Vaxart (OTCMKTS:VXRT) expects to report efficacy and safety data from the main cohort of its Phase 2b COVID-19 vaccine trial by mid-2027, while its current cash runway extends into the second quarter of that year, executives said during a third-quarter stockholder fireside chat.
The company is evaluating its oral tablet vaccine candidate against an approved mRNA injection in a study involving approximately 5,000 participants at 140 U.S. sites. Chief Executive Officer Steven Lo said the company’s operational focus remains on completing the main cohort after reporting 12-month safety data from a 400-participant sentinel cohort in July.
Chief Financial Officer Jeroen Grasman said Vaxart ended the third quarter with $65.5 million in cash, cash equivalents and short-term investments. Management is pursuing cost controls, non-dilutive funding and financing options to bridge the period around the trial readout and a potential decision by Sanofi on whether to opt into the COVID-19 program.
Trial Timeline and Data Release
Asked why the company was now describing the readout as mid-2027 after previously pointing to the first half of the year, Chief Medical Officer Dr. James F. Cummings cited required observation periods, laboratory processing and federal review procedures.
Participants must be followed over multiple months to assess infection endpoints and immune responses, Cummings said. Thousands of samples also require processing, assay validation and data locking before results can be unblinded. A significant share of the testing is being conducted by laboratories partnered with the Biomedical Advanced Research and Development Authority, or BARDA, whose schedules are outside Vaxart’s control.
Founder and Chief Scientific Officer Dr. Sean Tucker said Vaxart had not seen the underlying immunogenicity data from the sentinel cohort. He said samples were sent to two independent laboratories and that public release depends on completion of the analysis and BARDA’s formal review and approval.
“We cannot commit to a specific release date until the lab data is finalized, delivered, and cleared for disclosure through our established partner protocols,” Tucker said. He also said Vaxart did not yet have clinical immune data for its XBB vaccine candidate, although it had observed immunogenicity in animals.
Lo said he did not anticipate that recent election results would change funding or timing for the Phase 2b trial. He noted that the program continued after two stop-work orders in 2025.
Cash Runway and Quarterly Results
Third-quarter revenue fell to $10.6 million from $72.4 million a year earlier. Grasman said revenue was primarily driven by work under the BARDA Project NextGen contract, along with recognition associated with a collaboration agreement.
Research and development expenses declined to $22.8 million from $75.9 million, while general and administrative expenses rose to $5.1 million from $4.3 million. Vaxart reported a net loss of $17.7 million, or 7 cents per share, compared with a loss of $8.1 million, or 4 cents per share, in the prior-year quarter.
Through Sept. 30, Vaxart raised $420,000 by selling shares under its April 2026 purchase agreement with Lincoln Park Capital. Grasman acknowledged the sales were dilutive and said the company intended to use the equity line selectively. He said use of the full $25 million facility could potentially extend the cash runway into 2028, while emphasizing that Vaxart is prioritizing non-dilutive alternatives.
Partnership and Pipeline Efforts
Vaxart continues to seek a partner to fund its Phase 2-ready norovirus vaccine candidate, Lo said. He described a more selective biopharmaceutical market and longer diligence timelines, but said prospective partners and public health stakeholders remained interested.
In late August, the European Patent Office granted a patent covering Vaxart’s oral norovirus vaccine technology through at least 2036 in 13 European nations, Cummings said. He said the protection complements the company’s U.S. patent estate and has been incorporated into materials for partner discussions.
Lo also discussed Vaxart’s COVID-19 licensing agreement, originally signed with Dynavax and acquired by Sanofi. The agreement applies only to the COVID-19 program, he said. If Sanofi opts in, Vaxart would receive a $50 million payment; Lo said the company is working to deliver a clinical data package that supports such a decision.
Elsewhere in the pipeline, Cummings said peer-reviewed data published in early October showed 100% protection against a lethal H5N1 avian influenza challenge in a ferret model. The result was preclinical, not a finding from a human trial.
Board Oversight
Vaxart also highlighted the appointment of independent director Dr. Rocky Bono, a retired U.S. Navy vice admiral and former director of the Defense Health Agency. She chairs the newly formed Stockholder Engagement Committee, which also includes Lo and Lead Independent Director Mark Watson.
Lo said Bono was jointly selected by Vaxart and a stockholder group under a July cooperation agreement. Bono said she intends to bring stockholder perspectives into board discussions as the company oversees its strategy and execution.
About Vaxart (OTCMKTS:VXRT)
Vaxart, Inc is a biotechnology company focused on developing oral recombinant vaccines delivered in tablet form. Its proprietary platform is designed to stimulate immune responses at mucosal surfaces, such as those in the nose and mouth, in addition to generating systemic immunity. The company’s approach is intended to offer a needle-free alternative to traditional injectable vaccines.
Vaxart’s development programs have included oral vaccine candidates for coronavirus infections, norovirus and influenza.
