Nanobiotix Provides First Quarter 2025 Operational and Financial Update

• Dosing of a first patient in the CONVERGE study, a Phase 2 randomized controlled clinical trial for patients with stage 3 unresectable non-small cell lung cancer
• Presentation of data at the European Lung Cancer Conference in a Phase 1 study of re-irradiation with JNJ-1900 (NBTXR3) in locoregional recurrent NSCLC and a Phase 1 study of JNJ-1900 (NBTXR3) in combination with nivolumab or pembrolizumab for patients with lung metastases from NSCLC or other solid tumors
• Strengthened financial position through an amendment to the global licensing agreement for JNJ-1900 (NBTXR3) which extended cash runway into mid-2026 and permanently reduced operational cash burn
• €39.8 million in cash and cash equivalents as of March 31, 2025

PARIS and CAMBRIDGE, Mass., May 21, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, today provided an update on operational progress and reported financial results for the first quarter of 2025.

“We are pleased with the execution across the JNJ-1900 (NBTXR3) development programs and are excited for the important milestones ahead. NANORAY-312 continues to advance in head and neck cancer, with our ongoing global transfer of sponsorship moving toward completion, and the recent expansion of development into lung cancer through the CONVERGE study. We were also pleased by the updated clinical data further supporting expansion into indications including lung cancer amenable to re-irradiation recently presented by MD Anderson at ESTRO and ELCC, respectively and locally advanced or borderline resectable pancreatic cancer,” said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board.

Operational Highlights

• Ongoing Randomized Phase 2 Study in Unresectable Stage 3 NSCLC (CONVERGE)
  • First patient dosed in the Johnson & Johnson-sponsored Phase 2 randomized CONVERGE study evaluating JNJ-1900 (NBTXR3) for patients with unresectable stage 3 non-small cell lung cancer (“NSCLC”) in 1Q2025
• NSCLC Amenable to Re-irradiation (Phase 1 Study MDA 2020-0123 sponsored by MD Anderson)
  • Presented first data showing a favorable safety profile and early signals of efficacy from the completed dose escalation part of a Phase 1 study evaluating radiotherapy-activated JNJ-1900 (NBTXR3) as a second or later line (2L+) therapy at the 2025 European Lung Cancer Conference (ELCC).
• Amendment to global licensing agreement for JNJ-1900 (NBTXR3) extended cash runway to mid-2026 with a meaningful reduction in cash burn expected moving forward
  • Removed the vast majority of the funding obligation for NANORAY-312 and released Johnson & Johnson from select future potential milestone payments, while safeguarding hundreds of millions in potential milestone and royalty payments for lead programs for Nanobiotix

Subsequent events