8-K
false000142680000014268002023-11-082023-11-08

 

 

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): November 8, 2023

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.)

 

 

 

331 Oyster Point Blvd., Fourth 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 November 8, 2023, Assembly Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 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 November 8, 2023.

 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: November 8, 2023

By:

/s/ John O. Gunderson

John O. Gunderson

VP, General Counsel and Corporate Secretary

 

2


EX-99.1

Exhibit 99.1

 

Assembly Biosciences Reports Third Quarter 2023 Financial Results and Recent Updates

 

-
Established partnership with Gilead Sciences to advance differentiated treatments for herpesviruses, HBV, HDV and beyond
-
Now anticipate four development candidates from expanded pipeline in clinical development by the end of 2024
-
Named Anuj Gaggar, MD, PhD, as chief medical officer
-
$100 million up front payment and investment received from Gilead in October extends projected cash runway into 2H 2025

 

SOUTH SAN FRANCISCO, Calif., November 8, 2023 -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today reported financial results for the third quarter ended September 30, 2023, and recent corporate updates.

 

“The Assembly Bio team has made exceptional progress in building a portfolio of promising antiviral candidates for herpesviruses, hepatitis B and hepatitis D,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “With our new long-term partnership with Gilead, a pioneer in virology, we are excited by the opportunity to accelerate progress on our antiviral pipeline to bring next-generation therapeutics to individuals living with serious viral infections. We believe that the financial and scientific resources provided by the collaboration position us well to reach critical short- and long-term milestones and deliver value for patients and our shareholders. We are also pleased to announce the addition of Dr. Anuj Gaggar to our leadership team as chief medical officer as we look ahead to having multiple antiviral candidates in the clinic next year.”

Third Quarter 2023 and Recent Updates

 

Entered a long-term partnership with Gilead Sciences to advance discovery and development of novel antiviral therapies.
o
Collaboration combines Assembly Bio’s advanced virology research capabilities with Gilead’s established development and commercialization expertise in antiviral medicines to create a synergistic partnership focused on propelling scientific innovation and delivering new treatments to patients with significant unmet need.
o
Partnership includes Gilead opt-in rights on Assembly Bio’s current and future pipeline candidates, including two contributed Gilead herpesvirus programs.
o
$100 million upfront investment by Gilead, including equity investment, plus potential for future regulatory, commercial, opt-in and collaboration extension payments, provides runway to drive portfolio growth and support advancement of company’s current and future clinical and preclinical programs.
Strengthened the leadership team with the naming of Anuj Gaggar, MD, PhD, as chief medical officer, as announced separately today. Dr. Gaggar is an infectious disease specialist who has focused on the development of new therapies in viral diseases

 

including chronic hepatitis B virus (HBV), hepatitis C virus and hepatitis D virus (HDV) infections.
Nominated first development candidate for the treatment of chronic HDV infection. ABI-6250, an orally bioavailable small molecule entry inhibitor, is moving toward IND-enabling studies with the goal of beginning clinical studies by the end of 2024.
Presented preclinical data in two oral and one poster presentation highlighting the progress of multiple HBV and HDV pipeline programs at the 2023 International HBV Meeting held September 19-23, 2023.

 

Anticipated Milestones

 

Assembly Bio anticipates having four candidates in clinical studies by the end of 2024:

ABI-5366, a long-acting helicase-primase inhibitor targeting high-recurrence genital herpes, is expected to enter the clinic by mid-2024.
The herpes simplex virus (HSV) helicase-primase inhibitor candidate contributed by Gilead is expected to enter the clinic by the end of 2024.
ABI-4334, a potent next-generation capsid assembly modulator for HBV, has completed Phase 1a development and is expected to enter Phase 1b by mid-2024.
ABI-6250, a HDV entry inhibitor, is expected to enter the clinic by the end of 2024.

 

Upcoming Conferences

 

Preclinical and clinical data from the company’s viral hepatitis portfolio will be highlighted in two presentations at the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting®, taking place November 10-14, 2023, in Boston.

 

Third Quarter 2023 Financial Results

 

·
Cash, cash equivalents and marketable securities were $46.2 million as of September 30, 2023, compared to $59.8 million as of June 30, 2023. With the $100 million received from Gilead in October, Assembly Bio’s cash position is projected to fund operations into the second half of 2025.
·
Research and development expenses were $10.8 million for the three months ended September 30, 2023, compared to $18.1 million for the same period in 2022. The decrease is due to completion of the clinical trials for ABI-3733 and ABI-4334, discontinued development of vebicorvir and ABI-2158, and decreases in employee and contractor-related expenses.
·
General and administrative expenses were $4.2 million for the three months ended September 30, 2023, compared to $5.3 million for the same period in 2022. The decrease is due to overall cost-saving initiatives.
·
Net loss attributable to common stockholders was $14.4 million, or $0.27 per basic and diluted share, for the three months ended September 30, 2023, compared to $23.1 million, or $0.48 per basic and diluted share, for the same period in 2022.

 


 

About Assembly Biosciences
Assembly Biosciences is a biotechnology company dedicated to the development of innovative small-molecule antiviral 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; the occurrence of any event, change or other circumstance that could give rise to the termination of Assembly Bio’s collaboration with Gilead; 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
sryan@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)

 

 

 

September 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

 

 

(Unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

26,656

 

 

$

52,418

 

Marketable securities

 

 

19,554

 

 

 

39,192

 

Accounts receivable from collaboration

 

 

 

 

 

944

 

Prepaid expenses and other current assets

 

 

3,462

 

 

 

4,413

 

Total current assets

 

 

49,672

 

 

 

96,967

 

 

 

 

 

 

 

Property and equipment, net

 

 

561

 

 

 

743

 

Operating lease right-of-use assets

 

 

844

 

 

 

3,195

 

Other assets

 

 

552

 

 

 

889

 

Total assets

 

$

51,629

 

 

$

101,794

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

758

 

 

$

2,493

 

Accrued research and development expenses

 

 

1,619

 

 

 

3,122

 

Other accrued expenses

 

 

3,886

 

 

 

7,317

 

Operating lease liabilities - short-term

 

 

869

 

 

 

3,364

 

Total current liabilities

 

 

7,132

 

 

 

16,296

 

 

 

 

 

 

 

Deferred revenue

 

 

2,733

 

 

 

2,733

 

Operating lease liabilities - long-term

 

 

50

 

 

 

101

 

Total liabilities

 

 

9,915

 

 

 

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 September 30, 2023 and December 31, 2022; 52,614,194 and 48,894,973 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

 

 

53

 

 

 

49

 

Additional paid-in capital

 

 

816,722

 

 

 

807,938

 

Accumulated other comprehensive loss

 

 

(275

)

 

 

(803

)

Accumulated deficit

 

 

(774,786

)

 

 

(724,520

)

Total stockholders' equity

 

 

41,714

 

 

 

82,664

 

Total liabilities and stockholders' equity

 

$

51,629

 

 

$

101,794

 

 


 

ASSEMBLY BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands except for share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

10,824

 

 

$

18,130

 

 

$

37,894

 

 

$

53,127

 

General and administrative

 

 

4,224

 

 

 

5,271

 

 

 

14,201

 

 

 

18,009

 

Total operating expenses

 

 

15,048

 

 

 

23,401

 

 

 

52,095

 

 

 

71,136

 

Loss from operations

 

 

(15,048

)

 

 

(23,401

)

 

 

(52,095

)

 

 

(71,136

)

 

 

 

 

 

 

 

 

 

 

 

 

Other income

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other income, net

 

 

628

 

 

 

256

 

 

 

1,829

 

 

 

439

 

Total other income

 

 

628

 

 

 

256

 

 

 

1,829

 

 

 

439

 

Net loss

 

$

(14,420

)

 

$

(23,145

)

 

$

(50,266

)

 

$

(70,697

)

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

 

50

 

 

 

(1

)

 

 

528

 

 

 

(580

)

Comprehensive loss

 

$

(14,370

)

 

$

(23,146

)

 

$

(49,738

)

 

$

(71,277

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.27

)

 

$

(0.48

)

 

$

(0.97

)

 

$

(1.46

)

Weighted average common shares outstanding, basic and diluted

 

 

52,565,333

 

 

 

48,448,399

 

 

 

51,951,123

 

 

 

48,289,501