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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): March 20, 2025
Assembly Biosciences, Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware |
001-35005 |
20-8729264 |
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(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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Two Tower Place, 7th Floor, South San Francisco, California |
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94080 |
(Address of Principal Executive Offices) |
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(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) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, par value $0.001 |
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ASMB |
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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 March 20, 2025, Assembly Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2024. 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.
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Exhibit Number |
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Description |
99.1 |
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104 |
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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. |
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Date: March 20, 2025 |
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By: |
/s/ John O. Gunderson |
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John O. Gunderson |
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VP, General Counsel and Corporate Secretary |
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Exhibit 99.1
Assembly Biosciences Reports Year End 2024 Financial Results and Recent Highlights
– Four development candidates in clinical studies with data anticipated this year, continuing rapid progress of antiviral pipeline –
– Interim Phase 1b proof-of-concept data, including initial efficacy measures, anticipated in fall 2025 for ABI-5366 and ABI-1179, long-acting helicase-primase inhibitor candidates for recurrent genital herpes –
SOUTH SAN FRANCISCO, Calif., March 20, 2025 – Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results for the year ended December 31, 2024, and recent highlights.
“We are well-positioned to deliver important clinical data on four of our novel antiviral candidates in 2025, including proof-of-concept efficacy data expected this fall from the Phase 1b studies of ABI-5366 and ABI-1179 for recurrent genital herpes,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “We anticipate that the rapid progress across our clinical pipeline we saw in 2024 will continue this year, reinforcing the exceptional execution of our R&D organization and our commitment to changing the treatment paradigm for individuals living with serious viral diseases.”
Fourth Quarter 2024 and Recent Highlights
Anticipated Milestones and Events
ABI-1179 was contributed by Gilead under the collaboration between Assembly Bio and Gilead. ABI-5366, ABI-1179, ABI-6250, ABI-4334 and ABI-7423 are investigational product candidates that have not been approved anywhere globally, and their safety and efficacy have not been established.
Year End 2024 Financial Results
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 maintain financial resources necessary to continue its research activities, clinical studies and other business operations; Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., 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 presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; 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
Investor and Corporate:
Shannon Ryan
SVP, Investor Relations, Corporate Affairs and Alliance Management (In thousands except for share amounts and par value)
(415) 738-2992
investor_relations@assemblybio.com
Media:
Sam Brown Inc.
Hannah Hurdle
(805) 338-4752
ASMBMedia@sambrown.com
ASSEMBLY BIOSCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
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As of December 31, |
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2024 |
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2023 |
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ASSETS |
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Current assets |
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Cash and cash equivalents |
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$ |
38,344 |
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$ |
19,841 |
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Marketable securities |
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73,735 |
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110,406 |
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Accounts receivable from collaboration |
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— |
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43 |
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Prepaid expenses and other current assets |
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3,424 |
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3,497 |
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Total current assets |
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115,503 |
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133,787 |
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Property and equipment, net |
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284 |
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385 |
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Operating lease right-of-use assets |
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3,069 |
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2,339 |
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Other assets |
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312 |
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312 |
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Total assets |
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$ |
119,168 |
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$ |
136,823 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities |
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Accounts payable |
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$ |
585 |
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$ |
461 |
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Accrued research and development expenses |
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2,273 |
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885 |
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Other accrued expenses |
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6,862 |
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5,744 |
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Deferred revenue from a related party - short-term |
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37,622 |
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30,915 |
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Operating lease liabilities - short-term |
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461 |
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1,220 |
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Total current liabilities |
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47,803 |
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39,225 |
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Deferred revenue from a related party - long-term |
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35,378 |
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55,379 |
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Operating lease liabilities - long-term |
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2,628 |
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1,122 |
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Total liabilities |
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85,809 |
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95,726 |
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Commitments and contingencies |
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Stockholders' equity |
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Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding |
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— |
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— |
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Common stock, $0.001 par value; 150,000,000 shares authorized as of December 31, 2024 and December 31, 2023; 7,457,240 and 5,482,752 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively |
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7 |
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5 |
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Additional paid-in capital |
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859,488 |
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826,921 |
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Accumulated other comprehensive loss |
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(211 |
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(81 |
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Accumulated deficit |
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(825,925 |
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(785,748 |
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Total stockholders' equity |
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33,359 |
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41,097 |
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Total liabilities and stockholders' equity |
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$ |
119,168 |
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$ |
136,823 |
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ASSEMBLY BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands except for share and per share amounts)
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Year Ended December 31, |
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2024 |
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2023 |
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Collaboration revenue ($28,520 and $4,430 from a related party) |
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$ |
28,520 |
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$ |
7,163 |
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Operating expenses |
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Research and development |
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55,933 |
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48,900 |
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General and administrative |
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18,007 |
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22,909 |
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Total operating expenses |
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73,940 |
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71,809 |
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Loss from operations |
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(45,420 |
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(64,646 |
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Other income |
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Interest and other income, net |
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5,573 |
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3,451 |
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Total other income |
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5,573 |
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3,451 |
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Loss before income taxes |
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(39,847 |
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(61,195 |
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Income tax expense |
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330 |
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33 |
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Net loss |
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$ |
(40,177 |
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$ |
(61,228 |
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Other comprehensive loss |
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Unrealized (loss) gain on marketable securities |
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(130 |
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722 |
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Comprehensive loss |
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$ |
(40,307 |
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$ |
(60,506 |
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Net loss per share, basic and diluted |
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$ |
(6.69 |
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$ |
(13.38 |
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Weighted average common shares outstanding, basic and diluted |
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6,004,560 |
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4,577,371 |
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