Evaxion announces business update and third quarter 2025 financial results

Core Insights - Evaxion A/S has made significant advancements in its AI-Immunology™ powered vaccine development, particularly in cancer and infectious diseases, showcasing strong data from its lead asset, EVX-01, and successfully out-licensing EVX-B3 to MSD [2][8][20] Business Highlights - The company has validated its technology and strategy through impressive data from EVX-01, which targets multiple neoantigens in cancer vaccines, and the out-licensing of EVX-B3 confirms its capabilities in infectious disease vaccines [2][8] - Evaxion's cash runway has been extended to the second half of 2027, bolstered by a $7.5 million payment from MSD and $7.2 million raised from capital market activities [8][25] - The appointment of Dr. Helen Tayton-Martin as the new CEO is expected to bring over 30 years of experience in biotech M&A and business development [8] Research & Development Update - The phase 2 trial of EVX-01 in advanced melanoma patients showed an Objective Response Rate (ORR) of 75%, with 12 out of 16 patients responding clinically, and 92% of patients still responding at the two-year follow-up [6][10] - Evaxion has expanded its pipeline with EVX-04, targeting non-conventional ERV tumor antigens for acute myeloid leukemia (AML), developed using the AI-Immunology™ platform [12][15] - The company has developed an automated vaccine design module to enhance the efficiency and quality of vaccine development, reducing design time from months to days [17][18] Financial Performance - For Q3 2025, Evaxion reported a net income of $4.6 million, a significant improvement from a net loss of $1.9 million in Q3 2024, driven by revenue from MSD's option exercise [27][28] - Revenue for the quarter was $7.5 million, primarily from the MSD option exercise and included contributions from the Gates Foundation [28] - Research and development expenses were $3.1 million for Q3 2025, compared to $2.6 million in the same period last year, while general and administrative expenses decreased to $1.4 million from $2.1 million [29][30] Equity and Cash Position - As of September 30, 2025, cash and cash equivalents were $10.6 million, up from $6.0 million at the end of 2024, with total equity improving to $16.6 million from a negative equity of $(1.7) million [32][34] - The company has successfully managed its financial strategy, resulting in improved equity and extended cash runway, with an operational cash burn expected to be approximately $14 million in 2025 [34]