Core Insights - Pyxis Oncology is making significant progress in its Phase 1 clinical trials for micvotabart pelidotin (MICVO), targeting recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) with preliminary data expected in the second half of 2025 and first half of 2026 [1][6] - The company has a cash runway that is expected to last through data milestones and into the second half of 2026, with cash and cash equivalents totaling $90.4 million as of June 30, 2025 [1][6] Pipeline Updates - The Phase 1/2 combination study of MICVO and KEYTRUDA® (pembrolizumab) is progressing well, with preliminary data anticipated in the second half of 2025 [5][6] - Preliminary data from the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 clinical trial for R/M HNSCC patients is expected in the second half of 2025, with additional data from patients who have received prior EGFRi and PD-1 inhibitor therapy anticipated in the first half of 2026 [6] Financial Results - For the quarter ended June 30, 2025, Pyxis Oncology reported revenues of $2.8 million, a significant increase from $0 in the same quarter of 2024, primarily due to milestone revenue from the approval of suvemcitug in China [6][10] - Research and development expenses increased to $17.1 million for the quarter ended June 30, 2025, compared to $14.0 million for the same period in 2024, driven by increased manufacturing and clinical trial-related expenses [10] - The net loss for the quarter was $18.4 million, or ($0.30) per common share, compared to a net loss of $17.3 million, or ($0.29) per common share, for the same quarter in 2024 [10][12]

Core Insights - Pyxis Oncology, Inc. announced robust preclinical data supporting the unique mechanism of action of micvotabart pelidotin (MICVO), an antibody-drug conjugate (ADC) targeting extradomain-B fibronectin (EDB+FN), which is highly expressed in various solid tumors [1][5] - MICVO demonstrated significant anti-tumor activity across multiple solid tumor indications, with 45% of models showing strong to very strong tumor growth inhibition (TGI) and complete responses observed in several tumor types [2][3] - The combination of MICVO with anti-PD-1 therapy showed enhanced tumor clearance and longer immunological memory compared to either treatment alone, reinforcing the potential for MICVO as both a monotherapy and in combination therapies [1][3] Preclinical Findings - Evaluation of MICVO in patient-derived xenograft (PDX) models identified gene signatures associated with anti-tumor activity, with 45% of models showing TGI between 70% and 90% or greater than 90% [2][3] - The preclinical studies indicated that MICVO is well-tolerated at a dosage of 3 mg/kg, with significant tumor regression responses confirmed in Phase 1 studies [2][4] - Upregulation of certain proteases may enhance linker cleavage, contributing to increased MICVO activity, supporting the hypothesis for its extracellular mechanism [3] Clinical Development - MICVO is currently being evaluated in Phase 1 studies as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) for advanced solid tumors, particularly recurrent and metastatic head and neck squamous cell carcinoma [4][5][8] - The company has received Fast Track Designation from the U.S. FDA for MICVO in treating adult patients with recurrent and metastatic head and neck squamous cell carcinoma whose disease has progressed after prior treatments [8]

Core Insights - Pyxis Oncology, Inc. is a clinical-stage company focused on developing next-generation therapeutics for difficult-to-treat cancers [3] - The company will participate in the Stifel 2025 Virtual Targeted Oncology Forum on April 9, 2025, featuring a fireside chat with CEO Lara S. Sullivan [1] - The lead product candidate, micvotabart pelidotin (MICVO), is an antibody-drug conjugate targeting Extradomain-B Fibronectin, currently in Phase 1 clinical studies for various solid tumors [3] Company Overview - Pyxis Oncology is dedicated to creating differentiated mono and combination therapies for challenging cancers [3] - MICVO aims to combat difficult-to-treat cancers through multiple mechanisms, including direct cancer cell killing and enhancing anti-tumor immune response [3] - The company is focusing on recurrent and metastatic head and neck squamous cell carcinoma based on promising clinical signals [3] Event Participation - The company will hold one-on-one investor meetings during the Stifel 2025 Virtual Targeted Oncology Forum [1] - A live webcast of the fireside chat will be available on the company's Investor Relations website [2]

Core Insights - Pyxis Oncology, Inc. is advancing micvotabart pelidotin (MICVO), an antibody-drug conjugate (ADC) targeting EDB+FN, into clinical trials for recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) [1][6] - Preliminary data from ongoing clinical trials are expected in the second half of 2025 and the first half of 2026, focusing on patients who have previously received platinum and PD-1 inhibitor therapy [3][4] Company Developments - The company has initiated Part 2 of the Phase 1 clinical trial to evaluate MICVO in patients with R/M HNSCC who have received prior treatments [2][6] - A Phase 1/2 combination study of MICVO and Merck's anti-PD-1 therapy, KEYTRUDA®, has been launched, with preliminary data expected in the second half of 2025 [3][4] Mechanism of Action - MICVO utilizes a unique non-cellular mechanism to drive anti-tumor activity, potentially addressing resistance to other therapies by altering the tumor extracellular matrix [2][6] - The combination of MICVO and a mouse analog of anti-PD-1 therapy has shown significantly greater tumor regression compared to either treatment alone [1][5] Regulatory Status - MICVO has received Fast Track Designation from the U.S. FDA for treating adult patients with R/M HNSCC whose disease has progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy [4][6] Upcoming Presentations - New preclinical data will be presented at the AACR Annual Meeting in April 2025, highlighting the potential of MICVO and its mechanism of action [1][2]