Assembly Biosciences — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $314.3 million as of September 30, 2026, down from $320.4 million as of June 30, 2026.
• Collaboration revenue was $3.0 million for the three months ended September 30, 2026, a decrease from $10.8 million in the same period of 2025, primarily due to an $11.3 million reduction in the transaction price of the HPI license reflecting probable R&D cost reimbursements to Gilead.
• Research and development expenses were $20.2 million for the three months ended September 30, 2026, compared to $16.6 million in the same period of 2025, driven by higher external program expenses for ABI-6250 clinical studies and increased employee-related expenses.
• General and administrative expenses were $6.1 million for the three months ended September 30, 2026, compared to $5.1 million in the same period of 2025, driven by higher stock-based compensation and commercial planning expenses.
• Net loss attributable to common stockholders was $20.3 million ($0.93 per share) for the three months ended September 30, 2026, compared to $9.2 million ($0.72 per share) in the same period of 2025.
• For the nine months ended September 30, 2026, collaboration revenue was $24.5 million compared to $29.8 million in 2025; R&D expenses were $50.1 million compared to $47.6 million; and G&A expenses were $15.6 million compared to $14.2 million.
• Net loss for the nine months ended September 30, 2026, was $33.2 million ($1.73 per share) compared to $28.2 million ($3.03 per share) in 2025.
• Total assets were $325.3 million as of September 30, 2026, compared to $257.6 million as of December 31, 2025.
• Total liabilities were $26.5 million as of September 30, 2026, compared to $50.8 million as of December 31, 2025.
• Stockholders' equity was $298.8 million as of September 30, 2026, compared to $206.8 million as of December 31, 2025.

Guidance and Future Outlook:

• Cash position and the $75 million collaboration extension fee received from Gilead in November 2026 are projected to fund operations into 2029.
• Gilead is expected to initiate a Phase 2 clinical study evaluating GS-1179 for recurrent genital herpes by the end of 2026.
• The company expects to initiate a Phase 2 clinical study evaluating ABI-6250 in cholestatic liver diseases (PBC and PSC) in the first quarter of 2027.

Business Segments and Product Lines:

• Recurrent Genital Herpes: Exercised the option to participate in a 40% share of U.S. development costs and profits for the HSV helicase primase inhibitor (HPI) program (GS-1179) under the Gilead collaboration; final Phase 1b data was presented at IDWeek 2026 supporting development as a long-acting suppressive therapy.
• Liver Disease Programs: Initiated dosing in a Phase 2 study for ABI-6250 in chronic hepatitis delta (HDV) infection; received a Study May Proceed letter from the FDA for a planned Phase 2 study of ABI-6250 in primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC); initiated a Phase 1 hepatic impairment study for ABI-6250; presented Phase 1a data for ABI-6250 at The Liver Meeting 2026, with pharmacodynamic analysis recognized as a Poster of Distinction.
• Research Programs: Nominated new development candidate ABI-8914 targeting the respiratory virus space, advancing into regulatory filing-enabling studies.

Market and Competitive Landscape:

• ABI-6250 is a first-in-class oral small-molecule inhibitor of the sodium taurocholate cotransporting polypeptide (NTCP), a mechanism validated for blocking viral entry in HDV and HBV infections and addressing bile acid accumulation in cholestatic liver diseases.
• GS-1179 represents a mechanism distinct from currently available nucleoside analog therapies for HSV infections.

Risks and Challenges:

• Forward-looking statements are subject to risks including the ability to initiate and complete clinical studies in anticipated timeframes, potential failure of safety and efficacy data to warrant further development, and the inability to differentiate product candidates from competitors.
• Risks include the ability to realize benefits of the Gilead collaboration, maintain financial resources, and navigate changes in government regulation.

Management Commentary and Tone:

• CEO Jason Okazaki stated the company rapidly advanced its liver disease program and elected to share U.S. costs and profits for the HSV program to build long-term value.
• Management expressed confidence in a strong financial position and the continued expansion of the pipeline through Phase 2 studies for herpesvirus and liver disease programs.

Other Key Points:

• Received the first $75 million collaboration extension fee from Gilead following the third anniversary of the collaboration agreement.
• The receipt of the extension fee resulted in the cancellation of all outstanding Class B warrants issued in August 2025.
• Under the 12-year collaboration with Gilead entered in October 2023, Gilead has exercised its option for the HSV HPI program, and Assembly Bio elected to participate in a 40% U.S. cost and profit share.
• Outstanding shares increased to 20,368,351 as of September 30, 2026, from 15,855,329 as of December 31, 2025.