micvotabart pelidotin (PYX-201-101) - (MICVO)

March 23, 2026: Pyxis Oncology, Inc. (NASDAQ: PYXS) provided a business update and FY/Q4 2025 financial results, highlighting progress for micvotabart pelidotin (MICVO) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Target enrollment was completed in 1Q26 for the Phase 1 monotherapy dose-expansion study in 2L+ R/M HNSCC (two arms; ~20 patients each; ~40 total).

MICVO monotherapy (2L+ R/M HNSCC): December 2025 preliminary data showed 46% confirmed ORR and 92% DCR (N=13 efficacy-evaluable). Safety: no Grade 4 ADC payload TRAEs of interest and no Grade 5 events; higher-body-weight patients had more Grade 3 auristatin payload-related TRAEs and discontinuations. Updated Phase 1 monotherapy data are expected mid-year 2026, including patients treated with modified weight-based dosing (dose cap) alongside prior total body weight dosing, with analyses on safety/efficacy and PK/exposure.

MICVO + KEYTRUDA® (pembrolizumab): Preliminary December 2025 combination data in 1L/2L+ R/M HNSCC showed 71% confirmed ORR and 100% DCR across 3.6 mg/kg (N=4) and 4.4 mg/kg (N=3) MICVO Q3W plus fixed-dose KEYTRUDA; no Grade 3/4 ADC payload TRAEs of interest and no Grade 5 events. Updated combination dose-escalation data are expected in 2H26. The company also noted FDA alignment in Q4 2025 on a planned pivotal monotherapy trial design, an April 2026 AACR preclinical presentation, CEO interim appointment (Feb 2026), and cash runway into Q4 2026.