Company Description
Vaxart, Inc. (OTCQX: VXRT) is a clinical-stage biotechnology company in the biological product manufacturing sector that focuses on developing oral recombinant vaccines based on a proprietary pill delivery platform. According to the company’s disclosures, Vaxart’s vaccines are designed to be administered as pills that can be stored and shipped without refrigeration and that avoid the risk of needle-stick injury associated with injectable vaccines. The company states that it is using this platform to pursue both oral versions of currently marketed vaccines and new vaccine candidates for additional indications.
Vaxart’s development programs, as described in its news releases, include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine candidate for human papillomavirus (HPV), which the company identifies as its first immune-oncology indication. Across these programs, Vaxart reports that its oral pill vaccine constructs have generated systemic and mucosal immune responses and have been evaluated in multiple clinical trials.
Oral vaccine platform and technology focus
The company describes its core technology as a proprietary oral pill vaccine delivery platform that uses recombinant approaches. Vaxart has stated that its oral vaccines are based on an adenovirus vector and TLR3 agonists, and that it has filed broad domestic and international patent applications covering its technology and related creations for oral vaccination using these components. By formulating vaccines as room-temperature-stable pills, Vaxart aims to enable storage and shipment without refrigeration and to offer a needle-free administration format.
In its public communications, Vaxart has highlighted that its oral vaccine candidates are designed to induce immune responses at mucosal surfaces as well as systemically. For example, the company has reported data showing vaccine-induced antibody responses in serum, breast milk, saliva, nasal lining fluid and fecal samples in certain clinical studies of its norovirus and COVID-19 candidates. These disclosures emphasize the company’s focus on mucosal immunity as a potential differentiating feature of its pill-based vaccines.
Key clinical programs
Norovirus oral pill vaccine candidate: Vaxart has reported multiple clinical trials for an oral bivalent norovirus vaccine candidate targeting GI.1 and GII.4 strains. In a Phase 1, multicenter, randomized, double-blind, placebo-controlled, single-dose study in healthy lactating women, the company reported that the vaccine was safe and well tolerated, with adverse events similar between placebo and vaccine groups and no events beyond grade 2. The trial evaluated safety, tolerability and immunogenicity, including norovirus-specific IgA in serum and breast milk, and exploratory assessment of passive transfer of IgA to breastfed infants.
According to Vaxart, the high-dose group in this study showed increases in serum and breast milk norovirus-specific IgA, and newly reported data indicated that elevated breast milk IgA levels were maintained through day 180. The company also reported a trend of increased GI.1 and GII.4-specific IgA in the stool of paired infants and a positive association between maternal breast milk IgA and infant stool IgA. Vaxart has stated that these findings support the hypothesis of passive transfer of mucosal immunity from vaccinated mothers to their infants. The company has also reported that oral vaccination induced functional breast milk and serum antibody responses, and generated GI.1 and GII.4-specific IgA in saliva and nasal lining fluid in lactating women.
In additional Phase 1 work with second-generation norovirus constructs, Vaxart has disclosed that these constructs produced statistically significant increases in GI.1 and GII.4 norovirus blocking antibodies compared with first-generation constructs, and that they induced robust increases in fecal IgA. The company has noted that fecal IgA was previously correlated with protection against infection in an earlier Phase 2b challenge study, and has presented these data at scientific meetings such as the International Calicivirus Conference, World Vaccine Congress and IDWeek.
COVID-19 oral pill vaccine candidate: Vaxart is conducting a Phase 2b randomized, double-blind, multi-center comparative trial of its oral COVID-19 vaccine candidate against an FDA-approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19. The company has reported that this trial is funded under a Project NextGen/BARDA award administered through Advanced Technology International and the Rapid Response Partnership Vehicle. The primary endpoint is the relative efficacy of the oral candidate compared to the mRNA comparator for prevention of symptomatic disease, with a 12‑month follow-up period to assess safety, tolerability and both systemic and mucosal immunogenicity.
Vaxart has disclosed that it completed enrollment of approximately 5,400 participants in this Phase 2b trial and that participants are being monitored for up to 12 months post-vaccination. The company has also reported that BARDA issued a stop work order that delimited certain work under the related project agreement, but that follow-up of the enrolled participants continues and remains funded, and that it believes the resulting data will provide useful insights and a foundation of evidence for its COVID-19 program.
In November 2025, Vaxart entered into an exclusive, worldwide license and collaboration agreement with Dynavax Technologies Corporation covering its investigational oral COVID-19 vaccine candidate and related coronavirus indications. Under this agreement, as described in Vaxart’s 8‑K and joint press release, Vaxart granted Dynavax an exclusive license to develop and commercialize oral COVID-19 vaccines based on Vaxart’s platform for specified coronavirus indications, while retaining rights to its platform for other uses. Vaxart agreed to continue leading and funding development of the ongoing Phase 2b trial and associated obligations through an end-of-Phase 2 meeting with the U.S. Food and Drug Administration, after which Dynavax has the option to assume responsibility for further development and commercialization, subject to additional payments and potential milestones and royalties.
Influenza and HPV programs: In its company descriptions within multiple news releases, Vaxart states that its development pipeline includes pill vaccines designed to protect against influenza and a therapeutic vaccine candidate for HPV. The HPV program is described as the company’s first immune-oncology indication. The company has not provided in the supplied materials the same level of trial detail for these programs as for its norovirus and COVID-19 candidates, but consistently identifies them as part of its active development portfolio.
Regulatory and listing status
Vaxart is incorporated in Delaware and has historically been listed on The Nasdaq Stock Market under the symbol VXRT. According to multiple Form 8‑K filings, the company failed to satisfy Nasdaq’s minimum bid price requirement, received a delisting determination, and appealed that decision. A Nasdaq Hearings Panel granted continued listing subject to specified conditions, including shareholder approval and completion of a reverse stock split and subsequent bid price compliance. Vaxart later withdrew its reverse stock split proposal, and on September 19, 2025, the company reported that Nasdaq’s Office of the General Counsel had notified it that its securities would be delisted due to noncompliance with the panel’s conditions.
A Form 25 filed by Nasdaq Stock Market LLC on November 21, 2025, confirms removal of Vaxart’s common stock from listing and registration under Section 12(b) of the Securities Exchange Act of 1934. Vaxart’s filings state that trading in its common stock on Nasdaq was suspended at the open of trading on July 8, 2025, and that its common stock is quoted on the OTCQX Best Market under the symbol VXRT.
Facilities and cost management
In a Form 8‑K dated December 18, 2025, Vaxart reported entering into a termination agreement for a lease covering premises in South San Francisco, California that served as the company’s headquarters. The lease termination is described as part of the company’s efforts to identify cost reduction opportunities. Vaxart stated that the lease will terminate effective May 15, 2026, with no termination fees or penalties, and that it intends to relocate its headquarters and laboratories to one of its other offices in the South San Francisco area.
Intellectual property and collaborations
Across its public statements, Vaxart emphasizes that it has filed broad domestic and international patent applications related to its oral vaccine technology, including applications covering the use of adenovirus and TLR3 agonists for oral vaccination. The company’s collaboration with Dynavax for its oral COVID-19 vaccine program, as documented in both companies’ releases and Vaxart’s 8‑K, provides for an upfront license fee, an equity investment, and the possibility of additional payments tied to development decisions, regulatory milestones, commercial milestones and royalties on potential future net sales, contingent on Dynavax’s election to advance the program beyond Phase 2b.
Company status and investor considerations
Based on the supplied SEC filings and news releases, Vaxart remains a clinical-stage biotechnology company without approved commercial products in the indications described. Its common stock is no longer listed on Nasdaq and trades on the OTCQX Best Market under the symbol VXRT. The company continues to report on its clinical development activities, collaborations, financing arrangements and cost management steps through periodic SEC filings and press releases.
FAQs about Vaxart, Inc. (VXRT)
- What does Vaxart, Inc. do?
Vaxart is a clinical-stage biotechnology company that develops oral recombinant vaccines formulated as pills. According to its public disclosures, its platform is intended to deliver vaccines that can be stored and shipped without refrigeration and administered without needles, and is being applied to coronavirus, norovirus, influenza and HPV programs. - How are Vaxart’s vaccines administered?
Vaxart states that its vaccine candidates are designed to be administered orally as pills. The company highlights that this format is intended to avoid needle-stick injury and to enable storage and shipment without refrigeration. - What are Vaxart’s main vaccine programs?
In the provided materials, Vaxart identifies oral pill vaccine candidates for coronavirus (including COVID-19), norovirus and influenza, as well as a therapeutic vaccine candidate for HPV. The norovirus and COVID-19 programs are described in the greatest clinical detail, including Phase 1 and Phase 2b trials. - What clinical data has Vaxart reported for its norovirus program?
Vaxart has reported Phase 1 data for an oral bivalent norovirus vaccine candidate in lactating women, describing the vaccine as safe and well tolerated with increased norovirus-specific IgA in serum and breast milk, and evidence of norovirus-specific IgA in infant stool. The company has also reported that second-generation constructs produced stronger antibody responses and robust increases in fecal IgA compared with first-generation constructs. - What is the status of Vaxart’s oral COVID-19 vaccine trial?
According to Vaxart’s disclosures, the company has completed enrollment of approximately 5,400 participants in a Phase 2b randomized, double-blind, multi-center trial comparing its oral COVID-19 vaccine candidate with an mRNA COVID-19 vaccine in previously immunized adults. Participants are being followed for up to 12 months to assess safety, immunogenicity and efficacy, and this work is supported by a Project NextGen/BARDA contract that continues to fund follow-up of enrolled participants. - What is Vaxart’s collaboration with Dynavax?
Vaxart and Dynavax entered into an exclusive, worldwide license and collaboration agreement under which Dynavax received rights to develop and commercialize oral COVID-19 vaccines based on Vaxart’s platform for specified coronavirus indications. Vaxart continues to lead and fund the ongoing Phase 2b trial and related development through an end-of-Phase 2 meeting, after which Dynavax may elect to assume responsibility for further development and commercialization, with associated payments and potential milestones and royalties as described in Vaxart’s 8‑K and joint press release. - Where does Vaxart’s stock trade and under what symbol?
Vaxart’s SEC filings state that its common stock was suspended from trading on Nasdaq on July 8, 2025, and that a Nasdaq Hearings Panel later determined that the securities would be delisted. The company reports that its common stock is quoted on the OTCQX Best Market under the symbol VXRT. - Is Vaxart still a Nasdaq-listed company?
No. A Form 25 filed by Nasdaq Stock Market LLC on November 21, 2025, and Vaxart’s related 8‑K filings indicate that the company’s common stock has been removed from listing and registration under Section 12(b) of the Exchange Act. Vaxart reports that its shares trade on the OTCQX Best Market under the symbol VXRT. - Does Vaxart have any approved vaccines?
In the supplied materials, Vaxart describes itself as a clinical-stage biotechnology company and discusses its programs in terms of clinical trials and investigational candidates. No statements in the provided documents indicate that any of its vaccine candidates have received regulatory approval. - What intellectual property protection does Vaxart report?
Vaxart states in multiple news releases that it has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists. These applications are intended to protect its oral vaccine platform and related constructs.