Boston-based HilleVax, Inc. (NASDAQ:HLVX) announced today that it is discontinuing the development of its infant vaccine candidate, HIL-214, after the drug failed to meet primary efficacy endpoints in a Phase 2b clinical trial. The study, dubbed NEST-IN1, was designed to assess the vaccine's efficacy, safety, and immunogenicity in infants around 5 months old, with sites in the United States and Latin America participating.
The trial recorded 51 primary endpoint events, split nearly evenly between the vaccine arm (25 events out of 1,425 participants) and the placebo arm (26 events out of 1,399 participants), resulting in a vaccine efficacy of 5%. The efficacy measure fell within a 95% confidence interval ranging from -64% to 45%, indicating no significant difference from the placebo. Additionally, HilleVax reported that no clinical benefit was observed across secondary endpoints.
While the vaccine showed a safety and immunogenicity profile in line with previous studies, including an early analysis of the first 200 subjects in NEST-IN1, the lack of efficacy against moderate or severe acute gastroenteritis due to norovirus genotypes GI.1 or GII.4 led to the decision to halt further development for the pediatric population.
The company is now considering alternative paths, including the potential development of HIL-214 and another vaccine candidate, HIL-216, for the adult population. HIL-216 is currently ready for Phase 1 trials.
In light of these recent developments, HilleVax has expressed plans to shift its focus towards the development of its vaccine candidates in adult populations. This decision comes after prior studies, including the NOR-211 trial, showed significant efficacy in adults.
The above news is based on a recent SEC filing.
InvestingPro Insights
In light of HilleVax's recent announcement regarding its vaccine candidate, investors may find it valuable to consider certain financial metrics and analyst insights from InvestingPro. Currently, HilleVax has a market capitalization of approximately $667.5 million and is experiencing significant operating losses, with an operating income of around -$138.86 million over the last twelve months as of Q1 2024. This is further reflected in a negative P/E ratio of -3.96, which adjusts to -5.08 when considering the same time frame. Despite these challenges, InvestingPro Tips point out that HilleVax holds more cash than debt on its balance sheet, indicating a degree of financial stability that could support its strategic pivot towards developing vaccines for the adult population.
Analysts have revised their earnings upwards for the upcoming period, suggesting that there may be optimism about the company's potential to recover from the recent setback. Additionally, with liquid assets exceeding short-term obligations, HilleVax appears to have a buffer to navigate through its cash burn issues. However, it's important to note that analysts do not anticipate the company will be profitable this year, and HilleVax does not pay a dividend to shareholders, which may influence investment decisions.
For investors seeking a deeper analysis, there are additional InvestingPro Tips available, which can be accessed for HilleVax at https://www.investing.com/pro/HLVX. To gain more insights and make informed decisions, consider using the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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