Core Insights - Evaxion A/S is progressing well with its AI-Immunology™ powered vaccine development, maintaining operational momentum and aiming to achieve 2025 milestones [2][5][11] Business Highlights - The company is on track to present two-year clinical data for its personalized cancer vaccine EVX-01 at the ESMO Congress on October 17, 2025, which is expected to attract potential partners [6][7] - Evaxion has received a grant from the Gates Foundation to explore a new sub-unit vaccine against polio, highlighting external interest in its AI-Immunology™ platform [9][10] - The R&D pipeline has been expanded with the addition of EVX-B4, targeting Group A Streptococcus, showcasing the platform's scalability [10] Financial Update - As of June 30, 2025, cash and cash equivalents increased to $14.7 million from $6.0 million at the end of 2024, providing a cash runway until mid-2026 [16] - Revenue for the second quarter of 2025 was $37 thousand, a decrease from $154 thousand in the same period last year, primarily due to changes in collaborative agreements [17] - The net loss for the second quarter of 2025 was $4.8 million, an improvement from a net loss of $6.2 million in the same period of 2024 [21] R&D and Clinical Trials - The phase 2 trial for EVX-01 has completed patient treatment, with three-year data expected in 2026 following a one-year trial extension [8][7] - The company is actively engaged in preclinical activities and has received recognition for its AI-Immunology™ platform, which is applicable to over 100 diseases [9][10] Business Development - Ongoing discussions with MSD regarding the EVX-B2 and EVX-B3 programs may lead to option exercises in the latter half of 2025, with potential milestone payments for Evaxion [11][12] - The company aims to secure at least two new partnership deals in 2025, despite challenges posed by current financial market conditions [13] Capital Structure - An agreement with the European Investment Bank (EIB) converted €3.5 million of debt into equity, improving equity by $4.1 million and enhancing financial flexibility [14][15]

Core Insights - Evaxion A/S will present two-year clinical efficacy data from its phase 2 trial of the personalized cancer vaccine EVX-01 at the ESMO Congress 2025 in Berlin [1][3] - EVX-01, developed using Evaxion's AI-Immunology™ platform, is currently being evaluated for advanced melanoma treatment, showing a 69% Overall Response Rate in interim data [2][4] - The phase 2 trial combines EVX-01 with MSD's KEYTRUDA® therapy, tailored to each patient's unique tumor profile [4][6] Company Overview - Evaxion is a clinical-stage TechBio company focused on AI-driven immunotherapies for cancer and infectious diseases [9] - The company utilizes its AI-Immunology™ platform to create personalized vaccines, aiming to enhance immune responses against tumors [6][9] - Evaxion's pipeline includes novel personalized vaccines for oncology and preclinical candidates for bacterial and viral diseases [9] Clinical Trial Details - The phase 2 trial of EVX-01 has shown promising results, with 67% of metastatic melanoma patients achieving objective clinical responses in earlier trials [7] - The upcoming presentation at ESMO will include data on T-cell responses and disease control over two years [5][6] - The trial emphasizes the correlation between AI predictions and immune responses, highlighting the platform's predictive capabilities [2][7]

Core Viewpoint - Evaxion A/S has initiated a one-year extension of its ongoing phase 2 trial for its personalized cancer vaccine EVX-01, aimed at treating advanced melanoma, leveraging its AI-Immunology™ platform to explore the vaccine's long-term clinical and immune benefits [1][2][4]. Group 1: Trial Details - The first patient has been dosed in the one-year extension of the trial, which will involve two additional doses of EVX-01 as monotherapy [3]. - The initial two years of the trial involved EVX-01 in combination with standard anti-PD-1 therapy, and the extension phase allows for evaluation of EVX-01 as a standalone treatment [4][5]. - The trial extension incurs minimal costs since trial sites are already operational and the vaccine has been produced [2][10]. Group 2: Clinical Data and Results - Interim one-year data presented at the ESMO Congress in September 2024 showed a 69% Overall Response Rate, with tumor target lesions reduced in 15 out of 16 patients [8]. - At the AACR Annual Meeting in April 2025, it was reported that 80% of EVX-01's vaccine targets triggered a targeted immune response, indicating favorable outcomes compared to other treatment approaches [9]. - The completed phase 1/2a clinical trial demonstrated that 67% of metastatic melanoma patients had objective clinical responses, highlighting the predictive power of the AI-Immunology™ platform [12]. Group 3: Product and Technology Overview - EVX-01 is a personalized peptide-based cancer vaccine designed to engage the patient's immune system against tumors, tailored to each individual's unique tumor profile [6][11]. - The AI-Immunology™ platform is central to Evaxion's approach, enabling the development of novel immunotherapies for various diseases, including cancer [13].