Vaxart, Inc., a clinical-stage biotechnology company, announced significant business and financial developments for the second quarter of 2024. The company, headquartered in South San Francisco, highlighted achievements in their oral pill vaccine programs and shared financial performance details.
Steven Lo, Vaxart’s Chief Executive Officer, emphasized the importance of the Biomedical Advanced Research Development Authority (BARDA) contract awarded under Project NextGen, amounting to up to $453 million. This contract supports a Phase 2b trial comparing Vaxart’s oral pill COVID-19 vaccine candidate against a federally approved mRNA injectable vaccine. Enrollment for this trial is anticipated to start in the latter half of 2024, subject to regulatory alignment with the FDA. The interim analysis will focus on vaccine efficacy after 255 symptomatic COVID-19 cases, with the primary efficacy analysis set for 12 months post-vaccination for all participants.
In parallel, Vaxart is advancing its norovirus vaccine program. The company is engaged in discussions with the FDA to determine potential correlates of protection. Following initial feedback, Vaxart is preparing additional data for submission, which will influence the decision on whether to proceed with a Phase 2b study or conduct a GII.4 challenge study.
From a financial perspective, Vaxart reported cash, cash equivalents, and investments totaling $62.6 million as of June 30, 2024. The company received approximately $64.7 million from the BARDA contract post-quarter, facilitating the commencement of the COVID-19 Phase 2b clinical trial. Vaxart expects its cash runway to extend into 2026.
The financial results for the second quarter of 2024 showed a net loss of $16.5 million, a reduction from the $22.6 million loss in the same quarter of the previous year. This translates to a net loss per share of $0.09, compared to $0.16 in the second quarter of 2023. Revenue for the quarter increased to $6.4 million, primarily driven by government contracts linked to the BARDA award, compared to $1.4 million in the same quarter of 2023, which was mainly from the Bill & Melinda Gates Foundation grant.
Expenses in research and development were $17.5 million for the second quarter of 2024, down from $18.8 million in the previous year. This decrease was due to lower clinical trial expenses for the norovirus vaccine candidate, reduced stock-based compensation, and personnel-related costs, partially offset by increased expenses for the COVID-19 vaccine candidate. General and administrative expenses also decreased to $5.2 million from $5.6 million, mainly due to lower stock-based compensation, personnel-related costs, and insurance costs but were partially offset by higher legal and professional fees.
Vaxart continues to develop a range of oral recombinant vaccines using its proprietary delivery platform. The vaccines are designed to be administered in pill form, eliminating the need for refrigeration and reducing the risk of needle-stick injuries. Vaxart’s portfolio includes vaccine candidates for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV), which marks its entrance into the immune-oncology space. The company has also filed extensive domestic and international patent applications to cover its proprietary technologies for oral vaccination.
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