STOCK TITAN
  1. Home
  2. Sec-filings
  3. ASMB
  4. [8-K] ASSEMBLY BIOSCIENCES, INC. Reports Material Event

Assembly Biosciences (ASMB) narrows Q2 loss and boosts cash runway to 2029

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Assembly Biosciences reported second quarter 2026 results and pipeline progress. Cash, cash equivalents and marketable securities were $320.4 million as of June 30, 2026, helped by a recently completed $115 million gross financing and collaboration funding from Gilead, and are projected to fund operations into 2029, including a $75 million Gilead extension payment expected in the fourth quarter of 2026.

Collaboration revenue from Gilead rose to $13.4 million from $9.6 million a year earlier, while research and development expenses declined to $14.9 million from $16.1 million. Net loss narrowed to $3.9 million, or $0.20 per share, compared with $10.2 million, or $1.33 per share, reflecting higher revenue, lower R&D and higher interest income.

Strategically, the company expanded ABI-6250 into cholestatic liver diseases with a Phase 2 study planned in early 2027 and plans Phase 2 trials in chronic HDV and cholestatic liver diseases by late 2026 and early 2027. Gilead selected GS-1179 (HSV helicase‑primase inhibitor) to move into Phase 2 by year-end 2026, with Assembly Biosciences evaluating whether to opt into a 40% U.S. cost‑profit share.

Positive

  • Net loss improved to $3.9 million from $10.2 million year over year, with net loss per share narrowing from $1.33 to $0.20.
  • Cash, cash equivalents and marketable securities increased to $320.4 million, supporting a projected cash runway into 2029.
  • Collaboration revenue from Gilead grew to $13.4 million from $9.6 million, aided by a $5.1 million cumulative catch‑up adjustment.

Negative

  • None.

Filing Explained

As of June 30, 2026, common shares issued and outstanding were 19,850,342, versus 15,855,329 at December 31, 2025; the larger share base can reduce each existing share’s proportional ownership and per-share claim when holders do not add shares.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Cash, cash equivalents and marketable securities $320.4 million As of June 30, 2026
Gross financing completed $115 million Financing to support advancement of pipeline programs
Collaboration revenue Q2 2026 $13.4 million Three months ended June 30, 2026; includes $5.1 million cumulative catch‑up
Research and development expenses Q2 2026 $14.9 million Three months ended June 30, 2026
Net loss Q2 2026 $3.9 million Compared with $10.2 million in Q2 2025
Net loss per share Q2 2026 $0.20 Basic and diluted; compared with $1.33 in Q2 2025
Deferred revenue from related party $16.3 million As of June 30, 2026
Projected cash runway Into 2029 Includes first $75 million Gilead extension fee due in Q4 2026
cholestatic liver diseases medical
"Expanded ABI-6250 clinical development into cholestatic liver diseases, including PBC and PSC"
Cholestatic liver diseases are a group of conditions in which bile — the fluid the liver makes to help digest fats and clear waste — cannot flow properly because of blockages or damage, causing liver injury over time. For investors, these diseases matter because they create clear medical needs that drive demand for drugs, diagnostics and treatments, influence regulatory pathways and can shape market size and reimbursement prospects; think of it as a plumbing backup in the liver that requires specialized fixes.
primary biliary cholangitis (PBC) medical
"including primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC)"
Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease in which the body’s immune system gradually damages the small bile ducts that carry digestive fluids out of the liver, leading over time to scarring and reduced liver function. Investors care because PBC defines a specific patient population, shapes clinical trial design and regulatory review for treatments, and creates a predictable market opportunity or liability—like plumbing damage in a house that requires long‑term, often costly repairs or replacements.
primary sclerosing cholangitis (PSC) medical
"including primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC)"
helicase-primase inhibitor medical
"herpes simplex virus (HSV) helicase-primase inhibitor (HPI) program"
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.
pre-exposure prophylaxis (PrEP) medical
"possible evaluation as part of a combination strategy with HIV pre-exposure prophylaxis (PrEP)"
Pre-exposure prophylaxis (PrEP) is a medical prevention strategy in which an otherwise healthy person takes a medicine—typically a daily pill or periodic injection—before possible exposure to an infectious disease to greatly reduce the chance of becoming infected. For investors, PrEP matters because its regulatory approvals, pricing, delivery format, patent protection and uptake determine market size, recurring revenue potential and competitive dynamics in the preventative-treatment market—think of it like a seatbelt product that people buy to avoid rare but severe outcomes.
deferred revenue financial
"Deferred revenue from a related party was 16,304 as of June 30, 2026"
Cash a company has already received for goods or services it has promised but not yet delivered; it's recorded as a liability because the company still owes that product, service, or future revenue recognition. For investors, deferred revenue signals upcoming work or deliveries that will convert into reported sales over time and affects short-term obligations, cash flow quality, and how quickly a firm can grow recognized revenue—think of it like prepaid subscriptions or gift cards a business must honor later.
Collaboration revenue $13.4 million Up from $9.6 million in the same quarter of 2025
Net loss $3.9 million Improved from $10.2 million in the same quarter of 2025
Net loss per share $0.20 Improved from $1.33 in the same quarter of 2025
R&D expenses $14.9 million Down from $16.1 million in the same quarter of 2025
Cash, cash equivalents and marketable securities $320.4 million Up from $257.6 million at December 31, 2025

FAQ

How did Assembly Biosciences (ASMB) perform financially in Q2 2026?
Assembly Biosciences reported a Q2 2026 net loss of $3.9 million, or $0.20 per share, compared with a net loss of $10.2 million, or $1.33 per share, in Q2 2025, driven by higher collaboration revenue and lower research and development expenses.

What was Assembly Biosciences’ (ASMB) cash position as of June 30, 2026?
As of June 30, 2026, Assembly Biosciences held $320.4 million in cash, cash equivalents and marketable securities. Including a $75 million collaboration extension payment expected from Gilead in Q4 2026, this cash position is projected to fund operations into 2029.

How much revenue did Assembly Biosciences (ASMB) generate from Gilead in Q2 2026?
Revenue from collaborative research with Gilead was $13.4 million for the three months ended June 30, 2026, up from $9.6 million in the same period of 2025. This includes a $5.1 million cumulative catch‑up adjustment tied to updated estimates under the collaboration.

What are the key clinical plans for ABI-6250 at Assembly Biosciences (ASMB)?
Assembly Biosciences plans a Phase 2 study of ABI-6250 in chronic HDV by year-end 2026 and another Phase 2 in cholestatic liver diseases, including PBC and PSC, in the first quarter of 2027, expanding its liver disease development portfolio.

What is the status of GS-1179 in the Gilead collaboration with Assembly Biosciences (ASMB)?
Gilead’s clinical plan designates GS-1179 to advance into a Phase 2 trial in recurrent genital herpes by year-end 2026. The program may also be evaluated with HIV PrEP, while Assembly Biosciences weighs opting into a 40% U.S. cost‑profit share.

How did Assembly Biosciences’ (ASMB) operating expenses change in Q2 2026?
Total operating expenses were $19.7 million in Q2 2026 versus $20.7 million a year earlier. Research and development declined to $14.9 million, while general and administrative expenses rose slightly to $4.8 million, mainly from higher stock‑based compensation.

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

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
Understanding 8-K Material Events →
0001426800false00014268002026-08-132026-08-13

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 13, 2026

Assembly Biosciences, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-35005

20-8729264

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

Two Tower Place, 7th Floor,

South San Francisco, California

94080

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (833) 509-4583

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.001

 

ASMB

 

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 2.02 Results of Operations and Financial Condition.

On August 13, 2026, Assembly Biosciences, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2026. A copy of the press release is attached hereto as Exhibit 99.1.

The information furnished with this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

Description

99.1

Press Release dated August 13, 2026.

 104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Assembly Biosciences, Inc.

Date: August 13, 2026

By:

/s/ John O. Gunderson

John O. Gunderson

VP, General Counsel and Corporate Secretary

 

2

Exhibit 99.1

 

Assembly Biosciences Reports Second Quarter 2026 Financial Results and Recent Updates

– Expanded ABI-6250 clinical development into cholestatic liver diseases, including primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) –

– Completed $115 million gross financing to support advancement of pipeline programs through key development milestones –

– GS-1179 (formerly ABI-1179) selected to advance in HSV HPI program, with Phase 2 initiation expected by year-end 2026 –

– Cash runway projected into 2029, including first $75 million Gilead collaboration extension payment due in Q4 2026 –

SOUTH SAN FRANCISCO, Calif. – August 13, 2026 – Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral and liver diseases, today reported financial results for the second quarter ended June 30, 2026, and recent business updates.

“During the second quarter, we advanced several important strategic priorities, including expanding ABI-6250 into cholestatic liver diseases and strengthening our balance sheet through a successful financing to support the continued advancement of our pipeline," said Jason Okazaki, chief executive officer and president of Assembly Bio. "We were also pleased to receive Gilead’s clinical development plan for the HSV helicase primase inhibitor program, which includes plans for GS-1179 to advance into a Phase 2 clinical trial by the end of 2026. The plan also contemplates evaluation of GS-1179 across broader prevention settings, including in connection with HIV PrEP, further reinforcing the potential opportunity for this program. We expect to make our determination on whether to opt-in to the U.S. cost and profit share soon after we receive the commercial cost estimates from Gilead, which will complete the opt-in package.”

Second Quarter 2026 and Recent Updates

•
Announced expansion of ABI-6250 into cholestatic liver diseases, including PBC and PSC, with a Phase 2 study anticipated to initiate in the first quarter of 2027
•
Completed $115 million gross financing expected to extend funding beyond planned ABI-6250 Phase 2 studies in hepatitis delta virus (HDV) and cholestatic liver diseases
•
Presented topline Phase 1a data for ABI-6250 at the European Association for the Study of the Liver (EASL) Congress 2026 and participated in several scientific and investor conferences during the quarter
•
Received the clinical development plan from Gilead Sciences, Inc. (Gilead) for the herpes simplex virus (HSV) helicase-primase inhibitor (HPI) program. The plan indicates GS-1179 (formerly ABI-1179) has been selected to advance, with a Phase 2 clinical trial in participants with recurrent genital herpes expected to initiate by the end of 2026. The program is also being considered for possible evaluation as part of a combination strategy with HIV pre-exposure prophylaxis (PrEP). Assembly Bio’s decision to opt in to the 40% U.S. cost-profit share will be made after receipt and review of Gilead’s commercial cost estimates, which will complete the opt-in package.

Anticipated Milestones and Events

•
Following receipt of Gilead’s commercial cost estimates for the complete opt-in package for the HSV HPI program, determine by year-end 2026 whether to exercise Assembly Bio’s option to participate in a 40% U.S. cost-profit share in lieu of receiving U.S. milestones and royalties
•
Initiate a Phase 2 clinical study evaluating ABI-6250 in participants with chronic HDV by year-end 2026
•
Initiate a Phase 2 clinical study evaluating ABI-6250 in participants with cholestatic liver diseases, including PBC and PSC, in the first quarter of 2027

Upcoming Conferences

•
American Chemical Society (ACS) Fall 2026: August 23-27, 2026 – Chicago, Illinois
•
International HBV Meeting: September 6-10, 2026 – Singapore
•
ID Week: October 21-24, 2026 – Washington, D.C.
•
American Association for the Study of Liver Diseases (AASLD): November 5-9, 2026 – Denver, Colorado

GS-1179 and ABI-6250 are investigational product candidates that have not been approved anywhere globally, and their safety and efficacy have not been established. GS-1179 is exclusively licensed to Gilead under the collaboration between Assembly Bio and Gilead, and Gilead has the sole right and responsibility for further clinical development and commercialization of the HSV HPI program.

Second Quarter 2026 Financial Results

•
Cash, cash equivalents and marketable securities were $320.4 million as of June 30, 2026, compared to $226.6 million as of March 31, 2026. The company’s cash position, including the first $75 million extension fee due from Gilead in the fourth quarter of 2026 following the third anniversary of the collaboration agreement, is projected to fund operations into 2029.
•
Revenue from collaborative research with Gilead was $13.4 million for the three months ended June 30, 2026, compared to $9.6 million for the same period in 2025. The increase reflects the timing of activities performed and progress toward completion of services under the Gilead Collaboration Agreement, and includes a $5.1 million cumulative catch-up adjustment related to updated estimates of future activities under the collaboration.
•
Research and development expenses were $14.9 million for the three months ended June 30, 2026, compared to $16.1 million for the same period in 2025. The decrease was primarily driven by lower external program expenses due to the completion of clinical trials, partially offset by increased research and discovery activities and higher employee-related expenses.
•
General and administrative expenses were $4.8 million for the three months ended June 30, 2026, compared to $4.6 million for the same period in 2025, primarily driven by increased stock-based compensation related to performance-based awards.
•
Net loss attributable to common stockholders was $3.9 million, or $0.20 per basic and diluted share, for the three months ended June 30, 2026, compared to $10.2 million, or $1.33 per basic and diluted share, for the same period in 2025. The lower net loss was driven by increased revenue, lower research and development expenses and higher interest income from a larger cash balance following Assembly Bio’s recent financings. Lower net loss per share also reflects a higher weighted-average share count in 2026.

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 herpesvirus, 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 realize the potential benefits of its collaboration with Gilead, including all financial aspects of the collaboration and equity investments; 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, including studies 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 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)

 

 

 

June 30,

 

 

December 31,

 

 

 

2026

 

 

2025

 

 

 

(Unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

32,286

 

 

$

58,450

 

Marketable securities

 

 

288,075

 

 

 

189,656

 

Accounts receivable from collaboration with a related party

 

 

822

 

 

 

974

 

Prepaid expenses and other current assets

 

 

6,795

 

 

 

5,469

 

Total current assets

 

 

327,978

 

 

 

254,549

 

 

 

 

 

 

 

Property and equipment, net

 

 

315

 

 

 

221

 

Operating lease right-of-use assets

 

 

2,227

 

 

 

2,508

 

Other assets

 

 

312

 

 

 

312

 

Total assets

 

$

330,832

 

 

$

257,590

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

1,180

 

 

$

1,171

 

Accrued research and development expenses

 

 

2,007

 

 

 

2,387

 

Other accrued expenses

 

 

3,342

 

 

 

7,749

 

Deferred revenue from a related party

 

 

16,304

 

 

 

36,904

 

Operating lease liabilities - short-term

 

 

612

 

 

 

569

 

Total current liabilities

 

 

23,445

 

 

 

48,780

 

 

 

 

 

 

 

Operating lease liabilities - long-term

 

 

1,738

 

 

 

2,059

 

Total liabilities

 

 

25,183

 

 

 

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 June 30, 2026 and December 31, 2025; 19,850,342 and 15,855,329 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

 

 

20

 

 

 

16

 

Additional paid-in capital

 

 

1,151,235

 

 

 

1,038,823

 

Accumulated other comprehensive loss

 

 

(623

)

 

 

(41

)

Accumulated deficit

 

 

(844,983

)

 

 

(832,047

)

Total stockholders' equity

 

 

305,649

 

 

 

206,751

 

Total liabilities and stockholders' equity

 

$

330,832

 

 

$

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 June 30,

 

 

Six Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Collaboration revenue from a related party

 

$

13,374

 

 

$

9,626

 

 

$

21,587

 

 

$

19,045

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

14,917

 

 

 

16,125

 

 

 

29,817

 

 

 

30,976

 

General and administrative

 

 

4,801

 

 

 

4,594

 

 

 

9,484

 

 

 

9,103

 

Total operating expenses

 

 

19,718

 

 

 

20,719

 

 

 

39,301

 

 

 

40,079

 

Loss from operations

 

 

(6,344

)

 

 

(11,093

)

 

 

(17,714

)

 

 

(21,034

)

 

 

 

 

 

 

 

 

 

 

 

 

Other income

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other income, net

 

 

2,487

 

 

 

895

 

 

 

4,778

 

 

 

2,018

 

Total other income

 

 

2,487

 

 

 

895

 

 

 

4,778

 

 

 

2,018

 

Net loss

 

$

(3,857

)

 

$

(10,198

)

 

$

(12,936

)

 

$

(19,016

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on marketable securities

 

 

255

 

 

 

26

 

 

 

582

 

 

 

68

 

Comprehensive loss

 

$

(4,112

)

 

$

(10,224

)

 

$

(13,518

)

 

$

(19,084

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.20

)

 

$

(1.33

)

 

$

(0.72

)

 

$

(2.51

)

Weighted average common shares outstanding, basic and diluted

 

 

18,853,646

 

 

 

7,655,854

 

 

 

17,882,335

 

 

 

7,581,501

 

 

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

2 documents

Press Releases

Other Documents