Core Insights - Evaxion A/S will present two-year clinical efficacy data from its phase 2 trial of the personalized cancer vaccine EVX-01 at the ESMO Congress 2025 in Berlin [1][3] - EVX-01, developed using Evaxion's AI-Immunology™ platform, is currently being evaluated for advanced melanoma treatment, showing a 69% Overall Response Rate in interim data [2][4] - The phase 2 trial combines EVX-01 with MSD's KEYTRUDA® therapy, tailored to each patient's unique tumor profile [4][6] Company Overview - Evaxion is a clinical-stage TechBio company focused on AI-driven immunotherapies for cancer and infectious diseases [9] - The company utilizes its AI-Immunology™ platform to create personalized vaccines, aiming to enhance immune responses against tumors [6][9] - Evaxion's pipeline includes novel personalized vaccines for oncology and preclinical candidates for bacterial and viral diseases [9] Clinical Trial Details - The phase 2 trial of EVX-01 has shown promising results, with 67% of metastatic melanoma patients achieving objective clinical responses in earlier trials [7] - The upcoming presentation at ESMO will include data on T-cell responses and disease control over two years [5][6] - The trial emphasizes the correlation between AI predictions and immune responses, highlighting the platform's predictive capabilities [2][7]

Core Insights - Evaxion A/S has finalized an agreement with the European Investment Bank (EIB) to convert €3.5 million of its €7 million loan into equity, enhancing its capital structure and financial flexibility [1][2][6] Group 1: Financial Impact - The conversion involves EIB purchasing ordinary Evaxion warrants at a price of $4.87, which represents a premium of 89% over the share price at market close yesterday [2][6] - This agreement immediately increases Evaxion's equity by $4.1 million (€3.5 million), while also substantially reducing overall liabilities and simplifying the balance sheet [2][6] Group 2: Management Commentary - The CFO of Evaxion, Thomas F. Schmidt, expressed satisfaction with the favorable terms of the agreement, highlighting its importance for cash flow and financial management [3]

Core Insights - Evaxion A/S announces key executive management changes to enhance value from its AI-Immunology™ platform and pipeline [1] - Christian Kanstrup steps down as CEO, with Dr. Birgitte Rønø appointed as interim CEO while a search for a new permanent CEO begins [2][5] - Thomas Schmidt is appointed as the permanent CFO, having previously served as interim CFO since November 2024 [3][4] Management Changes - The company is actively searching for a new CEO with a strong focus on business development and transformational leadership [5] - Dr. Rønø has been with Evaxion since 2017 and has significant experience in scientific and strategic roles [2] - Thomas Schmidt's financial expertise is expected to support the company's operations and leadership during this transition [4] 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 [7] - The company has a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline for infectious diseases, addressing high unmet medical needs [7]

Core Insights - Evaxion A/S is developing a new preventive vaccine, EVX-B4, against Group A Streptococcus (GAS), which causes hundreds of millions of infections globally each year [1][2] - The AI-Immunology™ platform has been utilized to identify novel vaccine targets for GAS, enhancing the speed and effectiveness of target discovery and preclinical development [2][3] - The addition of EVX-B4 to the R&D pipeline aligns with Evaxion's strategy to increase partnership opportunities and out-licensing assets [4][9] Company Overview - Evaxion is a clinical-stage TechBio company focused on AI-driven vaccine development, with a pipeline that includes five infectious disease candidates and three cancer candidates [4][10] - The company aims to transform patient care by providing innovative immunotherapies for high unmet medical needs in cancer and infectious diseases [10] Industry Context - Group A Streptococcus infections can lead to severe health complications, including rheumatic heart disease and necrotizing fasciitis, with significant mortality rates if untreated [5][6] - The U.S. has seen an increase in invasive GAS disease rates since 2014, with an estimated 20,000 to 27,000 cases and 1,800 to 2,400 deaths annually [6] - Globally, rheumatic heart disease is a major cause of cardiovascular disease, with the World Health Organization estimating 470,000 new cases of acute rheumatic fever and 282,000 new cases of rheumatic heart disease each year [7]

Core Viewpoint - Evaxion A/S has received funding from the Gates Foundation to develop a new vaccine aimed at eradicating polio, utilizing its AI-Immunology™ platform to create innovative vaccine constructs [1][3][9] Company Overview - Evaxion A/S is a clinical-stage TechBio company focused on AI-powered vaccine development, particularly in the field of immunology [1][10] - The company employs its proprietary AI-Immunology™ platform to decode the human immune system and develop novel immunotherapies for various diseases [10] Project Details - The project will leverage Evaxion's AI-Immunology™ platform to identify and combine different antigens to combat the polio virus, with the goal of designing new vaccine constructs [3][4] - The funding from the Gates Foundation will cover the project's costs, allowing Evaxion to pursue this initiative without financial burden [3][4] Polio Context - Despite the availability of polio vaccines for decades, the disease remains a global health threat, with a risk of resurgence if not fully eradicated [2][8] - Polio primarily affects children under five, with one in 200 infections leading to irreversible paralysis, and a significant mortality rate among those paralyzed [7] Vaccine Innovation - Current polio vaccines rely on inactivated or attenuated viruses, which pose safety risks; the new approach aims to eliminate the use of live viruses in vaccine production [5][6] - The project seeks to create a safer and more effective alternative to existing polio vaccines, addressing unmet needs in the context of polio eradication efforts [6][8]

Financial Data and Key Metrics Changes - The company reported a cash position of $17.8 million at the end of Q1 2025, significantly up from $6 million at the end of 2024, indicating improved liquidity [23] - The operating loss for Q1 2025 was $3.9 million, compared to $4.4 million in the same period last year, reflecting lower operating expenses [24] - Total equity at the end of Q1 2025 was $10.3 million, a significant increase from the end of 2024, strengthening the company's financial position [27] Business Line Data and Key Metrics Changes - The company is on track to complete at least two new business development deals in 2025, despite increased risks due to the macroeconomic environment [6][7] - The EVX-one cancer vaccine continues to yield positive data, with 80% of neoantigens eliciting an immune response, which is higher than similar candidates [12][16] Market Data and Key Metrics Changes - The current turmoil in financial markets has led to potential partners pausing discussions, impacting deal execution [6][7] - The company is focusing on potential partners less affected by the macro environment to mitigate risks [7] Company Strategy and Development Direction - The company aims to maintain a strong execution momentum with a focus on value realization through a multi-partner approach [30] - Key milestones for 2025 include the Merck decision on option exercise and the EVX-one Phase II two-year readout, which are expected in the second half of the year [14][31] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the increased regulatory uncertainty and its impact on deal execution but remains confident in achieving business development targets [6][7] - The company has a cash runway until mid-2026, which supports upcoming clinical data readouts and potential option exercises from Merck [29][31] Other Important Information - The company has been active at various scientific conferences, presenting strong data and engaging with potential partners [12][13] - The first patient has been dosed in the one-year trial extension for EVX-one, allowing for better understanding of the vaccine's standalone effect [18] Q&A Session Summary Question: Was there a meaningful bias between CD4 and CD8 positive T cells in the two-year EVX-one data? - Management noted that CD4 T cells were primarily observed, with CD8 T cells present in approximately half of the patients, driven by the peptide-based nature of the vaccine [33] Question: Is the intention for the lead ERV candidate to be an ERV hotspot vaccine only, or will it combine with personalized cancer neoantigens? - The precision concept aims for an off-the-shelf vaccine with broad coverage, not initially combining it with other vaccine types [35] Question: Thoughts on the UK repurposing a meningitis vaccine for gonorrhea? - Management highlighted the urgency for effective preventive therapies for gonorrhea, indicating comfort regarding the commercial potential for EBXB2 [36]

Financial Data and Key Metrics Changes - The company reported a cash position of $17.8 million at the end of Q1 2025, significantly up from $6 million at the end of 2024, indicating improved liquidity [22] - The operating loss for Q1 2025 was $3.9 million, compared to $4.4 million in the same period last year, reflecting lower operating expenses [23] - Total equity at the end of Q1 2025 was $10.3 million, a significant increase from the previous year, and well above NASDAQ listing requirements [26] Business Line Data and Key Metrics Changes - The company is on track to complete at least two new business development deals in 2025, despite increased risks due to macroeconomic conditions [6][7] - EVX-one, the personalized peptide-based cancer vaccine, is currently in Phase II trials and has shown positive immune response data, with 80% of vaccine targets eliciting a specific immune response [15][16] Market Data and Key Metrics Changes - The current turmoil in financial markets has led to potential partners pausing discussions, impacting deal execution [6][7] - The company is focusing on potential partners less affected by the macro environment to mitigate risks [7] Company Strategy and Development Direction - The company aims to maintain a strong execution momentum with a focus on value realization through a multi-partner approach [29] - Key milestones for 2025 include the Merck decision on option exercise and the two-year readout for EVX-one, which are expected to drive future growth [12][13] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the impact of financial market turmoil and regulatory uncertainty on business development but remains confident in achieving its targets [6][7] - The company has a cash runway until mid-2026, which supports its ongoing projects and potential future income from business development [22][30] Other Important Information - The company has been active in scientific conferences, presenting strong data on EVX-one and engaging with potential partners [11][12] - The first patient has been dosed in the one-year trial extension for EVX-one, allowing for better understanding of the vaccine's standalone effect [16] Q&A Session Summary Question: Was there a meaningful bias between CD4 and CD8 positive T cells in the two-year EVX-one data? - The response indicated that CD4 T cells were mainly observed, with CD8 T cells present in approximately half of the patients, driven by the peptide-based nature of the vaccine [32] Question: Will the lead ERV candidate be an ERV hotspot vaccine only, or will it combine with personalized cancer neoantigens? - The intention is to create an off-the-shelf vaccine with broad coverage, not initially combining it with other types of vaccines [33] Question: Thoughts on the UK repurposing a meningitis vaccine for gonorrhea? - Management noted the urgency for effective therapies for gonorrhea and expressed confidence in the commercial potential for EBXB2, while the scientific rationale for a more precise vaccine is acknowledged [34][35]

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]

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]

Summary of Evaxion Biotech (EVAX) Conference Call - May 22, 2025 Company Overview - **Company**: Evaxion Biotech (EVAX) - **Industry**: Biotechnology, specifically focused on AI-powered drug development and vaccine creation Key Points and Arguments 1. **Funding and Financial Position**: - Raised significant cash early in the year, extending runway into mid-2026 [3] - Merck participated in the latest public offering, holding approximately 20% of the company [3][12] - Potential for an additional $10 million if Merck exercises options on vaccine candidates [4][12] 2. **AI Immunology Platform**: - Evaxion is a pioneer in AI-driven medicine development, founded in 2008 [5] - The platform has been clinically validated and is a key differentiator from newer AI companies [6] - Capable of rapid target discovery, reducing the number of targets tested by 80% compared to conventional methods [16] 3. **Pipeline and Partnerships**: - Focus on both platform and pipeline, allowing for high-value partnerships in vaccine development [7][10] - Collaboration with Merck on developing novel vaccine candidates for infectious diseases with no current vaccines [8][11] - Pipeline includes proprietary candidates for gonorrhea and staph aureus, both addressing significant unmet medical needs [23][28] 4. **Market Opportunities**: - Cancer immunotherapy market projected to reach $280 billion by the end of the decade; infectious disease market expected to be $70 billion [14] - Significant unmet needs in both cancer (10 million deaths annually) and infectious diseases (8 million deaths annually) [13] 5. **Clinical Data and Product Development**: - Lead candidate EVX-one shows a 69% overall response rate in metastatic melanoma, significantly higher than the 33% response rate of the current gold standard [25] - 80% of neoantigens in the vaccine candidates elicited an immune response, indicating strong efficacy [26] 6. **Strategic Ambitions**: - Aim to remain a leading AI-powered biotech company and drive best-in-class drug discovery [29] - Plans to enter at least two new partnerships and select a lead candidate for a precision-based cancer vaccine [32] 7. **Future Outlook**: - Anticipated milestones include Merck's decision on option exercise and upcoming phase two data for EVX-one [31][33] - Strong focus on generating new partnerships and maintaining a robust business development pipeline [30] Additional Important Content - **Partnership Development**: - Merck's involvement has been crucial, participating in multiple financing rounds and showing long-term commitment [45][46] - The partnership allows Evaxion to focus on R&D without incurring further costs for the development of partnered candidates [44] - **Market Perception**: - Despite a strong fundamental position, the market has not fully appreciated the company's potential, as reflected in share price trends [48][49] - The company emphasizes execution of its strategy over short-term market fluctuations [49] - **Technological Advancements**: - Continuous improvement of the AI platform is expected, with potential future applications in quantum computing [40][41] This summary encapsulates the key insights from the conference call, highlighting Evaxion's strategic positioning, financial health, and innovative capabilities in the biotechnology sector.