UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of July 2024
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 office)
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 [ X ] Form 40-F [ ]
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), on Form F-1, as amended (File No. 333-266050), Form F-1 (File No. 333-276505), and Form F-1 (File No. 333-279153), 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of such registration statements and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
On July 3, 2024, Evaxion Biotech A/S (the “Company”), issued an Update Letter to Shareholders (the “Letter”) available on its website. A copy of the Letter is attached hereto as Exhibit 99.1.
Exhibit
Exhibit No. | Description | |
99.1 | Letter to Shareholders |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Evaxion Biotech A/S | |||
(Registrant) | |||
Date: July 3, 2024 | By: | /s/ Christian Kanstrup | |
Christian Kanstrup | |||
Chief Executive Officer | |||
EXHIBIT 99.1
Evaxion Reinforces Milestone Timeline and Provides Shareholder Update
COPENHAGEN, Denmark, July 03, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, today issued the following letter to shareholders.
Dear Fellow Shareholders of Evaxion,
The first half of 2024 has been off to a very productive start to the year for Evaxion. We have launched our refined strategy, and we are well positioned for value realization via our three-pronged business model focusing on vaccine target discovery collaborations using our core AI-Immunology platform (Targets), advancing our pipeline of vaccine candidates (Pipeline) and using our core data and predictive capabilities to develop responder models (Responders). Value realization is being pursued via a multi-partner approach.
In early 2024, we bolstered our cash at hand via completion of a USD 15 million public offering. We were pleased to see MSD GHI (a corporate venture capital arm of Merck & Co., Inc., Rahway, NJ, USA) also participate in this offering, making them our largest shareholder.
Within the Target part of our strategy, in February we announced the successful completion of the initial phases of the ongoing vaccine collaboration with MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA). The collaboration is on track for completion of the vaccine discovery and early preclinical development part during the second half of the year, and we are excited to be developing a novel vaccine together with one of the world's leading companies in vaccine development and commercialization.
Our R&D Day in March, with a focus on our AI-Immunology platform, attracted a lot of attention and we are thrilled to see the interest from potential partners in gaining a deeper understanding of the unique opportunities for discovering, designing, and developing novel vaccines using AI-Immunology in partnership with Evaxion.
Within the Pipeline part of our strategy, a key focus for Evaxion during 2024 has been the ongoing personalized EVX-01 Phase 2 trial in metastatic melanoma. We were thrilled to see the first patient completing dosing with EVX-01 in April. This was followed by a presentation of exciting immune data at the ASCO Annual Meeting in early June, showing that the EVX-01 vaccine induced specific and targeted immune responses, with 71% of the administered neoantigens eliciting a T-cell response. This compares favorably to what other companies have shown. We are looking very much forward to the one-year readout from the Phase 2 trial, which is still expected in the third quarter of this year.
Also, within the Pipeline part of our strategy, we are continuing the work on a precision vaccine concept based on a novel source of cancer vaccine targets. This novel precision vaccine concept holds potential to broaden the use of cancer vaccines. We are on track for preclinical Proof-of-Concept in the second half of the year.
Finally, it’s worth mentioning that our ambition of generating business development income in 2024 corresponding to our yearly operational cash burn of USD 14 million remains in place. While there will always be uncertainty as to whether business development discussions materialize in actual agreements and the timing of such agreements, we are encouraged by the strong interest we are seeing from potential partners in both our pipeline assets and our AI-Immunology platform. We are fully focused on advancing these business development discussions.
We would like to take this opportunity to wish you all a great summer, and we look forward to continuing strong execution on our three-pronged business model during the second half of 2024. We remain committed to saving and improving lives with AI-Immunology.
On behalf of the Evaxion team, I would like to thank all our shareholders for the continued support.
Best regards,
Christian Kanstrup, CEO
About EVAXION
Evaxion Biotech 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 the worldwide ongoing COVID-19 pandemic and the ongoing conflict in the region surrounding Ukraine and Russia and the Middle East; 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