HilleVax Reports Full Year 2023 Financial Results and Highlights Recent Company Progress
- HilleVax making significant progress with HIL-214 vaccine candidate for norovirus gastroenteritis prevention
- Topline data from NEST-IN1 Phase 2B clinical study of HIL-214 expected in mid-2024
- Cash, cash equivalents, and marketable securities totaling $303.5 million as of December 31, 2023
- Appointment of Sean McLoughlin as Chief Operating Officer in Q1 2024
- Successful underwritten public offering of 9,200,000 shares of common stock in Q3 2023 at $12.50 per share for gross proceeds of $115.0 million
- Initiation of three clinical trials supporting HIL-214 advancement in Q3 2023
- Completion of enrollment of NEST-IN1 Phase 2b clinical trial in Q2 2023 with over 3,000 subjects enrolled in six countries
- Expected milestones include topline safety and clinical efficacy data from NEST-IN1 in mid-2024
- Net loss of $123.6 million for the full year ended December 31, 2023
- Increase in research and development expenses for the full year ended December 31, 2023 compared to 2022
- Increase in general and administrative expenses for the full year ended December 31, 2023 compared to 2022
Insights
The announcement from HilleVax, Inc. regarding its financial results and the progress of its HIL-214 vaccine candidate offers several points of interest. The vaccine, targeting norovirus-related acute gastroenteritis, is a significant endeavor, as norovirus is a leading cause of gastroenteritis worldwide and poses a substantial burden on healthcare systems. The completion of subject enrollment in the NEST-IN1 Phase 2b clinical trial is a positive indicator of the company's operational efficiency and adherence to development timelines, which is often a concern for investors monitoring clinical-stage biopharmaceutical companies.
From a financial perspective, the reported increase in cash reserves, primarily due to a successful public offering, provides the company with a more robust runway to fund ongoing trials and development efforts. This is a critical factor in assessing the company's ability to sustain operations without the immediate need for additional capital raises. The reported increase in R&D expenses aligns with the company's developmental stage and reflects its investment in HIL-214, which could be seen as a commitment to bringing the vaccine to market. However, it's important to monitor whether these investments translate into successful trial outcomes and eventual product approval.
The financial results from HilleVax, Inc. reveal a strategic emphasis on research and development, evidenced by the significant increase in R&D expenses year-over-year. This investment reflects the company's stage of growth and the critical nature of HIL-214's development cycle. The uptick in general and administrative expenses can be attributed to the expansion of the company's workforce, which is a natural progression for a company scaling up its operations. The net proceeds from the public offering have bolstered the company's cash position, which is a reassuring sign for investors as it suggests a decreased likelihood of short-term liquidity issues.
Despite these positive financial indicators, the reported net loss for both the fourth quarter and the full year signals that the company is still in a heavy investment phase, which is typical for clinical-stage biopharmaceutical firms. The shift from other expenses to other income, mainly due to interest income, is an encouraging sign of financial prudence. Investors should weigh the potential of HIL-214 against the inherent risks of investing in a company at this stage of clinical development, keeping an eye on the upcoming topline data from the NEST-IN1 study as a critical inflection point for the company's valuation.
The norovirus vaccine market is an area of unmet medical need with significant commercial potential. HilleVax's focus on this space could position the company well if HIL-214 proves to be effective and safe. The anticipation of topline data from the NEST-IN1 study in mid-2024 is a pivotal event that could impact the company's stock performance. Positive results could lead to a surge in investor confidence, while negative results could have the opposite effect.
It is essential to consider the competitive landscape and the potential market size for a norovirus vaccine. With a successful outcome, HilleVax could capture a substantial market share, given the high incidence of norovirus infections globally. The company's strategic investments in manufacturing activities also indicate foresight in preparing for potential commercialization, which is a positive sign for long-term planning. Investors should monitor the progress of the NEST-IN1 study closely as it is likely to be a significant determinant of HilleVax's future business trajectory and market positioning.
Topline data from NEST-IN1 Phase 2B clinical study of HIL-214 in infants expected in mid-2024
Enrollment for NEST-IN1 study completed in Q2 2023
BOSTON, March 20, 2024 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today reported financial results for the year ended December 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.
“Over the past year, we made significant progress with HIL-214, our vaccine candidate for the prevention of moderate-to-severe norovirus related acute gastroenteritis. We have continued to progress the NEST-IN1 clinical trial and remain on track to report topline data by mid-2024,” said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax. “We have also made good progress on our manufacturing activities for HIL-214 in support of continued development in subsequent registrational trials for infants and older adults.”
Recent Business Highlights
- In Q1 2024, HilleVax announced the appointment of Sean McLoughlin as Chief Operating Officer.
- In Q3 2023, HilleVax announced the closing of an underwritten public offering of 9,200,000 shares of its common stock at a price of
$12.50 per share for gross proceeds of$115.0 million . - In Q3 2023, HilleVax initiated three clinical trials supporting the advancement of HIL-214, including NOR-109, a Phase 1 clinical trial of HIL-214 in Japanese infants, NOR-206, a Phase 2 clinical trial co-administering HIL-214 with other standard infant vaccinations, and NOR-215, a Phase 2 serology study of HIL-214 in adults. As of October 2023, HilleVax has completed enrollment of subjects in all three clinical trials.
- 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.
Upcoming Expected Milestones
- Topline safety and clinical efficacy data from NEST-IN1 in mid-2024.
Full Year 2023 Financial Results
As of December 31, 2023 and December 31, 2022, the company had cash, cash equivalents and marketable securities totaling
Research and development expenses for the fourth quarter 2023 were
General and administrative expenses for the fourth quarter 2023 were
Other income for the fourth quarter 2023 was
Other income for the full year ended December 31, 2023 was
Net loss for the fourth quarter 2023 was
About HilleVax
HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Its most advanced 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 direct and indirect healthcare system and societal costs of
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, the advancement of HIL-214 to registration as the first norovirus vaccine, and longer-term market leadership plans. 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 military conflicts or other geopolitical developments outside our control; our reliance on intellectual property rights under our license agreements with Takeda Vaccines, Inc. and Kanghua Biological Products Co., Ltd.; 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)
| Three Months Ended | Year Ended | ||||||||||||||
| December 31, | December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 33,258 | $ | 17,556 | $ | 106,683 | $ | 45,908 | |||||||
| In-process research and development | — | — | — | 2,500 | |||||||||||
| General and administrative | 7,033 | 5,543 | 26,662 | 16,705 | |||||||||||
| Total operating expenses | 40,291 | 23,099 | 133,345 | 65,113 | |||||||||||
| Loss from operations | (40,291 | ) | (23,099 | ) | (133,345 | ) | (65,113 | ) | |||||||
| Total other income (expense) | 3,331 | 1,911 | 9,779 | (94,696 | ) | ||||||||||
| Net loss | $ | (36,960 | ) | $ | (21,188 | ) | $ | (123,566 | ) | $ | (159,809 | ) | |||
| Net loss per share, basic and diluted | $ | (0.78 | ) | $ | (0.56 | ) | $ | (3.04 | ) | $ | (5.89 | ) | |||
| Weighted-average shares of common stock outstanding, basic and diluted | 47,557,423 | 37,553,735 | 40,598,482 | 27,147,314 | |||||||||||
HilleVax, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
| December 31, 2023 | December 31, 2022 | ||||||
| Cash, cash equivalents and marketable securities | $ | 303,483 | $ | 279,401 | |||
| Total assets | 344,434 | 317,211 | |||||
| Total liabilities | 78,909 | 49,982 | |||||
| Total stockholders’ equity | 265,525 | 267,229 | |||||
| Total liabilities and stockholders’ equity | 344,434 | 317,211 | |||||
FAQ
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