EVX-01 Strong Immunogenicity in Phase II
EVX-01 Phase II translational data showed an 86% immunogenicity conversion rate and 86% de novo T-cell response rate, demonstrating broad and novel T-cell activation. The call also reported a positive correlation between predicted vaccine-target quality and magnitude of T-cell response, supporting the predictive power of the AI-Immunology platform.
Encouraging Clinical Response Metrics for EVX-01
Prior clinical results cited include a 75% overall response rate for EVX-01 (presented at ESMO), with more than half of patients converting to an improved clinical response and durable benefit signals (presentation noted '25 complete responders' and sustained responses). EVX-01 has received FDA Fast Track designation. A 3-year clinical outcome update is planned for H2 2026.
Platform Scalability Demonstrated in Glioblastoma (GBM)
In collaboration with Duke University, the AI-Immunology platform generated fully personalized vaccine designs for all 24 evaluated GBM cases. 21 of 24 designs (≈87.5%) included both classical neoantigens and endogenous retrovirus (ERV) antigens, showing applicability to low mutational burden, hard-to-treat tumors and expanding the platform beyond melanoma.
New Vaccine Concepts with Global Partners (Polio)
In collaboration with The Gates Foundation, Evaxion used AI-Immunology to design a novel hybrid capsid antigen and a de novo B-cell antigen for an improved polio vaccine concept, illustrating the platform's ability to reinvent classical vaccines for improved breadth and simplicity.
Clinical and Preclinical Validation of AI-Immunology
Management stated the platform is clinically validated with positive outcomes in 3 out of 3 oncology trials (100% of cited oncology trials) and has preclinical proof-of-concept across multiple disease areas (oncology, infectious disease, autoimmune), supporting multiple modalities (peptides, proteins, DNA, RNA) and diverse partnership potential.
Organizational Strengthening and Focused Strategy
Corporate changes include promotion of Birgitte Rono to combined CSO and COO to align R&D and operations, and appointment of Jens Bitsch-Norhave to the Board to bolster business development and corporate strategy capabilities, signaling increased external focus and BD outreach.
Disciplined Financial Management and Confirmed Runway
Evaxion reconfirmed disciplined resource allocation with an expected operational cash burn of roughly USD 14 million for 2026. Cash and equivalents were USD 18.4 million at quarter-end, providing a runway into the second half of 2027 (management statement does not assume new partnerships). Q1 operating expenses were broadly in line or slightly reduced year-over-year.
Active Business Development Efforts
Management reported multiple ongoing partnering discussions across oncology and infectious disease assets and emphasized strategic prioritization of partnerships (noting intent to partner certain programs such as GBM), indicating active BD engagement to monetize platform and assets.