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]

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]

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]

"We are pleased to receive BARDA approval to move forward with dosing in this large-scale study and expect to dose the first patient in this cohort in the second quarter of 2025," said Steven Lo, Chief Executive Officer of Vaxart. "We are deeply grateful for the continued support of our government partners at HHS and BARDA, whose collaboration is critical to advancing our clinical development program." The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study. It is designe ...

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]

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]

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]

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]

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]