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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 geneti

Key Takeaway: Evaxion Biotech A/S announced a business update and second quarter 2023 financial results, highlighting promising early clinical data for its cancer immunotherapies, EVX-01 and EVX-02. The company has successfully secured up to $20 million in financing to support ongoing research initiatives. Notably, preclinical data for EVX-B1 indicates its capacity to effectively clear Staphylococcus infections. However, the company emphasized the need for an additional $5-10 million in funding to advance its clinical trials.

Market Sentiment Analysis

POSITIVE FACTORS

  • Promising early clinical data for EVX-01 and EVX-02 indicates treatment benefits.
  • Successful financing of up to $20 million supports ongoing studies.
  • Presentation of preclinical data for EVX-B1 shows effective infection clearance.

CONCERNS & RISKS

  • Further funding of $5-10 million is required before advancing to Phase 1.
  • The company faces risks related to their financial condition and market acceptance.

Full Press Release Details

Evaxion Announces Business
Update and Second Quarter 2023 Financial Results
*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 Norl n, 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
*Subject to additional funding in the range of $5-10 million secured
Recent Milestones (April
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
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
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
Evaxion will host a webcast
on Tuesday, August 22, at 10:00 a.m. EDT.
To access the webcast, please
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
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 H rsholm, Denmark
and listed on the Nasdaq New York stock exchange. For more information, please visit www.evaxion-biotech.com.
For more information
Jesper Nyegaard Nissen
Interim Chief Financial Officer
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.

Frequently Asked Questions

What is Evaxion Biotech focused on?

Evaxion Biotech specializes in developing AI-driven immunotherapies.

What does the financing support?

The financing will cover working capital and advance EVX-03 to Phase 1 readiness.

What is the purpose of the genetic adjuvant technology?

This technology enhances the effectiveness of DNA and mRNA vaccines.

What were the key findings from recent clinical data?

Early-stage results indicated treatment benefits and good tolerability for EVX-01 and EVX-02.

When is Evaxion's webcast for financial results?

The webcast is scheduled for August 22, 2023, at 10:00 a.m. EDT.

Last updated: Aug 18, 2023