# EDGAR Filing Document

**Accession Number:** 0001426800
**File Stem:** 0001193125-26-211922
**Filing Date:** 2026-5
**Character Count:** 16559
**Document Hash:** 9428e54c07d011a3417fd55254b2cfee
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-211922.hdr.sgml**: 20260507

**ACCESSION NUMBER**: 0001193125-26-211922

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 10

**CONFORMED PERIOD OF REPORT**: 20260507

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260507

**DATE AS OF CHANGE**: 20260507

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** ASSEMBLY BIOSCIENCES, INC.
- **CENTRAL INDEX KEY:** 0001426800
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-35005
- **FILM NUMBER:** 26953397

**BUSINESS ADDRESS:**
- **STREET 1:** TWO TOWER PLACE
- **STREET 2:** 7TH FLOOR
- **CITY:** SOUTH SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94080
- **BUSINESS PHONE:** (833) 409-4583

**MAIL ADDRESS:**
- **STREET 1:** TWO TOWER PLACE
- **STREET 2:** 7TH FLOOR
- **CITY:** SOUTH SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94080

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** VENTRUS BIOSCIENCES INC
- **DATE OF NAME CHANGE:** 20080211

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549** 

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**FORM** 8-K

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**CURRENT REPORT**

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

**Date of Report (Date of earliest event reported):** May 7, 2026

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Assembly Biosciences, Inc.

 **(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-35005 | 20-8729264 |
| **(State or Other Jurisdiction**<br>**of Incorporation)** | **(Commission File Number)** | **(IRS Employer**<br>**Identification No.)** |
| Two Tower Place**,** 7th Floor**,**<br>South San Francisco**,** California |  | 94080 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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

**Not Applicable**

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

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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:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br>**Symbol(s)** | **Name of each exchange on which registered** |
| Common Stock, par value $0.001 | ASMB | The Nasdaq Global Select Market |

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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. ☐

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**Item 2.02 Results of Operations and Financial Condition.**

On May 7, 2026, Assembly Biosciences, Inc. (the "Company") issued a press release announcing its financial results for the quarter ended March 31, 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) <u>Exhibits</u>.

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| | |
|:---|:---|
| **Exhibit**<br>**Number** | **Description** |
| 99.1 | [<u>Press Release dated May 7, 2026.</u>](asmb-ex99_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**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.

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| | | |
|:---|:---|:---|
|  | Assembly Biosciences, Inc. | Assembly Biosciences, Inc. |
| Date: May 7, 2026 | By: | /s/ John O. Gunderson |
|  |  | John O. Gunderson |
|  |  | VP, General Counsel and Corporate Secretary |

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## Exhibit 99.1

**Exhibit 99.1**

**Assembly Biosciences Reports First Quarter 2026 Financial Results and Recent Highlights**

*– Completed Phase 1b studies for ABI-5366 and ABI-1179, helicase-primase inhibitors for recurrent genital herpes –*

*– Completed chronic toxicology studies for ABI-6250, an oral small-molecule entry inhibitor candidate for chronic hepatitis delta virus; Phase 2 initiation anticipated Q4 2026 –*

SOUTH SAN FRANCISCO, Calif. – May 7, 2026 – Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results for the first quarter ended March 31, 2026, and recent highlights.

"The first quarter reflected steady progress across our portfolio as we continue advancing our discovery and development programs," said Jason Okazaki, chief executive officer and president of Assembly Bio. "As we look ahead, we anticipate receiving Gilead's development plan and budget for the herpesvirus program and will evaluate our cost and profit share opt-in decision by mid-2026 while continuing to advance ABI-6250 toward Phase 2 in hepatitis delta virus by year-end."

**First Quarter 2026 and Recent Highlights**

• Completed follow-up period for all participants in the Phase 1b portion of the studies for ABI-5366 and ABI-1179, reinforcing continued confidence in the safety and efficacy findings previously disclosed for both candidates

• Completed chronic toxicology studies for ABI-6250, establishing support for anticipated phase 2 doses

• Presented an oral presentation and three posters, including one late-breaker, highlighting interim Phase 1b data for ABI-5366 and ABI-1179 at the 2026 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in Munich, Germany

**Anticipated Milestones and Events**

• By mid-2026, upon receipt of Gilead Sciences, Inc. (Gilead)'s development plan and budget for the helicase-primase inhibitor (HPI) program (ABI-5366 and ABI-1179) for recurrent genital herpes, Assembly Bio to determine whether to opt in to a 40% U.S. cost-profit share, in lieu of receiving U.S. milestones and royalties

• Initiation of a Phase 2 clinical study for ABI-6250 in participants with chronic hepatitis delta virus (HDV) infection expected in the fourth quarter of 2026

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**Upcoming Conferences**

• **European Association for the Study of the Liver (EASL) Congress:** May 27-30, 2026 – Barcelona, Spain

ABI-5366, ABI-1179 and ABI-6250 are investigational product candidates that have not been approved anywhere globally, and their safety and efficacy have not been established. ABI-5366 and ABI-1179 are 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 HPI program.

**First Quarter 2026 Financial Results**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Cash, cash equivalents and marketable securities** were $226.6 million as of March 31, 2026, compared to $248.1 million as of December 31, 2025. The company's cash position is projected to fund operations into 2028.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Revenue** from collaborative research with Gilead was $8.2 million for the three months ended March 31, 2026, compared to $9.4 million for the same period in 2025. The decrease reflects the timing of activities performed and progress toward completion of services under the Gilead Collaboration Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Research and development expenses** were $14.9 million for the three months ended March 31, 2026, consistent with the same period in 2025, with increases in employee compensation and research and discovery activities offset by decreases in external program expenses due to the completion of clinical trials.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**General and administrative expenses** were $4.7 million for the three months ended March 31, 2026, compared to $4.5 million for the same period in 2025, primarily driven by increased stock-based compensation related to performance-based awards.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Net loss attributable to common stockholders** was $9.1 million, or $0.54 per basic and diluted share, for the three months ended March 31, 2026, compared to $8.8 million, or $1.17 per basic and diluted share, for the same period in 2025, reflecting 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 designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For more information, visit assemblybio.com.

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**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, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio's product candidates; clinical and nonclinical data may not differentiate Assembly Bio's 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

<u>investor_relations@assemblybio.com</u> 

**Media:**

Sam Brown LLC

Jamie Strachota

(703) 819-7647

<u>ASMBMedia@sambrown.com</u>

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**ASSEMBLY BIOSCIENCES, INC.**

**CONDENSED CONSOLIDATED BALANCE SHEETS**

(In thousands except for share amounts and par value)

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| | | |
|:---|:---|:---|
|  | **March 31,** | **December 31,** |
|  | **2026** | **2025** |
|  | **(Unaudited)** |  |
| **ASSETS** |  |  |
| Current assets |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $31120 | $58450 |
| &nbsp;&nbsp;&nbsp;&nbsp;Marketable securities | 195481 | 189656 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts receivable from collaboration with a related party | 451 | 974 |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 5561 | 5469 |
| Total current assets | 232613 | 254549 |
| &nbsp;&nbsp;&nbsp;&nbsp;Property and equipment, net | 214 | 221 |
| &nbsp;&nbsp;&nbsp;&nbsp;Operating lease right-of-use assets | 2369 | 2508 |
| &nbsp;&nbsp;&nbsp;&nbsp;Other assets | 312 | 312 |
| **Total assets** | $**235508** | $**257590** |
| **LIABILITIES AND STOCKHOLDERS' EQUITY** |  |  |
| Current liabilities |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | $1129 | $1171 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accrued research and development expenses | 1538 | 2387 |
| &nbsp;&nbsp;&nbsp;&nbsp;Other accrued expenses | 2664 | 7749 |
| &nbsp;&nbsp;&nbsp;&nbsp;Deferred revenue from a related party | 29076 | 36904 |
| &nbsp;&nbsp;&nbsp;&nbsp;Operating lease liabilities - short-term | 590 | 569 |
| Total current liabilities | 34997 | 48780 |
| &nbsp;&nbsp;&nbsp;&nbsp;Operating lease liabilities - long-term | 1901 | 2059 |
| **Total liabilities** | **36898** | **50839** |
| **Commitments and contingencies** |  |  |
| **Stockholders' equity** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Common stock, $0.001 par value; 150,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 15,892,353 and 15,855,329 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively | 16 | 16 |
| &nbsp;&nbsp;&nbsp;&nbsp;Additional paid-in capital | 1040088 | 1038823 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accumulated other comprehensive loss | (368) | (41) |
| &nbsp;&nbsp;&nbsp;&nbsp;Accumulated deficit | (841126) | (832047) |
| &nbsp;&nbsp;&nbsp;&nbsp;Total stockholders' equity | 198610 | 206751 |
| **Total liabilities and stockholders' equity** | $**235508** | $**257590** |

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**ASSEMBLY BIOSCIENCES, INC.**

**CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS**

(In thousands except for share and per share amounts)

(Unaudited)

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| | | |
|:---|:---|:---|
|  | **Three Months Ended March 31,** | **Three Months Ended March 31,** |
|  | **2026** | **2025** |
| **Collaboration revenue from a related party** | $8213 | $9419 |
| **Operating expenses** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 14900 | 14851 |
| &nbsp;&nbsp;&nbsp;&nbsp;General and administrative | 4683 | 4509 |
| Total operating expenses | 19583 | 19360 |
| **Loss from operations** | **(11370)** | **(9941)** |
| **Other income** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest and other income, net | 2291 | 1123 |
| Total other income | 2291 | 1123 |
| **Net loss** | $**(9079)** | $**(8818)** |
| **Other comprehensive loss** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Unrealized loss on marketable securities | 327 | 42 |
| **Comprehensive loss** | $**(9406)** | $**(8860)** |
| Net loss per share, basic and diluted | $(0.54) | $(1.17) |
| Weighted average common shares outstanding, basic and diluted | 16900232 | 7506321 |

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