HilleVax Reports Full Year 2022 Financial Results and Highlights Recent Company Progress
HilleVax, Inc. (Nasdaq: HLVX) reported its financial results for 2022, highlighting key achievements and future milestones. The company ended 2022 with cash reserves of $279.4 million and experienced significant increases in both research and development expenses, totaling $45.9 million, compared to $10.0 million in 2021. For Q4 2022, the net loss reached $21.2 million, up from $37.3 million in Q4 2021, while the full year net loss was $159.8 million, compared to $102.4 million in the prior year. Upcoming milestones include topline data from the Phase 2b NEST-IN1 clinical trial expected in Q1 2024.
- 2022 cash reserves increased to $279.4 million.
- Positive immunogenicity results reported for the NEST-IN1 trial.
- Successful initiation of Phase 2b trial NEST-IN1.
- Net loss of $159.8 million in 2022, compared to $102.4 million in 2021.
- Research and development expenses rose significantly to $45.9 million in 2022.
BOSTON, March 17, 2023 (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, 2022, highlighted recent program 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.
“2022 was a momentous year for HilleVax where the company achieved many important milestones including the initiation and execution of our Phase 2b clinical trial NEST-IN1 and the completion of our initial public offering,” said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax. “We look forward to completing enrollment of our NEST-IN1 clinical trial in 2023 and announcing top line safety and clinical efficacy data in the first quarter of 2024.”
Recent Business Highlights
- In Q4 2022, HilleVax announced positive immunogenicity results for the NEST-IN1 run-in cohort.
- In Q3 2022, HilleVax announced the positive recommendation by the safety data monitoring committee to continue enrollment of the remaining 2,800 subjects in the NEST-IN1 clinical trial after the evaluation of safety data from the prespecified 200 subject run-in.
Upcoming Expected Milestones
- Topline safety and clinical efficacy data from NEST-IN1 in the first quarter of 2024.
Full Year 2022 Financial Results
As of December 31, 2022, the company had cash and cash equivalents totaling
Research and development expenses for the fourth quarter 2022 were
General and administrative expenses for the fourth quarter 2022 were
Other income for the fourth quarter 2022 was
Other expense for the full year ended December 31, 2022 was
Net loss for the fourth quarter 2022 was
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
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 continuation of enrollment in the NEST-IN1 trial and the expected timing of data readouts from this 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; our ability to maintain undisrupted business operations due to the COVID-19 pandemic or other epidemic diseases, including delaying or disrupting our clinical trials, manufacturing and supply chain; 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 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, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 17,556 | $ | 8,391 | $ | 45,908 | $ | 10,014 | ||||||||
| In-process research and development | — | (10 | ) | 2,500 | 37,656 | |||||||||||
| General and administrative | 5,543 | 2,692 | 16,705 | 5,756 | ||||||||||||
| Total operating expenses | 23,099 | 11,073 | 65,113 | 53,426 | ||||||||||||
| Loss from operations | (23,099 | ) | (11,073 | ) | (65,113 | ) | (53,426 | ) | ||||||||
| Total other income (expense) | 1,911 | (26,254 | ) | (94,696 | ) | (48,982 | ) | |||||||||
| Net loss | $ | (21,188 | ) | $ | (37,327 | ) | $ | (159,809 | ) | $ | (102,408 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.56 | ) | $ | (5.70 | ) | $ | (5.89 | ) | $ | (18.22 | ) | ||||
| Weighted-average shares of common stock outstanding, basic and diluted | 37,553,735 | 6,546,410 | 27,147,314 | 5,619,182 | ||||||||||||
HilleVax, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
| December 31, 2022 | December 31, 2021 | |||||||
| Cash and cash equivalents | $ | 279,401 | $ | 124,566 | ||||
| Total assets | 317,211 | 127,159 | ||||||
| Total liabilities | 49,982 | 227,916 | ||||||
| Total stockholders’ equity (deficit) | 267,229 | (100,757 | ) | |||||
| Total liabilities and stockholders’ equity (deficit) | 317,211 | 127,159 | ||||||
FAQ
What were HilleVax's financial results for the year ended December 31, 2022?
When will HilleVax announce data from the NEST-IN1 clinical trial?
What are the key achievements of HilleVax in 2022?
How did HilleVax's expenses change in 2022 compared to 2021?
