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Vaxart(VXRT) - 2025 Q1 - Quarterly Report
2025-05-13 20:13
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Vaxart, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 59-1212264 (State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.) 170 Harbor Way, Suite 300, South San Francisco, For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT ...
Vaxart Provides Business Update and Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-13 20:05
Core Insights - Vaxart, Inc. has resumed screening for the 10,000 participant portion of its COVID-19 Phase 2b trial, with dosing expected to start in Q2 2025 [4][7] - The company completed enrollment for its Phase 1 clinical trial of a second-generation oral norovirus vaccine, with topline data anticipated in mid-2025 [4][7] - A new avian influenza vaccine candidate demonstrated 100% protection in a ferret challenge model, contrasting with 0% survival in placebo-treated animals [9] COVID-19 Vaccine Developments - The stop work order for the COVID-19 Phase 2b trial was lifted, allowing Vaxart to proceed with participant screening [4][7] - The company is operating under a Project NextGen award, potentially receiving up to $460.7 million, with $240.1 million currently available [7] - Screening for the trial is currently underway, with dosing expected to begin in the second quarter of 2025 [7] Norovirus Vaccine Developments - Vaxart completed enrollment of 60 participants in its Phase 1 trial for the second-generation oral norovirus vaccine, with results expected in mid-2025 [7] - An independent Data and Safety Monitoring Board recommended the continuation of the study without modifications [7] Avian Influenza Program Developments - The new avian influenza vaccine candidate showed 100% protection against death in a ferret model, with plans to publish the findings in a peer-reviewed forum [9] Financial Results - For Q1 2025, Vaxart reported revenue of $20.9 million, a significant increase from $2.2 million in Q1 2024 [12][18] - Research and development expenses rose to $30.7 million in Q1 2025, compared to $19.0 million in Q1 2024, primarily due to increased clinical trial costs [12][18] - The net loss for Q1 2025 was $15.6 million, an improvement from a net loss of $24.4 million in Q1 2024, with a net loss per share of $0.07 compared to $0.14 in the previous year [12][18][19] Leadership Changes - Jeroen Grasman has been appointed as Chief Financial Officer effective May 19, 2025, succeeding Phillip Lee, who will remain as a non-executive employee until June 1, 2025 [12]
Vaxart Appoints Jeroen Grasman as Chief Financial Officer
GlobeNewswire News Room· 2025-05-13 20:01
Company Overview - Vaxart, Inc. is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [3] - 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 [3] Leadership Change - Jeroen Grasman has been appointed as the Chief Financial Officer (CFO) of Vaxart, effective May 19, 2025, succeeding Phillip Lee, who is resigning for personal reasons [1][2] - Mr. Grasman brings over 20 years of financial leadership experience in the biotech sector, having previously served as CFO at AltruBio and held senior positions at PACT Pharma and Intarcia Therapeutics [2] Strategic Focus - The company aims to advance its oral pill vaccine programs, leveraging Mr. Grasman's extensive financial expertise and operational acumen [2] - Vaxart's development pipeline includes vaccines targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [3]
Vaxart Addresses Frequently Asked Questions on Reverse Stock Split Proposal in Definitive Proxy Statement
Globenewswire· 2025-05-12 12:00
Core Viewpoint - Vaxart, Inc. is proposing a reverse stock split to avoid delisting from Nasdaq due to its current share price being below the minimum requirement of $1.00 [2][8] Group 1: Reverse Stock Split Proposal - The reverse stock split is necessary for Vaxart to regain compliance with Nasdaq's minimum bid price requirement [2] - The proposed reverse stock split ratio is between 1-for-5 and 1-for-50, with the intention to select a ratio only high enough to resolve the Nasdaq deficiency [5] - The company prefers to achieve compliance through stock price appreciation rather than executing the reverse stock split if possible [5] Group 2: Impact on Investments - The reverse stock split will not change the aggregate value of a stockholder's investment or their percentage ownership in the company [3][11] - There will be no dilution of Vaxart's stock as the reverse split affects all issued shares uniformly [4] Group 3: Benefits of the Reverse Stock Split - Anticipated benefits include maintaining Nasdaq listing, increasing market visibility, and enhancing long-term value through increased trading volume and financing opportunities [8][10] - Independent proxy advisory firms, ISS and Glass Lewis, recommend stockholders support the reverse stock split proposal due to the risk of delisting [9] Group 4: Company Strategy and Future Plans - The reverse stock split aligns with Vaxart's overall strategy to progress its clinical stage programs for COVID-19 and norovirus while advancing its preclinical pipeline [13] - Vaxart is exploring non-dilutive funding options and partnerships to enhance stockholder value [15]
Vaxart (VXRT) 2025 Conference Transcript
2025-05-07 18:00
Summary of Vaxart (VXRT) Conference Call Company Overview - **Company**: Vaxart, Inc. - **Industry**: Biotechnology, specifically focusing on vaccine development - **Key Personnel**: Steve Lowe (CEO), James Cummings (Chief Medical Officer) - **Location**: South San Francisco, California, with all manufacturing conducted in the U.S. [12][49] Core Technology and Approach - **Vaccine Platform**: Vaxart's oral vaccine platform, referred to as VaST (Vector Adjuvant Antigen Standardization Technology), utilizes a non-replicating adenovirus vector dried into a pill form [14] - **Delivery Method**: The vaccine is taken orally with water, activating the immune system in the lower small intestine, promoting both systemic and mucosal immunity [15][10] - **Advantages**: - Needle-free administration, reducing logistical complexities and waste [11][29] - Thermostable, eliminating the need for a cold chain, making it easier to distribute, especially in low to middle-income countries [28][30] Market Opportunity - **Public Health Importance**: Vaccines are essential for preventing illnesses, hospitalizations, and deaths, representing a consistent revenue stream for the company [5][6] - **Norovirus Impact**: - Over 680 million global infections annually, with 20 million clinical cases in the U.S. [21] - Economic burden estimated at $10 billion annually in the U.S. due to healthcare costs and lost productivity [22][23] - **Target Populations**: Elderly, immunocompromised individuals, and those in enclosed spaces (e.g., military personnel, healthcare workers) are at higher risk for severe disease [24][25] Pipeline and Clinical Development - **Current Projects**: - **Norovirus Vaccine**: - Bivalent vaccine targeting G1 and G24 strains, showing an 80% reduction in viral shedding in preclinical studies [31][33] - Phase one trial underway with top-line data expected by mid-2025 [37][48] - **COVID-19 Vaccine**: - Funded by BARDA with a $460 million contract, focusing on ease of administration and mucosal immunity [40][41] - A 10,000-person study is ongoing, with a focus on cross-reactivity to various coronaviruses [42][43] - **Influenza Vaccine**: - Demonstrated a 49% decrease in infection compared to placebo in a head-to-head study against Fluzone [46][48] Key Milestones - **Upcoming Data Releases**: - Top-line data from the norovirus phase one trial expected in mid-2025 [47] - Completion of the COVID-19 sentinel study by December 2025 [40][48] Conclusion - Vaxart is positioned to revolutionize vaccine delivery with its oral platform, addressing significant public health challenges while also presenting a robust pipeline of vaccine candidates targeting norovirus, COVID-19, and influenza. The company emphasizes the importance of mucosal immunity and aims to provide accessible and effective vaccination solutions globally [49]
Vaxart CEO Issues Letter to Stockholders Highlighting Company Progress
Globenewswire· 2025-05-05 12:00
Urges Stockholders to Vote FOR Reverse Stock Split Proposal at Upcoming Annual Meeting as Recommended by Leading Independent Proxy Advisory Firms SOUTH SAN FRANCISCO, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today issued the following letter to its stockholders from its President & Chief Executive Officer, Steven Lo. Dear Vaxart, Inc. Stockholders: We are writing to update you on recent developments that positively impact Vaxart's ability to advance our promising vaccine candidat ...
Vaxart to Host First Quarter 2025 Business Update and Financial Results Conference Call on May 13
GlobeNewswire News Room· 2025-05-02 12:00
Group 1 - Vaxart, Inc. will provide a business update and report financial results for Q1 2025 on May 13, 2025, after market close [1] - A conference call will be hosted by Vaxart's senior management team on the same day at 4:30 p.m. ET, with access details provided [1] - Investors can submit written questions in advance of the conference call by May 12, 2025 [1] Group 2 - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [3] - The company's vaccines are designed to be administered in pill form, which can be stored and shipped without refrigeration, reducing the risk of needle-stick injuries [3] - Current development programs include vaccines for 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]
Vaxart to Present at the Citizens Life Sciences Conference
Globenewswire· 2025-04-30 20:05
Core Points - Vaxart, Inc. will present at the Citizens Life Sciences conference on May 7-8, 2025 [1] - The presentation is scheduled for May 7 at 1:00 PM ET, with a live webcast available on the company's website [2] - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [3] Company Overview - Vaxart's vaccines are designed to be administered in pill form, which can be stored and shipped without refrigeration, reducing the risk of needle-stick injuries [3] - The company is developing oral vaccines for coronavirus, norovirus, and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV) [3] - Vaxart has filed broad domestic and international patent applications for its oral vaccination technology using adenovirus and TLR3 agonists [3]
Vaxart Completes Enrollment in Phase 1 Trial for its Norovirus Oral Pill Vaccine Candidate
Globenewswire· 2025-04-30 12:00
Company Overview - Vaxart, Inc. is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [6] - The company aims to provide vaccines that can be administered in pill form, eliminating the need for refrigeration and reducing the risk of needle-stick injuries [6] Clinical Trial Progress - Vaxart has completed enrollment for its Phase 1 clinical trial of its second-generation oral norovirus vaccine constructs, which are being evaluated against first-generation constructs [2][3] - The Phase 1 trial is designed to assess safety and immune responses correlated with protection from norovirus, a leading cause of acute gastroenteritis globally [3] Future Development Plans - If the Phase 1 trial is successful, Vaxart plans to initiate a Phase 2 safety and immunogenicity study potentially starting in the second half of 2025, followed by an End of Phase 2 meeting with the FDA [5] - A Phase 3 trial could commence as early as 2026, contingent on successful outcomes and potential partnerships or funding [5] Safety Review - An independent Data and Safety Monitoring Board (DSMB) conducted an interim safety review and recommended that the study continue without modifications [4] Market Need - The development of Vaxart's oral norovirus vaccine is driven by a significant unmet public health need, as norovirus is a major cause of gastroenteritis worldwide [3]
Vaxartto Present at World Vaccine Congress Washington 2025 on April 23
GlobeNewswire News Room· 2025-04-16 12:00
SOUTH SAN FRANCISCO, Calif., April 16, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that Dr. Sean Tucker, Founder and Chief Scientific Officer, and Dr. James F. Cummings, Chief Medical Officer, will present at the World Vaccine Congress Washington 2025 in Washington, D.C. on Wednesday, April 23, 2025. The Company has appeared repeatedly at the annual event in Washington, D.C. Presentation Information: Title: Moving the needle: Blocking transmission and boosting existing vaccines by o ...