Core Insights - Evaxion A/S is a clinical-stage TechBio company focused on developing AI-Immunology™ powered vaccines, with a financial calendar for 2026 announced [1][2] Financial Calendar - March 5, 2026: Business update and full year 2025 financial results [1] - April 16, 2026: Annual General Meeting [1] - May 7, 2026: Business update and first quarter 2026 financial results [1] - August 20, 2026: Business update and second quarter 2026 financial results [1] - November 19, 2026: Business update and third quarter 2026 financial results [1] Company Overview - Evaxion utilizes its proprietary AI platform, AI-Immunology™, to develop novel immunotherapies targeting cancer, bacterial diseases, and viral infections [2] - The company has a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline for infectious diseases with high unmet medical needs [2] - Evaxion aims to transform patient care by providing innovative and targeted treatment options [2]

Core Insights - Evaxion A/S has presented new data on its AI-designed personalized cancer vaccine EVX-01 at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, highlighting immune responses following treatment [1][8] - The vaccine targets multiple neoantigens and aims to induce a clinically relevant immune response, particularly in patients with advanced melanoma when combined with MSD's KEYTRUDA® [2][4] Company Overview - Evaxion is a clinical-stage TechBio company that utilizes its AI-Immunology™ platform to develop innovative vaccines for cancer and infectious diseases [6] - The company is focused on transforming patient care through targeted treatment options, leveraging AI to decode the human immune system [6] Clinical Data - The new biomarker and immune data presented is derived from a phase 2 trial of EVX-01 in combination with KEYTRUDA®, showing promising immune responses in patients [2][8] - Longitudinal blood samples were analyzed to understand treatment-induced changes in immune cell populations, revealing a rapid and sustained induction of EVX-01-specific T-cells in some patients [3] Market and Community Response - The presentation of the new data at SITC follows the recent disclosure of two-year clinical efficacy data from the same phase 2 trial, indicating strong interest from the medical community [4][8]

Financial Data and Key Metrics Changes - The cash runway has been extended to 2027, supported by a $7,500,000 exercise fee from MSD and additional capital market funding [5][18] - The company reported a quarterly income of $4,600,000, driven by the MSD deal and a net financial gain of $1,300,000 from a debt conversion [20][19] - Equity at the end of the quarter stands at $16,600,000, with a reduction in outstanding warrants to 2,800,000 [20][21] Business Line Data and Key Metrics Changes - The EVX-one program has shown a 75% objective overall response rate in a two-year clinical trial, with 11 out of 12 patients maintaining a sustained response [10][11] - The EVX-four program has been added to the pipeline, targeting acute myeloid leukemia with a novel AI-designed cancer vaccine [8][9] Market Data and Key Metrics Changes - The MSD deal represents the first in-licensing of an AI-discovered vaccine candidate by a major pharmaceutical company, indicating strong market validation [6][18] - The company is experiencing increased interest in its oncology and infectious disease programs, reflecting a growing market engagement [39] Company Strategy and Development Direction - The company aims to create value through partnerships, as evidenced by the MSD deal and ongoing discussions with other potential partners [6][22] - The focus remains on advancing R&D and business development, with multiple partnership discussions ongoing [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's operational momentum and the achievement of 2025 milestones, with expectations for further R&D updates [22] - The management noted that the questions from potential partners have shifted from data quality to applications of technology in other cancer indications, indicating a positive reception of clinical data [26] Other Important Information - The automated vaccine design module has been enhanced, significantly reducing design time and costs, positioning the company at the forefront of AI-driven vaccine innovation [12][14] - The evaluation period for the EVX-D2 program has been extended, allowing for further assessment [6] Q&A Session Summary Question: What are the key questions from potential partners regarding EVX-one? - The focus has shifted to how the technology can be applied to other cancer indications, with discussions ongoing about potential next steps for licensing [26] Question: Can you provide details on the EVX-four target in AML? - The company is targeting endogenous retroviral sequences from the dark genome, which are highly expressed in AML, allowing for a shared vaccine approach across patients [30] Question: How has the breadth of partnering conversations evolved? - There is increasing interest across the R&D pipeline, with dialogues centered on both target discovery and existing vaccine candidates [39] Question: Can the automated design module be used for partnerships? - The new module can support internal programs and has potential for monetization through partnerships, allowing other companies to utilize the technology [45] Question: What additional data is expected from the ongoing EVX-one trial? - Future presentations will include deeper analyses of immune profiles from patient samples collected during the trial [47] Question: What is the status of the MSD relationship regarding EVX-D2? - MSD is currently evaluating provided data and conducting confirmatory analyses, with an expected response in the first half of next year [49]

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 has expanded its R&D pipeline with the introduction of EVX-04, an AI-designed precision cancer vaccine candidate targeting acute myeloid leukemia (AML) [1][10] - The vaccine is designed to target non-conventional ERV tumor antigens from the dark genome, which are present in tumors but absent in normal tissue, making them attractive for cancer vaccines [2][9] - EVX-04 aims to be an "off-the-shelf" vaccine, preproduced and ready for immediate administration after diagnosis, effective across a wide range of patients regardless of immune and tumor ERV antigen differences [4][5] Research and Development - The AI-Immunology™ platform has identified ERV antigens in patient tumor sequencing data and selects optimal fragments for effective vaccine targets [3][9] - New preclinical data shows that EVX-04 induces strong T-cell responses and kills cancer cells, with results to be presented at the American Society of Hematology (ASH) Annual Meeting on December 6, 2025 [6][10] - The presentation will include an abstract titled "Dark genome interrogation identifies novel antigens in acute myeloid leukemia – developing an off-the-shelf vaccine from machine learning to clinic" [8] Company Overview - Evaxion is a pioneering TechBio company utilizing its AI platform, AI-Immunology™, to develop novel immunotherapies for cancer and infectious diseases [12] - The company is committed to transforming patient outcomes by providing innovative and targeted treatment options [12]

Core Points - Evaxion A/S, a clinical-stage TechBio company, will provide a business update and report its Q3 2025 financial results on November 6, 2025 [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 developing AI-Immunology™ powered vaccines, focusing on immunotherapies for cancer, bacterial diseases, and viral infections [4] Company Overview - Evaxion A/S utilizes its proprietary AI platform, AI-Immunology™, to decode the human immune system and develop novel immunotherapies [4] - The company has 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]

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 Viewpoint - Evaxion A/S has appointed Dr. Helen Tayton-Martin as the new CEO, effective November 24, 2025, marking a significant leadership change for the company as it continues to develop its AI-Immunology™ powered vaccines [1][4]. Company Leadership - Dr. Helen Tayton-Martin holds a Ph.D. in molecular immunology and an MBA from London Business School, with extensive experience in the biotech sector, including co-founding Adaptimmune and overseeing its growth and strategic partnerships [2][9]. - Birgitte Rønø, who served as interim CEO, will return to her role as Chief Scientific Officer, continuing to lead research and development efforts [5][9]. Board Changes - Dr. Tayton-Martin will step down from Evaxion's Board of Directors upon assuming the CEO role, while Jens Bitsch-Norhave will join the Board as an adviser and observer, with plans to seek election as a board member in 2026 [7][8]. Company Strategy and Potential - Dr. Tayton-Martin expressed excitement about joining Evaxion at a pivotal time, highlighting the company's AI-Immunology platform and recent achievements, such as the out-licensing of EVX-B3 to MSD and promising data for EVX-01 presented at ESMO [6][9]. - Evaxion is focused on developing novel immunotherapies for cancer and infectious diseases, leveraging its AI technology to address high unmet medical needs [11].

Group 1 - Evaxion (NASDAQ:EVAX) is identified as a promising investment opportunity with significant upside potential, highlighted by an increase in price target from $6 to $11 by Lake Street analyst Thomas Flaten, who maintains a Buy rating on the shares [1][2] - The recent announcement of two-year Phase 2 data for Evaxion's personalized cancer vaccine, EVX-01, in advanced melanoma has contributed to this positive sentiment, indicating the vaccine's potential in treating multiple advanced solid cancers [2] - EVX-01 is recognized as Evaxion's lead clinical asset, and the positive data not only supports the efficacy of the vaccine but also validates Evaxion's overall platform, especially in light of Merck & Co. Inc.'s option exercise for EVX-B3 [2][3] Group 2 - Evaxion is a clinical-stage biotech company focused on developing AI-powered immunology vaccines, previously known as Evaxion Biotech until its name change in May 2025 [3] - Merck & Co. Inc. is a key player in the healthcare sector, providing a range of products including human health pharmaceuticals, veterinary pharmaceuticals, and vaccines [3]