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 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]

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].