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Vaxart, Inc. develops oral recombinant pill vaccines based on a proprietary delivery platform. The clinical-stage biotechnology company’s programs include vaccine candidates for coronavirus, norovirus and influenza, as well as a therapeutic human papillomavirus vaccine as its first immune-oncology indication. Its pill-based vaccines are designed for oral administration, storage and shipping without refrigeration, and avoidance of needle-stick risk.
Vaxart news centers on clinical data and scientific publications, business updates, financial results, financing arrangements, collaborations, intellectual property around adenovirus and TLR3 agonist oral vaccination technology, and governance changes as the company advances its oral vaccine pipeline.
Vaxart (NASDAQ: VXRT) has announced its upcoming participation in the Citizens Life Sciences Conference, scheduled for May 7-8, 2025. The company's management team will deliver a presentation on Wednesday, May 7 at 1:00 PM ET.
The presentation will be accessible through a live webcast on Vaxart's official website (www.vaxart.com). For those unable to attend the live session, a replay will remain available for 30 days after the event.
Institutional investors interested in engaging with the management team during the conference can coordinate through their Citizens representative.
Vaxart has completed enrollment in its Phase 1 clinical trial comparing second-generation and first-generation oral norovirus vaccine constructs. The company expects to release topline data in mid-2025.
The open-label, dose-ranging study will evaluate safety and immune parameters that previously correlated with protection in a completed norovirus challenge study. A Data and Safety Monitoring Board has reviewed interim safety data and recommended continuing the study without modifications.
CEO Steven Lo emphasized the significant unmet need for a norovirus vaccine, expressing optimism about the potential increased potency of their second-generation constructs. Pending successful Phase 1 results and securing partnership or funding, Vaxart plans to:
- Launch Phase 2 safety and immunogenicity study in late 2025
- Hold End of Phase 2 meeting with FDA
- Potentially begin Phase 3 trials in 2026
Vaxart (Nasdaq: VXRT) has announced its participation in the World Vaccine Congress Washington 2025, scheduled for April 23, 2025, in Washington, D.C. Two key executives will deliver presentations at the event:
Dr. James F. Cummings, Chief Medical Officer, will present on 'Moving the needle: Blocking transmission and boosting existing vaccines by oral tablet vaccination' at 1:10 p.m. ET in Room 207A.
Dr. Sean Tucker, Founder and Chief Scientific Officer, will discuss 'Immune profiling on an oral norovirus vaccine candidate; correlates of protection for disease and infection' at 3:10 p.m. ET in the same room. The company has been a regular presenter at this annual Washington, D.C. event.
Vaxart (VXRT) has announced the granting of inducement equity awards to new employees on March 24, 2025. The awards include stock options and restricted stock units (RSUs) for seven non-executive employees, totaling 292,500 shares (195,000 stock options and 97,500 RSUs). Additionally, Laurie Hastings, the new Senior Vice President of Human Resources, received 300,000 stock options and 67,000 RSUs.
The stock options vest over four years, with 25% vesting after one year and the remainder vesting monthly. RSUs vest 25% annually over four years. These awards were granted under the Vaxart 2024 Inducement Award Plan in compliance with Nasdaq Listing Rule 5635(c)(4), specifically designed for new employees as employment inducement.
Vaxart (VXRT) reported its full year 2024 financial results and business updates. The company initiated a Phase 1 trial for its second-generation oral norovirus vaccine, with topline data expected by mid-2025. The company ended 2024 with $51.7 million in cash and equivalents, providing runway through Q4 2025.
Key financial metrics include:
- Net loss of $66.9 million ($0.33 per share) in 2024, improved from $82.5 million in 2023
- Revenue increased to $28.7 million in 2024, up from $7.4 million in 2023
- R&D expenses rose to $74.2 million from $68.1 million in 2023
The company continues follow-up for its COVID-19 Phase 2b 400-person sentinel cohort, though received a stop work order from the U.S. government in February 2025. Vaxart implemented a 10% workforce reduction following this order. The company is also advancing its avian influenza program with a new vaccine candidate.
Vaxart (NASDAQ: VXRT) has scheduled its full year 2024 business update and financial results conference call for March 20, 2025, after market close. The conference call will begin at 4:30 p.m. ET, featuring the senior management team.
Investors can participate through domestic line (877) 407-0832 or international line (201) 689-8433 using Conference ID 13751819. Questions can be submitted in advance to ir@vaxart.com. A webcast replay will be available on the company's website after the event.
Vaxart (VXRT) has initiated a Phase 1 clinical trial for its second-generation oral norovirus vaccine delivered in pill form. The open-label, dose-ranging study will compare the new constructs head-to-head against first-generation versions, focusing on safety and immune parameters that correlated with protection in previous challenge studies.
The company expects topline data as early as mid-2025. Upon successful completion and securing partnership or funding, Vaxart plans to conduct a Phase 2 safety and immunogenicity study in the second half of 2025, followed by an FDA End of Phase 2 meeting. A potential Phase 3 trial could commence in 2026.
With no currently approved vaccines against norovirus, Vaxart aims to address this urgent public health need as the virus continues to spread globally.
Vaxart (VXRT) has published complete data from its Phase 1b trial of its first-generation oral pill norovirus vaccine candidate in elderly adults aged 55-80 years. The study demonstrated strong and durable antibody responses in this population, which typically shows reduced immune responses to traditional injected vaccines.
Key findings include:
- Statistically significant increases in serum anti-VP1 IgA across all three dose cohorts
- Dose-dependent increases in vaccine-induced serum anti-VP1 IgG responses
- Strong IgA responses in saliva and nasal cavity
- Safety profile showing only mild to moderate side effects
The vaccine demonstrated effectiveness regardless of age group, with no significant differences between 55-65 and 66-80 year cohorts. Vaxart plans to initiate a Phase 1 trial comparing its second-generation oral norovirus vaccine constructs against first-generation versions in the first half of 2025.
Vaxart (NASDAQ: VXRT) has announced the appointment of Kevin Finney to its Board of Directors, effective immediately. Finney, who brings 35 years of healthcare industry experience in leadership, operations, and corporate development, will serve on the Board's Audit and Nominating and Governance Committees.
The appointment comes as part of Vaxart's strategy to strengthen its leadership team and advance its oral vaccine platform technology. Simultaneously, Robert A. Yedid has stepped down from the Board of Directors. CEO Steven Lo expressed confidence that Finney's broad expertise will be valuable in executing the company's strategy and achieving timely milestones.
Vaxart provided updates on its COVID-19, norovirus, and influenza programs. The COVID-19 Phase 2b study is set to begin a 10,000-participant trial pending FDA review of 30-day safety data. The Norovirus program is moving to a Phase 1 study, set to start in early 2025 with topline data expected mid-2025. A new avian influenza vaccine candidate is in preclinical testing.
CEO Steven Lo highlighted the progress, noting the 30-day safety data for the COVID-19 trial was favorably reviewed by an independent DSMB. The trial will continue upon FDA and BARDA approval. The norovirus Phase 1 trial will compare second-generation constructs against first-generation ones, aiming to identify the most effective candidate.
The company aims to sustain momentum through partnerships and non-dilutive funding. The COVID-19 project is funded under Project NextGen, with a potential award of up to $460.7 million. Vaxart's cash runway extends into 2026, supported by this award and existing funds.