On November 24, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported an operational update and financial results for the third quarter of 2025 along with an outlook for clinical updates from studies sponsored by Nanobiotix or The University of Texas MD Anderson Cancer Center ("MD Anderson") expected in 2026 and announced the closing of its non-dilutive royalty financing transaction with HCRx.
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Operational Highlights
Establishing the Financial Foundation for Self-sustained Long-term Growth
Closed the royalty financing transaction with Healthcare Royalty ("HCRx") triggering an upfront payment of $50 million
Nanobiotix expects to receive an additional $21 million in one year, subject to reaching certain conditions
Progressing JNJ-1900 (NBTXR3) Clinical Development
Presented first data from a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) for patients with esophageal cancer presented at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO), adding another potential indication that warrants further investigation
Completed the sponsorship transfer of Phase 3 study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced head and neck cancer who are ineligible for cisplatin (NANORAY-312) in the majority of regions, along with the transfer of full operational control of the Phase 3 study, to Johnson & Johnson ("J&J")
Advancing the Curadigm Nanoprimer Program
Four new patent applications filed to expand the Curadigm Nanoprimer intellectual property portfolio and support an initial proprietary internal pipeline of Nanoprimer-based products in addition to external collaborations
New in vivo pre-clinical data evaluating the Nanoprimer in combination with therapeutic vaccines presented at the 2025 Partnership Opportunities in Drug Delivery conference (PODD) that could serve as the foundation for an initial internal proprietary pipeline of Nanoprimer-based products
Momentum building for external collaborations featuring Nanoprimer platform combinations with numerous material transfer agreements already in place
Chemistry, Manufacturing, and Controls (CMC) activities launched to support internal pipeline and external collaborations
"2025 has been a year of strong execution against our strategic priorities, further accelerated by the momentum we built in the third quarter and to date," said Laurent Levy, Chief Executive Officer and Chairman of the Executive Board at Nanobiotix. "We took another disciplined financing step toward self-sustained, long-term growth through the closing of a non-dilutive strategic royalty monetization with HCRx. Clinically, we saw continued advancement of the JNJ-1900 (NBTXR3) program with completion of the Phase 3 head and neck cancer study sponsorship transfer to J&J in the majority of regions and first data from a Phase 1 esophageal cancer study supporting evaluation in yet another indication. In parallel, our Curadigm Nanoprimer program is rapidly emerging as a long-term growth driver for Nanobiotix. We are well positioned to accelerate our trajectory in 2026 and beyond."
Closing of the Royalty Financing Transaction
The closing of this royalty financing transaction with HCRx marks a significant milestone for the Company with an upfront payment of $50 million. The Company expects an additional $21 million in one year, subject to reaching certain conditions.
HCRx will be compensated and repaid out of a capped portion of milestones and royalties on sales of JNJ-1900 (NBTXR3) payable to Nanobiotix under the Janssen license agreement. This repayment and compensation will be implemented through a trust established between (i) Nanobiotix as settlor and beneficiary, (ii) HCRx funds as beneficiaries, and (iii) European Investment Bank ("EIB") as beneficiary. Furthermore, contractual covenants granted by Nanobiotix to HCRx regarding the proper implementation by Nanobiotix of the Janssen license agreement shall also benefit to EIB.
2026 JNJ-1900 (NBTXR3) Clinical Data Outlook for Studies Sponsored by Nanobiotix or MD Anderson
Final data from Nanobiotix Study 1100 evaluating JNJ-1900 (NBTXR3) followed by pembrolizumab or nivolumab anti-PD-1 checkpoint inhibitors for patients with primary cutaneous melanoma resistant to anti-PD-1
Updated data from a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced non-small cell lung cancer (NSCLC) who are amenable to re-irradiation
New data from expansion cohort of a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) in combination with standard-of-care chemotherapy (capecitabine) for patients with locally advanced or borderline resectable pancreatic cancer
Updated results and establishment of the recommended Phase 2 dose (RP2D) from the proton therapy cohort of a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) activated by photon or proton therapy for patients with locally advanced esophageal cancer
Third Quarter Financial Updates
Cash, Cash Equivalents and Operating Runway:
€20.4 million in cash and cash equivalents as of September 30, 2025
$50 million upfront payment to be received by Nanobiotix given the closing of the HCRx agreement, plus the additional $21 million expected one year post-closing upon reaching certain conditions, would extend cash visibility into early 2028
About JNJ-1900 (NBTXR3)
JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.
Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.
Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.
(Press release, Nanobiotix, NOV 24, 2025, View Source [SID1234660902])