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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): November 8, 2022

 

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 November 8, 2022, Assembly Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2022. 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, 2022.
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: November 8, 2022		By:	/s/ John O. Gunderson
			John O. Gunderson
			VP, General Counsel and Corporate Secretary

 

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Exhibit 99.1

Assembly Biosciences Reports Third Quarter 2022 Financial Results and Recent Highlights and Announces Upcoming Conference Participation

 

Phase 1a Trial of Next-Generation Core Inhibitor, ABI-4334, Now Underway Following Clinical Trial Application (CTA) Clearance

 

SOUTH SAN FRANCISCO, Calif., November 8, 2022 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative, investigational therapeutics targeting hepatitis B virus (HBV) and other viral diseases, today announced financial results and recent highlights for the third quarter ended September 30, 2022.

 

“During the third quarter, we have advanced clinical development of both of our next-generation, more potent, core inhibitors with the Phase 1b study of 3733 on track to report initial data by the end of this year and the initiation of the first clinical study for 4334,” said John McHutchison, AO, MD, chief executive officer of Assembly Bio. “This quarter also marked the further expansion of our pipeline with the introduction of our first research programs outside of HBV and hepatitis delta virus (HDV). These programs, targeting high-recurrence genital herpes and transplant-associated herpesviruses, apply the deep expertise of our organization in small molecule antiviral drug development to develop differentiated approaches for viral diseases with significant unmet medical need. We are thrilled with the progress of our preclinical and clinical programs, and we remain encouraged about the potential for our next-generation core inhibitors with the recently presented data at AASLD and upcoming clinical data readout for 3733.”

 

Recent Updates

 

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Anticipated Milestones and Events

 

Upcoming Conferences

 

Third Quarter 2022 Financial Results

 

 

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About Assembly Biosciences
 

Assembly Bio is a clinical-stage biotechnology company pioneering the development of novel therapeutics for serious viral diseases. Assembly Bio is advancing a leading portfolio of more potent, next-generation core inhibitor drug candidates that aim to break the complex viral replication cycle of hepatitis B virus (HBV) to achieve finite and potentially curative therapies for the 296 million people living with HBV worldwide. The company’s research pipeline includes differentiated antiviral approaches against HBV/hepatitis delta virus and herpesviruses. 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 successfully execute its previously announced reprioritization and restructuring activities, including the CEO transition; potential adverse legal, reputational, operational and financial effects on Assembly Bio resulting from the reprioritization and restructuring activities; 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 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; continued development and commercialization of ABI-H3733, if successful, in the China territory will be dependent on, and subject to, Assembly Bio’s collaboration agreement governing this activity in the China territory; Assembly Bio’s ability to maintain financial resources necessary to continue its clinical studies and fund business operations; any impact that the COVID-19 pandemic may have on Assembly Bio’s business and operations, including initiation, enrollment and continuation of its clinical studies or timing of discussions with regulatory authorities; and other risks identified from time to time

 

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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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands except for share amounts and par value)
		September 30,				December 31,
		2022				2021
		(Unaudited)
ASSETS
Current assets
Cash and cash equivalents		$	54,673			$	45,627
Marketable securities - short-term			53,978				101,000
Accounts receivable from collaborations			1,246				336
Prepaid expenses and other current assets			5,181				7,241
Total current assets			115,078				154,204
Marketable securities - long-term			—				27,972
Property and equipment, net			867				1,139
Operating lease right-of-use (ROU) assets			3,958				6,042
Other assets			1,613				1,703
Total assets		$	121,516			$	191,060
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable		$	1,942			$	2,659
Accrued research and development expenses			4,462				3,400
Other accrued expenses			5,686				6,863
Operating lease liabilities - short-term			3,371				3,151
Total current liabilities			15,461				16,073
Deferred revenue			2,733				2,733
Operating lease liabilities - long-term			918				3,325
Total liabilities			19,112				22,131
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 and 100,000,000 shares authorized as of September 30, 2022 and December 31, 2021, respectively; 48,481,194 and 48,120,437 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively			48				48
Additional paid-in capital			805,480				800,728
Accumulated other comprehensive loss			(999	)			(419	)
Accumulated deficit			(702,125	)			(631,428	)
Total stockholders' equity			102,404				168,929
Total liabilities and stockholders' equity		$	121,516			$	191,060

 

 

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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,
		2022				2021				2022				2021
Collaboration revenue		$	—			$	6,254			$	—			$	6,254
Operating expenses:
Research and development			18,130				18,474				53,127				53,777
General and administrative			5,271				6,655				18,009				22,276
Total operating expenses			23,401				25,129				71,136				76,053
Loss from operations			(23,401	)			(18,875	)			(71,136	)			(69,799	)
Other income:
Interest and other income, net			256				72				439				201
Total other income			256				72				439				201
Net loss		$	(23,145	)		$	(18,803	)		$	(70,697	)		$	(69,598	)
Other comprehensive loss
Unrealized loss on marketable securities			(1	)			(15	)			(580	)			(18	)
Comprehensive loss		$	(23,146	)		$	(18,818	)		$	(71,277	)		$	(69,616	)
Net loss per share, basic and diluted		$	(0.48	)		$	(0.41	)		$	(1.46	)		$	(1.63	)
Weighted average common shares outstanding, basic and diluted			48,448,399				45,569,276				48,289,501				42,725,109

 

 

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