BOSTON, Nov. 09, 2023 (GLOBE NEWSWIRE) — HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today announced plans to announce results for the year ending 2023. Financial results for the quarter ended September 30, 2019. highlighted recent advances and outlined key upcoming milestones for HIL-214, the company’s virus-like particle (VLP)-based vaccine for the prevention of moderate to severe norovirus-associated acute gastroenteritis.
“HilleVax is advancing our HIL-214 clinical development program with the potential to bring the first norovirus vaccine to market,” said Dr. Rob Hershberg, HilleVax Chairman and CEO. “We continue to advance the NEST-IN1 clinical trial, and continues to report key data in mid-2024 as planned.”
Recent business highlights
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In the third quarter of 2023, HilleVax announced the completion of a public underwriting of 9,200,000 shares of common stock at a price of $12.50 per share, raising total proceeds of $115 million.
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In the third quarter of 2023, HilleVax initiated three clinical trials supporting the progress of HIL-214, including NOR-109 (a HIL-214 Phase 1 clinical trial in Japanese infants), NOR-206 (a HIL-214 Phase 2 clinical trial of coadministration) with other standard infant vaccinations, and NOR-215 (Phase 2 serological study of HIL-214 in adults). As of October 2023, HilleVax has completed subject recruitment for all three clinical trials.
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In the second quarter of 2023, HilleVax announced the completion of enrollment in the NEST-IN1 (Infant Norovirus Efficacy and Safety Trial) Phase 2b clinical trial, enrolling more than 3,000 subjects in six countries.
Upcoming expected milestones
Third Quarter 2023 Financial Results
As of September 30, 2023, and December 31, 2022, the company had cash, cash equivalents, and marketable securities totaling $324.4 million and $279.4 million, respectively. The increase was driven by net proceeds of $107.4 million from an underwritten public offering of common stock.
Research and development expenses for the third quarter of 2023 were $27.3 million, compared with $13.3 million for the third quarter of 2022. This increase was primarily due to increased HIL-214 development activity and growth in R&D headcount.
General and administrative expenses were $6.6 million in the third quarter of 2023, compared to $4.6 million in the third quarter of 2022. This increase was primarily due to growth in G&A’s headcount.
Other income was $2.1 million in the third quarter of 2023, compared to $1.1 million in the third quarter of 2022. The increase in other income in the third quarter of 2023 compared to the third quarter of 2022 was primarily due to an increase in interest income due to rising interest rates on the Company’s cash, cash equivalents and marketable securities.
Net loss in the third quarter of 2023 was $31.8 million, compared with a net loss of $16.8 million in the third quarter of 2022.
About HilleVax
HilleVax is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel vaccines. Its initial program, HIL-214, is a virus-like particle (VLP)-based vaccine candidate being developed to prevent moderate to severe acute gastroenteritis (AGE) caused by norovirus infection. Globally, norovirus is estimated to cause more than approximately 700 million cases of AGE and 200,000 deaths annually, resulting in over $4 billion in direct health system costs and $60 billion in societal costs annually. The burden of norovirus falls disproportionately on young children and the elderly. For more information about HilleVax, please visit the company’s website at http://www.HilleVax.com.
forward-looking statements
HilleVax cautions you that statements contained in this press release that are not historical facts are forward-looking statements. Forward-looking statements are based on our current beliefs and expectations, including, without limitation, the potential opportunities and benefits of HIL-214 and the expected timing of data readout from the NEST-IN1 clinical trial. Actual results may differ from those stated in this press release due to risks and uncertainties inherent in our business, including, but not limited to: We are currently solely dependent on the success of HIL-214, and we have not yet completed the any clinical trial. HIL-214; possible delays in the initiation, enrollment, data readout and completion of clinical trials and preclinical studies; our reliance on third parties for manufacturing, research and clinical and preclinical testing; HIL-214 or any future candidates Unexpected adverse side effects or insufficient immunogenicity or efficacy of a vaccine, which may limit its development, regulatory approval and/or commercialization; Unfavorable results from clinical trials; Results from previous clinical trials and studies are not necessarily predictive of future results; Unstable market and economic conditions that could adversely affect our business and financial condition and the broader economy and the biotechnology industry; regulatory developments in the United States and other countries; the conflict between Russia and Ukraine or other geopolitics beyond our control the future impact of developments on our business; our dependence 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 experience higher costs than we anticipate faster access to our capital resources; and other risks described in our previous press releases and filings with the Securities and Exchange Commission (SEC), including in our Annual Report on Form 10-K and any subsequent filings with the SEC.” Risks under the heading “Risk Factors”. 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 by this cautionary statement, which is made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
touch:
Shane Maltby
IR@hillevax.com
+1-617-213-5054
HilleVax Corporation
Concise comprehensive operating data report
(In thousands, except stock and per share data)
(unaudited)
|
three months end |
end of nine months |
|||||||||||||||
|
September 30, |
September 30, |
|||||||||||||||
|
2023 |
2022 |
2023 |
2022 |
|||||||||||||
|
Operating expenses: |
||||||||||||||||
|
research and development |
$ |
27,308 |
$ |
13,315 |
$ |
73,425 |
$ |
28,352 |
||||||||
|
Process research and development |
— |
— |
— |
2,500 people |
||||||||||||
|
General and Administrative |
6,603 |
4,577 |
19,629 |
11,162 |
||||||||||||
|
total operating expenses |
33,911 |
17,892 |
93,054 |
42,014 |
||||||||||||
|
operating losses |
(33,911 |
) |
(17,892 |
) |
(93,054 |
) |
(42,014 |
) |
||||||||
|
Total other income (expenses) |
2,096 |
1,087 |
6,448 |
(96,607 |
) |
|||||||||||
|
net loss |
$ |
(31,815 |
) |
$ |
(16,805 |
) |
$ |
(86,606 |
) |
$ |
(138,621 |
) |
||||
|
Net loss per share, basic loss and diluted loss |
$ |
(0.81 |
) |
$ |
(0.45 |
) |
$ |
(2.26 |
) |
$ |
(5.86 |
) |
||||
|
Weighted average number of common, basic and diluted shares outstanding |
39,039,553 |
37,323,626 |
38,252,981 |
23,640,388 |
||||||||||||
HilleVax Corporation
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
|
September 30, |
December 31, |
|||||||
|
Cash, cash equivalents and marketable securities |
$ |
324,410 |
$ |
279,401 |
||||
|
Total assets |
366,969 |
317,211 |
||||||
|
total liabilities |
68,339 |
49,982 |
||||||
|
Total shareholders’ equity |
298,630 |
267,229 |
||||||
|
Total liabilities and stockholders’ equity |
366,969 |
317,211 |
||||||
