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HilleVax, Inc. Common Stock (symbol: HLVX) is a clinical-stage biopharmaceutical company that is pioneering the development and commercialization of innovative vaccines. The company's primary focus is on HIL-214, a virus-like particle (VLP) based vaccine candidate aimed at preventing moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. Norovirus is a highly contagious virus responsible for over 700 million cases of AGE and 200,000 deaths worldwide each year, leading to substantial healthcare costs.
HilleVax's HIL-214 program has shown significant progress, with the company completing enrollment for the NEST-IN1 clinical trial in April 2023. Due to logistical challenges in processing samples from various geographies, the top-line data readout has been moved to mid-2024. If successful, HIL-214 has the potential to be the first vaccine to address the global need for norovirus prevention.
In addition to HIL-214, HilleVax is expanding its pipeline with HIL-216, a next-generation norovirus VLP vaccine that covers multiple norovirus genotypes. The Investigational New Drug (IND) application for HIL-216 was cleared by the U.S. FDA in September 2023, and a Phase 1 trial is expected to commence in 2024.
As of June 30, 2023, HilleVax reported cash, cash equivalents, and marketable securities totaling $244.1 million. The company has seen a year-over-year increase in research and development expenses, reflecting its commitment to advancing HIL-214 and expanding its R&D team. General and administrative expenses also rose due to scaling G&A functions to support ongoing and future projects.
In recent financial updates, the third quarter of 2023 saw a net loss of $31.8 million, primarily driven by continued investment in clinical development and personnel. The company's strategic financial management and partnerships have positioned it well for future growth, including its recent collaboration with Kangh to develop HIL-216.
HilleVax is committed to fulfilling the unmet medical need for norovirus vaccines, and its strategic partnerships and robust pipeline underscore its leadership in this critical area of public health. For more information, please visit the company's website at http://www.HilleVax.com.
Forward-Looking Statements: This description includes forward-looking statements based on current beliefs and expectations. These statements involve risks and uncertainties, such as delays in clinical trials, regulatory hurdles, and dependency on third-party collaborations. For a detailed list of risk factors, refer to HilleVax's filings with the Securities and Exchange Commission (SEC).
HilleVax, Inc. (Nasdaq: HLVX) reported its financial results for 2022, highlighting key achievements and future milestones. The company ended 2022 with cash reserves of $279.4 million and experienced significant increases in both research and development expenses, totaling $45.9 million, compared to $10.0 million in 2021. For Q4 2022, the net loss reached $21.2 million, up from $37.3 million in Q4 2021, while the full year net loss was $159.8 million, compared to $102.4 million in the prior year. Upcoming milestones include topline data from the Phase 2b NEST-IN1 clinical trial expected in Q1 2024.
HilleVax, a clinical-stage biopharmaceutical company, announced key leadership changes including Ozzie Berger as Senior VP of Regulatory Affairs, Anju Chatterji as Chief Technical Officer, and Shane Maltbie as Chief Financial Officer. These promotions are part of a strategic transition aimed at enhancing their Phase 2b trial of HIL-214, a vaccine for norovirus. Berger brings nearly 30 years of experience, while Chatterji and Maltbie have significant backgrounds in technical operations and financial management, respectively. The company emphasizes the ongoing enrollment and expected data readouts from its clinical trials.
BOSTON, Jan. 04, 2023 (GLOBE NEWSWIRE) -- HilleVax, a clinical-stage biopharmaceutical company, will present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023. The presentation will cover HIL-214, an investigational vaccine for moderate-to-severe norovirus-related acute gastroenteritis, and the ongoing Phase 2b study NEST-IN1. The event will be held at the Westin St. Francis Hotel in San Francisco, starting at 4:30 p.m. EST. HilleVax aims to address the significant health burden of norovirus, which affects millions globally.
HilleVax reported results from the NEST-IN1 trial, focusing on the immunogenicity of its vaccine candidate HIL-214 for norovirus prevention in infants. In the trial's run-in cohort of 203 subjects, geometric mean titers (GMTs) of pan-IG antibodies were significantly higher for HIL-214 compared to placebo, with a greater than 18-fold increase observed. The seroresponse rates were 99.0% for GI.1 and 86.9% for GII.4 in the HIL-214 group versus only 4.1% and 3.1% for placebo. The full trial aims to enroll 3,000 subjects, with topline safety and efficacy data expected in late 2023.
BOSTON, Nov. 10, 2022 (GLOBE NEWSWIRE) -- HilleVax, a clinical-stage biopharmaceutical company, will participate in the Guggenheim Securities 4th Annual Immunology and Neurology Day and the Stifel Healthcare Conference. Key discussions will focus on HIL-214, an investigational virus-like particle vaccine aimed at preventing moderate-to-severe norovirus-related gastroenteritis, and its ongoing Phase 2b clinical trial, NEST-IN1. Events are scheduled for November 14 and November 16, 2022, featuring CEO Robert Hershberg.
HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company, reported third-quarter financial results for 2022, highlighting progress on its investigational vaccine HIL-214 for norovirus. The company began enrollment for 2,800 subjects in the Phase 2b NEST-IN1 trial and expects immunogenicity results from the initial 200 subjects in Q4 2022. HilleVax reported a cash balance of $292.1 million and a net loss of $16.8 million for the quarter, a significant reduction from $61.9 million in Q3 2021. R&D expenses were $13.3 million, up from $0.9 million the previous year.
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.
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