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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.

Evaxion (NASDAQ: EVAX) ha annunciato l'aggiunta di un nuovo programma vaccinale, EVX-B4, mirato al Gruppo A Streptococco (GAS) nel suo portafoglio di ricerca e sviluppo. L'analisi computazionale iniziale dimostra che la piattaforma AI-Immunology™ dell'azienda è in grado di identificare con successo nuovi obiettivi vaccinali per combattere il GAS, che colpisce centinaia di milioni di persone nel mondo ogni anno.

Il batterio può causare gravi complicazioni, tra cui la cardiopatia reumatica, la fascite necrotizzante, la faringite streptococcica e la scarlattina. Lo sviluppo di EVX-B4 rappresenta un traguardo importante negli obiettivi di Evaxion per il 2025, portando il loro portafoglio a otto candidati vaccinali - cinque per malattie infettive e tre per il cancro.

Evaxion (NASDAQ: EVAX) ha anunciado la incorporación de un nuevo programa de vacunas, EVX-B4, dirigido al Streptococo del Grupo A (GAS) en su cartera de I+D. El análisis computacional inicial muestra que la plataforma AI-Immunology™ de la compañía puede identificar con éxito nuevos objetivos vacunales para combatir el GAS, que afecta a cientos de millones de personas en todo el mundo cada año.

La bacteria puede causar complicaciones graves, incluyendo la enfermedad cardíaca reumática, fascitis necrotizante, faringitis estreptocócica y escarlatina. El desarrollo de EVX-B4 representa un hito importante en los objetivos de Evaxion para 2025, aumentando su cartera a ocho candidatos a vacuna - cinco para enfermedades infecciosas y tres para cáncer.

Evaxion (NASDAQ: EVAX)은 연구개발 파이프라인에 그룹 A 연쇄상구균(GAS)을 표적으로 하는 새로운 백신 프로그램 EVX-B4를 추가했다고 발표했습니다. 초기 컴퓨터 분석 결과, 회사의 AI-Immunology™ 플랫폼이 전 세계 수억 명에게 영향을 미치는 GAS와 싸우기 위한 새로운 백신 타깃을 성공적으로 식별할 수 있음을 보여줍니다.

이 박테리아는 류마티스 심장병, 괴사성 근막염, 인후염, 성홍열 등 심각한 합병증을 유발할 수 있습니다. EVX-B4 개발은 Evaxion의 2025년 목표에 중요한 이정표가 되며, 감염병용 5개와 암용 3개를 포함해 총 8개의 백신 후보를 보유하게 됩니다.

Evaxion (NASDAQ : EVAX) a annoncé l'ajout d'un nouveau programme vaccinal, EVX-B4, ciblant le Streptocoque du groupe A (GAS) à son portefeuille de R&D. L'analyse informatique initiale montre que la plateforme AI-Immunology™ de la société peut identifier avec succès de nouvelles cibles vaccinales pour combattre le GAS, qui affecte des centaines de millions de personnes dans le monde chaque année.

Cette bactérie peut provoquer des complications graves telles que la maladie cardiaque rhumatismale, la fasciite nécrosante, l'angine streptococcique et la scarlatine. Le développement de EVX-B4 représente une étape importante dans les objectifs d'Evaxion pour 2025, portant leur portefeuille à huit candidats vaccins – cinq pour les maladies infectieuses et trois pour le cancer.

Evaxion (NASDAQ: EVAX) hat die Aufnahme eines neuen Impfstoffprogramms, EVX-B4, das auf Gruppe-A-Streptokokken (GAS) abzielt, in seine F&E-Pipeline bekannt gegeben. Erste computergestützte Analysen zeigen, dass die AI-Immunology™-Plattform des Unternehmens erfolgreich neuartige Impfstoffziele zur Bekämpfung von GAS identifizieren kann, das weltweit jährlich Hunderte Millionen Menschen betrifft.

Das Bakterium kann schwere Komplikationen wie rheumatisches Herzleiden, nekrotisierende Fasziitis, Streptokokkenangina und Scharlach verursachen. Die Entwicklung von EVX-B4 stellt einen bedeutenden Meilenstein in Evaxions Zielen für 2025 dar und bringt die Pipeline auf acht Impfstoffkandidaten – fünf für Infektionskrankheiten und drei für Krebs.

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

Insights

Evaxion's new GAS vaccine program EVX-B4 expands pipeline, leveraging AI platform for significant unmet medical need with commercial potential.

Evaxion's announcement of a new vaccine program targeting Group A Streptococcus (GAS) represents a strategic expansion of their infectious disease portfolio. The company has leveraged its proprietary AI-Immunology™ platform to identify novel vaccine targets against GAS, a pathogen responsible for hundreds of millions of infections globally each year that can lead to serious complications including rheumatic heart disease and necrotizing fasciitis.

The medical significance of this program is substantial. GAS infections range from common strep throat to life-threatening conditions, with no preventive vaccine currently available despite the significant disease burden. This creates both a clear medical need and a potential commercial opportunity for Evaxion.

From a development perspective, Evaxion's AI-driven approach could provide competitive advantages in the vaccine space. Their platform potentially enables accelerated target discovery and preclinical development, which could translate to faster time-to-market and reduced R&D costs compared to traditional vaccine development methods.

The addition of EVX-B4 brings Evaxion's pipeline to eight vaccine candidates - five for infectious diseases and three for cancer. This pipeline expansion aligns with their stated partnership strategy, increasing potential assets for out-licensing deals. For a clinical-stage biotech company, having multiple partnership-ready assets creates various potential value inflection points and risk diversification.

This announcement represents achievement of a stated 2025 milestone, demonstrating execution against corporate objectives. While still in early research stages, the project's selection followed extensive evaluation and expert consultation, suggesting a disciplined approach to pipeline expansion rather than opportunistic development.

  • 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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