Pyxis Oncology Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Core Insights - The company has reported positive preliminary data from the Phase 1 dose escalation trial of micvotabart pelidotin (MICVO), achieving a confirmed 50% objective response rate in recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) [1][6] - MICVO has received Fast Track Designation from the U.S. FDA for treating adult patients with R/M HNSCC whose disease has progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy [1][10] - The company has initiated monotherapy expansion cohorts for MICVO in 2L and 3L R/M HNSCC patients, with preliminary data expected in 2H25 and 1H26 [1][7] Pipeline Updates - The lead therapeutic candidate, micvotabart pelidotin, has shown significant tumor regression in multiple tumor types during the Phase 1 dose escalation study [4] - A combination study of MICVO with Merck's anti-PD-1 therapy, KEYTRUDA®, has been initiated, with preliminary data expected in 2H25 [5][7] - The company has streamlined its organization and reduced its workforce by approximately 20% to focus resources on the MICVO clinical program [5][8] Financial Overview - As of December 31, 2024, the company had cash and cash equivalents of $128.4 million, sufficient to fund operations into the second half of 2026 [11] - Research and development expenses increased to$58.7 million in 2024 from $49.6 million in 2023, primarily due to clinical trial-related expenses [11] - The net loss for the year ended December 31, 2024, was$77.3 million, or $1.32 per common share, compared to a net loss of$73.8 million, or $1.85 per common share, in 2023 [11][16]