Evaxion A/S (EVAX) Q4 2025 Earnings Call Transcript

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Overview

The earnings call summary and Q&A indicate a positive outlook for Evaxion. The financial performance shows improved revenue and reduced operational costs, leading to a better financial position. The extended cash runway and strengthened equity are positive indicators. Product development, particularly the progress of EVX-01 and potential of EVX-04, is promising. The AI-Immunology platform enhancements and ongoing partnerships add further optimism. Despite some uncertainties in responses, the overall sentiment is positive, suggesting a likely stock price increase in the short term.

Key Financial Performance

Revenue Revenue improved in 2025, primarily driven by MSD option exercises and a grant from the Gates Foundation. The exact revenue figure was not disclosed, but it contributed to a better financial position compared to the previous year.

Operational Costs Operational costs were successfully lowered in 2025 while maintaining quality in pipeline and platform development. This reduction contributed to an improved financial position.

Net Loss Net loss for 2025 was $7.7 million, an improvement compared to the previous year. This was achieved through better revenue and cost management.

Cash Position The cash position at the end of 2025 was $23 million, with a cash runway extended into the second half of 2027. This improvement was due to public offerings, ATM usage, MSD exercise fees, and investor warrant exercises.

Equity Equity was significantly strengthened in 2025 through activities such as the EIB debt-to-equity conversion of $4.1 million and other capital market activities.

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Operating Highlights

EVX-B3 Program: Merck exercised its option over this infectious disease vaccine candidate, marking the first in-licensing of a vaccine identified through an AI discovery platform.

EVX-01 Program: Presented 2-year Phase II data showing strong clinical outcomes in advanced melanoma patients, with a high objective response rate of 75% and complete response rate of 25%.

EVX-04 Program: Preclinical data showed strong immune responses and tumor growth prevention in AML models. Clinical trial application submission planned for late 2026.

EVX-B2 Program: Retained full rights to this gonorrhea vaccine candidate, with strong preclinical data demonstrating significant protection and broad efficacy.

EVX-B1 Program: Developing a multi-target vaccine against CMV with promising preclinical data, including superior neutralization capacity and novel antigen identification.

Collaboration with MSD: Strengthened partnership with MSD, including the in-licensing of EVX-B3.

Gates Foundation Collaboration: Entered into a collaboration for the design of a new polio vaccine.

Partnership Discussions: Ongoing discussions with multiple parties for platform and pipeline programs.

AI-Immunology Platform: Recognized by the Galien Foundation for advances in human health. Expanded capabilities with an automated vaccine design module, reducing costs and development time.

Financial Position: Achieved a cash inflow of $32 million in 2025, extending the cash runway to the second half of 2027.

Focus on Autoimmune Diseases: Exploring applications of the AI-Immunology platform in autoimmune diseases, targeting underlying disease mechanisms.

Sustainability Goals: Progressed towards becoming a self-funding business by improving revenue and reducing operational costs.

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Risk or Challenges

Technical delay in conference call: The business update call was delayed by 24 hours due to technical reasons, which could indicate potential operational inefficiencies.

MSD's decision on EVX-B2: MSD chose not to exercise its option over the EVX-B2 candidate for gonorrhea, which could impact the program's development and partnership opportunities.

Dependence on partnerships: The company relies heavily on partnerships, such as with MSD and the Gates Foundation, for funding and validation, which could pose risks if these partnerships do not materialize or continue.

Regulatory hurdles: The company plans to submit a regulatory application for EVX-04 by the end of 2026, which could face delays or challenges in approval.

Financial sustainability: Although the company has extended its cash runway to the second half of 2027, it is not yet self-funding and remains dependent on external financing and partnerships.

Market competition: The company operates in highly competitive fields such as AI-based drug discovery and vaccine development, which could impact its market share and growth.

Uncertainty in clinical outcomes: While the company has reported promising preclinical and clinical data, future trials and regulatory approvals carry inherent risks and uncertainties.

Supply chain and manufacturing risks: The company is advancing CMC work and GMP manufacturing for EVX-04, which could face disruptions or delays.

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Guidance & Outlook

2026 Milestones: Evaxion plans to update on the EVX-01 program with additional biomarkers and immunogenicity data in the first half of 2026, and 3-year clinical data towards the end of the year. The company will also provide updates on autoimmune applications of its AI-Immunology platform and bring forward data on the new EVX-B4 candidate for Group A Streptococcus in the second half of the year. Additionally, Evaxion aims to submit a regulatory application for the EVX-04 candidate vaccine for shared ERV antigens in AML by the end of 2026.

EVX-01 Program: Two key milestones are expected: additional biomarker and immunogenicity data in the first half of 2026, and 3-year data from a subset of patients in the second half of 2026. Future trials are planned in partnership to ensure broad patient impact.

EVX-04 Program: Evaxion plans to submit a clinical trial application for the EVX-04 vaccine candidate targeting AML in the second half of 2026, enabling first-in-human testing.

EVX-B2 Program: Evaxion retained full global rights to the EVX-B2 vaccine candidate targeting Neisseria gonorrhoeae. The company sees opportunities to engage with potential partners to progress the program towards clinical development.

EVX-B1 Program: The EVX-B1 program is focused on developing a multi-target vaccine against cytomegalovirus (CMV). Supported by strong preclinical data, the program is positioned for future partnership discussions.

AI-Immunology Platform: Evaxion will continue to expand the capabilities of its AI-Immunology platform, including the automated vaccine design module launched in 2025, which reduces cost, development time, and risk. The platform will support ongoing and future programs in oncology and infectious diseases.

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Shareholder Return Plan

The selected topic was not discussed during the call.

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Key Q&A

Q:What overarching commentary did Helen provide about her tenure and any changes to strategy?

A:Helen mentioned that she joined at the end of November last year and has a strong impression of Evaxion from her prior role on the board. She emphasized that the fundamentals of Evaxion remain strong and have strengthened through 2025. She highlighted the AI platform's ability to generate meaningful clinical responses and its traction in oncology and infectious diseases. While there are no fundamental changes to strategy, there is a sharpening and deepening of focus on assets with the most value.

Q:What is the plan for EVX-04 and its regulatory submission?

A:Helen stated that they are preparing to take EVX-04 into the clinic to gain initial proof of concept. While it is not necessarily required to take it into Phase I to attract partner interest, additional critical validating data will strengthen the value proposition for external partners.

Q:What feedback has been received from partners regarding EVX-01, and what is key for driving partnering discussions?

A:Helen noted that the cancer vaccine space is gaining interest, particularly in the checkpoint era. The updated clinical data package, including translational data and immune response insights, is resonating with companies. There is interest in the shared antigen approach of EVX-04 and its applicability to other high mutational burden cancers beyond melanoma. Birgitte added that the AI-Immunology platform's 81% hit rate in identifying relevant targets is impressive and gaining attention.

Q:What is the strategy for applying the AI-Immunology platform to autoimmune diseases?

A:Helen and Birgitte mentioned that it is early in the prioritization of indications. They have analyzed prevalent autoimmune diseases and see a clear fit for the platform. Additional smaller units will be built to apply the platform to these diseases, and more details will be shared after further analysis and adjustments.

Q:What discussions are happening with large-cap pharma regarding AI tools and Evaxion's products?

A:Helen emphasized the importance of timing, data validation, and building relationships. She highlighted Evaxion's integrated expertise and the need to crystallize the offering through validated candidates. The team is working on expanding its profile and credibility with potential partners.

Q:What is the status of the relationship with Merck regarding EVX-B2?

A:Helen stated that she cannot comment on the specifics of Merck's decision to extend the evaluation of EVX-B2. She mentioned that R&D programs sometimes require additional work and time. Evaxion remains excited about the data and continues to build on the program internally.

Q:What markers are being tracked for EVX-01 durability at the 3-year mark?

A:Birgitte explained that they are conducting deep T-cell profiling, including activation and exhaustion markers, and analyzing different T-cell phenotypes. The profile so far is favorable, with a dominance of activation or effector-type cells and minimal exhaustion markers. Additional blood samples are being analyzed to understand EVX-01's monotherapy effects.

Q:What is the strategy for validating early candidates in the autoimmune disease program?

A:Birgitte mentioned that the first step is to settle on an indication, which involves analyzing the top 10 most prevalent autoimmune diseases. They are building additional smaller units in AI-Immunology and setting up mouse models to test candidates designed by the platform.

Q:Review of Unclear Management Responses

A:Management avoided providing direct answers or lacked clarity on the following: 1. The specifics of Merck's decision to extend the evaluation of EVX-B2, citing confidentiality and multidimensional reasons. 2. Detailed plans for the autoimmune disease program, as it is still in early stages and specifics were not disclosed.

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Earnings Word Cloud

The most frequently occurring keywords in this quarter's earning call

EVAX Transcript

Evaxion A/S (EVAX) Q4 2025 Earnings Call Transcript

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The earnings call highlights positive financial performance with a cash runway extended to 2027 and revenue from MSD. Significant progress in R&D, particularly in oncology and infectious diseases, enhances the company's growth prospects. While there are potential risks in partnerships and production, the overall sentiment is positive, supported by optimistic guidance and ongoing partnership discussions. The Q&A section reveals strong interest in the company's pipeline and technology, further boosting confidence. Despite some uncertainties, the overall outlook is positive, suggesting a potential stock price increase of 2% to 8%.

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The earnings call presents a mixed outlook. Positive aspects include a solid cash position and business development pipeline, along with reduced losses. However, challenging financial markets, increased regulatory uncertainty, and dependency on partnerships pose significant risks. The Q&A session highlighted management's avoidance of specifics, adding uncertainty. Overall, the potential for partnerships and the Merck collaboration are positive, but the risks and uncertainties balance out, leading to a neutral sentiment.

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The earnings call summary presents a positive outlook with anticipated revenue growth, improved margins, and a return to profitability. The Q&A session revealed confidence in the company's vaccine pipeline, despite competitive and regulatory challenges. The strategic focus on precision vaccines and partnerships like with MSD supports optimism. While supply chain and economic risks exist, the overall sentiment leans positive due to strong operational metrics and future milestones.

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