Core Insights - Evaxion A/S has announced promising new data for its AML vaccine candidate, EVX-04, which shows strong T-cell responses and effective tumor growth prevention in preclinical models [1][5][10] - The data was presented at the American Society of Hematology Annual Meeting, highlighting the company's engagement with the scientific community and potential business partners [2] - The AI-Immunology™ platform has been instrumental in identifying novel ERV tumor antigens, which are targeted by EVX-04, showcasing the platform's unique capabilities in cancer vaccine development [3][4][11] Company Overview - Evaxion A/S is a clinical-stage TechBio company focused on developing AI-Immunology™ powered vaccines, with a commitment to transforming patient care through innovative immunotherapies [12] - The company’s proprietary AI platform enables the identification of therapeutically relevant tumor antigens, which are crucial for the development of effective cancer vaccines [11][12] Product Details - EVX-04 is designed as an off-the-shelf therapeutic cancer vaccine specifically for acute myeloid leukemia (AML), addressing a significant unmet medical need due to the high mortality rates associated with the disease [10] - The vaccine targets non-conventional ERV tumor antigens, which are selectively expressed in tumors but absent in normal tissues, making them ideal candidates for cancer immunotherapy [4][10] AML Context - Acute myeloid leukemia (AML) is characterized by high mortality rates and limited treatment options, with a median age of diagnosis at 68 years [8][9] - Approximately 50% of AML patients are not fit for intensive treatment, leading to a low overall survival rate of 25% over three years for those receiving standard low-intensity chemotherapy [9]

Core Insights - Vaxart has entered into an exclusive license agreement with Dynavax for its COVID-19 oral pill vaccine candidate, potentially generating up to $700 million in cumulative proceeds plus royalties [1][4][3] - The company has completed enrollment of approximately 5,400 participants in its 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][9] - Vaxart reported positive data from its Phase 1 clinical trial for its second-generation oral norovirus vaccine, indicating improved protection against infection [1][3] COVID-19 Vaccine Developments - The exclusive agreement with Dynavax includes a $25 million upfront license fee and a $5 million equity investment, with additional potential payments of $50 million and up to $195 million in regulatory milestone payments [4] - Vaxart retains operational and financial responsibility for the oral COVID-19 vaccine program through the completion of the ongoing Phase 2b clinical trial [4] - The company has received $125.9 million in cash payments associated with its COVID-19 vaccine program as of September 30, 2025 [9] Norovirus Vaccine Developments - Vaxart's second-generation oral pill norovirus vaccine constructs have shown significantly stronger antibody responses compared to first-generation constructs [3][9] - The company plans to publish complete results of the Phase 1 study in a peer-reviewed journal and is exploring partnership opportunities for its norovirus candidate [3][9] Financial Results for Q3 2025 - Vaxart reported revenue of $72.4 million for Q3 2025, a significant increase from $4.9 million in Q3 2024, primarily from government contracts [9][15] - Research and development expenses rose to $75.9 million in Q3 2025 from $15.1 million in Q3 2024, mainly due to increased clinical trial expenses [9][15] - The net loss for Q3 2025 was $8.1 million, 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 [9][15] Cash Position and Runway - As of September 30, 2025, Vaxart had cash, cash equivalents, and investments totaling $28.8 million, with a current runway extended into the second quarter of 2027 following the Dynavax agreement [1][9]

Core Points - Vaxart, Inc. will host a conference call to discuss its third quarter 2025 financial results on November 13, 2025, at 4:30 p.m. ET [2] - A stockholder fireside chat is scheduled for November 18, 2025, at 4:30 p.m. ET, where senior management will address frequently asked questions from stockholders [3] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform that allows for non-refrigerated storage and eliminates needle-stick injury risks [5] - The company's vaccine development programs include oral vaccines targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [5] - Vaxart has filed extensive domestic and international patent applications for its oral vaccination technology, which utilizes adenovirus and TLR3 agonists [5]

Core Insights - Evaxion A/S has made significant advancements in its AI-Immunology™ powered vaccine development, particularly in cancer and infectious diseases, showcasing strong data from its lead asset, EVX-01, and successfully out-licensing EVX-B3 to MSD [2][8][20] Business Highlights - The company has validated its technology and strategy through impressive data from EVX-01, which targets multiple neoantigens in cancer vaccines, and the out-licensing of EVX-B3 confirms its capabilities in infectious disease vaccines [2][8] - Evaxion's cash runway has been extended to the second half of 2027, bolstered by a $7.5 million payment from MSD and $7.2 million raised from capital market activities [8][25] - The appointment of Dr. Helen Tayton-Martin as the new CEO is expected to bring over 30 years of experience in biotech M&A and business development [8] Research & Development Update - The phase 2 trial of EVX-01 in advanced melanoma patients showed an Objective Response Rate (ORR) of 75%, with 12 out of 16 patients responding clinically, and 92% of patients still responding at the two-year follow-up [6][10] - Evaxion has expanded its pipeline with EVX-04, targeting non-conventional ERV tumor antigens for acute myeloid leukemia (AML), developed using the AI-Immunology™ platform [12][15] - The company has developed an automated vaccine design module to enhance the efficiency and quality of vaccine development, reducing design time from months to days [17][18] Financial Performance - For Q3 2025, Evaxion reported a net income of $4.6 million, a significant improvement from a net loss of $1.9 million in Q3 2024, driven by revenue from MSD's option exercise [27][28] - Revenue for the quarter was $7.5 million, primarily from the MSD option exercise and included contributions from the Gates Foundation [28] - Research and development expenses were $3.1 million for Q3 2025, compared to $2.6 million in the same period last year, while general and administrative expenses decreased to $1.4 million from $2.1 million [29][30] Equity and Cash Position - As of September 30, 2025, cash and cash equivalents were $10.6 million, up from $6.0 million at the end of 2024, with total equity improving to $16.6 million from a negative equity of $(1.7) million [32][34] - The company has successfully managed its financial strategy, resulting in improved equity and extended cash runway, with an operational cash burn expected to be approximately $14 million in 2025 [34]

Core Insights - Evaxion A/S is set to provide a business update and report its Q3 2025 financial results on October 31, 2025, before the Nasdaq CM opens [1] - The company's Executive Management will host a conference call and webcast on the same day at 14:30 CET/08:30 EST, which is open to the public [2] - Evaxion specializes in AI-Immunology™ powered vaccines, focusing on developing novel immunotherapies for cancer, bacterial diseases, and viral infections [4] Company Overview - Evaxion A/S is a pioneering TechBio company utilizing its AI platform, AI-Immunology™, to decode the human immune system [4] - The company has developed a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline targeting bacterial and viral diseases with high unmet medical needs [4] - Evaxion aims to transform patients' lives by providing innovative and targeted treatment options [4]

Financial Position - Evaxion A/S has raised a total of $7.2 million recently, with $4.5 million from an at-the-market offering and $2.7 million from the exercise of investor warrants [2][7] - The company now has sufficient cash to fund its operations and R&D programs into the second half of 2027, extending from the first half of 2027 [1][7] Debt Management - By the end of the second quarter of 2025, Evaxion had cash on hand of $14.7 million and a debt of $9.2 million [4] - The debt was reduced by $4.1 million through a debt-to-equity conversion agreement with the European Investment Bank in July 2025, enhancing the company's equity position [4] Operational Insights - Evaxion expects to incur an operational cash spend of $14 million in 2025 [4] - The recent exercises of investor warrants have decreased the number of outstanding warrants to purchase Evaxion American Depositary Shares (ADSs) by 1.0 million, leaving a total of 2.8 million outstanding warrants [3][7] Company Overview - Evaxion is a clinical-stage TechBio company that utilizes its AI-Immunology™ platform to develop vaccines targeting cancer, bacterial diseases, and viral infections [5] - The company is focused on creating novel personalized vaccines and has a pipeline addressing high unmet medical needs in infectious diseases [5]

Core Insights - Vaxart, Inc. is presenting research on its second-generation norovirus oral pill vaccine candidate at IDWeek 2025, highlighting advancements in its vaccine development efforts [1][2] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [2] - 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 [2] - Vaxart's current development programs include vaccines targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [2] - The company has filed broad domestic and international patent applications for its proprietary technology related to oral vaccination using adenovirus and TLR3 agonists [2] Presentation Details - The presentation at IDWeek 2025 will feature an open-label Phase 1 clinical trial demonstrating improved immune responses to norovirus strains GI.1 and GII.4 from a next-generation oral bivalent vaccine candidate [2] - The session is scheduled for October 20, 2025, from 1:45 PM to 3:00 PM ET at the Georgia World Congress Center in Atlanta [2]

Core Insights - Vaxart, Inc. is a clinical-stage biotechnology company focused on developing oral recombinant pill vaccines, with significant advancements in norovirus and COVID-19 programs to be presented at the World Vaccine Congress Europe 2025 [1][2] Company Overview - Vaxart aims to enhance global public health through its innovative oral pill vaccine platform, addressing serious health challenges such as norovirus and COVID-19 [2] - The company’s proprietary delivery platform has shown the ability to generate systemic and mucosal immune responses, along with a favorable safety profile in clinical trials [2][4] - Vaxart's vaccine candidates include oral vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4] Presentation Details - Vaxart will present two key research updates at the World Vaccine Congress: 1. Title: Oral bivalent vaccine for norovirus protection, focusing on recent improvements in immunogenicity and efficacy, presented by Dr. Sean Tucker on October 15 at 11:45 a.m. CEST [3] 2. Title: Oral Covid Vaccine - Clinical update from phase 1 to phase 2B, also presented by Dr. Sean Tucker on October 15 at 3:45 p.m. CEST [3]

Core Insights - Evaxion A/S is set to present new data for its lead asset EVX-01, a personalized cancer vaccine, at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting [1] - The ongoing phase 2 trial of EVX-01 is investigating its efficacy in combination with Merck's KEYTRUDA® for advanced melanoma patients [3][5] - EVX-01 has shown promising results with overall response rates of 69% and 67% in advanced melanoma patients [6] Presentation Details - New biomarker and immune data from the phase 2 trial will be presented at SITC 2025, with two-year clinical efficacy data to be shared at the ESMO 2025 congress on October 17, 2025 [2][8] - The SITC presentation will include an abstract titled "Immune correlates of clinical response following treatment with the personalized cancer vaccine EVX-01 and Pembrolizumab in advanced melanoma patients" [9] About EVX-01 - EVX-01 is designed using Evaxion's AI-Immunology™ platform, targeting the unique tumor profile and immune characteristics of each patient [5][10] - The vaccine aims to engage the patient's immune system to mount a targeted response against tumors, representing a first-line treatment option for multiple advanced solid cancers [5] Clinical Trial Insights - The phase 2 trial combines EVX-01 with KEYTRUDA®, allowing for a personalized approach to treatment based on individual patient biology [3] - The trial has already provided strong one-year interim data, contributing to a robust data package for EVX-01 [2][8]

Core Insights - Evaxion A/S has out-licensed its vaccine candidate EVX-B3 to MSD, receiving an initial cash payment of $7.5 million and potential future payments totaling up to $592 million [1][2][10] - The EVX-B3 vaccine, currently in preclinical development, targets a pathogen linked to serious medical complications and aims to address a significant global health issue [3][4] - The collaboration with MSD validates Evaxion's AI-Immunology™ platform, which has identified novel vaccine targets for challenging pathogens [4][5] Financial Implications - The cash payment extends Evaxion's cash runway into the first half of 2027, allowing continued investment in its AI-Immunology™ platform and R&D projects [6] - Future milestone payments from MSD for EVX-B3 could reach up to $592 million, along with royalties on net sales [2][10] - Should MSD exercise its option on EVX-B2, Evaxion would receive an additional cash payment of $2.5 million and similar milestone and royalty structures as with EVX-B3 [9][10] Development and Collaboration - The collaboration between Evaxion and MSD began in September 2023 and has now expanded to include EVX-B2, a preclinical vaccine candidate against Gonorrhea [7][8] - The evaluation period for EVX-B2 has been extended, with a decision on potential licensing expected in the first half of 2026 [8][9] - MSD will assume full responsibility for the further development of EVX-B3, allowing Evaxion to focus on its strategic partnerships [2][10]