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Assembly Biosciences (ASMB) investor relations material
Assembly Biosciences Guggenheim Securities 2nd Annual Healthcare Innovation Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Guggenheim Securities 2nd Annual Healthcare Innovation Conference summary12 Nov, 2025
Pipeline overview and recent developments
Expanded from HBV focus to a broader herpes virus pipeline, with two lead compounds (5366 and 1179) in phase 1b for recurrent genital herpes and additional assets in hepatitis delta and HBV in clinical stages.
5366 and 1179 are both highly potent, long-acting molecules, with 5366 showing a 20-day half-life and 1179 a four-day half-life, supporting once-weekly dosing.
Positive interim data for 5366 showed over 90% reduction in viral shedding and lesions, with statistically significant results and strong safety profile.
Upcoming data releases in December will include unblinded safety data for 5366 and initial efficacy and safety data for 1179.
Phase 2 trials are planned to start mid-2026, with head-to-head studies against Valtrex and dose selection guided by PK/PD modeling.
Market opportunity and competitive landscape
Recurrent genital herpes remains inadequately treated, with current standard of care (valacyclovir) requiring daily dosing and only one-third of patients lesion-free for a year.
Once-weekly, more potent therapies could command a moderate premium over Valtrex, with a target market of over 1.3 million U.S. patients on chronic suppressive therapy.
Both 5366 and 1179 are being positioned for chronic suppressive therapy, with potential for monthly or injectable formulations and expansion into HSV-1 and episodic use.
Head-to-head data suggest the new compounds may outperform current and emerging competitors on both viral shedding and lesion reduction.
Additional programs and partnerships
Hepatitis delta program (6250) targets the same mechanism as bulevirtide but as a once-daily oral, showing strong safety, PK, and target engagement in phase 1a.
HBV program (4334) demonstrated high antiviral effect in phase 1b, with data under review by Gilead for potential opt-in.
Gilead partnership provides financial runway through at least 2027 and optionality for further development and commercialization, with opt-in decisions pending for HBV and HSV-2 assets.
How will 1179 data impact HSV-2 program path?
Oral HDV: How to compete with injectables?
Gilead HSV-2 opt-in: What are the strategic benefits?
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Next Assembly Biosciences earnings date
Q4 202520 Mar, 2026
Next Assembly Biosciences earnings date
Q4 202520 Mar, 2026
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Frequently asked questions
Assembly Biosciences, Inc. is a biopharmaceutical company focused on developing small molecule antiviral therapeutics. It is primarily engaged in the discovery and development of treatments targeting hepatitis B virus (HBV) and hepatitis delta virus (HDV), including a portfolio of HBV core inhibitors and other novel antiviral compounds aimed at managing chronic infections. Additionally, the company explores therapies for herpesviruses, with programs advancing long-acting inhibitors and other non-nucleoside polymerase inhibitors intended for transplant-associated infections and other serious disease conditions. Assembly Biosciences is headquartered in South San Francisco, California, and its shares are listed on the NASDAQ.
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