8-K
0001426800false00014268002023-08-092023-08-09

 

 

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): August 9, 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 August 9, 2023, Assembly Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 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 August 9, 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: August 9, 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 Second Quarter 2023 Financial Results and Recent Updates

-
Herpesvirus candidate ABI-5366 anticipated to enter clinic in first half of 2024
-
New data for several pipeline programs presented at IHW and EASL 2023
-
Additional development candidate nomination expected in 2023

 

SOUTH SAN FRANCISCO, Calif., August 9, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today reported financial results and recent updates for the second quarter ended June 30, 2023.

 

“We are excited about the advancement of 5366, our long-acting helicase-primase inhibitor targeting high-recurrence genital herpes, into GLP toxicology studies and are working quickly to begin clinical trials for this candidate in the first half of next year,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “In parallel, our research organization continues to progress towards a second development candidate nomination, which we expect later this year. We are pleased with the progress of our expanded virology pipeline, for which strong preclinical data from multiple programs were highlighted at recent scientific meetings.”

 

Second Quarter 2023 and Recent Updates

Continued IND-enabling studies, including initiation of GLP toxicology studies, for development candidate ABI-5366 (5366), a long-acting helicase-primase inhibitor targeting high-recurrence genital herpes
Scientific conferences:
Presented data highlighting the preclinical characterization of 5366 in one oral presentation and one poster at the 47th Annual International Herpesvirus Workshop (IHW) held July 15-19, 2023
Presented five posters at the International Liver CongressTM, the Annual Meeting of the European Association for the Study of the Liver (EASL), held June 21-24, 2023, including preclinical data for the company’s oral, small-molecule hepatitis B virus (HBV)/hepatitis delta virus (HDV) entry inhibitor program and results from in vitro and clinical studies of the next-generation core inhibitors ABI-4334 (4334) and ABI-H3733 (3733)
Presented during the Science of HBV Cure meeting held June 2-3, 2023, on 4334

 

Anticipated Milestones and Events

Nominate an additional development candidate from the expanded research portfolio in 2023
Complete IND/CTA submission for 5366 and initiate clinical studies in the first half of 2024
Advance an additional development candidate into clinical studies by year-end 2024

 


 

Upcoming Conferences

Three abstracts accepted for presentation at the 2023 International HBV Meeting taking place September 19-23, 2023, in Kobe, Japan, highlighting preclinical and in vitro data for the company’s oral, small-molecule HBV/HDV entry inhibitor program, small-molecule, liver-focused interferon alpha receptor agonist program and next-generation core inhibitor candidate 4334

 

Second Quarter 2023 Financial Results

Cash, cash equivalents and marketable securities were $59.8 million as of June 30, 2023, compared to $73.0 million as of March 31, 2023. Assembly Bio’s cash position is projected to fund operations through the third quarter of 2024.
Research and development expenses were $12.5 million for the three months ended June 30, 2023, compared to $17.8 million for the same period in 2022. The decrease is primarily due to prior year preclinical work and start-up costs preparing for the trials for 3733 and 4334 as well as the discontinued development of vebicorvir and ABI-H2158 and decreases in employee and contractor-related expenses.
General and administrative expenses were $5.0 million for the three months ended June 30, 2023, compared to $6.8 million for the same period in 2022. The decrease is primarily due to overall cost-saving initiatives.
Net loss attributable to common stockholders was $16.9 million, or $0.32 per basic and diluted share, for the three months ended June 30, 2023, compared to $24.5 million, or $0.51 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 maintain financial resources necessary to continue its clinical studies and fund business operations; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration agreements, in the currently anticipated timeframes; 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)

 

 

 

June 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

 

 

(Unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

21,623

 

 

$

52,418

 

Marketable securities

 

 

38,208

 

 

 

39,192

 

Accounts receivable from collaboration

 

 

342

 

 

 

944

 

Prepaid expenses and other current assets

 

 

3,908

 

 

 

4,413

 

Total current assets

 

 

64,081

 

 

 

96,967

 

 

 

 

 

 

 

Property and equipment, net

 

 

541

 

 

 

743

 

Operating lease right-of-use (ROU) assets

 

 

1,623

 

 

 

3,195

 

Other assets

 

 

332

 

 

 

889

 

Total assets

 

$

66,577

 

 

$

101,794

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

904

 

 

$

2,493

 

Accrued research and development expenses

 

 

2,037

 

 

 

3,122

 

Other accrued expenses

 

 

4,188

 

 

 

7,317

 

Operating lease liabilities - short-term

 

 

1,702

 

 

 

3,364

 

Total current liabilities

 

 

8,831

 

 

 

16,296

 

 

 

 

 

 

 

Deferred revenue

 

 

2,733

 

 

 

2,733

 

Operating lease liabilities - long-term

 

 

64

 

 

 

101

 

Total liabilities

 

 

11,628

 

 

 

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 June 30, 2023 and December 31, 2022; 52,450,731 and 48,894,973 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively

 

 

52

 

 

 

49

 

Additional paid-in capital

 

 

815,588

 

 

 

807,938

 

Accumulated other comprehensive loss

 

 

(325

)

 

 

(803

)

Accumulated deficit

 

 

(760,366

)

 

 

(724,560

)

Total stockholders' equity

 

 

54,949

 

 

 

82,624

 

Total liabilities and stockholders' equity

 

$

66,577

 

 

$

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 June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

12,523

 

 

 

17,792

 

 

 

27,070

 

 

 

34,997

 

General and administrative

 

 

4,965

 

 

 

6,781

 

 

 

9,977

 

 

 

12,738

 

Total operating expenses

 

 

17,488

 

 

 

24,573

 

 

 

37,047

 

 

 

47,735

 

Loss from operations

 

 

(17,488

)

 

 

(24,573

)

 

 

(37,047

)

 

 

(47,735

)

 

 

 

 

 

 

 

 

 

 

Other income

 

 

 

 

 

 

 

 

Interest and other income, net

 

 

592

 

 

 

112

 

 

 

1,201

 

 

 

183

 

Total other income

 

 

592

 

 

 

112

 

 

 

1,201

 

 

 

183

 

Net loss

 

$

(16,896

)

 

$

(24,461

)

 

$

(35,846

)

 

$

(47,552

)

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

 

188

 

 

 

(90

)

 

 

478

 

 

 

(579

)

Comprehensive loss

 

$

(16,708

)

 

$

(24,551

)

 

$

(35,368

)

 

$

(48,131

)

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.32

)

 

$

(0.51

)

 

$

(0.69

)

 

$

(0.99

)

Weighted average common shares outstanding, basic and diluted

 

 

52,260,088

 

 

 

48,293,495

 

 

 

51,638,928

 

 

 

48,208,735