NBTX · Nanobiotix S.A.

The FDA acceptance of the protocol amendment to the ongoing global Phase 3 NANORAY-312 study represents a significant advancement for Nanobiotix's lead product candidate, JNJ-1900 (NBTXR3), in locally advanced head and neck squamous cell cancer (HNSCC). Sponsored by Johnson & Johnson via Janssen Pharmaceutica NV under a 2023 global license agreement, the changes eliminate a previously planned interim analysis and modify the final analysis to require fewer clinical events, allowing it to occur earlier. This adjustment aligns the readout timing with what was originally the interim analysis schedule, contingent on event accrual. For investors, this accelerates the potential regulatory pathway, as Nanobiotix believes it expands opportunities for global registration and earlier revenue generation. The company remains eligible for substantial milestone payments—described as hundreds of millions in aggregate—tied to development and regulatory achievements in head and neck and lung cancer programs. JNJ-1900 (NBTXR3), hafnium oxide nanoparticles activated by radiotherapy, has Fast Track designation from the FDA for this HNSCC population ineligible for platinum chemotherapy, underscoring its priority status. This development de-risks the timeline without altering the study's core design, positioning Nanobiotix for key catalysts in the near term while leveraging its collaboration strategy with partners like MD Anderson.