Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company), a
clinical-stage biotechnology company specializing in the
development of AI-driven immunotherapies, announced today its third
quarter 2022 financial results and provided an operational and
business update.
Per Norlén, CEO of Evaxion, said: “Evaxion
continues to advance its drug development pipeline, reaching an
important milestone in the third quarter with the enrollment of the
first patient in our global Phase 2b clinical trial of EVX-01, our
personalized cancer immunotherapy for the treatment of patients
with metastatic melanoma. Going forward, we intend to further
increase our focus on our clinical lead oncology assets within
personalized cancer immunotherapy.”
Operational and Business Highlights in the Third Quarter
of 2022
Enrolled the first patient in the global Phase 2b
clinical trial of EVX-01 for the treatment of melanoma.In
the Company’s first Phase 2b clinical trial, Evaxion is evaluating
the efficacy and safety of EVX-01 in adults with metastatic
melanoma. The trial is being conducted globally at clinical
sites across the US, Europe, and Australia in collaboration with
Merck & Co., Inc. Patients enrolled in the Phase 2b clinical
trial will receive standard-of-care treatment along with KEYTRUDA®
in combination with EVX-01. Evaxion is responsible for the conduct
of the trial, and Merck will supply the required KEYTRUDA®. The
Company anticipates interim topline data readout in the second half
of 2023.
Announced an increased strategic focus on clinical lead
oncology assets and partnering. Evaxion intends to further
increase its focus on its clinical lead oncology product
candidates, EVX-01 and EVX-02/03, to bring them to clinical proof
of concept followed by out-licensing. Additionally, the Company
plans preclinical partnering of its early-stage programs under its
infectious disease platforms. This was announced by the Company’s
new Chief Executive Officer, Per Norlén, who emphasized the
importance of prioritizing the Company’s activities in the current
market. As previously announced by the Company, the EVX-01 program
recently started to enroll patients in the global Phase 2b trial in
metastatic melanoma. At the same time, the Phase 1/2a trial of the
DNA-based EVX-02 is progressing as planned, with data readout
currently expected by mid-2023. The next-generation DNA vaccine,
EVX-03, builds on EVX-02 and holds the potential for even stronger
results due to an integrated mechanism that boosts the immune
system. The Company plans to submit a regulatory filing of EVX-03,
following EVX-02 data, which may allow Evaxion to advance EVX-03
faster to clinical proof of concept. Regarding the Company’s early
programs for infectious diseases, such as our Staphylococcus aureus
vaccine, the Company aims to develop these in partnerships rather
than bringing them into clinical development by itself.
Announced NIH Grant for Research Collaboration with
UMass Chan Medical School to develop EVX-B2 gonorrhea vaccine
product candidate. Evaxion announced a discovery project
(EVX-B2) to create a gonorrhea vaccine based on the Company’s
artificial intelligence (AI) platform, EDEN. Chief Scientific
Officer at Evaxion, Birgitte Rønø, states that the scientific
collaboration with UMass Chan and the grant from NIH further
reinforces Evaxion’s capabilities within AI-based vaccine design
and allow the Company to fast-track the development of a gonorrhea
vaccine candidate.
A published peer-reviewed article in Future Oncology on
Phase 2b trial design for EVX-01. Evaxion published an
article in Future Oncology focusing on the Phase 2b trial
design of EVX-01. This trial is designed so that the
patients may continue treatment with Evaxion’s
immunotherapy, even if the standard-of-care treatment changes. With
this new and innovative trial design, Evaxion expands the patients’
otherwise limited treatment opportunities.
Events after the Reporting Period
Per Norlén, M.D., PhD. succeeded Lars Wegner, M.D., as
Chief Executive OfficerDr. Norlén is a board-certified
physician and associate professor in clinical pharmacology with
more than 20 years in the biotech sector. The last 12 years have
been in executive leadership roles. He brings a wealth of
experience from being CEO of listed drug development companies. He
has a proven business development track record, including major
out-licensing deals with biotech and Pharma.
Expected Milestones in the Fourth Quarter of
2022
- Selection of the first viral
candidate from our RAVEN platform.
Expected Milestones in the First Half of
2023
- Clinical readout of Phase 1/2a clinical study to evaluate
EVX-02 in patients with resectable melanoma.
Third Quarter 2022 Financial Results
- Cash position: As of September 30, 2022, cash and cash
equivalents were $17.9 million compared to $32.2 million as of
December 31, 2021. The decrease in cash and cash equivalents during
the first nine months of 2022 was primarily attributable to an
increase in our operating expenses for the first nine months of
2022, partially offset by the proceeds received from the first
tranche of our loan from the European Investment Bank.
- Research and Development expenses were $4.1 million for the
three months that ended September 30, 2022, compared to $4.4
million for the same period in 2021. The decrease was primarily due
to lower external costs related to clinical
trials.
- General and Administrative expenses were $2.0 million for the
three months ending September 30, 2022, compared to $1.5
million for the same period in 2021. The increase was primarily due
to an increase in fees associated with the expansion of our
business as a listed company.
- Net loss was $5.7 million for the
three months ended September 30, 2022, or ($0.24) loss per
basic and diluted share as compared to $5.3 million, or ($0.27)
loss per basic and diluted share for the three months ended
September 30, 2021.
Guidance
- We expect our existing cash and
cash equivalents, will be sufficient to fund our operating expenses
and capital expenditure requirements into mid-2023.
About EvaxionEvaxion Biotech A/S is a
clinical-stage biotech company developing AI-powered
immunotherapies. With our proprietary and scalable AI technology,
we decode the human immune system to discover and develop novel
immunotherapies for cancer, bacterial diseases, and viral
infections. Evaxion has a broad pipeline of novel product
candidates, including three patient-specific cancer
immunotherapies. It is located in Hørsholm, Denmark, with 70
employees.
For more informationEvaxion Biotech A/SBo
Karmark Chief
Financial
Officer bka@evaxion-biotech.com+45
27 10 20
50
Source: Evaxion Biotech
Forward-looking statement
This announcement contains forward-looking
statements that involve substantial risks and uncertainties. All
statements, other than statements of historical facts, included in
this announcement regarding the Company’s future operations, plans
and objectives are forward-looking statements. Although the Company
believes its expectations are based on reasonable assumptions, all
statements other than statements of historical fact included in
this announcement about future events are subject to (i) change
without notice and (ii) factors beyond the Company’s control. These
statements may include, without limitation, any statements preceded
by, followed by, or including words such as “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 or
the negative thereof. 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 associated
with the Company’s financial condition and need for additional
capital; risks associated with the Company’s development work; cost
and success of the Company’s product development activities and
preclinical and clinical trials; risks related to commercializing
any approved pharmaceutical product developed using the Company’s
AI platform technology, including the rate and degree of market
acceptance of the Company’s product candidates; risks related to
the Company’s dependence on third parties including for conduct of
clinical testing and product manufacture; risks associated with the
Company’s inability to enter into partnerships; risks related to
government regulation; risks associated with protection of the
Company’s intellectual property rights; risks related to employee
matters and managing growth; risks related to the Company’s ADSs
and ordinary shares, risks associated with the pandemic caused by
the coronavirus known as COVID-19 and the emergence and prevalence
of COVID-19 variants, such as the Delta and Omicron variant and
certain related variants such as the Omicron BA.4 and BA.5
variants, risks associated with the invasion of the Ukraine by
Russia and other risks and uncertainties affecting the Company’s
business operations and financial condition.
Forward-looking statements are subject to
inherent risks and uncertainties beyond the Company’s control that
could cause the Company’s actual results, performance, or
achievements to be materially different from the expected results,
performance, or achievements expressed or implied by such
forward-looking statements. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to the Company’s business in general, see the risks
described in the “Risk Factors” section included in the Company’s
Annual Report on Form 20-F filed on March 31, 2022 and the
Company’s current and future reports filed with, or furnished to,
the U.S. Securities and Exchange Commission (SEC). Any
forward-looking statements contained in this announcement speak
only as of the date hereof, and except as required by law, the
Company assumes no obligation to update these forward-looking
statements publicly, or to update the reasons actual results could
differ materially from those anticipated in the forward-looking
statements, even if new information becomes available in the
future.
Evaxion Biotech A/S
Consolidated Statements of Financial
Position Data (Unaudited)
(USD in thousands)
|
|
|
|
|
|
|
|
|
Sep 30, |
|
Dec 31, |
|
|
2022 |
|
2021 |
Cash and cash equivalents |
|
$ |
17,853 |
|
$ |
32,166 |
Total assets |
|
|
27,446 |
|
|
40,163 |
Total liabilities |
|
|
13,898 |
|
|
7,726 |
Share capital |
|
|
3,864 |
|
|
3,755 |
Other reserves |
|
|
75,444 |
|
|
79,114 |
Accumulated deficit |
|
|
(65,760) |
|
|
(50,432) |
Total equity |
|
|
13,548 |
|
|
32,437 |
Total liabilities and equity |
|
$ |
27,446 |
|
$ |
40,163 |
Evaxion Biotech A/S
Consolidated Statements of Comprehensive
Loss Data (Unaudited)
(USD in thousands, except per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
Nine months |
|
|
Ended Sep 30 |
|
Ended Sep 30 |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Research and development expenses |
|
$ |
4,068 |
|
$ |
4,417 |
|
$ |
12,983 |
|
$ |
13,429 |
General and administrative expenses |
|
|
2,015 |
|
|
1,495 |
|
|
5,756 |
|
|
4,684 |
Operating loss |
|
|
(6,083) |
|
|
(5,912) |
|
|
(18,739) |
|
|
(18,113) |
Finance income |
|
|
703 |
|
|
288 |
|
|
2,761 |
|
|
1,293 |
Finance expenses |
|
|
(535) |
|
|
(51) |
|
|
(918) |
|
|
(843) |
Net loss before tax |
|
|
(5,915) |
|
|
(5,675) |
|
|
(16,896) |
|
|
(17,663) |
Income tax benefit |
|
|
175 |
|
|
425 |
|
|
599 |
|
|
1,501 |
Net loss for the period |
|
$ |
(5,740) |
|
$ |
(5,250) |
|
$ |
(16,297) |
|
$ |
(16,162) |
Net loss attributable to equity holders of Evaxion Biotech A/S |
|
$ |
(5,740) |
|
$ |
(5,250) |
|
$ |
(16,297) |
|
$ |
(16,162) |
Loss per share – basic and diluted |
|
$ |
(0.24) |
|
$ |
(0.27) |
|
$ |
(0.69) |
|
$ |
(0.86) |
Number of shares used for calculation (basic and diluted) |
|
|
23,833,694 |
|
|
19,198,668 |
|
|
23,468,653 |
|
|
18,759,108 |
Evaxion Biotech AS (NASDAQ:EVAX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Evaxion Biotech AS (NASDAQ:EVAX)
Historical Stock Chart
From Jul 2023 to Jul 2024