Vaxart(US:VXRT)2024-11-13 21:23Vaccine Development - The Phase 2 GI.1 norovirus challenge study achieved a statistically significant 29% relative reduction in the rate of norovirus infection between the vaccinated and placebo arms [143]. - The bivalent norovirus vaccine candidate showed an 85% relative decrease in viral shedding in the vaccine arm compared to placebo [143]. - The Phase 2b clinical study for the COVID-19 vaccine candidate is funded with up to $456.1 million to involve 10,000 patients [153]. - The COVID-19 vaccine candidate boosted serum neutralizing antibody responses from a geometric mean of 481 to 778, a fold rise of 1.6 [150]. - The HPV therapeutic vaccine candidate targets HPV 16 and HPV 18, responsible for 70% of cervical cancers [162]. - The H1N1 flu vaccine candidate reduced clinical disease by 39% relative to placebo, outperforming the market-leading injectable vaccine [158]. - The company received constructive feedback from the FDA regarding the norovirus program, requesting new clinical data before further review [145]. - The Phase 1 study funded by the Bill and Melinda Gates Foundation showed a 5.6-fold increase in serum antibodies to norovirus in lactating mothers [146]. - The company is developing additional norovirus constructs that may be more potent than those currently in clinical trials [147]. - The company intends to work with governments to create pandemic monovalent influenza vaccines for emergency use or stockpiling [161]. Financial Performance - Revenue for the three months ended September 30, 2024, was $4.9 million, a 134% increase from $2.1 million in the same period of 2023 [181]. - Revenue for the nine months ended September 30, 2024, was $13.5 million, up from $4.1 million in the same period of 2023, representing a significant increase [181]. - Operating expenses for the three months ended September 30, 2024, were $19.4 million, a slight decrease of 3% from $19.9 million in the same period of 2023 [181]. - Operating loss for the three months ended September 30, 2024, was $(14.5) million, a 19% improvement compared to $(17.8) million in the same period of 2023 [181]. - Net loss for the three months ended September 30, 2024, was $(14.1) million, a 19% decrease from $(17.4) million in the same period of 2023 [181]. - The company was awarded the 2024 ASPR-BARDA Contract with a total value of $9.3 million to support clinical trial planning activities [171]. - The 2024 ATI-RRPV Contract provides funding of up to $456.1 million for a Phase 2b comparative study of a COVID-19 vaccine candidate [172]. - Research and development expenses for the three months ended September 30, 2024, totaled $15.1 million, slightly up from $15.0 million in the same period of 2023 [178]. - Total external research and development costs for the nine months ended September 30, 2024, were $12.2 million, down from $13.5 million in the same period of 2023 [178]. - Total revenue for the three months ended September 30, 2024, was $4.9 million, a significant increase from zero in the same period of 2023, while total revenue for the nine months was $12.9 million compared to zero in 2023 [184]. - Revenue from government contracts for the three months ended September 30, 2024, was $4.9 million, with $0.9 million from the ASPR-BARDA Contract and $4.0 million from the ATI-RRPV Contract [184]. Cash Flow and Investments - As of September 30, 2024, the company had approximately $58.7 million in cash, cash equivalents, and short-term investments, sufficient to fund operations for at least one year [201]. - The company entered into the 2024 ATI-RRPV Contract, which provides funding of up to $456.1 million for a Phase 2b study and vaccine manufacturing, with $65.4 million received as of September 30, 2024 [196]. - The company terminated the September 2021 ATM, having raised $9.1 million in gross proceeds from the sale of shares, resulting in net proceeds of $8.8 million [195]. - For the nine months ended September 30, 2024, the net cash used in operating activities was $37.4 million, a decrease from $56.9 million in the same period of 2023 [207]. - The company experienced a net cash decrease of $12.7 million in the nine months ended September 30, 2024, compared to a decrease of $12.8 million in 2023 [206]. - In the nine months ended September 30, 2024, the company provided net cash of $56.4 million from financing activities, significantly up from $15.3 million in 2023 [206]. - The company recorded a net loss of $55.0 million for the nine months ended September 30, 2024, compared to a net loss of $65.1 million in the same period of 2023 [207]. - The company has contractual obligations totaling $52.7 million as of September 30, 2024, with long-term debt obligations of $21.6 million [211]. - The company used $31.2 million of cash for investments in the nine months ended September 30, 2024, compared to receiving $30.7 million from maturities of marketable securities in 2023 [209]. Stock and Compensation - The unrecognized stock-based compensation cost related to outstanding unvested stock options and RSUs was $15.9 million, expected to be recognized over an estimated weighted average period of 2.3 years [214]. - The company’s royalty revenue is sensitive to exchange rate fluctuations, with a 1% increase in the U.S. dollar against the Japanese yen leading to a 1% reduction in royalty revenue [229]. - The company is obligated to pay HCRP a total of $3.0 million in royalties during the first royalty interest period, which runs until March 31, 2025 [211]. Internal Controls - No material change in internal control over financial reporting during the quarter ended September 30, 2024 [232]. - Management does not expect disclosure controls and internal controls to prevent all errors and fraud [233].