Vaxart Updates on Business and Q1 2024 Financials

Vaxart, Inc., a biotech firm based in South San Francisco, recently provided a business and financial update for the first quarter of 2024, highlighting key advancements in its vaccine programs and financial performance. The company announced significant progress in its norovirus and COVID-19 vaccine trials and reported its financial results for the quarter ending March 31, 2024.

A major milestone in Vaxart’s norovirus clinical program was the successful completion of a Phase 1 trial for its oral pill bivalent norovirus vaccine candidate, specifically targeting lactating mothers. The trial's positive topline results showed that the vaccine candidate prompted a significant rise in antibodies against norovirus strains GI.1 and GII.4 in the breastmilk of participants in the high dose group. This progress, supported by the Bill & Melinda Gates Foundation, paves the way for further pediatric studies and potential future trials.

In terms of COVID-19 developments, Vaxart is preparing to initiate a Phase 2b clinical study of its oral pill XBB COVID-19 vaccine candidate, comparing it against an approved mRNA vaccine. This trial, involving 10,000 subjects, is on track to start as early as the second quarter of 2024. Notably, this effort is backed by a $9.27 million contract from the United States Biomedical Advanced Research and Development Authority (BARDA) under the "Project NextGen" initiative. Recent preclinical data suggest that the new XBB construct generates a more robust immunogenic response than previous versions, offering promising potential for other vaccine indications in Vaxart’s pipeline.

The company is also planning a mid-2024 meeting with the U.S. Food and Drug Administration (FDA) to evaluate clinical data and discuss the next steps for its norovirus program. This could include conducting a Phase 2b study or a GII.4 challenge study based on the data collected.

Financially, Vaxart ended the first quarter of 2024 with $36.7 million in cash, cash equivalents, and investments. Despite not receiving any cash payments from BARDA during this period, the company anticipates having sufficient funds to support its operations into the late fourth quarter of 2024. For the first quarter of 2024, Vaxart reported a net loss of $24.4 million, a slight improvement from the $25.1 million loss reported for the same period in 2023. The net loss per share decreased to $0.14 from $0.19 in the previous year. Revenue for the quarter was $2.2 million, a significant increase from $0.7 million in the first quarter of 2023, primarily due to revenue recognized from the BARDA contract and non-cash royalty revenue from sales of Inavir in Japan.

Research and development expenses for the first quarter of 2024 were $19.0 million, down from $19.6 million in the same period of 2023. This reduction was mainly due to decreased personnel costs and clinical trial expenses related to the norovirus vaccine candidate, partially offset by increased manufacturing and clinical trial costs related to the COVID-19 vaccine candidate. General and administrative expenses rose to $7.2 million from $6.6 million in the first quarter of 2023, driven by higher personnel stock-based expenses and recruiting costs, though partially offset by lower insurance and legal fees.

Vaxart's innovative approach to vaccine delivery through oral pills, which can be stored and shipped without refrigeration, continues to hold promise. Their proprietary platform not only aims to deliver recombinant vaccines for widespread diseases like coronavirus, norovirus, and influenza but also seeks to address new indications with the potential to impact public health significantly.