Assembly Biosciences (ASMB) Jefferies Global Healthcare Conference 2025 summary

Pipeline and upcoming catalysts

• Four major catalysts expected in the next six months, including data from trials in HBV, hepatitis delta, and genital herpes.

• Phase 1B data for capsid assembly modulator 4334 (HBV) expected, focusing on viral decline and de-risking for future development.

• Phase 1A data for hepatitis delta molecule 6250 anticipated by Q3, with focus on target engagement and safety.

• Two long-acting helicase-primase inhibitors (5366 and 1179) for high recurrence genital herpes to present proof-of-concept data in the fall.

• Both herpes candidates are in large, parallel phase 1B/2 studies, aiming to benchmark efficacy and safety.

Market opportunities and product positioning

• U.S. market for recurrent genital herpes estimated at 1.3–1.4 million patients, with global potential exceeding $1 billion in annual revenue.

• New herpes treatments aim to improve efficacy and convenience, potentially expanding the treated patient pool.

• Hepatitis delta remains underdiagnosed and undertreated; current standard is a daily injectable, while the new candidate is an oral pill.

• Oral hepatitis delta therapy could match or exceed efficacy of injectables, with significant patient preference for oral dosing.

Clinical development strategy and decision criteria

• Efficacy is the primary criterion for advancing herpes candidates, followed by convenience and safety.

• Both 5366 and 1179 have favorable pharmacokinetics for weekly or monthly dosing; 5366 has a longer half-life, while 1179 is more potent.

• Large phase 1B/2 studies are designed to be de-risking, with endpoints including viral shedding, lesion reduction, and safety.

• Decision on which herpes asset to advance will be based on comparative efficacy, convenience, and safety data from ongoing trials.