Business Context and Reporting Period
This Form 6-K filing by Nanobiotix S.A. is dated May 20, 2026. The report updates investors on clinical trial progress for its lead product candidate, JNJ-1900 (NBTXR3), and the advancement of its Curadigm Nanoprimer platform. The disclosures are provided in connection with an underwritten offering announced on the filing date.
Key Financial Metrics
The filing text does not provide specific values for revenue, profit, cash flow, margins, debt, or liquidity for the reporting period. However, it notes that under the license agreement with Johnson & Johnson (J&J), the Company is eligible to receive up to approximately $200 million in aggregate milestone payments over the next few years, contingent on achieving development and regulatory milestones for head and neck cancer and lung cancer programs.
Material Changes and Clinical Updates
CONVERGE Trial (NSCLC)
- Status: Part 1 data (safety lead-in) presented at ESTRO 2026 on May 17, 2026, covering 7 patients with Stage 3 unresectable NSCLC.
- Efficacy: Following full treatment (chemoradiation + NBTXR3 + durvalumab), the trial showed an 85.7% Objective Response Rate (ORR), 57.1% Complete Response Rate (CRR), and 100% Disease Control Rate (DCR).
- Safety: Intratumoral/intranodal injection was deemed feasible and safe in this population.
- Comparison: The filing contrasts these results with historical PACIFIC trial data, noting that adjusted PACIFIC data showed a CRR of 1.6% and ORR of 36.5% after chemoradiotherapy alone.
NANORAY-312 Trial (Head and Neck Cancer)
- Protocol Amendment: In May 2026, J&J announced an amendment eliminating the planned interim analysis and modifying the final analysis to require fewer events (335 vs. originally planned higher number).
- Impact: This change is expected to accelerate the global registration pathway and potential revenue generation. Power for the primary Progression-Free Survival (PFS) endpoint improved to 92%.
- Design: The trial evaluates NBTXR3 in cisplatin-ineligible elderly patients. Expected median PFS is 13 months (active) vs. 9 months (control).
Curadigm Nanoprimer Platform
- Progress: Preclinical data presented in April 2026 demonstrated that Nanoprimer enhances the performance of LNP-DNA immunotherapies by reducing liver clearance and improving systemic bioavailability.
- Intellectual Property: Four new patent applications were filed in November 2025. The platform holds five existing patents covering composition and method of use.
Guidance, Outlook, and Risks
Outlook: Management believes the NANORAY-312 protocol amendment could accelerate registration and revenue. The Company anticipates final data from the MD Anderson NSCLC reirradiation trial in the second half of 2026. The Curadigm platform is positioned as a future growth driver with plans for internal product development and external collaborations.
Risks and Contingencies:
- Small Sample Size: The filing explicitly cautions that CONVERGE Part 1 results are based on only seven patients and should not be relied upon as predictive of future performance.
- Cross-Trial Comparisons: The Company states that no inference regarding relative efficacy should be drawn from the comparison of CONVERGE data with the PACIFIC trial due to inherent differences in trial design and patient populations.
- Development Risk: Milestone payments are contingent on achieving specific regulatory and development events.
Investor Verification Checklist
- Verify the exact terms and timing of the underwritten offering mentioned in the filing.
- Confirm the specific milestones required to trigger the up to $200 million in payments from J&J.
- Monitor the enrollment progress and safety data for the randomized Part 2 of the CONVERGE trial.
- Track the event-driven timeline for the modified final analysis of the NANORAY-312 trial.
- Review the status of the IND readiness package for the first Curadigm Nanoprimer product.