Pyxis Oncology Provides Business Update and Reports Fourth Quarter and Full Year 2025 Financial Results

Core Insights - Pyxis Oncology has completed target enrollment in the Phase 1 monotherapy dose expansion study of micvotabart pelidotin (MICVO) for 2L+ recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in Q1 2026, with updated data expected mid-2026 [1][5] - The company has appointed Thomas Civik as Interim Chief Executive Officer, focusing on clinical execution and operations to deliver robust datasets [3][6] - Financial results for the year ended December 31, 2025, show revenues of $13.9 million, a decrease from $16.1 million in 2024, with a net loss of $79.6 million [8][10] Clinical Development Updates - The Phase 1 monotherapy study of MICVO in 2L+ R/M HNSCC reported a 46% confirmed objective response rate (ORR) and a 92% disease control rate (DCR) [4] - In combination with KEYTRUDA, MICVO showed a 71% confirmed ORR and a 100% DCR in 1L/2L+ R/M HNSCC [4] - The ongoing studies are designed to evaluate the impact of modified weight-based dosing on safety and efficacy, with results anticipated in mid-2026 [7][11] Financial Performance - Total revenues for 2025 were $13.9 million, down from $16.1 million in 2024, primarily due to changes in milestone revenues and royalty rights [10][15] - Research and development expenses increased to $73.7 million in 2025 from $58.7 million in 2024, attributed to higher clinical trial costs [10][16] - The company reported a net loss of $79.6 million for 2025, slightly higher than the $77.3 million loss in 2024 [10][16] Leadership and Corporate Updates - Thomas Civik was appointed as Interim CEO in February 2026, bringing extensive experience in advancing cancer therapeutics [6][10] - Heather Knowles joined as Senior Vice President, Head of Global Clinical Operations, enhancing the company's clinical development capabilities [10] - The company has also appointed Alex Kane as Senior Vice President, Investor Relations and Capital Markets, to strengthen investor engagement [10] Pipeline and Future Outlook - Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1/2 combination study with KEYTRUDA in the second half of 2026 [7][11] - The company has received Fast Track Designation from the FDA for MICVO in treating adult patients with R/M HNSCC [12]