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HilleVax, Inc. - HLVX STOCK NEWS

Welcome to our dedicated page for HilleVax news (Ticker: HLVX), a resource for investors and traders seeking the latest updates and insights on HilleVax stock.

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).

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HilleVax announced topline results from the NEST-IN1 Phase 2b study of HIL-214 in infants. The trial, conducted in the US and Latin America, did not meet its primary or secondary efficacy endpoints. Specifically, the vaccine showed a mere 5% efficacy against moderate or severe acute gastroenteritis caused by norovirus, which was statistically insignificant. Consequently, HilleVax will discontinue the development of HIL-214 for infants but will explore its continued development in adults. The safety and immunogenicity profiles were consistent with previous studies. HilleVax also plans to explore the potential of HIL-216, another vaccine candidate, in adults.

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HilleVax, Inc. (Nasdaq: HLVX) reported Q1 2024 financial results, highlighting $272.7 million in cash, cash equivalents, and marketable securities as of March 31, 2024. The company remains on track to report top-line data from the NEST-IN1 Phase 2B clinical study of HIL-214 in infants by mid-2024. With positive results, HIL-214 is expected to progress into Phase 3 trials for norovirus prevention. Recent business highlights include the appointment of Sean McLoughlin as COO.

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HilleVax, Inc. (HLVX) reports financial results for 2023, highlights progress on HIL-214 vaccine development for norovirus-related gastroenteritis, with topline data expected in mid-2024. The company had $303.5 million in cash and securities as of December 31, 2023. Recent business highlights include new COO appointment and successful public stock offering.
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HilleVax, Inc. (Nasdaq: HLVX) will present at the Guggenheim 6th Annual Biotechnology Conference to discuss HIL-214, its investigational virus-like particle (VLP) based vaccine for the prevention of norovirus-related acute gastroenteritis. The company focuses on developing and commercializing novel vaccines to address the global burden of norovirus, which results in over 700 million cases of acute gastroenteritis and 200,000 deaths annually, with significant economic impact.
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HilleVax, Inc. (Nasdaq: HLVX) announced the appointment of Sean McLoughlin as Chief Operating Officer, with Dr. Aditya Kohli transitioning to Chief Business Officer. McLoughlin brings three decades of experience in vaccines, previously serving in leadership roles at GSK. His appointment is expected to support the progress of NEST-IN1, HilleVax's Phase 2b clinical trial of HIL-214 for norovirus prevention.
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HilleVax, Inc. (Nasdaq: HLVX) and Chengdu Kanghua Biological Products Co., Ltd. (Kangh) (SHE: 300841) have entered into an exclusive license agreement for rights to Kangh’s hexavalent virus-like particle (VLP) vaccine candidate for norovirus, referred to by HilleVax as HIL-216, outside of Greater China. This collaboration adds a Phase 1-ready next-generation program to HilleVax’s pipeline and includes VLPs for six of the most common norovirus genotypes. The Investigational New Drug (IND) application for HIL-216 was cleared by the U.S. FDA in September 2023. HilleVax will pay Kangh an upfront payment of $15 million with the potential for additional payments of up to $255.5 million upon achieving certain development and sales milestones. Kangh is also eligible to receive a single-digit tiered royalty on net sales outside of Greater China.
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HilleVax, Inc. (Nasdaq: HLVX) will present at the 42nd Annual J.P. Morgan Healthcare Conference to discuss HIL-214, an investigational virus-like particle (VLP) based vaccine for the prevention of norovirus-related acute gastroenteritis, and the ongoing Phase 2b study NEST-IN1. The presentation will be held on January 8, 2024, at 1:30 p.m. PST in San Francisco, California.
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HilleVax, Inc. (HLVX) Reports Strong Financial Results and Progress on HIL-214 Vaccine Development
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HilleVax, Inc. will be presenting at the Guggenheim 5th Annual Inflammation, Neurology & Immunology Conference on November 6, 2023, and at the Stifel Healthcare Conference on November 14, 2023. The focus of the presentations will be on HilleVax's investigational virus-like particle (VLP) based vaccine for norovirus-related acute gastroenteritis and the ongoing Phase 2b study NEST-IN1.
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HilleVax, Inc. to present at Cantor Global Healthcare Conference on September 28, 2023. Discussion to focus on HIL-214 vaccine for norovirus prevention. Webcast available.
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FAQ

What does HilleVax, Inc. do?

HilleVax, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative vaccines, particularly for norovirus.

What is HIL-214?

HIL-214 is a virus-like particle (VLP) based vaccine candidate developed by HilleVax for preventing moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection.

When will the NEST-IN1 clinical trial data be available?

Top-line data from the NEST-IN1 clinical trial for HIL-214 is expected to be available by mid-2024.

What is HilleVax's financial status?

As of June 30, 2023, HilleVax reported $244.1 million in cash, cash equivalents, and marketable securities.

What are the future plans for HIL-216?

HilleVax intends to initiate a Phase 1 clinical trial for HIL-216, a next-generation norovirus VLP vaccine, in 2024.

What recent achievements has HilleVax made?

HilleVax completed enrollment for the NEST-IN1 trial for HIL-214 and entered a collaboration with Kangh for the development of HIL-216.

What are the main financial highlights for HilleVax?

HilleVax saw increased R&D and G&A expenses in 2023 due to higher activity levels and team growth, with a net loss of $31.8 million for Q3 2023.

Who are HilleVax's key partners?

HilleVax has partnerships with entities such as Kangh and relies on collaborations for manufacturing and development activities.

How does HilleVax plan to use its capital?

HilleVax intends to use its capital to fund the clinical development of HIL-214, including manufacturing activities, and for general corporate purposes.

Where can I find more information about HilleVax?

For more information, visit HilleVax's official website at http://www.HilleVax.com.

HilleVax, Inc.

Nasdaq:HLVX

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87.01M
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17.14%
81.36%
3.11%
Biological Product (except Diagnostic) Manufacturing
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