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HilleVax Inc. news centered on its clinical-stage vaccine business, including development updates for HIL-214 and HIL-216, virus-like particle vaccine candidates for norovirus-associated acute gastroenteritis. Company updates also covered clinical data from the NEST-IN1 study, the discontinuation of HIL-214 development in infants, and evaluation of adult norovirus vaccine opportunities.
Recurring HLVX news also included operating and financial results, research and development spending, cash and marketable securities, workforce and expense actions, material agreements, shareholder matters, capital-structure disclosures, governance matters, risk factors, and corporate-status developments.
BOSTON, Sept. 1, 2022 - HilleVax, a clinical-stage biopharmaceutical company, will participate in the J.P. Morgan Biotech – 2022 Conference Call Series on September 6, 2022. Key topics will include HIL-214, an investigational virus-like particle vaccine aimed at preventing moderate-to-severe norovirus-related acute gastroenteritis, and its ongoing Phase 2b study NEST-IN1. The fireside chat will be moderated by Eric Joseph, Ph.D., featuring CEO Robert Hershberg.
Norovirus accounts for over 700 million cases of acute gastroenteritis globally, resulting in significant health costs.
HilleVax, Inc. (Nasdaq: HLVX) has resumed enrollment in its Phase 2b trial, NEST-IN1, for HIL-214, a vaccine against norovirus-related acute gastroenteritis in infants. An independent data monitoring committee recommended continuing the trial after reviewing safety data from 203 subjects. The company anticipates immunogenicity results from the initial 200 subjects by Q4 2022 and plans to complete enrollment of 3,000 subjects. Topline data from the study is expected in H2 2023, marking a significant milestone for HIL-214.
BOSTON, Aug. 15, 2022 (GLOBE NEWSWIRE) -- HilleVax, a clinical-stage biopharmaceutical company, announced its participation in a fireside chat at the SVB Securities Virtual Vaccine Forum. The discussion will focus on HIL-214, an investigational VLP-based vaccine targeting norovirus-related acute gastroenteritis. This session is scheduled for August 18, 2022, from 3:00 – 3:50 p.m. EDT, moderated by David Risinger. Norovirus causes an estimated 700 million cases of acute gastroenteritis globally, leading to significant health costs and impacts on vulnerable populations.
HilleVax, Inc. (Nasdaq: HLVX) reported its Q2 2022 financial results, highlighting significant developments in its pipeline, particularly for HIL-214, a vaccine for norovirus. The company completed enrollment in a key Phase 2b study, expecting safety assessment results soon. Financially, HilleVax holds $314.6 million in cash, with a net loss of $53.9 million for Q2, up from $1.7 million in Q2 2021. Research and development expenses surged to $8.8 million, and other expenses rose significantly due to convertible note valuations. Upcoming milestones include interim safety data in Q3 2022.
HilleVax, Inc. (Nasdaq: HLVX) announced results from the NOR-213 Phase 2 clinical trial, showing that antibody responses to the HIL-214 vaccine persisted at year 5, similar to year 3 results. The trial involved 528 adult subjects who received HIL-214 to prevent moderate-to-severe gastroenteritis caused by norovirus. No adverse events related to HIL-214 were reported. The company plans to present detailed data at a future meeting and is optimistic about the vaccine's long-term immunogenicity and safety.
HilleVax has initiated its Phase 2b clinical trial of the HIL-214 vaccine candidate aimed at preventing norovirus-related acute gastroenteritis in infants. The company raised $230 million through an upsized IPO to fund this trial and future phases. As of March 31, 2022, HilleVax reported a net loss of $67.9 million, significantly up from $1.5 million in Q1 2021. With cash reserves of $111.3 million, the company also has a $75 million loan agreement in place. Upcoming milestones include interim safety results in Q3 2022 and topline results in late 2023.
HilleVax, a clinical-stage biopharmaceutical company, announced the successful closing of its initial public offering (IPO) of 13,529,750 shares at $17.00 per share, totaling approximately $230.0 million in gross proceeds. This includes the full exercise of a 1,764,750-share underwriter option. The shares are listed on the Nasdaq under the ticker HLVX. Joint book-running managers for the offering included J.P. Morgan, SVB Securities, Stifel, and Guggenheim Securities.