Pyxis Oncology(US:PYXS)2025-11-03 12:36Product Development - Pyxis Oncology's product candidate micvotabart pelidotin (MICVO) targets EDB+FN, a component of the tumor extracellular matrix, aiming to destabilize tumor support while directly killing tumor cells[90]. - In the Phase 1 dose escalation study, micvotabart pelidotin achieved a 50% objective response rate (ORR) in six patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) at a dose range of 3.6 mg/kg – 5.4 mg/kg IV Q3W[96]. - The study also reported a disease control rate (DCR) of 100% among the six heavily pre-treated R/M HNSCC patients[96]. - Across six solid tumor types of interest, micvotabart pelidotin achieved a 26% ORR (n=31) at the same dose range[97]. - The FDA granted Fast Track Designation to micvotabart pelidotin for the treatment of adult patients with R/M HNSCC whose disease has progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy[103]. - Pyxis Oncology plans to prioritize resources to further develop micvotabart pelidotin based on the promising efficacy signals observed in R/M HNSCC[104]. - A clinical trial collaboration with Merck has been established to study micvotabart pelidotin in combination with KEYTRUDA®[108]. - The company initiated a Phase 1/2 combination study with KEYTRUDA® to evaluate the safety and preliminary efficacy of micvotabart pelidotin in advanced solid tumors[109]. - Preliminary data from the ongoing studies are expected to be disclosed in the fourth quarter of 2025[111]. - The company is actively recruiting patients for two monotherapy expansion cohorts in the R/M HNSCC study, each expecting to enroll approximately 20 patients at the 5.4 mg/kg IV Q3W dose[111]. Financial Performance - For the nine months ended September 30, 2025, the company reported a net loss of $61.5 million, compared to a net loss of $41.8 million for the same period in 2024, representing an increase in losses of $19.8 million[115]. - Research and development expenses for the nine months ended September 30, 2025, increased by $7.3 million to $52.0 million, up from $44.7 million in the same period in 2024[136]. - The company recognized $2.8 million in milestone revenue related to regulatory approval of Suvemcitug in China during the nine months ended September 30, 2025, compared to $16.1 million in total revenues for the same period in 2024[133]. - The accumulated deficit as of September 30, 2025, was $425.1 million, with net equity of $68.8 million and cash and cash equivalents totaling $77.7 million[115]. - Research and development expenses for the three months ended September 30, 2025, were $17.8 million, a slight increase of $0.1 million from $17.7 million in the same period in 2024[126]. - The company expects to continue incurring significant operating losses and expenses in the foreseeable future, primarily due to ongoing clinical and preclinical activities[115]. - General and administrative expenses decreased by $0.4 million to $5.6 million for the three months ended September 30, 2025, compared to $6.0 million in the same period in 2024[130]. - Micvotabart pelidotin program-specific research and development costs increased by $2.0 million, primarily due to increased contract manufacturing and clinical trial expenses[127]. - The company has not generated any revenues from product sales and does not expect to do so in the foreseeable future[116]. - Other income, net for the three months ended September 30, 2025, was $1.4 million, down from $2.5 million in the same period in 2024, primarily due to decreased interest and investment income[131]. - Micvotabart pelidotin program-specific R&D costs increased by $9.1 million, driven by a $5.0 million rise in contract manufacturing costs and a $3.9 million increase in clinical trial expenses[137]. - PYX-106 program-specific R&D costs decreased by $3.9 million due to the pause in clinical development[138]. - General and administrative expenses decreased by $3.4 million, from $20.3 million in 2024 to $16.9 million in 2025, primarily due to lower stock-based compensation and professional fees[139]. - Other income decreased from $7.6 million in 2024 to $4.9 million in 2025, mainly due to reduced interest and investment income[140]. - As of September 30, 2025, the company had cash and short-term investments totaling $77.7 million, with net losses of $61.5 million for the nine months ended September 30, 2025[141]. - The company expects substantial increases in expenses related to ongoing clinical trials and may finance operations through equity offerings and collaborations[143]. - Net cash used in operating activities was $53.1 million for the nine months ended September 30, 2025, compared to $38.4 million in 2024[146][148]. - Net cash provided by investing activities was $42.6 million in 2025, primarily from the redemption of marketable debt securities[149]. - The company had $106.2 million of remaining capacity available under its ATM facility as of September 30, 2025[142]. - The company raised substantial doubt about its ability to continue as a going concern for the next 12 months due to insufficient cash resources[154].