Assembly Biosciences (ASMB) Q1 2026 earnings summary

Executive summary

• Focused on developing therapeutics for serious viral diseases, with a pipeline including clinical-stage candidates for genital herpes, hepatitis delta virus (HDV), hepatitis B virus (HBV), and transplant-related herpesviruses.

• Completed Phase 1b studies for ABI-5366 and ABI-1179, reinforcing safety and efficacy for recurrent genital herpes, and finished chronic toxicology studies for ABI-6250, supporting Phase 2 initiation for HDV in Q4 2026.

• In December 2025, Gilead exercised its option to license the HPI program for recurrent genital herpes, resulting in a $35 million payment.

• All participants in key Phase 1a/b studies for lead candidates completed dosing and follow-up, supporting readiness for Phase 2 studies.

• The company retains full control of its next-generation HBV capsid assembly modulator (4334) after Gilead declined its option, and is seeking partners for further development.

Financial highlights

• Collaboration revenue was $8.2 million for Q1 2026, down 13% from $9.4 million in Q1 2025, reflecting timing of activities under the Gilead agreement.

• Research and development expenses remained flat at $14.9 million year-over-year, with increased employee costs offset by lower external program expenses.

• General and administrative expenses rose to $4.7 million from $4.5 million, mainly due to higher stock-based compensation.

• Interest and other income more than doubled to $2.3 million, driven by a larger investment portfolio and proceeds from the Gilead license payment.

• Net loss for Q1 2026 was $9.1 million ($0.54 per share), compared to $8.8 million ($1.17 per share) in Q1 2025, reflecting a higher share count.

• Cash, cash equivalents, and marketable securities totaled $226.6 million as of March 31, 2026, projected to fund operations into 2028.

Outlook and guidance

• Sufficient funds are available to meet operating requirements into 2028 based on current plans.

• Anticipates Gilead will initiate a Phase 2 clinical study for the HPI program in 2026; decision on 40% U.S. cost-profit share opt-in for herpesvirus program with Gilead expected by mid-2026.

• Preparation for Phase 2 clinical studies of HDV candidate 6250 is ongoing, with initiation expected in Q4 2026.

• 4334 will not advance further without a partner; partnering process is underway.