Evaxion Biotech A/S Receives Approval from FDA to Proceed with the Clinical Phase 2B Study for Evx-01

Evaxion Biotech A/S announced that the U.S. Food and Drug Administration ("FDA") determined that the Company may proceed with its Phase 2b clinical trial of EVX-01. In November 2022, the Company submitted an Investigational New Drug Application ("IND") along with a Fast Track designation application to the FDA for a Phase 2b clinical trial of EVX-01 in combination with KEYTRUDA(R) for the treatment of patients with metastatic melanoma. On December 22, 2022, the FDA issued approval for the Company to proceed with its Phase 2b trial.

The Company anticipates a response to the Fast Track designation submission in the first quarter of 2023.