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 –

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.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Jacquie Ross, Investors
investor_relations@gilead.com

Meaghan Smith, Media
public_affairs@gilead.com

News Provided by Business Wire via QuoteMedia

GILD
The Conversation (0)
CHMP Adopts Positive Opinion Recommending Hepcludex®  for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus

CHMP Adopts Positive Opinion Recommending Hepcludex® for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus

-- If Granted by the European Commission, Hepcludex will Become the Only Approved Treatment for HDV in the EU --

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Hepcludex ® (bulevirtide) for the treatment of adults with chronic HDV and compensated liver disease, and recommended granting full Marketing Authorisation (MA) that is no longer subject to specific obligations. Bulevirtide was initially granted conditional marketing authorisation in July 2020 to provide people living with HDV urgent access to treatment. The CHMP recommendation for full Marketing Authorisation of bulevirtide follows the submission of the Phase 3 MYR301 Week 48 study data, which reinforces the efficacy and safety profile of bulevirtide for the treatment of HDV.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Gilead Remains Steadfast in Support for Hepatitis C Elimination Efforts

Gilead Remains Steadfast in Support for Hepatitis C Elimination Efforts

The recent national conversation on hepatitis C (HCV) is an encouraging step towards viral hepatitis elimination in the U.S. With its long history of leadership in viral hepatitis, Gilead continues to support efforts that focus on HCV elimination. Gilead is proud that its medicines have treated over four million individuals living with HCV globally. Today, some 2.4 million people are living with HCV in the U.S., even though ~95% of those treated with direct-acting antivirals (DAAs) are cured. Prices of HCV medicines have dropped significantly, and many acknowledge that price is not a barrier for most payers and patients. Curative HCV drug therapies are just one part of an elimination strategy that needs to dedicate considerable resources and attention to screening and linkage to care so that all patients in need of HCV treatment can access it in a timely manner and achieve a cure

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
Gilead Sciences Announces First Quarter 2023 Financial Results

Gilead Sciences Announces First Quarter 2023 Financial Results

Product Sales Excluding Veklury Increased 15% Year-Over-Year to $5.7 billion

Biktarvy Sales Increased 24% Year-Over-Year to $2.7 billion

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Gilead Sciences Releases Inaugural ESG Impact Report

Gilead Sciences Releases Inaugural ESG Impact Report

Gilead Sciences recently released its inaugural Environmental, Social and Governance (ESG) Impact Report. This is an evolution of our traditional Year in Review, and uses the ESG framework to highlight the successes and achievements of the prior year

Though the report itself is new, our commitment to practicing ESG is not: We've been guided by Environmental, Social and Governance principles for more than 35 years.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
abigail echo-hawk

CORRECTION: Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

This document corrects and updates the final paragraph in the body of this news release. No other changes were required in this release.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Longboard Pharmaceuticals Announces Positive Interim Results from the Open-Label Extension  of the Phase 1b/2a PACIFIC Study Evaluating Bexicaserin in Participants with Developmental and Epileptic Encephalopathies

Longboard Pharmaceuticals Announces Positive Interim Results from the Open-Label Extension of the Phase 1b/2a PACIFIC Study Evaluating Bexicaserin in Participants with Developmental and Epileptic Encephalopathies

  • Bexicaserin achieved an overall median seizure reduction of 56.1% in countable motor seizures over an approximate 6-month treatment period; participants randomized to the PACIFIC placebo group achieved a median seizure reduction of 57.3%
  • Favorable safety and tolerability results observed
  • 100% of participants who completed the PACIFIC Study entered the OLE
  • End of Phase 2 Meeting scheduled for this summer

Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced positive interim results from its ongoing 52-week open-label extension of the PACIFIC Study evaluating bexicaserin (LP352) in participants ages 12-65 years old with Developmental and Epileptic Encephalopathies.

"We are thrilled to see a sustained, durable response in seizure reduction and a favorable safety and tolerability profile across a broad range of DEE patients. Additionally, we saw compelling seizure reduction in the PACIFIC placebo patients who transitioned to bexicaserin in the OLE. These data provide further support to bexicaserin's potential to offer a highly differentiated and best-in-class profile," stated Dr. Randall Kaye, Longboard's Chief Medical Officer.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Surrozen Presents Preliminary Results from Phase 1a Study of SZN-043 in Healthy Volunteers and Patients with a History of Liver Cirrhosis at the 2024 European Association for the Study of the Liver  in Milan

Surrozen Presents Preliminary Results from Phase 1a Study of SZN-043 in Healthy Volunteers and Patients with a History of Liver Cirrhosis at the 2024 European Association for the Study of the Liver in Milan

SZN-043 is a novel biotherapeutic shown to potentiate Wnt signaling and induce proliferation of hepatocytes in preclinical models

Treatment with SZN-043 in the Phase 1a trial was safe and well tolerated in healthy volunteers and patients with a history of liver cirrhosis

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Annexon Announces Pricing of $125 Million Underwritten Public Offering

Annexon Announces Pricing of $125 Million Underwritten Public Offering

Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced the pricing of its previously announced underwritten public offering of 13,001,120 shares of its common stock at a price to the public of $6.25 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 7,000,000 shares of common stock at a purchase price of $6.249 per share, which equals the public offering price per share of the common stock less the $0.001 exercise price per share of each pre-funded warrant.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
MiNK Therapeutics Announces Virtual Annual Shareholders Meeting

MiNK Therapeutics Announces Virtual Annual Shareholders Meeting

MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (INKT) cell therapies to treat cancer and other immune-mediated diseases, today announced that its Annual Shareholders Meeting will begin at 9:30 a.m. ET. on June 12, 2024, and will be conducted in a virtual format only. Registration for attendees will start at 9:15 a.m. ET.

To participate in the Annual Shareholders Meeting, shareholders should visit www.virtualshareholdermeeting.com/INKT2024 and enter the 16-digit control number found in their proxy materials. Guests may also access the meeting in listen-only mode. No control number is required for guests.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Atea Pharmaceuticals Presents Positive Initial Phase 2 Data for Bemnifosbuvir and Ruzasvir Combination for Treatment of Hepatitis C Virus at EASL Congress 2024

97% SVR12 Rate Observed with 8 Weeks of Treatment in Lead-In Cohort of HCV-Infected Patients in Ongoing Phase 2 Clinical Study

EASL Presentations Continue to Support Best-in-Class Potential with High Antiviral Potency, Short Treatment Duration, Low Risk of Drug Interaction and High Barrier to Resistance

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Aligos Therapeutics Presents Positive Data at the EASL Congress 2024

Aligos Therapeutics Presents Positive Data at the EASL Congress 2024

Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from six poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy.

The clinical poster presentations highlight the continued potent antiviral activity of ALG-000184 for chronic hepatitis B (CHB) in both HBeAg-positive and HBeAg-negative subjects.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×