Evaxion AS Stock Price, News & Analysis

Evaxion A/S (NASDAQ: EVAX) is a clinical-stage TechBio company that applies artificial intelligence to vaccine and immunotherapy discovery. Built on its proprietary AI-Immunology™ platform, Evaxion develops AI-designed vaccines and immunotherapies targeting cancer, bacterial diseases, viral infections and, going forward, autoimmune diseases. The company describes itself as using scalable AI prediction models to decode the human immune system and generate novel immunotherapies in areas with high unmet medical need.

According to Evaxion, the AI-Immunology™ platform consists of proprietary and scalable AI prediction models that harness artificial intelligence to identify immune-relevant targets. These models are used to discover and design personalized cancer vaccines, off-the-shelf therapeutic cancer vaccines and vaccine candidates for infectious diseases. Based on this platform, Evaxion has built a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases.

Core disease areas and pipeline focus

Evaxion states that it focuses on three main disease areas: cancer, infectious diseases and autoimmune diseases. Historically, the company has concentrated on oncology and infectious diseases, and it has announced plans to expand AI-Immunology™ into autoimmune indications. Within oncology, Evaxion highlights a clinical-stage personalized cancer vaccine program, EVX-01, designed for patients with advanced melanoma. EVX-01 is created using AI-Immunology™ to identify and select multiple neoantigens – cancer-specific proteins arising from mutations – with the goal of inducing clinically relevant immune responses.

In addition to EVX-01, Evaxion has introduced EVX-04, described as an AI-designed precision cancer vaccine candidate for acute myeloid leukemia (AML). EVX-04 targets non-conventional endogenous retrovirus (ERV) tumor antigens from the so-called dark genome. These antigens are reported to be present in tumors but absent in normal tissue, making them attractive targets for cancer vaccines. EVX-04 is developed as an off-the-shelf therapeutic cancer vaccine, preproduced and intended to be ready for administration after diagnosis.

On the infectious disease side, Evaxion reports a preclinical infectious disease pipeline that includes bacterial and viral vaccine candidates. Examples mentioned by the company include EVX-B2, a gonorrhea vaccine candidate that has shown protective effects in preclinical studies, and EVX-V1, a multi-component cytomegalovirus (CMV) vaccine program. EVX-V1 combines AI-discovered CMV antigens with AI-optimized versions of established CMV vaccine antigens, including an AI-optimized pre-fusion glycoprotein B (gB) antigen that has demonstrated enhanced CMV neutralization in preclinical models.

AI-Immunology™ platform and technology approach

Evaxion describes AI-Immunology™ as central to its business. The platform is used to decode the immune system and identify targets for vaccines and immunotherapies. In oncology, AI-Immunology™ analyzes sequencing data from patient tumors to identify neoantigens or ERV tumor antigens and then selects fragments with high immunogenic potential across patients. This approach is used in EVX-01, which targets multiple neoantigens, and in EVX-04, which focuses on ERV antigens from the dark genome.

The company has also reported the development of an automated vaccine design module within AI-Immunology™. This module replaces earlier manual vaccine design processes and is intended to improve vaccine design quality and shorten design timelines. Evaxion notes that the automated design capability can be applied to both new vaccines and optimization of existing vaccines, and that it addresses common challenges such as ensuring that vaccine targets can be expressed and obtained in the correct conformations.

In infectious diseases, AI-Immunology™ is used to discover novel antigens that may not have been identified through traditional research. For example, in the CMV program EVX-V1, Evaxion reports that the platform uncovered previously unexplored CMV antigens that induce specific immune responses, inhibit viral infection and reduce cell-to-cell spread in preclinical models. Similarly, the gonorrhea vaccine candidate EVX-B2 is described as an example of how AI-Immunology™ can discover vaccine candidates for pathogens where no approved vaccines exist.

Oncology programs and personalized vaccines

Evaxion’s EVX-01 personalized cancer vaccine program is a central part of its oncology pipeline. Developed with AI-Immunology™, EVX-01 is designed to target multiple patient-specific neoantigens. In a phase 2 trial in advanced melanoma, Evaxion has reported data showing that EVX-01 induced immune responses in all patients, with a high proportion of targeted neoantigens generating specific T-cell responses. The company also highlights clinical response data from this trial and notes that it is seeking a partner for further development of EVX-01.

The company’s ERV-based program, EVX-04, represents another oncology application of AI-Immunology™. By interrogating the dark genome and identifying ERV tumor antigens that are selectively expressed in certain tumors, Evaxion aims to design vaccines that provide broad tumor coverage across patients. EVX-04 includes multiple ERV fragments selected for cross-patient relevance and immunogenic potential, and preclinical data have shown strong T-cell responses and prevention of tumor growth in models described by the company.

Infectious disease vaccine candidates

In bacterial and viral diseases, Evaxion reports several vaccine candidates discovered with AI-Immunology™. EVX-B2, a gonorrhea vaccine candidate, has demonstrated protection against gonorrhea bacteria in preclinical studies according to the company. Evaxion notes that no vaccine for gonorrhea has been approved to date and that EVX-B2 illustrates the potential of AI-Immunology™ to generate novel vaccine candidates in areas of persistent unmet need.

The EVX-V1 CMV program is described as a next-generation, multi-component vaccine approach. Evaxion states that AI-Immunology™ has identified novel CMV antigens that significantly reduce viral infection in preclinical models. These antigens are combined with AI-optimized versions of established CMV antigens, including an optimized pre-fusion gB antigen with improved neutralization performance compared to traditional gB in the company’s preclinical work. Evaxion continues preclinical advancement of EVX-V1 and is exploring potential partnerships to support later-stage development.

Expansion into autoimmune diseases

Evaxion has announced that it will expand the use of AI-Immunology™ into autoimmune diseases, adding a third core disease area alongside cancer and infectious diseases. The company plans to train and adapt its platform to discover and develop drug candidates targeting underlying disease mechanisms in autoimmune conditions. Evaxion emphasizes that autoimmune diseases represent a high unmet medical need and that this expansion is intended to increase the number and diversity of programs generated from AI-Immunology™, with potential for partnerships across stages of drug development.

According to Evaxion, the scalability of AI-Immunology™ allows it to be applied across different disease areas, and the move into autoimmune diseases is presented as a strategic milestone. The company notes that work on the autoimmune application is included in its internal cash flow outlook and that it expects its existing cash resources to support this expansion within its stated planning horizon.

Partnerships and business development

Evaxion describes an active business development effort built around both its AI-Immunology™ platform and its pipeline assets. The company has reported an out-licensing agreement for the bacterial vaccine candidate EVX-B3 to MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA). EVX-B3 was discovered using AI-Immunology™, and Evaxion notes that this makes it the first AI-designed vaccine candidate it has licensed to a pharmaceutical company. Under this agreement, Evaxion has received an option exercise fee and is eligible for future milestone payments and royalties on net sales, while MSD assumes responsibility for further development of EVX-B3.

For EVX-B2, the gonorrhea vaccine candidate, Evaxion has reported that MSD chose not to exercise its option, leaving Evaxion with global rights to the program. The company has indicated that it will seek another potential licensing partner for EVX-B2 and continues to view the candidate as promising based on preclinical protection data. Beyond these specific programs, Evaxion states that it is engaged in multiple partnership discussions across disease areas and aims to create value by monetizing both its platform and pipeline through collaborations.

Financial and corporate profile

Evaxion A/S is incorporated in Denmark and files reports with the U.S. Securities and Exchange Commission as a foreign private issuer on Form 20-F. The company’s shares trade on the Nasdaq Capital Market under the symbol EVAX. Evaxion has reported that it uses capital market activities, option exercise proceeds and partnership income to fund its operations and research and development programs. In its public communications, the company has highlighted an extended cash runway into the second half of 2027 following capital raises and the EVX-B3 option exercise fee.

Evaxion’s SEC filings also document amendments to its Articles of Association related to share capital increases from the exercise of investor warrants. These filings show that the company has issued additional ordinary shares over time in connection with warrant exercises, reflecting its use of equity financing as part of its capital structure.

Research and development strategy

Evaxion describes its R&D strategy as centered on generating and advancing AI-designed vaccine candidates in oncology and infectious diseases, and expanding into autoimmune diseases. The company reports that it maintains a high level of preclinical activity with multiple programs and that it prioritizes further clinical development of EVX-01 and the advancement of EVX-04 toward clinical testing. It has also stated that it aims to replenish its infectious disease pipeline with additional candidates, potentially through target discovery collaborations with external partners.

In addition to pipeline programs, Evaxion emphasizes ongoing development of AI-Immunology™ itself. The platform’s evolution, including the automated vaccine design module, is presented as a way to improve vaccine target discovery and design, potentially enabling new and improved generations of vaccines. The company positions this dual focus on platform and pipeline as a foundation for long-term value creation and for attracting partnerships.

Mission and therapeutic focus

Across its public statements, Evaxion expresses a commitment to transforming patients’ lives by providing targeted treatment options in areas of high unmet medical need. Its work in personalized cancer vaccines, ERV-based off-the-shelf cancer vaccines, and vaccines for pathogens such as gonorrhea and CMV is framed as addressing diseases where existing therapies or preventive options are limited. By applying AI-Immunology™ to decode the immune system and identify new targets, Evaxion aims to bring forward therapies that may improve outcomes for patients with cancer, bacterial infections, viral infections and, in the future, autoimmune diseases.