Evaxion Biotech A/S Q2 FY2026 earnings call

R&D Pipeline Progress

• Lead program EVXO1, a personalized neoantigen cancer vaccine for advanced melanoma in Phase 2, previously reported 86% of vaccine targets triggered tumor-specific de novo T cell responses, a 75% overall response rate, 25% complete responses, and 92% of patients remaining in response at 2 years. Three-year efficacy and durability data will be presented at ESMO in October 2026.
• New off-the-shelf program EVXO5 for glioblastoma (GBM) launched, building on the EVXO4 conserved endogenous retrovirus (ERV) antigen targeting approach. 16 optimal ERV targets selected from 1.5 million mined patient ERV fragments; program is advancing to lead candidate selection and IND-enabling activities in collaboration with Duke University.
• EVXO4, the off-the-shelf AML vaccine, presented new preclinical data at EHA 2026 demonstrating target activation of immune cells across HLA types and targeted cancer cell killing. The program remains on track for regulatory filing by the end of 2026.
• EVXV1, the CMV vaccine program, presented new preclinical data at the International Herpes Virus Workshop showing AI-discovered T cell epitopes can control acute infection, latency, and reactivation in mouse models, guiding antigen selection for a broadly protective candidate.

AI Immunology Platform

• The platform was awarded a second Galeon UK award in 12 months, recognizing its value for target prediction across oncology, infectious disease, and autoimmune disease. It is clinically validated with positive results in 3 out of 3 oncology trials, supports multiple modalities (peptide, DNA, RNA, recombinant protein), and is scalable across additional disease indications.

Business Development & Financial Discipline

• Active partnership discussions are ongoing for multiple programs, with increased interest following the positive Phase 3 results from the Moderna/Merck personalized cancer vaccine program, which validates the entire field. The company maintains a disciplined approach to resource allocation focused on high-value pipeline opportunities.

Oveaction is a clinical-stage biotech with a single business segment focused on AI-driven immunology product development. For Q2 2026, the company reported a net loss of 3.7 million USD, with operating expenses slightly reduced year-over-year driven by lower general and administrative capital market costs. R&D expenses saw a slight year-over-year increase aligned with pipeline progress. Cash position at quarter end was 14 million USD, with a net loss of 9.5 million USD reported for the first half of 2026. No separate product segment revenue is reported as all programs are in preclinical or clinical development.

• Cash runway is maintained and reconfirmed at funding for operations into the second half of 2027, unchanged from prior guidance.
• EVXO1 three-year clinical data will be released at the ESMO Congress in October 2026, as previously planned.
• EVXO4 remains on track for regulatory filing by the end of 2026, with all IND-enabling activities on schedule with no delays.
• Full year 2026 cash burn is expected to be approximately 14 million USD, with a slight downside to this projection, in line with prior planning.

• No new material operational or clinical risks were explicitly called out on the call. Timeline details for the early-stage EVXO5 program have not been finalized, as they are dependent on lead candidate selection results.
• Partnership deal timelines remain uncertain, as is typical for business development discussions, with no guarantee of transactions closing in a specific timeframe.
• The company relies on external collaboration (with Duke University for EVXO5) for trial execution, though management noted no current issues with the collaboration.

Q: What is the development timeline for EVXO5 and what role has Duke University played to date?

A: Duke provided GBM patient sequencing data that enabled target discovery. Oveaction identified shared conserved ERV antigens across patient samples to design the off-the-shelf vaccine. Target discovery is complete, and the program is now testing lead candidates, then will move to IND-enabling activities. No firm timeline for first-in-human study has been set yet.

Q: What constitutes a clinically meaningful three-year durability result for EVXO1 at ESMO, and how does the Moderna/Merck Phase 3 data impact partnership discussions?

A: Management considers maintaining the current overall response rate and durable T cell responses across patients as a positive outcome. The Moderna/Merck data validates the entire personalized neoantigen vaccine field, which has greatly increased partner interest in Oveaction's program, which already has strong early clinical data.

Q: What are the remaining gating steps for EVXO4 to enter the clinic?

A: All IND-enabling activities including GMP manufacturing, potency testing, clinical site selection, and regulatory documentation preparation are ongoing and on track. The program remains on schedule for regulatory filing by the end of 2026, and does not require a partnership to advance to the clinic.

Q: Can you confirm your cash runway to H2 2027 and what sources of funding will you use?

A: Cash burn is not linear quarter over quarter, and full-year burn is expected to come in at or slightly below 14 million USD. The company maintains an ATM facility, which was partially activated recently after the positive Moderna/Merck field validation, and future partnership deals will also add cash. Management remains confident in the H2 2027 cash runway.