Vaxart Reports Favorable Safety Data for Oral COVID-19 Vaccine, Eyes 2027 Readout for 5,000-Patient Cohort
核心洞察
Vaxart's 400-participant Sentinel cohort showed its oral COVID-19 (搜索) vaccine had fewer systemic side effects than an mRNA comparator, with no vaccine-related serious adverse events over 12 months.
The company remains on track to report top-line data from the fully enrolled ~5,000-participant main cohort targeting the KP.2 variant in the first half of 2027.
BARDA (搜索) released $29 million in dedicated funding for expanded exploratory analyses including mucosal immunity profiling and sub-variant genomic sequencing.
Vaxart has reported positive 12-month safety data from the 400-participant Sentinel cohort of its Phase II-B COVID-19 (搜索) vaccine trial, reinforcing the tolerability profile of its oral tablet vaccine platform. The company also confirmed it remains on track to disclose top-line data from the larger, approximately 5,000-participant main cohort in the first half of 2027.
The clinical update was discussed during a stockholder fireside chat alongside second-quarter financial results. Vaxart's Phase II-B COVID-19 (搜索) study is funded through the Biomedical Advanced Research and Development Authority's (BARDA (搜索)) Project NextGen initiative.
Sentinel Cohort Safety Findings
Chief Medical Officer Dr. James F. Cummings detailed the safety outcomes from the Sentinel cohort, which was designed primarily to evaluate safety before expansion into the larger study population. In the cohort, 201 participants received Vaxart's oral COVID-19 (搜索) vaccine candidate targeting the XBB variant, while 199 received an approved injectable mRNA vaccine comparator.
According to Cummings, there were no vaccine-related serious health complications and no severe or long-lasting adverse events in either group over the 12-month period.
The most commonly reported side effects among oral-vaccine recipients were mild-to-moderate fatigue (20.9%), headache (18.9%), and loss of appetite (approximately 10%). Fewer than 10% of oral-vaccine recipients reported other side effects.
By contrast, among mRNA vaccine recipients, more than 60% reported injection-site pain and 40.2% reported injection-site tenderness. Other reported side effects included fatigue (35.2%), muscle pain (33.2%), and headache (28.6%). Between 10% and 15% of mRNA recipients reported joint pain, chills, nausea, diarrhea, and arm swelling.
CEO Steven Lo said the company was "very happy" with the safety findings, including systemic effects, and noted the Vaxart cohort "did much better than the mRNA" comparator on certain safety measures. He said the findings reinforced the safety of the company's oral vaccine platform, adding that Vaxart has cumulatively dosed more than 1,000 subjects across studies.
Efficacy Signals and Main Cohort Outlook
There were 33 symptomatic COVID-19 (搜索) cases in the oral-vaccine arm and 30 in the mRNA comparator arm, with each group recording 12 asymptomatic cases. However, Cummings emphasized that the 400-person Sentinel cohort was not designed or powered to establish statistically significant differences in vaccine efficacy. Lo described the numbers as "certainly very close" and said Vaxart was encouraged by the results.
The larger main cohort, which is fully enrolled, has been vaccinated against the KP.2 strain, matching the updated mRNA comparator. This cohort is intended to evaluate comparative safety and relative efficacy. Vaxart expects the complete data set, including both the Sentinel and main cohorts, to be released in the first half of 2027, subject to BARDA (搜索) approval of the timing and content of disclosures.
BARDA (搜索) Funding and Expanded Analyses
A June contract modification with BARDA (搜索) released dedicated funding for additional scientific analyses. Cummings said $29 million under the modification will support final study execution as well as expanded exploratory safety, immunogenicity, and efficacy analyses.
These analyses include deeper sub-variant genomic sequencing and extended mucosal and cellular biomarker profiling across the more than 5,000 participants in the main cohort. The company also plans to evaluate mucosal immunity, including antibodies in the nose and mouth where respiratory viruses enter the body.
Founder and Chief Scientific Officer Dr. Sean Tucker said Vaxart's platform generates mucosal immunoglobulin A (搜索) (IgA) responses, and the company believes IgA may have a greater ability to handle viral variation than IgG. Prior studies have shown broad cross-reactivity from the company's oral COVID-19 (搜索) vaccine candidate, though further conclusions about durability and variant coverage will depend on analysis of the current Phase II-B data.
Norovirus (搜索) Partnership Strategy
Vaxart continues to pursue a partner for its norovirus (搜索) vaccine program, which Lo described as a significant unmet need. He emphasized that the company views the norovirus asset as highly valuable and would only be interested in offers that reflect what management sees as the full potential of the market.
"We only are going to be interested in offers that realize the full value of the potential of the norovirus (搜索) market," Lo said.
Lo characterized Moderna's recent decision to extend enrollment in its Phase III norovirus (搜索) study for another season as a "mixed blessing." While the delay could provide Vaxart with a competitive advantage, prospective partners are also weighing the longer timeline and prior setbacks in the norovirus field, including HilleVax's failed program.
Tucker noted that Vaxart believes intestinal antibodies are important for protection against norovirus (搜索) and that its oral tablet could potentially provide stronger intestinal antibody responses than an injected vaccine. If Vaxart does not secure a suitable commercial partner, Lo said the company is also evaluating non-dilutive funding sources, including governments outside the U.S.
Financial Position and Governance
Chief Financial Officer Jeroen Grasman reported that Vaxart ended the second quarter of 2026 with $64 million in cash equivalents and short-term investments. Based on its current operating plan, the company expects its capital to fund operations into the second quarter of 2027.
Second-quarter revenue was $27.2 million, compared with $39.7 million in the prior-year quarter. Revenue primarily came from the BARDA (搜索) contract, along with $2.9 million from Vaxart's license and collaboration agreement with Dynavax (搜索). Research and development expense fell to $33.7 million from $49.7 million a year earlier. Net loss was $13.5 million, or $0.06 per share, compared with a net loss of $15 million, or $0.07 per share, in the second quarter of 2025.
Grasman said Vaxart also has access to a $25 million share purchase agreement with Lincoln Park Capital. The company is prioritizing financial discipline and evaluating government grants, nonprofit funding, and strategic partnerships as potential non-dilutive funding sources.
Separately, Lo outlined governance actions following a cooperation agreement with a shareholder group. Vaxart reorganized board leadership, appointed new committee chairs, and is creating a Stockholder Engagement Committee and a Clinical and Regulatory Affairs Committee. The company is also seeking an additional independent director in collaboration with the shareholder group.
At the company's 2026 Annual Meeting, stockholders rejected the non-binding advisory say-on-pay proposal on executive compensation. Lo also confirmed that Vaxart is "not working on a reverse stock split at the present moment," preferring to see the stock price grow organically through execution of its corporate strategy.