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].

Core Insights - Vaxart, Inc. has initiated dosing in a Phase 2b clinical trial for its oral COVID-19 vaccine candidate, involving 10,000 participants, marking a significant advancement in its development process [1][2] - The trial is designed as a double-blind, multi-center, randomized, comparator-controlled study to assess the efficacy, safety, and immunogenicity of Vaxart's oral vaccine compared to an approved mRNA vaccine in previously vaccinated adults [2][3] - The trial follows a positive review of safety data from an initial cohort of 400 participants, with the independent Data Safety Monitoring Board recommending the study proceed without modifications [3] Funding and Support - Vaxart's project has received funding under Project NextGen, a U.S. government initiative aimed at accelerating the development of innovative COVID-19 vaccines, with a project award valued at up to $460.7 million [4] 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 [5] - The company is working on various oral vaccines targeting diseases such as coronavirus, norovirus, and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV) [5]

Core Points - Vaxart, Inc. has adjourned its 2025 annual meeting of stockholders to June 2, 2025, at 8:30 a.m. Pacific Time [1] - The meeting will be held in a virtual-only format, accessible via a specific website [2] - Stockholders who have not yet voted are encouraged to do so by June 1, 2025, at 11:59 p.m. Eastern Time [4] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [6] - The company's vaccines are designed to be administered in pill form, eliminating the need for refrigeration and reducing the risk of needle-stick injuries [6] - Current development programs include vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [6]

Core Viewpoint - Vaxart, Inc. is urging stockholders to vote in favor of a reverse stock split proposal to avoid delisting from Nasdaq, with support from leading independent proxy advisory firms ISS and Glass Lewis [1] Group 1: Proposal Details - The board of directors has approved two items contingent on the passage of Proposal 2, emphasizing the importance of maintaining the Nasdaq listing for stockholder liquidity and attracting institutional investors [1] - Stockholders who previously voted against Proposal 2 can change their vote by the deadline of May 20, 2025, at 11:59 p.m. Eastern Time [1] Group 2: 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 [3] - The company's vaccine development programs include oral 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] Group 3: Stock Split Information - The current authorized number of shares will be proportionally reduced according to the reverse stock split ratio, which will not exceed 1-for-20 [5]

"We are pleased to receive BARDA approval to move forward with dosing in this large-scale study and expect to dose the first patient in this cohort in the second quarter of 2025," said Steven Lo, Chief Executive Officer of Vaxart. "We are deeply grateful for the continued support of our government partners at HHS and BARDA, whose collaboration is critical to advancing our clinical development program." The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study. It is designe ...

Core Insights - Vaxart, Inc. announced the publication of complete data from a Phase 2b challenge study of its first-generation oral pill norovirus vaccine candidate, which met five of its six primary endpoints, demonstrating safety, efficacy, and immunogenicity [1][4] - Machine learning analyses identified functional blocking antibody and fecal IgA as robust correlates of protection, which will inform the development of Vaxart's second-generation norovirus vaccine candidate currently in a Phase 1 clinical trial [1][2] Study Details - The Phase 2b challenge study enrolled 165 healthy adults, randomized to receive either the vaccine candidate targeting norovirus GI.1 genotype or a placebo, with a primary objective to determine vaccine efficacy against norovirus infection and gastroenteritis [3] - Key findings included a 30% relative reduction in norovirus infection for the vaccine group compared to placebo (p=0.003) and a 21% relative reduction in norovirus gastroenteritis, although not statistically significant (p=0.178) [4] Immunogenicity and Safety - The vaccine significantly increased serum IgA, IgG, and norovirus-blocking antibodies (p<0.001 for all endpoints), and stimulated mucosal-homing B cells, increasing norovirus-specific antibodies in saliva, nasal lining fluid, and intestine [4] - The vaccine was reported to be safe and well-tolerated, with no serious vaccine-related events or dose-limiting toxicities, and most adverse events were mild [4] Future Development - Vaxart initiated a Phase 1 trial comparing its first- and second-generation norovirus vaccine candidates in March 2025, aiming to enhance immunogenicity and protection [1][5][6] - The company believes that a safe and effective norovirus vaccine is essential for global health and is confident in its oral pill vaccine platform [6]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $20.9 million, a significant increase from $2.2 million in Q1 2024, primarily driven by the BARDA contract awarded in June 2024 [22][23] - The company ended Q1 2025 with cash, cash equivalents, and investments totaling $41.9 million, with an expected cash runway into Q1 2026 [23] Business Line Data and Key Metrics Changes - The COVID-19 vaccine program has resumed activities following the lifting of the stop work order, with patient screening underway and dosing expected to start in Q2 2025 [5][12] - Enrollment in the Phase 1 trial for the norovirus vaccine was completed quickly, with top-line data expected in mid-2025 [8][15] Market Data and Key Metrics Changes - The company is actively pursuing strategic partnerships to enhance funding and support for its clinical programs, particularly in the norovirus and avian flu vaccine markets [17][19] Company Strategy and Development Direction - The company emphasizes the importance of vaccines in public health and aims to innovate oral pill vaccines that can provide effective and durable protection against infections [9][19] - A reverse stock split is being considered as a measure to maintain NASDAQ listing compliance, with management acknowledging the need for a strategic approach to regain investor confidence [26][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the COVID-19 program's potential and the importance of timely communication with stakeholders, despite contractual limitations [5][6] - The company is navigating challenges in the biotech environment and has made workforce reductions to streamline costs and maximize future opportunities [10][23] Other Important Information - The CFO, Phil Lee, announced his resignation for personal reasons, with Jerome Grossman set to take over [10][11] - The avian flu vaccine program has shown promising preclinical results, with plans to advance to clinical trials [19][20] Q&A Session All Questions and Answers Question: What are the gating factors to start patient dosing in the COVID-19 program? - Management indicated that the stop work order lifting allowed for immediate discussions with BARDA, and patient screening is currently underway, with dosing expected to start soon [37][39] Question: What does a positive outcome look like for the Phase 1 norovirus study? - Success is defined as the new constructs trending better than the old constructs on key immunogenicity endpoints, although statistical significance may not be achievable due to the study size [41][42] Question: What impact did the stop work order have on the expected timeline for the COVID-19 study? - The stop work order had a minor impact, but the company is now reactivating study sites and screening participants, with a projected six-month enrollment period once dosing begins [60][62] Question: Are there ongoing discussions for partnerships related to the norovirus program? - Management confirmed active discussions with a range of companies, with expectations that these will accelerate following the release of top-line results [65][66]