Pyxis Oncology (PYXS) H.C. Wainwright 26th Annual Global Investment Conference summary

Portfolio and technology overview

• Focus is on three clinical-stage candidates: PYX-201 (ADC), PYX-106, and PYX-107, with PYX-201 as the lead asset targeting tumor stroma via a splice variant of fibronectin.

• PYX-201 targets EDB-FN, highly specific to tumor stroma with no expression in normal tissue, minimizing off-target toxicity.

• Mechanism of PYX-201 involves payload cleavage in the stroma, passive diffusion into tumor cells, a bystander effect, and immunomodulatory activity.

• Clinical data for PYX-201 expected later this fall, anticipated to renew interest in stroma as a therapeutic target.

Clinical development and trial design

• PYX-201 is in a phase I basket trial across ten tumor types, with careful patient allocation to ensure evaluable data per type.

• Highest publicly disclosed dose is 8 mg/kg, with dose escalation managed cautiously due to novel target and payload.

• Recruitment was enhanced in select tumor types to increase patient numbers at therapeutic doses for better decision-making.

• Criteria for advancing indications include both quantitative response rates and qualitative assessment of clinical signals.

• Data disclosure will clarify which tumor types advance, which are deprioritized, and plans for further evaluation.

Combination strategies and future plans

• PYX-201 is considered for combinations with PD-1/PD-L1 inhibitors and potentially other ADCs, leveraging its unique stroma-targeting profile.

• Combination regimens are seen as a future upside, but monotherapy data is prioritized to establish efficacy.

• PYX-106 targets Siglec-15, with a focus on PD-1/PD-L1 refractory populations; data expected by year-end.

• Decision to expand PYX-106 to other tumor types will depend on clinical findings and competitiveness.

• Pipeline includes PYX-107 (CD40 agonist), currently on hold pending data from lead programs; further pipeline plans to be communicated after clinical readouts.