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Evaxion expands R&D pipeline with new vaccine program targeting Group A Streptococcus

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Evaxion (NASDAQ: EVAX) has announced the addition of a new vaccine program, EVX-B4, targeting Group A Streptococcus (GAS) to its R&D pipeline. Initial computational analysis shows that the company's AI-Immunology™ platform can successfully identify novel vaccine targets to combat GAS, which affects hundreds of millions globally each year.

The bacteria can cause severe complications including rheumatic heart disease, necrotizing fasciitis, strep throat, and scarlet fever. The development of EVX-B4 represents a significant milestone in Evaxion's 2025 objectives, bringing their pipeline to eight vaccine candidates - five for infectious diseases and three for cancer.

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Positive

  • AI-Immunology™ platform successfully identified novel vaccine targets for GAS
  • Expansion of R&D pipeline to 8 total vaccine candidates
  • Large market potential with hundreds of millions of GAS infections globally
  • Accelerated preclinical development potential through AI platform
  • Strategic alignment with company's partnership and out-licensing strategy

Negative

  • EVX-B4 is still in early research phase with no clinical validation yet
  • Development and partnership success not guaranteed

News Market Reaction 1 Alert

+5.71% News Effect

On the day this news was published, EVAX gained 5.71%, reflecting a notable positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

  • Initial computational analysis demonstrated that Evaxion’s AI-Immunology™ platform can identify novel vaccine targets to combat Group A Streptococcus (GAS)
  • New vaccine program is added to Evaxion’s pipeline under the name EVX-B4
  • Urgent need for preventive measures against GAS underscores the significant medical and commercial potential of EVX-B4
  • Addition of a novel infectious disease candidate to the pipeline is in line with Evaxion’s partnership strategy

COPENHAGEN, Denmark, June 25, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, initiates work to develop a new preventive vaccine against Group A Streptococcus (GAS), a bacteria causing hundreds of millions of infections globally each year. Infection carries the risk of several complications including life threatening conditions like rheumatic heart disease and necrotizing fasciitis (“flesh eating bacteria”) and less severe yet serious diseases like strep throat and scarlet fever.

The new vaccine program, named EVX-B4, has been added to Evaxion’s research & development (R&D) pipeline of cancer and infectious disease vaccine candidates. Initial computational analysis demonstrated that AI-Immunology™ can identify novel vaccine targets to combat GAS, which could pave the way for a new approach to fight the bacteria. Deploying AI-Immunology™ allows for fast and effective target discovery, design and validation, accelerating preclinical development of EVX-B4. This work will create a comprehensive preclinical data package to facilitate partnership discussions.

“We are excited to add EVX-B4 to our R&D pipeline following an extensive evaluation of numerous bacterial pathogens causing severe medical complications, and for which no preventive vaccine exists. With guidance from a panel of world-renowned experts, we prioritized GAS as a key target where our AI-Immunology™ platform could provide substantial benefit. The urgent need for options to prevent GAS infections is huge, underscoring the significant medical and commercial potential of EVX-B4 as well as multiple partnering options,” says Birgitte Rønø, CSO of Evaxion.

Adding EVX-B4 to the pipeline achieves another of Evaxion’s milestones for 2025. Evaxion’s R&D pipeline now comprises five specified vaccine candidates for infectious diseases and three for cancer. The build-up of the pipeline supports Evaxion’s partnership strategy as we increase the number of assets for out-licensing.

About GAS
Group A Streptococcus (GAS) can cause a wide range of conditions ranging from life-threatening to mild depending on the severity of infection. Invasive GAS infections can cause diseases like sepsis, toxic shock, rheumatic heart disease and necrotizing fasciitis (“flesh eating bacteria”), all of which can be fatal if not treated immediately.

The U.S. rates of invasive GAS disease began increasing in 2014. The increase was largest among adults aged 18 through 64 years, but the rate also increased among older adults. Annually, 20,000 to 27,000 cases and 1,800 to 2,400 deaths are estimated in the US.

Worldwide, rheumatic heart disease remains a significant cause of cardiovascular disease and death. The World Health Organization estimates 470,000 new cases of acute rheumatic fever and 282,000 new cases of rheumatic heart disease each year. In 2015, there was an estimated 33.4 million cases of rheumatic heart disease. In addition, over 300,000 people die each year from rheumatic heart disease or its complications.

The number of non-invasive GAS infections, which can cause diseases like strep throat (pharyngitis), scarlet fever and impetigo, are estimated to be much higher. The World Health Organization estimates that each year over 100 million children worldwide have impetigo and over 600 million have pharyngitis due to GAS. (Source: The US Centers for Disease Control and Prevention).

Contact information 
Evaxion A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion.ai

About Evaxion
Evaxion 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 is Evaxion's new EVX-B4 vaccine program targeting?

EVX-B4 is targeting Group A Streptococcus (GAS), a bacteria that causes hundreds of millions of infections globally each year and can lead to serious complications like rheumatic heart disease and necrotizing fasciitis.

How many vaccine candidates are now in Evaxion's pipeline after adding EVX-B4?

After adding EVX-B4, Evaxion's R&D pipeline now comprises 8 vaccine candidates - five for infectious diseases and three for cancer.

How is Evaxion using AI technology in the EVX-B4 development?

Evaxion is using its AI-Immunology™ platform to identify novel vaccine targets and accelerate preclinical development through fast and effective target discovery, design, and validation.

What is the market potential for Evaxion's EVX-B4 vaccine?

The market potential is significant as GAS affects hundreds of millions globally each year, with no preventive vaccine currently available, presenting substantial medical and commercial opportunities.

How does EVX-B4 fit into Evaxion's business strategy?

EVX-B4 aligns with Evaxion's partnership strategy by increasing the number of assets available for out-licensing and represents achievement of one of their 2025 milestones.
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