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 Condition - The company has incurred an accumulated deficit of $476.5 million as of December 31, 2024, and expects to continue incurring significant losses for the foreseeable future [167]. - As of December 31, 2024, the company had $51.7 million in cash, cash equivalents, and investments, which are expected to fund operations into the fourth quarter of 2025 [168]. - As of December 31, 2024, the company had $51.7 million in cash, cash equivalents, and investments, which may not be sufficient to fund operations for at least one year [182]. - The company expects to require substantial additional capital to complete the development and potential commercialization of its tablet vaccine candidates for norovirus, coronavirus, influenza, and HPV [181]. - The company may be forced to seek alternative funding sources if it cannot raise additional capital, which could adversely affect its business operations [168]. Product Development and Regulatory Approval - The company is largely dependent on the success of its tablet vaccine candidates for norovirus and coronavirus, which are still in clinical development and may never receive regulatory approval [169]. - The company has not yet produced a commercially viable vaccine and may never be able to do so, impacting its ability to generate significant revenue [160]. - The company is in the early stages of developing oral vaccine candidates for norovirus and coronavirus, with no product candidates having advanced to late-stage clinical trials yet [175]. - The company’s tablet vaccine candidates for norovirus, coronavirus, and influenza are still in early-stage clinical development and require extensive additional clinical testing before submitting a Biologics License Application (BLA) [232]. - The company’s clinical trials are subject to delays due to regulatory requirements, which may impact the timeline for obtaining marketing approvals [236]. - The company’s ability to produce vaccines is dependent on successful scaling of manufacturing capacity and compliance with regulatory requirements [179]. - The regulatory pathway for the approval of a norovirus vaccine is unclear, posing potential unforeseen challenges in its development [226]. - The FDA has the authority to grant Emergency Use Authorization, allowing the company to commercialize vaccine candidates prior to full approval, but this authorization could be revoked [228]. Competition and Market Challenges - The company faces significant competition from larger pharmaceutical and biotechnology companies, which could affect its operating results [245]. - The competitive landscape includes established pharmaceutical companies with greater resources and experience, which could hinder the company's ability to compete effectively [247]. - The COVID-19 vaccine market is highly competitive, with approved vaccines from Pfizer-BioNTech, Moderna, and Novavax already established in the U.S. and many other countries [256]. - The company anticipates facing intense competition as new vaccines enter the market and advanced technologies become available, particularly in terms of efficacy, safety, convenience, and pricing [253]. - The company faces challenges in achieving market acceptance for its tablet vaccine candidates, which is critical for commercial success [269]. Operational Risks - The company faces numerous risks related to clinical development, regulatory approval, and competition from other biotechnology and pharmaceutical companies [158]. - The company relies on third-party contract manufacturers for certain portions of its manufacturing process, which could lead to delays or increased expenses if they do not perform as required [160]. - The company may experience delays in obtaining regulatory approvals, which could materially affect its business and financial condition [177]. - The company may face significant challenges in maintaining relationships with critical third parties, which could impair its ability to compete in the marketplace [178]. - The company may struggle to attract and retain qualified personnel due to competition from other pharmaceutical and biotechnology companies [218]. Legal and Compliance Issues - The company is subject to legal proceedings that may result in substantial costs and divert management's attention, potentially impacting its financial condition [222]. - The company is subject to various federal and state laws regarding healthcare fraud, which could result in significant penalties if violated [276]. - The company may face significant penalties and operational curtailments if it fails to comply with healthcare regulatory laws [271]. Insurance and Liability - The company maintains product liability insurance coverage of up to $10 million per claim, which may not be adequate to cover all potential liabilities [280]. - The company faces significant risks related to product liability claims, which could materially harm its business if successful claims exceed insurance coverage [282]. - The company anticipates needing to increase its insurance coverage as it continues clinical trials and commercializes products, with insurance costs becoming increasingly expensive [280]. Intellectual Property and Patent Risks - Patent protection for the company's technology is critical, and failure to secure or maintain patents could hinder competitive positioning and collaboration opportunities [349]. - The validity and enforceability of the company's patents may be challenged, potentially limiting its ability to protect its technology and product candidates [355]. - Changes in patent laws or challenges to patent validity could diminish the value of the company's intellectual property rights [352]. - The company's patent portfolio may not provide sufficient rights to exclude others from similar product commercialization [355]. Strategic Partnerships and Collaborations - The company intends to pursue collaborative arrangements for marketing its tablet vaccine candidates internationally, but success is uncertain [285]. - The company may need to establish or maintain collaborative arrangements for commercialization, which could require relinquishing rights to intellectual property [286]. - The company may face challenges in maintaining strategic partnerships, which could adversely affect product development and commercialization efforts [339]. - If the company fails to establish partnerships for unpartnered product candidates, it may incur increased costs and cash burn rates [340]. Market and Economic Factors - Ongoing military conflicts could lead to economic uncertainty and financial market volatility, adversely affecting the company's revenue and financial condition [212]. - The company may experience pricing pressures due to increasing efforts by payors to cap healthcare costs, which could limit coverage and reimbursement for its products [216]. - Recent changes in federal healthcare policy in the U.S. are expected to result in reduced reimbursement rates for many pharmaceutical products in the future [316].

Core Insights - Vaxart, Inc. has initiated a Phase 1 clinical trial for its second-generation oral norovirus vaccine, with topline data expected by mid-2025 [1][5] - The company 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 revenue increasing to $28.7 million from $7.4 million [12][20] - Vaxart's cash, cash equivalents, and investments totaled $51.7 million as of December 31, 2024, providing a financial runway into the fourth quarter of 2025 [1][12] Norovirus Vaccine Developments - The Phase 1 trial for the second-generation oral norovirus vaccine constructs is designed to compare safety and immune responses against the first-generation constructs [5] - If successful, a Phase 2b safety and immunogenicity study could begin in the second half of 2025, followed by a potential Phase 3 trial in 2026 [5] - Data from a completed Phase 1b trial of the first-generation vaccine in elderly adults showed strong antibody responses, supporting its immunogenicity [5] COVID-19 Vaccine Developments - Vaxart's COVID-19 Phase 2b trial has completed enrollment of a 400-person sentinel cohort, with participants monitored for up to 12 months post-vaccination [12] - An independent Data Safety Monitoring Board recommended proceeding with the study based on initial safety assessments [5] - A stop work order was issued in February 2025, limiting activities on the COVID-19 trial, but follow-up work for the sentinel cohort can continue [5][6] Influenza Program Developments - Vaxart is advancing its avian influenza program and has created a new vaccine candidate to cover the latest clade 2.3.4.4b [7] - Preclinical studies are being conducted to evaluate the new construct, with results expected to be published upon completion [7] Corporate Update - In January 2025, Vaxart appointed Kevin Finney to its Board of Directors, bringing extensive healthcare leadership experience [8] Financial Results - For the full year 2024, Vaxart reported revenue of $28.7 million, primarily from government contracts related to BARDA [12][20] - Research and development expenses increased to $74.2 million, driven by clinical trial costs for the COVID-19 vaccine and other development activities [12][20] - General and administrative expenses decreased to $20.8 million, reflecting reduced personnel-related costs [12][20]

Company Overview - Vaxart, Inc. 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, thus eliminating the risk of needle-stick injury [4] - Vaxart's current development programs include vaccines targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4] Upcoming Events - Vaxart will provide a business update and report financial results for the full year ended December 31, 2024, after market close on March 20, 2025 [2] - A conference call hosted by the senior management team will take place on the same day at 4:30 p.m. ET, with access details provided for investors [2][3] - Investors are encouraged to submit written questions in advance of the conference call [2]

Core Insights - Vaxart, Inc. has initiated a Phase 1 clinical trial for its second-generation oral norovirus vaccine, aiming to demonstrate improved immune responses compared to its first-generation constructs [2][3] - The Phase 1 trial is designed to evaluate safety and immune parameters correlated with protection, with topline data expected as early as mid-2025 [3][4] - If successful, Vaxart plans to conduct a Phase 2 study in the second half of 2025, potentially followed by a Phase 3 trial in 2026 [4] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform that allows for non-refrigerated storage and eliminates needle-stick injury risks [5] - The company's current development programs include vaccines for norovirus, coronavirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [5] - Vaxart has filed broad patent applications covering its technology for oral vaccination using adenovirus and TLR3 agonists [5]

Core Insights - Vaxart's first-generation oral pill norovirus vaccine candidate demonstrates strong and durable antibody responses in elderly adults, indicating its potential effectiveness in a demographic that typically has reduced immune responses to traditional vaccines [1][2][3] Group 1: Study Findings - The Phase 1b trial published in Science Translational Medicine shows robust immunogenicity, with significant increases in serum anti-VP1 IgA and IgG in vaccinated cohorts compared to placebo [4] - The vaccine induced mucosal-homing antibody-secreting B cells and T cells, suggesting a protective mechanism against persistent infections [4] - Oral administration resulted in strong IgA responses in saliva and the nasal cavity, highlighting the vaccine's ability to generate mucosal immunity beyond the gastrointestinal tract [4] Group 2: Implications for Elderly Population - The study indicates that the oral vaccine may uniquely protect elderly individuals from severe norovirus outcomes, addressing the higher risk of morbidity in this age group [3][2] - Vaxart's oral vaccine platform could provide a safer alternative for older adults, as most approved mucosal vaccines are not recommended for them due to safety concerns [3] Group 3: Future Developments - Vaxart plans to initiate a Phase 1, open-label, dose-ranging clinical trial for its second-generation oral norovirus vaccine candidate in the first half of 2025 [5] - The company has previously reported a Phase 2 challenge study showing a statistically significant reduction in norovirus infection rates, further supporting the vaccine's potential [3]

Core Viewpoint - Vaxart, Inc. has appointed Kevin Finney to its Board of Directors, bringing extensive healthcare industry experience to support the company's strategic goals and milestones [1][3]. Group 1: Appointment Details - Kevin Finney's appointment is effective immediately, and he will serve on the Audit and Nominating and Governance Committees of the Board [2]. - The CEO of Vaxart, Steven Lo, expressed confidence that Finney's expertise will be a significant asset as the company advances its oral vaccine platform technology [3]. Group 2: Background of Kevin Finney - Finney has 35 years of leadership experience in the healthcare sector, currently serving as President and CEO of Autobahn Therapeutics since 2019 [1][5]. - His previous roles include President and COO of Abide Therapeutics, and he has held executive positions at Allergan, Prometheus Laboratories, and Amylin Pharmaceuticals [6][7]. Group 3: Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines that can be stored and shipped without refrigeration [9]. - The company's current development programs include vaccines targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [9].