HLVX HilleVax 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): November 07, 2024

 

 

HILLEVAX, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-41365	85-0545060
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
321 Harrison Avenue
Boston, Massachusetts				02118
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 617 213-5054

 

(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:

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 $0.0001 per share		HLVX		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 7, 2024, HilleVax, Inc. (the "Company") issued a press release announcing its financial results for the quarter ended September 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, 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 in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Exhibit Description
99.1	Press Release issued on November 7, 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 hereunto duly authorized.

			HilleVax, Inc.
Date:	November 7, 2024	By:	/s/ Paul S. Bavier
			Name: Paul S. Bavier Title: General Counsel and Chief Administrative Officer

 

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HilleVax Reports Third Quarter 2024 Financial Results and Highlights Recent Company Progress

$189.3 million of cash, cash equivalents and marketable securities as of September 30, 2024

The company is exploring the potential for continued development of its norovirus vaccine candidates in adults as well as business development related activities and other strategic alternatives

BOSTON, November 7, 2024 – HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today reported financial results for the quarter ended September 30, 2024.

Third Quarter 2024 Financial Results

As of September 30, 2024 and December 31, 2023, the company had cash, cash equivalents and marketable securities totaling $189.3 million and $303.5 million, respectively.

Research and development expenses for the third quarter 2024 were $20.2 million, compared to $27.3 for the third quarter 2023. The decrease was primarily due to lower clinical development costs.

General and administrative expenses for the third quarter 2024 were $6.2 million, compared to $6.6 million for the third quarter 2023. The decrease was primarily due to lower professional service costs.

Other income for the third quarter 2024 was $0.6 million, compared to $2.1 million for the third quarter 2023. The decrease was primarily driven by interest expense incurred on the repayment of the term loan facility during the third quarter of 2024.

Net loss for the third quarter 2024 was $25.8 million, compared to $31.8 million for the third quarter 2023.

About HilleVax

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Its initial programs, HIL-214 and HIL-216, are virus-like particle (VLP) based vaccine candidates in development for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. Globally, norovirus is estimated to result in over approximately 700 million cases of AGE and 200,000 deaths per year, resulting in over $4 billion in direct health system costs and $60 billion in societal costs per year. The burden of norovirus falls disproportionately on young children and older adults. For more information about HilleVax, visit the company’s website at http://www.HilleVax.com.

Forward-Looking Statements

The Company cautions you that statements contained in this report regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on the Company’s current beliefs and expectations and include, but are not limited to: the timing and scope of any workforce reductions, the amount and timing of the related charges and costs, and intended objectives and benefits of a workforce reduction; and the Company’s plan to explore the potential for continued development of its norovirus vaccine candidates as well as business development-related activities for these vaccine candidates. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in the Company’s business, including, without limitation: the preliminary nature of

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the Company’s estimates of the charges and cash expenditures to be incurred in connection with the recent workforce reduction; the Company may not realize the benefits expected from the workforce reduction, including the Company’s ability to conserve cash; the Company’s ability to retain key personnel; to date the Company has depended primarily on the success of HIL-214, and the Company may be unable to identify a viable development path forward for its vaccine candidates; the Company may be unable to secure partnerships or other strategic collaborations on acceptable terms or at all; and other risks described in the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:

Shane Maltbie

IR@hillevax.com

+1-617-213-5054

 

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HilleVax, Inc.

Condensed Consolidated Statement of Operations Data

(in thousands, except share and per share data)

(unaudited)

		Three Months Ended								Nine Months Ended
		September 30,								September 30,
		2024				2023				2024				2023
Operating expenses:
Research and development		$	20,165			$	27,308			$	72,744			$	73,425
In-process research and development			—				—				15,325				—
General and administrative			6,215				6,603				22,836				19,629
Impairment charges			—				—				8,235				—
Total operating expenses			26,380				33,911				119,140				93,054
Loss from operations			(26,380	)			(33,911	)			(119,140	)			(93,054	)
Total other income			557				2,096				5,820				6,448
Net loss		$	(25,823	)		$	(31,815	)		$	(113,320	)		$	(86,606	)
Net loss per share, basic and diluted		$	(0.52	)		$	(0.81	)		$	(2.31	)		$	(2.26	)
Weighted-average shares of common stock outstanding, basic and diluted			49,382,277				39,039,553				49,008,614				38,252,981

HilleVax, Inc.

Condensed Consolidated Balance Sheet Data

(in thousands)

(unaudited)

		September 30, 2024				December 31, 2023
Cash, cash equivalents and marketable securities		$	189,310			$	303,483
Total assets			220,622				344,434
Total liabilities			36,349				78,909
Total stockholders’ equity			184,273				265,525
Total liabilities and stockholders’ equity			220,622				344,434

 

 

 

 

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v3.24.3

Document And Entity Information	Nov. 07, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 07, 2024
Entity Registrant Name	HILLEVAX, INC.
Entity Central Index Key	0001888012
Entity Emerging Growth Company	true
Entity File Number	001-41365
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	85-0545060
Entity Address, Address Line One	321 Harrison Avenue
Entity Address, City or Town	Boston
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02118
City Area Code	617
Local Phone Number	213-5054
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	HLVX
Security Exchange Name	NASDAQ

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