HilleVax Q1 2024 Financials and Company Progress Highlights

HilleVax, Inc., a clinical-stage biopharmaceutical company (Nasdaq: HLVX) based in Boston, has announced its financial results for the first quarter ending March 31, 2024. The company, which focuses on developing and commercializing innovative vaccines, has highlighted significant progress and upcoming milestones for HIL-214, its investigational virus-like particle (VLP) based vaccine targeting moderate-to-severe norovirus-related acute gastroenteritis.

CEO Rob Hershberg expressed enthusiasm about the company's trajectory, particularly regarding the NEST-IN1 clinical trial of HIL-214 in infants. The company is on schedule to release top-line data from this Phase 2B study by mid-2024. Hershberg indicated that positive results could propel HIL-214 into Phase 3 clinical trials for both infants and older adults swiftly. HIL-214 is noted as the most advanced norovirus vaccine currently under development, with the potential to meet significant medical needs among children and adults.

In the first quarter of 2024, HilleVax appointed Sean McLoughlin as Chief Operating Officer, marking a notable addition to the company’s leadership team.

Financially, HilleVax reported cash, cash equivalents, and marketable securities amounting to $272.7 million as of March 31, 2024, down from $303.5 million at the end of December 2023. Research and development (R&D) expenses for the first quarter of 2024 were $26.0 million, compared to $23.2 million for the same period in 2023. This increase was primarily due to a rise in the number of R&D employees. General and administrative (G&A) expenses also saw an increase, totaling $8.5 million versus $5.8 million in the first quarter of 2023, largely driven by the expansion of the G&A team. Other income for the quarter stood at $3.0 million, up from $2.1 million in the previous year’s first quarter, mainly due to accretion in marketable securities.

HilleVax's net loss for the first quarter of 2024 was $46.8 million, compared to $26.9 million for the same period in 2023. This increase in net loss reflects the company's intensified investment in its development programs and operational expansion.

HilleVax's flagship vaccine candidate, HIL-214, is being developed to tackle norovirus-induced acute gastroenteritis, a significant global health concern. Norovirus is estimated to cause about 700 million cases of acute gastroenteritis annually, with approximately 200,000 resulting in death. The infection leads to substantial economic burdens, costing the U.S. healthcare system and society about $10 billion annually, with global costs reaching $60 billion. The impact of norovirus is particularly severe on young children and the elderly.

Looking ahead, HilleVax anticipates key milestones, including the release of top-line safety and clinical efficacy data from the NEST-IN1 study by mid-2024. The company remains focused on advancing HIL-214 through its clinical phases and addressing the significant unmet medical need in norovirus prevention.

HilleVax's commitment to addressing critical health challenges through vaccine innovation is underscored by its robust financial standing and strategic leadership appointments. The upcoming months are poised to be pivotal for the company, particularly with the expected data readout from the NEST-IN1 clinical trial, which could significantly influence the trajectory of HIL-214's development and commercialization.

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