[8-K] Pyxis Oncology, Inc. Reports Material Event

Rhea-AI Filing Summary

Pyxis Oncology (PYXS) Form 8-K – Item 8.01

On 31 Jul 2025 the company amended the ClinicalTrials.gov record for its first-in-human, open-label Phase 1 monotherapy trial of micvotabart pelidotin (MICVO, formerly PYX-201; NCT05720117). The revision increases the maximum number of participants that may be enrolled in both dose-escalation (Part 1) and dose-expansion (Part 2) cohorts. Management states the change is procedural and does not alter prior guidance on the expected head-and-neck squamous cell carcinoma (HNSCC) enrollment disclosed in the 15 May 2025 10-Q.

No safety, efficacy, or financial data were released, and all other disclosure items remain unchanged.

Positive

• Clinical trial progressing with higher allowable enrollment, indicating operational momentum and regulatory alignment.

Negative

• No new efficacy or safety results were provided, offering investors no additional insight into MICVO's therapeutic potential.

Insights

Clinical Trials Analyst

TL;DR: Enrollment cap raised but study timeline and guidance unchanged; neutral clinical signal.

The filing simply aligns ClinicalTrials.gov with protocol language, lifting the ceiling on possible participants. Because target HNSCC enrollment guidance remains intact, there is no shift in projected data-readout timing or cost profile. The absence of interim safety/efficacy results limits investors’ ability to reassess probability-of-success. Overall, the disclosure is administrative and not a value-inflecting event.

Portfolio Manager

TL;DR: Procedural update; negligible impact on valuation or near-term catalysts.

Raising the patient cap may signal flexibility to over-enroll, but without new data or timeline changes the risk-reward profile for PYXS equity is fundamentally unchanged. Cash-burn implications appear minimal at Phase 1 scale. I regard the event as neutral for position sizing and would wait for dose-expansion efficacy signals before revisiting the thesis.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 04, 2025

Pyxis Oncology, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-40881	83-1160910
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
321 Harrison Avenue
Boston, Massachusetts				02118
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (617) 453-3596

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		PYXS		The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

			Pyxis Oncology, Inc.
Date:	August 04, 2025	By:	/s/ Jitendra Wadhane
			Jitendra Wadhane Principal Financial and Accounting Offier

FAQ

What did Pyxis Oncology (PYXS) disclose in its 8-K dated August 4 2025?

The company reported an amended ClinicalTrials.gov entry increasing the maximum number of participants for its Phase 1 MICVO study.

Does the enrollment change affect prior head-and-neck cancer guidance?

No; Pyxis confirmed the previously stated HNSCC enrollment estimate remains valid.

Were any new MICVO safety or efficacy data released?

No. The filing contains no interim results, only an administrative update on participant numbers.

Will the trial timeline or budget change due to the new enrollment cap?

The company did not indicate any timeline or budget revisions connected to the enrollment adjustment.

What phase is the MICVO (PYX-201) study currently in?

It is in an ongoing Phase 1 dose-escalation and dose-expansion study for advanced solid tumors.