HilleVax, Inc. - HLVX STOCK NEWS

HilleVax (HLVX) reported its Q3 2024 financial results, showing cash and equivalents of $189.3 million as of September 30, 2024, down from $303.5 million at year-end 2023. R&D expenses decreased to $20.2 million from $27.3 million in Q3 2023, mainly due to lower clinical development costs. G&A expenses slightly decreased to $6.2 million from $6.6 million. Other income declined to $0.6 million from $2.1 million, primarily due to interest expenses from term loan facility repayment. Net loss improved to $25.8 million compared to $31.8 million in Q3 2023.

HilleVax (Nasdaq: HLVX) reported its Q2 2024 financial results and recent company progress. Key points include:

- Cash position of $245.0 million as of June 30, 2024
- NEST-IN1 clinical study for HIL-214 in infants failed to meet efficacy endpoints
- Announced 40% workforce reduction to cut operating expenses
- Exploring potential development of HIL-214 and HIL-216 norovirus vaccines in adults
- Q2 2024 R&D expenses: $26.6 million, up from $23.0 million in Q2 2023
- Q2 2024 G&A expenses: $8.1 million, up from $7.2 million in Q2 2023
- Q2 2024 net loss: $40.7 million, increased from $27.9 million in Q2 2023

HilleVax (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing novel vaccines, has announced a significant workforce reduction to cut operating expenses. The company is laying off approximately 41 employees, which represents about 40% of its total workforce. This decision is aimed at preserving cash while maintaining core capabilities.

The restructuring comes as HilleVax explores potential continued development of its HIL-214 and HIL-216 norovirus vaccine candidates. The company is also considering business development-related activities for these vaccine candidates. This move suggests that HilleVax is facing financial challenges and is taking strategic steps to extend its runway while focusing on its key projects.

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.

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.

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.

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.

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.

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.