On May 15, 2025 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation ADC therapeutics for difficult-to-treat cancers, reported financial results for the quarter ended March 31, 2025, and provided a business update (Press release, Pyxis Oncology, MAY 15, 2025, View Source [SID1234653180]).

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"We are enthusiastic about the progress we are making with micvotabart pelidotin, particularly our recent preclinical data that validate its unique three-pronged mechanism of action and indicate that MICVO monotherapy may be eliciting immune responses in previously unresponsive tumors," said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. "Our focus remains on delivering durable and efficacious therapies for patients with recurrent or metastatic head and neck squamous cell carcinoma and other advanced solid tumors, building on the tremendous potential of our next generation ADC. We look forward to reporting data from our ongoing Phase 1 trials evaluating MICVO as a monotherapy and in combination with pembrolizumab later this year."

Pipeline Updates

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Pyxis Oncology presented promising preclinical data at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supporting the unique three-pronged mechanism of action of MICVO driving anti-tumor activity via direct tumor killing, bystander effect and immunogenic cell death. These data further reinforce the potential patient benefit of MICVO as a monotherapy and in combination with an anti-PD-1 therapy.
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MICVO demonstrated broad anti-tumor activity across ten solid tumor indications in PDX models, attributed to EDB+FN target expression, proteolytic activity for MICVO linker cleavage and tumor responsiveness to the cytotoxic Auristatin0101 payload.
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Differential gene expression analysis enabled identification of gene signatures associated with anti-tumor activity.
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Upregulation of certain proteases may contribute to increased linker cleavage and subsequent increased MICVO activity, supporting hypothesis for extracellular mechanism.

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Combining a mouse analog of MICVO with anti-PD-1 therapy inhibited EMT6 tumor growth and improved survival.

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The Company expects to report 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 and 2L and 3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy in the first half of 2026. R/M HNSCC continues to be an area of high medical need despite improvements in treatment options.

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Pyxis Oncology anticipates selecting a dose of MICVO in the ongoing Phase 1/2 combination study of micvotabart pelidotin and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors by mid-year 2025 and reporting preliminary data from the trial in the second half of 2025.

First Quarter 2025 Financial Results

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As of March 31, 2025, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $106.9 million. The Company believes that its current cash, cash equivalents, and short-term investments will be sufficient to fund its operations into the second half of 2026.

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Research and development expenses were $17.0 million for the quarter ended March 31, 2025, compared to $13.0 million for the quarter ended March 31, 2024. The increase was primarily due to increased clinical trial-related expenses related to monotherapy and combination therapy of micvotabart pelidotin, increase in preclinical and translation work to support clinical development of micvotabart pelidotin and increased manufacturing of drug product and drug substance.

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General and administrative expenses were $5.9 million for the quarter ended March 31, 2025, compared to $8.2 million for the quarter ended March 31, 2024. The decrease was primarily due to lower stock-based compensation costs, lower corporate insurance costs and decrease in legal, professional and consulting fees.

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Net loss was $21.2 million, or ($0.35) per common share, for the quarter ended March 31, 2025, compared to $3.3 million, or ($0.06) per common share, for the quarter ended March 31, 2024. Net loss for the quarter ended March 31, 2024 included total revenues of $16.1 million related to the settlement agreement with Novartis for sale of royalty rights of Beovu for a one-time amount of $8.0 million and Novartis agreed to forgo its right to reclaim royalties previously paid of $8.1 million to us and Apexigen. Excluding non-cash stock-based compensation expense, the net loss for the quarter ended March 31, 2025 was $17.5 million, compared to net income of $1.1 million for the quarter ended March 31, 2024.

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As of May 14, 2025, the outstanding number of shares of Common Stock of Pyxis Oncology was 61,947,665.