Core Points - Vaxart held a Stockholder Fireside Chat Conference Call to discuss company updates and future strategies [1][2] - Key executives present included the CEO, Chief Scientific Officer, Chief Medical Officer, Chief Financial Officer, Chief Technology Officer, and General Counsel [2] - The company may provide forward-looking statements regarding financial results, business strategies, clinical data, partnerships, regulatory approvals, and product development [3] Financial and Operational Insights - Vaxart's discussion may include financial guidance and anticipated timing for clinical data results [3] - The company is focused on its ongoing and planned clinical trials, which are critical for its product development and regulatory progress [3]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $72.4 million, a significant increase from $6.4 million in Q3 2024, primarily driven by a BARDA contract awarded in June 2024 [16] - The company ended Q3 2025 with cash, cash equivalents, and investments totaling $28.8 million, with an expected cash runway extending into Q2 2027 due to the recent partnership with Dynavax [16] Business Line Data and Key Metrics Changes - The COVID-19 clinical program has seen a major partnership with Dynavax, which includes an upfront license fee of $25 million and potential future payments totaling up to $700 million [4][5] - The norovirus program reported positive phase I results, showing a 25-fold increase in GII.4 fecal IgA response and a 10-fold increase in GI.1 fecal IgA response over baseline [14][15] Market Data and Key Metrics Changes - The company acknowledges the ongoing prevalence of COVID-19 and the need for new solutions, indicating a sizable market opportunity despite a decrease in vaccination rates [35] - Norovirus remains a significant health concern, with an economic cost exceeding $10 billion in the U.S., highlighting the urgent need for effective vaccines [9] Company Strategy and Development Direction - The partnership with Dynavax is seen as a major milestone, validating the potential of the oral vaccine platform and providing critical non-dilutive capital [5][8] - The company aims to advance its pipeline of vaccines, including norovirus, flu, and HPV, while actively seeking strategic partnerships [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the collaboration with Dynavax, emphasizing its importance for advancing the COVID-19 program and the overall potential of the oral vaccine platform [17] - The company remains committed to securing partnerships for its other vaccine candidates, including norovirus, and anticipates initiating the next clinical trial in 2026 [10][16] Other Important Information - The company is focused on maintaining a strong cash position while exploring non-dilutive funding options and managing expenses prudently [16] - The next scheduled update will be during a webcasted fireside chat on November 18, where further questions from stockholders will be addressed [18] Q&A Session Summary Question: Why did Dynavax decide to reach a deal now instead of waiting for data from the Sentinel cohort? - Management indicated that the partnership was based on the scientific potential of the platform and the good fit between the companies, rather than solely on clinical data [22][23] Question: Can the company start the phase 2b trial for norovirus by itself with the additional funding? - Management expressed excitement about the validation from Dynavax and indicated ongoing discussions with potential partners for all assets, including norovirus [26][28] Question: How does the company view the current COVID season compared to last year? - Management noted that while fewer people are taking COVID shots, there remains a good market opportunity for oral vaccines, which offer advantages over traditional methods [35]

Vaccine 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].

Licensing and Partnerships - Vaxart entered into an exclusive license agreement with Dynavax for its COVID-19 oral pill vaccine candidate, with potential cumulative proceeds of up to $700 million plus royalties[1]. - Vaxart received an upfront license fee of $25 million from Dynavax, along with a $5 million equity investment, enhancing its financial position[4]. - The company is exploring partnership opportunities for its norovirus, HPV, and flu vaccine programs, which have shown promising data in preclinical and clinical studies[3][6]. Clinical Trials and Research - Approximately 5,400 participants have been enrolled in the COVID-19 Phase 2b trial, with topline data expected in late 2026 and data from a 400-person sentinel cohort anticipated in the first quarter of 2026[1][6]. - The company showcased positive topline results from its Phase 1 trial for the second-generation oral norovirus vaccine, indicating stronger antibody responses compared to first-generation constructs[3][6]. Financial Performance - Revenue for the third quarter of 2025 was $72.4 million, a significant increase from $4.9 million in the same quarter of 2024, primarily from government contracts[6][15]. - Research and development expenses rose to $75.9 million in Q3 2025, compared to $15.1 million in Q3 2024, mainly due to increased clinical trial expenses[6][15]. - Vaxart reported a net loss of $8.1 million for Q3 2025, an improvement from a net loss of $14.1 million in Q3 2024, with a net loss per share of $0.04 compared to $0.06[6][15]. - Cash, cash equivalents, and investments totaled $28.8 million as of September 30, 2025, with a current runway extended into the second quarter of 2027[1][6]. - Total assets increased to $208.99 million as of September 30, 2025, compared to $166.39 million at the end of 2024[13].

Core Insights - Vaxart has entered into an exclusive license agreement with Dynavax for its COVID-19 oral pill vaccine candidate, potentially generating up to $700 million in cumulative proceeds plus royalties [1][4][3] - The company has completed enrollment of approximately 5,400 participants in its COVID-19 Phase 2b trial, with topline data expected in late 2026 and data from a 400-person sentinel cohort anticipated in the first quarter of 2026 [1][9] - Vaxart reported positive data from its Phase 1 clinical trial for its second-generation oral norovirus vaccine, indicating improved protection against infection [1][3] COVID-19 Vaccine Developments - The exclusive agreement with Dynavax includes a $25 million upfront license fee and a $5 million equity investment, with additional potential payments of $50 million and up to $195 million in regulatory milestone payments [4] - Vaxart retains operational and financial responsibility for the oral COVID-19 vaccine program through the completion of the ongoing Phase 2b clinical trial [4] - The company has received $125.9 million in cash payments associated with its COVID-19 vaccine program as of September 30, 2025 [9] Norovirus Vaccine Developments - Vaxart's second-generation oral pill norovirus vaccine constructs have shown significantly stronger antibody responses compared to first-generation constructs [3][9] - The company plans to publish complete results of the Phase 1 study in a peer-reviewed journal and is exploring partnership opportunities for its norovirus candidate [3][9] Financial Results for Q3 2025 - Vaxart reported revenue of $72.4 million for Q3 2025, a significant increase from $4.9 million in Q3 2024, primarily from government contracts [9][15] - Research and development expenses rose to $75.9 million in Q3 2025 from $15.1 million in Q3 2024, mainly due to increased clinical trial expenses [9][15] - The net loss for Q3 2025 was $8.1 million, an improvement from a net loss of $14.1 million in Q3 2024, with a net loss per share of $0.04 compared to $0.06 [9][15] Cash Position and Runway - As of September 30, 2025, Vaxart had cash, cash equivalents, and investments totaling $28.8 million, with a current runway extended into the second quarter of 2027 following the Dynavax agreement [1][9]

Core Points - Vaxart, Inc. will host a conference call to discuss its third quarter 2025 financial results on November 13, 2025, at 4:30 p.m. ET [2] - A stockholder fireside chat is scheduled for November 18, 2025, at 4:30 p.m. ET, where senior management will address frequently asked questions from stockholders [3] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform that allows for non-refrigerated storage and eliminates needle-stick injury risks [5] - The company's vaccine development programs include oral vaccines targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [5] - Vaxart has filed extensive domestic and international patent applications for its oral vaccination technology, which utilizes adenovirus and TLR3 agonists [5]

Core Insights - Dynavax Technologies Corporation and Vaxart, Inc. have entered into an exclusive worldwide license and collaboration agreement for Vaxart's investigational oral COVID-19 vaccine candidate [1][3][6] Financial Terms - Dynavax will pay Vaxart an upfront license fee of $25 million and make a $5 million equity investment [3][10] - Additional payments may include up to $50 million after Phase 2b results, $195 million in regulatory milestone payments, and $425 million in potential future net sales milestone payments [10] Vaccine Development - Vaxart's oral vaccine candidate utilizes a novel mechanism of action and delivery method, aiming to induce mucosal immunity and improve patient acceptance [2][4] - The ongoing Phase 2b clinical trial involves approximately 5,400 participants and compares Vaxart's oral vaccine to an FDA-approved mRNA vaccine [7][10] Collaboration Goals - The collaboration aims to leverage Vaxart's oral vaccine platform and Dynavax's commercial experience to address the long-term need for easily administered COVID-19 vaccine options [6][10] - Vaxart will retain operational and financial responsibility for the oral COVID-19 vaccine program through the completion of the Phase 2b trial [3][10] Strategic Importance - The agreement allows Dynavax to evaluate Phase 2b data before committing to late-stage development, aligning with its strategy to build a diversified vaccine portfolio [4][6] - Vaxart's proprietary VAAST™ platform is designed for room-temperature stable pill vaccines, potentially enhancing global distribution and compliance [4][8]

Core Insights - Vaxart, Inc. is presenting research on its second-generation norovirus oral pill vaccine candidate at IDWeek 2025, highlighting advancements in its vaccine development efforts [1][2] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [2] - The company's vaccines are designed to be administered in pill form, which can be stored and shipped without refrigeration, thus eliminating the risk of needle-stick injuries [2] - Vaxart's current development programs include vaccines targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [2] - The company has filed broad domestic and international patent applications for its proprietary technology related to oral vaccination using adenovirus and TLR3 agonists [2] Presentation Details - The presentation at IDWeek 2025 will feature an open-label Phase 1 clinical trial demonstrating improved immune responses to norovirus strains GI.1 and GII.4 from a next-generation oral bivalent vaccine candidate [2] - The session is scheduled for October 20, 2025, from 1:45 PM to 3:00 PM ET at the Georgia World Congress Center in Atlanta [2]

Core Insights - Vaxart, Inc. is a clinical-stage biotechnology company focused on developing oral recombinant pill vaccines, with significant advancements in norovirus and COVID-19 programs to be presented at the World Vaccine Congress Europe 2025 [1][2] Company Overview - Vaxart aims to enhance global public health through its innovative oral pill vaccine platform, addressing serious health challenges such as norovirus and COVID-19 [2] - The company’s proprietary delivery platform has shown the ability to generate systemic and mucosal immune responses, along with a favorable safety profile in clinical trials [2][4] - Vaxart's vaccine candidates include oral vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4] Presentation Details - Vaxart will present two key research updates at the World Vaccine Congress: 1. Title: Oral bivalent vaccine for norovirus protection, focusing on recent improvements in immunogenicity and efficacy, presented by Dr. Sean Tucker on October 15 at 11:45 a.m. CEST [3] 2. Title: Oral Covid Vaccine - Clinical update from phase 1 to phase 2B, also presented by Dr. Sean Tucker on October 15 at 3:45 p.m. CEST [3]

Core Viewpoint - Vaxart, Inc. has officially withdrawn its reverse stock split proposal and will focus on advancing its oral recombinant vaccine platform to create long-term value for stockholders [1][2]. Company Overview - Vaxart is a clinical-stage biotechnology company developing oral recombinant vaccines using a proprietary delivery platform that allows for storage and shipping without refrigeration [3]. - The company's vaccine candidates include those targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [3]. - Vaxart has filed broad domestic and international patent applications for its oral vaccination technology [3].