Pyxis Oncology reports Q3 2026 financial results and pipeline updates

Item 2.02 Results of Operations and Financial Condition.

On November 5, 2026, Pyxis Oncology, Inc. ("the Company") issued a press release announcing its financial results for the quarter ended September 30, 2026 and provided a corporate update.¹ A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in Item 2.02 of this Current Report, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing with the U.S. Securities and Exchange Commission made by the Company, regardless of any general incorporation language in such filings.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release dated November 5, 2026

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:

November 5, 2026

By:

/s/ Jitendra Wadhane

Jitendra Wadhane

Principal Financial and Accounting Officer

Pyxis Oncology Reports Third Quarter 2026 Financial Results and Highlights Progress Toward Pivotal Development of Micvotabart Pelidotin (MICVO)

Updated Phase 1 monotherapy results in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) showed compelling efficacy data with a manageable safety profile

FDA feedback on dose selection from the End-of-Phase 2 meeting expected in the first quarter of 2027; global Phase 3 Headliner SM trial initiation planned for mid-2027

Updated overall survival data from the MICVO Phase 1 monotherapy study expected in the first half of 2027

MICVO Phase 1 monotherapy data in previously treated R/M HNSCC to be presented in a late-breaking oral presentation and preclinical findings to be presented in two posters at the 38th EORTC-NCI-AACR Symposium

December 2026 corporate update to outline MICVO's development strategy in R/M HNSCC, including updated data from the first-line pembrolizumab combination study

Quarter-end cash and net upfront proceeds from October public offering expected to fund operations into the first half of 2028

BOSTON, November 5, 2026 -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today reported financial results for the quarter ended September 30, 2026, and highlighted continued progress in the development of micvotabart pelidotin (MICVO).

"The September monotherapy data reinforce our confidence in MICVO's potential to serve a significant population of patients with previously treated recurrent/metastatic head and neck cancer," said Tom Civik, Chief Executive Officer and Chairman of Pyxis Oncology. "We have aligned with feedback received from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the design of the global Phase 3 Headliner SM trial and plan to initiate it in mid-2027, with FDA feedback on dose selection expected in the first quarter of 2027. We look forward to presenting MICVO monotherapy data, along with two preclinical posters, at the EORTC-NCI-AACR Symposium in November, and providing a comprehensive update on our head and neck cancer strategy in December, including updated efficacy and safety data from MICVO in combination with pembrolizumab in the first-line setting. Our strengthened balance sheet positions us to execute on these priorities, continue evaluating MICVO's broader potential and advance toward becoming a pre-commercial organization."

Pipeline Updates

• Pyxis Oncology has aligned with feedback from the FDA and the EMA on the design of the global pivotal Phase 3 Headliner SM trial, which the Company plans to initiate in mid-2027. The randomized, open-label, two-arm trial will evaluate MICVO monotherapy in patients with second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) who have progressed following treatment with both platinum-based chemotherapy and an anti-PD-1 therapy. Approximately 500 patients are expected to be randomized 1:1 to receive MICVO or investigator's choice of cetuximab, docetaxel or methotrexate. The co-primary endpoints are overall response rate and overall survival.

• Pyxis Oncology expects to provide an update in the first quarter of 2027 on FDA feedback regarding dose selection following its End-of-Phase 2 meeting.

• Updated overall survival data from the ongoing MICVO monotherapy study are expected in the first half of 2027.

• Additional data from the Phase 1/2 combination study of MICVO and Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in first-line (1L) R/M HNSCC, including initial durability data to inform selection of the recommended Phase 3 dose, are expected in the second half of 2027.

Reported Updated Phase 1 Monotherapy Data in 2L+ R/M HNSCC

On September 9, 2026, Pyxis Oncology announced updated data from its ongoing global Phase 1 monotherapy study of MICVO in 2L+ R/M HNSCC, as of a data cutoff of August 18, 2026.

In the efficacy-evaluable population receiving MICVO at 5.4 mg/kg intravenously once every three weeks (IV Q3W) at or below a dose cap (N=33):

• Confirmed objective response rate was 36% (12/33), and disease control rate was 94% (31/33).

• Responses were rapid and deep, with 75% of responders responding by the first scan at six weeks and 83% of responders achieving greater than 50% tumor reduction.

• Median progression-free survival was 6.2 months (95% CI: 4.8–8.8), and the 12-month overall survival probability was 79% (95% CI: 58.1, 90.3). Median overall survival had not yet been reached.

• Clinical activity was observed across HPV status and prior-treatment subgroups.

In the safety-evaluable population (N=35), no new safety signals were observed. Dose capping reduced the frequency and severity of adverse events in high body weight patients.

Planned December 2026 Corporate Update

Pyxis Oncology plans to provide a corporate update in December 2026, including:

• A comprehensive development strategy for MICVO in R/M HNSCC, including how emerging combination data inform potential opportunities across treatment settings.

• Updated efficacy and safety data from the ongoing Phase 1/2 combination dose-escalation study evaluating MICVO with KEYTRUDA® (pembrolizumab) across multiple doses in 1L R/M HNSCC.

o The update is expected to include data from a total of at least 20 patients with 1L R/M HNSCC