8-K
0001426800false00014268002024-03-282024-03-28

 

 

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 28, 2024

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 March 28, 2024, Assembly Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2023. 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 March 28, 2024.

 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: March 28, 2024

By:

/s/ John O. Gunderson

John O. Gunderson

VP, General Counsel and Corporate Secretary

 

2


EX-99.1

Exhibit 99.1

 

Assembly Biosciences Reports Fourth Quarter and Year End 2023 Financial Results and Recent Highlights

Four candidates planned to be in clinical development in 2024 with interim data from two studies anticipated by year end
Clinical development timelines accelerated for ABI-5366; now anticipating interim data from Phase 1a available in 3Q2024, initiation of Phase 1b in individuals with recurrent genital herpes by end of 2024 and interim Phase 1b data available in 1H2025
Gilead Sciences, Inc. partnership supports advancement and strengthening of antiviral pipeline targeting serious viral diseases

SOUTH SAN FRANCISCO, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent highlights for the fourth quarter and year ended December 31, 2023.

“Our progress in 2023 demonstrated our capacity to drive our expanded antiviral pipeline forward and our commitment to individuals suffering from life-impacting viral diseases,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “With our long-term partnership in place with Gilead and the addition of Dr. Anuj Gaggar to our management team as CMO, we are well-positioned to make critical progress clinically across multiple programs in 2024 and look forward to sharing preliminary data on 5366 and 4334 later this year.”

Fourth Quarter 2023 and Recent Highlights

Entered a long-term partnership with Gilead to advance discovery and development of novel antiviral therapies
Strengthened the leadership team with the naming of Anuj Gaggar, MD, PhD, as chief medical officer
Filed a clinical trial application for ABI-5366 to support initiation of Phase 1a/1b clinical studies

Anticipated Milestones and Events

By mid-year 2024:

ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor targeting recurrent genital herpes, is expected to enter a Phase 1a/1b study
ABI-4334, a next-generation, highly potent capsid assembly modulator, is anticipated to enter a Phase 1b study in individuals with chronic hepatitis B virus infection

Q3 2024:

Interim clinical data from the ABI-5366 Phase 1a study portion expected to be available

By the end of 2024:

Interim clinical data from the ABI-4334 Phase 1b study expected to be available
The Phase 1b portion of the ABI-5366 study, in individuals with recurrent genital herpes, is anticipated to be underway

Two additional candidates are anticipated to enter the clinic:
o
ABI-1179, a long-acting HSV helicase-primase inhibitor contributed by Gilead under the collaboration between Assembly Bio and Gilead
o
ABI-6250, a small molecule orally-bioavailable hepatitis delta virus entry inhibitor

First half 2025:

Interim clinical data from the Phase 1b portion of the ABI-5366 study expected to be available

Fourth Quarter 2023 and Year End Financial Results

Cash, cash equivalents and marketable securities were $130.2 million as of December 31, 2023, compared to $46.2 million as of September 30, 2023, and $91.6 million as of the year ended December 31, 2022. The company’s cash position is projected to fund operations into the second half of 2025.
Revenues from collaborative research were $7.2 million for the year ended December 31, 2023. There was no revenue recognized for the same period in 2022. Revenue for the year ended December 31, 2023, consists of $4.4 million recognized under the collaboration with Gilead and the remaining deferred revenue balance of $2.7 million under the collaboration agreement with BeiGene following Assembly Bio’s decision to discontinue further development of ABI-H3733 in conjunction with entering into the Gilead collaboration, following the previous prioritization of ABI-4334 over ABI-H3733.
Research and development expenses were $48.9 million for the year ended December 31, 2023, compared to $70.0 million in 2022. The decrease is due to completion of the clinical trials for ABI-H3733 and ABI-4334, discontinued development of vebicorvir and ABI-H2158, and decreases in employee and contractor-related expenses.
General and administrative expenses were $22.9 million for the year ended December 31, 2023, compared to $24.1 million in 2022. The decrease is due to overall cost-saving initiatives.
Net loss attributable to common stockholders was $61.2 million, or $13.38 per basic and diluted share, for the year ended December 31, 2023, compared to $93.1 million, or $23.08 per basic and diluted share in 2022.

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.

CONSOLIDATED BALANCE SHEETS

(In thousands except for share amounts and par value)

 

 

 

As of December 31,

 

 

 

2023

 

 

2022

 

ASSETS

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

19,841

 

 

$

52,418

 

Marketable securities

 

 

110,406

 

 

 

39,192

 

Accounts receivable from collaboration

 

 

43

 

 

 

944

 

Prepaid expenses and other current assets

 

 

3,497

 

 

 

4,413

 

Total current assets

 

 

133,787

 

 

 

96,967

 

 

 

 

 

 

 

Property and equipment, net

 

 

385

 

 

 

743

 

Operating lease right-of-use assets

 

 

2,339

 

 

 

3,195

 

Other assets

 

 

312

 

 

 

889

 

Total assets

 

$

136,823

 

 

$

101,794

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

461

 

 

$

2,493

 

Accrued research and development expenses

 

 

885

 

 

 

3,122

 

Other accrued expenses

 

 

5,744

 

 

 

7,317

 

Deferred revenue - short-term ($30,915 and $− to a related party)

 

 

30,915

 

 

 

 

Operating lease liabilities - short-term

 

 

1,220

 

 

 

3,364

 

Total current liabilities

 

 

39,225

 

 

 

16,296

 

 

 

 

 

 

 

Deferred revenue - long-term ($55,379 and $− to a related party)

 

 

55,379

 

 

 

2,733

 

Operating lease liabilities - long-term

 

 

1,122

 

 

 

101

 

Total liabilities

 

 

95,726

 

 

 

19,130

 

 

 

 

 

 

 

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 December 31,
   2023 and December 31, 2022; 5,482,752 and 4,074,552 shares issued and
   outstanding as of December 31, 2023 and December 31, 2022, respectively

 

 

5

 

 

 

4

 

Additional paid-in capital

 

 

826,921

 

 

 

807,983

 

Accumulated other comprehensive loss

 

 

(81

)

 

 

(803

)

Accumulated deficit

 

 

(785,748

)

 

 

(724,520

)

Total stockholders' equity

 

 

41,097

 

 

 

82,664

 

Total liabilities and stockholders' equity

 

$

136,823

 

 

$

101,794

 

 


ASSEMBLY BIOSCIENCES, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands except for share and per share amounts)

 

 

 

Year Ended December 31,

 

 

 

2023

 

 

2022

 

Collaboration revenue ($4,430 and $− from a related party)

 

$

7,163

 

 

$

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

Research and development

 

 

48,900

 

 

 

69,980

 

General and administrative

 

 

22,909

 

 

 

24,134

 

Total operating expenses

 

 

71,809

 

 

 

94,114

 

Loss from operations

 

 

(64,646

)

 

 

(94,114

)

 

 

 

 

 

 

Other income

 

 

 

 

 

 

Interest and other income, net

 

 

3,451

 

 

 

1,022

 

Total other income

 

 

3,451

 

 

 

1,022

 

Loss before income taxes

 

 

(61,195

)

 

 

(93,092

)

 

 

 

 

 

 

Income tax expense

 

 

(33

)

 

 

 

Net loss

 

$

(61,228

)

 

$

(93,092

)

 

 

 

 

 

 

Other comprehensive loss

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

 

722

 

 

 

(384

)

Comprehensive loss

 

$

(60,506

)

 

$

(93,476

)

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(13.38

)

 

$

(23.08

)

Weighted average common shares outstanding, basic and diluted

 

 

4,577,371

 

 

 

4,034,105