UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION 

Washington, D.C. 20549

 

 

 

FORM 6-K

 

 

 

REPORT OF FOREIGN PRIVATE ISSUER 

PURSUANT TO SECTION 13a-16 OR 15d-16 

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of September 2023

 

Commission File Number: 001-39950

 

 

 

Evaxion Biotech A/S 

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

Dr. Neergaards Vej 5f 

DK-2970 Hoersholm 

Denmark 

(Address of principal executive offices)

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F xForm 40-F ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨

 

 

  

 

 

 

INCORPORATION BY REFERENCE

 

This report on Form 6-K shall be deemed to be incorporated by reference in Evaxion Biotech A/S’s registration statements on Form S-8 (File No. 333-255064), on Form F-3 (File No. 333-265132) and on Form F-1, as amended (File No. 333-266050), including any prospectuses forming a part of such registration statements and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

 

Press Releases.

 

On September 18, 2023, Evaxion Biotech A/S (the “Company”), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, announced the initiation of a novel pipeline program, EVX-B3, an AI-designed vaccine candidate against an undisclosed bacterial pathogen. A copy of this press release is attached to this Form 6-K as Exhibit 99.1.

 

On September 20, 2023, Evaxion Biotech A/S (the “Company”), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, announced a collaboration with Afrigen Biologics (Afrigen). A copy of this press release is attached to this Form 6-K as Exhibit 99.2.

 

Exhibit No.Description
99.1 Press Release dated September 18, 2023.
99.2  Press Release dated September 20, 2023.

 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Evaxion Biotech A/S
Date: September 27, 2023 By: /s/ Sabine Mølleskov
Sabine Mølleskov
VP Investor Relations

 

 

Exhibit 99.1

 

 

Evaxion expands preclinical bacterial vaccine pipeline in collaboration with leading pharmaceutical company

 

September 18, 2023

 

 AI-powered target discovery for a bacterial pathogen with a high medical need where no vaccine is currently available

 

Evaxion’s proprietary AI-platforms EDEN™ and RAVEN™ will be utilized for rapid design of a completely novel vaccine candidate capable of eliciting both a humoral (antibody) and cellular immune response to the pathogen

 

Collaborative and co-funded project between two companies with strong scientific alignment and complementary skill sets and capabilities

 

This collaboration underlines Evaxion’s strategic focus of harnessing the power of AI to identify new targets significantly more efficiently than traditional methods

 

COPENHAGEN, Denmark, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, today announced the initiation of a novel pipeline program, EVX-B3, an AI-designed vaccine candidate against an undisclosed bacterial pathogen. The new vaccine project will be a collaboration between Evaxion and an undisclosed leading pharmaceutical company, leveraging unique assets and know-how from both organizations.

 

To develop an effective vaccine, Evaxion has initiated discovery activities for EVX-B3 using both its EDEN™ and RAVEN™ AI platforms to identify protective antigens capable of eliciting both a humoral (antibody) and cellular response to the pathogen. EVX-B3 aims to address a serious global medical issue, targeting a pathogen associated with repeated infections, increasing incidence and often serious medical complications, and for which no vaccines are currently available. The project will be a collaborative and co-funded effort between the two companies.

 

Evaxion’s Chief Scientific Officer, Birgitte Rønø, states: “We are thrilled to announce our upcoming collaboration, aimed at jointly investigating the capabilities of our AI platforms to design a groundbreaking vaccine targeting this specific pathogen. We strongly believe that this collaboration will further validate the power of AI to benefit global health through the design of unique vaccines against serious medical conditions.”

 

About EDEN™

 

EDEN™ is a proprietary AI platform capable of rapidly identifying those antigens that will trigger a robust and highly protective immune response against virtually any bacterial infectious disease. EDEN™ is fully AI-driven and designed to identify vaccine candidates faster and cheaper than current state-of-the-art methods. With EDEN™, we take a novel approach to vaccine development to combat the rising global issue of antibiotic resistance. For more information, visit our website.

 

About RAVEN™

 

RAVEN™ is a proprietary AI platform that rapidly identifies vaccine candidates against existing, emerging, and mutating viral diseases. We are developing next-generation vaccine candidates that aim to simultaneously trigger potent B- and T-cell responses. Current vaccines against viral infection are challenged by fading efficacy and evasion by mutating viruses. With RAVEN™, the addition of the T-cell component is designed to secure broader, more durable protection. For more information, visit our website.

 

About EVAXION

 

Evaxion Biotech A/S is a clinical-stage biotech company developing world-leading AI platforms. Evaxion's proprietary and scalable technologies harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. The company is committed to transforming patients' lives with unmet clinical needs by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking immunotherapies, please visit www.evaxion-biotech.com.

 

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 the worldwide COVID-19 pandemic and the ongoing conflict in the region surrounding Ukraine and Russia; 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 U.S. 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.

 

Contact information Evaxion Biotech A/S Christian Kanstrup      Chief Executive Officer cka@evaxion-biotech.com Source: Evaxion Biotech

 

 

Exhibit 99.2

 

 

Evaxion Partners With Pharmaceutical Company Afrigen Biologics to Develop Novel mRNA Vaccine Against Gonorrhea

 

September 20, 2023

 

Partnership based on a highly protective vaccine candidate identified by Evaxion’s EDEN™ platform

 

The collaboration will access mRNA technology from the WHO and Medicines Patent Pool’s mRNA Vaccine Technology Transfer Hub

 

Afrigen responsible for the development and commercialization of the resulting mRNA vaccine in LMICs and African territories

 

COPENHAGEN, Denmark, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, today announced a collaboration with Afrigen Biologics (Afrigen). The collaboration aims at developing a prophylactic vaccine based on Evaxion’s EDEN™-discovered gonorrhea targets.

 

Evaxion’s Chief Scientific Officer, Birgitte Rønø, expressed enthusiasm about the collaboration, stating, “We are thrilled about this partnership. It offers a unique opportunity to deliver our EDEN™-identified antigens using mRNA and it accelerates clinical validation of the EDEN™ platform. This partnership has the potential to address a serious unmet global medical need against the pathogen for which no vaccine currently exists.”

 

Gonorrhea, caused by the bacteria Neisseria gonorrhoeae, is a sexually transmitted disease that exerts a significant influence on global sexual and reproductive health and elevates the susceptibility to HIV, another major health problem in many low- and middle-income countries (LMICs). The World Health Organization (WHO) has reported an alarming estimate of 82 million new gonorrhea infections occurring annually worldwide with a rise in antibiotic-resistant cases.

 

The EDEN™-discovered antigens have demonstrated high levels of protection in preclinical studies. This partnership will explore the expression and biological activity of the antigens in mRNA format. Following the validation phase, the partners will negotiate a subsequent agreement for clinical development and commercialization, with the opportunity to bring in additional partners.

 

“We are excited to announce Evaxion’s second partnership this week. This is a further validation of our strategy to identify the right partners who can bring our novel AI-designed vaccines to the market,” said Evaxion CEO Christian Kanstrup.

 

Afrigen’s Managing Director Professor Petro Terblanche states, “This innovative exciting partnership enables the mRNA technology platform established at Afrigen through the support of the WHO and MPP to expand the pipeline of products to be developed for the mRNA Programme. This supports the sustainability of manufacturing capacity being created in the LMIC partners.”

 

About EDEN

 

EDEN™ is a proprietary AI platform capable of rapidly identifying those antigens that will trigger a robust and highly protective immune response against virtually any bacterial infectious disease. EDEN™ is fully AI-driven and designed to identify vaccine candidates faster and cheaper than current state-of-the-art methods. With EDEN™, we take a novel approach to vaccine development to combat the rising global issue of antibiotic resistance. For more information, visit our website.

 

About EVAXION

 

Evaxion Biotech A/S is a clinical-stage biotech company developing world-leading AI platforms. Evaxion's proprietary and scalable technologies harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. The company is committed to transforming patients' lives with unmet clinical needs by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking immunotherapies, please visit www.evaxion-biotech.com.

 

About Afrigen Biologics

 

Afrigen Biologics is a Cape Town-based biotechnology company supported and capitalized by Avacare Healthcare Group and the Industrial Development Corporation (IDC) of South Africa. Afrigen is being supported by the WHO and MPP mRNA Technology Transfer Programme to operate as the Center for mRNA vaccine technology development and transfer. Afrigen through international partnerships and local capacity building has established the first-ever vaccine adjuvant production and formulation technology center on the African continent. This center, in partnership with IDRI, a world leader in adjuvant development, focuses on next-generation vaccine adjuvants, which are not only geared at preventing disease, but have therapeutic value. For more information in Afrigen, please visit https://www.afrigen.co.za/.

 

 

 

 

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 the worldwide COVID-19 pandemic and the ongoing conflict in the region surrounding Ukraine and Russia; 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 U.S. 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.

 

Contact information Evaxion Biotech A/S Christian Kanstrup      Chief Executive Officer cka@evaxion-biotech.com Source: Evaxion Biotech

 

 


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