing regimen were randomized 2:1 in a blinded fashion to receive oral lenacapavir or placebo for 14 days (randomized cohort), in addition to continuing their failing regimen (functional monotherapy). An additional 36 participants were enrolled to a non-randomized cohort. The primary endpoint is the proportion of participants in the randomized cohort achieving ≥ 0.5 log₁₀ copies/mL reduction from baseline in HIV-1 RNA at the end of the functional monotherapy period.

The study achieved its primary endpoint by demonstrating that a significantly higher proportion of participants in the randomized cohort receiving lenacapavir achieved a clinically meaningful viral load reduction of at least 0.5 log₁₀ copies/mL from baseline compared with those receiving placebo during the 14-day functional monotherapy period (88% vs. 17%, p<0.0001). Specifically, those who received lenacapavir (n=24) achieved statistically significantly greater mean decrease in viral load than those who received placebo (n=12) during the functional monotherapy period (-1.93 log₁₀ copies/mL vs. -0.29 log₁₀ copies/mL, p<0.0001).

Following the 14-day functional monotherapy period, participants in the randomized cohort started open-label lenacapavir and an optimized background regimen, while those in the non-randomized cohort received open-label lenacapavir and an optimized background regimen on Day 1. This ongoing maintenance period of the study is evaluating the safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen.

Lenacapavir was generally well tolerated. The most common adverse events (AEs) observed to date in this study were injection site swelling (22%) and erythema (18%) and nodules (18%). Importantly, there were no serious AEs related to study drug and no AEs leading to discontinuation. Two participants experienced treatment-emergent capsid mutations and later re-suppressed while continuing lenacapavir.

For further information, please see https://clinicaltrials.gov/ct2/show/NCT04150068

About Lenacapavir

Lenacapavir is an investigational, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV infection. Lenacapavir’s multi-stage mechanism of action profile is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting regimens for people living with or at risk for HIV. While most antivirals act on just one stage of viral replication, lenacapavir is developed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes.

The safety, efficacy and dosing of lenacapavir are being evaluated in multiple ongoing clinical studies. Data presented at AIDS 2020 from the ongoing Phase 1 study support subcutaneous every six-month administration of lenacapavir for both HIV treatment and prevention studies. During IDWeek 2020, the company announced plans to evaluate the use of lenacapavir as an injectable PrEP option administered every six months among cisgender women, men who have sex with men and persons of trans experience. The trials have projected initiation dates in 2021.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, and cure research. Today, millions of people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir and GS-CA1, and the possibility that Gilead may be unable to complete one or more of such trials on the currently anticipated timelines or at all. In addition, it is possible that Gilead may make a strategic decision to discontinue development of lenacapavir and GS-CA1, or that FDA and other regulatory agencies may not approve lenacapavir and GS-CA1, and any marketing approvals, if granted, may have significant limitations on its use. As a result, lenacapavir and GS-CA1 may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These and other risks are described in detail from time to time in Gilead’s periodic reports filed with the U.S. Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Sorana Segal-Maurer, MD, is a paid consultant for Gilead Sciences, Inc.

GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. All other trademarks are the property of their respective owners.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

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Disney+ Tops 100 Million Global Paid Subscriber Milestone

The Service is Available in 59 Countries around the World and Features an Impressive Collection of High-Quality Content from Disney’s Content Studios

BURBANK, Calif.–(BUSINESS WIRE)–
Disney+ has surpassed 100 million global paid subscribers in just 16 months since its launch, Bob Chapek, Chief Executive Officer, The Walt Disney Company (NYSE: DIS), announced today during the Company’s virtual Annual Meeting of Shareholders.

“The enormous success of Disney+ —which has now surpassed 100 million subscribers—has inspired us to be even more ambitious, and to significantly increase our investment in the development of high-quality content,” Mr. Chapek said. “In fact, we set a target of 100+ new titles per year, and this includes Disney Animation, Disney Live Action, Marvel, Star Wars, and National Geographic. Our direct-to-consumer business is the Company’s top priority, and our robust pipeline of content will continue to fuel its growth.”

Disney+ launched in the U.S. on November 12, 2019, and has rolled out rapidly across Canada, Australia, New Zealand, Europe, Latin America, and most recently, Singapore.

About Disney+

Disney+ is the dedicated streaming home for movies and shows from Disney, Pixar, Marvel, Star Wars, and National Geographic, as well as the new general entertainment content brand in select International markets, Star. As part of Disney’s Media & Entertainment Distribution segment, Disney+ is available on most internet-connected devices and offers commercial-free programming with a variety of original feature-length films, documentaries, live-action and animated series, and short-form content. Alongside unprecedented access to Disney’s incredible library of film and television entertainment, the service is also the exclusive streaming home for the latest releases from The Walt Disney Studios.

About The Walt Disney Company

The Walt Disney Company, together with its subsidiaries and affiliates, is a leading diversified international family entertainment and media enterprise that includes Disney Parks, Experiences and Products; Disney Media & Entertainment Distribution; and three content groups—Studios, General Entertainment and Sports—focused on developing and producing content for DTC, theatrical and linear platforms. Disney is a Dow 30 company and had annual revenues of $65.4 billion in its Fiscal Year 2020.

Cautionary Note on Forward-Looking Statements

Certain statements in this communication may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include our priorities, ambitions, planned investments, expansion expectations and other statements that are not historical in nature. These statements are made on the basis of management’s views and assumptions regarding future events and business performance as of the time the statements are made. Management does not undertake any obligation to update these statements. Actual events may differ materially from those expressed or implied. Such differences may result from actions taken by the Company, as well as from developments beyond the Company’s control, including changes in competitive conditions; consumer preferences; international, political, regulatory, health concern and military developments; and changes in domestic and global economic conditions that may affect our businesses generally. Additional factors are set forth in the Company’s Annual Report on Form 10-K for the year ended October 3, 2020 under Item 1A, “Risk Factors,” Item 7, “Management’s Discussion and Analysis,” Item 1, “Business,” and in subsequent reports.

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