Vaxart(US:VXRT)2025-11-13 21:16Vaccine Development and Clinical Trials - The Phase 2 GI.1 norovirus challenge study achieved a statistically significant 30% relative reduction in the rate of norovirus infection between the vaccinated and placebo arms [129]. - The study also indicated a 21% relative reduction in norovirus acute gastroenteritis in the vaccine arm compared to placebo, although this finding did not reach statistical significance [130]. - The second-generation norovirus constructs demonstrated a significant increase in NBAA titers, with a 141% increase for the GI.1 vaccine candidate and a 94% increase for the GII.4 vaccine candidate [134]. - A contract with HHS BARDA for $9.3 million was awarded in January 2024 to fund preparation for a Phase 2b clinical study involving 10,000 participants for the COVID-19 vaccine candidate [137]. - The Phase 2b study has enrolled approximately 5,000 participants, with a primary endpoint measuring the relative efficacy of Vaxart's COVID-19 vaccine candidate compared to an approved mRNA comparator [145]. - The Phase 2 challenge study of the H1N1 flu vaccine candidate showed a 39% reduction in clinical disease relative to placebo, outperforming the market-leading injectable quadrivalent influenza vaccine, which reduced clinical disease by 27% [147]. - The norovirus vaccine candidate was well tolerated with no vaccine-related serious adverse events reported in the Phase 1 study involving breastfeeding mothers [137]. - The company received constructive feedback from the FDA regarding potential correlates of protection for the norovirus program, requesting new clinical data before further review [132]. - The Phase 2b study will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and the incidence of adverse events [146]. - The company has committed to global access for its bivalent norovirus vaccine candidate in breastfeeding mothers from low- and middle-income countries if proven effective and approved [137]. - The company plans to continue the development of its preclinical tri-valent seasonal influenza vaccine candidate and work with governments to create pandemic monovalent influenza vaccines [150]. - The company has demonstrated immunogenicity for its HPV-16 and HPV-18 vaccine candidates in preclinical studies, targeting strains responsible for approximately 70% of cervical cancers [150]. Financial Performance - The company reported a revenue of $72.4 million for the three months ended September 30, 2025, representing a 1,368% increase compared to $4.9 million in the same period of 2024 [166]. - Operating expenses increased to $80.2 million for the three months ended September 30, 2025, a 313% rise from $19.4 million in the prior year [166]. - The net loss for the three months ended September 30, 2025, was $8.1 million, a 42% decrease from a net loss of $14.1 million in the same period of 2024 [166]. - The company has incurred significant research and development expenses totaling $75.9 million for the three months ended September 30, 2025, compared to $15.1 million in 2024 [162]. - Revenue from government contracts recognized under the 2024 ATI-RRPV Contract was $71.8 million for the three months ended September 30, 2025, compared to $4.0 million in 2024 [158]. - Total revenue for the three months ended September 30, 2025, was $72.4 million, a 1,368% increase from $4.9 million in the same period of 2024 [169]. - Revenue from government contracts for the nine months ended September 30, 2025, reached $131.4 million, up 923% from $12.9 million in 2024 [169]. - Research and development expenses for the three months ended September 30, 2025, increased by $60.9 million, or 404%, compared to the same period in 2024 [171]. - Total operating expenses for the nine months ended September 30, 2025, were $170.4 million, a 149% increase from $68.3 million in 2024 [170]. - Interest income for the three months ended September 30, 2025, was $0.3 million, a 70% decrease from $1.0 million in 2024 [175]. - The provision for income taxes for the nine months ended September 30, 2025, was $132,000, a 57% increase from $84,000 in 2024 [177]. - The company recorded a net loss of $38.7 million for the nine months ended September 30, 2025 [193]. - The company experienced a net cash decrease of $8.3 million for the nine months ended September 30, 2025 [192]. Capital and Funding - The company entered into an At the Market Offering Agreement in March 2025, allowing for the sale of up to $50 million in common stock [180]. - The company was notified of its securities being delisted from The Nasdaq Stock Market due to noncompliance with listing conditions [181]. - The 2024 ASPR-BARDA Contract awarded to the company had a total value of $9.3 million, supporting clinical trial planning activities [183]. - The company raised $40.0 million in gross proceeds from a registered direct offering in June 2024 [185]. - As of September 30, 2025, the company had approximately $28.8 million in cash, cash equivalents, and short-term investments, which are insufficient to fund planned operations for the next 12 months [187]. - The company has received $125.9 million in cash payments under the 2024 ATI-RRPV Contract as of September 30, 2025, with an additional $42.7 million received after that date [186]. - Negative cash flow from operating activities for the nine months ended September 30, 2025, was $22.9 million, compared to $37.4 million for the same period in 2024 [193]. - The company expects to have cash runway into the second quarter of 2027 based on current management plans [189]. - Total contractual obligations as of September 30, 2025, amount to $59.8 million, with $32.3 million due within one year [197]. - The company had approximately $24.5 million in non-cancelable purchase commitments, primarily for clinical services expected to be paid within the next year [199]. - The company may need to raise additional capital to continue operations, which could involve selling additional securities or debt financing [188]. Market and Investment Strategy - The company maintains a strategy to preserve principal, maintain liquidity, and maximize total return without significantly increasing risk through investments in marketable debt securities [211]. - The company does not engage in trading or speculative investments and holds no equity securities [211]. - A 1% increase in the strength of the U.S. dollar against the Japanese yen would result in a 1% reduction in royalty revenue and related accounts receivable [213]. - The company has not experienced significant foreign exchange gains or losses recently and does not anticipate significant foreign exchange impacts in the near future [213]. Clinical Trial Challenges - The company had enrolled approximately half of the targeted number of participants for the COVID-19 Phase 2b trial before receiving a stop work order [186]. - The company expects to incur significant research and development expenses as it advances its tablet vaccine candidates into clinical trials and prepares for potential commercial launch [162].