Assembly Biosciences Reports Third Quarter 2026 Financial Results and Recent Updates

Rhea-AI Summary

Assembly Biosciences (ASMB) reported a third-quarter 2026 net loss of $20.3 million while advancing its liver disease and herpes programs. Loss per share was $0.93, versus $0.72 a year earlier, while collaboration revenue fell to $3.0 million from $10.8 million.

The company began dosing in a Phase 2 ABI-6250 study for chronic hepatitis delta and received FDA permission to proceed with a cholestatic liver disease study. Assembly expects that study to begin in the first quarter of 2027 and Gilead to initiate Phase 2 GS-1179 by year-end 2026. Assembly elected a 40% U.S. development-cost and profit share for the herpes program. It received a $75 million Gilead extension fee in November, cancelling outstanding Class B warrants. Cash, equivalents and marketable securities totaled $314.3 million at September 30, versus $320.4 million at June 30; with the fee, Assembly projects funding into 2029.

11 points · 1 major

MixediHow this balance works

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It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

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0 major · 11 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointGilead collaboration extension delivered $75 million in November 2026 and cancelled all outstanding August 2025 Class B warrants. 16% of market cap
• Moderate point. Forward-looking: it has not happened yet and may not happen.HSV program election gives Assembly a 40% share of U.S. profits.
• Minor point. Forward-looking: it has not happened yet and may not happen.Cash resources plus the extension fee are projected to fund operations into 2029.
• Minor pointABI-6250 Phase 2 dosing began in participants with chronic hepatitis delta infection.
• Minor pointFDA Study May Proceed letter permits the planned ABI-6250 Phase 2 cholestatic liver disease study.

6 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.Assembly expects ABI-6250 Phase 2 initiation in cholestatic liver diseases in first-quarter 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Gilead is expected to initiate GS-1179 Phase 2 for recurrent genital herpes by year-end 2026.
• Minor pointABI-6250 Phase 1 hepatic impairment study initiated to support potential future labeling.
• Minor pointRespiratory virus candidate ABI-8914 was nominated and is advancing into regulatory filing-enabling studies.
• Minor pointInterest and other income rose to $3.159 million in Q3 2026 from $1.687 million a year earlier.
• Minor pointNine-month interest and other income rose to $7.937 million from $3.705 million in 2025.

Negative

• Moderate pointQ3 2026 net loss widened to $20.3 million, or $0.93 per share, from $9.2 million, or $0.72.
• Moderate pointQ3 collaboration revenue fell to $3.0 million from $10.8 million in 2025.
• Moderate pointHPI license transaction price fell $11.3 million, reflecting estimated development-cost reimbursements to Gilead considered probable. 2.5% of market cap
• Moderate point. Forward-looking: it has not happened yet and may not happen.HSV profit-share election makes Assembly responsible for 40% of U.S. development costs.
• Moderate pointQ3 research and development expenses increased to $20.2 million from $16.6 million a year earlier.

6 minor points

• Minor pointQ3 general and administrative expenses increased to $6.1 million from $5.1 million a year earlier.
• Minor pointCash, equivalents and marketable securities fell to $314.3 million at September 30 from $320.4 million at June 30.
• Minor pointNine-month collaboration revenue declined to $24.543 million from $29.834 million in 2025.
• Minor pointNine-month net loss widened to $33.192 million from $28.212 million; loss per share narrowed to $1.73 from $3.03.
• Minor pointNine-month research and development expenses increased to $50.051 million from $47.563 million in 2025.
• Minor pointNine-month general and administrative expenses increased to $15.621 million from $14.188 million in 2025.

News Explained

The balance sheet lists 20,368,351 common shares issued and outstanding at September 30, 2026, versus 15,855,329 at December 31, 2025; for holders whose share count did not change, the higher total means each share represents a smaller ownership fraction.

Key Figures

U.S. development cost and profit share: 40% Collaboration extension fee: $75 million Cash runway: Projected into 2029 +5 more

U.S. development cost and profit share

40%

Assembly Bio elected to participate in the HSV HPI program with Gilead

Collaboration extension fee

$75 million

Received from Gilead in November 2026

Cash runway

Projected into 2029

Based on the company’s cash position and the received Gilead fee

Cash, cash equivalents and marketable securities

$314.3 million

September 30, 2026; compared with $320.4 million at June 30, 2026

Collaboration revenue

$3.0 million vs. $10.8 million

Third quarter 2026 vs. third quarter 2025

Research and development expenses

$20.2 million vs. $16.6 million

Third quarter 2026 vs. third quarter 2025

Net loss attributable to common stockholders

$20.3 million vs. $9.2 million

Third quarter 2026 vs. third quarter 2025

Planned Phase 2 study initiation

First quarter of 2027

ABI-6250 study in cholestatic liver diseases, including PBC and PSC

Previous Earnings Reports

2 past events · Latest: Aug 13

Same Type 2 events

1. Aug 13

   Q2 earnings

   24h Move

   +10.0%

   Reported cash of $320.4 million and projected runway into 2029, including a planned Gilead payment.

2. Nov 10

   Q3 earnings

   24h Move

   +3.3%

   Reported Q3 collaboration revenue of $10.8 million and net loss of $9.2 million alongside positive clinical data.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pharmacokinetic, ntcp, pre-ind, helicase-primase inhibitor

4 terms

pharmacokinetic medical

"safety, tolerability, pharmacokinetic and target-engagement data for ABI-6250"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

ntcp medical

"sodium taurocholate cotransporting polypeptide (NTCP)"

NTCP is a protein on the surface of liver cells that normally helps move bile acids into the liver, and it also acts like a doorway that certain liver-targeting viruses use to enter cells. Investors watch NTCP because drugs or antibodies that block this doorway can prevent or treat viral liver diseases, which can change a drug candidate’s clinical prospects, market potential, and the valuation of companies developing those therapies.

pre-ind regulatory

"following the company’s pre-IND meeting regarding the development"

"Pre-ind" is short for "pre-indication" and refers to the period before a formal announcement or official signal that a significant change or event is about to happen, such as a company preparing to release important news. For investors, it can signal a time of increased activity or uncertainty, as market participants try to interpret hints and anticipate future developments. Recognizing pre-ind conditions helps investors make more informed decisions ahead of major shifts.

helicase-primase inhibitor medical

"HSV helicase-primase inhibitors target an enzyme complex essential for viral replication"

A helicase-primase inhibitor is a type of antiviral drug that blocks two key viral enzymes that unzip and kick-start copying of a virus’s genetic material, effectively stopping the virus from reproducing. Think of it as jamming both the unroll and start buttons on a photocopier so no new copies get made. Investors care because these drugs can become new treatments for viral infections, affecting market value, regulatory milestones, and commercial potential tied to trial results and approvals.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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– Initiated Phase 2 clinical study of ABI-6250 in patients with chronic hepatitis delta virus infection –

– Exercised 40% U.S. Profit-Share option for the HSV helicase primase inhibitor program –

– Received first $75 million collaboration extension fee from Gilead; cash runway projected into 2029 –

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral and liver diseases, today reported financial results for the third quarter ended September 30, 2026, and recent business updates.

“This quarter, we rapidly advanced our liver disease program by initiating the Phase 2 study of ABI-6250 in chronic hepatitis delta virus and preparing for our Phase 2 study in cholestatic liver diseases, which we expect to begin in the first quarter next year,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “Alongside that progress, we elected to share U.S. costs and profits for the HSV helicase primase inhibitor program under our collaboration with Gilead, a decision we believe represents a significant opportunity to build long-term value. With a strong financial position, we look forward to the continued expansion of our pipeline and advancement of the herpesvirus and liver disease programs through their respective Phase 2 studies.”

Third Quarter 2026 and Recent Updates

• Recurrent genital herpes
  • Exercised the company’s option to participate in a 40% share of U.S. development costs and profits for the herpes simplex virus (HSV) helicase primase inhibitor (HPI) program under its collaboration with Gilead Sciences, Inc. (Gilead)
  • Final Phase 1b data for GS-1179 was presented at IDWeek 2026, supporting the continued development as a long-acting suppressive therapy for recurrent genital herpes
• Liver disease programs
  • Initiated dosing in a Phase 2 study evaluating ABI-6250 in participants with chronic hepatitis delta (HDV) infection
  • Received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) for the planned Phase 2 study of ABI-6250 in primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) following the company’s pre-IND meeting regarding the development of 6250 in cholestatic liver diseases (CLD)
    
  • Initiated a Phase 1 hepatic impairment study to support potential future labeling for ABI-6250
  • Presented two posters featuring additional Phase 1a safety, tolerability, pharmacokinetic and target-engagement data for ABI-6250 at The Liver Meeting 2026, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). The pharmacodynamic analysis was recognized as a Poster of Distinction.
• Research programs
  • Nominated a new development candidate, ABI-8914, targeting the respiratory virus space, which is advancing into regulatory filing-enabling studies
• Collaboration
  • Received the first $75 million collaboration extension fee from Gilead following the third anniversary of the companies’ collaboration resulting in the cancellation of all outstanding Class B warrants issued in August 2025
    
    

Anticipated Milestones and Events

• Initiation by Gilead of a Phase 2 clinical study evaluating GS-1179 in participants with recurrent genital herpes by the end of 2026
• Initiation of a Phase 2 clinical study evaluating ABI-6250 in participants with cholestatic liver diseases, including PBC and PSC, in the first quarter of 2027
  
  

Third Quarter 2026 Financial Results

• Cash, cash equivalents and marketable securities were $314.3 million as of September 30, 2026, compared to $320.4 million as of June 30, 2026. The company’s cash position, together with the $75 million collaboration extension fee received from Gilead in November 2026 following the third anniversary of the collaboration agreement, 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 to $10.8 million for the same period in 2025. The decrease was primarily due to an $11.3 million reduction in the transaction price of our HPI license, reflecting research and development costs under the Profit-Share that we estimate are probable of being reimbursed to Gilead, partially offset by an increase in research and development activities we performed under the Gilead Collaboration Agreement.
• Research and development expenses were $20.2 million for the three months ended September 30, 2026, compared to $16.6 million for the same period in 2025. The increase was primarily driven by higher external program expenses, reflecting the start-up of multiple clinical studies for ABI-6250 and increased research and discovery activities, as well as higher employee-related expenses. These increases were partially offset by lower external program expenses for GS-1179 and GS-5366 following completion of their Phase 1 clinical studies. Gilead now leads further development of the HSV HPI program, with Assembly Bio responsible for 40% of U.S. development costs.
• General and administrative expenses were $6.1 million for the three months ended September 30, 2026, compared to $5.1 million for the same period in 2025, primarily driven by higher stock-based compensation expense and increased commercial planning and market research expenses.
• Net loss attributable to common stockholders was $20.3 million, or $0.93 per basic and diluted share, for the three months ended September 30, 2026, compared to $9.2 million, or $0.72 per basic and diluted share, for the same period in 2025.
  
  

About GS-1179
GS-1179, formerly ABI-1179, is an investigational helicase-primase inhibitor being developed for HSV infections. It was advanced through early clinical stage development under Assembly Bio’s collaboration with Gilead. HSV helicase-primase inhibitors target an enzyme complex essential for viral replication and represent a mechanism distinct from currently available nucleoside analog therapies. GS-1179 was selected for advancement by Gilead in the HSV HPI program based on encouraging Phase 1b results and its potential to support once-weekly oral dosing.

About ABI-6250
ABI-6250 is an investigational first-in-class oral small-molecule inhibitor of the sodium taurocholate cotransporting polypeptide (NTCP), a membrane protein selectively expressed on hepatocytes that facilitates bile acid transport into hepatocytes and also serves as the receptor for hepatitis B virus (HBV) and hepatitis delta virus (HDV) to enter hepatocytes. Assembly Bio is developing ABI-6250 for the treatment of chronic HDV infection, where inhibition of NTCP blocks viral entry and represents a clinically validated therapeutic mechanism. ABI-6250 is also being evaluated in cholestatic liver diseases, such as primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), where bile acid accumulation in the liver drives liver inflammation and liver injury.

About the Assembly Bio-Gilead Collaboration
In October 2023, Assembly Bio and Gilead entered into a 12-year collaboration to advance the research and development of novel antiviral therapies. Under the collaboration, Gilead has an option to obtain exclusive rights to each of Assembly Bio’s current and future programs, and Assembly Bio is eligible to receive collaboration extension fees, option fees, milestone payments and royalties. Following Gilead’s exercise of an option, Assembly Bio has the right to elect to share costs and profits in the U.S., as well as certain co-promotion rights for future programs.

To date, Gilead has exercised its option for Assembly Bio’s helicase-primase inhibitor program for recurrent genital herpes, and Assembly Bio has elected to participate in a 40% U.S. cost and profit share for the program.

About Assembly Biosciences
Assembly Biosciences is a biotechnology company dedicated to the development of innovative small-molecule therapeutics aimed at advancing the treatment paradigm of serious viral and liver diseases and improving the lives of patients worldwide. Led by an accomplished leadership team in antiviral and liver disease drug development, Assembly Bio is committed to improving outcomes for people living with the chronic impacts of herpesviruses, hepatitis delta virus (HDV) infections, cholestatic liver diseases and hepatitis B virus (HBV). For more information, visit assemblybio.com.

Forward-Looking Statements
The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, some of which will be conducted by Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of product candidates; clinical and nonclinical data may not differentiate product candidates from other companies’ candidates; Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead, including all financial aspects of the collaboration; Assembly Bio’s ability to maintain financial resources and secure additional funding necessary to continue its research activities, clinical studies, and other business operations; potential effects of changes in government regulation; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Investors:
Patrick Till
Meru Advisors
(484) 788-8560
investor_relations@assemblybio.com

Media:
Jamie Strachota
Sam Brown LLC
(703) 819-7647
ASMBMedia@sambrown.com

ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands except for share amounts and par value)
		September 30,				December 31,
		2026				2025
		(Unaudited)
ASSETS
Current assets
Cash and cash equivalents		$	29,073			$	58,450
Marketable securities			285,189				189,656
Accounts receivable from collaboration with a related party			582				974
Prepaid expenses and other current assets			6,316				5,469
Total current assets			321,160				254,549
Property and equipment, net			291				221
Operating lease right-of-use assets			2,081				2,508
Other assets			1,754				312
Total assets		$	325,286			$	257,590
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable		$	3,182			$	1,171
Accrued research and development expenses			2,168				2,387
Other accrued expenses			5,194				7,749
Contract liability to a related party			13,742				36,904
Operating lease liabilities - short-term			635				569
Total current liabilities			24,921				48,780
Operating lease liabilities - long-term			1,572				2,059
Total liabilities			26,493				50,839
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding			—				—
Common stock, $0.001 par value; 150,000,000 shares authorized as of September 30, 2026 and December 31, 2025; 20,368,351 and 15,855,329 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively			20				16
Additional paid-in capital			1,165,001				1,038,823
Accumulated other comprehensive loss			(989	)			(41	)
Accumulated deficit			(865,239	)			(832,047	)
Total stockholders' equity			298,793				206,751
Total liabilities and stockholders' equity		$	325,286			$	257,590

ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands except for share and per share amounts)
(Unaudited)
		Three Months Ended September 30,								Nine Months Ended September 30,
		2026				2025				2026				2025
Collaboration revenue from a related party		$	2,956			$	10,789			$	24,543			$	29,834
Operating expenses
Research and development			20,234				16,587				50,051				47,563
General and administrative			6,137				5,085				15,621				14,188
Total operating expenses			26,371				21,672				65,672				61,751
Loss from operations			(23,415	)			(10,883	)			(41,129	)			(31,917	)
Other income
Interest and other income, net			3,159				1,687				7,937				3,705
Total other income			3,159				1,687				7,937				3,705
Net loss		$	(20,256	)		$	(9,196	)		$	(33,192	)		$	(28,212	)
Other comprehensive loss
Unrealized gain (loss) on marketable securities			(366	)			189				(948	)			121
Comprehensive loss		$	(20,622	)		$	(9,007	)		$	(34,140	)		$	(28,091	)
Net loss per share, basic and diluted		$	(0.93	)		$	(0.72	)		$	(1.73	)		$	(3.03	)
Weighted average common shares outstanding, basic and diluted			21,780,874				12,686,122				19,196,128				9,301,740

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Assembly Biosciences' third-quarter 2026 financial results?

Assembly reported a $20.3 million net loss, or $0.93 per basic and diluted share, for the quarter ended September 30, 2026. That compares with a $9.2 million loss, or $0.72 per share, a year earlier. Collaboration revenue was $3.0 million versus $10.8 million.

How long does Assembly Biosciences expect its cash to last after the Gilead extension payment?

Assembly projects funding into 2029 from its September 30, 2026 cash, cash equivalents and marketable securities of $314.3 million, together with the $75 million Gilead collaboration extension fee received in November 2026.

Why did Assembly Biosciences' research and development expenses increase in Q3 2026?

Higher external program spending for ABI-6250 clinical-study start-ups, increased research and discovery activities, and higher employee-related expenses drove the increase. Lower external spending for GS-1179 and GS-5366 following completion of their Phase 1 studies partly offset those increases.