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Vaxart Inc (VXRT) Q1 2024 Earnings Call Transcript Highlights: Promising Developments and ...

  • Revenue: Q1 2024 revenue was $2.2 million, up from $0.7 million in Q1 2023.

  • Cash, Cash Equivalents, and Investments: Ended Q1 2024 with $36.7 million.

  • BARDA Funding: Received approximately $1.6 million from BARDA after Q1 2024; working towards securing the remaining $7.67 million of the current contract.

  • Cash Runway: Anticipated to last into late Q4 2024 based on current plans.

Release Date: May 13, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • Vaxart Inc (NASDAQ:VXRT) reported positive results from the Phase 1 clinical trial of its oral pill bivalent norovirus vaccine candidate in lactating mothers, showing significant antibody increases in breast milk.

  • The company is preparing for a Phase 2b trial of its COVID-19 XBB vaccine candidate, with potential initiation as early as this quarter, pending additional funding and regulatory alignment.

  • Vaxart Inc (NASDAQ:VXRT) has received initial contract support from BARDA for its COVID-19 vaccine development under Project NextGen.

  • Recent preclinical data suggests that the COVID-19 XBB vaccine construct has produced a more robust immunogenic response compared to previous constructs.

  • The company ended the first quarter with $36.7 million in cash, cash equivalents, and investments, providing a financial runway into late fourth quarter of 2024.

Negative Points

  • Vaxart Inc (NASDAQ:VXRT) is still in need of securing additional funding to initiate the COVID-19 Phase 2b trial.

  • The company's financial results show a reliance on BARDA funding and contracts, which could pose risks if not sustained or expanded.

  • There are inherent risks in clinical development, as highlighted by the forward-looking statements disclaimer, indicating potential future challenges in product development and regulatory approvals.

  • The safety data from the norovirus vaccine study remains blinded and will only become available 12 months after enrollment, delaying full assessment of the vaccine's safety profile.

  • Vaxart Inc (NASDAQ:VXRT) faces the challenge of securing regulatory alignment and meeting FDA requirements for advancing its vaccine candidates to later stages of clinical trials.

Q & A Highlights

Q: Could you speak to what you need to demonstrate to procure additional funding to initiate the Phase 2b BARDA? And your confidence levels regarding obtaining those funds? A: Steven Lo, CEO of Vaxart, mentioned that the initial $9.27 million award was to fund the preparation for the 10,000-subject study, and they have made significant progress. They are prepared to start the trial as early as this quarter, pending additional funding, which they are confident about securing.

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Q: Can you talk about possible specific endpoints and criteria that will be used to evaluate the efficacy and safety of the Phase 2b study COVID-19 vaccine against the mRNA vaccine comparator? A: James Cummings, CMO of Vaxart, explained that the trial will be conducted in the United States, targeting healthy individuals and those at risk, aged 18 and above. The endpoints will focus on safety and efficacy for symptomatic COVID-19 infection compared to the comparator vaccine, along with immunological and mucosal readouts.

Q: Regarding the potential Phase 2 challenge study, what are some considerations around whether there would be such a study or not? A: James Cummings stated that they anticipate a mid-2024 meeting with the FDA to review clinical findings and determine the proper regulatory pathway and clinical next steps, which might include a Phase 2b dose confirmation study and, if required, a G24 challenge study.

Q: Regarding the Phase 1 lactating mothers' data, will there be any data around measurements in an infant? A: James Cummings noted that while they have top-line data, further analyses will look at the amount of material in the infant's feces, but this is planned for the future.

Q: Do you have enough manufacturing capacity to produce your COVID vaccine for the Phase 2b trial? A: James Cummings confirmed that they have sufficient material already produced for the upcoming trial.

Q: How do you intend to educate the medical community and consumers on your COVID and norovirus oral vaccine benefits to rapidly drive adoption, particularly given vaccine hesitancy? A: Sean Tucker, SVP and CSO of Vaxart, mentioned that their tablet vaccine might help overcome vaccine hesitancy, as polling data suggests a preference for pills over shots or nasal sprays. They plan to continue engaging in scientific exchanges and attending medical conferences to promote understanding and adoption.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.