SANTA MONICA - Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta (axicabtagene ciloleucel).

With this approval, Kite's median turnaround time (TAT) in the U.S. is anticipated to be reduced from 16 days to 14 days.

Median TAT is defined as time from leukapheresis, when a patient's T cells are collected, to product release; manufacturing is a key step within this process to prepare a patient's cells for a one-time cell therapy infusion customized for each patient.

'For patients with relapsed or refractory large B-cell lymphoma, every day matters as the patient's disease can be aggressive and worsen rapidly,' said Cindy Perettie, Executive Vice President, Kite. 'Yescarta is the first and only treatment to demonstrate superior overall survival over the standard of care as a second-line treatment with curative intent for these patients, and today's decision by the FDA allows us to further shorten our delivery time of Yescarta so that patients have the best possible chance of survival.'

CAR T-cell therapies are one-time treatments individually made starting from a patient's own white blood cells, called T-cells. The cells are removed through leukapheresis and sent to Kite's specialized manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR). Once an individual therapy is created for a patient, the cells are carefully checked, preserved, packed and sent back to the hospital to be infused back into the patient. The CAR T-cell therapy process is a continuous one, from leukapheresis to the delivery of the final product, so the timing and scheduling of this process are critical to the supply.

Industry experts agree that shortening the time to Yescarta product release and delivery can allow healthcare providers at Kite Authorized Treatment Centers to better support their patients.

'Since the first CAR T-cell therapies were approved more than five years ago and the volume of patients treated has grown from hundreds to several thousand patients each year, we have significantly strengthened our knowledge and understanding of cell therapy delivery,' said David Miklos, MD, PhD, a Kite clinical investigator/Chief of Blood and Marrow Transplant and Cell Therapy at Stanford University. 'Time is a critical factor in cell therapy, and it can make the difference between a patient being able to receive CAR T or their cancer progressing to the point where they are no longer strong enough for treatment. Therefore, optimizing steps in the process and ultimately reducing the time to CAR T-cell therapy infusion is paramount.'

Stanford is one of Kite's more than 135 authorized treatment centers (ATCs) in the U.S. and more than 400 total across the world.

More than 17,700 patients have been treated with Kite's CAR T-cell therapies through these ATCs across the globe. Kite has taken a unique approach to scaling the technology of cell therapy, combining capacity, speed, and reliability and the largest in-house cell therapy manufacturing network in the world to rapidly deliver products to these authorized treatment centers.

'Given that each cell therapy batch is unique to each patient, manufacturing is central to how we deliver our therapies, and quality, reliability, and speed are critical,' said Chris McDonald, SVP, Global Head of Technical Operations, Kite. 'As the global leader in cell therapy, patients and physicians count on our 96% manufacturing success rate, and with a reduced manufacturing time in the U.S., we will continue to expand the reach of Yescarta to even more patients.'

Kite has continued to increase its manufacturing network capacity to meet growing demand, ensuring scheduling availability to meet the needs of physicians and their patients.

About Yescarta (Axicabtagene Ciloleucel)

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on the response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial(s).

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production, and commercial product manufacturing.

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.

Forward-Looking Statements

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 Gilead and Kite's ability to increase its CAR T-cell therapy manufacturing capacity, timely manufacture and deliver such therapies (or otherwise reduce the time to manufacture such therapies), or produce an amount of supply sufficient to satisfy demand for such therapies; the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Yescarta; the risk that CAR T-cell therapy will not be broadly accepted by physicians, patients, hospitals, cancer treatment centers, payers and others in the medical community and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, as filed with the U.S. Securities and Exchange Commission. 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. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.

Contact:

Jacquie Ross

Email: investorrelations@gilead.com

Meaghan Smith

Email: msmith@gilead.com

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