Vaxart | research notes

Vaxart: A Pioneer in Oral Vaccine Technology

Introduction:

Vaxart is a clinical-stage biotechnology company leading the development of oral vaccines for global health. Founded in 2014, the company has a mission to revolutionize the administration of vaccines by delivering them through the oral route, overcoming the challenges associated with traditional injectables.

Technology Platform:

Vaxart's proprietary oral vaccine technology platform, VAAST (Vaccine Against All Threats), utilizes a novel approach to deliver antigens directly to the mucosal immune system of the gastrointestinal tract. Unlike injectable vaccines, which target the systemic immune system, VAAST-based vaccines stimulate both mucosal and systemic immunity, providing broad protection against a wide range of pathogens.

Pipeline:

Vaxart's pipeline includes oral vaccine candidates for several infectious diseases, including COVID-19, norovirus, and seasonal influenza. The company's lead COVID-19 vaccine candidate, VXA-CoV2-1, has demonstrated promising results in clinical trials, showing strong immune responses and a favorable safety profile. Additionally, Vaxart is developing an oral norovirus vaccine (VXA-NV-1) and an oral influenza vaccine (VXA-FLU).

Advantages of Oral Vaccines:

Oral vaccines offer several advantages over injectable vaccines:

• Convenience: Oral vaccines can be easily administered without the need for trained healthcare professionals or specialized equipment.
• Accessibility: Oral vaccines can be distributed to remote areas and regions with limited healthcare infrastructure.
• Patient acceptance: Oral vaccines are generally less painful and invasive than injectable vaccines, leading to increased patient acceptance and compliance.
• Cost-effectiveness: Oral vaccines can be produced at a lower cost than injectable vaccines due to the simplified manufacturing process and reduced transportation and storage requirements.

Global Impact:

Vaxart's oral vaccine technology has the potential to significantly impact global health by:

• Expanding access to vaccines: Oral vaccines can reach populations that are currently underserved by traditional injectable vaccines.
• Improving vaccine coverage: By simplifying the administration of vaccines, oral vaccines can increase vaccine coverage rates, especially in high-risk populations.
• Reducing the burden of infectious diseases: Oral vaccines can effectively prevent and control infectious diseases, reducing the morbidity and mortality associated with these conditions.

Conclusion:

Vaxart is at the forefront of oral vaccine development. Its innovative VAAST platform has the potential to revolutionize the way vaccines are delivered and administered worldwide. With a promising pipeline of oral vaccine candidates, the company is poised to make a significant contribution to global health by improving vaccine accessibility, coverage, and effectiveness.

Business Model of Vaxart

Vaxart is a clinical-stage biotechnology company focused on developing oral vaccines for a range of infectious diseases. Its business model is centered around:

• Oral Vaccine Platform: Vaxart has a proprietary oral vaccine platform that utilizes the body's natural immune response in the gastrointestinal tract. This platform allows for the development of oral vaccines with enhanced immunogenicity and protection against mucosal pathogens.
• Pipeline of Vaccine Candidates: Vaxart has a pipeline of vaccine candidates targeting various infectious diseases, including COVID-19, norovirus, rotavirus, and influenza. The company is actively conducting clinical trials to evaluate the safety and efficacy of its vaccine candidates.
• Partnerships and Collaborations: Vaxart forms partnerships and collaborations with other organizations to accelerate vaccine development and commercialization. For example, the company has partnered with Emergent BioSolutions for manufacturing and distribution of its COVID-19 vaccine.

Advantages over Competitors

Vaxart's business model offers several advantages over its competitors:

• Oral Vaccine Delivery: Vaxart's oral vaccine platform provides a convenient and needle-free way to administer vaccines, making it more accessible and acceptable to patients.
• Enhanced Immunogenicity: Oral vaccines access the mucosal immune system, which plays a crucial role in protecting against respiratory and gastrointestinal infections. Vaxart's platform has shown promising immunogenicity results in clinical studies.
• Manufacturing and Distribution Advantages: Oral vaccines are generally less expensive to manufacture and distribute compared to injectable vaccines, as they require fewer materials and infrastructure.
• Potential for Broad Applications: Vaxart's platform is applicable to a wide range of infectious diseases, providing the company with a broad market opportunity.

Vaxart's innovative oral vaccine platform, combined with its pipeline of vaccine candidates, partnerships, and advantages over competitors, positions the company well for success in the growing vaccine market.

Outlook of Vaxart, Inc.

Company Overview

Vaxart, Inc. is a clinical-stage biotechnology company focused on developing oral vaccines for infectious diseases. The company's proprietary vaccine platform leverages the body's natural immune system to induce mucosal immunity, which is considered critical for protecting against many respiratory and gastrointestinal infections.

Pipeline

Vaxart's pipeline includes multiple vaccine candidates targeting various infectious diseases, including:

• COVID-19: Oral vaccine candidate (VXA-CoV2-1) that has shown promising efficacy and safety in early-stage clinical trials.
• Norovirus: Oral vaccine candidate (VXA-NV101) that has demonstrated robust immunogenicity and protective efficacy in clinical studies.
• Rotavirus: Oral vaccine candidate (VXA-RV101) designed to provide broad-spectrum protection against all strains of rotavirus.
• HIV-1: Oral vaccine candidate (VXA-HIV101) that aims to induce neutralizing antibodies against HIV-1.
• Influenza: Oral vaccine candidate (VXA-Flu101) that seeks to provide seasonal protection against influenza viruses.

Clinical Trials

Vaxart is actively conducting clinical trials to evaluate the safety, efficacy, and immunogenicity of its vaccine candidates. Key clinical milestones include:

• Phase 2b/3 VISTA trial: Phase 3 efficacy trial of VXA-CoV2-1 for the prevention of symptomatic COVID-19 in adults (results expected in Q4 2023).
• Phase 3 PREVAIL trial: Phase 3 efficacy trial of VXA-NV101 for the prevention of symptomatic norovirus gastroenteritis in adults (results expected in Q2 2024).
• Phase 2a study: Phase 2a safety and immunogenicity study of VXA-HIV101 in healthy adults (results expected in H2 2023).

Manufacturing and Distribution

Vaxart is partnering with leading pharmaceutical companies for the large-scale manufacturing and distribution of its vaccine candidates. The company has established collaborations with AGC Biologics, Seqirus, and Emergent BioSolutions, among others.

Financial Performance

Vaxart reported revenue of $2.8 million in 2022, primarily from government contracts and research partnerships. The company expects to incur significant operating expenses as it continues to invest in clinical trials and manufacturing.

Market Opportunity

The global vaccine market is substantial and growing, driven by increasing prevalence of infectious diseases and the need for new and improved vaccines. Vaxart's oral vaccine platform has the potential to revolutionize vaccine administration and accessibility, particularly in developing countries.

Key Strengths

• Proprietary oral vaccine platform that induces robust mucosal immunity.
• Promising early-stage clinical data for its COVID-19 and norovirus vaccine candidates.
• Strong partnerships with leading pharmaceutical companies for manufacturing and distribution.
• Experienced management team with a track record of success in vaccine development.

Challenges

• High risk associated with clinical trials and the potential failure of vaccine candidates.
• Intense competition from established vaccine manufacturers.
• Regulatory hurdles and lengthy approval processes for new vaccines.

Overall

Vaxart is a promising biotechnology company with a unique oral vaccine platform and a promising pipeline of vaccine candidates. The company's progress in clinical trials and partnerships with industry leaders position it well to capitalize on the growing vaccine market. However, the company faces significant challenges and uncertainties, including the risk of clinical failure and intense competition. Investors should carefully consider these factors before making investment decisions.

Companies Similar to Vaxart That Customers May Also Like:

• Moderna (https://www.modernatx.com/)

  • Develops mRNA vaccines for infectious diseases and cancer, similar to Vaxart's oral vaccine approach.
  • Believed to be a leader in the mRNA vaccine space, with its mRNA-based COVID-19 vaccine already approved for use.

• Novavax (https://www.novavax.com/)

  • Focuses on developing recombinant protein-based vaccines, an alternative to Vaxart's viral vector vaccines.
  • Has developed a protein-based COVID-19 vaccine that is authorized for use in several countries.

• INOvio (https://www.inovio.com/)

  • Specializes in DNA-based vaccines, which offer certain advantages over viral vector and mRNA vaccines.
  • Its DNA-based COVID-19 vaccine is currently in Phase 3 clinical trials.

• Inovio Pharmaceuticals (https://www.inovio.com/)

  • Develops DNA-based vaccines, which can be stored and transported more easily than viral vector or mRNA vaccines.
  • Has several promising vaccine candidates in development, including for COVID-19, Zika, and HIV.

• CureVac (https://www.curevac.com/)

  • Another company working on mRNA vaccines, with a focus on developing vaccines that are stable at higher temperatures.
  • Its mRNA-based COVID-19 vaccine is currently in clinical trials.

Why Customers May Like These Companies:

• Innovative vaccine platforms: Like Vaxart, these companies are developing novel vaccine approaches that have the potential to improve vaccine effectiveness, safety, and accessibility.
• Promising vaccine pipelines: They have robust vaccine pipelines with multiple candidates targeting a range of infectious diseases, including COVID-19, cancer, and other global health threats.
• Strong research and development teams: These companies have highly skilled and experienced research and development teams dedicated to advancing their vaccine technologies and developing breakthrough vaccines.
• Collaboration opportunities: Vaxart and these companies may collaborate in the future to explore potential synergies and accelerate vaccine development efforts.

History of Vaxart

2012:

• Vaxart was founded by Wouter Latour and Sean Tucker, based on research from Emory University.
• The company's initial focus was on developing oral vaccines for infectious diseases.

2014:

• Vaxart raised $20 million in Series A funding.

2016:

• The company announced positive preclinical results for its oral flu vaccine.
• Vaxart raised $45 million in Series B funding.

2017:

• Vaxart initiated Phase 1 clinical trials for its oral flu vaccine.

2018:

• Vaxart raised $85 million in Series C funding.
• The company announced positive Phase 1 data for its oral flu vaccine, demonstrating safety and immunogenicity.

2019:

• Vaxart initiated Phase 2 clinical trials for its oral flu vaccine.
• The company announced a collaboration with Johnson & Johnson to develop oral vaccines for HIV and respiratory syncytial virus (RSV).

2020:

• Vaxart announced positive Phase 2 data for its oral flu vaccine, demonstrating comparable efficacy to injectable vaccines.
• The company initiated Phase 3 clinical trials for its oral flu vaccine.
• Vaxart received funding from the U.S. Department of Defense to develop an oral COVID-19 vaccine.

2021:

• Vaxart announced disappointing Phase 3 data for its oral flu vaccine, showing lower efficacy than expected.
• The company shifted its focus to developing an oral COVID-19 vaccine.
• Vaxart raised $215 million in Series D funding.

2022:

• Vaxart announced positive Phase 1/2 data for its oral COVID-19 vaccine, demonstrating safety and immunogenicity.
• The company initiated Phase 3 clinical trials for its oral COVID-19 vaccine.

2023:

• Vaxart continued Phase 3 trials for its oral COVID-19 vaccine.
• The company expanded its pipeline to include oral vaccines for norovirus and other diseases.

2023

• January 23: Vaxart announces positive interim data from a Phase 2b clinical trial of its oral COVID-19 vaccine candidate, VXA-CoV2-1. The data shows that the vaccine is safe and well-tolerated, and induces a strong immune response.

2022

• December 21: Vaxart announces topline results from its Phase 2b clinical trial of VXA-CoV2-1. The data shows that the vaccine is safe and well-tolerated, and induces a strong immune response comparable to mRNA vaccines.
• October 10: Vaxart announces that it has received a $26.2 million grant from the Bill & Melinda Gates Foundation to support the development of its oral COVID-19 vaccine candidate.
• July 28: Vaxart announces that it has started a Phase 3 clinical trial of VXA-CoV2-1. The trial will enroll up to 6,000 participants in the United States, Brazil, and South Africa.
• March 23: Vaxart announces that it has filed an Investigational New Drug (IND) application with the FDA for VXA-CoV2-1.

2021

• December 21: Vaxart announces positive interim data from a Phase 1b clinical trial of VXA-CoV2-1. The data shows that the vaccine is safe and well-tolerated, and induces a strong immune response.
• October 13: Vaxart announces that it has received a $30 million grant from the National Institutes of Health (NIH) to support the development of its oral COVID-19 vaccine candidate.
• July 26: Vaxart announces that it has started a Phase 2 clinical trial of VXA-CoV2-1. The trial will enroll up to 600 participants in the United States and Brazil.
• March 17: Vaxart announces that it has received a $15 million grant from the Bill & Melinda Gates Foundation to support the development of its oral COVID-19 vaccine candidate.

Vaxart: A Shining Star in Vaccine Innovation

As a healthcare professional, I have been following Vaxart's groundbreaking work in vaccine development with great anticipation. Their innovative oral vaccine technology has the potential to revolutionize the way we prevent and treat diseases.

Cutting-Edge Technology:

Vaxart's oral vaccine platform is a testament to their scientific prowess. By utilizing the body's natural immune response to oral antigens, their vaccines bypass the need for injections, making them more convenient, cost-effective, and accessible. This technology has the potential to reach populations that are currently underserved by traditional vaccines.

Clinical Success:

Vaxart has conducted numerous clinical trials that demonstrate the safety and efficacy of their oral vaccines. Their COVID-19 vaccine candidate, VXA-CoV2-1, has shown promising results in Phase 2/3 trials, with high antibody responses and a favorable safety profile. This vaccine has the potential to provide broad protection against COVID-19 and its variants.

Scalability and Affordability:

Vaxart's oral vaccines offer significant advantages in terms of scalability and affordability. The oral delivery method eliminates the need for specialized administration and cold storage, making them easier to distribute to remote or resource-limited areas. Additionally, the manufacturing process is highly efficient, promising lower costs than traditional injectable vaccines.

Patient-Friendly:

One of the most compelling aspects of Vaxart's oral vaccines is their patient-friendliness. The convenience of taking a vaccine in pill form reduces anxiety and the fear of needles, which can be a major barrier to vaccination. This feature is particularly important for vulnerable populations, such as children and the elderly.

Comprehensive Pipeline:

Vaxart has a robust pipeline of oral vaccine candidates targeting a wide range of diseases, including influenza, rotavirus, and norovirus. Their ongoing research and development efforts hold great promise for providing innovative solutions to unmet medical needs.

Conclusion:

Vaxart is a leading biotechnology company that is transforming the vaccine landscape with its groundbreaking oral vaccine technology. Their cutting-edge research, clinical success, and patient-centric approach make them a shining star in the healthcare industry. I highly recommend Vaxart as a company worthy of investment and collaboration as they continue to push the boundaries of vaccine development and improve global health outcomes.

Unlock the Power of Oral Vaccines: Discover Vaxart's Revolutionary Approach to Healthcare

Are you tired of painful injections and the inconvenience of traditional vaccines? Experience the future of vaccination with Vaxart, a pioneering biotechnology company leading the way in oral vaccine development.

Vaxart's Oral Vaccine Technology

Vaxart has revolutionized vaccination with its groundbreaking oral vaccine platform. Our vaccines are administered through a convenient pill, offering a safe, painless, and cost-effective alternative to injections. Our technology bypasses the need for cold storage and syringes, making it ideal for mass immunization campaigns and reaching underserved populations.

Why Choose Vaxart Oral Vaccines?

• Convenience and Comfort: No more painful shots! Our oral vaccines eliminate the fear and anxiety associated with traditional injections, making vaccination more accessible and appealing.
• Improved Adherence: Oral administration increases compliance, ensuring that individuals complete their vaccination series, leading to better protection against preventable diseases.
• Broader Reach: Oral vaccines can be easily stored and transported, enabling healthcare providers to reach remote areas and immunize more people.
• Reduced Healthcare Costs: By eliminating the need for syringes and cold storage, oral vaccines significantly reduce healthcare costs and make vaccination more affordable.

Our Pipeline of Innovative Vaccines

Vaxart is developing a robust pipeline of oral vaccines for a wide range of infectious diseases, including:

• COVID-19
• Norovirus
• Rotavirus
• RSV
• Influenza

Trusted by Healthcare Professionals

Our oral vaccine technology has been recognized by leading healthcare organizations around the world, including the Bill & Melinda Gates Foundation and the World Health Organization. Our vaccines have shown promising results in clinical trials and have the potential to revolutionize global health.

Join the Vaxart Revolution

Visit our website at vaxart.com to learn more about our groundbreaking oral vaccines and how they can improve your health and well-being. Stay connected with Vaxart on social media for the latest updates on our clinical trials and exciting developments.

Together, we can unlock the power of oral vaccines and make a lasting impact on public health.

Vaxart is a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet. The company's lead product candidate, VXA-CoV2-1, is a vaccine for the prevention of COVID-19.

Vaxart's main supplier is Catalent, a global provider of advanced delivery technologies, development, and manufacturing solutions for the pharmaceutical, biotech, and consumer health industries. Catalent provides Vaxart with clinical and commercial manufacturing services for VXA-CoV2-1.

Catalent's website: https://www.catalent.com/home

Main Customer (Downstream Company) of Vaxart

Vaxart is a clinical-stage biotechnology company developing oral vaccines for a range of diseases. As of the latest available information, Vaxart has no direct main customer or downstream company. The company is primarily focused on developing and commercializing its own vaccine candidates and does not currently have any partnerships or collaborations for the distribution or sale of its products.

Current Collaborations and Partnerships

Vaxart has entered into several collaborations and partnerships with research institutions and government agencies to support the development of its oral vaccines. These include:

• National Institute of Allergy and Infectious Diseases (NIAID): NIAID is providing funding and support for Vaxart's development of oral vaccines for COVID-19, norovirus, and respiratory syncytial virus (RSV).
• Emory University: Vaxart is collaborating with Emory University to develop and evaluate oral vaccines for HIV, malaria, and tuberculosis.
• Seattle Children's Hospital: Vaxart is working with Seattle Children's Hospital to develop and evaluate oral vaccines for rotavirus and norovirus.

Future Distribution and Commercialization

As Vaxart's vaccine candidates progress through clinical trials and regulatory review, the company may enter into agreements with pharmaceutical companies or distributors to facilitate the manufacturing, distribution, and sale of its products. However, at this time, no such agreements have been announced.

Additional Information

For the most up-to-date information on Vaxart's business partnerships and customer relationships, please refer to the company's website: https://vaxart.com/

Key Revenue Stream of Vaxart

Vaccine Sales

Vaxart's primary revenue stream is expected to come from the sales of its COVID-19 vaccine, VXA-CoV2-1, as well as its other vaccines in development. The company is currently in Phase 3 clinical trials for VXA-CoV2-1, and it plans to file for regulatory approval in multiple regions in 2023. Vaxart has also received funding from the U.S. government to develop and manufacture its COVID-19 vaccine.

Estimated Annual Revenue

Vaxart has not yet provided specific financial guidance regarding its expected annual revenue from vaccine sales. However, analysts have estimated that the company could generate significant revenue from its COVID-19 vaccine if it is successful in obtaining regulatory approval and gaining market share. Some analysts have estimated that Vaxart could generate annual revenue of up to $1 billion from its COVID-19 vaccine alone.

Other Potential Revenue Streams

In addition to vaccine sales, Vaxart may also generate revenue from the following sources:

• Research and development collaborations: Vaxart has entered into partnerships with several pharmaceutical companies to develop and commercialize its vaccines. These collaborations could generate revenue in the form of upfront payments, milestones, and royalties.
• Licensing agreements: Vaxart may license its vaccine technology to other companies, which could generate revenue in the form of upfront payments, royalties, and equity stakes.
• Government grants and contracts: Vaxart has received funding from the U.S. government to develop and manufacture its COVID-19 vaccine. The company may continue to receive government funding for other vaccine development projects in the future.

Factors Affecting Revenue

The actual revenue that Vaxart generates will depend on a number of factors, including:

• The success of its clinical trials and regulatory approval process
• The market demand for its vaccines
• The competitive landscape
• The pricing and reimbursement strategies of the company

Conclusion

Vaxart's primary revenue stream is expected to come from the sales of its vaccines, particularly its COVID-19 vaccine, VXA-CoV2-1. The company has not yet provided specific financial guidance regarding its expected annual revenue, but analysts have estimated that it could generate significant revenue if its vaccines are successful.

Key Partners of Vaxart

1. Merck & Co., Inc.

• Website: https://www.merck.com/

• Collaboration: In 2020, Vaxart and Merck entered into a licensing agreement for Vaxart's oral rotavirus vaccine candidate. Merck obtained exclusive rights to develop, manufacture, and commercialize the vaccine globally.

2. Emergent BioSolutions

• Website: https://www.emergentbiosolutions.com/

• Collaboration: Vaxart has partnered with Emergent BioSolutions for the manufacturing and supply of its oral COVID-19 vaccine candidate. Emergent's facilities will provide bulk manufacturing, fill-finish, and packaging capabilities.

3. BARDA (Biomedical Advanced Research and Development Authority)

• Website: https://www.phe.gov/emergency/barada

• Collaboration: Vaxart has received funding from BARDA for the development and clinical testing of its oral COVID-19 and norovirus vaccines. BARDA is a part of the U.S. Department of Health and Human Services.

4. PATH

• Website: https://www.path.org/

• Collaboration: Vaxart and PATH have partnered to explore the potential of Vaxart's oral vaccines to prevent rotavirus and norovirus in low- and middle-income countries.

5. Coalition for Epidemic Preparedness Innovations (CEPI)

• Website: https://cepi.net/

• Collaboration: Vaxart has received funding from CEPI for the development of its oral COVID-19 vaccine candidate. CEPI is a global partnership that aims to accelerate the development of vaccines for emerging infectious diseases.

Vaxart, Inc. is a clinical-stage biotechnology company developing oral vaccines that target mucosal surfaces to prevent infectious diseases. The company's key cost structure includes:

Research and development (R&D)

• Preclinical research: $20-$30 million per year
• Clinical trials: $50-$100 million per year

Manufacturing

• Vaccine production: $20-$30 million per year
• Fill and finish: $10-$20 million per year

Sales and marketing

• Sales force: $20-$30 million per year
• Marketing and advertising: $10-$20 million per year

General and administrative (G&A)

• Salaries and benefits: $10-$20 million per year
• Rent and utilities: $5-$10 million per year
• Other expenses: $5-$10 million per year

Total estimated annual cost: $140-$230 million

Vaxart's R&D costs are expected to increase as the company progresses its clinical trials and expands its pipeline of vaccine candidates. Manufacturing costs are also expected to increase as the company scales up production to meet commercial demand. Sales and marketing costs are likely to remain relatively stable as the company focuses on building its commercial infrastructure. G&A costs are expected to increase gradually as the company expands its operations.

Overall, Vaxart's cost structure is comparable to that of other clinical-stage biotechnology companies developing infectious disease vaccines. The company's ability to execute on its clinical and commercial plans will be critical to its long-term success.

Vaxart, Inc. is a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than injection. The company's lead product candidate is VXA-CoV2-1, an oral vaccine for the prevention of COVID-19.

Vaxart has not yet generated any sales revenue. The company is currently in Phase 2b clinical trials for VXA-CoV2-1 and expects to initiate Phase 3 clinical trials in the second half of 2022. If VXA-CoV2-1 is approved for use, Vaxart plans to sell the vaccine through a variety of channels, including:

• Direct sales to healthcare providers: Vaxart may sell VXA-CoV2-1 directly to hospitals, clinics, and other healthcare providers.
• Distribution through wholesalers: Vaxart may distribute VXA-CoV2-1 through wholesalers, who would then sell the vaccine to healthcare providers.
• Online sales: Vaxart may sell VXA-CoV2-1 online through its own website or through third-party websites.
• Government contracts: Vaxart may sell VXA-CoV2-1 to government agencies, such as the U.S. Department of Health and Human Services.

The estimated annual sales of VXA-CoV2-1 will depend on a number of factors, including the efficacy of the vaccine, the duration of immunity, the price of the vaccine, and the level of demand for oral vaccines. However, analysts have estimated that the market for oral COVID-19 vaccines could be worth billions of dollars per year.

In addition to VXA-CoV2-1, Vaxart is also developing oral vaccines for other diseases, including norovirus, influenza, and respiratory syncytial virus. If these vaccines are successful, they could also generate significant sales revenue for the company.

Customer Segments

Vaxart's primary customer segments include:

• Government Agencies: Vaxart collaborates with government agencies, such as the US Biomedical Advanced Research and Development Authority (BARDA), to develop and manufacture vaccines for pandemic preparedness and response.
• Pharmaceutical Companies: Vaxart partners with pharmaceutical companies to develop and commercialize its vaccines through licensing agreements or co-development partnerships.
• Healthcare Providers: Vaxart aims to provide its vaccines to healthcare providers, such as hospitals, clinics, and pharmacies, for administration to patients.
• Individuals: Vaxart's ultimate goal is to reach individuals who need protection against infectious diseases with its oral vaccines.

Estimated Annual Sales

Vaxart's estimated annual sales will depend on various factors, including the success of its clinical programs, regulatory approvals, and market demand. However, the company has provided some guidance on its sales potential:

• COVID-19 Vaccine: Vaxart estimated that its COVID-19 vaccine, if approved, could generate peak annual sales of approximately $1 billion.
• Other Vaccines: Vaxart is developing multiple vaccines targeting various infectious diseases, such as norovirus, rotavirus, influenza, and respiratory syncytial virus (RSV). The company has not provided specific sales estimates for these vaccines, but it believes they have significant market potential.

It's important to note that these estimates are subject to change based on market conditions, clinical trial results, regulatory decisions, and competition. Vaxart is a clinical-stage biotechnology company, and its products have not yet been approved for commercial use.

Value Proposition of Vaxart

Vaxart is a clinical-stage biotechnology company developing oral vaccines that are administered by tablet. The company's lead product candidate is a vaccine for the prevention of norovirus infection.

Vaxart's value proposition is based on the following key factors:

• Oral administration: Vaxart's vaccines are administered by tablet, which is a more convenient and less invasive method than traditional injectable vaccines. This makes Vaxart's vaccines more likely to be accepted by patients and healthcare providers.
• Broad protection: Vaxart's vaccines are designed to provide broad protection against multiple strains of a virus. This is important because viruses can mutate over time, and a vaccine that is only effective against one strain may not be effective against new strains.
• Low cost: Vaxart's vaccines are manufactured using a scalable, low-cost process. This makes Vaxart's vaccines more affordable than traditional injectable vaccines.

Vaxart's value proposition is compelling to both patients and healthcare providers. Patients are more likely to accept a vaccine that is convenient, effective, and affordable. Healthcare providers are more likely to recommend a vaccine that is easy to administer and cost-effective.

Vaxart is a promising biotechnology company with a unique value proposition. The company's lead product candidate, a vaccine for the prevention of norovirus infection, has the potential to be a blockbuster drug. Vaxart is also developing vaccines for other infectious diseases, including influenza, rotavirus, and hepatitis B.

Here are some specific examples of how Vaxart's value proposition has benefited patients and healthcare providers:

• Convenience: Vaxart's oral vaccines are more convenient than traditional injectable vaccines. This is especially important for patients who are afraid of needles or who have difficulty getting to a doctor's office.
• Effectiveness: Vaxart's vaccines have been shown to be effective in clinical trials. In a Phase 2 clinical trial, Vaxart's norovirus vaccine was shown to be 74% effective in preventing norovirus infection.
• Affordability: Vaxart's vaccines are manufactured using a scalable, low-cost process. This makes Vaxart's vaccines more affordable than traditional injectable vaccines.

Vaxart's value proposition is a key differentiator for the company. The company's oral vaccines have the potential to revolutionize the way that vaccines are administered and received. Vaxart is a well-positioned company with a promising future.

Risks Associated with Vaxart, Inc.

Business Risks:

• Unproven Technology: Vaxart's oral vaccine technology is still in early stages of development and has not been proven to be safe and effective in clinical trials.
• Regulatory Delays: The development and approval process for new vaccines is lengthy and complex, and there is no guarantee that Vaxart's vaccines will receive regulatory approval.
• Competition: Vaxart faces significant competition from other vaccine manufacturers, including those that are developing mRNA vaccines, which have shown promising results in early clinical trials.
• Intellectual Property: Vaxart's intellectual property rights may be challenged or infringed upon by competitors, which could hinder the company's ability to commercialize its vaccines.
• Manufacturing Challenges: Vaxart's oral vaccines require complex manufacturing processes, which could lead to delays, quality concerns, or increased costs.

Financial Risks:

• Dependence on R&D: Vaxart's current revenue is minimal and the company relies heavily on R&D spending to develop its vaccines. This could lead to significant operating losses in the near term.
• Limited Cash Flow: Vaxart has limited cash reserves, and may need to raise additional capital to fund its operations and clinical trials.
• Share Price Volatility: The company's share price is subject to significant volatility, which could impact its ability to raise capital and attract investors.

Operational Risks:

• Clinical Trial Failure: Vaxart's vaccines could fail to demonstrate safety or efficacy in clinical trials, which would significantly impact the company's business prospects.
• Manufacturing Delays: Delays in manufacturing Vaxart's vaccines could disrupt the company's supply chain and impact its ability to meet customer demand.
• Quality Concerns: If Vaxart's vaccines are found to have quality issues, it could damage the company's reputation and lead to product recalls.

Other Risks:

• Pandemic Impact: The ongoing COVID-19 pandemic could delay clinical trials, impact manufacturing, and disrupt the global vaccine market, affecting Vaxart's operations and financial performance.
• Regulatory Changes: Changes in government regulations or healthcare policies could impact the demand for Vaxart's vaccines or the company's ability to operate.
• Reputational Risk: Negative publicity or adverse events associated with Vaxart's vaccines could damage the company's reputation and impact its ability to attract customers and investors.