Vaxart's Oral Vaccine Platform - Vaxart's oral pill vaccines can revolutionize how the immune system responds and the way vaccines are delivered[8] - Vaxart's oral vaccine candidates have the potential to address many of the shortcomings of injectable vaccines, offering needle-free administration, mucosal and systemic immunity, potential to reduce transmission, benign safety & tolerability profile, thermostability, and self-administration[15] - Vaxart's proprietary VAAST® Platform utilizes mucosal immunity to generate IgA in addition to IgG to potentially block infection and transmission[18, 100] - Vaxart's oral platform drives broader immunity through mucosal IgA responses, offering greater cross-reactivity and potential for high variant coverage compared to injectable vaccines that only induce systemic IgG[31] Norovirus Vaccine Program - Norovirus is attributed to nearly one out of every five episodes of diarrheal disease globally[43] - Norovirus causes 685 million infections and 200,000 deaths worldwide annually, with economic costs of $60 billion[44] - The total potential market size for a Norovirus vaccine in the US is $3 – 5 billion[46] - Vaxart's bivalent Norovirus vaccine candidate is designed to address the major circulating genotypes, GI1 and GII4, with GII4 accounting for 68% of norovirus genotypes in the US from 2009-2015[53, 54] - In a Norovirus challenge study, Vaxart's oral tablet showed a 29% relative reduction in infection and a 21% relative reduction in Norovirus AGE, along with an 85% reduction in viral shedding[109, 111] COVID-19 and Influenza Vaccine Programs - Vaxart received a BARDA Project NextGen award of up to $460.7 million, with ~$240.1 million currently available for payment, to conduct a Phase 2b trial evaluating their COVID-19 vaccine candidate head-to-head against an approved mRNA comparator[69, 73, 95] - In a Phase 1 trial, 46% of participants that had increased IgA antibodies to SARS-CoV-2 S also had increased antibody responses to the S protein of other coronaviruses[78] - Vaxart's oral influenza vaccine candidate reduced infection rates by 49% compared to placebo and 38% compared to Fluzone in a human influenza challenge design[90]

Core Points - Vaxart, Inc. held its Annual Meeting of Stockholders in a virtual format, where preliminary results indicated that two proposals were approved and two were rejected by stockholders [1][2] - Stockholders voted in favor of the election of six director nominees and the ratification of WithumSmith+Brown, PC as the independent registered public accounting firm [5] - A proposal for an amendment to the Restated Certificate of Incorporation to effect a reverse stock split is under evaluation by the company [5] - The company is developing oral recombinant vaccines using its proprietary delivery platform, which allows for storage and shipping without refrigeration [3] - Current development programs include vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [3] Company Overview - Vaxart is a clinical-stage biotechnology company focused on oral recombinant vaccines [3] - The company's proprietary technology includes adenovirus and TLR3 agonists for oral vaccination [3] - Vaxart has filed broad domestic and international patent applications covering its technology [3]

Summary of Vaxart Neurovirus Phase One Top Line Results Conference Call Company Overview - **Company**: Vaxart - **Focus**: Development of an oral pill vaccine for norovirus Key Industry Insights - **Norovirus Impact**: - Leading cause of acute gastroenteritis (AGE) globally - Approximately 685 million norovirus infections worldwide annually, with 20 million in the U.S. - Responsible for nearly 20% of diarrheal diseases globally - Economic burden estimated at $60 billion worldwide and $10 billion in the U.S. [5][6] - **Market Opportunity**: - Potential U.S. market size for a safe and effective norovirus vaccine is in the multibillion-dollar range - Target populations include elderly, immunocompromised individuals, healthcare professionals, and travelers [6][8] Core Findings from Phase One Clinical Trial - **Positive Results**: - Significant increase in norovirus blocking antibodies in both high and low dose cohorts of the new generation constructs - High dose cohort showed a statistically significant increase in antibodies [3][4] - **Immunogenicity Data**: - 141% increase in G11 NbAA titers in the high dose cohort (from 2.2 to 5.4) - 84% increase in G24 NbAA titers in the high dose cohort (from 1.9 to 3.5) [11] - **Safety Profile**: - All vaccine candidates were well tolerated with no serious adverse events reported [12][49] Future Development Plans - **Next Steps**: - Plans for a Phase 2b safety and immunogenicity study, potentially starting in the second half of 2025, followed by a Phase III trial in 2026 [14][15] - **Partnership Discussions**: - Ongoing discussions with various potential partners, including large multinational companies and regional players [52][53] - Interest in licensing the norovirus vaccine asset and potential collaborations on other vaccine programs [55] Additional Considerations - **Vaccine Characteristics**: - The vaccine must provide durable immune responses, be safe, easy to administer, and stable without complex cold chain logistics [7][8] - **Comparative Analysis**: - The new constructs are expected to show better performance compared to previous generation products, with ongoing studies to validate these findings [10][30] - **Scientific Rationale**: - The Phase one trial aimed to validate the superior immunogenicity of the new generation constructs using a proprietary norovirus blocking antibody assay [10][20] - **Upcoming Presentations**: - Plans to present complete data at relevant medical conferences, including the Khaleesi virus conference and the World Vaccine Congress in Europe [46] This summary encapsulates the critical insights and future directions for Vaxart's norovirus vaccine development, highlighting the significant public health need and market potential for effective vaccination against norovirus.

Core Insights - Vaxart, Inc. reported positive topline results from a Phase 1 clinical trial for its second-generation oral pill norovirus vaccine constructs, showing significant increases in norovirus blocking antibodies compared to first-generation constructs [3][4][5] - The second-generation constructs demonstrated a 141% increase in GI.1 and a 94% increase in GII.4 norovirus blocking antibodies, indicating potential for improved protection against infection [4][8] - All vaccine candidates were found to be safe and well-tolerated, with no serious adverse events reported [4][8] Clinical Trial Details - The Phase 1 trial involved 60 healthy volunteers, randomized to receive either first-generation constructs, an equivalent dose of second-generation constructs, or a lower dose of second-generation constructs [4] - The primary endpoint was the measurement of norovirus blocking antibody assay (NBAA) titers at Day 0 and Day 28, with significant increases observed in the second-generation constructs [4][8] - The study results showed a geometric fold response (GMFR) increase from 2.2 to 5.4 for GI.1 and from 1.9 to 3.7 for GII.4 at the higher dose [8] Future Plans - Vaxart plans to publish the complete results of the study in a peer-reviewed journal and is considering a Phase 2b safety and immunogenicity study, potentially starting in the second half of 2025 [6][9] - The company aims to conduct an End of Phase 2 meeting with the U.S. FDA, with a Phase 3 trial anticipated to begin as early as 2026 [9] Industry Context - Norovirus is a leading cause of acute gastroenteritis worldwide, with approximately 685 million infections globally each year, resulting in significant economic burden estimated at $60 billion [11] - There is currently no approved vaccine for norovirus, highlighting the unmet need for effective vaccination solutions in the market [11][7] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform, which allows for storage and shipping without refrigeration [14] - The company is also working on oral vaccines for other diseases, including COVID-19 and influenza, and has filed broad patent applications for its technology [14]

Core Insights - Vaxart, Inc. is set to release topline data from its norovirus Phase I trial on June 11, 2025, before market opening [1] - A live conference call will be held on the same day at 8:30 a.m. Eastern Time to discuss the data and provide updates on the trial [1][2] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using its proprietary delivery platform [3] - The company's vaccines are designed to be administered in pill form, which can be stored and shipped without refrigeration, thus eliminating needle-stick injury risks [3] - Current development programs include vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [3] - Vaxart has filed broad domestic and international patent applications for its oral vaccination technology [3]

Summary of Vaxart Conference Call Company Overview - **Company**: Vaxart - **Industry**: Vaccine Development - **Key Products**: Oral vaccines, including those for COVID-19 and norovirus Core Points and Arguments 1. **Unique Oral Vaccine Platform**: Vaxart is developing an oral vaccine that can be self-administered, contrasting with traditional injected vaccines which require appointments and can have side effects [2][3][4] 2. **Scientific Advantages**: The oral vaccine elicits both systemic immune responses (IgG) and mucosal immune responses (dimeric IgA), which may provide better protection against variant strains [5][6][31] 3. **Health Economic Benefits**: The oral vaccine eliminates the need for cold chain storage and reduces medical waste, potentially lowering overall healthcare costs [8][10] 4. **COVID-19 Program**: Vaxart received over $450 million in funding from BARDA for a study comparing its oral vaccine to an mRNA vaccine, with a 10,000 participant study currently underway [11][12][33] 5. **Study Design**: The study includes both symptomatic and asymptomatic COVID-19 infection tracking, with a follow-up period of 12 months [15][16][19] 6. **Funding Structure**: The funding agreement is milestone-driven, with $240 million immediately available to support the study [33][34] 7. **Norovirus Vaccine Development**: Norovirus causes significant health issues, particularly in vulnerable populations, and Vaxart aims to develop a vaccine targeting this virus, with no approved vaccines currently available [41][42] 8. **Second Generation Norovirus Vaccine**: Vaxart is advancing a second-generation vaccine with improved immunogenicity and manufacturing efficiency, with data expected mid-year [44][46][49] 9. **Market Potential**: The financial impact of norovirus in the U.S. is estimated at $10 billion annually, indicating a significant market opportunity for a vaccine [41] 10. **Partnership Opportunities**: Vaxart is in discussions with various companies for potential partnerships to support its vaccine programs, particularly for norovirus [72][73] 11. **Influenza Programs**: Vaxart is also developing vaccines for seasonal and pandemic influenza, with promising preclinical results [66][68] Other Important Content - **Regulatory Environment**: The company has maintained a good relationship with the U.S. government, which has allowed it to proceed with its studies without major changes [12][36] - **Safety Monitoring**: An independent Data Safety Monitoring Board has recommended proceeding with the study without modifications, indicating confidence in the study's design [25][26] - **Cross-Reactivity and Viral Shedding**: The oral vaccine shows potential for cross-reactivity against various strains and may reduce viral shedding, which is critical for controlling pandemics [31][32][60] - **Runway and Future Funding**: Vaxart's current financial runway extends into the first quarter of the following year, with plans to seek additional funding based on positive study results [74][75]

Core Insights - Vaxart, Inc. is participating in a fireside chat at the Jefferies Global Healthcare Conference on June 5, 2025 [1] - The company is focused on developing oral recombinant vaccines that can be stored and shipped without refrigeration [3] Company Overview - Vaxart is a clinical-stage biotechnology company specializing in oral recombinant vaccines based on a proprietary delivery platform [3] - The company's vaccines aim to eliminate the risk of needle-stick injury and are designed for various diseases, including coronavirus, norovirus, influenza, and HPV [3] - Vaxart has filed broad domestic and international patent applications for its oral vaccination technology [3] Event Details - A live webcast of the fireside chat will be available on Vaxart's website, with a replay accessible for 30 days post-event [2] - Investors interested in meeting with Vaxart's management during the conference can contact their Jefferies representative [2]

Core Viewpoint - Vaxart, Inc. is urging stockholders to vote in favor of a reverse stock split proposal to regain compliance with Nasdaq's minimum bid price rule by the deadline of June 1, 2025 [1][2] Group 1: Reverse Stock Split Proposal - Dr. Sean Tucker, Founder and CSO of Vaxart, emphasizes the importance of voting FOR Proposal No. 2, which would allow the Board of Directors to implement a reverse stock split [1] - The company has provided a fact sheet to clarify misconceptions regarding the reverse stock split proposal [2] - Stockholders who have not yet voted are encouraged to do so by the deadline, and those who previously voted against the proposal can change their vote [2] Group 2: Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [4] - The company's vaccines are designed to be administered in pill form, which can be stored and shipped without refrigeration, thus eliminating the risk of needle-stick injury [4] - Current development programs include vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4]

Core Viewpoint - Vaxart, Inc. is urging stockholders to vote in favor of a reverse stock split proposal to maintain compliance with Nasdaq listing requirements, with a deadline for voting set for June 1, 2025 [1][16]. Group 1: Reverse Stock Split Proposal - The Board of Directors adjourned the Annual Meeting to give stockholders more time to understand the implications of the reverse stock split, especially in light of a potential delisting from Nasdaq [2]. - The reverse stock split is proposed to help regain compliance with Nasdaq's minimum bid price requirement, with a high end of 1-for-20 split ratio being considered [4]. - A proportional reduction in authorized shares will be proposed alongside the reverse stock split to align with investor feedback [3]. Group 2: Financial Strategy and Capital Raising - Vaxart raised $40 million through an underwritten offering to extend its cash runway, as its previous cash guidance was less than six months [8]. - The company has been proactive in exploring partnerships to avoid dilutive financings, although more data is needed to advance discussions [11]. Group 3: Operational Updates and Future Plans - Vaxart is advancing multiple clinical programs, including norovirus and COVID-19 vaccines, which are expected to drive investor interest [5]. - The company has filed broad patent applications for its oral vaccine technology, which is designed to be administered in pill form [17].

- Study will assess relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA comparator at 12 months - SOUTH SAN FRANCISCO, Calif., May 27, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced the first patient was dosed in the 10,000-participant portion of its ongoing Phase 2b clinical trial evaluating its oral pill COVID-19 vaccine candidate. “Initiating dosing in the 10,000-participant portion of this study is a significant st ...