Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage
TechBio company specializing in developing AI-Immunology™ powered
vaccines, provides business update and announces second quarter
2024 financial results.
Business Highlights Since Last Quarterly
UpdateSince the Q1 2024 financial results were released,
we have continued to make progress on our three-pronged business
model focusing on Targets, Pipeline, and Responders with a
multi-partner approach. Key highlights include:
- Several partnership discussions ongoing as our multi-partner
approach advances
- Positive and validating Phase 2 immune data on lead asset
EVX-01 presented at ASCO, 67% Objective Response Rate from Phase 1
published in leading medical journal. On track for Phase 2 one-year
clinical data readout at the ESMO Congress 2024 in September, as we
continue the solid progress for this program
- Improved performance of key AI-Immunology™ building block
showcased at computational biology conference
- Several important milestones are on track for reporting over
the coming months
Christian Kanstrup, Chief Executive Officer at
Evaxion, commented: “I am very pleased with our continued progress
executing on our three-pronged business model. We remain on track
to achieve several of our key 2024 milestones in the coming months
as planned and communicated. I am excited that we are seeing solid
interest from external parties in both our AI-Immunology™ platform
and our pipeline candidates and we are very focused on advancing
ongoing business development discussions. Further, the EVX-01
immune data presented at ASCO makes us eagerly await the upcoming
one-year clinical readout, which will be presented at ESMO Congress
2024. On the technology side I am excited about the continued
strengthening of our AI-Immunology™ platform. This is evidenced by
the positive feedback from the World Intellectual Property
Organization on our patent application for an AI-based novel cancer
target identification method as well as the presentation of our
updated EvaxMHC building block during July.”
Anticipated 2024
Milestones
|
Milestones |
Target |
EVX-B1 |
Conclusion of final MTA study with potential partner |
Q1 2024 |
AI-Immunology™ |
Launch of EDEN™ model version 5.0 |
Mid 2024(ECCB, September) |
EVX-B2-mRNA |
EVX-B2-mRNA preclinical Proof-of-Concept obtained |
Q3 2024(18th Vaccine Congress, September) |
EVX-01 |
Phase 2 one-year readout |
Q3 2024(ESMO Congress, September) |
EVX-B3 |
Conclusion of target discovery and validation work in collaboration
with MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA) |
H2 2024 |
Precision ERV cancer vaccines |
Preclinical Proof-of-Concept obtained |
H2 2024 |
Funding |
Ambition for full year 2024 is to generate business development
income or cash in equal to 2024 cash burn (excluding financing
activities) of $14 million* |
|
*No assurances can be made that we will generate such business
development income
Second Quarter 2024 Financial
Results
Cash position as of June 30, 2024, was $8.0
million, as compared to $5.6 million as of December 31, 2023. The
company expects that its existing cash and cash equivalents will be
sufficient to fund its operating expenses and capital expenditure
requirements into February 2025.
Research and Development expenses were $2.8
million for the quarter ending June 30, 2024, as compared to $2.9
million for the quarter ending June 30, 2023. The decrease was
primarily due to a decrease in headcount partly countered by
increased external costs related to development activities in
general.
General and Administrative expenses were $2.0
million for the quarter ending June 30, 2024, as compared to $2.7
million for the quarter ending June 30, 2023. The decrease was
primarily due to a decrease in external costs related to overhead
and professional fees but also a decrease in employee-related costs
due to reduced headcount.
Net loss of $6.2 million for the quarter ending
June 30, 2024, or $(0.12) per basic and diluted share, as compared
to a net loss of $5.7 million, or $(0.21) per basic and diluted
share for the quarter ending June 30, 2023. The increased loss in
net income was driven by the remeasurement of $1.7 million of
derivative liabilities in the period until the warrant terms were
amended and the liabilities reversed and included in other
reserves. The derivative liability which has been reversed related
to warrants associated with the December 2023 PIPE and February
2024 public offering financing transactions.
Total equity amount to $1.3 million on June 30,
2024. Effects from derivative liabilities mentioned in the
announcement for first quarter have been eliminated as warrant
terms have been amended and the derivative liabilities reversed.
Remeasurement of derivative liabilities for the 6 months
period ending June 30, 2024, is accounted for as financial income
and expenses with an income of $3.8 million for the period until
the term was amended and the remaining balance was transferred to
other reserves, where it together with the initial recognition of
the liability amounted to a net cost of $1.1 million.
Evaxion Biotech A/SConsolidated Statement of
Financial Position Data (Unaudited)(USD in thousands)
|
June
30,2024 |
Dec 31,2023 |
Cash and cash equivalents |
$ |
7,993 |
$ |
5,583 |
Total assets |
15,231 |
12,889 |
Total liabilities |
13,978 |
17,618 |
Share capital |
8,244 |
5,899 |
Other reserves |
105,983 |
99,946 |
Accumulated deficit |
(112,974) |
(107,860) |
Total equity before derivative
warrant liability |
1,253 |
(2,015) |
Effect from derivative
liabilities from investor warrants |
- |
(2,714) |
Total equity |
1,253 |
(4,729) |
Total liabilities and equity |
$ |
15,231 |
$ |
12,889 |
Based on the company’s current cash position
with an expected cash runway into February 2025, income from
business development deals and/or further funding is required to
mitigate the conclusion that there is significant doubt about the
company’s ability to continue as a going concern. Please refer to
the Form 20-F, filed March 27, 2024, for additional background on
the company.
As shared earlier, the company received on May
7, 2024, a Nasdaq equity deficiency letter. This deficiency is
partly a consequence of the IFRS accounting treatment of the
company’s investor warrants which has been reversed as described
above. A plan to regain compliance has been shared with and
accepted by Nasdaq providing until November 04, 2024, to evidence
compliance.
Evaxion Biotech A/SConsolidated Statement of
Comprehensive Loss Data (Unaudited)(USD in thousands, except per
share data)
|
Three Months Ended June 30, |
Six Months EndedJune 30, |
|
2024 |
2023 |
2024 |
2023 |
|
(USD in thousands, except per share amounts) |
Revenue |
$ |
154 |
$ |
— |
$ |
205 |
$ |
— |
Research and
development |
(2,752) |
(2,936) |
(5,588) |
$ |
(6,788) |
General and
administrative |
(1,983) |
(2,741) |
(3,594) |
(5,283) |
|
|
|
|
|
Operating
loss |
(4,581) |
(5,677) |
(8,977) |
(12,071) |
Finance
income |
220 |
47 |
5,838 |
332 |
Finance
expenses |
(2,036) |
(278) |
(2,282) |
(604) |
|
|
|
|
|
Net loss before tax |
$ |
(6,198) |
$ |
(5,908) |
$ |
(5,421) |
$ |
(12,343) |
Income tax
benefit |
199 |
225 |
417 |
419 |
Net loss for the
period |
$ |
(6,198) |
$ |
(5,683) |
$ |
(5,004) |
$ |
(11,924) |
Net loss attributable to shareholders of Evaxion
Biotech
A/S |
$ |
(6,198) |
$ |
(5,683) |
$ |
(5,004) |
$ |
(11,924) |
Loss per share – basic and diluted |
$ |
(0.12) |
$ |
(0.21) |
$ |
(0.10) |
$ |
(0.46) |
Number of shares used for calculation (basic and diluted) |
53,787,469 |
26,438,007 |
50,212,854 |
26,112,734 |
Contact InformationEvaxion
Biotech A/S Mads
Kronborg Vice
President, Investor Relations & Communication+45 53 54 82
96mak@evaxion-biotech.com
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.
Evaxion Biotech AS (NASDAQ:EVAX)
Gráfica de Acción Histórica
De Oct 2024 a Nov 2024
Evaxion Biotech AS (NASDAQ:EVAX)
Gráfica de Acción Histórica
De Nov 2023 a Nov 2024