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HilleVax, Inc. Common Stock (symbol: HLVX) is a clinical-stage biopharmaceutical company that is pioneering the development and commercialization of innovative vaccines. The company's primary focus is on HIL-214, a virus-like particle (VLP) based vaccine candidate aimed at preventing moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. Norovirus is a highly contagious virus responsible for over 700 million cases of AGE and 200,000 deaths worldwide each year, leading to substantial healthcare costs.
HilleVax's HIL-214 program has shown significant progress, with the company completing enrollment for the NEST-IN1 clinical trial in April 2023. Due to logistical challenges in processing samples from various geographies, the top-line data readout has been moved to mid-2024. If successful, HIL-214 has the potential to be the first vaccine to address the global need for norovirus prevention.
In addition to HIL-214, HilleVax is expanding its pipeline with HIL-216, a next-generation norovirus VLP vaccine that covers multiple norovirus genotypes. The Investigational New Drug (IND) application for HIL-216 was cleared by the U.S. FDA in September 2023, and a Phase 1 trial is expected to commence in 2024.
As of June 30, 2023, HilleVax reported cash, cash equivalents, and marketable securities totaling $244.1 million. The company has seen a year-over-year increase in research and development expenses, reflecting its commitment to advancing HIL-214 and expanding its R&D team. General and administrative expenses also rose due to scaling G&A functions to support ongoing and future projects.
In recent financial updates, the third quarter of 2023 saw a net loss of $31.8 million, primarily driven by continued investment in clinical development and personnel. The company's strategic financial management and partnerships have positioned it well for future growth, including its recent collaboration with Kangh to develop HIL-216.
HilleVax is committed to fulfilling the unmet medical need for norovirus vaccines, and its strategic partnerships and robust pipeline underscore its leadership in this critical area of public health. For more information, please visit the company's website at http://www.HilleVax.com.
Forward-Looking Statements: This description includes forward-looking statements based on current beliefs and expectations. These statements involve risks and uncertainties, such as delays in clinical trials, regulatory hurdles, and dependency on third-party collaborations. For a detailed list of risk factors, refer to HilleVax's filings with the Securities and Exchange Commission (SEC).
HilleVax (HLVX) reported its Q3 2024 financial results, showing cash and equivalents of $189.3 million as of September 30, 2024, down from $303.5 million at year-end 2023. R&D expenses decreased to $20.2 million from $27.3 million in Q3 2023, mainly due to lower clinical development costs. G&A expenses slightly decreased to $6.2 million from $6.6 million. Other income declined to $0.6 million from $2.1 million, primarily due to interest expenses from term loan facility repayment. Net loss improved to $25.8 million compared to $31.8 million in Q3 2023.
HilleVax (Nasdaq: HLVX) reported its Q2 2024 financial results and recent company progress. Key points include:
- Cash position of $245.0 million as of June 30, 2024
- NEST-IN1 clinical study for HIL-214 in infants failed to meet efficacy endpoints
- Announced 40% workforce reduction to cut operating expenses
- Exploring potential development of HIL-214 and HIL-216 norovirus vaccines in adults
- Q2 2024 R&D expenses: $26.6 million, up from $23.0 million in Q2 2023
- Q2 2024 G&A expenses: $8.1 million, up from $7.2 million in Q2 2023
- Q2 2024 net loss: $40.7 million, increased from $27.9 million in Q2 2023
HilleVax (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing novel vaccines, has announced a significant workforce reduction to cut operating expenses. The company is laying off approximately 41 employees, which represents about 40% of its total workforce. This decision is aimed at preserving cash while maintaining core capabilities.
The restructuring comes as HilleVax explores potential continued development of its HIL-214 and HIL-216 norovirus vaccine candidates. The company is also considering business development-related activities for these vaccine candidates. This move suggests that HilleVax is facing financial challenges and is taking strategic steps to extend its runway while focusing on its key projects.
HilleVax announced topline results from the NEST-IN1 Phase 2b study of HIL-214 in infants. The trial, conducted in the US and Latin America, did not meet its primary or secondary efficacy endpoints. Specifically, the vaccine showed a mere 5% efficacy against moderate or severe acute gastroenteritis caused by norovirus, which was statistically insignificant. Consequently, HilleVax will discontinue the development of HIL-214 for infants but will explore its continued development in adults. The safety and immunogenicity profiles were consistent with previous studies. HilleVax also plans to explore the potential of HIL-216, another vaccine candidate, in adults.
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.
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