ASMB Assembly Biosciences Inc

Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced that the company will present data from its herpes simplex virus (HSV) and hepatitis D virus (HDV) pipeline programs at upcoming medical congresses. Assembly Bio’s abstracts for ABI-5366 and ABI-1179 have been accepted for one oral and two poster presentations at the International Herpesvirus Workshop, taking place in Portland, Ore., July 13-17, 2024. An abstract for ABI-6250 has been accepted for poster presentation at the European Association for the Study of the Liver (EASL) Congress™ 2024 taking place in Milan, Italy, June 5-8, 2024.

International Herpesvirus Workshop 2024At the International Herpesvirus Workshop, Assembly Bio will present data describing the preclinical profile of ABI-5366, a long-acting helicase-primase inhibitor candidate in development for the treatment of recurrent genital herpes. Additionally, the company will present data highlighting the preclinical characterization of ABI-1179, a structurally distinct long-acting helicase-primase inhibitor candidate, which was licensed from Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and Gilead.

“We’re excited to present data from both of these potent, long-acting HSV helicase-primase inhibitors at the International Herpesvirus Workshop,” said William Delaney, PhD, chief scientific officer of Assembly Bio. “Improved therapeutic options are urgently needed for people living with recurrent genital herpes, as the current standard of care is only partially effective in controlling recurrences. Our HSV program employs a highly innovative approach, with candidates designed from the start for long-acting administration and targeting the viral helicase-primase complex, a different viral target than the standard of care. We look forward to an important year for the program, as we remain on track to begin dosing in a Phase 1a/1b study for ABI-5366 by mid-year and anticipate bringing ABI-1179 into the clinic by end of year.”

Details of the presentations are as follows:

ABI-5366:

• Poster Presentation: The Helicase-Primase Inhibitor ABI-5366 is a Novel, Potent, Long-Acting Inhibitor for the Treatment of Recurrent Genital HerpesPresenter: Ran Yan, PhD, Assembly BioPoster Session Date and Time: Not Yet Available

ABI-1179:

• Oral and Poster Presentation: Preclinical Characterization of ABI-1179, a Potent Helicase-Primase Inhibitor for the Treatment of Recurrent Genital HerpesPresenter: Heidi Contreras, PhD, Assembly BioOral Presentation Date and Time: July 16, 2024, at 11:00 AM PDTPoster Session Date and Time: Not Yet Available

EASL Congress™ 2024At EASL, Assembly Bio will present preclinical profiling of ABI-6250, the company’s novel, small molecule orally-bioavailable entry inhibitor candidate for the treatment of chronic HDV.

“The preclinical findings we are presenting for ABI-6250 underscore the potential of this candidate to offer improved treatment options to individuals living with chronic HDV,” said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio. “Chronic HDV infection is the most serious form of viral hepatitis, progressing to cirrhosis in the majority of cases within 10 years. Unfortunately, the standard of care is currently only available in Europe and requires daily injections, highlighting the potential we see for a once-daily oral therapeutic option. We look forward to moving ABI-6250 into the clinic, anticipated by the end of this year.”

Details of the presentation are as follows:

ABI-6250:

• Poster WED-377: Preclinical profiling of ABI-6250, a novel orally bioavailable small-molecule therapeutic candidate for the treatment of chronic hepatitis DPresenter: Marc P. Windisch, PhD, Assembly BioSession: Viral Hepatitis B and D: New therapies, unapproved therapies or strategiesDate and Time: June 5, 2024, 8:30 AM-6:00 PM

The investigational product candidates referenced here have not been approved anywhere globally, and their safety and efficacy have not been established.

About Assembly BiosciencesAssembly Biosciences is a biotechnology company dedicated to the development of innovative small-molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For more information, visit assemblybio.com.

Forward-Looking StatementsThe information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes 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 (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to 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. More information about 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, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. 

ContactsInvestor and Corporate:Shannon RyanSVP, Investor Relations, Corporate Affairs and Alliance Management(415) 738-2992sryan@assemblybio.com

Media:Sam Brown Inc. Hannah Hurdle (805) 338-4752 ASMBMedia@sambrown.com