Evaxion A/S (NASDAQ: EVAX) Q1 2025 Earnings Call | 05/27/2025

Day of Action: Q1 2025 Conference Call Summary

Day of Action (Evaxion) held its Q1 2025 earnings conference call, highlighting strong progress across its business, R&D pipeline, and financial position. CEO Christian Kanstrup emphasized continued execution and anticipation of key milestones in the second half of the year.

Key Business Updates

• Merck Partnership on Track: The partnership with Merck is progressing towards a potential option exercise in the second half of 2025, which would entitle Evaction to receive $10 million if options for both compounds (EVAXB2 and EVAXB3) are exercised.
• Business Development Pipeline: The company remains confident in achieving its full-year target of at least two new business development deals, despite increased risk due to current financial market turmoil and regulatory uncertainty, which led one potential partner to pause discussions.
• R&D Progress:
  • EVX01 (personalized cancer vaccine): Continued to yield positive Phase 2 data, presented at AACR, showing an 80% immune response rate to new antigens. The two-year readout is on track for H2 2025, and the first patient has been dosed in a one-year trial extension.
  • AI Immunology Platform: Being deployed to develop new pipeline candidates, with the selection of a new infectious disease candidate on track for H1 2025.
  • Platform Optimization: Ongoing efforts to refine the AI platform for novel target discovery and development, aiming for lead candidate selection for the precision vaccine concept in H2 2025.
• Financial Runway: Cash on hand is sufficient until mid-2026, which extends beyond key milestones like the potential Merck option exercise and EVX01's two-year clinical data readout. The EIB loan conversion is expected in Q2.
• Scientific Conferences: Active participation at events like AACR, World Vaccine Congress, and NextGen Biomed to engage with the scientific community and potential partners.

Financial Highlights (Q1 2025)

• Cash Position: Significantly improved to $17.8 million (up from $6 million at the end of 2024), providing a cash runway until mid-2026.
• Operational Cash Burn: Estimated at $14 million for the full year, not including potential income from business development deals.
• Equity: Total equity strengthened to $10.3 million, exceeding NASDAQ listing requirements.
• Operating Loss: $3.9 million, an improvement from $4.4 million in Q1 2024, despite expectations for project costs to increase in coming quarters.
• Net Loss: $1.6 million, impacted by a significant financial income from a derivative liability reassessment ($2.4 million in Q1 2025 vs. $5.6 million in Q1 2024).

R&D Pipeline Details

• EVX01: In Phase 2 for advanced melanoma, showing strong CD4 T-cell responses (and CD8s in about half of patients). The extended trial phase will administer EVX01 as immunotherapy to understand its standalone effect.
• Precision Cancer Vaccine Concept (ERV): Aims for an off-the-shelf vaccine targeting shared tumor antigens. Proof-of-concept achieved in mice, and optimization of AI immunology is underway to select a human lead vaccine candidate with broad HLA coverage. IND/CTA-enabling activities have begun.
• Infectious Disease Pipeline: The first of two planned new vaccine candidates for 2025 is on track, with promising bacterial targets shortlisted after comprehensive assessment and expert review.

Outlook and Milestones

Evaction has delivered on its initial Q1 milestones and anticipates an even busier second half of 2025 with several potential value catalysts:

• Merck's decision on option exercise.
• EVX01 Phase 2 two-year readout.
• Selection of the lead candidate for the precision cancer vaccine concept.
• Achieving the target of at least two new business development agreements.
• Adding another infectious disease candidate to the pipeline in H2 2025.