HilleVax Inc

Item 1A. Risk Factors

OtTher than as set forth below, there he have been no material changes to the risk factors disclosed in Part I, Item 1A, Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2023.

We cannot provide any assurance we will be successful in identifying a viable development path for HIL-214 or HIL-216 in adults, or otherwise in securing business-development-related arrangements sufficient to advance these candidates.

In July 2024, we reported top-line data from NEST-IN1 for HIL-214.The study did not meet its primary endpoint of efficacy against moderate or severe AGE events due to GI.1 or GII.4 norovirus genotypes. No clinical benefit was observed across secondary endpoints. HIL-214 exhibited a safety and immunogenicity profile consistent with what was observed in the prespecified analysis of the first 200 subjects in NEST-IN1 and in previously reported studies. We also announced a workforce reduction of approximately 41 employees, or approximately 40% of our workforce, intended to preserve cash while maintaining core capabilities as we explore the potential for continued development of HIL-214 and HIL-216 in adults as well as business development-related activities for these vaccine candidates.

Despite these efforts, we may be unable to identify a viable development path forward for HIL-214 or HIL-216. Even if we do identify a development path forward for our vaccine candidates, we may require additional capital and other resources, including business development partnerships or other strategic collaborations. However, we may be unable to secure such partnerships, other strategic collaborations or other resources on acceptable terms or at all. In addition, we may not realize the benefits expected from the workforce reduction, including our ability to conserve cash and such actions may make it more difficult to retain key personnel.

We currently depend primarily on the success of HIL-214, and to a lesser extent, HIL-216. If we are unable to develop, receive marketing approval for or successfully commercialize our vaccine candidates, or if we experience delays as a result of any of t than as set forth in Part II, Item 1A, "Risk Factors" of our Quarterly Report on Form 10-Q for the above factors or otherwise, our business would be significantly harmed. We may dequartermine to evaluate other strategic alternatives, such as a business combination, merger or reverse merger, in order to maximize shareholder value. Even if we pursue strategic alternatives, we may be unable to complete a transaction on acceptable terms or at all, and if any of the above events occur, you may lose all or part of your investment ended June 30, 2024.

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PART II