Pyxis Oncology (NasdaqGS:PYXS) Earnings Call Presentation
Pyxis OncologyPyxis Oncology(US:PYXS)2025-12-18 13:30

MICVO Monotherapy Efficacy - MICVO monotherapy demonstrated a validated efficacy signal in 2L+ R/M HNSCC, with a 46% confirmed ORR and a 92% DCR (n=13, 5.4 mg/kg)[4] - In the Phase 1 monotherapy dose expansion study at 5.4 mg/kg, Arm 1 (post-PD1/post-Platinum) showed a 60% confirmed ORR (N=5)[32] - Arm 2 (post-PD1/post-EGFRi) in the monotherapy study showed a 25% confirmed ORR (N=4), exceeding the PI benchmark of 20%+[32] - MICVO monotherapy at 5.4 mg/kg demonstrated clear activity with deep responses and exceptional disease control[35] MICVO + KEYTRUDA® Combination Efficacy - MICVO combined with KEYTRUDA® showed a promising emerging efficacy profile in 1L/2L+ R/M HNSCC, with a 71% confirmed ORR and 100% DCR (n=7, 3.6 mg/kg & 4.4 mg/kg)[4] MICVO Safety and Tolerability - MICVO at 5.4 mg/kg in R/M HNSCC showed no Grade 4 or Grade 5 ADC payload TRAEs of interest[40] - Initial data supports a lack of overlapping toxicities observed between MICVO and KEYTRUDA®[52] Market and Clinical Development - FDA aligned on a 2L+ monotherapy pivotal trial design for MICVO[4] - The US R/M HNSCC market is large, growing, and relatively uncrowded, making it ripe for innovation[17] - Projected 2029 US market data shows a significant number of drug-treatable patients, with ~31K in 1L, ~21K in 2L, and ~8K in 3L[18]