Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a
clinical-stage TechBio company specializing in developing
AI-Immunology™ powered vaccines, today provides a business update
and announces full year 2023 financial results.
Christian Kanstrup, Chief Executive Officer at
Evaxion, commented: “We have made significant progress in our
business and our financing strategies in recent months, notably the
successful closing of our bridge financing round towards the end of
2023 and a subsequent public offering in early February 2024. We
are very pleased with the MSD GHI participation in both financing
rounds, following which we now have cash at hand into Q1 2025.”
Christian continues: “With our refined strategy
centered around AI-Immunology™ focusing on value realization via
Targets, Pipeline and Responders based upon a muti-partner
approach, we are enthusiastic about the prospects this brings for
2024. Further, we are executing to progress our ambition to fund
our projected $14 million operational cash burn for 2024 through
revenue generated from our business development activities.”
Business Updates Since Last Quarterly
Update
In January 2024, Evaxion announced it had
commenced developing tailored novel cancer vaccines using the
AI-Immunology™ platform. The initiative involves a new category of
AI-identified tumor vaccine targets, ERVs, and aims to obtain
preclinical Proof-of-Concept by the second half of 2024. With the
AI-Immunology™ discovered novel cancer targets, designing
personalized and precision vaccines may become feasible. This
approach holds the potential to provide treatment solutions for
cancer patients who typically do not respond to cancer
immunotherapy.
In February 2024, the initial phases of an
ongoing vaccine collaboration with MSD were successfully completed.
The collaboration was initiated in September 2023, and in February
2024 MSD was revealed as the pharma partner for the EVX-B3 vaccine
collaboration in connection with the collaboration update. The
project aims to develop a vaccine against a bacterial pathogen
responsible for a pressing global medical issue, lacking preventive
or curative options.
Evaxion hosted an R&D Day on March 19, 2024,
providing deeper insights into the validated and differentiated
AI-Immunology™ platform. Key takeaway messages from the day
were:
- The proprietary AI-Immunology™ platform brings the potential
for a new era in vaccine discovery, design and development using
advanced AI and machine learning technologies.
- AI-Immunology™ outcompetes standard vaccine target discovery
approaches and holds the promise of addressing serious unmet
needs.
- With a unique modular architecture, AI-Immunology™ is scalable
and adaptable towards partner needs.
- The potential of AI-Immunology™ is validated by established
partnerships, including the ongoing vaccine collaboration with
MSD.
In the initial months of 2024, we showcased our
differentiated AI-Immunology™ platform for vaccine target
discovery, design and development, alongside our refined strategy
for value generation, at the following conferences:
January 8-11: |
CEO Christian Kanstrup attended the 42nd annual J.P. Morgan
Healthcare Conference. |
February 27: |
Chief AI Officer, Andreas Holm
Mattsson, participated in a panel discussion at the Sachs
Associates 5th Annual European HealthTech CEO Forum. |
February 28: |
CEO Christian Kanstrup presented
the Sachs Associates 17th Annual European Life Sciences CEO
Forum. |
March 7: |
VP of AI & Innovation, Jens
Kringelum, presented the 5th Biologics World Nordics 2024
Conference. |
March 7: |
CEO Christian Kanstrup and CSO
Birgitte Rønø participated in a fireside chat at the
H.C. Wainwright 1st Annual Artificial Intelligence Based
Drug Discovery & Development Virtual Conference. |
March 7-8: |
Senior Project Manager,
Immuno-oncology, Daniela Kleine-Kohlbrecher, presented at the 8th
Annual MarketsandMarkets Next-Gen Immuno-Oncology Conference. |
|
|
|
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 |
EVX-B2-mRNA |
EVX-B2-mRNA preclinical Proof-of-Concept obtained |
Q3 2024 |
EVX-01 |
Phase 2 one-year readout |
Q3 2024 |
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 equal to 2024 cash burn (excluding financing activities) of
$14 million* |
|
* No assurances can
be made that we will generate such business development
income |
Full Year 2023 Financial
Results
- Cash position: As of December 31,
2023, cash and cash equivalents were $5.6 million compared to $13.2
as of December 31, 2022. Cash position was strengthened by a
private placement with gross proceeds of $5.3 million, which closed
on December 21, 2023. The private placement included participation
from existing and new shareholders, with the largest new
shareholder being MSD Global Health Innovation Fund (MSD GHI), a
corporate venture capital arm of Merck & Co., Inc., Rahway, NJ,
USA, accounting for some 25% of the total aggregate offering
amount. Further, the Private Placement included significant
participation by all members of the Company’s management and the
Company’s board of directors. After a public offering in February
2024, resulting in net proceeds of $12.7 million, we expect that
our existing cash and cash equivalents will be sufficient to fund
our operating expenses and capital expenditure requirements into
February 2025. If all pre-funded warrants included in the public
offering are exercised, we expect necessary funding will be in
place into April 2025.
- Research and Development expenses
were $11.9 million for the year ended December 31, 2023, as
compared to $17.1 million for the year ended December 31, 2022. The
decrease was primarily due to a reduction in external costs.
- General and Administrative expenses
were $10.4 million for the year ended December 31, 2023, as
compared to $8.2 million for the year ended December 31, 2022. The
increase was primarily due to an increase in external costs in
connection with funding activities.
- Net loss was $22.1 million for the
year ended December 31, 2023, or ($0.81) per basic and diluted
share, as compared to a net loss of $23.2 million, or ($0.98) per
basic and diluted share for the year ended December 31, 2022.
Based on the Company’s current cash position,
with an estimated cash runway into February 2025 and the need for
further funding, it is the assessment of management that there
exists substantial doubt about the Company’s ability to continue as
a going concern.
Webcast
Evaxion will host a Business Update and Full
Year 2023 Financial Results webcast on Tuesday, April 2, at 15:00
CEST / 9:00 a.m. EDT. To join the conference call, listen to the
presentation and ask verbal questions, please register in advance
via this link to receive the dial-in telephone numbers and a unique
pin code. The call can be accessed 15 minutes prior to the start of
the live event. To join the webcast, please click on this link. The
webcast recording will be available shortly after the event.
Evaxion Biotech A/S |
|
Consolidated Statement of Financial Position Data (Audited) |
|
(USD in thousands) |
|
|
|
Dec 31,2023 |
Dec 31,2022 |
|
Cash and cash equivalents |
|
$ |
5,583 |
|
$ |
13,184 |
Total assets |
|
12,889 |
|
22,025 |
Total liabilities |
|
17,618 |
|
13,722 |
Share capital |
|
5,899 |
|
3,886 |
Other reserves |
|
97,342 |
|
90,262 |
Accumulated deficit |
|
(107,970) |
|
(85,845) |
Total equity |
|
(4,729) |
|
8,303 |
Total liabilities and equity |
|
$ |
12,889 |
|
$ |
22,025 |
Evaxion Biotech A/S |
Consolidated Statement of Comprehensive Loss Data
(Audited) |
(USD in thousands, except per share data) |
|
|
Three Months Ended December 31, |
|
Twelve Months EndedDecember 31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
$ |
73 |
|
$ |
— |
|
$ |
73 |
|
$ |
— |
Research and development |
|
(2,298) |
|
(4,073) |
|
(11,916) |
|
$ |
(17,056) |
General and administrative |
(2,138) |
|
(2,452) |
|
(10,354) |
|
(8,208) |
|
|
|
|
|
|
|
|
Operating loss |
(4,363) |
|
(6,525) |
|
(22,197) |
|
(25,264) |
Finance income |
559 |
|
70 |
|
963 |
|
2,831 |
Finance expenses |
(895) |
|
(590) |
|
(1,681) |
|
(1,508) |
|
|
|
|
|
|
|
|
Net loss before tax |
$ |
(4,699) |
|
$ |
(7,045) |
|
$ |
(22,915) |
|
$ |
(23,941) |
|
|
|
|
|
|
|
|
Income tax benefiT |
177 |
|
173 |
|
790 |
|
772 |
|
|
|
|
|
|
|
|
Net loss for the period |
$ |
(4,522) |
|
$ |
(6,872) |
|
$ |
(22,125) |
|
$ |
(23,169) |
|
|
|
|
|
|
|
|
Net loss attributable to shareholders of Evaxion Biotech
A/S |
$ |
(4,522) |
|
$ |
(6,872) |
|
$ |
(22,125) |
|
$ |
(23,169) |
|
|
|
|
|
|
|
|
Loss per share – basic and diluted |
$ |
(0.16) |
|
$ |
(0.29) |
|
$ |
(0.81) |
|
$ |
(0.98) |
Number of shares used for calculation (basic and diluted) |
29,061,036 |
|
24,082,247 |
|
27,335,829 |
|
23,638,685 |
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 Statements
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
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