Evaxion A/S (NASDAQ:EVAX) executives highlighted progress across partnerships, clinical and preclinical programs, and the company’s AI-Immunology platform during a business update and full-year 2025 results call led by newly appointed CEO Helen Tayton-Martin. Management also outlined key 2026 milestones, including additional EVX-01 readouts, new infectious disease candidate data, and a planned regulatory submission for the company’s EVX-04 program.
2025 business development: Merck option exercise and new collaborations
Tayton-Martin said 2025 delivered “tremendous progress across all core pillars” of the company, including business development. She emphasized progress in Evaxion’s collaboration with MSD (Merck), including Merck’s decision to exercise its option over Evaxion’s EVX-B3 program candidate. While the target for EVX-B3 was not disclosed, Tayton-Martin described the development as, to the company’s knowledge, the first in-licensing of an infectious disease vaccine candidate “identified and validated through an AI discovery platform.”
EVX-01 melanoma vaccine: 2-year Phase II data and upcoming updates
Chief Scientific Officer Birgitte Rønø detailed results for EVX-01, Evaxion’s personalized peptide-based cancer vaccine in advanced melanoma. Rønø said the company presented two-year Phase II data in an oral session at ESMO in October, describing a 75% objective response rate and a 25% complete response rate. She added that 92% of responders remained in response at the two-year mark.
Rønø highlighted biomarker data showing what she called a high immunogenicity “hit rate,” with 20 (or 81%) of individual neoantigens administered across patients generating a specific T-cell response. She said this hit rate compares favorably with other programs, which she characterized as typically reporting hit rates below 60%.
Looking ahead, management said EVX-01 milestones in 2026 include:
- Additional biomarker and immunogenicity data in the first half of 2026 (also referenced by Tayton-Martin as an AACR update).
- Three-year data from a subset of patients in an expansion portion of the Phase II study in the second half of 2026.
In the Q&A, Tayton-Martin said partnering discussions in cancer vaccines hinge on clinical outcomes as well as translational data connecting immune response to clinical response. She also said the company is seeing interest in applying the approach beyond melanoma to other high mutational burden cancers. Rønø specifically cited non-small cell lung cancer and some colorectal cancers as potential areas where the concept could be relevant.
EVX-04 in AML: ERV-based shared antigen approach and planned regulatory submission
Rønø provided an update on EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia (AML) targeting endogenous retroviruses (ERVs) that Evaxion says are selectively and highly expressed in AML blasts. She said the company used AI-Immunology to identify millions of short ERV fragments from patient tumor sequencing data and designed EVX-04 with 16 ERV antigen fragments chosen for cross-patient relevance and immunological potential.
According to Rønø, in vitro vaccination studies showed all 16 fragments induced strong specific immune responses, and EVX-04 prevented tumor growth in several mouse tumor models while inducing strong T-cell responses. She said the program has completed key steps including antigen selection and lead development, with ongoing human cell-based translational assays. CMC work and GMP manufacturing are advancing “according to plan.”
Rønø said the next major milestone is submission of a clinical trial application in the second half of 2026 to enable first-in-human testing. In Q&A, Tayton-Martin said the company is preparing to take EVX-04 into the clinic and believes it can generate initial proof-of-concept, while adding that additional validation can strengthen the partnering value proposition.
Infectious disease pipeline and AI-Immunology platform advances
On infectious diseases, Rønø said Evaxion is now fully in control of EVX-B2, a preclinical gonorrhea vaccine candidate, after retaining global rights. She described a preclinical package that includes significant protection in a mouse infection model, efficacy against 50 clinically relevant isolates, and induction of humoral and cellular responses in mice. She also cited antibody-dependent, complement-mediated killing as part of the proposed mechanism of action, and said the company sees an opportunity to engage partners to move the program toward clinical development.
Rønø also discussed EVX-B1, a multi-target cytomegalovirus (CMV) vaccine program that combines well-described glycoproteins with novel antigens. She said Evaxion used AI-Immunology to optimize known glycoproteins and identify new antigens. As one example, she said the company engineered glycoprotein B by locking it in a prefusion state, and that the resulting construct showed superior neutralization capacity compared to the native protein. She added that several novel antigens have demonstrated an ability to inhibit viral entry, with characterization ongoing.
At the platform level, Rønø said AI-Immunology integrates multi-omic datasets to generate ranked antigen lists within 24 hours. In October, Evaxion launched an automated vaccine design module enabling sequence and structural optimization directly from shortlisted antigens. She said the module is intended to reduce cost, development time, and risk, and to improve expression, formulation, and manufacturability for soluble antigen constructs, including via “inverse folding” approaches to generate more reliable constructs than wild-type variants.
Tayton-Martin also noted the company received recognition from the Galien Foundation for AI advances in human health.
Financial results: $23 million cash and runway into H2 2027
CFO Thomas Schmidt said Evaxion expanded its cash runway and strengthened equity during 2025 through a public offering and at-the-market (ATM) activity, the MSD exercise fee, and investor warrant exercises. He said these actions resulted in $32 million of cash inflow. Schmidt also noted a European Investment Bank (EIB) debt-to-equity conversion in July of $4.1 million, which he said reduced future cash outflows.
For full-year 2025, Schmidt said revenue improved and operational costs declined, while the company continued investing in its platform and pipeline. He attributed revenue to the MSD option exercise and also noted a Gates Foundation grant recognized in 2025. He reported a net loss for the year of $7.7 million, describing it as an improvement versus the prior year.
On the balance sheet, Schmidt said Evaxion ended 2025 with $23 million in cash and a runway extended into the second half of 2027. He also provided capital structure updates, including 8.3 million outstanding ADS (assuming all shares converted into ADS) and 2.8 million warrants outstanding after warrant exercises reduced the outstanding count by 1.0 million.
In closing remarks, Tayton-Martin reiterated that 2025 strengthened the company’s financial position and platform validation, and said Evaxion intends to pursue value creation through partnerships across both its platform and pipeline as it works toward its 2026 milestones.
About Evaxion A/S (NASDAQ:EVAX)
Evaxion A/S is a clinical-stage biotechnology company headquartered in Copenhagen, Denmark, with additional operations in the United States. The company specializes in the development of immunotherapies and vaccines driven by its proprietary AI-based computational immunology platform. By leveraging machine learning and deep learning algorithms, Evaxion identifies and optimizes antigen targets for both therapeutic cancer vaccines and prophylactic vaccines against infectious diseases.
At the core of Evaxion’s business is its AI platform, which analyzes large datasets of genomic, proteomic and immunological information to predict immune-stimulating epitopes.
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