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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, Inc. (Nasdaq: HLVX) announced the completion of enrollment for its NEST-IN1 trial, a Phase 2b study evaluating HIL-214, a vaccine candidate for norovirus, with over 3,000 subjects enrolled across six countries. The trial focuses on infants aged around 5 months and aims to assess the vaccine's efficacy and safety against moderate-to-severe norovirus-related acute gastroenteritis (AGE). Topline safety and clinical efficacy data are anticipated in Q1 2024. Currently, there are no approved vaccines for norovirus, which causes approximately 700 million cases of AGE and 200,000 deaths annually, highlighting the critical need for effective vaccination.
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