Assembly Biosciences (ASMB) Corporate Presentation summary

Strategic focus and pipeline overview

• Advancing four clinical-stage investigational therapies targeting herpesviruses and viral hepatitis, with a focus on high unmet medical need and significant market opportunity.

• Rapid portfolio advancement with multiple near-term clinical data readouts expected in 2025.

• Collaboration with Gilead provides expertise, assets, funding, and a partner for late-stage development and commercialization.

• R&D team has experience with over 15 approved drugs in viral disease and hepatitis.

Clinical programs and development highlights

• ABI-5366 and ABI-1179: Long-acting helicase-primase inhibitors for recurrent genital herpes, both in Phase 1b with interim data showing 94% reduction in HSV-2 shedding and lesions, and a clean safety profile.

• ABI-4334: Next-generation capsid assembly modulator for hepatitis B, Phase 1b data shows potent antiviral activity with up to 3.2 log10 IU/mL mean decline in HBV DNA over 28 days.

• ABI-6250: Oral entry inhibitor for hepatitis D, Phase 1a completed with dose-dependent NTCP engagement, favorable pharmacokinetics, and preparation for Phase 2 underway.

• ABI-7272: Oral broad-spectrum non-nucleoside polymerase inhibitor for transplant-associated herpesviruses, currently in IND/CTA-enabling studies.

Market opportunity and unmet needs

• Over 60 million people in the US/EU living with HSV-2; current therapies have limited efficacy, high pill burden, and no new approvals since 1995.

• Chronic hepatitis B and D represent major global unmet needs, with millions affected and limited curative options.

• Transplant recipients face significant morbidity from herpesviruses, with current antivirals being only partially efficacious and having tolerability issues.