Gilead Strengthens Early Pipeline in Oncology and Inflammation Through the Acquisition of XinThera

– Acquisition of XinThera Provides Gilead with Precision Small Molecules Focused on PARP1 and MK2 Inhibitors –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the acquisition of all outstanding shares of XinThera, a privately held biotech company in San Diego. The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation.

Through the acquisition, Gilead gains rights to a portfolio of small molecule inhibitors targeting PARP1 for oncology and MK2 for inflammatory diseases that could enter clinical trials later this year. Both programs have the potential to address multiple indications, offering broad development opportunities alone and in combination with Gilead’s portfolio.

“The team at XinThera has developed research assets with the potential to target the DNA damage repair pathway in treating cancer and direct the body’s immune response in inflammatory diseases, both of which may improve outcomes for people living with these diseases,” said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences. “Guided by our scientific framework, this acquisition will allow us to further expand our early pipeline of diverse assets that will continue to fuel our durable late-phase portfolio.”

“Gilead and XinThera share similar missions to discover new therapies to treat cancer and inflammatory diseases, which drive our determination to unlock the body’s ability to better respond to these diseases,” said Chris LeMasters, who served as XinThera CEO. “We are eager to join Gilead and together explore the potential of our precision medicines as critical components of the next generation of therapies targeting diseases with high unmet need.”

First-generation, dual PARP1/2 inhibitors have been shown to be highly efficacious in the treatment of patients with homologous recombination deficiency (HRD) tumors with BRCA-mutations such as breast, ovarian, prostate, and pancreatic cancers, but their use is limited due to hematological toxicities. PARP1 selective inhibitors have the potential to mitigate the hematological toxicities seen in first-generation, dual PARP1/2 inhibitors and enable combination with a wide variety of DNA-damaging agents, including systemic chemotherapy and targeted agents such as Trodelvy^® (sacituzumab govitecan-hziy). For important safety information, including boxed warning, for Trodelvy, please see full Prescribing Information.

The financial terms of the agreement were not disclosed. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with XinThera to reduce Gilead’s GAAP and non-GAAP 2023 EPS by approximately $0.12 - $0.15.

About XinThera

XinThera is a private biotechnology company whose mission is to develop best-in-class small molecule drugs to treat cancer and immunologic diseases. The company was founded in 2021 by Stephen Kaldor, Ph.D., Qing Dong, Ph.D., and Gene Hung, M.D., and is headquartered in San Diego. XinThera is backed by a group of international investors including Foresite Capital, OrbiMed Advisors, LLC and TTM Capital.

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.

Gilead 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’s ability to realize the anticipated benefits from the transaction; difficulties or unanticipated expenses in connection with the acquisition or integration and the potential effects on Gilead’s earnings; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional trials, including those involving XIN5789 and XIN5494; the possibility that Gilead may make a strategic decision to discontinue development of any of the acquired investigational agents, and therefore these investigational agents may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2022, 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 Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

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