Pyxis Oncology (PYXS) investor relations material

Program overview and mechanistic rationale

• Focus on developing a novel antibody drug conjugate (ADC) targeting the extracellular matrix in hard-to-treat cancers, especially head and neck cancer.

• Lead program, MICVO, has shown efficacy in multiple tumor types and is being advanced in head and neck cancer.

• Mechanism targets tumor stroma rather than tumor cells directly, aiming for broad applicability regardless of HPV status or prior therapies.

Clinical development and trial design

• Dose escalation and expansion studies identified 5.4 mg as an effective dose, with dose capping implemented to address safety in high body weight patients.

• Two trial arms: one for platinum plus PD-1 (current standard), another for EGFR inhibitors plus PD-1 (emerging standard), each with about 20 patients.

• Mid-year update will present data from both arms, focusing on efficacy and safety in second-line head and neck cancer.

Safety and dosing strategy

• High discontinuation rates in heavy patients led to dose capping, which improved safety and enrollment.

• Dose cap and adjusted ideal body weight (AIBW) dosing expected to yield similar results; AIBW remains a backup plan.

• Plan to share robust safety and efficacy data at mid-year update to support pivotal trial readiness.