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]

Vaxart (VXRT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Edward Berg - Senior Vice President and General CounselSteven Lo - CEO , President & DirectorJames Cummings - Chief Medical OfficerSean Tucker - Founder & Chief Scientific OfficerPhillip Lee - Chief Financial OfficerCheng Li - Director - Equity ResearchMayank Mamtani - Senior Managing Director & Group Head of HealthcareLiang Cheng - Senior Research Associate Operator Greetings. Welcome to Vaxart Business Update and First Quart ...

Vaxart (VXRT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Speaker0 Greetings. Welcome to Vaxart Business Update and First Quarter twenty twenty five Financial Results Conference Call. A question and answer session will follow management's opening remarks. Individual investors may submit written questions to vaxart.com. As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel. Speaker1 Good afternoon, and w ...

Vaxart (VXRT) 2025 Conference May 07, 2025 01:00 PM ET Speaker0 Alright. Thanks everybody for joining us again at the Citizens Life Science Conference. Next company we have presenting, has a really interesting oral, vaccine platform unique, I I believe. It's Vaxart. We have Steve Lowe, who's president and CEO, and James Cummings, chief medical officer, and they're going to run you through a presentation. So take it away, Steve. Speaker1 Great. Thank you very much. Good afternoon. As Roy mentioned, James Cum ...