UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
|
|
||
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s Telephone Number, Including Area Code:
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 |
|
|
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 8, 2024, Assembly Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 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.
Exhibit Number |
|
Description |
99.1 |
|
|
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 8, 2024 |
|
By: |
/s/ John O. Gunderson |
|
|
|
John O. Gunderson |
|
|
|
VP, General Counsel and Corporate Secretary |
2
Exhibit 99.1
Assembly Biosciences Reports Second Quarter 2024 Financial Results and Recent Updates
SOUTH SAN FRANCISCO, Calif., August 8, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent updates for the second quarter ended June 30, 2024.
“Entering the second half of the year, I’m incredibly proud of our team’s accomplishments on our path to delivering novel therapeutics for individuals living with serious viral diseases,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “We are rapidly progressing toward key inflection points for our clinical development programs and remain on track with the data sets we plan to deliver in 2024. Specifically, in the third quarter, we look forward to sharing interim Phase 1a data for ABI-5366 in healthy participants. The pharmacokinetic data in this study will enable us to assess ABI-5366's ability to reach the target concentrations we have established for antiviral efficacy and to support our once-weekly oral dosing profile, while also informing dose selection in the Phase 1b part of the study in participants with recurrent genital herpes.”
Second Quarter 2024 and Recent Highlights
Upcoming Anticipated Milestones
Upcoming Conferences
Second Quarter 2024 Financial Results
The investigational products and investigational product candidates referenced here have not been approved anywhere globally, and their safety and efficacy have not been established.
|
|
|
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 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
(415) 738-2992
investor_relations@assemblybio.com
|
|
|
Media:
Sam Brown Inc.
Hannah Hurdle
(805) 338-4752
ASMBMedia@sambrown.com
|
|
|
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands except for share amounts and par value)
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
|
|
(Unaudited) |
|
|
|
|
||
ASSETS |
|
|
|
|
|
|
||
Current assets |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
19,208 |
|
|
$ |
19,841 |
|
Marketable securities |
|
|
90,011 |
|
|
|
110,406 |
|
Accounts receivable from collaboration |
|
|
— |
|
|
|
43 |
|
Prepaid expenses and other current assets |
|
|
3,712 |
|
|
|
3,497 |
|
Total current assets |
|
|
112,931 |
|
|
|
133,787 |
|
|
|
|
|
|
|
|
||
Property and equipment, net |
|
|
349 |
|
|
|
385 |
|
Operating lease right-of-use assets |
|
|
1,731 |
|
|
|
2,339 |
|
Other assets |
|
|
312 |
|
|
|
312 |
|
Total assets |
|
$ |
115,323 |
|
|
$ |
136,823 |
|
|
|
|
|
|
|
|
||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
||
Current liabilities |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
801 |
|
|
$ |
461 |
|
Accrued research and development expenses |
|
|
2,531 |
|
|
|
885 |
|
Other accrued expenses |
|
|
3,587 |
|
|
|
5,744 |
|
Deferred revenue from a related party - short-term |
|
|
33,060 |
|
|
|
30,915 |
|
Operating lease liabilities - short-term |
|
|
1,295 |
|
|
|
1,220 |
|
Total current liabilities |
|
|
41,274 |
|
|
|
39,225 |
|
|
|
|
|
|
|
|
||
Deferred revenue from a related party - long-term |
|
|
38,916 |
|
|
|
55,379 |
|
Operating lease liabilities - long-term |
|
|
451 |
|
|
|
1,122 |
|
Total liabilities |
|
|
80,641 |
|
|
|
95,726 |
|
|
|
|
|
|
|
|
||
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, 2024 and December 31, 2023; 6,345,561 and 5,482,752 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively |
|
|
6 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
840,946 |
|
|
|
826,921 |
|
Accumulated other comprehensive loss |
|
|
(293 |
) |
|
|
(81 |
) |
Accumulated deficit |
|
|
(805,977 |
) |
|
|
(785,748 |
) |
Total stockholders' equity |
|
|
34,682 |
|
|
|
41,097 |
|
Total liabilities and stockholders' equity |
|
$ |
115,323 |
|
|
$ |
136,823 |
|
|
|
|
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, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Collaboration revenue from a related party |
|
$ |
8,533 |
|
|
$ |
— |
|
|
$ |
14,318 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
16,259 |
|
|
|
12,523 |
|
|
|
28,138 |
|
|
|
27,070 |
|
General and administrative |
|
|
4,477 |
|
|
|
4,965 |
|
|
|
9,112 |
|
|
|
9,977 |
|
Total operating expenses |
|
|
20,736 |
|
|
|
17,488 |
|
|
|
37,250 |
|
|
|
37,047 |
|
Loss from operations |
|
|
(12,203 |
) |
|
|
(17,488 |
) |
|
|
(22,932 |
) |
|
|
(37,047 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest and other income, net |
|
|
1,457 |
|
|
|
592 |
|
|
|
3,109 |
|
|
|
1,201 |
|
Total other income |
|
|
1,457 |
|
|
|
592 |
|
|
|
3,109 |
|
|
|
1,201 |
|
Loss before income taxes |
|
|
(10,746 |
) |
|
|
(16,896 |
) |
|
|
(19,823 |
) |
|
|
(35,846 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Income tax expense |
|
|
406 |
|
|
|
— |
|
|
|
406 |
|
|
|
— |
|
Net loss |
|
$ |
(11,152 |
) |
|
$ |
(16,896 |
) |
|
$ |
(20,229 |
) |
|
$ |
(35,846 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized (loss) gain on marketable securities |
|
|
(54 |
) |
|
|
188 |
|
|
|
(212 |
) |
|
|
478 |
|
Comprehensive loss |
|
$ |
(11,206 |
) |
|
$ |
(16,708 |
) |
|
$ |
(20,441 |
) |
|
$ |
(35,368 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share, basic and diluted |
|
$ |
(1.98 |
) |
|
$ |
(3.88 |
) |
|
$ |
(3.64 |
) |
|
$ |
(8.33 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
5,642,752 |
|
|
|
4,355,007 |
|
|
|
5,563,033 |
|
|
|
4,303,244 |
|
|
|
|