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Vaxart, Inc. (symbol: VXRT) is a clinical-stage biotechnology company dedicated to transforming vaccine delivery through its innovative oral recombinant vaccine platform. Founded in 2004, Vaxart's primary focus is the development of vaccines in tablet form, offering a needle-free alternative that is easy to administer and store. This proprietary technology aims to revolutionize the global vaccine market, addressing common diseases such as Coronavirus, Norovirus, Seasonal Influenza, Respiratory Syncytial Virus (RSV), and Human Papillomavirus (HPV).
Headquartered in the United States, Vaxart operates in a single segment focused exclusively on the discovery and development of these groundbreaking oral recombinant protein vaccines. The company has made significant strides in the clinical development of its diverse pipeline, with several candidates currently undergoing trials. Vaxart’s oral vaccines are designed to simplify distribution and administration, potentially increasing vaccination rates and improving global health outcomes.
Recent achievements for Vaxart include the ongoing development and testing of its oral COVID-19 vaccine candidate, which has shown promise in preclinical studies and early-phase clinical trials. This innovation could play a crucial role in global vaccination efforts, especially in regions where cold-chain requirements pose logistical challenges. Other notable projects include the development of oral vaccines for Norovirus and Influenza, which are also advancing through various stages of clinical testing.
Financially, Vaxart remains focused on strategic partnerships and funding opportunities to support its research and development initiatives. The company's recent financial results for the full year ended December 31, 2023, and the first quarter ended March 31, 2024, reflect its ongoing commitment to advancing its oral vaccine candidates through clinical trials and towards regulatory approval.
For more information and the latest updates, contact Vaxart Media Relations: Mark Herr (mherr@vaxart.com, 203-517-8957) or Investor Relations: Andrew Blazier (IR@vaxart.com, 646-871-8486).
Vaxart, Inc. (Nasdaq: VXRT) will participate in the H.C. Wainwright BioConnect Virtual Conference from January 10-13, 2022. Key executives, including CEO Andrei Floroiu, will engage in a fireside chat available on the company's Events & Presentations page starting at 7:00 a.m. ET on January 10. Vaxart is advancing the only oral COVID-19 vaccine in Phase II clinical trials, which began in October 2021. The company's innovative oral vaccine technology aims to provide a safer, needle-free alternative suitable for a range of infectious diseases.
Vaxart, Inc. (NASDAQ: VXRT) announced plans to test its oral COVID-19 vaccine candidate's cross-reactivity against the Omicron variant through two studies starting next month. The first study will assess samples from Phase II clinical participants, while the second will involve an animal challenge study. Vaxart's COVID-19 vaccine is engineered to potentially offer broader protection against variants, leveraging mucosal immunity differences compared to conventional vaccines. Initial Phase I results suggested significant cross-reactivity against other coronaviruses, supporting expectations for responsiveness to Omicron.
Vaxart, Inc. (NASDAQ: VXRT) has acquired manufacturing equipment and a GMP facility from Kindred Bioscience to enhance its production capabilities. This transaction, closed on Nov. 30, 2021, provides Vaxart with greater control over manufacturing schedules and quality control, allowing for parallel development of multiple oral vaccine candidates. The facility is set to become operational in Q1 2022 and will support the production of COVID-19 and norovirus vaccine tablets. Vaxart is also advancing its clinical trials, including a Phase II study for its COVID-19 vaccine.
Vaxart, Inc. (NASDAQ: VXRT) announced that Dr. Sean Tucker will present at the World Vaccine & Immunotherapy Congress on November 30, 2021, discussing Vaxart’s oral COVID-19 vaccine candidate. This vaccine is unique as it is the only oral candidate with clinical data supporting its immunological potential and is currently in Phase II trials, which began in October 2021. Vaxart focuses on developing oral recombinant vaccines that can be stored without refrigeration, eliminating needle-related risks. The company is advancing vaccines for various infectious diseases, including norovirus and HPV.
Vaxart's investigational oral flu vaccine VXA-A1.1 demonstrated significant cellular immune responses in a Stanford study, published in Cell Host and Microbe. The study revealed that protection against influenza may rely on cellular correlates rather than serum antibodies. The Phase II study indicated that VXA-A1.1 outperformed traditional injected vaccines by offering greater protection against viral shedding. This research could accelerate vaccine development by predicting immunity from early immune responses. The findings highlight the potential of oral vaccines in combating influenza.
Vaxart's oral COVID-19 vaccine shows promise in a study published in the Journal of Infectious Diseases. The research indicates that the vaccine significantly reduces viral load in the lungs of vaccinated hamsters. Vaxart's Chief Scientific Officer emphasized its potential for broader public health impact, especially in areas with limited healthcare infrastructure. Key findings include complete protection in vaccinated hamsters, no significant weight loss post-infection, and a notable drop in lung inflammation. Vaxart plans to release further data from its ongoing clinical studies in early 2022.
Vaxart, Inc. (Nasdaq: VXRT) announced participation in virtual fireside chats at two upcoming conferences. The first chat at the Jefferies London Healthcare Conference will be available on-demand from November 18, while the second at the 33rd Annual Piper Sandler Healthcare Conference starts on November 22. Both webcasts will be accessible on the Company’s Events & Presentations page. Vaxart’s oral COVID-19 vaccine is currently the only one in Phase II trials, which commenced in October 2021.
Vaxart, Inc. (NASDAQ: VXRT) provided a business update for Q3 2021, highlighting significant advancements in its oral vaccine platform. The company initiated its first Phase II trial for a COVID-19 oral tablet vaccine, with results expected in Q1 2022. Cash reserves totaled $204 million, up from $198.9 million in Q2 2021. The company reported a net loss of $17.6 million, increasing from $8.1 million year-over-year. Revenue fell to $200,000 from $265,000. Research and development expenses surged to $12.4 million, driven by clinical trial activities.
Vaxart, Inc. (NASDAQ: VXRT) has initiated its Phase II clinical trial for an oral tablet COVID-19 vaccine, marking a significant milestone as the only Phase II oral vaccine trial globally. The U.S. trial aims to enroll 96 subjects and will assess safety, immunogenicity, and efficacy. With a focus on mucosal immunity, the vaccine could enhance protection against airborne viruses. Vaxart has also commenced production at its GMP facility for upcoming trials, building on promising pre-clinical data showing reduced SARS-CoV-2 transmission in animal models. Full results from the U.S. trial are expected by Q1 2022.
A study led by Duke University, published in bioRxiv, indicates that Vaxart's (NASDAQ: VXRT) oral COVID-19 vaccine candidate can reduce the airborne transmission of the SARS-CoV-2 virus in an animal model. Results suggest Vaxart’s oral tablet vaccine outperforms traditional injected vaccines by lowering viral shedding. The preclinical trials showed that vaccinated hamsters exhibited faster viral clearance and caused fewer infections in unvaccinated counterparts. Vaxart has initiated a global Phase II clinical trial for this oral vaccine, which targets the SARS-CoV-2 spike protein.
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