Pyxis Oncology — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net loss for the quarter ended September 30, 2026, was $20.0 million ($0.24 per share), compared to $22.0 million ($0.35 per share) in the same period in 2025.
• Research and development expenses were $16.6 million for the quarter, a decrease from $17.8 million in Q3 2025, driven by a $3.6 million reduction in manufacturing costs partially offset by a $3.0 million increase in clinical trial expenses.
• General and administrative expenses were $4.0 million for the quarter, down from $5.7 million in Q3 2025, primarily due to a $1.4 million decrease in stock-based compensation.
• Cash, cash equivalents, restricted cash, and short-term investments totaled $57.0 million as of September 30, 2026.
• Total operating expenses for the quarter were $20.5 million, compared to $23.5 million in Q3 2025.
• Loss from operations was $20.5 million for the quarter, compared to $23.5 million in the prior year period.
• Total other income, net, was $0.5 million for the quarter, compared to $1.5 million in Q3 2025.

Guidance and Future Outlook:

• The company expects to receive FDA feedback on dose selection for the Phase 3 Headliner trial in the first quarter of 2027.
• Initiation of the global Phase 3 Headliner trial is planned for mid-2027.
• Updated overall survival data from the MICVO Phase 1 monotherapy study is expected in the first half of 2027.
• Additional data from the Phase 1/2 combination study of MICVO and pembrolizumab in first-line R/M HNSCC, including durability data, is expected in the second half of 2027.
• A comprehensive corporate update outlining the MICVO development strategy in R/M HNSCC is planned for December 2026.
• The company believes its current cash position, combined with net upfront proceeds from the October public offering, will fund operations into the first half of 2028.

Business Segments and Product Lines:

• MICVO (micvotabart pelidotin) is the lead candidate, an investigational antibody-drug conjugate targeting extradomain-B of fibronectin (EDB+FN).
• Updated Phase 1 monotherapy data in 2L+ R/M HNSCC showed a confirmed objective response rate of 36% (12/33) and a disease control rate of 94% (31/33) at a dose of 5.4 mg/kg IV Q3W.
• Median progression-free survival was 6.2 months, and the 12-month overall survival probability was 79% in the efficacy-evaluable population.
• The Phase 3 Headliner trial will be a randomized, open-label, two-arm study evaluating MICVO monotherapy versus investigator's choice of cetuximab, docetaxel, or methotrexate in approximately 500 patients.
• Co-primary endpoints for the Phase 3 trial are overall response rate and overall survival.
• A Phase 1/2 combination study evaluating MICVO with KEYTRUDA® (pembrolizumab) in first-line R/M HNSCC is ongoing, with data from at least 20 patients expected in the December 2026 update.
• MICVO received Fast Track Designation from the FDA for the treatment of adult patients with R/M HNSCC who have progressed following platinum-based chemotherapy and anti-PD-(L)1 therapy.

Market and Competitive Landscape:

• MICVO is designed to treat difficult-to-treat cancers by targeting the tumor extracellular matrix, a non-cellular structural component largely absent from normal adult tissues.
• The company is presenting updated clinical data and preclinical findings at the 38th EORTC-NCI-AACR Symposium in November 2026.

Risks and Challenges:

• The press release references "Risk Factors" detailed in the Company's Quarterly Report on Form 10-Q filed with the SEC on November 5, 2026, which may include factors causing actual results to differ from forward-looking statements.
• Clinical trial outcomes, including efficacy and safety, remain uncertain and subject to regulatory approval.
• The company is a clinical-stage biopharmaceutical company with no commercial products and relies on funding to continue operations.

Management Commentary and Tone:

• CEO Tom Civik stated that the September monotherapy data reinforce confidence in MICVO's potential to serve a significant population of patients with previously treated recurrent/metastatic head and neck cancer.
• Management expressed confidence in the company's strengthened balance sheet to execute on development priorities and advance toward becoming a pre-commercial organization.
• The company has aligned with FDA and EMA feedback regarding the design of the global Phase 3 Headliner trial.

Other Key Points:

• On October 1, 2026, Pyxis Oncology closed a registered public offering generating approximately $110.0 million in net upfront gross proceeds.
• The offering included milestone-linked warrants that, if exercised in full for cash, could provide an additional $172.6 million, for a total potential proceeds of up to $282.6 million.
• Tom Civik was appointed Chief Executive Officer and Chairman of the Board in September 2026, having served as Interim CEO since February 2026.
• John Flavin transitioned from founding Chairman to Lead Independent Director.
• Outstanding shares of Common Stock were 119,607,855 as of November 4, 2026.
• CEO Tom Civik will participate in fireside chats at the Guggenheim 3rd Annual Healthcare Innovation Conference (November 9, 2026) and the Stifel 2026 Healthcare Conference (November 10, 2026).