Pyxis Oncology Reports Q4 and Full-Year 2025 Results, Provides Key Business Update

Key Milestones Achieved in MICVO Clinical Program; Strong Cash Position Supports Continued Pipeline Progression

BOSTON, March 23, 2026 – Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage biopharmaceutical company focused on developing next-generation therapies for hard-to-treat cancers, has released its business update and reported financial results for the fourth quarter and full year ended December 31, 2025. The company disclosed significant clinical, financial, and corporate developments that are likely to be closely watched by shareholders and the broader biotech investment community.

Key Highlights

• Clinical Milestones:
  • Completed target enrollment for the Phase 1 monotherapy dose expansion study of micvotabart pelidotin (MICVO) in second-line or later (2L+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) during Q1 2026.
  • Updated data from the MICVO Phase 1 monotherapy study (with focus on modified weight-based dosing) is expected mid-2026.
  • Updated results from the MICVO Phase 1/2 combination study with KEYTRUDA^® in first- and second-line R/M HNSCC patients are anticipated in the second half of 2026.
  • Positive preliminary data announced in December 2025 showed:
    • Monotherapy: 46% confirmed objective response rate (ORR) and 92% disease control rate (DCR) in efficacy-evaluable patients (N=13). MICVO monotherapy was generally well tolerated, with no Grade 4 treatment-related adverse events (TRAEs) or Grade 5 events observed.
    • Combination with KEYTRUDA: 71% confirmed ORR and 100% DCR in patients dosed at 3.6 mg/kg (N=4) and 4.4 mg/kg (N=3). No Grade 3/4 ADC payload TRAEs or Grade 5 events.
  • The company has introduced a modified weight-based dosing approach in ongoing trials to optimize patient outcomes and reduce adverse events, particularly in higher body weight patients.
  • Feedback and alignment obtained from the FDA regarding the pivotal monotherapy trial design for 2L+ R/M HNSCC, supporting the path towards potential registration.
  • Pyxis Oncology will present novel preclinical data on a murine analog of MICVO at the 2026 AACR Annual Meeting, supporting further exploration in immunotherapy-refractory models.
• Corporate and Leadership Updates:
  • Appointment of Thomas Civik as Interim CEO in February 2026, a biotech veteran with a track record of successful M&A (notably leading Five Prime Therapeutics through a \$1.9 billion acquisition by Amgen).
  • Appointment of Heather Knowles as SVP, Head of Global Clinical Operations (formerly at Moderna), and Alex Kane as SVP, Investor Relations and Capital Markets (formerly at Guggenheim Securities).
  • Appointment of Brian Freeman as SVP, Global Program Leader for MICVO, bringing extensive ADC and oncology experience.
  • Sale of royalty rights to Enzeshu^® (Suvemcitug for Injection) for \$11 million upfront and four semi-annual \$175,000 installments in December 2025, providing non-dilutive funding for pipeline development.
• Financial Performance and Guidance:
  • Cash runway: Expected to fund operations into Q4 2026.
  • As of December 31, 2025, cash and equivalents (including restricted cash and short-term investments) totaled \$68.3 million.
  • Revenues: \$13.9 million for FY2025 (vs. \$16.1 million in FY2024), primarily from a regulatory milestone for suvemcitug approval in China and the Enzeshu royalty sale.
  • R&D expenses: \$73.7 million in FY2025 (up from \$58.7 million in FY2024), reflecting increased investment in MICVO clinical programs.
  • Net loss: \$79.6 million (\$1.28/share) for FY2025 vs. \$77.3 million (\$1.32/share) in FY2024. Excluding non-cash expenses, net loss was \$67.8 million (vs. \$43.4 million).
  • Shares outstanding: 62,831,246 as of March 20, 2026.
  • Total assets: \$91.5 million as of December 31, 2025 (down from \$157.2 million a year earlier), reflecting increased R&D spend and the asset sale.
• Pipeline and Scientific Advances:
  • MICVO is a first-in-concept antibody-drug conjugate (ADC) targeting extradomain-B of fibronectin (EDB+FN), a structure highly expressed in tumor microenvironments and largely absent from normal adult tissue.
  • Demonstrated three mechanisms of action: direct tumor cell killing, bystander effect, and immunogenic cell death.
  • New pharmacokinetic (PK) simulation data indicate that the modified dosing approaches (dose capping and adjusted ideal body weight dosing) reduce drug exposure—and thus side effects—particularly in higher body weight patients, while preserving efficacy across all weight categories.
  • MICVO has received FDA Fast Track Designation for adult R/M HNSCC patients whose disease progressed after platinum chemotherapy and anti-PD-(L)1 therapy.

Potentially Price-Sensitive Information for Investors

• Clinical Data Readouts: Upcoming updated results from both the monotherapy and combination studies in 2026 could serve as significant share price catalysts if data are positive or negative.
• Regulatory Alignment: Feedback from the FDA on pivotal trial design for MICVO in 2L+ R/M HNSCC is a major step towards potential registration and future commercialization.
• Cash Runway: The company expects current funds to last into Q4 2026; investors should monitor for future financing needs as clinical trials progress.
• Leadership Changes: The appointment of experienced executives, especially the interim CEO, may increase investor confidence in execution and value creation.
• Non-Dilutive Funding: The sale of royalty rights provides additional capital without shareholder dilution, supporting continued development of MICVO.
• R&D Spending: Notable increase in research and development expenses reflects greater investment in multiple clinical programs, which, if successful, could add significant value but also represents a risk if trials falter.

About Pyxis Oncology

Pyxis Oncology is developing innovative ADCs and other modalities for difficult-to-treat solid tumors. Its lead asset, MICVO, is being evaluated in multiple ongoing clinical trials for R/M HNSCC as both monotherapy and in combination with KEYTRUDA. The company aims to provide new therapeutic options for patients with limited alternatives while generating value for shareholders through scientific and clinical advancement.

Investor Contact

For investor inquiries, contact Alex Kane at [email protected].
For media, contact Cailyn McCutcheon at [email protected].

Disclaimer

This article is for informational purposes only and does not constitute investment advice or a recommendation to buy or sell any securities. Forward-looking statements are subject to risks and uncertainties, including those described in Pyxis Oncology’s SEC filings. Readers are encouraged to review the full filings for a comprehensive understanding of risks. The author assumes no responsibility for investment decisions made based on this information.

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