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Vaxart Announces Trading on OTCQX Best Market
Globenewswire· 2025-07-08 12:00
Core Viewpoint - Vaxart, Inc. has received approval to trade its common stock on the OTCQX Best Market, enhancing transparency and accessibility for investors, following a delisting notice from Nasdaq [1][2]. Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform, which allows for storage and shipping without refrigeration [4]. - The company is advancing multiple vaccine candidates targeting infectious diseases, including those for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4]. Stock Listing Situation - After receiving a delisting notice from Nasdaq, Vaxart has requested a hearing to appeal the decision, with its common stock currently suspended pending the outcome [2][3]. - The company is exploring all options regarding its stock listing while prioritizing shareholder interests [3].
Vaxart Announces Preliminary Results of Annual Meeting of Stockholders
Globenewswire· 2025-06-13 20:52
Core Points - Vaxart, Inc. held its Annual Meeting of Stockholders in a virtual format, where preliminary results indicated that two proposals were approved and two were rejected by stockholders [1][2] - Stockholders voted in favor of the election of six director nominees and the ratification of WithumSmith+Brown, PC as the independent registered public accounting firm [5] - A proposal for an amendment to the Restated Certificate of Incorporation to effect a reverse stock split is under evaluation by the company [5] - The company is developing oral recombinant vaccines using its proprietary delivery platform, which allows for storage and shipping without refrigeration [3] - Current development programs include vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [3] Company Overview - Vaxart is a clinical-stage biotechnology company focused on oral recombinant vaccines [3] - The company's proprietary technology includes adenovirus and TLR3 agonists for oral vaccination [3] - Vaxart has filed broad domestic and international patent applications covering its technology [3]
Vaxart's Founder and Chief Scientific Officer Provides Video Update to Stockholders
GlobeNewswire News Room· 2025-05-29 12:00
Core Viewpoint - Vaxart, Inc. is urging stockholders to vote in favor of a reverse stock split proposal to regain compliance with Nasdaq's minimum bid price rule by the deadline of June 1, 2025 [1][2] Group 1: Reverse Stock Split Proposal - Dr. Sean Tucker, Founder and CSO of Vaxart, emphasizes the importance of voting FOR Proposal No. 2, which would allow the Board of Directors to implement a reverse stock split [1] - The company has provided a fact sheet to clarify misconceptions regarding the reverse stock split proposal [2] - Stockholders who have not yet voted are encouraged to do so by the deadline, and those who previously voted against the proposal can change their vote [2] Group 2: Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [4] - 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 injury [4] - Current development programs include vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4]
Vaxart Initiates Dosing in 10,000-Participant Portion of Phase 2b COVID-19 Trial
Globenewswire· 2025-05-27 12:00
Core Insights - Vaxart, Inc. has initiated dosing in a Phase 2b clinical trial for its oral COVID-19 vaccine candidate, involving 10,000 participants, marking a significant advancement in its development process [1][2] - The trial is designed as a double-blind, multi-center, randomized, comparator-controlled study to assess the efficacy, safety, and immunogenicity of Vaxart's oral vaccine compared to an approved mRNA vaccine in previously vaccinated adults [2][3] - The trial follows a positive review of safety data from an initial cohort of 400 participants, with the independent Data Safety Monitoring Board recommending the study proceed without modifications [3] Funding and Support - Vaxart's project has received funding under Project NextGen, a U.S. government initiative aimed at accelerating the development of innovative COVID-19 vaccines, with a project award valued at up to $460.7 million [4] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform, which allows for storage and shipping without refrigeration [5] - The company is working on various oral vaccines targeting diseases such as coronavirus, norovirus, and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV) [5]
Evaxion announces business update and first quarter 2025 financial results
Globenewswire· 2025-05-27 11:30
Core Insights - Evaxion A/S is progressing well with its strategy, achieving key milestones and focusing on the execution of its clinical trials and collaborations [2][4][11] - The company is advancing its AI-Immunology™ platform and pipeline, with a focus on personalized cancer vaccines and infectious disease candidates [3][10][31] Business Highlights - The company has achieved the first two milestones for 2025, including the ongoing phase 2 trial of EVX-01 for advanced melanoma, which is expected to yield two-year data in the second half of 2025 [2][4] - Collaboration with MSD on EVX-B2 and EVX-B3 is on track for potential option exercise, which could lead to significant milestone payments and royalties for Evaxion [11][12] Research & Development Update - The phase 2 trial of EVX-01 has shown promising results, with 80% of vaccine targets triggering a tumor-specific immune response, an increase from previous hit rates of 71% and 79% [5][7] - The company is also developing a precision vaccine targeting non-conventional endogenous retrovirus (ERV) tumor antigens, with plans to select a lead candidate in 2025 [7][9] Financial Overview - As of March 31, 2025, cash and cash equivalents were $17.8 million, a significant increase from $6.0 million at the end of 2024, providing a cash runway until mid-2026 [17][27] - The company reported a net loss of $1.6 million for the first quarter of 2025, compared to a net income of $1.2 million for the same period in 2024, primarily due to changes in financial income [22][30] Equity and Liabilities - Total equity improved to $10.3 million as of March 31, 2025, compared to a negative equity of $(1.7) million at the end of 2024, reflecting the company's strengthened financial position [23][27] - The company is in the process of converting €3.5 million of its €7 million loan from the European Investment Bank into an equity-type instrument, expected to enhance financial flexibility [15][16]
Evaxion to announce business update and first quarter 2025 financial results on May 27, 2025
Globenewswire· 2025-05-23 12:00
Company Overview - Evaxion A/S is a clinical-stage TechBio company that specializes in developing AI-Immunology™ powered vaccines [4] - The company utilizes proprietary AI prediction models to decode the human immune system and create novel immunotherapies for cancer, bacterial diseases, and viral infections [4] - Evaxion has a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline targeting infectious diseases with high unmet medical needs [4] Upcoming Events - Evaxion will provide a business update and report its first quarter 2025 financial results on May 27, 2025, before the opening of Nasdaq CM [1] - The Executive Management will host a conference call and webcast on the same day at 14:30 CET/08:30 EST, which is free and open to the public [2] - Participants can register in advance to receive dial-in numbers and a unique PIN code for the conference call [2] Communication and Contact - Mads Kronborg is the Vice President of Investor Relations & Communication at Evaxion, and can be contacted at +45 53 54 82 96 or via email at mak@evaxion.ai [4]
Vaxart Announces Adjournment of Annual Meeting of Stockholders
Globenewswire· 2025-05-21 20:45
Core Points - Vaxart, Inc. has adjourned its 2025 annual meeting of stockholders to June 2, 2025, at 8:30 a.m. Pacific Time [1] - The meeting will be held in a virtual-only format, accessible via a specific website [2] - Stockholders who have not yet voted are encouraged to do so by June 1, 2025, at 11:59 p.m. Eastern Time [4] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [6] - The company's vaccines are designed to be administered in pill form, eliminating the need for refrigeration and reducing the risk of needle-stick injuries [6] - Current development programs include vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [6]
Vaxart Approves Resolutions to Narrow Proposed Reverse Split Range and Proposes Reducing Authorized Shares at Future Stockholder Meeting
Globenewswire· 2025-05-16 12:00
Core Viewpoint - Vaxart, Inc. is urging stockholders to vote in favor of a reverse stock split proposal to avoid delisting from Nasdaq, with support from leading independent proxy advisory firms ISS and Glass Lewis [1] Group 1: Proposal Details - The board of directors has approved two items contingent on the passage of Proposal 2, emphasizing the importance of maintaining the Nasdaq listing for stockholder liquidity and attracting institutional investors [1] - Stockholders who previously voted against Proposal 2 can change their vote by the deadline of May 20, 2025, at 11:59 p.m. Eastern Time [1] Group 2: Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform, which allows for storage and shipping without refrigeration [3] - The company's vaccine development programs include oral 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] Group 3: Stock Split Information - The current authorized number of shares will be proportionally reduced according to the reverse stock split ratio, which will not exceed 1-for-20 [5]
Vaxart Receives BARDA Approval to Initiate Dosing in 10,000-Participant Portion of Phase 2b COVID-19 Trial
Globenewswire· 2025-05-15 12:00
Core Insights - Vaxart, Inc. has received approval from BARDA to initiate dosing in a 10,000-participant Phase 2b clinical trial for its oral COVID-19 vaccine candidate [1][2] - The trial aims to evaluate the efficacy, safety, and immunogenicity of Vaxart's oral vaccine compared to an approved mRNA COVID-19 vaccine in previously vaccinated adults [2] - The project is part of Project NextGen, a $5 billion initiative to accelerate the development of innovative COVID-19 vaccines, with Vaxart's award valued at up to $460.7 million [3] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [4] - The company's vaccines are designed to be administered in pill form, eliminating the need for refrigeration and reducing the risk of needle-stick injuries [4] - Vaxart's development pipeline includes vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for HPV [4]
Vaxart(VXRT) - 2025 Q1 - Earnings Call Transcript
2025-05-13 21:32
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 [22][23] - The company ended Q1 2025 with cash, cash equivalents, and investments totaling $41.9 million, with an expected cash runway into Q1 2026 [23] Business Line Data and Key Metrics Changes - The COVID-19 vaccine program has resumed activities following the lifting of the stop work order, with patient screening underway and dosing expected to start in Q2 2025 [5][12] - Enrollment in the Phase 1 trial for the norovirus vaccine was completed quickly, with top-line data expected in mid-2025 [8][15] 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 [17][19] 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 [9][19] - A reverse stock split is being considered as a measure to maintain NASDAQ listing compliance, with management acknowledging the need for a strategic approach to regain investor confidence [26][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the COVID-19 program's potential and the importance of timely communication with stakeholders, despite contractual limitations [5][6] - The company is navigating challenges in the biotech environment and has made workforce reductions to streamline costs and maximize future opportunities [10][23] Other Important Information - The CFO, Phil Lee, announced his resignation for personal reasons, with Jerome Grossman set to take over [10][11] - The avian flu vaccine program has shown promising preclinical results, with plans to advance to clinical trials [19][20] Q&A Session All Questions and Answers 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 immediate discussions with BARDA, and patient screening is currently underway, with dosing expected to start soon [37][39] 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 [41][42] Question: What impact did the stop work order have on the expected timeline for the COVID-19 study? - The stop work order had a minor impact, but the company is now reactivating study sites and screening participants, with a projected six-month enrollment period once dosing begins [60][62] Question: Are there ongoing discussions for partnerships related to the norovirus program? - Management confirmed active discussions with a range of companies, with expectations that these will accelerate following the release of top-line results [65][66]