SOUTH SAN FRANCISCO, Calif., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Vaxart, Inc. (OTCQX: VXRT), a clinical-stage biotechnology company developing a range of oral vaccines based on its proprietary delivery platform, today announced that members of the management team will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference taking place virtually February 25-26, 2026. Presentation Details: Date and Time: Wednesday, February 25 at 4:00pm ETRegistration and Webcast: Click Here The webcast will ...

Core Viewpoint - A class action lawsuit has been certified for all Vaxart shareholders, including those who participated in a previous partial settlement, with a deadline for exclusion set for March 11, 2026 [1][2] Group 1: Class Action Details - The lawsuit is certified as a class action in the United States District Court for the Northern District of California, related to Vaxart, Inc. securities litigation [1][2] - The class includes individuals or entities that purchased or acquired Vaxart common stock or options between June 25 and July 24, 2020, and were damaged [1][2] - Members who purchased shares on June 26 or June 29, 2020, are part of a Subclass, which has specific criteria for participation [1] Group 2: Legal Representation and Options - Hagens Berman Sobol Shapiro LLP and Scott+Scott Attorneys at Law LLP are appointed as Class Counsel, representing the interests of the class members without requiring payment from them [1][2] - Class members have the option to either remain in the class, which binds them to court decisions, or request exclusion by the specified deadline, allowing them to pursue separate legal action [1][2] Group 3: Exclusion Process - To exclude from the class, individuals must submit a written request including personal details and proof of stock transactions by March 11, 2026 [1] - Excluded individuals will not be eligible for any recovery from the class action but can pursue their own claims against the Armistice Defendants [1][2]

Core Insights - Penny stocks attract speculative investors seeking high-risk/high-reward opportunities, often focusing on companies with disruptive technologies or compelling turnaround stories [3] - MarketBeat provides a tool listing the 100 Most Popular Penny Stocks based on subscriber interest, which may enhance investor confidence despite not guaranteeing success [4] Company Insights - Vaxart Inc. (NASDAQ: VXRT) is a clinical-stage biotechnology company developing oral vaccines for infectious diseases, aiming to simplify distribution and improve global accessibility [5] - The bull case for Vaxart hinges on its innovative oral vaccine platform, which could significantly impact global immunization efforts if FDA approval is obtained and successful scaling occurs [5] - Clinical risk is a major challenge for Vaxart, as it has not yet brought a product to market, and the vaccine development process is costly and unpredictable [6] Industry Insights - The biotechnology sector is characterized by high volatility and significant competition, particularly from established players with larger R&D budgets [6] - Other companies in the speculative investment space include Microvision, which develops lidar technology for autonomous vehicles, and Datavault AI, which focuses on monetizing digital data through AI and blockchain tools [7]

Core Insights - Vaxart's oral bivalent norovirus vaccine candidate has shown safety and immunogenicity in a Phase 1 trial, leading to significant increases in norovirus-specific antibodies in both serum and breast milk of vaccinated postpartum women [1][2][3] Group 1: Vaccine Efficacy and Safety - The vaccine was well-tolerated with mild to moderate adverse events similar between vaccine and placebo groups, with no adverse events beyond grade 2 reported [4] - Serum norovirus-specific IgA increased by an average of 5.6-fold for GI.1 and 4.7-fold for GII.4 in the high-dose group, while breast milk IgA rose by 4.0-fold for GI.1 and 6.0-fold for GII.4 [4][5] - Elevated levels of specific IgA in breast milk were maintained through day 180, indicating sustained immune response [5] Group 2: Passive Immunity Transfer - The study demonstrated a positive correlation between breast milk IgA levels and norovirus-specific IgA in the stool of breastfed infants, suggesting effective passive transfer of immunity [1][2][5] - This passive immunity could protect infants under five years old, who are particularly vulnerable to severe norovirus infections [2] Group 3: Trial Details and Funding - The Phase 1 trial involved 76 healthy lactating women aged 18-43, randomized into high-dose, medium-dose, and placebo groups [3][4] - The study was partially funded by the Bill & Melinda Gates Foundation, highlighting its significance in addressing global health challenges [3] Group 4: Future Developments - Vaxart plans to initiate the next clinical trial for its norovirus oral vaccine candidate in 2026, pending partnership or additional funding [6]

Summary of Vaxart's Conference Call Company Overview - **Company**: Vaxart - **Ticker**: VXRT - **Industry**: Biotechnology, specifically vaccine development - **Focus**: Development of oral recombinant pill vaccines using an innovative delivery platform [1][2] Core Points and Arguments Innovation in Vaccines - Vaxart aims to change the traditional narrative of vaccines being injections by developing oral pill vaccines [2] - The company has lead candidates in Phase 2 for COVID-19, norovirus, and influenza vaccines, along with a preclinical program for HPV [2] Technology Platform - The technology allows for easy administration via tablets, which do not require medical training to use [4] - Oral vaccines stimulate mucosal immunity, producing IgA antibodies in the nose and intestines, which are crucial for defending against pathogens like flu and COVID [5][6] - The platform is adaptable, allowing for rapid development of vaccines for various indications without needing to overhaul manufacturing processes [7][8] Public Health Benefits - Oral vaccines could improve efficacy by stimulating both mucosal and systemic immunity [10] - They have a benign safety profile, with no injection site reactions, and have shown similar safety to placebo in trials [10][11] - The ease of administration at home could increase vaccination rates and simplify distribution, eliminating cold chain requirements and medical waste [11][12] Clinical Data and Trials Preclinical Studies - Studies in hamsters demonstrated that oral vaccines could reduce transmission of COVID-19, showing potential for public health impact [16][18] - Preclinical data supports the safety and efficacy of the technology, with significant immune responses observed [15][18] Ongoing Clinical Trials - Norovirus vaccine trials showed safety and robust immune responses, including IgA transfer to breastfeeding infants [20][21] - COVID-19 vaccine trials are ongoing, with preliminary results expected in Q1 2026 [26] - A head-to-head study of the influenza vaccine showed a 39% reduction in symptomatic infection compared to placebo, outperforming a leading injected vaccine [23][24] Future Expectations - Vaxart anticipates significant data releases in 2026, including results from COVID-19 and norovirus vaccine trials [26][27] - The company is positioned to rapidly adapt to emerging pathogens and variants, enhancing global health responses [28] Additional Insights - The oral vaccine approach could revolutionize vaccine delivery, making it more accessible and convenient for the public [32] - Vaxart's commitment to innovation in the vaccine space is highlighted as a key differentiator in the biotechnology industry [30][32]

Company Overview - Vaxart, Inc. is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using its proprietary delivery platform [3] - The company aims to create vaccines that can be administered in pill form, which can be stored and shipped without refrigeration, thus eliminating the risk of needle-stick injuries [3] - Vaxart's current development programs include vaccines targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [3] Upcoming Event - Vaxart will participate in the Global BioInnovation Forum, a virtual event featuring senior leaders in life sciences and health innovation [1] - Key speakers at the event will include Steven Lo (CEO), Sean Tucker (Founder and CSO), and James F. Cummings (CMO) [2] - The event is scheduled for January 13, 2026, at 11:30 AM PT, and the webcast will be available for 30 days post-event on the company's investor relations website [2]

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].