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]

Evaxion Biotech (EVAX) Q1 2025 Earnings Call May 27, 2025 08:30 AM ET Company Participants Christian Kanstrup - Chief Executive OfficerBirgitte Rønø - Chief Scientific OfficerThomas Schmidt - CFO Conference Call Participants Thomas Flaten - Senior Research Analyst Operator Good day, and thank you for standing by. Welcome to the Evaction First Quarter twenty twenty five Conference Call and Webcast. At this time, all participants are in listen only mode. After the speakers' presentation, there will be the que ...

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.

Core Viewpoint - Evaxion A/S has initiated a one-year extension of its ongoing phase 2 trial for its personalized cancer vaccine EVX-01, aimed at treating advanced melanoma, leveraging its AI-Immunology™ platform to explore the vaccine's long-term clinical and immune benefits [1][2][4]. Group 1: Trial Details - The first patient has been dosed in the one-year extension of the trial, which will involve two additional doses of EVX-01 as monotherapy [3]. - The initial two years of the trial involved EVX-01 in combination with standard anti-PD-1 therapy, and the extension phase allows for evaluation of EVX-01 as a standalone treatment [4][5]. - The trial extension incurs minimal costs since trial sites are already operational and the vaccine has been produced [2][10]. Group 2: Clinical Data and Results - Interim one-year data presented at the ESMO Congress in September 2024 showed a 69% Overall Response Rate, with tumor target lesions reduced in 15 out of 16 patients [8]. - At the AACR Annual Meeting in April 2025, it was reported that 80% of EVX-01's vaccine targets triggered a targeted immune response, indicating favorable outcomes compared to other treatment approaches [9]. - The completed phase 1/2a clinical trial demonstrated that 67% of metastatic melanoma patients had objective clinical responses, highlighting the predictive power of the AI-Immunology™ platform [12]. Group 3: Product and Technology Overview - EVX-01 is a personalized peptide-based cancer vaccine designed to engage the patient's immune system against tumors, tailored to each individual's unique tumor profile [6][11]. - The AI-Immunology™ platform is central to Evaxion's approach, enabling the development of novel immunotherapies for various diseases, including cancer [13].