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Vaxart CEO Issues Letter to Stockholders
Globenewswire· 2025-08-08 12:00
Core Viewpoint - Vaxart, Inc. is urging stockholders to vote in favor of a reverse stock split proposal to facilitate relisting on Nasdaq, which is deemed essential for the company's future growth and stockholder value [3][6][11]. Group 1: Importance of Relisting - Relisting on Nasdaq is a strategic imperative for Vaxart, as it enhances visibility, liquidity, and access to a broader range of investors, including institutional ones [4][5]. - A Nasdaq listing is expected to improve market perception and provide credibility, which is crucial for attracting partnerships and funding [5][10]. - The company acknowledges the frustration of stockholders regarding the current share price and emphasizes that a reverse stock split is necessary to meet Nasdaq's listing requirements [3][6]. Group 2: Reverse Stock Split Proposal - The reverse stock split proposal aims to minimize dilution by implementing a narrower split ratio and reducing the authorized share count [7][8]. - The company clarifies that the reverse stock split will not alter the fundamental value of investments, only the number of shares held [7]. - All equity holders, including employees and management, will be equally affected by the reverse stock split, aligning interests in share price appreciation [8]. Group 3: Scientific Progress and Financial Position - Vaxart is advancing its oral vaccine development, with significant milestones including rapid enrollment in a COVID-19 Phase 2b trial and positive results for a norovirus vaccine [10][12]. - The company is focused on extending its cash runway into 2026 through cost reductions while maintaining the ability to deliver multiple data readouts [10]. - Vaxart's proprietary delivery platform for oral vaccines positions it to develop innovative solutions for various health challenges [14].
Vaxart to Host Second Quarter 2025 Business Update and Financial Results Conference Call on August 13
Globenewswire· 2025-08-06 20:05
Company Update - Vaxart, Inc. will provide a business update and report financial results for the second quarter ended June 30, 2025, after market close on August 13, 2025 [2] - A conference call hosted by Vaxart's senior management team will take place on the same day at 4:30 p.m. ET [2] - Investors can submit written questions in advance of the conference call by August 12, 2025 [2] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [4] - The company's vaccines are designed to be administered in pill form, which can be stored and shipped without refrigeration, eliminating needle-stick injury risks [4] - Current development programs include vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4] - Vaxart has filed broad domestic and international patent applications covering its proprietary technology for oral vaccination [4]
Vaxart Submits Proxy Statement for Reverse Stock Split to Support Resumption of Trading on Nasdaq
GlobeNewswire News Room· 2025-07-24 20:01
Core Viewpoint - Vaxart, Inc. is seeking stockholder approval for a reverse stock split to regain compliance with Nasdaq's minimum bid price requirements following a trading suspension due to non-compliance [2][3][4] Group 1: Reverse Stock Split Proposal - The preliminary proxy statement includes a proposal for a reverse stock split with a ratio of not less than 1-for-5 and not more than 1-for-20 [9] - The proposal aims to reduce the number of authorized shares of common stock in proportion to the reverse stock split [4][9] - The Board of Directors believes that compliance with Nasdaq listing requirements is essential for liquidity and capital raising [3] Group 2: Stockholder Engagement - A special meeting of stockholders is scheduled for September 5, 2025, to discuss the reverse stock split proposal [5] - Management plans to hold a live stockholder fireside chat to address questions and explain the necessity of the reverse stock split [3][8] Group 3: Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [6] - The company's vaccine candidates include those for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [6]
Vaxart Announces Trading on OTCQX Best Market
Globenewswire· 2025-07-08 12:00
Core Viewpoint - Vaxart, Inc. has received approval to trade its common stock on the OTCQX Best Market, enhancing transparency and accessibility for investors, following a delisting notice from Nasdaq [1][2]. 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 [4]. - The company is advancing multiple vaccine candidates targeting infectious diseases, including those for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4]. Stock Listing Situation - After receiving a delisting notice from Nasdaq, Vaxart has requested a hearing to appeal the decision, with its common stock currently suspended pending the outcome [2][3]. - The company is exploring all options regarding its stock listing while prioritizing shareholder interests [3].
OTC Markets Group Welcomes Vaxart, Inc. to OTCQX
Globenewswire· 2025-07-08 11:00
Company Overview - Vaxart, Inc. is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [4]. - The company aims to create vaccines that can be administered in pill form, which can be stored and shipped without refrigeration, thus eliminating the risk of needle-stick injuries [4]. Trading Transition - Vaxart, Inc. has transitioned from trading on NASDAQ to the OTCQX® Best Market, now trading under the symbol "VXRT" [1][2]. - The OTCQX Market provides companies with efficient and cost-effective access to U.S. capital markets, with streamlined requirements designed to lower the cost and complexity of being publicly traded [3]. Development Programs - Vaxart's current development programs include oral vaccines targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4]. - The company has filed broad domestic and international patent applications for its proprietary technology related to oral vaccination using adenovirus and TLR3 agonists [4]. Market Position - OTC Markets Group Inc. operates regulated markets for trading 12,000 U.S. and international securities, with a focus on data-driven disclosure standards [5]. - The OTCQX Best Market is one of the four markets operated by OTC Markets Group, which also includes OTCQB® Venture Market, OTCID™️ Basic Market, and Pink Limited Market [5].
Vaxart (VXRT) 2025 Earnings Call Presentation
2025-06-25 12:43
Vaxart's Oral Vaccine Platform - Vaxart's oral pill vaccines can revolutionize how the immune system responds and the way vaccines are delivered[8] - Vaxart's oral vaccine candidates have the potential to address many of the shortcomings of injectable vaccines, offering needle-free administration, mucosal and systemic immunity, potential to reduce transmission, benign safety & tolerability profile, thermostability, and self-administration[15] - Vaxart's proprietary VAAST® Platform utilizes mucosal immunity to generate IgA in addition to IgG to potentially block infection and transmission[18, 100] - Vaxart's oral platform drives broader immunity through mucosal IgA responses, offering greater cross-reactivity and potential for high variant coverage compared to injectable vaccines that only induce systemic IgG[31] Norovirus Vaccine Program - Norovirus is attributed to nearly one out of every five episodes of diarrheal disease globally[43] - Norovirus causes 685 million infections and 200,000 deaths worldwide annually, with economic costs of $60 billion[44] - The total potential market size for a Norovirus vaccine in the US is $3 – 5 billion[46] - Vaxart's bivalent Norovirus vaccine candidate is designed to address the major circulating genotypes, GI1 and GII4, with GII4 accounting for 68% of norovirus genotypes in the US from 2009-2015[53, 54] - In a Norovirus challenge study, Vaxart's oral tablet showed a 29% relative reduction in infection and a 21% relative reduction in Norovirus AGE, along with an 85% reduction in viral shedding[109, 111] COVID-19 and Influenza Vaccine Programs - Vaxart received a BARDA Project NextGen award of up to $460.7 million, with ~$240.1 million currently available for payment, to conduct a Phase 2b trial evaluating their COVID-19 vaccine candidate head-to-head against an approved mRNA comparator[69, 73, 95] - In a Phase 1 trial, 46% of participants that had increased IgA antibodies to SARS-CoV-2 S also had increased antibody responses to the S protein of other coronaviruses[78] - Vaxart's oral influenza vaccine candidate reduced infection rates by 49% compared to placebo and 38% compared to Fluzone in a human influenza challenge design[90]
Vaxart Announces Preliminary Results of Annual Meeting of Stockholders
Globenewswire· 2025-06-13 20:52
Core Points - Vaxart, Inc. held its Annual Meeting of Stockholders in a virtual format, where preliminary results indicated that two proposals were approved and two were rejected by stockholders [1][2] - Stockholders voted in favor of the election of six director nominees and the ratification of WithumSmith+Brown, PC as the independent registered public accounting firm [5] - A proposal for an amendment to the Restated Certificate of Incorporation to effect a reverse stock split is under evaluation by the company [5] - The company is developing oral recombinant vaccines using its proprietary delivery platform, which allows for storage and shipping without refrigeration [3] - Current development programs include vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [3] Company Overview - Vaxart is a clinical-stage biotechnology company focused on oral recombinant vaccines [3] - The company's proprietary technology includes adenovirus and TLR3 agonists for oral vaccination [3] - Vaxart has filed broad domestic and international patent applications covering its technology [3]
Vaxart (VXRT) Update / Briefing Transcript
2025-06-11 13:30
Summary of Vaxart Neurovirus Phase One Top Line Results Conference Call Company Overview - **Company**: Vaxart - **Focus**: Development of an oral pill vaccine for norovirus Key Industry Insights - **Norovirus Impact**: - Leading cause of acute gastroenteritis (AGE) globally - Approximately 685 million norovirus infections worldwide annually, with 20 million in the U.S. - Responsible for nearly 20% of diarrheal diseases globally - Economic burden estimated at $60 billion worldwide and $10 billion in the U.S. [5][6] - **Market Opportunity**: - Potential U.S. market size for a safe and effective norovirus vaccine is in the multibillion-dollar range - Target populations include elderly, immunocompromised individuals, healthcare professionals, and travelers [6][8] Core Findings from Phase One Clinical Trial - **Positive Results**: - Significant increase in norovirus blocking antibodies in both high and low dose cohorts of the new generation constructs - High dose cohort showed a statistically significant increase in antibodies [3][4] - **Immunogenicity Data**: - 141% increase in G11 NbAA titers in the high dose cohort (from 2.2 to 5.4) - 84% increase in G24 NbAA titers in the high dose cohort (from 1.9 to 3.5) [11] - **Safety Profile**: - All vaccine candidates were well tolerated with no serious adverse events reported [12][49] Future Development Plans - **Next Steps**: - Plans for a Phase 2b safety and immunogenicity study, potentially starting in the second half of 2025, followed by a Phase III trial in 2026 [14][15] - **Partnership Discussions**: - Ongoing discussions with various potential partners, including large multinational companies and regional players [52][53] - Interest in licensing the norovirus vaccine asset and potential collaborations on other vaccine programs [55] Additional Considerations - **Vaccine Characteristics**: - The vaccine must provide durable immune responses, be safe, easy to administer, and stable without complex cold chain logistics [7][8] - **Comparative Analysis**: - The new constructs are expected to show better performance compared to previous generation products, with ongoing studies to validate these findings [10][30] - **Scientific Rationale**: - The Phase one trial aimed to validate the superior immunogenicity of the new generation constructs using a proprietary norovirus blocking antibody assay [10][20] - **Upcoming Presentations**: - Plans to present complete data at relevant medical conferences, including the Khaleesi virus conference and the World Vaccine Congress in Europe [46] This summary encapsulates the critical insights and future directions for Vaxart's norovirus vaccine development, highlighting the significant public health need and market potential for effective vaccination against norovirus.
Vaxart Reports Positive Clinical Data Demonstrating that its Second-Generation Vaccine Technology Produces Much Stronger Antibody Responses than its First-Generation Technology
Globenewswire· 2025-06-11 11:30
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 to Host Conference Call on June 11 at 8:30 AM ET to Discuss Topline Results from Its Phase I Norovirus Trial
Globenewswire· 2025-06-10 20:47
Core Insights - Vaxart, Inc. is set to release topline data from its norovirus Phase I trial on June 11, 2025, before market opening [1] - A live conference call will be held on the same day at 8:30 a.m. Eastern Time to discuss the data and provide updates on the trial [1][2] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using its proprietary delivery platform [3] - The company's vaccines are designed to be administered in pill form, which can be stored and shipped without refrigeration, thus eliminating needle-stick injury risks [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]