Evaxion Biotech (EVAX) Q1 2025 Earnings Call May 27, 2025 08:30 AM ET Speaker0 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 question and answer session. To ask a question during the session, you will need to press 11 on your telephone keypad. You will hear an automatic message advising your hand is raised. To withdraw a ...

COPENHAGEN, Denmark, May 27, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, provides business update and announces first quarter 2025 financial results.Business highlights (since last quarterly update)Evaxion has made good progress with continued execution of our strategy and plans. We have achieved the first two milestones for the year and are tracking towards future milestones and value catalysts. Highlights inclu ...

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.

Generation of additional clinical data allows for a more comprehensive assessment of the full potential of EVX-01, while strengthening the already strong clinical data packageWill provide insights into the durability of immune and clinical responses up to three yearsExtension phase enables exploration of EVX-01 as monotherapy, following initial combination with standard of careMinimal costs are associated with the extension as clinical sites are already running and the vaccines are producedThe trial remains ...

COPENHAGEN, Denmark, April 28, 2025 - Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical- stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces new data underscoring the ability of cancer vaccine EVX-01 to drive a targeted and robust immune response. Designed with Evaxion's AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). New immune data from the ongoing phase 2 trial w ...

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]

C O R P O R A T E P R E S E N T A T I O N – A P R I L 2 0 2 5 DE C ODI N G T HE H UM A N I M MUN E SY ST EM T O DE VEL OP NO VEL V A CC I N ES FOR C A NC E R A N D I N FEC T I OUS DI SEA SE S WI T H OUR A I - I MM UN OL OGY P LA T FO RM EVAX EVAX A black and Forward-looking statement This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words "target," "believe ...