GlobeNewswire Inc | Nov 9, 2021 06:30AM EST

November 09, 2021

-- Expect to close our follow-on public offering (FPO) of 3,942,856 ordinary shares represented by American Depositary Shares (ADSs) for gross proceeds of $27.6 million before deducting underwriter fees and commissions and other offering expenses -- Data reported in early July2021 from EVX-01 Phase 1/2a clinical trial showed a robust anti-tumor effect in combination with anti-PD-1 treatment for patients with metastatic melanoma, supporting advancement into a Phase 2b clinical trial -- Data also reported in early July2021 from the EVX-02 clinical trial in adjuvant melanoma support advancing into a Phase 2b clinical trial

COPENHAGEN, Denmark, Nov. 09, 2021 (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 to improve the lives of patients with cancer, bacterial diseases and viral infections, announced today the third quarter 2021 financial results and provided an operational update.

Lars Wegner, CEO of Evaxion, said: Evaxion has continued to make very encouraging clinical progress in the third quarter of 2021, reporting data in July2021 which we believe support advancing two of our lead programs into Phase 2b clinical trials. Phase 1/2a clinical trial data on our lead product candidate, EVX-01, showed that 67% of the patients benefited from EVX-01 in combination with anti-PD-1 for the treatment of metastatic melanoma, compared to the historical data of only 40% benefiting from the check point inhibitor alone. In addition, EVX-02 showed T-cell activation in adjuvant melanoma and appeared to be well tolerated. We plan to initiate a Phase 2b clinical trial for EVX-01 in melanoma by the end of 2021 in collaboration with Merck and initiate a Phase 2b clinical trial of EVX-02, in conjunction with our third product candidate, EVX-03, in Q2 2022. Our cash reserves of $11.9 million as of the end of the third quarter, combined with the follow-on financing provide a solid financial foundation and will facilitate the continued development of our lead programs.

Operational and Business Highlights in Q3 2021

-- Reportednew clinical data in early July2021 from Phase 1/2a clinical trials of EVX-01 and EVX-02.EVX-01, our peptide-based patient-specific cancer therapy, demonstrated anti-tumor effect in combination with anti-PD-1 treatment, for metastatic melanoma. Results from the combination therapy compares favorably to historical data from anti-PD-1 treatment alone. A Phase 2b clinical trial of EVX-01 is planned to start by the end of 2021.Preliminary data with EVX-02, our DNA-based patient-specific cancer therapy, demonstrated T-cell activation induced by EVX-02 and appeared to be well tolerated. We intend to submit a regulatory filing for a Phase 2b clinical trial of EVX-02 and EVX-03, in combination with anti-PD-1 in adjuvant melanoma in a three-arm trial, in the first half of 2022.

Events after the Reporting Period

-- Announced clinical trial and supply agreement with subsidiaries of Merck& Co.,Inc. (known as MSD outside of the United States and Canada) to evaluate the combination of Evaxions cancer immunotherapy EVX-01 with MSDs anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a new Phase 2b clinical trial in patients with metastatic melanoma -- Awarded thisyears Enabling Technology Leadership Award in the artificial intelligence-enabled drug discovery industry by global research and consulting firm Frost& Sullivan -- Presentation at the Immuno UK 2021 conference held in London in October -- Announced pricing of our FPO on November5, 2021, and expect to raise gross proceeds of $27.6 million before deducting underwriting discounts and commissions and other offering expenses.

Expected milestones in 2021& 2022

-- Phase 2b Investigational New Drug (IND) / Clinical Trial Application (CTA) of EVX-01 in metastatic melanoma H2 2021. -- Phase 2b IND / CTA filing for EVX-02 in combination with EVX-03 in adjuvant melanoma H1 2022. -- Phase 1a IND / CTA filing for EVX-B1 for S. aureus in skin and soft tissue infections (SSTIs) H2 2022. -- First viral candidate selected from RAVEN platform H2 2022.

Third Quarter 2021 Financial Results

-- Cash position: As of September30, 2021, cash and cash equivalents were $11.9 million compared to $5.8 million as of December31, 2020. On February9, 2021, we closed our IPO raising net proceeds of $27.9 million after deducting underwriting discounts and commissions, but before offering expenses. -- Research and Development expenses were $4.4 million for the quarter ended September30, 2021, compared to $3.0 million for the same period in 2020. The increase of $1.4 million was primarily related to increased spending, net of grant income, for ongoing development utilizing our AI platforms, preclinical product candidates, and clinical trials. In addition, employee-related costs increased due to higher headcount. -- General and Administrative expenses were $1.5 million for the quarter ended September30, 2021, compared to $1.7 million for the same period in 2020. The decrease of $0.2 million was primarily related to higher share-based compensation in the period ended September30, 2020 due to accelerated vesting period and sign-on warrants issued associated with the IPO. -- Net loss was $5.3 million for the quarter ended September30, 2021 or ($0.27) loss per basic and diluted share, compared to $4.0 million, or ($0.26) loss per basic and diluted share, for the same period in 2020.

Guidance

-- We expect the net proceeds from our IPO and FPO combined with our existing cash reserves will be sufficient to fund our operating expenses and capital expenditure requirements through at least 12months from September30, 2021.

Webcast and Conference Call

Evaxion will host a webcast and conference call today, November9, at 8:30a.m. EST.

To dial-in for the conference call, please use the following details:

US: 877-407-0792

International: +1-201-689-8263

Conference ID: 13723544

Alternatively to access the audio webcast, please visit the events pageof Evaxions website at:

https://evaxion-biotech.com/news-and-events/events/default.aspx

About EvaxionEvaxion Biotech A/S is a clinical-stage AI-immunology platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer, bacterial diseases and viral infections. Based on its proprietary and scalable AI-immunology core technology, Evaxion is developing a broad pipeline of novel product candidates which currently includes three patient-specific cancer immunotherapies, two of which are in Phase 1/2a clinical development. In addition, Evaxion is advancing a portfolio of vaccines to prevent bacterial and viral infections currently in preclinical development.

For more informationEvaxion Biotech A/S LifeSci Advisors LLCNiels Iversen Moller, M.D. Corey Davis, Ph.D.Chief Financial Officer Managing Directornim@evaxion-biotech.com cdavis@lifesciadvisors.com+45 27 11 62 27 212-915-2577

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 Companys 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 Companys 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 Companys financial condition and need for additional capital; risks associated with the Companys development work; cost and success of the Companys product development activities and preclinical and clinical trials; risks related to commercializing any approved pharmaceutical product developed using the Companys AI platform technology, including the rate and degree of market acceptance of the Companys product candidates; risks related to the Companys dependence on third parties including for conduct of clinical testing and product manufacture; risks associated with the Companys inability to enter into partnerships; risks related to government regulation; risks associated with protection of the Companys intellectual property rights; risks related to employee matters and managing growth; risks related to the Companys ADSs and ordinary shares, risks associated with the pandemic caused by the coronavirus known as COVID-19 and other risks and uncertainties affecting the Companys business operations and financial condition.

Forward-looking statements are subject to inherent risks and uncertainties beyond the Companys control that could cause the Companys 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 Companys business in general, see the risks described in the Risk Factors section included in the Companys Form20-F for theyear ended December31, 2020 and the Companys other reports filed with, or submitted 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)

Sep30, Dec31, 2021 2020Cash and cash equivalents $ 11,944 $ 5,834 Total assets 24,116 11,965 Total liabilities 7,466 4,927 Share capital 3,132 2,648 Other reserves 55,658 31,669 Accumulated deficit (42,140 ) (27,279 )Total equity 16,650 7,038 Total liabilities and equity $ 24,116 $ 11,965

Evaxion Biotech A/S

Consolidated Statements of Comprehensive Loss Data (Unaudited)

(USD in thousands, except per share data)

ThreeMonths Ninemonths Ended Sep 30 Ended Sep 30 2021 2020 2021 2020 Research anddevelopment $ 4,417 $ 2,966 $ 13,429 $ 8,046 expensesGeneral andadministrative 1,495 1,719 4,684 3,872 expensesOperating loss (5,912 ) (4,685 ) (18,113 ) (11,918 )Finance income 288 100 1,293 122 Finance (51 ) (3 ) (843 ) (7 )expensesNet loss (5,675 ) (4,588 ) (17,663 ) (11,803 )before taxIncome tax 425 578 1,501 1,054 benefitNet loss for $ (5,250 ) $ (4,010 ) $ (16,162 ) $ (10,749 )the periodNet lossattributableto equity $ (5,250 ) $ (4,010 ) $ (16,162 ) $ (10,749 )holders ofEvaxionBiotech A/SLoss pershare? basic $ (0.27 ) $ (0.26 ) $ (0.86 ) $ (0.71 )and dilutedNumber ofshares usedfor 19,198,668 15,289,477 18,759,108 15,219,517 calculation(basic anddiluted)