UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
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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.
Item 2.02 Results of Operations and Financial Condition.
On August 14, 2023, HilleVax, Inc. (the "Company") issued a press release announcing its financial results for the quarter ended June 30, 2023. 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 |
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104 |
Cover Page Interactive Data File (embedded within the Ingline XBRL document) |
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.
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HilleVax, Inc. |
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Date: |
August 14, 2023 |
By: |
/s/ Paul S. Bavier |
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Name: Paul S. Bavier |
Exhibit 99.1
HilleVax Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress
BOSTON, August 14, 2023 – HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today reported financial results for the quarter ended June 30, 2023, highlighted recent progress and outlined key upcoming milestones for HIL-214, the company’s investigational virus-like particle (VLP) based vaccine for the prevention of moderate-to-severe norovirus-related acute gastroenteritis.
“HilleVax has continued to make excellent progress in our HIL-214 program following completion of enrollment of our NEST-IN1 clinical trial in late April 2023. Due to issues relating solely to the logistical complexity of processing diarrheal samples from various geographies, we are adjusting our guidance to read out top line clinical data on all subjects in our NEST-IN1 clinical trial to mid-2024,” said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax. “We remain committed to potentially bringing the first vaccine to market to address the global unmet need associated with norovirus infections.”
Recent Business Highlights
Upcoming Expected Milestones
Second Quarter 2023 Financial Results
As of June 30, 2023, the company had cash, cash equivalents and marketable securities totaling $244.1 million.
Research and development expenses for the second quarter 2023 were $23.0 million, compared to $8.8 million for the second quarter 2022. The increase was primarily due to increased activities for the development of HIL-214 and the growth in the number of R&D employees.
General and administrative expenses for the second quarter 2023 were $7.2 million, compared to $4.0 million for the second quarter 2022. The increase was primarily due to the growth in the number of G&A employees.
Other income for the second quarter 2023 was $2.3 million, compared to $41.1 million of other expense for the second quarter 2022. The other income in the second quarter of 2023 was primarily driven by interest income on the company’s cash, cash equivalents and marketable securities, while the other expense in the second quarter of 2022 was primarily driven by changes in the fair value of convertible promissory notes and warrant liabilities.
Net loss for the second quarter 2023 was $27.9 million, compared to $53.9 million for the second quarter 2022.
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. 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
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 potential opportunity for and benefits of HIL-214 and the expected timing of a data readout from the NEST-IN1 clinical trial. 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, data readouts 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; and unstable market and economic conditions may adversely affect our business and financial condition and the broader economy and biotechnology industry; regulatory developments in the United States and foreign countries; any future impacts to our business resulting from the conflict between Russia and Ukraine or other geopolitical developments outside our control; 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 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 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.
Contact:
Shane Maltbie
IR@hillevax.com
+1-617-213-5054
HilleVax, Inc.
Condensed Consolidated Statement of Operations Data
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
22,953 |
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$ |
8,826 |
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$ |
46,117 |
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$ |
15,037 |
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In-process research and development |
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— |
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— |
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— |
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2,500 |
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General and administrative |
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7,231 |
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3,982 |
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13,026 |
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6,585 |
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Total operating expenses |
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30,184 |
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12,808 |
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59,143 |
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24,122 |
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Loss from operations |
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(30,184 |
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(12,808 |
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(59,143 |
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(24,122 |
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Total other income (expense) |
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2,282 |
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(41,121 |
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4,352 |
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(97,694 |
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Net loss |
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$ |
(27,902 |
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$ |
(53,929 |
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$ |
(54,791 |
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$ |
(121,816 |
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Net loss per share, basic and diluted |
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$ |
(0.74 |
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$ |
(2.03 |
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$ |
(1.45 |
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$ |
(7.30 |
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Weighted-average shares of common stock outstanding, basic and diluted |
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37,951,735 |
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26,512,881 |
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37,853,176 |
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16,685,372 |
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HilleVax, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
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June 30, |
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December 31, |
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Cash, cash equivalents and marketable securities |
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$ |
244,050 |
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$ |
279,401 |
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Total assets |
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286,522 |
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317,211 |
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Total liabilities |
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67,759 |
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49,982 |
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Total stockholders’ equity |
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218,763 |
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267,229 |
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Total liabilities and stockholders’ equity |
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286,522 |
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317,211 |
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