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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 4, 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. ☐

 

 

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Item 2.02 Results of Operations and Financial Condition.

On May 4, 2023, Assembly Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 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 May 4, 2023.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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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 4, 2023		By:	/s/ John O. Gunderson
			John O. Gunderson
			VP, General Counsel and Corporate Secretary

 

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Exhibit 99.1

 

 

Assembly Biosciences Reports First Quarter 2023 Financial Results and Recent Highlights

 

SOUTH SAN FRANCISCO, Calif., May 4, 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 highlights for the first quarter ended March 31, 2023.

 

“Thanks to the depth and breadth of our team’s virology drug development expertise, we were thrilled to nominate the first development candidate from our expanded virology pipeline, 5366, during the first quarter,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “With 5366 targeting high-recurrence genital herpes expected to enter the clinic in the first half of 2024 and nomination of a second pipeline candidate anticipated later this year, we look forward to advancing these new programs that are designed to address significant unmet medical needs with the potential for shorter paths to reaching key inflection points and clinical proof of concept.”

 

“With respect to our core inhibitors, we reported promising additional clinical data for 4334 and made the strategic decision to evaluate partnering options for our core inhibitor portfolio,” continued Mr. Okazaki. “We believe partnering the core inhibitors will enable opportunities for further clinical development aimed at achieving a functional cure for HBV, including through combination approaches. It also allows our teams to focus on accelerating 5366 and other compounds in our expanded virology portfolio, which offer us greater potential to have a near-term impact for patients and stockholders.”

 

First Quarter 2023 and Recent Highlights

 

Anticipated Milestones and Events

 

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Upcoming Conferences

 

First Quarter 2023 Financial Results

 

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

 

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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

 

 

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ASSEMBLY BIOSCIENCES, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands except for share amounts and par value)

 

		March 31,				December 31,
		2023				2022
		(Unaudited)
ASSETS
Current assets
Cash and cash equivalents		$	43,482			$	52,418
Marketable securities			29,534				39,192
Accounts receivable from collaboration			717				944
Prepaid expenses and other current assets			6,011				4,413
Total current assets			79,744				96,967
Property and equipment, net			619				743
Operating lease right-of-use (ROU) assets			2,419				3,195
Other assets			334				889
Total assets		$	83,116			$	101,794
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable		$	1,224			$	2,493
Accrued research and development expenses			3,046				3,122
Other accrued expenses			3,154				7,317
Operating lease liabilities - short-term			2,546				3,364
Total current liabilities			9,970				16,296
Deferred revenue			2,733				2,733
Operating lease liabilities - long-term			80				101
Total liabilities			12,783				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 March 31, 2023 and December 31, 2022; 52,015,268 and 48,894,973 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively			52				49
Additional paid-in capital			814,264				807,938
Accumulated other comprehensive loss			(513	)			(803	)
Accumulated deficit			(743,470	)			(724,560	)
Total stockholders' equity			70,333				82,624
Total liabilities and stockholders' equity		$	83,116			$	101,794

 

 

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ASSEMBLY BIOSCIENCES, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands except for share and per share amounts)

 

		Three Months Ended March 31,
		2023				2022
Operating expenses
Research and development		$	14,547			$	17,205
General and administrative			5,012				5,957
Total operating expenses			19,559				23,162
Loss from operations			(19,559	)			(23,162	)
Other income
Interest and other income, net			609				71
Total other income			609				71
Net loss		$	(18,950	)		$	(23,091	)
Other comprehensive loss
Unrealized gain (loss) on marketable securities			290				(489	)
Comprehensive loss		$	(18,660	)		$	(23,580	)
Net loss per share, basic and diluted		$	(0.37	)		$	(0.48	)
Weighted average common shares outstanding, basic and diluted			51,012,450				48,123,930

 

 

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