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Precision BioSciences Announces Presentation of Clinical Data from the ELIMINATE-B Trial at HEP-DART 2025

via Business Wire

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that it will deliver an oral presentation at the Hep-DART 2025 meeting, to take place December 7–11, 2025, at the Hilton Hawaiian Village in Honolulu, Hawaii. The presentation will feature data from the Phase 1 ELIMINATE-B trial of PBGENE-HBV.

“We are pleased to share the latest clinical results from ELIMINATE-B with the international hepatology community at Hep-DART 2025,” said Dr. Cassie Gorsuch, Chief Scientific Officer of Precision BioSciences. “Chronic hepatitis B continues to impose a significant global disease burden, and current therapies fall short of addressing the underlying cause of viral persistence. PBGENE-HBV is being developed to directly eliminate and inactivate the viral templates that drive ongoing infection with the potential to provide complete cures for patients.”

Details of the presentation:

Presentation title: PBGENE-HBV, a first-in-class gene editing therapy for chronic hepatitis B, demonstrates safety and antiviral activity across three cohorts

Type of presentation: Oral presentation

Presenter: Man-Fung Yuen, MBBS, MD, PhD, DSc

Authors: Man-Fung Yuen, Alina Jucov, Edward Gane, Emily B. Harrison, Andrew Van Cott, Abhishek Chandiramani, Neil Leatherbury, John Fry, Jeff Smith, Cassandra L. Gorsuch, Stanley Frankel, Mark Sulkowski

Date and time: Tuesday, December 9th, 4:45pm HST

About PBGENE-HBV (Viral Elimination Program):

PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to potentially cure chronic hepatitis B infection. Currently, it is estimated that 300 million people worldwide are afflicted with chronic hepatitis B. PBGENE-HBV is the first and only potentially curative gene editing program to enter clinical investigation that is specifically designed to eliminate cccDNA and inactivate integrated HBV DNA. Lipid nanoparticle technology for PBGENE-HBV has been provided by Acuitas Therapeutics, Inc.

About the ELIMINATE-B Trial:

The Phase 1 ELIMINATE-B study is currently enrolling HBeAg-negative chronic hepatitis B patients at world-class sites in Hong Kong, New Zealand, United States and Moldova. The goal of the study is to define the optimal dose and number of dose administrations for safely eliminating cccDNA and inactivating integrated HBV DNA. With regulatory approval already granted, Precision expects to expand the study to clinical trial sites in the U.K. and continue accelerating recruitment and evaluation of a genetically diverse patient population in the Phase 1 study.

About Hepatitis B:

Hepatitis B is a leading cause of morbidity in the US and death globally, with no curative options currently available for patients. Despite the availability of approved antiviral therapies, an estimated 300 million people globally and 1-2 million people in the US are estimated to have chronic hepatitis B infection. An estimated 15% to 40% of patients with HBV infections may develop complications, such as cirrhosis, liver failure, or liver cancer (hepatocellular carcinoma), which account for the majority of HBV-related deaths.

Chronic hepatitis B infection is primarily driven by persistence of HBV cccDNA, which enables continued viral replication, and integration of HBV DNA into the human genome in liver cells. Current treatments for patients with chronic hepatitis B include agents that result in long-term viral suppression as indicated by reduction of circulating HBV DNA, but these therapies do not eradicate HBV cccDNA, rarely lead to functional cure, and require lifelong administration.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, expectations about operational initiatives, strategies, further development, or timing of additional updates or data releases of PBGENE-HBV; the design and development of PBGENE-HBV to directly eliminate or inactivate the viral templates that drive ongoing infection with the potential to provide complete cures for patients; the goal of the ELIMINATE-B study to define the optimal dose and number of dose administrations for safely eliminating cccDNA and inactivating integrated HBV DNA; ; and the expectation to expand the ELIMINATE-B study to clinical trial sites in the U.K. and continue accelerating recruitment and evaluation of a genetically diverse patient population in the Phase 1 study. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “belief”, “believe,” “contemplate,” “could,” “design,” “designed,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “strive,” “suggest,” “target,” “will,” “would,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs, and assumptions and on information currently available to us. These statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; ; our ability to advance product candidates into, and successfully design, implement and complete, clinical trials; changes in interim “top-line” and initial data that we announce or publish; our current and future relationships with and reliance on third parties including suppliers and manufacturers; and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2025, June 30, 2025, and September 30, 2025 as any such factors may be updated from time to time in our other filings with the U.S. Securities and Exchange Commission (SEC), which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

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