VXRT — Vaxart, Inc. SEC Filings | FilingIndex← The WireVXRTOTC
Vaxart, Inc.
Biological Products, (No Diagnostic Substances) · DE · CIK 72444
Vaxart develops oral recombinant vaccines for infectious diseases and potential cancers using its VAAST platform
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Comparable business profile · signals at a glance
FORM 10-Q
Aug 8, 2024
$405.4M
-2.0%
Insider Activity
◆ Cluster Buy · 2 insidersIn the 90 days to Nov 17, 2025: 2 insiders bought $24K.
| Date | Insider | Action | Shares | Price | Value |
|---|
| Nov 17, 2025 | Heron Elaine JDirector | Buy | 23,217 | $0.39 | $9K |
| Nov 17, 2025 | Heron Elaine JDirector | Buy | 16,783 | $0.41 | $7K |
| Nov 17, 2025 | Watson W. MarkDirector | Buy | 15,000 | $0.41 | $6K |
| Nov 17, 2025 | Watson W. MarkDirector | Buy | 5,000 | $0.41 | $2K |
Open-market buys & sells (Form 4, transaction codes P/S). Source: SEC structured insider data.
What Changed
Risk factors · Mar 20, 2025 → Mar 13, 202652 added · 51 removed between the two most recent 10-Ks. The risks a company starts — or stops — disclosing are often the story.
Newly disclosed
- As of the filing date of this Annual Report on Form 10-K, we anticipate that the Phase 2b study, which enrolled healthy adults 18 years and older in the U.S. with 400 participants from the sentinel cohort and approximately 5,000 participants enrolled from the main cohort as of our receipt of the August 2025 SWO, will continue to collect participant data over a 12 month period post-vaccination and will continue to be funded under the 2024 ATI-RRPV Contract.
- In June 2025, we reported positive topline results from the Phase 1 clinical trial (Study VXA-109) evaluating our second-generation bivalent norovirus vaccine constructs head-to-head against our first-generation bivalent norovirus vaccine constructs.
- Subsequently, in April 2025, the Company received written notification from ATI in the form of a stop work order lift (the “Lift Notice”) that the February 2025 SWO had been lifted and that the Company may resume incurring costs, participating in meetings, and communicating with the Government and ATI concerning the project award.
- In August 2025, the Company received written notification from ATI in the form of a second stop work order (the “August 2025 SWO”) directing the Company to stop work on screening and enrollment for the 10,000-person cohort of the Phase 2b clinical study.
- The Follow-Up Notice definitively confirmed that BARDA intends to stop all ongoing enrollment under the 2024 ATI-RRPV Contract but allows efforts in support of participants already enrolled in the study, who will continue to be followed, including planned analyses of the sentinel cohort as well as the enrolled main study population.
- In February 2026, Altesa announced a $75 million Series B funding round to support the Phase 2b study. ● Relenza and Inavir are antivirals for the treatment of influenza, marketed by GlaxoSmithKline, plc (“GSK”) and Daiichi Sankyo Company, Limited (“Daiichi Sankyo”), respectively.
- However, the patent covering the laninamivir octanoate compound expired in 2024, opening the market for generic competition, potentially decreasing or eliminating the royalties received. 15 Table of Contents In addition to the above, we have established expertise and development capabilities focused in the areas of preclinical research and development, manufacturing and manufacturing process scale-up, quality control, quality assurance, regulatory affairs and clinical trial design and implementation.
- The Company anticipates a further modification to the 2024 ATI-RRPV Contract that will reflect the reduced scope of work and corresponding reduction in funding that resulted from previously issued stop work orders.
- Pursuant to Modification No. 6 to the 2024 ATI-RRPV Contract, dated March 10, 2026, the total amount of funding available for payment under the 2024 ATI-RRPV Contract is approximately $316.0 million.
- Pursuant to Modification No. 6 to the 2024 ATI-RRPV Contract, pursuant to which the total amount of funding available for payment under the 2024 ATI-RRPV Contract was increased to $316.0 million.
- Following the successful outcome of the VXA-109 trial, the next step, pending a partnership or other funding, would be to advance the program to the next stage of clinical development in 2026.
- In May 2025, following additional discussion between the Company and HHS BARDA regarding costs, timelines, and regulatory pathway, we received approval from HHS BARDA to initiate dosing.
No longer disclosed
- If the Phase 1 trial is successful, the next step, pending a partnership or other funding, would be to conduct a Phase 2 safety and immunogenicity study that could potentially begin as early as the second half of 2025.
- However, the patent covering the laninamivir octanoate compound expired in 2024, at which time generic competition may enter the market, potentially decreasing or eliminating the royalties received.
- Subject to the stop work order described above, if we receive approval from BARDA, we will progress to the next part of the study to enroll approximately 10,000 participants comparing our KP.2 COVID-19 vaccine candidate against an approved mRNA KP.2 comparator. 6 Table of Contents Our Influenza Program Market Overview Influenza is one of the most common global infectious diseases, causing mild to life-threatening illness with symptoms such as sore throat, nasal discharge, fever, and even death.
- Failure to submit timely, accurately, and completely the required information may result in civil monetary penalties of up to an aggregate of $150,000 per year and up to an aggregate of $1 million per year for “knowing failures”.
- Government, will either cancel the stop work order, extend the stop work, or terminate the work covered by the 2024 ATI-RRPV Contract.
- On February 23, 2018, Osaka-based drug maker Shionogi gained marketing approval for Xofluza, a new drug to treat influenza in Japan.
- In contrast, our oral Ad5 vectored vaccine is designed to circumvent the complications related to anti-Ad5 immunity, allowing the platform to be used for multiple vaccines and repeat annual and booster vaccinations. 3 Table of Contents Our Product Pipeline The following table outlines the status of our oral vaccine development programs: 4 Table of Contents Our Norovirus Program Market Overview Norovirus is the leading cause of vomiting and diarrhea from acute gastroenteritis among people of all ages in the U.S.
- Altesa is conducting a double-blind, randomized, placebo-controlled trial in participants with chronic obstructive pulmonary disease to evaluate the impact of Vapendavir on the development of lower respiratory tract symptoms following rhinovirus challenge. ● Relenza and Inavir are antivirals for the treatment of influenza, marketed by GlaxoSmithKline, plc (“GSK”) and Daiichi Sankyo Company, Limited (“Daiichi Sankyo”), respectively.
In addition to the above, we have established expertise and development capabilities focused in the areas of preclinical research and development, manufacturing and manufacturing process scale-up, quality control, quality assurance, regulatory affairs and clinical trial design and implementation.Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the biological product has been associated with unexpected serious harm to subjects.Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of the product for unapproved, and thus non-reimbursable, uses. 14 Table of Contents HIPAA created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to business associates, independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity.