Earnings

Assembly Bio Starts ABI-6250 Phase 2 in Hepatitis Delta

The Tip Desk · November 13, 2026 · 3 min read

Collaboration revenue from Gilead fell to $3.0 million in the third quarter as the company booked a $20.3 million net loss, or $0.93 a share.

Assembly Biosciences, Inc. (ASMB), a biotechnology company developing therapeutics for viral and liver diseases, initiated dosing in a Phase 2 study of ABI-6250 in chronic hepatitis delta virus infection, a start the company had previously targeted for year-end 2026.

Chief executive Jason Okazaki said the company also received a Study May Proceed letter from the U.S. Food and Drug Administration for a planned Phase 2 study of ABI-6250 in primary biliary cholangitis and primary sclerosing cholangitis, and expects that cholestatic liver disease trial to begin in the first quarter of 2027.

ABI-6250 is an investigational oral small-molecule inhibitor of NTCP, a hepatocyte membrane protein that transports bile acids and serves as the entry receptor for hepatitis B and hepatitis delta viruses. The company said it also started a Phase 1 hepatic impairment study to support potential future labeling.

On the herpes simplex virus front, Assembly Bio exercised its option to share 40% of U.S. development costs and profits for the HSV helicase primase inhibitor program under its collaboration with Gilead Sciences. In the second-quarter update, the company had said it would decide after receiving Gilead’s commercial cost estimates. Gilead now leads further development of the program, with Assembly Bio responsible for 40% of U.S. development costs. Final Phase 1b data for GS-1179 were presented at IDWeek 2026. The company said Gilead is expected to initiate a Phase 2 study of GS-1179 in recurrent genital herpes by the end of 2026.

The company also received the first $75 million collaboration extension fee from Gilead following the third anniversary of the 12-year collaboration, resulting in cancellation of all outstanding Class B warrants issued in August 2025. The prior-quarter release had described that payment as due in the fourth quarter of 2026.

Cash, cash equivalents and marketable securities were $314.3 million as of September 30, 2026, compared with $320.4 million as of June 30, 2026. The company said that cash position, together with the $75 million fee received in November 2026, is projected to fund operations into 2029.

Revenue from collaborative research with Gilead was $3.0 million for the three months ended September 30, 2026, compared with $10.8 million for the same period in 2025. The company said the decrease was primarily due to an $11.3 million reduction in the transaction price of the HPI license, reflecting research and development costs under the Profit-Share that it estimates are probable of being reimbursed to Gilead, partially offset by an increase in research and development activities performed under the collaboration.

Research and development expenses were $20.2 million for the three months ended September 30, 2026, compared with $16.6 million a year earlier. The company attributed the increase primarily to higher external program expenses from start-up of multiple ABI-6250 clinical studies and increased research and discovery activities, as well as higher employee-related expenses, partially offset by lower external program expenses for GS-1179 and GS-5366 after completion of their Phase 1 studies. General and administrative expenses were $6.1 million, compared with $5.1 million a year earlier, primarily from higher stock-based compensation and increased commercial planning and market research.

Net loss attributable to common stockholders was $20.3 million, or $0.93 a share, for the three months ended September 30, 2026, compared with $9.2 million, or $0.72 a share, a year earlier.

Assembly Bio also nominated a new development candidate, ABI-8914, targeting the respiratory virus space, which it said is advancing into regulatory filing-enabling studies.

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