false 0001888012 0001888012 2022-06-08 2022-06-08





Washington, D.C. 20549









Date of Report (Date of earliest event reported): June 8, 2022



HilleVax, Inc.

(Exact name of registrant as specified in its charter)




Delaware   001-41365   85-0545060

(State or other jurisdiction

of incorporation)



File Number)


(I.R.S. Employer

Identification No.)

75 State Street, Suite 100 - #9995

Boston, Massachusetts

(Address of principal executive offices)   (Zip Code)

(617) 213-5054

(Registrant’s telephone number, including area code)

(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





Name of each exchange

on which registered

Common stock, $0.0001 par value 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 (Sec.230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (Sec.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 June 8, 2022, HilleVax, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2022. 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





99.1    Press Release issued on June 8, 2022
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


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: June 8, 2022     By:  

/s/ David Socks

    Name:   David Socks
    Title:   Chief Financial Officer and Chief Business Officer

Exhibit 99.1



HilleVax Reports First Quarter 2022 Financial Results and Highlights Recent Company Progress

Initiated Phase 2b Clinical Trial of HIL-214 Vaccine Candidate for the Prevention of Norovirus-Related Acute Gastroenteritis in Infants (NOR-212)

Completed Upsized Initial Public Offering Raising $230 Million in Gross Proceeds

BOSTON, June 8, 2022 – HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today reported financial results for the quarter ended March 31, 2022, highlighted recent program progress, and outlined key upcoming milestones for HIL-214, the company’s virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe norovirus-related acute gastroenteritis.

“HilleVax achieved significant milestones this year, including the initiation of NOR-212, a Phase 2b clinical trial of HIL-214 in infants, as well as completion of enrollment of the 200 subject safety run-in for the trial. We look forward to resuming enrollment following the prespecified data monitoring committee safety assessment expected in the third quarter,” said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax. “Through the completion of our recent initial public offering (IPO), we also secured the capital needed to fund the Phase 2b clinical trial and prepare HIL-214 for Phase 3.”

First Quarter 2022 and Recent Business Highlights

Financial and Corporate



In May 2022, HilleVax dosed the first subjects in NOR-212, the first ever field efficacy clinical trial of a norovirus vaccine candidate in infants.



In May 2022, HilleVax completed enrollment of the prespecified 200 subject run-in for NOR-212.



In May 2022, HilleVax completed its IPO, raising $230 million in aggregate gross proceeds, before deducting underwriting discounts and commissions and offering expenses, and began trading on The Nasdaq Global Select Market.



In April 2022, HilleVax entered into a Loan and Security Agreement (Loan Agreement) with Hercules Capital, Inc. providing for term loans of up to $75 million in the aggregate, of which $5 million has been borrowed.

Upcoming Expected Milestones



Phase 2b interim safety results from first 200 subjects in the third quarter of 2022



Phase 2b interim immunogenicity results from first 200 subjects in the first half of 2023



Phase 2b topline safety and clinical efficacy results in the second half of 2023

First Quarter 2022 Financial Results

As of March 31, 2022, the company had cash and cash equivalents totaling $111.3 million, which does not include gross proceeds of $230.0 million from the IPO or the $5.0 million drawn under the Loan Agreement.

Research and development expenses for the first quarter 2022 were $6.2 million, compared to $0.3 million for the first quarter 2021.

General and administrative expenses for the first quarter 2022 were $2.6 million, compared to $1.2 million for the first quarter 2021.

Other expenses for the first quarter 2022 were $56.6 million, compared to $0.1 million for the first quarter 2021. The increase in other expense was driven by changes in the fair value of convertible promissory notes and warrant liabilities.

Net loss for the first quarter 2022 was $67.9 million, compared to $1.5 million for the first quarter 2021.

About HilleVax

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Its initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate in development for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. For more information about HilleVax, visit the company’s website at http://www.HilleVax.com.

Forward-Looking Statements

HilleVax cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the expected timing of data readouts from the NOR-212 trial; and projected cash runway and expectations regarding the sufficiency of existing capital to support our operating plan. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: we currently depend entirely on the success of HIL-214, and we have not yet completed any clinical trials of HIL-214; potential delays in the commencement, enrollment, and completion of clinical trials and preclinical studies; our dependence on third parties in connection with manufacturing, research and clinical and preclinical testing; unexpected adverse side effects or inadequate immunogenicity or efficacy of HIL-214 or any future vaccine candidates that may limit their development, regulatory approval, and/or commercialization; unfavorable results from clinical trials; results from prior clinical trials and studies not necessarily being predictive of future results; our ability to maintain undisrupted business operations due to the COVID-19 pandemic, including delaying or disrupting our clinical trials, manufacturing and supply

chain; regulatory developments in the United States and foreign countries; our reliance on intellectual property rights under our license agreement with Takeda Vaccines, Inc.; our ability to obtain, maintain and enforce intellectual property protection for our vaccine candidates; we may use our capital resources sooner than we expect; and other risks described in our prior press releases and our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our quarterly report on Form 10-Q 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 we undertake 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.


David Socks



HilleVax, Inc.

Condensed Consolidated Statement of Operations Data

(in thousands, except share and per share data)



     Three Months Ended
March 31,
     2022      2021  

Operating expenses:


Research and development

   $ 6,211      $ 267  

In-process research and development

     2,500        —    

General and administrative

     2,603        1,198  







Total operating expenses

     11,314        1,465  







Loss from operations

     (11,314)        (1,465)  

Total other income (expense)

     (56,573)        (81)  







Net loss

   $ (67,887)      $ (1,546)  







Net loss per share, basic and diluted

   $ (10.06)      $ (0.32)  







Weighted-average shares of common stock outstanding, basic and diluted

     6,748,668        4,802,907  







HilleVax, Inc.

Condensed Consolidated Balance Sheet Data

(in thousands, except share and par value data)



     March 31,
    December 31,

Cash and cash equivalents

   $ 111,252     $ 124,566  

Total assets

     114,696     $ 127,159  

Total liabilities

     283,068       227,916  

Total stockholders’ deficit

     (168,372     (100,757

Total liabilities and stockholders’ deficit

     114,696       127,159