HilleVax Files IPO Registration Statement

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The company describes itself as: ‘We are a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year, as well as significant additional economic and social burden. To date, HIL-214 has been studied in nine clinical trials conducted by Takeda Vaccines, Inc. (Takeda) and its predecessor, LigoCyte Pharmaceuticals, Inc. (LigoCyte), which collectively generated safety data from more than 4,500 subjects and immunogenicity, or the ability of the vaccine to provoke an immune response, data from more than 2,200 subjects, including safety and immunogenicity data from more than 800 pediatric subjects. A randomized, placebo-controlled Phase 2b field efficacy trial enrolled 4,712 adult subjects, and HIL-214 was well tolerated and demonstrated clinical proof of concept in preventing moderate-to-severe cases of AGE from norovirus infection. In September 2021, an open investigational new drug application (IND) was transferred to us from Takeda, under which we plan to initiate a Phase 2b clinical trial in the second quarter of 2022 to evaluate the safety, immunogenicity, and efficacy of HIL-214 in infants. We expect to report interim safety data from this trial for the first 200 subjects in the second half of 2022, interim immunogenicity data for the first 200 subjects in the first half of 2023, and top-line data in the second half of 2023. We believe HIL-214 has the potential to be the first ever vaccine approved for norovirus-related illness and that it will help grow HilleVax into a leading global vaccines company.”

J.P. Morgan, SVB Leerink, Stifel and Guggenheim Securities will serve as underwriters.