Pyxis Oncology Files 8-K for Regulation FD Disclosure

Ticker: PYXS · Form: 8-K · Filed: 2025-12-18T00:00:00.000Z

Sentiment: neutral

Topics: regulation-fd, disclosure, corporate-event

Related Tickers: PYXS

TL;DR

PYXS filed an 8-K today for Reg FD disclosure - details TBD.

AI Summary

Pyxis Oncology, Inc. filed an 8-K on December 18, 2025, to report on events that occurred on the same date. The filing indicates it is for a Regulation FD Disclosure and Other Events, with no specific details provided in the provided text about the nature of these events or any associated financial figures.

Why It Matters

This 8-K filing signals that Pyxis Oncology has made a disclosure under Regulation FD, which could involve material information impacting investors.

Risk Assessment

Risk Level: medium — The filing itself is procedural, but the lack of specific details in the provided text about the 'Regulation FD Disclosure' and 'Other Events' creates uncertainty about potential material information.

Key Players & Entities

FAQ

What specific information was disclosed under Regulation FD by Pyxis Oncology on December 18, 2025?

The provided text of the 8-K filing does not specify the content of the Regulation FD disclosure.

What were the 'Other Events' reported by Pyxis Oncology on December 18, 2025?

The filing indicates 'Other Events' were reported, but the specific nature of these events is not detailed in the provided text.

What is the Commission File Number for Pyxis Oncology, Inc.?

The Commission File Number for Pyxis Oncology, Inc. is 001-40881.

Where is Pyxis Oncology, Inc. headquartered?

Pyxis Oncology, Inc. is headquartered at 321 Harrison Avenue, Boston, Massachusetts, 02118.

What is the IRS Employer Identification Number for Pyxis Oncology, Inc.?

The IRS Employer Identification Number for Pyxis Oncology, Inc. is 83-1160910.

Filing Stats: 1,551 words · 6 min read · ~5 pages · Grade level 14.4 · Accepted 2025-12-18 07:25:28

Key Financial Figures

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure On December 18, 2025, Pyxis Oncology, Inc. (the "Company") provided a corporate update and issued a press release announcing positive preliminary Phase 1 data for Micvotabart Pelidotin (MICVO) in recurrent / metastatic head and neck squamous cell carcinoma. A copy of the press release is attached as Exhibit 99.1 and the corporate presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K. The information furnished under Item 7.01, including Exhibit 99.1 and Exhibit 99.2, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

01 Other Events

Item 8.01 Other Events. The Company today announced positive preliminary data from its ongoing Phase 1 clinical studies evaluating micvotabart pelidotin (MICVO), a first-in-concept antibody-drug conjugate (ADC) targeting extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM), in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The cutoff for all data reported below is as of November 3, 2025. Monotherapy The ongoing MICVO Phase 1 monotherapy study is a two-part study. Part 1 was a dose escalation study across multiple doses and tumor types, with initial data shared in November 2024. Part 2, a dose expansion cohort at 5.4 mg/kg in 2L+ R/M HNSCC, is currently ongoing. The data below incorporate all R/M HNSCC patients dosed at 5.4 mg/kg in the MICVO Phase 1 monotherapy study. 18 patients were treated at 5.4 mg/kg; intravenous (IV) dosed every three weeks (Q3W) 13 patients were evaluable for response (1 post-baseline scan within protocol limits, or discontinued early due to disease progression) All patients treated had prior systemic therapy, including: Median of 3 prior lines of therapy 100% (18/18) had prior platinum-based therapy 100% (18/18) had prior checkpoint inhibitor therapy 67% (12/18) had prior taxane therapy 50% (9/18) had prior EGFR targeting therapy Confirmed overall response rate (ORR) of 46% (6/13) 1 , including 1 complete response by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors v1.1). Confirmed responses observed in both arms of dose expansion: post platinum & anti-PD(L)-1 experienced patients (Arm 1) and post EGFRi and/or anti-PD(L)-1 experienced patients (Arm 2) Arm 1: 60% confirmed ORR (N=5) Arm 2: 25% confirmed ORR (N=4) Confirmed responses observed in patients with HPV-positive, HPV-negative, and HPV-not applicable tumors Disease control rate (DCR) of 92% (12/13) 12 patients demonstrated significant tumor

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release dated December 18, 2025 99.2 Presentation dated December 18, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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: December 18, 2025 By: /s/ Jitendra Wadhane Jitendra Wadhane Principal Financial and Accounting Officer

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