UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K/A
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO SECTION 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 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
x Form 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): ¨
EXPLANATORY NOTE
This Amendment to the Report on Form 6-K originally filed with the
Securities and Exchange Commission on August 17, 2023 (the “Form 6-K”), is being filed solely for the purposes of furnishing
a corrected press release. The corrected press release updates the time of the webcast to 10:00 a.m. EDT from 8:00 a.m. EDT on Tuesday,
August 22.
Furnished as Exhibit 99.1 to this Report on Form 6-K is the corrected press release of Evaxion Biotech A/S (the “Company”)
dated August 18, 2023, announcing the Company’s financial results for the three months ended June 30, 2023.
Exhibits
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: August 18, 2023 |
By: |
/s/ Per Norlén |
| |
|
Per Norlén
Chief Executive Officer |
Exhibit 99.1
Evaxion Announces Business
Update and Second Quarter 2023 Financial Results
| · | Promising
clinical data from Phase 1 and 2a studies with EVX-01 and EVX-02 were presented at AACR and
ASCO in Q2 2023 |
| · | A novel
proprietary genetic vaccine adjuvant was presented at Evaxion’s R&D Day in May.
The technology is an integral part of the next-generation cancer vaccine, EVX-03, planned
for phase 1 clinical trial application in Q4 2023* |
| · | Promising
results on EVX-B1, a Staphylococcus aureus vaccine candidate, were presented at the Staphylococcal
Diseases Gordon Research Conference in New Hampshire, USA, in Q2 2023. |
| · | Financial
agreement secured with Global Growth Holding Limited (GGHL) totaling up to USD 20 million |
| · | Cash and
cash equivalents of $7.1 million at June 30, 2023 sufficient to fund operations
into December 2023 |
*Subject to additional funding
in the range of $5-10 million secured before initiation
COPENHAGEN, Denmark, August
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-driven immunotherapies, today provided a business update and announced its
second quarter 2023 financial results.
“At Evaxion, we believe
that AI-powered, personalized cancer vaccines have the potential to transform the care of patients with melanoma and other cancers. Early-stage
clinical data reported at AACR 2023 and ASCO23 indicated that patients treated with our vaccines, EVX-01 or EVX-02, in combination with
a checkpoint inhibitor, experienced a treatment benefit, with good overall tolerability” said Per Norlén, Chief Executive
Officer of Evaxion. “These data support the potential clinical utility for personalized cancer immunotherapy and the opportunity
to advance our next-generation, DNA-based candidate, EVX-03, towards clinical trials in cancer patients.”
“Additionally, at a time
of positive industry data and renewed interest in personalized cancer vaccines, Evaxion is making excellent scientific progress. Utilization
of two new, proprietary technologies, including the AI platform ObsERV™, which enables identification of novel cancer antigens
called ERVs, which are patient-specific cancer targets of viral origin, plus our novel genetic adjuvant, are believed to further enhance
the efficacy of EVX-03,” said Per, concluding, “On a separate note, we were pleased to present preclinical proof-of-concept
data at the Gordon Conference showing that EVX-B1 can clear staphylococcus infections. Taken together, these clinical advances and proof-of-concept
milestones highlight the potential for Evaxion’s AI-powered technology to address unmet medical needs in oncology and infectious
diseases. The recent completion of an up to $20 million USD financing will support progression of our current studies and operations,
while initiation of EVX-03 phase 1 activities are subject to additional funding."
Anticipated milestones
| · | Q4 2023 - Interim results
of EVX-01 Phase 2 trial in melanoma |
| · | Q4 2023 – Clinical
trial application for EVX-03* |
*Subject to additional funding in the range of $5-10 million secured
before initiation
Recent Milestones (April
to August 2023)
Completion of financing commitments totaling up to USD 20 million
[Press Release with hyperlink]. Evaxion announced completion of a
financing commitment totaling up to $20 million with Global Growth Holding Limited, available in tranches over the next three
years.
The financing is intended to cover the company’s working capital
needs, including the advancement of EVX-03 to Phase 1 readiness.
Promising preclinical data presented at the Staphylococcal Diseases
Gordon Research Conference
[Press Release with hyperlink]. Preclinical data showed EVX-B1, a
vaccine against Staphylococcus aureus (S. aureus) containing AI-identified antigens, is highly protective against S.
aureus disease in pre-clinical models and that EVX-B1 effectively clears S. aureus infections.
Promising early clinical data presented for EVX-01 and EVX-02
| · | EVX-01 presentation
at ASCO23. Phase 1 results showed positive clinical responses in 8 out of 12 patients
receiving EVX-01 in combination with a checkpoint inhibitor. The trial also met primary endpoints
for tolerability and safety, with only mild AEs being related to EVX-01. |
| · | EVX-02 presentation
at AACR 2023. Phase 1/2a results showed that all 10 patients with late stage melanoma
who completed EVX-02 treatment demonstrated robust and treatment-specific immune responses
and were relapse-free at their last assessment. |
R&D Day Highlights Preclinical Data on genetic adjuvant technology
R&D Day 2023. In a series of talks from its scientists
and collaborators, Evaxion provided an introduction to its proprietary genetic adjuvant technology developed to enhance the effectiveness
of DNA and mRNA vaccines. The genetic adjuvant can be encoded into either DNA or mRNA vaccines to boost the immune response. Preclinical
data show that the technology boosts both B cell and T cell immune responses, making it applicable to a wide range of vaccines, both
for cancer and for infectious disease.
Second Quarter of 2023 Financial Results
| · | Cash position:
As of June 30, 2023, cash and cash equivalents were $7.1 million as compared to $13.2 as
of December 31, 2022. Operating spending for the second quarter of 2023 was offset by the
proceeds from issue of shares and exercise of warrants. We expect that our existing cash
and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure
requirements into December 2023. |
| · | Research and Development expenses were $2.9 million for the quarter ended June 30, 2023 as compared to $4.1 million for the
quarter ended June 30, 2022. The decrease in research and development expenses was primarily due to a decrease of $0.7 million in
external costs related to finalized clinical trials and a decrease in employee-related costs of $0.5 million due to reduced headcount. |
| · | General and Administrative expenses were $2.7 million for the quarter ended June 30, 2023 as compared to $2.1 million for the
quarter ended June 30, 2022. The increase in general and administrative expenses was primarily due to an increase of $0.3 million in
external costs related to overhead and professional fees and an increase in employee-related costs of $0.2 million. These increases are due to the timing
of funding projects and business initiatives compared to 2022 and the expansion of the organization throughout 2022 to meet the requirements
as a listed company. |
| · | Net loss was $5.7 million
for the quarter ended June 30, 2023 or ($0.21) per basic and diluted share as compared to
a net loss of $4.8 million, or ($0.20) per basic and diluted share for the quarter ended
June 30, 2022. |
Webcast
Evaxion will host a webcast
on Tuesday, August 22, at 10:00 a.m. EDT.
To access the webcast, please
visit:
https://edge.media-server.com/mmc/p/f5f7dbrd
Notes and abbreviations:
ASCO23 = the 2023 Annual Meeting
of the American Society for Clinical Oncology, AACR 2023 = the 2023 Annual Meeting for the American Association for Cancer Research,
ERVs = endogenous retroviruses
About Evaxion
Evaxion Biotech A/S is a clinical-stage,
pioneering company, advancing AI-powered immunotherapies. Evaxion’s proprietary and scalable AI technologies decode the human immune
system to discover and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Evaxion has a broad pipeline
of candidates, including two clinical-stage, personalized cancer immunotherapies. The Company is located in Hørsholm, Denmark
and listed on the Nasdaq New York stock exchange. For more information, please visit www.evaxion-biotech.com.
For more information
Evaxion Biotech A/S
Jesper Nyegaard Nissen
Interim Chief Financial Officer
jnn@evaxion-biotech.com
+45 9383 2033
Source: Evaxion Biotech
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.
Based on the Company’s current cash position, with a cash runway
until December 2023, further funding is required, to mitigate the Company’s ability to continue as a going concern.
Please refer to the interim financial statements as of June 30, 2023
for further information.
Evaxion Biotech AS (NASDAQ:EVAX)
Historical Stock Chart
From Nov 2023 to Dec 2023
Evaxion Biotech AS (NASDAQ:EVAX)
Historical Stock Chart
From Dec 2022 to Dec 2023
