Assembly Biosciences (ASMB) investor relations material

Pipeline progress and clinical development

• Four programs advanced through phase I, with lead HSV candidate licensed to Gilead and entering phase II for recurrent genital herpes by year-end 2026.

• ABI-6250 for hepatitis delta virus (HDV) to start phase II by end of 2026; expansion into cholestatic liver diseases (PBC, PSC) with phase II studies planned for 2027.

• 7272, a pan-herpes program for transplant patients, is in IND-enabling studies and expected to enter the clinic in 2027.

• Strong research engine supports ongoing pipeline expansion.

Strategic collaborations and financial outlook

• Long-term collaboration with Gilead allows licensing of discovered programs; opted into 40% cost and profit share in the U.S. for HSV program, with milestones and royalties ex-U.S.

• Eligible for up to $280 million in global milestones and royalties in the high single digits to low teens for HSV program.

• Ended Q2 with $320 million in cash, runway into 2029, covering phase II development for 6250 and Gilead's phase II for 1179.

• $75 million extension payment expected by year-end 2026, supporting continued pipeline advancement.

Clinical differentiation and market landscape

• ABI-6250 targets NTCP like bulevirtide but offers oral dosing and potentially greater 24-hour receptor occupancy.

• Phase I-A showed good safety and bile acid elevations; phase II will test two doses with different predicted receptor occupancies.

• Composite endpoints in phase II for HDV focus on HDV RNA reduction and ALT normalization over 16 weeks.

• Finite treatment duration is being explored, with PK modeling suggesting sustained receptor binding.