HilleVax Reports First Quarter 2024 Financial Results and Highlights Recent Company Progress
HilleVax, Inc. (Nasdaq: HLVX) reported Q1 2024 financial results, highlighting $272.7 million in cash, cash equivalents, and marketable securities as of March 31, 2024. The company remains on track to report top-line data from the NEST-IN1 Phase 2B clinical study of HIL-214 in infants by mid-2024. With positive results, HIL-214 is expected to progress into Phase 3 trials for norovirus prevention. Recent business highlights include the appointment of Sean McLoughlin as COO.
Topline data from the NEST-IN1 Phase 2B study of HIL-214 expected in mid-2024
$272.7 million in cash, cash equivalents, and marketable securities as of March 31, 2024
Expectation for rapid progression of HIL-214 into Phase 3 trials upon positive NEST-IN1 results
Net loss of $46.8 million in Q1 2024 compared to $26.9 million in Q1 2023
Decrease in cash, cash equivalents, and marketable securities from $303.5 million on December 31, 2023, to $272.7 million on March 31, 2024
Insights
Reviewing the financial health of HilleVax, Inc., the uptick in R&D and G&A expenses aligns with the company's strategic focus on the development of HIL-214. From a financial perspective, the increase in the workforce indicates an expanding operational capacity to support its clinical pipeline, which investors often view as a precursor to progress in biopharmaceutical companies. However, the resulting widened net loss year-over-year could cause some concern regarding the rate of cash burn and future financing needs, especially in the absence of revenue-generating products. The cash reserves of
The anticipated mid-2024 readout of the NEST-IN1 Phase 2B study is a critical inflection point for HilleVax, as positive data could significantly de-risk the program and bolster investor confidence in HIL-214's commercial prospects. The vaccine candidate's progress is particularly notable given the high incidence and lack of existing vaccines for norovirus-related acute gastroenteritis. The potential to transition into Phase 3 trials, as noted by the CEO, could catalyze the stock depending on the magnitude of the clinical data and clarity on the regulatory pathway ahead. Given the population's broad demographic encompassing infants and older adults, the market opportunity could be substantial, pending favorable trial outcomes.
Topline data from NEST-IN1 Phase 2B clinical study of HIL-214 in infants expected in mid-2024
BOSTON, May 09, 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 quarter ended March 31, 2024, 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.
“We are excited to remain on track to report top-line data from our ongoing NEST-IN1 clinical trial in infants by mid-2024," said Rob Hershberg, MD, PhD, Chairman and CEO of HilleVax. "With positive results from NEST-IN1, we expect HIL-214 to rapidly progress into Phase 3 clinical trials in both infants and older adults, and we will provide clarity around those plans when we announce the NEST-IN1 data. HIL-214 remains the most advanced norovirus vaccine in clinical development and has the potential to address an enormous unmet medical need in both children and adults."
Recent Business Highlights
- In Q1 2024, HilleVax announced the appointment of Sean McLoughlin as Chief Operating Officer.
Upcoming Expected Milestones
- Topline safety and clinical efficacy data from NEST-IN1 in mid-2024.
First Quarter 2024 Financial Results
As of March 31, 2024 and December 31, 2023, the company had cash, cash equivalents and marketable securities totaling
Research and development expenses for the first quarter 2024 were
General and administrative expenses for the first quarter 2024 were
Other income for the first quarter 2024 was
Net loss for the first quarter 2024 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 | |||||||
| March 31, | |||||||
| 2024 | 2023 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 25,978 | $ | 23,164 | |||
| In-process research and development | 15,325 | — | |||||
| General and administrative | 8,494 | 5,795 | |||||
| Total operating expenses | 49,797 | 28,959 | |||||
| Loss from operations | (49,797 | ) | (28,959 | ) | |||
| Total other income | 2,968 | 2,070 | |||||
| Net loss | $ | (46,829 | ) | $ | (26,889 | ) | |
| Net loss per share, basic and diluted | $ | (0.97 | ) | $ | (0.71 | ) | |
| Weighted-average shares of common stock outstanding, basic and diluted | 48,460,185 | 37,753,522 | |||||
| HilleVax, Inc. Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) | ||||||
| March 31, 2024 | December 31, 2023 | |||||
| Cash, cash equivalents and marketable securities | $ | 272,743 | $ | 303,483 | ||
| Total assets | 314,175 | 344,434 | ||||
| Total liabilities | 75,266 | 78,909 | ||||
| Total stockholders’ equity | 238,909 | 265,525 | ||||
| Total liabilities and stockholders’ equity | 314,175 | 344,434 | ||||
FAQ
When is the top-line data from the NEST-IN1 Phase 2B study of HIL-214 expected?
What is the cash position of HilleVax as of March 31, 2024?
Who was appointed as the Chief Operating Officer in Q1 2024?
What was the net loss for the first quarter of 2024 compared to the same period in 2023?
