Evaxion announces business update and first quarter 2025 financial results
- 80% of EVX-01 vaccine targets triggered tumor-specific immune response, higher than other similar vaccines
- Cash position significantly improved to $17.8M, extending runway to mid-2026
- R&D expenses decreased to $2.2M from $2.8M year-over-year due to cost management
- Potential value catalysts in H2 2025 with EVX-01 trial readout and MSD collaboration
- Total equity improved to $10.3M from negative $1.7M in December 2024
- Net loss of $1.6M in Q1 2025 compared to net income of $1.2M in Q1 2024
- No revenue recorded in Q1 2025 compared to $0.1M in Q1 2024
- Market turmoil and regulatory uncertainty affecting partnership discussions
- General and administrative expenses increased to $1.7M from $1.6M year-over-year
Insights
Evaxion shows promising EVX-01 trial data, but financial situation remains mixed with modest cash runway until mid-2026.
Evaxion's Q1 2025 results reveal a mixed financial picture with some encouraging clinical progress. Their cash position improved to
On the clinical front, Evaxion's lead asset EVX-01, a personalized cancer vaccine for advanced melanoma, shows promising efficacy with
The company's partnership with MSD (on EVX-B2 and EVX-B3) represents a significant potential value catalyst, with possible option exercise in H2 2025. However, I note management's acknowledgment that current market turmoil and regulatory uncertainty are impacting partnership discussions, which raises concerns about their target of securing at least two new agreements in 2025.
The ongoing EIB loan conversion will improve their balance sheet by increasing equity by
Evaxion's AI-driven cancer vaccine EVX-01 shows robust 80% immune response hit rate, significantly outperforming competitors.
The clinical data presented at AACR for Evaxion's personalized cancer vaccine EVX-01 reveals remarkable efficacy with
What makes this hit rate particularly notable is how it substantially outperforms comparable personalized cancer vaccine approaches. The ability to consistently induce immune responses against
The company's endogenous retrovirus (ERV) program represents another innovative approach. ERVs are remnants of ancient viral infections integrated into the human genome that can be reactivated in cancer cells. By targeting these shared ERV elements across patients rather than unique neoantigens, Evaxion could potentially develop off-the-shelf cancer vaccines applicable to broader patient populations. Their work analyzing over 3,000 cancer samples and 1,000 immunopeptidomics datasets provides a robust foundation for identifying clinically relevant ERV targets.
The extension of the EVX-01 Phase 2 trial to explore long-term clinical and immune benefits is scientifically sound. Cancer immunotherapies often demonstrate improved efficacy over extended timeframes as immune responses evolve and expand, a phenomenon known as epitope spreading. This trial extension will provide valuable insights into the durability of vaccine-induced immune responses and their correlation with clinical outcomes.
COPENHAGEN, Denmark, May 27, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, provides business update and announces first quarter 2025 financial results.
Business highlights (since last quarterly update)
Evaxion has made good progress with continued execution of our strategy and plans. We have achieved the first two milestones for the year and are tracking towards future milestones and value catalysts. Highlights include:
- Continued progression of the development of our lead asset EVX-01 with the ongoing phase 2 trial on track for two-year readout in the second half of 2025, and the first patient in the one-year trial extension being dosed in May.
- Another set of positive data from the EVX-01 phase 2 trial presented at the AACR Annual Meeting in April. The new data shows that
80% of EVX-01 vaccine targets triggered a tumor-specific immune response, a substantially higher hit-rate than what has been reported for other similar vaccine candidates. - Completion of a thorough analysis of infectious diseases to target as basis for developing new vaccine candidates. We have assembled a panel of world-renowned experts and key opinion leaders to advise on the most promising of the opportunities identified, all addressing significant unmet needs and with solid commercial potential.
- Further optimization of the AI-Immunology™ platform via curation of extensive cancer samples and immunopeptidomics datasets. This will enable optimal selection of the lead candidate for our precision cancer vaccine concept targeting non-conventional endogenous retrovirus (ERV) tumor antigens shared across patients.
- Current cash at hand sufficient to fund our operating expenses and capital expenditure requirements until mid-2026.
“We continue to execute on our strategy and plans and are pleased to have achieved the first milestones set for the year. First and foremost, priorities are the continued execution of the EVX-01 phase 2 trial towards readout of two-year data and bringing the collaboration on EVX-B2 and EVX-B3 with MSD to option exercise. Each of these events are significant potential value catalysts in the second half of the year. Further, we remain focused advancing our ongoing business development discussions in combination with creation of new partnering opportunities via continued enhancement of our AI-Immunology™ platform,” says Christian Kanstrup, CEO of Evaxion.
Research & Development update
Evaxion has a pipeline of innovative development candidates for both cancer and infectious diseases.
Our most advanced asset, personalized cancer vaccine EVX-01, is currently being evaluated as a treatment for advanced melanoma (skin cancer). The ongoing phase 2 trial is tracking towards two-year readout in the second half of 2025. Further, the first patient in the one-year extension of the trial has now been dosed. The extension of the trial will explore the full potential of EVX-01 as a possible new and innovative treatment of advanced melanoma, particularly its long-term clinical and immune benefits. The trial extension involves minimal cost as trial sites are running and the vaccine product has already been produced.
The phase 2 trial continues to yield striking data. Most recently, new immune data presented at the American Association for Cancer Research (AACR) Annual Meeting in April demonstrated that
The AACR Annual Meeting was just one of several events in recent months where we have been presenting and interacting with stakeholders to showcase our AI-Immunology™ platform and pipeline of vaccine candidates. Interacting with both existing and potential partners as well as scientific collaborators is a central element in the execution of our multi-partner strategy. Other conferences with Evaxion participation over recent months include the World Vaccine Congress in Washington, DC, and the NextGen Biomed conference in London.
Within cancer we are also developing a precision vaccine concept targeting non-conventional endogenous retrovirus (ERV) tumor antigens shared across patients. We expect to select the lead candidate for the program to be added to our pipeline in the second half of 2025.
Having demonstrated pre-clinically that the concept works, our efforts are now focused on working with patient data to progress the concept towards clinical trials. To this end, we have curated and analyzed data, including proteomics and RiboSeq data, from more than 3,000 cancer samples.
Further, we have analyzed more than 1,000 immunopeptidomics datasets of cancer samples to identify ERVs that are presented as cancer targets to the immune system. These data will support the vaccine design. We have optimized AI-Immunology™ based on the findings to further improve the platform’s ability to identify the ideal shared cancer vaccine candidate.
We are also making headway in preclinical development where the identification of two new vaccine candidates for infectious diseases is an important 2025 company milestone. The build-up of our R&D pipeline with new vaccine candidates addressing significant unmet medical needs will support our partnership strategy. We have successfully completed a thorough analysis of potential indications to target and have assembled a panel of world-renowned experts and key opinion leaders. The panel will help us select the most promising of the opportunities identified, allowing us to add the first new candidate to our R&D pipeline during the first half of 2025 as planned.
The EVX-B2 and EVX-B3 programs, being conducted in collaboration with MSD, continue to track towards potential option exercise in the second half of 2025. Following potential option exercise, MSD would take over further development and commercialization with Evaxion entitled to significant milestone payments as development successfully progresses. Evaxion is also entitled to royalties on future sales.
Business development update
Our strategy for long-term value creation rests on monetization of both our R&D pipeline assets and AI-Immunology™ platform through multiple partnerships. Our investments are aimed at creating and improving our opportunities to enter such partnerships. The MSD collaboration on EVX-B2 and EVX-B3 is a great example of the partnering strategy we are pursuing.
As per our strategy, business development remains a very high priority, and we continue to be engaged in multiple parallel partnership discussions based on a solid level of external interest in both our platform and pipeline.
We are encouraged by our business development pipeline and are still targeting at least two new agreements for 2025. However, it is also clear that the current turmoil in the financial markets and increased regulatory uncertainty is having an impact on the decision processes with some potential partners. To mitigate the risk of not meeting our business development target, we are focusing our partnering efforts on potential partners who are expected to be less impacted by the current turmoil.
EIB loan conversion
The formal finalization of the agreement with the European Investment Bank (EIB) about conversion of
When completed, the conversion will increase our equity by
First quarter 2025 financial results
Our financial situation remains solid with our cash runway extending to mid-2026.
Cash and cash equivalents as of March 31, 2025, were
No revenue was recorded in the three months ended March 31, 2025, as compared to
Research and development (R&D) expenses were
General and administrative expenses were
Financial income in the first quarter of 2025 is driven by
For the period ended March 31, 2025, we generated a net loss of
Total equity amounts to
The equity is negatively impacted by
During March 2025, an agreement has been made with approximately
We will continue to focus and maintain our strict cost control and diligently prioritize and optimize our resource allocation. This enables us to absorb the general cost increase, inflation and increased level of activity in 2025 within the same cash spend as in 2024, e.g. we expect an operational cash burn of approximately
Evaxion A/S
(Unaudited) Consolidated Statement of Financial Position Data
(USD in thousands)
Mar 31, | Dec 31, | |
Cash and cash equivalents | 17,843 | 5,952 |
Total assets | 25,239 | 12,485 |
Total liabilities | 14,896 | 14,137 |
Share capital | 11,823 | 10,516 |
Other reserves | 118,632 | 106,369 |
Accumulated deficit | (120,112) | (118,537) |
Total equity before derivative warrant liability | 10,365 | (1,652) |
Effect from derivative liabilities from investor warrants | (22) | - |
Total equity | 10,343 | (1,652) |
Total liabilities and equity | 25,239 | 12,485 |
Evaxion A/S
(Unaudited) Consolidated Statement of Comprehensive Loss Data
(USD in thousands, except per share data)
Three Months Ended | ||
2025 | 2024 | |
Revenue | 0 | 51 |
Research and development | (2,156) | (2,836) |
General and administrative | (1,712) | (1,611) |
Operating loss | (3,868) | (4,396) |
Finance income | 2,493 | 5,618 |
Finance expenses | (397) | (246) |
Net loss before tax | (1,772) | 976 |
Income tax benefit | 192 | 218 |
Net loss for the period | (1,580) | 1,194 |
Net loss attributable to shareholders of Evaxion A/S | (1,580) | 1,194 |
Loss per share – basic and diluted | (0.01) | 0.03 |
Number of shares used for calculation (basic and diluted) | 276,311,927 | 46,638,239 |
Contact information
Evaxion A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion-biotech.com
About Evaxion
Evaxion A/S is a pioneering TechBio company based upon its AI platform, AI-Immunology™. Evaxion’s proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology™, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Evaxion is committed to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology™ platform and vaccine pipeline, please visit our website.
Forward-looking statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.
FAQ
What were Evaxion's (EVAX) key financial results for Q1 2025?
What is the success rate of Evaxion's EVX-01 cancer vaccine in clinical trials?
How long will Evaxion's current cash runway last?
What are the major upcoming catalysts for Evaxion (EVAX) stock in 2025?
How many partnership agreements is Evaxion targeting for 2025?
