Analysts Sound Alarm On Pyxis Oncology's Tiny Trial

Core Insights - Pyxis Oncology Inc. has released preliminary data from its ongoing Phase 1 studies of micvotabart pelidotin (MICVO) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) [1][5] Group 1: Study Results - In the monotherapy cohort, the confirmed overall response rate was 46% (6 of 13 patients), with a disease control rate of 92% (12 of 13 patients) [3] - The combination therapy cohort showed a confirmed overall response rate of 71% (5 of 7 patients) and a disease control rate of 100% (7 of 7 patients) [4] Group 2: Tolerability and Safety - MICVO was generally well tolerated, with no Grade 4 or Grade 5 treatment-related adverse events reported [4] - There was a noted 28% discontinuation rate in the study, which is significantly higher than the typical 10%-15% seen in oncology trials [7] Group 3: Future Plans - Pyxis Oncology plans to present updated data from the Phase 1 monotherapy study in mid-2026 and from the Phase 1/2 study in the second half of 2026 [5] - The company is evaluating the path forward for pivotal studies of MICVO as both a monotherapy and in combination with pembrolizumab [5] Group 4: Financial Update - Pyxis Oncology completed the sale of its rights to royalties from the commercialization of Enzeshu for a one-time cash payment of $11 million, which will support the development of MICVO [6] - The current cash runway is expected to fund operations through data milestones and into the fourth quarter of 2026 [6] Group 5: Market Reaction - Following the data release, Pyxis Oncology shares closed down about 49% at $1.73, reflecting concerns over limited data interpretability and tolerability issues [7] - Analysts have reiterated a Market Perform rating on Pyxis shares due to uncertainties regarding efficacy and the small sample size of the studies [9]