0000950170-24-055650.txt : 20240508 0000950170-24-055650.hdr.sgml : 20240508 20240508161014 ACCESSION NUMBER: 0000950170-24-055650 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20240508 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240508 DATE AS OF CHANGE: 20240508 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ASSEMBLY BIOSCIENCES, INC. CENTRAL INDEX KEY: 0001426800 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 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: 24926098 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 8-K 1 asmb-20240508.htm 8-K 8-K
False000142680000014268002024-05-082024-05-08

 

 

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): May 8, 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 May 8, 2024, Assembly Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 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.

 

Exhibit

Number

Description

99.1

 

Press Release dated May 8, 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: May 8, 2024

By:

/s/ John O. Gunderson

John O. Gunderson

VP, General Counsel and Corporate Secretary

 

2

 EX-99.1 2 asmb-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

Assembly Biosciences Reports First Quarter 2024 Financial Results and Recent Highlights

•
Clinical trial application clearances received for a Phase 1a/1b trial for ABI-5366 targeting recurrent genital herpes, and a Phase 1b trial for ABI-4334 in chronic HBV infection; both studies on track to initiate by mid-2024
•
ABI-5366 interim Phase 1a first-in-human data expected in Q3 2024 and ABI-4334 interim Phase 1b data expected by end of year

SOUTH SAN FRANCISCO, Calif., May 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 highlights for the first quarter ended March 31, 2024.

“We are pleased that we now have regulatory clearance to initiate trials evaluating our promising investigational therapies ABI-5366 and ABI-4334 and look forward to sharing interim data from these studies later this year,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “These clearances are a significant step toward our goal of reaching key clinical inflection points for multiple programs in our antiviral pipeline by year end. Our continued clinical progress reflects the strength and agility of our highly experienced team and our singular focus of improving treatment options for those living with serious viral diseases.”

First Quarter 2024 and Recent Highlights

•
Two clinical trial applications received clearance to proceed:
o
ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate, for initiation of Phase 1a/1b clinical studies in both healthy volunteers and in individuals with recurrent genital herpes
o
ABI-4334, a next-generation, highly potent capsid assembly modulator candidate, for initiation of a Phase 1b study in individuals with chronic hepatitis B virus (HBV) infection
•
An abstract highlighting preclinical data for ABI-6250, an oral, small molecule HBV/hepatitis delta virus (HDV) entry inhibitor candidate, has been accepted for poster presentation at the European Association for the Study of the Liver (EASL) CongressTM 2024, June 5-8, 2024

Anticipated 2024 Milestones

•
ABI-5366 and ABI-4334 studies expected to initiate by mid-2024
o
ABI-5366 Phase 1a interim clinical data expected in Q3 2024 and interim Phase 1b data expected in the first half of 2025
o
ABI-4334 Phase 1b interim clinical data expected by the end of 2024
•
Two additional candidates are anticipated to enter the clinic by the end of 2024:
o
ABI-1179, a long-acting HSV helicase-primase inhibitor contributed by Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and Gilead
o
ABI-6250, a small molecule orally-bioavailable HDV entry inhibitor

 

First Quarter 2024 Financial Results

•
Cash, cash equivalents and marketable securities were $113.0 million as of March 31, 2024, compared to $130.2 million as of December 31, 2023. Assembly Bio’s cash position is projected to fund operations into the second half of 2025.
•
Revenues from collaborative research were $5.8 million for the three months ended March 31, 2024. There was no revenue recognized for the same period in 2023. Revenue for the three months ended March 31, 2024 consists of amounts recognized under the collaboration with Gilead.
•
Research and development expenses were $11.9 million for the three months ended March 31, 2024, compared to $14.5 million for the same period in 2023. Increased expenses related to the development of ABI-1179 and ABI-6250 were more than offset by savings from the discontinuation of ABI-H3733 and vebicorvir as well as reduced employee and contractor-related expenses.
•
General and administrative expenses were $4.6 million for the three months ended March 31, 2024, compared to $5.0 million for the same period in 2023. The decrease is primarily due to a decrease in non-cash stock-based compensation expense.
•
Net loss attributable to common stockholders was $9.1 million, or $1.66 per basic and diluted share, for the three months ended March 31, 2024, compared to $19.0 million, or $4.46 per basic and diluted share, for the same period in 2023.

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)

 

 

 

March 31,

 

 

December 31,

 

 

 

2024

 

 

2023

 

 

 

(Unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

18,749

 

 

$

19,841

 

Marketable securities

 

 

94,227

 

 

 

110,406

 

Accounts receivable from collaboration

 

 

43

 

 

 

43

 

Prepaid expenses and other current assets

 

 

4,149

 

 

 

3,497

 

Total current assets

 

 

117,168

 

 

 

133,787

 

 

 

 

 

 

 

Property and equipment, net

 

 

367

 

 

 

385

 

Operating lease right-of-use assets

 

 

2,036

 

 

 

2,339

 

Other assets

 

 

312

 

 

 

312

 

Total assets

 

$

119,883

 

 

$

136,823

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

727

 

 

$

461

 

Accrued research and development expenses

 

 

2,059

 

 

 

885

 

Other accrued expenses

 

 

2,051

 

 

 

5,744

 

Deferred revenue from a related party - short-term

 

 

32,771

 

 

 

30,915

 

Operating lease liabilities - short-term

 

 

1,145

 

 

 

1,220

 

Total current liabilities

 

 

38,753

 

 

 

39,225

 

 

 

 

 

 

 

Deferred revenue from a related party - long-term

 

 

47,738

 

 

 

55,379

 

Operating lease liabilities - long-term

 

 

791

 

 

 

1,122

 

Total liabilities

 

 

87,282

 

 

 

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 March 31, 2024 and December 31, 2023; 5,482,752 shares issued and outstanding as of March 31, 2024 and December 31, 2023

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

827,660

 

 

 

826,921

 

Accumulated other comprehensive loss

 

 

(239

)

 

 

(81

)

Accumulated deficit

 

 

(794,825

)

 

 

(785,748

)

Total stockholders' equity

 

 

32,601

 

 

 

41,097

 

Total liabilities and stockholders' equity

 

$

119,883

 

 

$

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 March 31,

 

 

 

2024

 

 

2023

 

Collaboration revenue from a related party

 

$

5,785

 

 

$

—

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

Research and development

 

 

11,879

 

 

 

14,547

 

General and administrative

 

 

4,635

 

 

 

5,012

 

Total operating expenses

 

 

16,514

 

 

 

19,559

 

Loss from operations

 

 

(10,729

)

 

 

(19,559

)

 

 

 

 

 

 

Other income

 

 

 

 

 

 

Interest and other income, net

 

 

1,652

 

 

 

609

 

Total other income

 

 

1,652

 

 

 

609

 

Net loss

 

$

(9,077

)

 

$

(18,950

)

 

 

 

 

 

 

 

Other comprehensive loss

 

 

 

 

 

 

Unrealized (loss) gain on marketable securities

 

 

(158

)

 

 

290

 

Comprehensive loss

 

$

(9,235

)

 

$

(18,660

)

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(1.66

)

 

$

(4.46

)

Weighted average common shares outstanding, basic and diluted

 

 

5,483,313

 

 

 

4,251,037

 

 

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