Vaxart Q4 Earnings Call Highlights

13 Mar 2026, 04:08 by Sarita Garza · The Markets Daily

Vaxart (OTCMKTS:VXRT) used its fourth-quarter business update and year-end 2025 financial results conference call to highlight a new partnership for its oral COVID-19 vaccine candidate, updates on an ongoing Phase 2b trial funded in part by the U.S. Biomedical Advanced Research and Development Authority (BARDA), and newly published clinical data supporting its oral norovirus vaccine program.

Dynavax partnership and Sanofi acquisition

Chief Executive Officer Steven Lo said the company established a partnership with Dynavax in November 2025 for its oral COVID-19 vaccine candidate. Vaxart received a $25 million upfront payment and a $5 million equity investment “at a premium to the closing price,” Lo said, adding that the agreement both validates the company’s oral vaccine platform and extends its cash runway.

Lo also noted that Sanofi announced the acquisition of Dynavax in late December 2025, and that the transaction closed on February 10, positioning Dynavax as a Sanofi company. He said Vaxart has developed a “highly productive working relationship” with collaborators over the past three months and remains focused on completing the Phase 2b trial and delivering results.

Under the terms described on the call, Vaxart may receive an additional $50 million if Dynavax elects to continue development following submission of Phase 2b data to the FDA. Lo said Vaxart is also eligible for up to $195 million in future regulatory milestones, $425 million in sales milestones, and tiered royalties in the low to mid-teens. He characterized the total potential value of the agreement as up to $700 million, including license, regulatory and milestone fees, tiered royalties, and the equity investment.

COVID-19 Phase 2b trial timing and BARDA’s role

Chief Medical Officer Dr. James F. Cummings reviewed the design and timing expectations for Vaxart’s Phase 2b trial of its oral COVID-19 vaccine candidate compared with an mRNA vaccine. The primary endpoint is the relative efficacy of Vaxart’s oral pill vaccine versus the mRNA vaccine for 12 months post-vaccination, with the trial also measuring symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events.

Cummings said the trial originally planned to enroll 400 subjects in a sentinel cohort and 10,000 subjects in the larger KP2 cohort. He reiterated that BARDA amended the work order in October 2025 and is now funding follow-up for approximately 5,400 subjects enrolled before a stop-work order issued on BARDA’s behalf in August 2025. That group includes 400 participants in the sentinel cohort and approximately 5,000 participants in the KP2 cohort.

Vaxart expects to report 12-month top-line data from the 400-participant sentinel cohort early in the second quarter of 2026, Cummings said, noting the timing will be determined in collaboration with BARDA. He added that Vaxart is “contractually required” to consult with and receive BARDA approval regarding the timing and content of press releases related to the trial.

During Q&A, management acknowledged the expected sentinel-cohort timing moved from prior guidance of late first quarter to early second quarter. Cummings attributed the change to coordination with BARDA on data analysis and release timing.

When the sentinel-cohort update is announced, Cummings said Vaxart expects to include data for the primary safety endpoints, along with “initial data on efficacy measures.” He emphasized the sentinel cohort was designed to assess safety and was not designed to determine efficacy.

For the larger KP2 cohort, Cummings said the approximately 5,000-subject data set is expected to provide efficacy insights, with results anticipated late in the fourth quarter of 2026, again subject to BARDA collaboration. In response to an analyst question about immunogenicity data, Cummings said immunogenicity work takes longer and is performed primarily by BARDA partners, suggesting those results would follow the initial top-line readouts for both the sentinel cohort and KP2 cohort.

Lo clarified how future development decisions are structured under Vaxart’s agreements. He said Vaxart and BARDA are responsible for the Phase 2b portion of the trial, while Dynavax—now part of Sanofi—would have the opportunity to decide whether to opt in after the Phase 2 package is completed and submitted to the FDA.

Norovirus clinical publication and second-generation constructs

Vaxart also pointed to progress in its oral norovirus vaccine program. Cummings said the company published the complete data set from a clinical study in lactating mothers in January 2026 in npj Vaccines. The Phase 1 multi-center, randomized, double-blind, placebo-controlled, single-dose, dose-ranging study evaluated the safety, tolerability, and immunogenicity of an orally administered bivalent GI.1/GII.4 norovirus vaccine in healthy lactating women, with primary outcomes including safety, reactogenicity, and norovirus-specific IgA in breast milk and serum.

According to Cummings, the trial enrolled 76 women ages 18 to 43 at five sites in South Africa and randomized participants to high-dose vaccine, medium-dose vaccine, or placebo. He said the vaccine was safe and well tolerated, with reports of mild or moderate adverse events similar between placebo and vaccine groups and no adverse events beyond grade two.

Cummings detailed IgA responses at day 29 post-vaccination for the high-dose group, stating serum norovirus-specific IgA rose an average of 5.6-fold for GI.1 and 4.7-fold for GII.4. Breast milk norovirus-specific IgA rose on average four-fold for GI.1 and six-fold for GII.4, with both breast milk increases statistically significant and maintained through day 180, he said.

He also described exploratory findings suggesting passive transfer of IgA to infants. Cummings said the data showed a consistent trend of increased GI.1- and GII.4-specific IgA in infant stool at days 29 and 60 among paired infants of vaccinated women, with a positive association between IgA levels in maternal breast milk and infant stool. He said the observation supports the hypothesis of passive transfer of mucosal immunity and could represent a novel approach to confer mucosal antiviral immunity to infants, a population he noted is vulnerable to norovirus infection.

Cummings also referenced a June 2025 Phase 1 head-to-head trial comparing second-generation norovirus vaccine constructs with the original first-generation oral vaccine. He said Vaxart previously reported that second-generation constructs produced significantly higher antibody responses—141% higher for one strain and 94% higher for the other—compared with first-generation vaccines. Cummings said the technology underlying the second-generation constructs has been incorporated into other pipeline programs, and that the company believes it could increase immunogenicity of its COVID-19, seasonal and pandemic flu, and HPV vaccine candidates.

Preclinical work and plans dependent on funding

Founder and Chief Scientific Officer Dr. Sean Tucker said Vaxart is building a broader evidence package for its norovirus program to support business development efforts. He said the company is positioned to initiate the next clinical trial of its second-generation norovirus vaccine constructs in 2026, pending a partnership or other funding.

Tucker also outlined preclinical work assessing whether Vaxart’s GII.4 construct cross-reacts with and protects against the GII.17 strain of norovirus. He said GII.4 is typically predominant, but GII.17 was associated with a significant outbreak in late 2024 continuing into 2025. Tucker said demonstrating cross-reactivity could potentially broaden the utility of the current constructs and increase the value of the program by enabling protection against a broader spectrum of strains. He said Vaxart expects to share results from these studies later in 2026 and, if positive, include them in partnership discussions.

In response to an analyst question about regulatory input on endpoints for a next norovirus study, Cummings said the company has held discussions with the FDA and described safety as the primary endpoint for a Phase 2b study, along with immunogenicity assessments.

Financial results, cash position, and cost actions

Chief Financial Officer Jeroen Grasman said full-year 2025 revenue was $237.3 million, compared with $28.7 million in 2024. He said revenue in both years was primarily from government contracts related to the BARDA contract awarded in June 2024, with 2025 also including revenue recognized from the Dynavax license and collaboration agreement signed in November 2025.

Vaxart ended the fourth quarter with $63.8 million in cash, cash equivalents, and investments. Based on its current plan, Grasman said the company expects its cash runway to extend into the second quarter of 2027. He said Vaxart intends to remain aggressive in seeking strategic partnerships, pursuing non-dilutive funding options, and managing expenses to extend runway.

Lo also pointed to cost management actions, including a lease termination agreement signed in December 2025 that allows Vaxart to terminate one lease on May 15, 2026 rather than March 31, 2029. Lo said the accelerated termination is expected to provide significant cost savings and reduce operating expenses.

Looking ahead, Lo said Vaxart’s priorities for 2026 include executing on data collection and analysis for the COVID-19 clinical trial and securing a partnership or funding to advance the norovirus program. He added that the company is exploring potential licensing or partnership opportunities for earlier-stage assets, including seasonal and pandemic flu candidates and its HPV program.

About Vaxart (OTCMKTS:VXRT)

Vaxart, Inc is a clinical-stage biotechnology company pioneering the development of oral recombinant vaccines administered in tablet form. Leveraging a proprietary, room-temperature-stable platform, the company aims to simplify vaccine delivery while eliciting both systemic and mucosal immune responses. Its technology is based on the replication-defective adenovirus vector system, which encodes target antigens designed to protect against a range of infectious diseases without the need for injections or cold-chain logistics.

The company’s pipeline includes multiple vaccine candidates in various stages of development.