Summary of Evaxion Biotech A/S Conference Call Company Overview - **Company**: Evaxion Biotech A/S (Ticker: EVAX) - **Industry**: Biotechnology, specifically focusing on AI-powered vaccine development - **Founded**: 17 years ago as an AI company aimed at decoding the human immune system [2][3] Core Business and Strategy - **AI Immunology Platform**: A clinically validated platform for target discovery in vaccine development, significantly faster and more cost-effective than traditional methods [3][5][6] - **Partnerships**: Multi-partner approach with a focus on outlicensing programs by phase two of development, with Merck as a key collaborator and investor holding a 15% stake [4][10] - **Pipeline**: Strong pipeline in both cancer vaccines (e.g., EVX-01 for melanoma) and infectious disease vaccines (e.g., EVX-B2 for gonorrhea) [16][21] Financial Highlights - **Recent Deal**: Historic outlicensing deal with Merck for the EVX-B3 program, providing an immediate cash inflow of $7.5 million and potential milestone payments of up to $592 million [10][11] - **Cash Runway**: Extended cash runway until the second half of 2027, supported by various financial strategies including public offerings and agreements with the European Investment Bank [13][22] Market Potential - **Market Size**: The global market for cancer immunology and infectious disease vaccines is projected to grow significantly, with the infectious disease vaccine market expected to reach $68 billion by 2031 [7][8] - **Unmet Needs**: Focus on diseases with no approved vaccines, such as Staph aureus, gonorrhea, and CMV virus, indicating strong potential for future growth [9] Key Achievements - **Clinical Trials**: EVX-01 showed a 75% overall response rate in a two-year phase two trial, significantly outperforming Merck's Keytruda [18][19] - **Innovative Development**: Introduction of an automated vaccine design module to enhance efficiency and quality in vaccine development [12] Leadership and Team - **New CEO**: Helen Tayton-Martin appointed as CEO, bringing extensive experience from previous roles in the biotech industry [9] - **Experienced Team**: Strong leadership with backgrounds in major pharmaceutical companies, enhancing the company's credibility and operational capability [9] Future Outlook - **Resource Allocation**: Focus on developing infectious disease vaccines to the clinic stage while maintaining a higher investment in oncology programs [26] - **Partnership Opportunities**: Open to collaborations with various pharmaceutical companies, including potential expansions with Merck [27] Investor Insights - **Stock Performance**: The stock has increased by 110% over the last six months, driven by successful milestones and partnerships [29] - **Recognition**: Collaboration with the Gates Foundation for target discovery, highlighting the company's growing reputation in the industry [30] Conclusion - **Investment Case**: Evaxion presents a compelling investment opportunity with its pioneering AI platform, strong pipeline, and strategic partnerships, aiming for continued growth and value creation in the biotech sector [24][30]

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 - 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 commitment to engaging with the scientific community and potential partners [2] - The AI-Immunology™ platform has enabled the identification of unique ERV tumor antigens, which are selectively expressed in tumors but absent in normal tissues, making them ideal targets for cancer vaccines [4][11] Company Overview - Evaxion is a clinical-stage TechBio company focused on developing AI-powered vaccines, particularly in the field of immunology [1][12] - The company utilizes its proprietary AI-Immunology™ platform to decode the human immune system and create novel immunotherapies for various diseases, including cancer [12] Product Details - EVX-04 is designed as an off-the-shelf therapeutic cancer vaccine for acute myeloid leukemia (AML), addressing a significant unmet medical need due to high mortality rates associated with the disease [10] - The vaccine targets multiple non-conventional ERV tumor antigens, which have been shown to elicit specific immune responses and prevent tumor growth in preclinical models [5][10] - The data-driven approach ensures broad tumor coverage, making EVX-04 applicable across various cancers where current immunotherapies are inadequate [6][10] Market Context - AML is characterized by high mortality rates and limited treatment options, with a median age of diagnosis at 68 years and a long-term survival rate of only 40% for younger patients undergoing intensive treatment [8][9] - Approximately 50% of AML patients are not fit for intensive treatment, relying on low-intensity chemotherapy, which has a poor three-year overall survival rate of only 25% [9]

Core Insights - Several biotechnology and pharmaceutical companies experienced significant gains in after-hours trading due to corporate updates and upcoming event announcements [1] Company Updates - Jasper Therapeutics, Inc. (JSPR) saw a 21.51% increase to $2.09 after hours, following the announcement of a webinar on December 2 to present findings from the BEACON study and preliminary data from the ETESIAN study [2] - NRx Pharmaceuticals, Inc. (NRXP) rose 13.39% to $2.71 after hours, with the CEO scheduled to present at NobleCon21 on December 3, discussing the company's expanded focus and clinical revenue progress [3] - Unicycive Therapeutics, Inc. (UNCY) increased by 5.42% to $6.33, with the CEO participating in two upcoming events, although no new announcements were made on Monday [4] - Spruce Biosciences, Inc. (SPRB) shares rose 4.68% to $87.00 after reporting a net loss of $8.2 million for the quarter ending September 30, 2025, an improvement from a net loss of $8.7 million in the previous year [5] - Evaxion A/S (EVAX) added 3.96% to $5.65, announcing progress in its CMV vaccine program with new protective data and ongoing preclinical development [6] - Solana Company (HSDT) gained 3.48% to $3.87, reporting a net loss of $352.8 million for the third quarter, a significant increase from a net loss of $3.7 million in the prior-year period, with revenue totaling $697,000 [7] - Protara Therapeutics, Inc. (TARA) rose 5.04% to $7.08, planning a conference call on December 3 to review interim data from its Phase 2 trial of TARA-002 in bladder cancer patients [8]

Core Insights - Evaxion A/S is advancing its multi-component cytomegalovirus (CMV) vaccine program, EVX-V1, demonstrating protective effects of lead antigens [1][3] - The company utilizes its AI-Immunology™ platform to discover novel CMV antigens that induce specific immune responses and inhibit viral infection [2][4] - The CMV treatment market was valued at $474.6 million in 2023 and is expected to grow at a CAGR of 6.6% from 2024 to 2032, driven by increased awareness and prevalence of CMV infections [7] Company Overview - Evaxion is a clinical-stage TechBio company focused on developing AI-powered vaccines, particularly for CMV and other infectious diseases [1][10] - The company’s proprietary AI-optimized pre-fusion glycoprotein B (gB) antigen shows superior performance in neutralizing CMV compared to traditional antigens [3][9] - Evaxion is actively seeking strategic partnerships to accelerate the development of its vaccine programs [5] Industry Context - CMV infects approximately 60% to 70% of adults in developed countries and nearly 100% in developing economies, highlighting a significant medical need for effective treatments [6][8] - Despite extensive research over decades, no CMV vaccine has been approved to date, underscoring the importance of Evaxion's discoveries [9][10]

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]