# EDGAR Filing Document

**Accession Number:** 0001426800
**File Stem:** 0001193125-25-274235
**Filing Date:** 2025-11
**Character Count:** 19319
**Document Hash:** e320d9195d389fd571b1f995baad614e
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-274235.hdr.sgml**: 20251110

**ACCESSION NUMBER**: 0001193125-25-274235

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 11

**CONFORMED PERIOD OF REPORT**: 20251110

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

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251110

**DATE AS OF CHANGE**: 20251110

**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:** 251466280

**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):** November 10, 2025

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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 November 10, 2025, Assembly Biosciences, Inc. (the "Company") issued a press release announcing its financial results for the quarter ended September 30, 2025. 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 November 10, 2025.</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: November 10, 2025 | 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 Third Quarter 2025 Financial Results and Recent Updates**

*– Released positive Phase 1b interim results for long-acting helicase-primase inhibitor candidate ABI-5366 showing significant reductions in viral shedding rate and genital lesion rate in recurrent genital herpes –*

*– Announced Phase 1a interim results for orally bioavailable HDV entry inhibitor candidate ABI-6250 supporting progression into Phase 2 evaluation –*

*– Additional interim Phase 1b data readouts from HSV program anticipated to include monthly oral dosing for ABI-5366 and two cohorts of weekly oral dosing for ABI-1179, with data now expected by end of year –*

*– Raised $175 million gross proceeds from equity financings –*

SOUTH SAN FRANCISCO, Calif. – November 10, 2025 – Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent updates for the third quarter ended September 30, 2025.

"Our third quarter was marked by significant progress across our pipeline and important data releases, particularly the impressive interim antiviral activity and clinical outcomes data from our Phase 1b study for ABI-5366 in participants with recurrent genital herpes," said Jason Okazaki, chief executive officer and president of Assembly Bio. "The $175 million equity investment we completed in August enables us to advance both our HSV and HDV programs into Phase 2 while continuing our efforts to discover and develop new programs. With enrollment in our Phase 1b study for ABI-5366 and two cohorts in our Phase 1b study for ABI-1179 now complete, we look forward to sharing additional data updates from our HSV program later this year."

**Third Quarter 2025 and Recent Highlights**

• **Herpes Simplex Virus (HSV)**

oReleased positive interim results from a Phase 1b study of ABI-5366, a long-acting helicase-primase inhibitor development candidate, demonstrating significant reductions in HSV type 2 (HSV-2) shedding rate, high viral load shedding and genital lesion rates in participants with recurrent genital herpes

oCompleted enrollment in the ongoing Phase 1b study of ABI-5366 in participants with recurrent genital herpes

oCompleted enrollment in two cohorts of the ongoing Phase 1b study in participants with recurrent genital herpes for ABI-1179, a second long-acting helicase-primase inhibitor development candidate

oPresented interim Phase 1b data for ABI-5366 in a late-breaking oral presentation at the 38th Congress of the International Union Against Sexually Transmitted Infections (IUSTI)-Europe

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• **Hepatitis D Virus (HDV)**

oReleased interim results from a Phase 1a study of ABI-6250, an oral HDV entry inhibitor candidate, showing a pharmacokinetic profile supporting once-daily dosing, and dose-dependent increases in a biomarker of target engagement supporting progression to Phase 2 clinical evaluation in HDV

oCompleted enrollment and follow-up period in the Phase 1a study of ABI-6250 in healthy participants

oPresented preclinical profiling of ABI-6250 in an oral presentation at the 2025 International HBV meeting

• **Hepatitis B Virus (HBV)**

oPresented positive data from a Phase 1b study for ABI-4334, a next-generation, highly potent HBV capsid assembly modulator candidate, in a late-breaking poster presentation at the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting®

• **Financing**

oRaised $175 million in gross proceeds from equity financing with key institutional investors, strengthening financial position to support ongoing and future clinical development

**Anticipated Milestones and Events**

• Mr. Okazaki and Anuj Gaggar, MD, PhD, chief medical officer, will present in a fireside chat during the Guggenheim 2nd Annual Healthcare Innovation Conference on November 12, 2025

• Interim Phase 1b data readout for the HSV program in participants with recurrent genital herpes now anticipated by end of year from two cohorts of weekly dosing of ABI-1179 and one cohort of monthly dosing of ABI-5366. These datasets are expected to be announced together once all virology analyses are completed

• Initiation of a Phase 2 clinical study of ABI-5366 anticipated in mid-2026

ABI-1179 was contributed by Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and Gilead. ABI-5366, ABI-1179, ABI-6250 and ABI-4334 are investigational product candidates that have not been approved anywhere globally, and their safety and efficacy have not been established.

**Third Quarter 2025 Financial Results**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Cash, cash equivalents and marketable securities** were $232.6 million as of September 30, 2025, compared to $75.0 million as of June 30, 2025. Assembly Bio's cash position is projected to fund operations into late 2027. This cash runway guidance does not include potential future payments to Assembly Bio under the collaboration with Gilead or from potential warrant exercises, which would further extend cash runway beyond 2028.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Revenue** from collaborative research with Gilead was $10.8 million for the three months ended September 30, 2025, compared to $6.8 million in the same period in 2024. The change reflects the increase in research and development incurred under the collaboration as well as an increase in collaboration funding.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Research and development expenses** were $16.6 million for the three months ended September 30, 2025, compared to $13.5 million for the same period in 2024. The increase is largely driven by an increase in spending on the Company's HSV program, as both ABI-1179 and ABI-5366 saw significant enrollment in their respective Phase 1b clinical studies during the current quarter.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**General and administrative expenses** were $5.1 million for the three months ended September 30, 2025, compared to $4.3 million for the same period in 2024. The increase was primarily due to higher professional fees and increased stock-based compensation related to performance-based awards.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Net loss attributable to common stockholders** was $9.2 million, or $0.72 per basic and diluted share, for the three months ended September 30, 2025, compared to $9.6 million, or $1.51 per basic and diluted share, for the same period in 2024.

**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.

**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; the U.S. federal government shutdown and potential effects of changes in government regulation, including as a result of the change in U.S. administration in 2025; 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

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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:**<br>Sam Brown LLC<br>Alyssa Kuciunas

(331) 481-3751<br>ASMBMedia@sambrown.com

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**ASSEMBLY BIOSCIENCES, INC.**

**CONDENSED CONSOLIDATED BALANCE SHEETS**

(In thousands except for share amounts and par value)

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| | | |
|:---|:---|:---|
|  | **September 30,** | **December 31,** |
|  | **2025** | **2024** |
|  | **(Unaudited)** |  |
| **ASSETS** |  |  |
| Current assets |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $22534 | $38344 |
| &nbsp;&nbsp;&nbsp;&nbsp;Marketable securities | 210023 | 73735 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts receivable from collaboration with a related party | 912 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 3343 | 3424 |
| Total current assets | 236812 | 115503 |
| &nbsp;&nbsp;&nbsp;&nbsp;Property and equipment, net | 229 | 284 |
| &nbsp;&nbsp;&nbsp;&nbsp;Operating lease right-of-use assets | 2644 | 3069 |
| &nbsp;&nbsp;&nbsp;&nbsp;Other assets | 312 | 312 |
| **Total assets** | $**239997** | $**119168** |
| **LIABILITIES AND STOCKHOLDERS' EQUITY** |  |  |
| Current liabilities |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | $1683 | $585 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accrued research and development expenses | 3058 | 2273 |
| &nbsp;&nbsp;&nbsp;&nbsp;Other accrued expenses | 5728 | 6862 |
| &nbsp;&nbsp;&nbsp;&nbsp;Deferred revenue from a related party - short-term | 42363 | 37622 |
| &nbsp;&nbsp;&nbsp;&nbsp;Operating lease liabilities - short-term | 548 | 461 |
| Total current liabilities | 53380 | 47803 |
| &nbsp;&nbsp;&nbsp;&nbsp;Deferred revenue from a related party - long-term | 1715 | 35378 |
| &nbsp;&nbsp;&nbsp;&nbsp;Operating lease liabilities - long-term | 2207 | 2628 |
| **Total liabilities** | **57302** | **85809** |
| **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 September 30, 2025 and December 31, 2024; 15,816,987 and 7,457,240 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | 16 | 7 |
| &nbsp;&nbsp;&nbsp;&nbsp;Additional paid-in capital | 1036906 | 859488 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accumulated other comprehensive loss | (90) | (211) |
| &nbsp;&nbsp;&nbsp;&nbsp;Accumulated deficit | (854137) | (825925) |
| &nbsp;&nbsp;&nbsp;&nbsp;Total stockholders' equity | 182695 | 33359 |
| **Total liabilities and stockholders' equity** | $**239997** | $**119168** |

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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 September 30,** | **Three Months Ended September 30,** | **Nine Months Ended September 30,** | **Nine Months Ended September 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
| **Collaboration revenue from a related party** | $10789 | $6845 | $29834 | $21163 |
| **Operating expenses** |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 16587 | 13515 | 47563 | 41653 |
| &nbsp;&nbsp;&nbsp;&nbsp;General and administrative | 5085 | 4286 | 14188 | 13398 |
| Total operating expenses | 21672 | 17801 | 61751 | 55051 |
| **Loss from operations** | **(10883)** | **(10956)** | **(31917)** | **(33888)** |
| **Other income** |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest and other income, net | 1687 | 1343 | 3705 | 4452 |
| Total other income | 1687 | 1343 | 3705 | 4452 |
| **Loss before income taxes** | **(9196)** | **(9613)** | **(28212)** | **(29436)** |
| Income tax expense |  |  |  | 406 |
| **Net loss** | $**(9196)** | $**(9613)** | $**(28212)** | $**(29842)** |
| **Other comprehensive loss** |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Unrealized gain (loss) on marketable securities | 189 | 137 | 121 | (75) |
| **Comprehensive loss** | $**(9007)** | $**(9476)** | $**(28091)** | $**(29917)** |
| Net loss per share, basic and diluted | $(0.72) | $(1.51) | $(3.03) | $(5.12) |
| Weighted average common shares outstanding, basic and diluted | 12686122 | 6351431 | 9301740 | 5827750 |

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