GlobeNewswire Inc | May 13, 2021 07:30AM EDT

May 13, 2021

-- Raised net proceeds of $27.9 million in U.S. initial public offering in February 2021 -- Lead programs EVX-01 and EVX-02 on track for Phase 1/2a data readouts late in Q2 -- Product candidates EVX-03 and EVX-B1 progressing through pre-clinical development -- Cash reserves of $27 million at March 31, 2021

COPENHAGEN, Denmark, May 13, 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 first quarter 2021 financial results and provided an operational update.

Lars Wegner, CEO of Evaxion, said: Evaxion made strong progress in Q1 2021, successfully concluding our U.S. IPO and continuing to advance our clinical programs. Our two lead product candidates, EVX-01 and EVX-02, are on track for results from Phase 1/2a trials late in Q2 and we continue to develop our RAVEN AI platform for vaccine design and development for viral infections. We believe that our cash reserves of $27 million provide a solid financial foundation and will facilitate the continued development of our four lead programs.

Operational and Business Highlights in Q1 2021

-- Closed U.S. initial public offering of 3,000,000 American Depositary Shares at a public offering price of $10.00 per ADS. The gross proceeds from the offering, before deducting underwriting fees and commissions and other offering expenses, were $30 million. -- Recruitment for two lead product candidates, EVX-01 and EVX-02, in Phase 1/2a clinical trials remains on track for data readouts late in Q2. -- Other lead product candidates, EVX-03 for multiple cancer indications and EVX-B1, a vaccine for the prevention of Staphylococcus aureus including MRSA, continue to progress as expected through pre-clinical development and Chemistry, Manufacturing and Controls (CMC). -- Cash reserves at March 31, 2021 of $27.0 million, provide continued funding of key programs. -- Opened new corporate headquarters and research laboratory facility located in the DTU Science Park in Hoersholm near Copenhagen, Denmark. -- Publication of a paper in the peer-reviewed journal Scientific Reports, describing a study into the bacterium S. aureus, which may facilitate a better understanding of host-pathogen interactions during invasive infection.

Events after the Reporting Period

-- Presentation at the 4th Neoantigen Summit Europe, described Evaxions recent improvement in determining cancer neoepitopes through measurement and prediction of peptide-MHC (pMHC) complex stability.

Expected milestones in 2021

-- Phase 1/2a data readout on EVX-01 in metastatic melanoma - Q2 2021 -- Phase 1/2a data readout on EVX-02 in adjuvant melanoma - Q2 2021 -- Regulatory filing for clinical trial of EVX-03 in multiple cancers - H2 2021

First Quarter 2021 Financial Results

-- Cash position: As of March 31, 2021, cash and cash equivalents were $27.0 million compared to $5.8 million as of December 31, 2020. On February 9, 2021, we closed our IPO raising net proceeds of $27.9 million after underwriting discounts and commissions, but before offering expenses. -- Research and Development expenses were $3.9 million for the quarter ended March 31, 2021, compared to $2.5 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 on our platform, pre-clinical product candidates, and clinical trials. In addition, employee-related costs increased due to higher headcount. -- General and Administrative expenses were $1.3 million for the quarter ended March 31, 2021, compared to $0.8 million for the same period in 2020. The increase of $0.5 million was primarily related to increases in overhead and professional fees related to the expansion of our corporate function for our initial public offering. -- Net loss was $4.1 million for the quarter ended March 31, 2021 or ($0.23) loss per basic and diluted share, compared to $3.1 million, or ($0.20) loss per basic and diluted share, for the same period in 2020.

Guidance

-- Evaxions operating plan extends its cash runway into 2022.

Webcast and Conference Call

Evaxion will host a webcast and conference call today, May 13, at 8:30 a.m. EDT.

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

US: 877-407-0792

International: +1-201-689-8263

Conference ID: 13718732

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

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

About Evaxion Evaxion 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 information Evaxion LifeSci Advisors LLCGlenn S. Vraniak Mary-Ann ChangChief Financial Officer Managing Directorgvr@evaxion-biotech.com mchang@lifesciadvisors.com+1 (513) 476-2669 +44 7483 284 853

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 Form 20-F for the year ended December 31, 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/SConsolidated Statements of Financial Position Data (Unaudited)(USD in thousands) March 31, Dec 31, 2021 2020 Cash and cash equivalents $ 26,955 $ 5,834 Total assets 34,920 11,965 Total liabilities 7,121 4,927 Share capital 3,132 2,648 Other reserves 55,745 31,669 Accumulated deficit (31,078 ) (27,279 )Total equity 27,799 7,038 Total liabilities and equity $ 34,920 $ 11,965

Evaxion Biotech A/SConsolidated Statements of Comprehensive Loss Data (Unaudited)(USD in thousands, except per share data) Year Ended March 31, 2021 2020 Research and development expenses $ 3,893 $ 2,510 General and administrative expenses 1,282 781 Operating loss (5,175 ) (3,291 )Finance income 972 16 Finance expenses (297 ) (4 )Net loss before tax (4,500 ) (3,279 )Income taxes 407 180 Net loss for the period $ (4,093 ) $ (3,099 )Net loss attributable to equity holders of $ (4,093 ) $ (3,099 )Evaxion Biotech A/SLoss per share ? basic and diluted $ (0.23 ) $ (0.20 )Number of shares used for calculation (basic and 17,865,335 15,184,152 diluted)