On April 6, 2021 Evaxion Biotech A/S (Nasdaq: EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, reported the fourth quarter and full year 2020 financial results and provided an operational update (Press release, Evaxion Biotech, APR 6, 2021, View Source [SID1234578287]).

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Lars Wegner, CEO of Evaxion, said: "Evaxion made outstanding progress in 2020 in redefining the immunotherapy discovery process through our AI platform technologies, despite the complications caused by the COVID-19 pandemic. We are very pleased with the successful initial public offering on U.S. Nasdaq, concluded in February 2021, which raised gross proceeds of $30 million and positions Evaxion for further progress with our patient-specific cancer immunotherapies."

"In 2020, we initiated a Phase 1/2a clinical trial of the adjuvant immunotherapy EVX-02, in combination with checkpoint inhibitors in patients with advanced melanoma. Both this study and our Phase 1/2a trial with EVX-01 remain on track and our other product candidates – EVX-03 for multiple cancer indications and EVX-B1, a vaccine for prevention of S. aureus – are progressing well through preclinical development."

"Financially, Evaxion is in a strong position with cash and cash equivalents of $5.8 million at December 31, 2020, to which we have now added the proceeds from our IPO. This provides funding to advance our four product candidates into 2022, covering a number of key expected milestones. These include Phase 1/2a data on EVX-01 and EVX-02 expected in late Q2 2021 and filing for approval of a clinical trial of EVX-03 in multiple cancers in the second half of the year."

Operational and Business Highlights in 2020

Dosed first patient in Phase 1/2a melanoma trial of cancer vaccine EVX-02 in combination with checkpoint inhibitors
Appointed Marianne Søgaard, previously an attorney practicing technology law, including processes to acquire technology solutions, and commercial law, as Chairwoman of the Board of Directors
Launched new AI powered platform, RAVEN, to enable faster response to emerging viral pandemics
Partnered with SB3000 for rapid scale up for commercial production of corona virus vaccines with its continuous manufacturing technology
Publication of an article in Nature Communications showing how deep data on immune complex stability could optimize immunotherapy in cancer
Events after the Reporting Period

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.
The shares began trading on the Nasdaq Capital Market on February 5, 2021 under the ticker symbol "EVAX".
Opened new corporate headquarters and research laboratory facility located in the DTU Science Park in Hoersholm near Copenhagen, Denmark.
Expected milestones in 2021

Phase 1/2a data on EVX-01 in metastatic melanoma – Q2 2021
Phase 1/2a data on EVX-02 in adjuvant melanoma – Q2 2021
Regulatory filing for clinical trial of EVX-03 in multiple cancers – H2 2021
Fourth Quarter and Full Year 2020 Financial Results

Cash position: As of December 31, 2020, cash and cash equivalents were $5.8 million compared to $9.6 million as of December 31, 2019. On February 9, 2021, we closed our recent IPO raising net proceeds of $27.9 million after underwriting discounts and commissions.
Research and Development expenses were $10.9 million for the year ended December 31, 2020, compared to $8.2 million for the same period in 2019. The increase of $2.7 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 $5.7 million for the year ended December 31, 2020, compared to $2.6 million for the same period in 2019. The increase of $3.1 million was primarily related to increased employee-related costs due to increased headcount and increases in overhead and professional fees related to the expansion of our corporate function for our initial public offering.
Net loss was $15.0 million for the year ended December 31, 2020 or ($0.97) loss per basic and diluted share, compared to $11.2 million, or ($0.81) loss per basic and diluted share, for the same period in 2019.
Guidance

Evaxion’s operating plan extends its cash runway into 2022.
Webcast and Conference Call

Evaxion will host a webcast and conference call today, April 6, 2021, at 8.30 a.m. EDT.

To access dial-in details for the conference call, please use the following link:
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Alternatively to access the webcast, please use the following link:
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