PYXS

EX-99.1

2 pyxs-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Pyxis Oncology Reports First Quarter 2026 Financial Results and Advances MICVO Toward Key 2026 Clinical Milestones

Updated micvotabart pelidotin (MICVO) Phase 1 monotherapy data in 2L+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) on track for mid-year 2026; update to include analyses focused on patients treated at or below a dose cap

Completed target enrollment in Phase 1 monotherapy dose expansion study of MICVO in 2L+ R/M HNSCC in the first quarter of 2026

Updated data from MICVO Phase 1/2 dose escalation study in combination with pembrolizumab in 1L R/M HNSCC on track for the second half of 2026

Presented new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting 2026 that support the clinical development of MICVO as both a monotherapy and in combination with pembrolizumab for the treatment of R/M HNSCC

Announced the appointment of Nelson Azoulay as Chief Business Officer

Expected cash runway into the fourth quarter of 2026

BOSTON, May 14, 2026 (GLOBE NEWSWIRE) — 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 March 31, 2026, and highlighted continued advancement of the micvotabart pelidotin (MICVO) clinical development program.

“Our team’s exceptional clinical and operational execution in the first quarter of 2026, combined with growing investigator enthusiasm for MICVO’s potential to positively impact the lives of patients with cancer, has positioned us to deliver key milestones for the MICVO program this year,” said Tom Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. “We remain on track to share updated monotherapy data in mid-year 2026 and updated combination data in the second half of 2026. The mid-year 2026 monotherapy update will focus on 2L+ R/M HNSCC patients treated at or below a dose cap, which we implemented in December 2025. The goal of moving to a dose cap was to maintain MICVO’s strong efficacy profile while improving safety and tolerability. In the Phase 1/2 dose escalation combination study with pembrolizumab, we have refined our focus to 1L R/M HNSCC patients. We believe these two datasets will help establish MICVO’s broad potential as a novel ADC for patients with difficult-to-treat cancers and substantial unmet need.”

Pipeline & Corporate Updates

• Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study for 2L+ R/M HNSCC in mid-year 2026. The mid-year 2026 update will focus on participants who were treated at 5.4 mg/kg IV Q3W, with a dose equivalent to or below a dose cap. Results will include detailed analyses of the impact of a dose cap on safety, tolerability and efficacy.

• The ongoing MICVO Phase 1 monotherapy study is a multi-part study. Part 1 was a dose escalation study across multiple doses and tumor types, with initial results shared in November 2024. Part 2, a dose expansion study in 2L+ R/M HNSCC, is currently ongoing. Preliminary Phase 1 study results in 2L+ R/M HNSCC were shared in December 2025.

• The dose expansion study of the ongoing MICVO Phase 1 monotherapy study includes two arms: post platinum and anti-PD-(L)1 experienced patients (Arm 1) and post EGFRi and anti-PD-(L)1 experienced patients (Arm 2). Target enrollment for each arm of the study was n=~20. Total study target enrollment was completed in 1Q26.

• In December 2025, a dose cap was implemented for higher body weight patients. Based on internal PK simulation modeling indicating that MICVO exposures with dose capping and adjusted ideal bodyweight (AIBW) dosing are expected to be comparable, dose capping was prioritized due to its operational simplicity and speed of implementation.

• Dose capping and AIBW are both well-established approaches to modified weight-based dosing and have demonstrated improved tolerability without sacrificing clinical activity in studies of other ADCs[i].

• A protocol amendment permitting AIBW has been approved, and AIBW dosing has begun. AIBW will be selected as a go-forward dose strategy only if it offers a superior profile to dose capping.

• Pyxis Oncology expects to report updated data from the ongoing Phase 1/2 combination dose escalation study of MICVO and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for 1L R/M HNSCC patients in 2H26.

• The ongoing MICVO Phase 1/2 study evaluating MICVO in combination with KEYTRUDA® (pembrolizumab) is currently in dose escalation across multiple doses for the treatment of 1L R/M HNSCC. Preliminary positive results for the treatment of 1L/2L+ R/M HNSCC were shared in December 2025.

• The MICVO Phase 1/2 combination dose escalation study update in 2H26 will focus on 1L R/M HNSCC patients.

• In April 2026, Pyxis Oncology presented new preclinical data in a poster

EX-99.1

2 pyxs-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Pyxis Oncology Provides Business Update and Reports Fourth Quarter and Full Year 2025 Financial Results

Completed target enrollment in Phase 1 monotherapy dose expansion study of micvotabart pelidotin (MICVO) in 2L+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) in the first quarter of 2026

Updated data from MICVO Phase 1 monotherapy study in 2L+ R/M HNSCC on track for mid-year 2026; to include patients treated with modified weight-based dosing and patients treated with total body weight dosing

Updated data from MICVO Phase 1/2 dose escalation study in combination with KEYTRUDA® in 1L/2L+ R/M HNSCC on track for the second half of 2026

Announced appointment of Thomas Civik as Interim Chief Executive Officer

Expected cash runway into the fourth quarter of 2026

BOSTON, March 23, 2026 (GLOBE NEWSWIRE)— Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today provided a business update, and reported financial results for the year and quarter ended December 31, 2025.

“The completion of target enrollment in the Phase 1 monotherapy study of MICVO in patients with recurrent/metastatic head and neck squamous cell carcinoma is an important milestone for the Company and reflects the incredible effort of the Pyxis Oncology team,” said Thomas Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. “We are laser focused on clinical execution and operations so that we can deliver a robust dataset in mid-2026 that will allow us to further assess the potential of MICVO as monotherapy. Following the preliminary results shared last December, we implemented a modified weight-based dosing approach that is expected to deliver optimal drug exposure for patients across all weight ranges to further improve the benefit-risk profile for MICVO. We look forward to sharing these results mid-year, and plan to provide an assessment of whether the dosing modification achieved these intended goals. We also expect to share updated combination data in 2H26 as we continue to evaluate the potential of MICVO in the front-line setting, building on the encouraging initial combination data shared last December.”

Pipeline Updates

• Pyxis Oncology announced positive preliminary data for micvotabart pelidotin (MICVO) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in December 2025.

• Monotherapy: 46% confirmed objective response rate (ORR) and 92% disease control rate (DCR) observed with MICVO as monotherapy in 2L+ R/M HNSCC (N=13, efficacy evaluable). MICVO as monotherapy was generally well tolerated, with no Grade 4 ADC payload treatment-related adverse events (TRAEs) of interest observed. No Grade 5 events occurred. Preliminary results shared in December 2025 included all Phase 1 patients (N=18) dosed at 5.4 mg/kg IV Q3W total body weight (TBW).

• Combination: 71% confirmed ORR and 100% DCR observed with MICVO in combination with a fixed dose of 200 mg of KEYTRUDA® (pembrolizumab) in 1L/2L+ R/M HNSCC at 3.6 mg/kg (N=4) and 4.4 mg/kg (N=3) IV Q3W. MICVO in combination with KEYTRUDA® was generally well tolerated, with no Grade 3 or Grade 4 ADC payload TRAEs of interest observed. No Grade 5 events occurred. The combination study is part of a Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada).

• During the fourth quarter of 2025, the Company obtained feedback and alignment from the U.S. Food and Drug Administration (FDA) regarding the clinical trial design for a planned pivotal monotherapy study in 2L+ R/M HNSCC.

• Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study in 2L+ R/M HNSCC mid-year 2026.

• 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 results shared in November 2024. Part 2, a dose expansion study at 5.4 mg/kg IV Q3W in 2L+ R/M HNSCC, is currently ongoing.

• The dose expansion study of the ongoing MICVO Phase 1 monotherapy study includes two arms: post platinum & anti-PD(L)-1 experienced patients (Arm 1) and post EGFRi and/or anti-PD(L)-1 experienced patients (Arm 2). Target enrollment for each arm of the study was n=~20. Total study target enrollment of n=~40 was completed in 1Q26.

• MICVO Phase 1 monotherapy data in 2L+ R/M HNSCC expected mid-year 2026 will include patients dosed at 5.4 mg/kg IV Q3W with a dose cap for patients with higher body weight, in addition to patients previously treated at 5.4 mg/kg IV Q3W TBW. Results are anticipated to include detailed analyses of the impact of the modified weight-based dosing approach on safety and efficacy. Adjusted Ideal Body weight (AIBW) dosing, which has demonstrated improved tolerability without sacrificing activity in clinical studies of other ADCs[1], is being implemented in ongoing

8-K

false000178222300017822232025-11-032025-11-03

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): November 03, 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 2.02 Results of Operations and Financial Condition. On November 3, 2025, Pyxis Oncology, Inc. (“the Company”) issued a press release announcing its financial results for the quarter ended September 30, 2025 and provided a corporate update. 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 3, 2025

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 3, 2025

By:

/s/ Jitendra Wadhane

Jitendra Wadhane Principal Financial and Accounting Officer