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.

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].

Core Insights - Evaxion Biotech A/S has announced new data highlighting the effectiveness of its personalized cancer vaccine EVX-01 in generating a targeted immune response against advanced melanoma [1][4] - The ongoing phase 2 trial of EVX-01 shows an 80% tumor-specific immune response rate, an improvement from previous rates of 71% and 79% reported at earlier conferences [2][3][9] - The trial is set to provide two-year clinical data in the second half of 2025, with an extension allowing for a more comprehensive evaluation of EVX-01's potential [5] Company Overview - Evaxion Biotech A/S specializes in AI-Immunology™ powered vaccines, focusing on personalized treatments for cancer and other diseases [1][12] - The company’s lead clinical asset, EVX-01, is designed to target the unique tumor profiles of individual patients, enhancing the immune system's ability to combat cancer [10][8] Clinical Trial Details - The phase 2 trial investigates EVX-01 in combination with Merck's KEYTRUDA® (pembrolizumab) for patients with advanced melanoma [6] - The trial has demonstrated overall response rates of 69% and 67% in previous analyses, indicating a strong correlation between clinical responses and AI-Immunology™ predictions [11] Presentation Information - New immune data will be presented at the AACR Annual Meeting, with details including the abstract title and session information [7]

Core Insights - Evaxion Biotech A/S will participate in the World Vaccine Congress from April 21-24, 2025, in Washington, D.C., showcasing its AI-Immunology™ powered vaccine development [1][3] - The company will present two key topics: the application of its AI-Immunology™ platform for cancer vaccine target discovery and for infectious disease vaccine target discovery [2][4] Company Overview - Evaxion is a clinical-stage TechBio company that utilizes its proprietary AI-Immunology™ platform to develop innovative immunotherapies for cancer and infectious diseases [5] - The company has a clinical-stage oncology pipeline focused on personalized vaccines and a preclinical pipeline addressing bacterial and viral diseases with significant unmet medical needs [5] Event Details - Birgitte Rønø, Chief Scientific Officer, will present on April 23, 2025, at 11:40 ET regarding AI-powered antigen target discovery for cancer vaccines [4] - Pär Comstedt, Vice President of Infectious Disease Vaccine Development, will present on the same day at 15:10 ET about AI-powered target discovery for infectious disease vaccines [4]

Financial Data and Key Metrics Changes - In 2024, the company recorded revenue of $3.3 million from an optional license agreement with MSD, with expectations for future income from this agreement [44] - The net loss for 2024 was $10.6 million, an improvement from a loss of $22 million in 2023, driven by increased revenue and reduced R&D and G&A expenses [48][49] - Cash and cash equivalents at the end of December 2024 were $6 million, up from $5.6 million at the end of 2023, with sufficient funds projected to last into mid-2026 [46][51] Business Line Data and Key Metrics Changes - The ongoing EBX01 Phase II trial showed a 69% overall response rate at the one-year readout, with 15 out of 16 patients showing a reduction in tumor target lesions [8][33] - The company has established a new precision cancer vaccine concept targeting non-conventional endogenous retroviruses, broadening the potential of cancer vaccines [9][35] Market Data and Key Metrics Changes - The partnership with MSD, established in September 2024, is expected to generate significant future income, with a potential option exercise in the second half of 2025 [6][15] - The company aims to generate at least two new agreements in 2025, focusing on a multi-partner approach to build its pipeline [17][19] Company Strategy and Development Direction - The company is focused on deriving value from both its platform and pipeline, emphasizing a dual focus on platform and pipeline development [18][20] - The strategy includes entering into high-value, low-risk partnerships around target discovery and the development of novel vaccine candidates [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong position, highlighting the successful execution of the pipeline and the transformative agreement with MSD [55][56] - The company is well-positioned for strong execution in 2025, with key milestones and value triggers identified [56] Other Important Information - The company extended the EVX01 trial from two to three years to collect three-year outcome data, which will provide a strong data package [27][34] - The company has raised $17 million through public offerings and other capital market activities, extending its cash runway to mid-2026 [12][21] Q&A Session Summary Question: How does the company ensure new pipeline candidates are partnerable assets? - The company emphasizes unmet medical needs and commercial potential as primary criteria, engaging in early dialogues with potential partners to shape preclinical programs accordingly [62][64] Question: What is the status of the CMV vaccine program after Expression Biotech returned rights? - The decision was made by Expression Biotech, and the company is confident in its plan to drive the program forward independently, exploring alternative solutions for antigen production [68][70] Question: What data should be expected at the upcoming AACR meeting regarding EBX01? - The company will present biomarker data and additional T cell data from patients, providing a more in-depth analysis than previously shared [80] Question: What types of cancers could the ERV vaccines target? - The company has identified specific cancer indications with a high burden where ERV sequences are shared across patients, with plans to share more information by the end of the year [85][86] Question: Will any data be released ahead of submitting to MSD for their decision on exercising the option for EVX B2 and B3? - No additional data will be released for B2, as MSD is conducting confirmatory work, while B3 is finalizing the current work plan [88][89]

Financial Data and Key Metrics Changes - In 2024, the company recorded revenue of $3.3 million from an optional license agreement with MSD, with expectations for future income from this agreement [44] - The net loss for 2024 was $10.6 million, an improvement from a loss of $22 million in 2023, driven by increased revenue and reduced R&D and G&A expenses [48][49] - Cash and cash equivalents at the end of December 2024 were $6 million, up from $5.6 million at the end of 2023, with sufficient funds projected to last into mid-2026 [46][51] Business Line Data and Key Metrics Changes - The ongoing EBX01 Phase II trial showed a 69% overall response rate at the one-year readout, with 15 out of 16 patients showing a reduction in tumor target lesions [8] - The company has established a new precision cancer vaccine concept targeting non-conventional endogenous retroviruses, broadening the potential of cancer vaccines [9][10] Market Data and Key Metrics Changes - The partnership with MSD, established in September 2024, is expected to lead to potential option exercises in the second half of 2025, which could generate up to $10 million in income [6][15] - The company aims to generate at least two new agreements in 2025, focusing on a multi-partner approach to expand its pipeline [17][18] Company Strategy and Development Direction - The company is focused on deriving value from both its platform and pipeline, emphasizing the complementarity of its AI immunology capabilities [18][20] - The strategy includes entering into high-value, low-risk partnerships for target discovery and the development of novel vaccine candidates [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong position, highlighting the successful execution of the pipeline and the transformative agreement with MSD [55][56] - The company is well-positioned for strong execution in 2025, with key milestones and value triggers locked in [56] Other Important Information - The company extended the EVX01 trial from two to three years to collect three-year outcome data, which is expected to enhance the data package for the personalized cancer vaccine [27] - The company has raised $17 million through public offerings and other capital market activities, extending its cash runway to mid-2026 [12][21] Q&A Session Summary Question: How does the company ensure new pipeline candidates are partnerable assets? - The company emphasizes unmet medical needs and commercial potential as primary criteria, engaging in early dialogues with potential partners to shape preclinical programs accordingly [62][64] Question: What data should be expected at the AACR regarding EBX01? - The company will present biomarker data and additional T cell data, providing a more in-depth analysis of the ongoing trial [80] Question: What types of cancers could the ERV vaccines target? - The company has identified specific cancer indications with a high burden where ERV sequences are shared across patients, with further information expected by the end of the year [86] Question: Will any data be released ahead of submitting to MSD for EVX B2 and B3? - No additional data will be released for B2, as MSD is conducting confirmatory work on existing data, while B3 is in the finalization stage of the work plan [89]