ASMB Assembly Biosciences Inc

 

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 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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On August 8, 2024, Assembly Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 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 August 8, 2024.
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: August 8, 2024		By:	/s/ John O. Gunderson
			John O. Gunderson
			VP, General Counsel and Corporate Secretary

 

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Assembly Biosciences Reports Second Quarter 2024 Financial Results and Recent Updates

 

 

SOUTH SAN FRANCISCO, Calif., August 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 updates for the second quarter ended June 30, 2024.

 

“Entering the second half of the year, I’m incredibly proud of our team’s accomplishments on our path to delivering novel therapeutics for individuals living with serious viral diseases,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “We are rapidly progressing toward key inflection points for our clinical development programs and remain on track with the data sets we plan to deliver in 2024. Specifically, in the third quarter, we look forward to sharing interim Phase 1a data for ABI-5366 in healthy participants. The pharmacokinetic data in this study will enable us to assess ABI-5366's ability to reach the target concentrations we have established for antiviral efficacy and to support our once-weekly oral dosing profile, while also informing dose selection in the Phase 1b part of the study in participants with recurrent genital herpes.”

 

Second Quarter 2024 and Recent Highlights

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Upcoming Anticipated Milestones

 

Upcoming Conferences

 

Second Quarter 2024 Financial Results

 

The investigational products and investigational product candidates referenced here have not been approved anywhere globally, and their safety and efficacy have not been established.

 

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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

 

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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)

 

		June 30,				December 31,
		2024				2023
		(Unaudited)
ASSETS
Current assets
Cash and cash equivalents		$	19,208			$	19,841
Marketable securities			90,011				110,406
Accounts receivable from collaboration			—				43
Prepaid expenses and other current assets			3,712				3,497
Total current assets			112,931				133,787
Property and equipment, net			349				385
Operating lease right-of-use assets			1,731				2,339
Other assets			312				312
Total assets		$	115,323			$	136,823
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable		$	801			$	461
Accrued research and development expenses			2,531				885
Other accrued expenses			3,587				5,744
Deferred revenue from a related party - short-term			33,060				30,915
Operating lease liabilities - short-term			1,295				1,220
Total current liabilities			41,274				39,225
Deferred revenue from a related party - long-term			38,916				55,379
Operating lease liabilities - long-term			451				1,122
Total liabilities			80,641				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 June 30, 2024 and December 31, 2023; 6,345,561 and 5,482,752 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively			6				5
Additional paid-in capital			840,946				826,921
Accumulated other comprehensive loss			(293	)			(81	)
Accumulated deficit			(805,977	)			(785,748	)
Total stockholders' equity			34,682				41,097
Total liabilities and stockholders' equity		$	115,323			$	136,823

 

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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 June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
Collaboration revenue from a related party		$	8,533			$	—			$	14,318			$	—
Operating expenses
Research and development			16,259				12,523				28,138				27,070
General and administrative			4,477				4,965				9,112				9,977
Total operating expenses			20,736				17,488				37,250				37,047
Loss from operations			(12,203	)			(17,488	)			(22,932	)			(37,047	)
Other income
Interest and other income, net			1,457				592				3,109				1,201
Total other income			1,457				592				3,109				1,201
Loss before income taxes			(10,746	)			(16,896	)			(19,823	)			(35,846	)
Income tax expense			406				—				406				—
Net loss		$	(11,152	)		$	(16,896	)		$	(20,229	)		$	(35,846	)
Other comprehensive loss
Unrealized (loss) gain on marketable securities			(54	)			188				(212	)			478
Comprehensive loss		$	(11,206	)		$	(16,708	)		$	(20,441	)		$	(35,368	)
Net loss per share, basic and diluted		$	(1.98	)		$	(3.88	)		$	(3.64	)		$	(8.33	)
Weighted average common shares outstanding, basic and diluted			5,642,752				4,355,007				5,563,033				4,303,244

 

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v3.24.2.u1

Document And Entity Information	Aug. 08, 2024
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001426800
Document Type	8-K
Document Period End Date	Aug. 08, 2024
Entity Registrant Name	Assembly Biosciences, Inc.
Entity Incorporation State Country Code	DE
Entity File Number	001-35005
Entity Tax Identification Number	20-8729264
Entity Address, Address Line One	Two Tower Place
Entity Address, Address Line Two	7th Floor
Entity Address, City or Town	South San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94080
City Area Code	(833)
Local Phone Number	509-4583
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, par value $0.001
Trading Symbol	ASMB
Securtiy Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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