Pyxis Oncology Inc.

08/04/2025 | Press release | Distributed by Public on 08/04/2025 05:26

Material Event (Form 8-K)

Item 8.01 Other Events.

On July 31, 2025, revisions to patient enrollment participants related to Pyxis Oncology, Inc.'s (the "Company") Phase 1 monotherapy clinical trial to evaluate micvotabart pelidotin ("MICVO", formerly PYX-201) were made available on ClinicalTrials.gov. This clinical trial is a first-in-human, open-label, multicenter, Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Micvo in participants with advanced solid tumors and includes a part 1 dose escalation and part 2 dose expansion (NCT05720117).

Consistent with the industry practices, the revision in patient enrollment participants reflects the maximum number of patients that will be allowed to be enrolled as per protocol. The Company confirms its prior guidance related to estimated number of head and neck squamous cell carcinoma ("HNSCC") patients to be enrolled in the dose expansion phase (Part 2) of the PYX-201-101 monotherapy study as disclosed in its quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2025.

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