T h e C i t i z e n s L i f e S c i e n c e s C o n f e r e n c e R e d e f i n i n g t h e F u t u r e o f I m m u n i z a t i o n s Steven Lo Chief Executive Officer James F. Cummings, M.D. Chief Medical Officer May 7, 2025 Forward Looking Statement This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, resu ...

Vaxart (VXRT) Update / Briefing June 11, 2025 08:30 AM ET Speaker0 Greetings, and welcome to the Vaxart Neurovirus Phase one Top Line Results Conference Call. A question and answer session will follow management's opening remarks. Investors may submit written questions to irvaxart.com. As a reminder, this conference is being recorded. I would now like to turn the call over to your host, Ed Berg, Senior Vice President and General Counsel. Please go ahead. Speaker1 Good afternoon and welcome to today's call. ...

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]

Moderna (MRNA) 2025 Conference June 05, 2025 10:30 AM ET Speaker0 Everyone, thank you. Good morning, and thank you for joining us on our next discussion here at the Jefferies Healthcare Conference. I have the pleasure of having the President of Moderna, Stephen Hoag, up here with us. Obviously, timely. A lot's going on in the world, both from a regulatory administrative standpoint. We had Marty Makary here yesterday. Obviously, a lot going on with your commercial business, the pipeline, all of that. So I lo ...

Dr. Sean Tucker, Founder and CSO of Vaxart, Urges Stockholders to Vote FOR Reverse Stock Split Proposal by 11:59 p.m. Eastern Time on June 1, 2025 Company Corrects Record on Common Misconceptions Regarding the Reverse Stock Split Proposal SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) (the “Company” OR “Vaxart”) today announces a video update for stockholders by Dr. Sean Tucker. The video is available on Vaxart’s investor relations website at investors.vaxart.com. ...

Company Urges Stockholders to Vote FOR Reverse Stock Split Proposal by 11:59 p.m. Eastern Time on June 1, 2025 SOUTH SAN FRANCISCO, Calif., May 28, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) (the "Company" OR "Vaxart") today answers additional frequently asked stockholder questions it has received from retail investors in advance of the Company's Annual Meeting of Stockholders scheduled to take place on Monday, June 2, 2025. "We appreciate the continued interest from our passionate and loyal stock ...

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]

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 ...

Core Insights - Vaxart, Inc. has resumed screening for the 10,000 participant portion of its COVID-19 Phase 2b trial, with dosing expected to start in Q2 2025 [4][7] - The company completed enrollment for its Phase 1 clinical trial of a second-generation oral norovirus vaccine, with topline data anticipated in mid-2025 [4][7] - A new avian influenza vaccine candidate demonstrated 100% protection in a ferret challenge model, contrasting with 0% survival in placebo-treated animals [9] COVID-19 Vaccine Developments - The stop work order for the COVID-19 Phase 2b trial was lifted, allowing Vaxart to proceed with participant screening [4][7] - The company is operating under a Project NextGen award, potentially receiving up to $460.7 million, with $240.1 million currently available [7] - Screening for the trial is currently underway, with dosing expected to begin in the second quarter of 2025 [7] Norovirus Vaccine Developments - Vaxart completed enrollment of 60 participants in its Phase 1 trial for the second-generation oral norovirus vaccine, with results expected in mid-2025 [7] - An independent Data and Safety Monitoring Board recommended the continuation of the study without modifications [7] Avian Influenza Program Developments - The new avian influenza vaccine candidate showed 100% protection against death in a ferret model, with plans to publish the findings in a peer-reviewed forum [9] Financial Results - For Q1 2025, Vaxart reported revenue of $20.9 million, a significant increase from $2.2 million in Q1 2024 [12][18] - Research and development expenses rose to $30.7 million in Q1 2025, compared to $19.0 million in Q1 2024, primarily due to increased clinical trial costs [12][18] - The net loss for Q1 2025 was $15.6 million, an improvement from a net loss of $24.4 million in Q1 2024, with a net loss per share of $0.07 compared to $0.14 in the previous year [12][18][19] Leadership Changes - Jeroen Grasman has been appointed as Chief Financial Officer effective May 19, 2025, succeeding Phillip Lee, who will remain as a non-executive employee until June 1, 2025 [12]