Vaxart(VXRT)
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Vaxart(VXRT) - 2025 Q1 - Earnings Call Transcript
2025-05-13 21:30
Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $20.9 million, a significant increase from $2.2 million in Q1 2024, primarily driven by the BARDA contract awarded in June 2024 [19][20] - The company ended Q1 2025 with cash, cash equivalents, and investments totaling $41.9 million, with an expected cash runway into Q1 2026 [20] Business Line Data and Key Metrics Changes - The COVID-19 vaccine program is progressing with the lifting of the stop work order, allowing for the initiation of patient dosing in the Phase 2b trial [4][10] - Enrollment in the Phase 1 trial for the norovirus vaccine was completed quickly, with top-line data expected in mid-2025 [6][12] Market Data and Key Metrics Changes - The company is actively pursuing strategic partnerships to enhance funding and support for its clinical programs, particularly in the norovirus and avian flu vaccine markets [6][17][64] Company Strategy and Development Direction - The company emphasizes the importance of vaccines in public health and aims to innovate oral pill vaccines that can provide effective and durable protection against infections [7][12] - A reverse stock split is being considered as a measure to maintain NASDAQ listing compliance, reflecting the company's focus on regaining investor confidence and market visibility [24][25] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges in the biotech environment and has made workforce reductions to streamline costs and maximize future opportunities [8] - The lifting of the stop work order for the COVID-19 trial is seen as a positive development, reinforcing the need for novel vaccine technologies [29][30] Other Important Information - The resignation of the CFO, Phil Lee, was announced, with Jerome Grossman set to take over, bringing over 20 years of biotech experience [8][9][21] - The company is committed to transparent communication with shareholders while adhering to contractual obligations with BARDA and HHS [4][5] Q&A Session Summary Question: What are the gating factors to start patient dosing in the COVID-19 program? - Management indicated that the stop work order lifting allowed for the resumption of activities, with patient dosing expected to start in Q2 2025 [32][34] Question: What does a positive outcome look like for the Phase 1 norovirus study? - Success is defined as the new constructs trending better than the old constructs on key immunogenicity endpoints, although statistical significance may not be achievable due to the study size [37][38] Question: What are the implications of the recent DSMB review for the norovirus trial? - The review focused on safety, ensuring a clean safety profile to proceed with the protocol as designed [52] Question: How is the company planning to handle the results from the Sentinel cohort? - Management intends to engage with BARDA for potential interim analysis, with the study concluding in December [48] Question: What is the company's strategy regarding partnerships for the norovirus program? - The company is in discussions with various potential partners, with expectations that interest will accelerate following the release of top-line results [64]
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
Core Viewpoint - Vaxart, Inc. is urging stockholders to vote in favor of a reverse stock split proposal to maintain its Nasdaq listing and support ongoing vaccine development efforts [1][9][11] Recent Developments - A government stop work order was lifted on April 24, 2025, allowing Vaxart to proceed with its COVID-19 vaccine clinical trial, which is expected to secure non-dilutive government funding [3] - The company has completed enrollment for its norovirus program, with topline data anticipated in mid-2025, which could attract strategic partnerships and additional funding [4] Strategic Measures - Vaxart is implementing cost control measures, including workforce reductions, to extend its cash runway into 2026 while balancing cost savings with R&D investments [5] - The company is actively seeking additional sources of non-dilutive funding to support its initiatives [5] Stockholder Communication - Vaxart acknowledges stockholder concerns regarding stock performance and emphasizes the importance of compliance with SEC regulations in its communications [6] - The company will host a Q1 2025 earnings call on May 13, 2025, to provide updates and address stockholder questions [7] - A webcast presentation at the Citizens Life Sciences Conference on May 7, 2025, will also be available for stockholders [8] Reverse Stock Split Proposal - The reverse stock split proposal is aimed at preventing delisting from Nasdaq due to a minimum bid price requirement of $1.00 per share, with recommendations from leading proxy advisors to vote "FOR" the proposal [9][10] - The board intends to implement a reverse stock split only if necessary to maintain Nasdaq compliance, preferring to achieve compliance through stock price appreciation [10][11] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines, including candidates for COVID-19, norovirus, and HPV, utilizing a proprietary delivery platform [13]
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]