Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a
clinical-stage TechBio company specializing in developing
AI-Immunology™ powered vaccines, today provided a business update
and announced its third quarter 2023 financial results.
Christian Kanstrup, Evaxion’s CEO, reports, “It
has been a great pleasure to join Evaxion, and the first three
months have confirmed my belief in a world-class organization and
business with strong potential for addressing significant unmet
needs within cancer and infectious diseases. Our AI-Immunology™
platform offers unique opportunities in this connection. A key
focus for the first months has been to refine the Evaxion strategy
with a strong focus on execution and value realization.
“I am pleased to be able to share the refined
strategy in a simple, straightforward overview below. The core of
our strategy lies in our pioneering AI-Immunology™ platform, which
has been continuously refined and validated over the past many
years. This platform holds the potential for generating one new
target every 24 hours, is delivery modality agnostic, and is easily
adaptable to partner needs. Based on the unique multi-disciplinary
capabilities built around our different AI prediction models, we
focus on value realization via Targets, Pipeline and
Responders. We have already seen substantial progress
within each of these three areas: two partnerships announced within
Targets and encouraging initial EVX-01 Phase 2
data showcase significant progress in our
Pipeline. Within Responders, we
have obtained proof-of-principle for our checkpoint inhibitor
responder model.
“The refined strategy also means reduced focus
on Evaxion-driven clinical trials, significantly reducing the cash
burn. Combined with a stronger focus on value realization based
upon our AI-Immunology™ platform, we have the ambition of being
able to generate full-year 2024 business development income equal
to our cash burn in 2024, excluding financing activities. We
believe we are set for strong business execution based on our
refined strategy.”
The Evaxion Three-Pronged Strategy
Christian Kanstrup continued, “I am also very
pleased with the bridge financing round we just priced. It is an
important element in our long-term financing strategy. The investor
base in the round consists of existing investors, management, and
the board of directors, as well as new investors. The largest new
investor is MSD Global Health Innovation Fund (MSD GHI), the
corporate venture capital arm of Merck & Co., Inc., Rahway, NJ,
USA, accounting for some 25% of the private placement. I am looking
very much forward to be working with the capable team from MSD GHI.
We believe this financing round shows strong confidence in our
future business outlook.
“We are also excited to see that the validation
of the AI-Immunology™ platform has continued. The EDEN™ AI
prediction model has been validated for B-cell antigen discovery
across seven different pathogens and formed a central component of
the two important partnerships Evaxion entered into during the
third quarter. One of these partnerships brings together
AI-discovered antigens and mRNA technology – a first in the Evaxion
pipeline. EDEN™ and the T-cell epitope discovery model, RAVEN™, are
pivotal components of the other partnership forged with a leading
pharmaceutical company to discover and develop vaccines against a
pathogen with high unmet medical need for which no vaccines are
available. Evaxion plans to build on this momentum and leverage our
AI-Immunology™ platform to pursue new partnerships for novel
vaccine targets within infectious diseases.
“This quarter has also seen significant
developments in our cancer portfolio and capabilities. A
comprehensive clinical update on the EVX-01 Phase 2 trial shared at
the SITC conference confirms the encouraging Phase 1 immune profile
seen for our lead personalized cancer vaccine asset. This
achievement solidifies our confidence in the potential
AI-Immunology™ holds at becoming a new treatment paradigm for
metastatic melanoma.
“Another truly exciting element in the
AI-Immunology™ platform is the ObsERV™ model, which is unique to
Evaxion and allows us to harness a new source of tumor-specific
antigens in oncology patients. With ObsERV™, we hope to expand the
therapeutic reach of personalized cancer vaccines to patients with
high mutational burden tumors but low numbers of high-quality
neoantigens and patients with low tumor mutational burden who would
otherwise not qualify for many of the treatment options available
today. One exciting possibility we are currently looking into is
whether we could use ObsERV™ to identify shared cancer antigens in
particular cancer subtypes. This would hold the promise to develop
the first precision cancer vaccines targeting indications with no
equivalent treatment option to date. Details on this principle were
shared at ASH in December this year.
“With the recent development within cancer and
infectious diseases, we have been seeing a further confirmation of
our approach and are looking forward to discussing partnering
opportunities across all parts of our strategy and associated with
our three-pronged business model: Targets, Pipeline, and
Responders.”
Anticipated 2024 Milestones
- EVX-B1 – Conclusion of final MTA
study with a potential partner, Q1, 2024
- AI-Immunology™ – Launch of EDEN™
model 5.0, mid-2024
- EVX-B2-mRNA – Preclinical
proof-of-principle obtained, Q3-2024
- EVX-01 – Phase 2 one-year readout,
Q3, 2024
- EVX-B3 – Conclusion of target
discovery and validation work in collaboration with leading pharma,
H2, 2024
- Precision ERV cancer vaccines –
Preclinical proof-of-concept obtained, H2, 2024
- Value realization – Ambition for
full year 2024 to generate business development income equal to
2024 expected cash burn of $14 million (excluding financing
activities)
Recent Events (July-December
2023)
Christian Kanstrup Leads Evaxion’s AI
Strategy as CEO Evaxion appoints Christian Kanstrup as
CEO, emphasizing his unique leadership and strategic development
skills. Kanstrup’s vision aims to harness the full potential of
Evaxion’s AI platform for therapeutic innovation.
Evaxion’s EDEN™ Model Validated:
Revolutionizing Vaccine Development Evaxion shared data at
the Vaccines Europe conference validating the EDEN™ model for
bacterial vaccine discovery. This groundbreaking achievement
emphasizes the models’ ability to swiftly generate novel vaccine
targets, offering a faster, cheaper, and lower-risk approach to
vaccine development. CEO Christian Kanstrup and Founder Andreas
Holm Mattsson highlight its potential impact on high unmet medical
needs, signaling a paradigm shift in vaccine discovery.
Evaxion Initiates AI-Designed Vaccine
Program EVX-B3 in Collaboration with Leading Pharmaceutical
Partner Evaxion Biotech launches EVX-B3, an AI-guided
vaccine program, in collaboration with a leading pharmaceutical
company. Leveraging Evaxion’s EDEN™ and RAVEN™ AI models, the
project aims to efficiently identify protective antigens against an
undisclosed bacterial pathogen, addressing a critical global health
concern. The collaborative effort highlights Evaxion’s dedication
to harnessing AI for innovative vaccine design.
Evaxion and Afrigen Join Forces for
Gonorrhea mRNA VaccineEvaxion Biotech partners with
Afrigen Biologics to develop an mRNA vaccine against gonorrhea,
utilizing EDEN™-discovered targets. The collaboration, leveraging
mRNA technology from the WHO and Medicines Patent Pool, aims to
address the global medical need for a gonorrhea vaccine. Evaxion
CEO Christian Kanstrup sees this collaboration as a strategic step
to bring AI-designed vaccines to market, emphasizing the importance
of identifying the right partners.
Evaxion’s EVX-01 Phase 2 Trial Shows
Promise in Personalized Cancer Treatment Evaxion Biotech
reports encouraging Phase 2 data for its personalized cancer
vaccine, EVX-01, confirming earlier Phase 1 findings. Notably, a
metastatic melanoma patient with initial progressive disease showed
significant and continuous tumor reduction after EVX-01 treatment.
CEO Christian Kanstrup highlights the potential of their
AI-Immunology™ platform to revolutionize oncology.
Webinar: Evaxion Shares Insights on
EVX-01 Phase 2 Clinical Data Evaxion Biotech hosted an
online webinar on November 8 featuring KOL Professor Adnan Khattak,
one of the principal investigators of the EVX-01 Phase 2 clinical
trial. The 30-minute event explores malignant melanoma, summarizes
Phase 1 results, and details the Phase 2 update.
Evaxion Introduces AI Model for
Predicting Cancer Immunotherapy Responses Evaxion unveils
its AI model at the Biomarkers & Precision Oncology Europe
conference, aiming to predict patient responses to cancer
immunotherapy. The model shows promise in enhancing outcomes and
reducing healthcare costs, aligning with Evaxion’s commitment to
advancing the AI-Immunology™ Responders area.
Evaxion Unveils Innovative Precision
Vaccine Concept for Hematological MalignanciesEvaxion
announces a groundbreaking precision vaccine concept for
hematological malignancies at the 65th American Society of
Hematology (ASH) Annual Meeting. The use of AI-Immunology™ to
target endogenous retroviruses represents a significant
advancement, offering tailored vaccines for hematological
malignancies. The upcoming oral presentation on December 9
signifies a major milestone in Evaxion’s pursuit of innovative
cancer solutions.
Third Quarter of 2023 Financial
Results
- Cash position: as of September 30,
2023, cash and cash equivalents were $2.6 million as compared to
$13.2 as of December 31, 2022
- Research and Development expenses
were $2.9 million for the quarter ending September 30, 2023, as
compared to $4.1 million for the quarter ending September 30, 2022.
The decrease was primarily due to a reduction in external
costs
- General and administrative expenses
were $2.9 million for the quarter ending September 30, 2023, as
compared to $2.0 million for the quarter ending September 30, 2022.
The increase was primarily due to increased external costs in
connection with the current funding activities
- Net loss was $5.9 million for the
quarter ended September 30, 2023, or ($0.21) per basic and diluted
share, as compared to a net loss of $5.9 million, or ($0.24) per
basic and diluted share for the quarter ended September 30,
2022
About EVAXIONEvaxion 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
StatementThis 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 US 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.
Financials
Evaxion Biotech A/SConsolidated Statements
of Financial Position Data (Unaudited) |
|
|
|
|
(USD in thousands) |
|
|
September 30,2023 |
|
December 31,2022 |
Cash and cash equivalents |
|
$ |
2,605 |
|
$ |
13,184 |
Total
assets |
|
|
11,942 |
|
|
22,025 |
Total
liabilities |
|
|
14,676 |
|
|
13,722 |
Share
capital |
|
|
4,415 |
|
|
3,886 |
Other
reserves |
|
|
82,614 |
|
|
77,076 |
Accumulated deficit |
|
|
(89,763) |
|
|
(72,659) |
Total
equity |
|
|
(2,734) |
|
|
8,303 |
Total
liabilities and equity |
|
$ |
11,942 |
|
$ |
22,025 |
|
|
|
|
|
|
|
The number of shares sold through the ATM
Program since September 30, 2023, amounts to 301,913 shares.
|
Evaxion Biotech A/SConsolidated Statements
of Comprehensive Loss Data (Unaudited) (USD in thousands, except
per share data) |
|
|
|
|
|
|
|
|
Three months |
|
Nine months |
|
Ended September 30 |
|
Ended September 30 |
|
2023 |
2022 |
|
2023 |
2022 |
Research and development expenses |
$ |
2,830 |
$ |
4,068 |
|
$ |
9,618 |
$ |
12,983 |
General
and administrative expenses |
2,932 |
2,015 |
8,215 |
5,756 |
Operating loss |
(5,762) |
(6,083) |
(17,833) |
(18,739) |
Finance
income |
72 |
703 |
404 |
2,761 |
Finance
expenses |
(182) |
(535) |
(786) |
(918) |
Net loss
before tax |
(5,872) |
(5,915) |
(18,215) |
(16,896) |
Income
tax benefit |
194 |
175 |
613 |
599 |
Net loss
for the period |
$ |
(5,678) |
$ |
(5,740) |
$ |
(17,602) |
$ |
(16,297) |
Net loss
attributable to equity holders of Evaxion Biotech A/S |
$ |
(5,678) |
$ |
(5,740) |
$ |
(17,602) |
$ |
(16,297) |
Loss per
share – basic and diluted |
$ |
(0.21) |
$ |
(0.24) |
$ |
(0.66) |
$ |
(0.69) |
Number
of shares used for calculation (basic and diluted) |
27,659,878 |
23,894,684 |
26,754,440 |
23,489,206 |
Based on the Company’s current cash position,
including the bridge financing round expected to raise aggregate
proceeds of approximately $5.3 million, the Company has a cash
runway towards the end of March 2024. Further funding is required
and will be pursued through the Company´s long-term funding
strategy. Please refer to form 20-F, filed April 28, for additional
background on the Company.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/16050912-bd9d-4e2a-bc01-9199b4e30b5f
Contact Information
Evaxion Biotech A/S
Christian Kanstrup
Chief Executive Officer
cka@evaxion-biotech.com
Source: Evaxion Biotech
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