Core Insights - Vaxart reported positive topline data from its second-generation oral norovirus vaccine, indicating potential for improved protection against infection [1][6] - The company enrolled approximately 5,000 participants in its COVID-19 Phase 2b trial before a stop work order was issued, with follow-up for all participants continuing [1][3] - As of June 30, 2025, Vaxart had cash, cash equivalents, and investments totaling $26.3 million, providing a runway into 2026 [1][11] Norovirus Vaccine Developments - Vaxart's second-generation norovirus vaccine constructs showed statistically significant increases in GI.1 and GII.4 norovirus blocking antibodies, with increases of 141% and 94% respectively compared to first-generation constructs [6] - The company plans to conduct a Phase 2b safety and immunogenicity study for the norovirus vaccine, potentially starting in the second half of 2025, followed by an End of Phase 2 meeting with the FDA [6] COVID-19 Vaccine Developments - The COVID-19 Phase 2b trial had enrolled about half of the planned 10,000 participants before the stop work order, with participants being monitored for up to 12 months post-vaccination [6] - Topline data from the COVID-19 trial is anticipated in late 2026 [6] Financial Results - Vaxart reported revenue of $39.7 million for the second quarter of 2025, a significant increase from $6.4 million in the same quarter of 2024, primarily from government contracts [11][20] - Research and development expenses rose to $49.7 million in Q2 2025 from $17.5 million in Q2 2024, driven by increased clinical trial expenses [11][20] - The net loss for the second quarter of 2025 was $15.0 million, compared to a net loss of $16.5 million in Q2 2024, with a net loss per share of $0.07 [11][20] Upcoming Events - A live stockholder fireside chat is scheduled for August 20, 2025, to address frequently asked questions ahead of a special meeting of stockholders [2][12] - A special meeting of stockholders will be held on September 5, 2025, to seek approval for a potential reverse stock split [10]

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]