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]

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.

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]