Summary of Vaxart (VXRT) Conference Call Company Overview - **Company**: Vaxart, Inc. - **Industry**: Biotechnology, specifically focusing on vaccine development - **Key Personnel**: Steve Lowe (CEO), James Cummings (Chief Medical Officer) - **Location**: South San Francisco, California, with all manufacturing conducted in the U.S. [12][49] Core Technology and Approach - **Vaccine Platform**: Vaxart's oral vaccine platform, referred to as VaST (Vector Adjuvant Antigen Standardization Technology), utilizes a non-replicating adenovirus vector dried into a pill form [14] - **Delivery Method**: The vaccine is taken orally with water, activating the immune system in the lower small intestine, promoting both systemic and mucosal immunity [15][10] - **Advantages**: - Needle-free administration, reducing logistical complexities and waste [11][29] - Thermostable, eliminating the need for a cold chain, making it easier to distribute, especially in low to middle-income countries [28][30] Market Opportunity - **Public Health Importance**: Vaccines are essential for preventing illnesses, hospitalizations, and deaths, representing a consistent revenue stream for the company [5][6] - **Norovirus Impact**: - Over 680 million global infections annually, with 20 million clinical cases in the U.S. [21] - Economic burden estimated at $10 billion annually in the U.S. due to healthcare costs and lost productivity [22][23] - **Target Populations**: Elderly, immunocompromised individuals, and those in enclosed spaces (e.g., military personnel, healthcare workers) are at higher risk for severe disease [24][25] Pipeline and Clinical Development - **Current Projects**: - **Norovirus Vaccine**: - Bivalent vaccine targeting G1 and G24 strains, showing an 80% reduction in viral shedding in preclinical studies [31][33] - Phase one trial underway with top-line data expected by mid-2025 [37][48] - **COVID-19 Vaccine**: - Funded by BARDA with a $460 million contract, focusing on ease of administration and mucosal immunity [40][41] - A 10,000-person study is ongoing, with a focus on cross-reactivity to various coronaviruses [42][43] - **Influenza Vaccine**: - Demonstrated a 49% decrease in infection compared to placebo in a head-to-head study against Fluzone [46][48] Key Milestones - **Upcoming Data Releases**: - Top-line data from the norovirus phase one trial expected in mid-2025 [47] - Completion of the COVID-19 sentinel study by December 2025 [40][48] Conclusion - Vaxart is positioned to revolutionize vaccine delivery with its oral platform, addressing significant public health challenges while also presenting a robust pipeline of vaccine candidates targeting norovirus, COVID-19, and influenza. The company emphasizes the importance of mucosal immunity and aims to provide accessible and effective vaccination solutions globally [49]

Urges Stockholders to Vote FOR Reverse Stock Split Proposal at Upcoming Annual Meeting as Recommended by Leading Independent Proxy Advisory Firms SOUTH SAN FRANCISCO, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today issued the following letter to its stockholders from its President & Chief Executive Officer, Steven Lo. Dear Vaxart, Inc. Stockholders: We are writing to update you on recent developments that positively impact Vaxart's ability to advance our promising vaccine candidat ...

Group 1 - Vaxart, Inc. will provide a business update and report financial results for Q1 2025 on May 13, 2025, after market close [1] - A conference call will be hosted by Vaxart's senior management team on the same day at 4:30 p.m. ET, with access details provided [1] - Investors can submit written questions in advance of the conference call by May 12, 2025 [1] Group 2 - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [3] - The company's vaccines are designed to be administered in pill form, which can be stored and shipped without refrigeration, reducing the risk of needle-stick injuries [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]

Core Points - Vaxart, Inc. will present at the Citizens Life Sciences conference on May 7-8, 2025 [1] - The presentation is scheduled for May 7 at 1:00 PM ET, with a live webcast available on the company's website [2] - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [3] Company Overview - Vaxart's vaccines are designed to be administered in pill form, which can be stored and shipped without refrigeration, reducing the risk of needle-stick injuries [3] - The company is developing oral vaccines for coronavirus, norovirus, and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV) [3] - Vaxart has filed broad domestic and international patent applications for its oral vaccination technology using adenovirus and TLR3 agonists [3]

Company Overview - Vaxart, Inc. is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [6] - The company aims to provide vaccines that can be administered in pill form, eliminating the need for refrigeration and reducing the risk of needle-stick injuries [6] Clinical Trial Progress - Vaxart has completed enrollment for its Phase 1 clinical trial of its second-generation oral norovirus vaccine constructs, which are being evaluated against first-generation constructs [2][3] - The Phase 1 trial is designed to assess safety and immune responses correlated with protection from norovirus, a leading cause of acute gastroenteritis globally [3] Future Development Plans - If the Phase 1 trial is successful, Vaxart plans to initiate a Phase 2 safety and immunogenicity study potentially starting in the second half of 2025, followed by an End of Phase 2 meeting with the FDA [5] - A Phase 3 trial could commence as early as 2026, contingent on successful outcomes and potential partnerships or funding [5] Safety Review - An independent Data and Safety Monitoring Board (DSMB) conducted an interim safety review and recommended that the study continue without modifications [4] Market Need - The development of Vaxart's oral norovirus vaccine is driven by a significant unmet public health need, as norovirus is a major cause of gastroenteritis worldwide [3]

SOUTH SAN FRANCISCO, Calif., April 16, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that Dr. Sean Tucker, Founder and Chief Scientific Officer, and Dr. James F. Cummings, Chief Medical Officer, will present at the World Vaccine Congress Washington 2025 in Washington, D.C. on Wednesday, April 23, 2025. The Company has appeared repeatedly at the annual event in Washington, D.C. Presentation Information: Title: Moving the needle: Blocking transmission and boosting existing vaccines by o ...

Financial Performance - Vaxart reported a net loss of $66.9 million for the full year 2024, an improvement from a net loss of $82.5 million in 2023, with net loss per share decreasing from $0.57 to $0.33[11] - Revenue for 2024 was $28.7 million, significantly up from $7.4 million in 2023, primarily driven by government contracts related to BARDA[11] - Cash, cash equivalents, and investments totaled $51.7 million as of December 31, 2024, providing a runway into the fourth quarter of 2025[11] - Vaxart's total assets increased to $166.4 million as of December 31, 2024, compared to $91.8 million in 2023[19] Expenses - Research and development expenses increased to $74.2 million in 2024 from $68.1 million in 2023, mainly due to clinical trial expenses for the COVID-19 vaccine candidate[11] - General and administrative expenses decreased to $20.8 million in 2024 from $22.6 million in 2023, attributed to lower personnel-related costs[12] - The company implemented a restructuring plan leading to a 10% reduction in workforce following a stop work order on the COVID-19 Phase 2b trial[11] Clinical Trials and Programs - Vaxart initiated a Phase 1 clinical trial for its second-generation oral norovirus vaccine in March 2025, with topline data expected by mid-2025[5] - The 400-person sentinel cohort for the COVID-19 Phase 2b trial completed enrollment, with initial safety assessments showing no modifications recommended by the Data Safety Monitoring Board[10] - Vaxart's avian influenza program is advancing with a new vaccine candidate targeting the latest clade 2.3.4.4b, with preclinical studies ongoing[7]

Vaxart, Inc. (NASDAQ:VXRT) Q4 2024 Earnings Conference Call March 20, 2025 4:30 PM ET Company Participants Ed Berg - SVP and General Counsel Steven Lo - CEO James Cummings - CMO Sean Tucker - Founder and CSO Phillip Lee - CFO Ray Stapleton - CTO Conference Call Participants Cheng Li - Oppenheimer Liang Cheng - Jefferies Operator Greetings and welcome to the Vaxart Business Update and Fourth Quarter and Full Year 2024 Financial Results Conference call. A question-and-answer session will follow management's o ...

Company Performance - VAXART, INC. reported a quarterly loss of $0.05 per share, better than the Zacks Consensus Estimate of a loss of $0.10, and an improvement from a loss of $0.12 per share a year ago, representing an earnings surprise of 50% [1] - The company posted revenues of $15.19 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 51.28%, compared to year-ago revenues of $3.25 million [2] - Over the last four quarters, VAXART has surpassed consensus EPS estimates three times, but has topped consensus revenue estimates only once [2] Stock Performance - VAXART shares have declined approximately 11.8% since the beginning of the year, while the S&P 500 has decreased by 3.5% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.16 on revenues of $12.39 million, and for the current fiscal year, it is -$0.44 on revenues of $58.5 million [7] Industry Outlook - The Medical - Drugs industry, to which VAXART belongs, is currently ranked in the top 34% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact VAXART's stock performance [5]

Financial Data and Key Metrics Changes - Revenue for 2024 was $28.7 million compared to $7.4 million in 2023, primarily from government contracts related to BARDA and non-cash royalty revenue from sales of INNOVERE in Japan [25] - The company ended 2024 with cash, cash equivalents, and investments of $51.7 million, and anticipates cash runway into the fourth quarter of 2025 [26] Business Line Data and Key Metrics Changes - The COVID-19 program received an award of approximately $460 million for a 10,000 participant study, with initial enrollment of 400 participants completed [6][7] - The norovirus program initiated a Phase one trial evaluating second-generation oral vaccine constructs against first-generation constructs, with promising preclinical data indicating improved immune responses [10][15] Market Data and Key Metrics Changes - The norovirus market represents a $10 billion annual economic burden in the U.S., affecting approximately 20 million Americans, highlighting the unmet need for effective vaccines [11][62] Company Strategy and Development Direction - The company aims to transform global public health by developing next-generation oral pill vaccines, focusing on pandemic preparedness and addressing the shortcomings of injectable vaccines [4][5] - Vaxart is committed to advancing multiple vaccine programs and exploring strategic partnerships and non-dilutive funding to extend its cash runway [26][55] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges posed by the regulatory environment but emphasizes the importance of their oral vaccine platform's safety profile and potential for broader acceptance [54] - The company remains optimistic about the progress of its vaccine candidates and looks forward to sharing updates in 2025 and beyond [27] Other Important Information - The company is reviewing preclinical programs for avian influenza and HPV vaccines, with plans for further studies [24] - A stop work order related to the BARDA-funded project has been issued, impacting the planned 10,000 participant study but not affecting the ongoing SENTINEL cohort activities [8][9] Q&A Session Summary Question: Can you discuss the new Phase one study for norovirus and its product type? - The Phase one study will enroll individuals aged 18-49, focusing on second-generation constructs G11 and G24 [31][33] Question: How does the new second-generation product's animal data translate to efficacy? - The new constructs are expected to yield significantly better immune responses in humans, enhancing protective efficacy [37][40] Question: What immunogenicity measurements should be focused on in the Phase one trial? - Key measurements will include serum norovirus blocking antibody responses and fecal IgA levels [45] Question: How does the stop work order impact manufacturing? - The company maintains its own GMP manufacturing facilities, allowing for quick adjustments and confidence in product stability [60] Question: What is the market opportunity for norovirus given existing competition? - There is a significant market opportunity for norovirus vaccines, and the company believes an oral option will be competitive [62]