On May 14, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported financial results for the quarter ended March 31, 2026, and highlighted continued advancement of the micvotabart pelidotin (MICVO) clinical development program.

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"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

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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.

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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.
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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.
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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.
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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].
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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.
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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.
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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.
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The MICVO Phase 1/2 combination dose escalation study update in 2H26 will focus on 1L R/M HNSCC patients.
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In April 2026, Pyxis Oncology presented new preclinical data in a poster presentation at the 2026 AACR (Free AACR Whitepaper) Annual Meeting that showed treatment with a mouse analog of MICVO (maMICVO) in combination with anti-mouse PD-1 produced synergistic anti-tumor activity in an immune-refractory syngeneic preclinical model of HNSCC (MOC2). Additional key poster findings include:
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Monotherapy with maMICVO produced dose-dependent inhibition of tumor outgrowth.
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Monotherapy with maMICVO modulated the immune compartment toward a more favorable immune-permissive environment for immunotherapy. Treatment with maMICVO reduced the overall abundance of immune-suppressive regulatory T cells (Tregs) in MOC2 tumors, increased the CD8 T cell-to-Treg ratio and enhanced the abundance of a progenitor exhausted T cell subset that is highly responsive to anti-PD-1 therapy.
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Despite the MOC2 model being insensitive to anti-mouse PD-1 as a monotherapy, the combination of maMICVO and anti-mouse PD-1 resulted in greater tumor control and tumor growth inhibition than maMICVO monotherapy. Bliss independence analysis confirmed that maMICVO acted synergistically with anti-mouse PD-1 in a preclinical model unresponsive to anti-mouse PD-1 monotherapy.

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In May 2026, Pyxis Oncology announced the appointment of Nelson Azoulay as Chief Business Officer. Mr. Azoulay most recently served as Senior Vice President, Strategy and Business Development at Flagship Pioneering, where he spearheaded business development initiatives across select portfolio companies. Previously, he was Vice President of Corporate Development at ImmunoGen, where he helped shape the Company’s mid- to long-term strategy, led search and evaluation efforts, supported fundraising activities, and helped secure key transactions, including collaborations and partnerships with major pharmaceutical companies. He also played a role in ImmunoGen’s acquisition by AbbVie and subsequent integration in 2024. Earlier in his career, at PDL BioPharma, Mr. Azoulay led corporate restructuring and managed strategic divestitures. At Syneos Health Consulting, he advised global pharmaceutical and biotechnology companies on portfolio strategy, transactions and commercial planning. He holds an MBA from Columbia Business School, an MS in Neuroscience from McGill University and a BA from Wesleyan University.
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In February 2026, Pyxis Oncology announced the appointment of Thomas Civik as Interim Chief Executive Officer. Mr. Civik has been a member of Pyxis Oncology’s Board of Directors since October 2021 and is a highly experienced biotechnology executive with a proven track record in advancing cancer therapeutics. He most recently served as President and Chief Executive Officer of Five Prime Therapeutics, where he led the company through its acquisition by Amgen for $1.9 billion in April 2021. Mr. Civik previously served as Chairperson of the Board of ImCheck Therapeutics and Repare Therapeutics through their respective acquisitions by Ipsen and XOMA.

First Quarter 2026 Financial Results

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As of March 31, 2026, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $42.5 million. The Company believes that its current cash, cash equivalents, and short-term investments will be sufficient to fund its operations into the fourth quarter of 2026.
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Research and development expenses were $20.0 million for the quarter ended March 31, 2026, compared to $17.0 million for the quarter ended March 31, 2025. The increase was primarily due to a $5.5 million increase in clinical trial related expenses including CMC, related to monotherapy and combination therapy of MICVO, offset by reduction in employee-related costs and other costs.
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General and administrative expenses were $4.4 million for the quarter ended March 31, 2026, compared to $5.9 million for the quarter ended March 31, 2025. The decrease was primarily due to lower employee-related costs including stock-based compensation.
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Net loss was $23.3 million, or ($0.37) per common share, for the quarter ended March 31, 2026, compared to $21.2 million, or ($0.35) per common share, for the quarter ended March 31, 2025. Excluding non-cash stock-based compensation expense, the net loss for the quarter ended March 31, 2026 was $22.1 million, compared to a net loss of $17.5 million for the quarter ended March 31, 2025.
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As of May 13, 2026, the outstanding number of shares of Common Stock of Pyxis Oncology was 63,355,482.

(Press release, Pyxis Oncology, MAY 14, 2026, View Source [SID1234665711])