HilleVax Reports First Quarter 2023 Financial Results and Highlights Recent Company Progress
12 Mai 2023 - 10:05PM
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,
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 on our
HIL-214 program, including the recent completion of enrollment of
over 3,000 subjects in our NEST-IN1 clinical trial,” said Rob
Hershberg, MD, PhD, Chairman and Chief Executive Officer of
HilleVax. “We look forward to continuing to execute on our HIL-214
program and announcing top line safety and clinical efficacy data
in the first quarter of 2024 for our NEST-IN1 clinical trial.”
Recent Business Highlights
- In Q2 2023, HilleVax announced
completion of enrollment of the NEST-IN1 (Norovirus Efficacy and
Safety Trial for INfants) Phase 2b clinical trial with over 3,000
subjects enrolled in six countries.
- In Q2 2023, HilleVax announced the
appointment of Nanette Cocero, Ph.D., MBA, to its Board of
Directors.
- In Q4 2022, HilleVax announced positive
immunogenicity results for the NEST-IN1 run-in cohort.
Upcoming Expected Milestones
- Topline safety and
clinical efficacy data from NEST-IN1 in the first quarter of
2024.
First Quarter 2023 Financial
Results
As of March 31, 2023, the company had cash and cash equivalents
totaling $260.5 million.
Research and development expenses for the first quarter 2023
were $23.2 million, compared to $6.2 million for the first quarter
2022. The increase was primarily due to increased efforts in the
advancement of the HIL-214 program and the growth in the number of
R&D employees and their related activities.
General and administrative expenses for the first quarter 2023
were $5.8 million, compared to $2.6 million for the first quarter
2022. The increase was primarily due to the growth in the number of
G&A employees and other administrative expenses related to
operating as a public company.
Other income for the first quarter 2023 was $2.1 million,
compared to $56.6 million of other expense for the first quarter
2022. The other income in the first quarter of 2023 was primarily
driven by interest income on the company’s cash and cash
equivalents while the other expense in the first quarter of 2022
was primarily driven by changes in the fair value of convertible
promissory notes and warrant liabilities.
Net loss for the first quarter 2023 was $26.9 million, compared
to $67.9 million for the first 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 expected timing of data readouts 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, 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; unstable market and economic
conditions and adverse developments with respect to financial
institutions and associated liquidity risk 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 MaltbieIR@hillevax.com+1-617-213-5054
HilleVax, Inc.Condensed
Consolidated Statement of Operations Data(in
thousands, except share and per share
data)(unaudited)
|
Three Months Ended |
|
March 31, |
|
2023 |
|
2022 |
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
23,164 |
|
|
$ |
6,211 |
|
In-process research and development |
|
— |
|
|
|
2,500 |
|
General and administrative |
|
5,795 |
|
|
|
2,603 |
|
Total operating expenses |
|
28,959 |
|
|
|
11,314 |
|
Loss from operations |
|
(28,959 |
) |
|
|
(11,314 |
) |
Total other income
(expense) |
|
2,070 |
|
|
|
(56,573 |
) |
Net loss |
$ |
(26,889 |
) |
|
$ |
(67,887 |
) |
Net loss per share, basic and
diluted |
$ |
(0.71 |
) |
|
$ |
(10.06 |
) |
Weighted-average shares of
common stock outstanding, basic and diluted |
|
37,753,522 |
|
|
|
6,748,668 |
|
|
|
|
|
|
|
|
|
HilleVax, Inc. Condensed
Consolidated Balance Sheet Data(in
thousands)(unaudited)
|
March 31,2023 |
|
December 31,2022 |
Cash and cash equivalents |
$ |
260,542 |
|
|
$ |
279,401 |
|
Total
assets |
|
300,961 |
|
|
|
317,211 |
|
Total
liabilities |
|
57,900 |
|
|
|
49,982 |
|
Total
stockholders’ equity |
|
243,061 |
|
|
|
267,229 |
|
Total
liabilities and stockholders’ equity |
|
300,961 |
|
|
|
317,211 |
|
|
|
|
|
|
|
|
|
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