Vaxart, Inc. (VXRT) Q2 2025 Earnings Call Transcript
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Overview
The earnings call presented a mixed outlook. Positive aspects include revenue growth, a strong cash runway, and promising vaccine developments. However, workforce reductions, dependency on external funding for trials, and uncertainties in partnerships and trial progress are concerning. The Q&A highlighted management's lack of clarity on key issues, such as the COVID-19 trial's stop work order, which raises uncertainty. Despite potential catalysts like the avian flu vaccine, uncertainties and financial challenges balance out the positives, leading to a neutral sentiment.
Key Financial Performance
Revenue for Q2 2025 $39.7 million compared to $6.4 million for Q2 2024, representing a significant increase. The increase was primarily due to the BARDA contract awarded in June 2024.
Cash, cash equivalents, and investments $26.3 million as of the end of Q2 2025. The company expects this cash runway to last into Q1 2026. The cash position was supported by aggressive cost-cutting measures, including workforce reductions.
Workforce reduction Approximately 21% reduction in Q2 2025, following a 10% reduction in Q1 2025. This was done to decrease operating costs and align the workforce with business needs.
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Operating Highlights
COVID-19 oral vaccine: Received a second stop work order notice on Phase IIb trial from ATI, but allowed to continue study for already enrolled 5,000 participants. The trial aims to assess safety, immunogenicity, and efficacy compared to mRNA vaccines. Data readout expected in 2026.
Norovirus vaccine: Reported positive Phase I results for second-generation constructs, showing statistically significant increase in blocking antibodies in high-dose cohort. Plans to advance to Phase IIb study in late 2025, pending funding or partnership.
Avian influenza vaccine: Preclinical data showed 100% survival in ferrets with new vaccine construct. Plans to seek funding or partnerships for further development.
Norovirus vaccine market: Estimated $10 billion market in the U.S. and $60 billion globally due to significant unmet need and healthcare costs.
Workforce reduction: Reduced workforce by 21% in Q2 2025 to align with business needs and decrease operating costs.
Financials: Revenue increased to $39.7 million in Q2 2025 from $6.4 million in Q2 2024, primarily due to BARDA contracts. Cash runway expected into Q1 2026.
NASDAQ relisting: Company aims to regain NASDAQ compliance through a reverse stock split proposal, with a special stockholder meeting scheduled for September 5, 2025.
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Risk or Challenges
COVID-19 Phase IIb Trial Stop Work Orders: The company received two stop work orders for its COVID-19 Phase IIb trial from Advanced Technology International (ATI), funded by BARDA. This has disrupted the trial's progress, halting enrollment and creating uncertainty about the trial's future. Although 5,000 participants were enrolled, the stop work orders could delay data readouts and impact the company's ability to meet its projected timelines.
Financial Constraints and Cash Runway: Vaxart has limited cash reserves, with $26.3 million in cash, cash equivalents, and investments, providing a runway only into Q1 2026. The company has implemented workforce reductions to cut costs but remains dependent on securing strategic partnerships or additional funding to sustain operations and advance its pipeline.
NASDAQ Listing Suspension: The company's stock listing on NASDAQ has been suspended due to non-compliance with the $1 minimum bid price requirement. This has reduced its attractiveness to institutional investors and could hinder potential partnerships. Efforts to regain compliance, including a proposed reverse stock split, face uncertainty.
Regulatory and Clinical Development Risks: The company faces inherent risks in clinical development and regulatory approval processes for its vaccine candidates. Delays or failures in trials, such as the COVID-19 Phase IIb trial, could adversely impact its ability to bring products to market.
Competitive Pressures in Vaccine Development: Vaxart operates in a highly competitive market with established players in vaccine development. Its ability to differentiate its oral vaccine platform and secure market share remains uncertain, especially given the challenges in advancing its clinical programs.
Dependence on External Funding and Partnerships: The company’s ability to advance its pipeline is heavily reliant on securing external funding or partnerships. Delays or failures in achieving these could significantly impact its operational and strategic objectives.
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Guidance & Outlook
COVID-19 Vaccine Program: The company is conducting a Phase IIb trial for its oral COVID-19 vaccine candidate, with approximately 5,000 participants enrolled. Despite a stop work order, the trial will continue follow-up for these participants, funded by BARDA. Comprehensive data readout is anticipated in 2026, with interim data for a 400-person sentinel cohort expected in Q1 2026.
Norovirus Vaccine Program: The company plans to advance its second-generation norovirus vaccine constructs to a Phase IIb study in the second half of 2025, contingent on securing partnerships or funding. This could enable a Phase III trial initiation as early as 2026. The vaccine has shown statistically significant improvements in immune response and has a multibillion-dollar market potential.
Avian Influenza Vaccine Program: Preclinical studies for the avian influenza vaccine candidate demonstrated 100% survival in ferrets and significant reduction in viral load. The company is seeking partnerships or funding to advance this program.
Financial Guidance: The company expects its cash runway to extend into Q1 2026 and is actively seeking strategic partnerships and non-dilutive funding to support its operations and pipeline development.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:What is the statistical assumption and plan for the COVID trial with 5,000 enrolled participants?
A:The statistical analysis plan is being reviewed to ensure the best use of the data. The study is randomized with about half of the participants receiving the test construct and the other half receiving a comparator mRNA.
Q:What is the expectation for the enrollment pace if the trial resumes towards the 10,000 goal?
A:The impact on enrollment pace depends on when changes might occur. More information is awaited to provide clarity.
Q:Is the progression to the Phase IIb trial for the norovirus program contingent on partnership or additional funding?
A:Yes, the progression of the study is contingent on securing funding, either through a partnership or external funding sources.
Q:Are there any gating factors besides funding for the norovirus Phase IIb study?
A:No, funding is the primary gating factor. Preparations like lining up CROs have already started.
Q:What is the rationale behind the second stop work order for the COVID-19 program?
A:The company has not received specific information regarding the rationale for the stop work order. They are waiting for additional information from BARDA.
Q:Is there a particular deal structure or economic model that seems most appealing for the norovirus program?
A:The company is open-minded and agnostic about the deal structure. They are focused on moving the science forward and are open to co-development or licensing.
Q:What is the development plan for the norovirus program, including potential correlates of protection?
A:The key correlates of protection are being monitored to show immunogenicity and predict success. The Phase II trial aims to gather enough safety data to proceed to an end-of-Phase II meeting with the FDA.
Q:Is there a publication planned for the avian flu data, and what is the process for securing federal funding?
A:The paper for the avian flu data is being written. The company sees opportunities for funding due to the need for addressing avian flu in cattle and poultry.
Q:How should R&D expenses be viewed in light of the stop work order?
A:BARDA will continue to fund the follow-up for the 5,000 participants dosed. The company anticipates collecting greater than 50% of the original contract due to fixed cost components.
Q:Will a 5,000-person Phase IIb clinical trial produce useful data for the COVID-19 program?
A:Yes, the trial is likely to provide useful data from both scientific and regulatory standpoints. The statistical analysis plan is being reviewed to optimize data use.
Q:Could the stop work order accelerate the timeline for the COVID-19 program?
A:Yes, if no additional participants are enrolled, the timeline for reporting top-line data could be earlier than expected.
Q:Why was the COVID-19 trial successful in achieving a rapid enrollment pace?
A:There was robust demand for participation, showcasing the need for a better COVID vaccine. The company acknowledges the efforts of participants and study sites.
Q:Were there any surprises in the top-line Phase I norovirus data?
A:Yes, the increase in MBAA titers with the second-generation constructs was statistically significant, leading to a pivot to the new construct high dose.
Q:How close is the company to a partnership for the norovirus program?
A:The company is in productive conversations with potential partners, but timing is uncertain due to confidentiality.
Q:Are there plans for another trial to study passive immune transfer in the breast milk study?
A:The next steps are being evaluated, and any new study will likely depend on funding from nondilutive sources or a partnership.
Q:How does Vaxart's construct compare to whole inactivated virus vaccines?
A:Whole inactivated virus vaccines have not performed well compared to mRNA. If Vaxart's construct performs as well or better than mRNA, it is expected to outperform whole inactivated virus vaccines.
Q:What capital-raising strategies is the company exploring?
A:The company is in discussions with potential partners and is managing expenses to extend cash flows. They emphasize the importance of a NASDAQ listing and encourage shareholders to vote for a reverse stock split.
Q:Review of Unclear Management Responses
A:Management avoided giving direct answers or lacked clarity on the following: 1. The rationale behind the second stop work order for the COVID-19 program, as they are still waiting for information from BARDA. 2. The timing for a partnership for the norovirus program, as discussions are confidential. 3. Specific details on the development plan for the breast milk study, as it depends on funding.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
AGE
ATI
Cheng
General Counsel
HN
Inc Research
International
Jeroen
Phase II
Phase IIb
Principal
Research Division
Senior VP
antibody generation
benefit vaccine
case
class
construct reduction
course
dose cohort
evidence
ferret vaccine
funding program
infection Phase
level norovirus
line result
load
norovirus antibody
order notice
outbreak
peer journal
poultry
program Phase
survival
trial participant
vaccination
vaccine placebo
vaccine platform
VXRT Transcript
Vaxart, Inc. (VXRT) Q3 2025 Earnings Call Transcript
Unknown11-13
The earnings call highlights a significant revenue increase and extended cash runway, which are positive. However, the dependency on partnerships for advancing the norovirus program and the BARDA stop work order pose risks. The Q&A session revealed uncertainty about independent trial initiation for the norovirus program, reflecting potential challenges. These mixed signals suggest a neutral sentiment, with positive financials balanced by strategic uncertainties.
Vaxart, Inc. (VXRT) Q2 2025 Earnings Call Transcript
Unknown8-13
The earnings call presented a mixed outlook. Positive aspects include revenue growth, a strong cash runway, and promising vaccine developments. However, workforce reductions, dependency on external funding for trials, and uncertainties in partnerships and trial progress are concerning. The Q&A highlighted management's lack of clarity on key issues, such as the COVID-19 trial's stop work order, which raises uncertainty. Despite potential catalysts like the avian flu vaccine, uncertainties and financial challenges balance out the positives, leading to a neutral sentiment.
Vaxart, Inc. (VXRT) Q1 2025 Earnings Call Transcript
Unknown5-13
The earnings call summary presents mixed signals: strong revenue growth and positive discussions with BARDA and potential partners are countered by regulatory and operational risks, including NASDAQ compliance concerns and workforce reductions. The Q&A reveals management's cautious optimism but also highlights uncertainties, especially regarding timelines and specifics on the COVID program. These factors, along with a potential reverse stock split, suggest a neutral short-term stock price movement, with no clear catalyst for significant gains or losses.
Vaxart, Inc. (NASDAQ:VXRT) Q4 2024 Earnings Call Transcript
Unknown3-24
The earnings call highlights significant challenges, including a stop work order from BARDA and workforce reductions, indicating financial and operational strain. Despite a positive EPS surprise, the lack of clear guidance on future product efficacy and management's vague responses during the Q&A add to uncertainties. The increase in revenue is overshadowed by these issues, and future funding strategies are speculative. The overall sentiment leans negative due to regulatory and competitive pressures, potential supply chain issues, and the need for strategic funding to maintain operations.
VXRT Report
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