Pyxis Oncology (PYXS) investor relations material

Business strategy and clinical focus

• Lead asset MICO, an ADC licensed from Pfizer, is prioritized for head and neck cancer and advanced solid tumors, with two main clinical programs: monotherapy and combination with pembrolizumab.

• Monotherapy targets two patient groups: those resistant to platinum/PD-1 and those resistant to EGFR/PD-1, aiming to address evolving standards of care and mitigate commercial risk.

• Combination program with pembrolizumab is supported by a supply agreement with Merck & Co., with upcoming catalysts from both programs.

• Focus remains on head and neck cancer due to strong early signals, with potential to expand into other tumor types as data and funding allow.

• Portfolio narrowed to MICO to maximize resource allocation and capitalize on its broad applicability.

Drug mechanism, design, and differentiation

• MICO targets EDB, a novel extracellular splice variant of fibronectin, enabling broad tumor applicability.

• Construct optimized by Pfizer for stability and potency, using a modified orostatin payload and site-specific conjugation.

• Unique mechanism leverages extracellular matrix cleavage, enhancing the bystander effect, a key differentiator among ADCs.

• Empirical testing ensured the construct was best-in-class among ADC candidates.

Clinical development, data, and expectations

• Three main catalysts expected: monotherapy data in platinum/PD-1-resistant patients (2H this year), EGFR-resistant patients (1H next year), and combination dose escalation data (timing not specified).

• Combination trial uses three dose levels and includes multiple tumor types to expedite escalation.

• Efficacy benchmarks set by Merus: 36% ORR for monotherapy, 63% for combination; MICO aims for similar or better results.

• Durability data is limited to patient anecdotes, with one patient showing 17 months on therapy and strong partial response.