HilleVax Reports $147.3 Million Net Loss for 2024, Driven by Increased Operating Expenses

HilleVax, Inc., a clinical-stage biopharmaceutical company, reported a net loss of $147.3 million for the year ended December 31, 2024, compared to a net loss of $123.6 million in 2023. This increase in net loss is primarily attributable to a rise in total operating expenses from $133.3 million to $155.3 million, driven by a $33 million increase in restructuring and impairment charges and a $2.1 million increase in general and administrative expenses. Research and development expenses decreased by $28.5 million, primarily due to the discontinuation of further development of HIL-214 in infants following the failure of the NEST-IN1 Phase 2b trial to meet its primary efficacy endpoint. The company also incurred $15.3 million in in-process research and development expenses related to the in-licensing of HIL-216.

Significant changes in the company's financial performance during 2024 included the $33 million in restructuring and impairment charges, primarily resulting from the termination of HIL-214 development and a workforce reduction of approximately 84 employees (80% of the workforce). The company's cash, cash equivalents, and marketable securities totaled $171.4 million as of December 31, 2024. The company's term loan facility with Hercules Capital, Inc. was repaid in full during the year, resulting in a loss on extinguishment of debt. The company also completed an at-the-market offering, raising approximately $14.9 million in net proceeds.

Strategic developments during the year included the in-licensing of HIL-216, a hexavalent VLP vaccine candidate for norovirus, from Chengdu Kanghua Biological Products Co., Ltd. The IND for HIL-216 was cleared by the FDA in September 2023. The company also underwent a significant workforce reduction to conserve cash and is exploring further development of its vaccine candidates and business development activities. As of December 31, 2024, HilleVax had 14 full-time employees, including two in research and development.

Key operational developments included the completion of enrollment for the NEST-IN1 trial in April 2023 and the reporting of top-line data in July 2024, which showed the trial did not meet its primary endpoint. The company holds 25 issued U.S. patents for HIL-214 as of March 20, 2025, licensed from Takeda under an exclusive license agreement. The company's commercial strategy includes seeking advisory body recommendations, particularly from the ACIP, for its norovirus vaccine candidates. The company anticipates that its cash resources will be sufficient to fund operations for at least the next 12 months. However, the company acknowledges significant risks related to its limited operating history, reliance on third-party manufacturers and collaborators, and the inherent uncertainties of clinical development and regulatory approval.