Pyxis Oncology (PYXS) 3rd Annual Guggenheim Healthcare Innovation Conference summary

MICVO rationale and clinical data

• MICVO is a first-in-concept ADC targeting extracellular matrix; phase I showed activity with low EDB-FN levels, supporting development without an EDB-FN biomarker and potential expansion across solid tumors.

• A basket study showed activity in nine tumor types, including breast, lung, pancreatic cancer and sarcoma; prioritization is based on clinical activity and potential to become standard of care in a meaningful population.

• In heavily pretreated head and neck cancer, September data showed a 36% response rate regardless of HPV status or prior therapy, PFS over six months and 79% 12-month OS probability.

• Modified weight-based dosing with a dose cap cut discontinuations and grade 3 peripheral neuropathy nearly in half; grade 3 neuropathy occurred in six patients at an average 5.5 months, with five resolved or resolving.

• Among patients with grade 3 neuropathy, response rate was 67% and median PFS exceeded eight months; neuropathy generally arose late and improved after dose interruption.

Second-line head and neck development

• Headliner is planned as a global pivotal trial with response rate and OS primary endpoints, comparing MICVO with investigator-choice cetuximab, docetaxel or methotrexate; FDA and EMA discussions informed the design.

• The team is working toward first patient, first dose in mid-next year and rapid enrollment; its stated 2027 priorities include starting and enrolling Headliner quickly and advancing access to patients.

• First-quarter-next-year update planned on end-of-phase-II feedback and dose optimization; 5.4 with the dose cap is the anticipated dose, pending agency discussion.

• OS data are planned for the first half of next year; the Triple Meeting presentation in Barcelona is intended to build investigator engagement ahead of pivotal development.

• Estimated U.S. second-line population exceeds 20,000, based on ~30,000 patients receiving frontline treatment and ~70% proceeding to second line.

Frontline combination and lifecycle opportunities

• December update planned for MICVO plus pembrolizumab, focused on frontline patients across HPV status and doses of 3.6 and 4.4; an earlier seven-patient dataset spanning lines of therapy showed a 71% response rate.

• The December review is expected to assess early response and safety; more durability follow-up is planned for H2 2027 to help determine whether to pursue further development.

• No EDB-FN H-score biomarker strategy has emerged; biomarker work continues to identify whether any patient subgroup may benefit more.

• Other tumor types receive selective investment, subject to clinical signal, standard-of-care potential and available resources; MICVO rights are wholly held and the focus remains on second-line head and neck cancer.