On August 14, 2025 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing antibody-drug conjugate (ADC) therapeutics for difficult-to-treat cancers, reported financial results for the quarter ended June 30, 2025, and provided a business update (Press release, Pyxis Oncology, AUG 14, 2025, View Source [SID1234655314]).

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"We are invigorated by the progress we’re making, particularly in our ongoing clinical trials, where we’re seeing that MICVO’s unique mechanism as an extracellular targeted ADC has the potential to transform the treatment of advanced solid tumors," said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. "The encouraging clinical and preclinical data observed to date suggest that MICVO may offer a differentiated treatment approach as both a monotherapy and in combination with pembrolizumab for HNSCC and other advanced solid tumors. We look forward to evaluating the emerging clinical data as we continue to advance this novel ADC."

Pipeline Updates

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Pyxis Oncology anticipates having preliminary data from the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 clinical trial evaluating MICVO in 2L and 3L R/M HNSCC patients who have received prior platinum and PD-1 inhibitor therapy in the second half of 2025. Preliminary data from the trial in 2L and 3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy are anticipated in the first half of 2026. R/M HNSCC continues to be an area of high medical need despite potential improvements in treatment options.

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Pyxis Oncology anticipates having preliminary data from the Phase 1/2 combination study of MICVO in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in R/M HNSCC and other advanced solid tumors in the second half of 2025.

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In July 2025, Pyxis Oncology received a $2.8 million ($3 million milestone payment, less $0.2 million of tax in China) milestone payment from Simcere Pharmaceutical Group Limited ("Simcere") for the approval of suvemcitug (BD0801) in China by the National Medical Products Administration. The Company is eligible to receive mid to high single-digit percentage royalties on net sales of suvemcitug in China, under the terms of the Company’s license and collaboration agreement. In addition to suvemcitug, Pyxis Oncology retains rights to two other antibodies in development by Apexigen’s licensees, discovered through the APXiMAB platform.

Second Quarter 2025 Financial Results

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As of June 30, 2025, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $90.4 million. The Company believes that its current cash, cash equivalents, restricted cash and short-term investments will be sufficient to fund its operations into the second half of 2026.

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Revenues for the quarter ended June 30, 2025 were $2.8 million, compared to $0 for the quarter ended June 30, 2024. During the quarter, we recognized $2.8 million of milestone revenue ($3 million of milestone less $0.2 million of tax in China) related to regulatory approval of suvemcitug in China. The regulatory milestone was pursuant to an out-licensing and collaboration agreement between our subsidiary company, Apexigen, and Simcere, for the development and commercialization of suvemcitug for oncology in China.

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Research and development expenses were $17.1 million for the quarter ended June 30, 2025, compared to $14.0 million for the quarter ended June 30, 2024. The increase in expenses of $3.1 million was due to increased manufacturing of drug product and drug substance and clinical trial-related expenses for monotherapy and combination therapy of MICVO aggregating to $3.8 million, partially offset by reduction in expenses related to PYX-106 by $1.1 million as the clinical development of PYX-106-101 was paused in December 2024.

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General and administrative expenses were $5.4 million for the quarter ended June 30, 2025, compared to $6.1 million for the quarter ended June 30, 2024. The decrease was primarily due to lower corporate insurance costs, lower facilities costs and decrease in legal, professional, and consulting fees.

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Net loss was $18.4 million, or ($0.30) per common share, for the quarter ended June 30, 2025, compared to $17.3 million, or ($0.29) per common share, for the quarter ended June 30, 2024. Excluding non-cash stock-based compensation expense, the net loss for the quarter ended June 30, 2025 was $15.3 million, compared to net loss of $14.4 million for the quarter ended June 30, 2024.

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As of August 13, 2025, the outstanding number of shares of Common Stock of Pyxis Oncology was 62,018,135.