––Partnership combines Gilead’s strong track record and mission to develop transformative therapies for severe viral diseases with Assembly Bio’s expertise and focused antiviral R&D mission to advance treatments for herpes viruses, B Differentiated treatment for hepatitis virus, hepatitis D virus, etc. –
—Collaboration includes Assembly Bio’s current and future product candidates and incorporates two of Gilead’s herpesvirus programs—
—Assembly Bio will receive $100 million upfront, including equity investment, as well as the potential for future regulatory, commercial, opt-in and partnership deferred payments—
—Assembly Bio management will host a webcast today at 8:30 a.m. ET/5:30 a.m. PT —
FOSTER CITY, Calif. and SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–
Gilead Sciences, Inc. (NASDAQ: GILD) and Assembly Biosciences, Inc. (NASDAQ: ASMB), a biotechnology company developing innovative antiviral therapies for serious viral diseases, today announced The companies have entered into a 12-year partnership to advance research and development of novel antiviral therapies, initially focusing on Assembly Bio’s established areas of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) .
Assembly Bio’s current portfolio of small molecule antiviral therapeutics includes clinical and preclinical programs, including ABI-4334, a next-generation core inhibitor for the treatment of HBV, and long-acting helicase primase for the treatment of herpes simplex virus (HSV) inhibitor ABI-5366, the orally bioavailable HDV entry inhibitor ABI-6250, and the pan-herpes polymerase inhibitor program.
“Advancing the next wave of virology innovation remains a core focus for Gilead as we work to address the unmet needs of people affected by severe viral infections around the world,” said Tomas Cihlar, senior vice president of virology research at Gilead. ” Collaboration and partnerships are key in pursuing the next wave of transformative innovation. “We are pleased to announce our partnership with Assembly Bio to synergize our efforts to advance and accelerate the discovery and development of novel antiviral therapies. ”
“We are pleased to partner with Gilead to address significant unmet medical needs in herpes viruses, viral hepatitis and more,” said Jason Okazaki, CEO and President of Assembly Bio. “With Gilead’s unique expertise in Combining its success in antiviral drug development and commercialization and Assembly Bio’s advanced virology research capabilities, we believe the shared expertise and promising investigational therapies both companies contribute to this collaboration have the potential to deliver significant advances for patients. . This transaction represents a critical step in Assembly Bio’s journey to becoming a fully integrated biotechnology company, and we are eager to begin working with our new partners.”
Terms of cooperation
Under the terms of the agreement, Assembly Bio will receive $100 million, including an upfront payment of $84.8 million and an equity investment of $15.2 million from Gilead. As of the closing date, Gilead’s premium initial equity investment represents 19.9% of Assembly Bio’s outstanding voting shares. In addition, subject to certain conditions, Gilead has agreed to purchase up to 29.9% of Assembly Bio’s outstanding voting shares at a premium.
Gilead has the option to obtain exclusive rights to each of Assembly Bio’s current and future programs, including two preclinical programs targeting HSV and transplant-associated herpesviruses that Gilead has licensed to Assembly Bio, subject to payment of a minimum $45 opt-in fee Upon achieving clinical proof of concept, each project will receive $1 million. If Gilead elects to join any current or future programs under the collaboration, Assembly Bio is eligible to receive up to $330 million in funding for each program in potential regulatory and commercial milestones, in addition to funding ranging from the high single digits to the high teens Royalties. Assembly Bio will also be eligible to receive three separate $75 million collaboration extension payments at pre-specified points during the collaboration to help fund future research and development.
After Gilead exercises its option on the Assembly Bio plan, Assembly Bio will have the option to share U.S. profits and costs. For future new initiatives, Assembly Bio may also choose to co-promote these products in the United States.
Assembly Bio will be primarily responsible for R&D on the collaboration’s projects, including the two projects to which Gilead is contributing, before Gilead may choose to join. Once Gilead opts in, Gilead will control the discovery, research, development and commercialization of the selected projects.
Gilead has the right to appoint two individuals to Assembly Bio’s board of directors.
ABI-4334, ABI-5366 and ABI-6250 are under investigation and have not yet been approved anywhere in the world. Their efficacy and safety have not been established. For more information about the ABI-4334 clinical trials, please visit www.clinicaltrials.gov.
Starting in the first quarter of 2022, Gilead will no longer exclude acquisition IPR&D expenses from its non-GAAP financial measures, according to recent industry communications from the U.S. Securities and Exchange Commission (SEC). The deal with Assembly Bio is expected to reduce Gilead’s 2023 GAAP and non-GAAP earnings per share by approximately $0.05 to $0.07.
BofA Securities, Inc. and Mizuho Securities USA LLC are serving as financial advisors to Assembly Bio. Wilson Sonsini serves as Assembly Bio’s legal counsel.
Assembly Bio Webcast
Assembly Bio management will host an investor webcast today at 8:30 a.m. ET/5:30 a.m. PT to discuss the Gilead partnership. The live webcast will be available on the Events and Presentations page in the Investors section of Assembly Bio’s website, and a replay will be available after the event. An accompanying slide presentation will also be provided. To register for the live webcast and replay, please visit: https://investor.assemblebio.com/events-presentations.
About Assembly Biosciences
Assembly Biosciences is a biotechnology company developing innovative small molecule antiviral therapies designed to change the path of serious viral diseases and improve the lives of patients around the world. Led by a team of proven leaders in virology drug development, Assembly Bio is committed to improving outcomes for patients suffering the serious, chronic effects of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections.For more information, please visit assemblybio.com.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that has been pursuing and achieving breakthroughs in medicine for more than three decades with the goal of creating a healthier world for all. The company develops innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19 and cancer. Gilead operates in more than 35 countries around the world and is headquartered in Foster City, California.
Assembly Biosciences Forward-Looking Statements
The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of the collaboration with Gilead, including all financial aspects of the collaboration and equity investment; Assembly Bio’s ability to initiate and complete the therapies involved in its collaboration within the currently expected timeframe or at all; Clinical studies of product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead; The occurrence of any events, changes or other circumstances that may result in the termination of Assembly Bio’s collaboration with Gilead; Safety and efficacy data from clinical or non-clinical studies Further development of Assembly Bio’s product candidates may not be guaranteed; clinical and non-clinical data presented at meetings may not differentiate Assembly Bio’s product candidates from those of other companies; results from non-clinical studies may not be representative of those in a clinical setting disease behavior, and may not predict the results of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (SEC). We urge you to consider statements that include words such as may, will, will, could, should, could, believe, hope, estimate, project, potential, expect, plan, anticipate, intend, continue, predict, design, target or the negative of these words or other similar words that are uncertain and forward-looking. Assembly Bio intends that such forward-looking statements will be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Additional information regarding Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K, 10- Quarterly reports on Form Q and current reports on Form 10-Q. Form 8-K. Except as required by law, Assembly Bio undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Gilead Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks, uncertainties and other factors, including Gilead’s ability to realize anticipated benefits from the collaboration with Assembly; related to the collaboration difficult or unexpected expenses, including Gilead’s equity investment in Assembly, and the potential impact on Gilead’s earnings; the parties’ ability to initiate, progress, or complete clinical trials within the currently expected timeframe or at all, and the possibility that trials will produce adverse results nature, including the subject of experimental collaborations involving ABI-4334, ABI-5366, ABI-6250 and other projects that may become; the possibility that the parties may make a strategic decision to terminate the collaboration or cease development of any investigational agents under the collaboration, and therefore these investigations 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those indicated in the forward-looking statements. All statements other than statements of historical fact may be deemed to be forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and readers 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 and does not attempt to update any such forward-looking statements.
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its affiliates. The Assembly Bio name and logo are trademarks of Assembly Biosciences, Inc.
For more information about Gilead, please visit the company’s website:
www.gilead.com
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
Please call 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences