On March 31, 2026 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, reported an update on operational progress, announced financial results for the year ended December 31, 2025, and announced the filing of its universal registration document (URD) for the financial year ended December 31, 2025 with the French financial market authority (Autorité des marchés financiers or AMF), as well as of the annual report on Form 20-F for the financial year ended December 31, 2025 with the U.S. Securities and Exchange Commission (SEC).
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Operational Highlights
Addressing One of the Largest Untapped Markets in Oncology with JNJ-1900 (NBTXR3)1
Regulatory harmonization with health authorities in major European countries in 3Q2025, who accepted the reclassification of JNJ-1900 (NBTXR3) from a medical device to a medicinal product, aligning with regulatory status in the US and other major markets
Filing of new composition of matter patent for JNJ-1900 (NBTXR3) in 3Q2025 that aims to reinforce the intellectual property foundation of the product candidate
Lead programs in head and neck cancer (NANORAY-312) and lung cancer (CONVERGE) proceeded as planned
Completed the transfer of NANORAY-312 sponsorship in 4Q2025
First CONVERGE patient dosed in 1Q2025
First CONVERGE data presented in 1Q2026
Multiple early-stage studies across solid tumor types beyond the lead programs continued to progress
NSCLC Amenable to Re-irradiation (Phase 1 Study MDA 2020-0123 sponsored by The University of Texas MD Anderson Cancer Center ("MD Anderson"))
First data presentation showed a favorable safety profile and early signals of efficacy in 1Q2025, with 12-month local PFS of 64% and 12-month OS of 83% (N=12)
Locally Advanced or Borderline Resectable Pancreatic Cancer (Phase 1 Study MDA 2019-1001 sponsored by MD Anderson)
Presented updated data showing favorable safety, injection feasibility, and encouraging oncologic outcomes with mOS of 23 months from date of diagnosis in patients (n=22) with locally advanced or borderline resectable pancreatic cancer in 2Q2025
Locally Advanced Adenocarcinoma of the Esophagus (Phase 1 Study MDA 2020-0122 sponsored by MD Anderson)
First data on JNJ-1900 (NBTXR3) activated by photon chemoradiation (cohort 1) or proton chemoradiation (cohort 2) showed 85% (11/13) disease control rate (DCR) and 69% (9/13) objective response rate (ORR), including 6 CR and 3 PR, in 4Q2025
Melanoma Resistant to Anti-PD-1 (Phase 1 Study 1100 sponsored by Nanobiotix)
Presented new data showing a favorable safety profile and early efficacy signals in a heavily pre-treated population whose cancer progressed after multiple prior lines of therapy including anti-PD-1 in 3Q2025
Recurrent and/or Metastatic Head and Neck Cancer Naïve or Resistant to Anti-PD-1 (Phase 1 Study 1100 sponsored by Nanobiotix)
Presented updated data showing treatment remained well-tolerated with consistent injection feasibility in 103 heavily pre-treated patients with recurrent and/or metastatic head and neck cancer (RM-HNSCC) naïve or resistant to anti-PD-1 with encouraging efficacy signals in 3Q2025 with:
63% disease control rate ("DCR") and 37% objective response rate ("ORR") in evaluable anti-PD-1 naïve patients per RECIST 1.1 (N=41)
74% DCR and 32% ORR in evaluable anti-PD-1 resistant patients per RECIST 1.1 (N=50)
Disciplined Financial Strategy Establishing Financial Foundation Toward Self-Sustainability and The Advancement of Next Wave Nanotherapeutic Platforms for Long-Term Sustainability and Growth
Executed amendment to global licensing agreement for JNJ-1900 (NBTXR3) in 1Q2025, removing the vast majority of Nanobiotix funding obligation for NANORAY-312, safeguarding Nanobiotix’s path to sustainable cashflow through hundreds of millions in potential milestone payments related to lead programs expected in the coming years
Announced strategic non-dilutive royalty monetization agreement with HealthCare Royalty ("HCRx") for up to $71 million in 4Q2025, with $50 million already received in December 2025. Extended cash runway into early 2028, assuming the receipt of the remaining $21 million funding from HCRx expected one year post-closing upon reaching certain conditions, enabling Nanobiotix development beyond key milestones in head and neck cancer and lung cancer
Other Operational Highlights
Advancements of the Curadigm Nanoprimer Platform, the Company’s next lever for growth, in 4Q2025 with momentum building for external collaborations featuring Nanoprimer platform combinations with numerous material transfer agreements already in place
Four new patent applications filed that aim to expand the Curadigm Nanoprimer platform intellectual property portfolio and support an initial proprietary internal pipeline of Nanoprimer products in addition to external collaborations
Presented new in vivo pre-clinical data evaluating the Nanoprimer in combination with therapeutic vaccines that could serve as the foundation for an initial internal proprietary pipeline of Nanoprimer products
Chemistry, Manufacturing, and Controls (CMC) activities launched to support both internal pipeline and external collaborations
Announced admission of Nanobiotix to both the CAC Mid 60 and SBF 120 indices, two of the most widely followed benchmarks for mid-sized and leading listed companies in France
"2025 was a year of meaningful clinical and operational advancement, reinforcing the potential of our nanoradioenhancer technology for millions of patients with cancer and laying the foundation for our next phase of growth," said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. "We are encouraged by the progress of JNJ-1900 (NBTXR3)’s lead programs in head and neck cancer and lung cancer, and look forward to supporting J&J as these studies continue to mature. In parallel, Nanobiotix presented JNJ-1900 (NBTXR3) data from Phase 1 Study 1100 in recurrent or metastatic head and neck cancer and melanoma, and MD Anderson presented clinical results from Phase 1 and 2 studies across pancreatic, esophageal, and lung cancers. Taken together, we believe the global clinical development program for JNJ-1900 (NBTXR3) supports the broad potential of the investigational radioenhancer across tumor types and therapeutic combinations. Beyond the Nanoradioenhancer platform, 2025 saw important steps forward for our next-generation Curadigm Nanoprimer platform that included plans for the establishment of an internal pipeline, momentum in external collaborations, and the launch of CMC activities to supply both of these industrial pathways. With a strengthened financial position and anticipated clinical updates on the horizon, we believe Nanobiotix is strongly positioned to deliver continued momentum and meaningful impact in 2026 and beyond."
Full Year 2025 Financial Results
Revenue and Other Income: €32.6 million in revenues recorded for the year ended December 31, 2025, compared to negative €7.2 million for the year ended December 31, 2024, which included a one-off positive revenue recognition impact of €21.8 million in accordance with IFRS15 application (non-cash impact). This adjustment was driven by the amendment to the licensing agreement with Janssen signed in March 2025 reducing the Company’s funding obligation for the NANORAY-312 study costs (further to the initiation of the transfer of the global sponsorship to Janssen). In addition, Revenue and other income also included €7.0m of clinical products sales to Janssen and €0.9m of services related to technology transfer recharged to Janssen NV, and Research Tax Credit for €2.8million.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of preclinical, clinical, and manufacturing expenses related to the development of JNJ-1900 (NBTXR3) and totaled €23.1 million for the twelve-month period ended December 31, 2025, as compared to €40.5 million for the twelve months ended December 31, 2024. This year over year 43% decrease primarily reflected the removal of funding obligations on the NANORAY-312 study and the decrease of JNJ-1900 (NBTXR3) clinical development activity related costs, together with the decrease of R&D expenses on its Phase 1 multi-cohort trial of RT-activated NBTXR3 followed by anti-PD-1 checkpoint inhibitors (Study 1100).
Selling, General and Administrative ("SG&A") Expenses: SG&A expenses were €20.4 million for the year ended December 31, 2025, compared to €20.5 million for the year ended December 31, 2024. This year-over-year decrease of 1% is mainly driven by close monitoring of the general expenses.
Net loss: Net loss attributable to shareholders was €24.0 million, or €0.50 per share, for the twelve-month period ended December 31, 2025, a year-over-year decrease of 65%, which was primarily attributable to the one-off non-cash positive revenue recognition accounting impact together with the removal of the funding obligation on the 312 study. This compares to a net loss of €68.1 million, or €1.44 per share for the year ended December 31, 2024.
Cash and Cash Equivalents: As of December 31, 2025, Nanobiotix had €52.8 million in cash and cash equivalents, compared to €49.7 million as of December 31, 2024.
Financial Guidance: Based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of €52.8 million as of December 31, 2025, will fund its operations into early 2028, assuming the receipt of the remaining $21 million funding from HCRx expected one year post-closing upon reaching certain conditions. This runway excludes any milestone receipt.
The supervisory board of the Company reviewed the financial statements 2025, together with the management and corporate governance reports, on March 31, 2026, and the Company’s statutory auditors finalized their audit and issued on March 31, 2026, a clean opinion on both statutory and consolidated financial statements 2025.
"We fortified our financial position and, assuming the receipt of the remaining $21 million, extended our cash runway into 2028 by securing $71 million in royalty financing with HCRx." said Bart Van Rhijn, chief financial and business officer at Nanobiotix. "This non-dilutive financing solution has us well positioned to continue taking the necessary operational and financial steps to ensure the future of our business and our potential to benefit millions of patients around the world with our technology and signifies our continued financial discipline in capital allocation."
Availability of the Full Year 2025 Financial Reports
The URD and 20-F are available on the Nanobiotix website here. In addition, the URD is available on the AMF website (www.amf-france.org) and the 20-F is available on the SEC website (www.sec.gov).
The Company’s 2025 URD includes its:
2025 annual financial report including management and corporate governance reports
Reports from the Company’s statutory auditors and information on their fees
Required information in relation to the Company’s share buyback program
Conference Call and Webcast
Nanobiotix will host a conference call and live audio webcast on Wednesday, April 1, 2026, at 8:00 AM EDT / 2:00 PM CEST, prior to the open of the U.S. market. During the call, Laurent Levy, chief executive officer, and Bart van Rhijn, chief financial and business officer, will briefly review the Company’s year-end results and provide an update on business activities for the full year of 2025 before taking questions from participants.
(Press release, Nanobiotix, MAR 31, 2026, View Source [SID1234664099])