Business Context and Reporting Period
Company: Nanobiotix S.A.
Filing Type: Form 20-F (Annual Report)
Reporting Period: Fiscal year ended December 31, 2025
Business Overview: Nanobiotix is a late-stage clinical biotechnology company developing physics-based nanotherapeutics. Its lead product candidate, JNJ-1900 (formerly NBTXR3), is a nanoradioenhancer designed to increase the efficacy of radiotherapy. The Company operates under a global licensing agreement with Janssen Pharmaceutica NV (Janssen) for the development and commercialization of JNJ-1900 worldwide, excluding the Asia Licensing Territory (which was novated to Janssen in late 2023).
Key Financial Metrics (Year Ended Dec 31, 2025)
| Metric | 2025 (€) | 2024 (€) | 2023 (€) |
|---|---|---|---|
| Total Revenues and Other Income | 32,593 | (7,191) | 36,207 |
| Net Loss | (23,961) | (68,132) | (39,700) |
| Operating Loss | (10,818) | (68,392) | (26,779) |
| Cash and Cash Equivalents (Year End) | 52,750 | 49,737 | 75,283 |
| Total Assets | 67,760 | 67,418 | 93,897 |
| Total Liabilities | 152,242 | 133,122 | 95,740 |
| Shareholders' Equity | (84,483) | (65,704) | (1,843) |
Note: All figures in thousands of Euros unless otherwise specified.
Material Changes vs. Prior Period
- Revenue Volatility: Total revenues and other income swung from a negative €7.2 million in 2024 to a positive €32.6 million in 2025. This reversal was primarily driven by a one-time positive revenue recognition of €21.8 million in 2025 resulting from a contract modification to the Janssen Agreement (Amendment No. 1). Conversely, 2024 included a one-time negative revenue impact of €23.4 million due to the transfer of sponsorship for the NANORAY-312 study to Janssen, which created a refund liability.
- Net Loss Improvement: The net loss decreased significantly to €24.0 million in 2025 from €68.1 million in 2024. This improvement was driven by the revenue recognition mentioned above and a €17.4 million decrease in Research and Development (R&D) expenses.
- R&D Expense Reduction: R&D expenses dropped to €23.1 million in 2025 from €40.5 million in 2024. This 43% decrease is attributed to the transfer of the NANORAY-312 study sponsorship and funding obligations to Janssen.
- Financing Activity: In October 2025, the Company entered into a Royalty Financing Agreement with HCRx, receiving an initial installment of $50 million (€42.9 million) in December 2025. This significantly boosted cash flows from financing activities to €37.4 million in 2025, compared to an outflow of €5.1 million in 2024.
Guidance, Outlook, and Risks
- Clinical Development: The Company has completed the transfer of global sponsorship for the pivotal Phase 3 NANORAY-312 study (head and neck cancer) to Janssen. Janssen now assumes nearly all financial responsibility for this trial. Nanobiotix continues to sponsor Study 1100 (immuno-oncology combination) and other trials in collaboration with MD Anderson.
- Liquidity Outlook: As of December 31, 2025, the Company held €52.8 million in cash. Management projects this is sufficient to fund operations for at least the next 12 months. Future funding may be required to support ongoing clinical trials and the development of the Curadigm and Oocuity platforms.
- Key Risks:
- Reliance on Janssen: The Company's future revenue and commercial success depend heavily on Janssen's ability to successfully develop, obtain regulatory approval for, and commercialize JNJ-1900.
- Regulatory Uncertainty: JNJ-1900 is being reclassified from a medical device to a medicinal product in the EU and other jurisdictions, which may impact the regulatory pathway.
- Financing Contingencies: The second installment of the HCRx royalty financing ($21 million) is contingent on the absence of clinical holds on the NANORAY-312 and CONVERGE trials for 60+ days in the following year.
- Going Concern: While currently sufficient, the Company has a history of losses and requires additional funding to achieve profitability.
Important Facts for Investor Verification
- Revenue Recognition Accounting: Verify the accounting treatment of the Janssen Agreement amendments (2024 and 2025) under IFRS 15, which caused significant volatility in reported revenue due to contract modifications and refund liabilities.
- Royalty Financing Terms: Review the terms of the HCRx agreement, specifically the repayment multiple (175% if repaid by 2030, 250% thereafter) and the conditions for the second $21 million tranche.
- EIB Loan Obligations: Confirm the status of the European Investment Bank (EIB) loan, including the €20 million milestone payment obligation and the potential for early repayment triggers based on cash balances or change of control.
- Clinical Trial Progress: Monitor the enrollment and data readout timelines for the NANORAY-312 study (now sponsored by Janssen) and the CONVERGE study (lung cancer), as these are critical for triggering milestone payments.
- Share-Based Compensation: Note the significant share-based payment expenses (€3.5 million in 2025) and the dilution potential from outstanding options and warrants (approx. 4.98 million shares underlying).