On March 22, 2022 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, repoted the fourth quarter and full-year 2021 financial results and provided an operational update (Press release, Evaxion Biotech, MAR 22, 2022, View Source [SID1234610580]).
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Lars Wegner, CEO of Evaxion, said: "Evaxion continued to demonstrate exciting clinical momentum in the fourth quarter of 2021, beginning a clinical collaboration with Merck for a new Phase 2b trial, combining EVX-01 and Merck’s KEYTRUDA, to address a significant unmet medical need. On January 18, 2022, we received Australian clearance to begin this Phase 2b trial, which is a significant step forward for Evaxion and our exciting pipeline of immunotherapies. Data from the previous Phase 1/2a trial have shown that EVX-01 may be able to improve the treatment landscape in melanoma and possibly other cancers and we are excited to continue the clinical progress of our lead product candidate EVX-01 in collaboration with Merck. Our cash reserves of $32.2 million as of the end of the fourth quarter provide a solid financial foundation and will facilitate the continued development of our lead programs."
Operational and Business Highlights in the Fourth Quarter of 2021
Completed FPO of 3,942,856 ordinary shares represented by ADSs raising net proceeds of $24.9 million after deducting underwriting discounts, commissions and other offering expenses
Announced clinical trial collaboration and supply agreement with Merck to evaluate the combination of Evaxion’s cancer immunotherapy EVX-01 with KEYTRUDA in Phase 2b clinical trial in patients with metastatic melanoma
Awarded this year’s Enabling Technology Leadership Award in the artificial intelligence-enabled drug discovery industry by global research and consulting firm Frost & Sullivan
Presented at the Immuno UK 2021 conference held in London in October
Events after the Reporting Period
Received regulatory clearance to initiate phase 2b trial of EVX-01 in combination with KEYTRUDA for treatment of metastatic melanoma
Completed recruitment for Phase 1/2a clinical trial for EVX-02, advancing into a dedicated Phase 2b clinical adjuvant trial in patients with resectable melanoma
Announced publication on personalized therapy with EVX-01 in patients with metastatic melanoma in open access, peer-reviewed journal OncoImmunology
Announced leadership changes for Chief Operating Officer and Chief Financial Officer
Received first tranche €7.0 million (approximately $7.7 million) from our European Investment Bank (EIB) loan in February 2022
Expected milestones in 2022
Phase 2b first patient, first visit with EVX-01 for metastatic melanoma (peptide-based, personalized cancer therapy)
Phase 2b regulatory filing for EVX-02/03 in patients with resectable melanoma (DNA-based, personalized cancer therapy)
Phase 2b first patient, first visit with EVX-02/03
Phase 1 regulatory filing for EVX-B1 (S. aureus) in skin and soft tissue infections
Second bacteria target selected from EDEN platform
First viral candidate selected from RAVEN platform
Full Year 2021 Financial Results
Cash position: As of December 31, 2021, cash and cash equivalents were $32.2 million as compared to $5.8 million as of December 31, 2020. On November 9, 2021, we closed our FPO raising net proceeds of $24.9 million after deducting underwriting discounts, commissions and other offering expenses.
Research and Development expenses were $19.6 million for the year ended December 31, 2021 as compared to $10.9 million for the year ended December 31, 2020. The increase was primarily related to increased spending, net of grant income, for ongoing development on our platform, preclinical product candidates, and clinical trials. In addition, employee-related costs increased due to higher headcount.
General and Administrative expenses were $6.3 million for the year ended December 31, 2021 as compared to $5.7 million for the year ended December 31, 2020. The increase was primarily due to an increase in professional fees related to the expansion of our corporate function for our Initial Public Offering (IPO), partially offset by a decrease in employee-related costs.
Net loss was $24.5 million for the year ended December 31, 2021 or ($1.26) loss per basic and diluted share as compared to $15.0 million, or ($0.97) loss per basic and diluted share for the year ended December 31, 2020.
Guidance
We expect the net proceeds from our IPO, our FPO, funds from draws on amounts available under our EIB loan and our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements through at least 12 months subsequent to the date of our 2021 annual report.
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KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Kenilworth, NJ, USA.