NANOBIOTIX Announces Updates to JNJ-1900 (NBTXR3) Clinical Program Following Transfer of Ongoing Phase 3 Head and Neck Cancer Trial Sponsorship and Operational Control

Rhea-AI Summary

NANOBIOTIX (NASDAQ:NBTX) announced completion of the transfer of sponsorship for the NANORAY-312 Phase 3 head and neck cancer trial (initiated 3Q2024) in the majority of regions and transfer of full operational control to Johnson & Johnson.

Following Nanobiotix's review of the latest information, the Company now estimates that NANORAY-312 interim data will be analyzed and reported in 1H2027 after the requisite number of events and last patient recruitment. Future guidance for NANORAY-312 and other JNJ-1900 (NBTXR3) studies sponsored by J&J will be provided by J&J. Nanobiotix will continue to update on Nanobiotix-sponsored studies and MD Anderson-sponsored trials.

Positive

• Completed transfer of NANORAY-312 sponsorship in the majority of regions
• Transferred full operational control of the Phase 3 trial to Johnson & Johnson
• Clear interim data timing: analysis and report expected in 1H2027

Negative

• Loss of operational control may reduce Nanobiotix visibility into JNJ-1900 study conduct
• Future guidance for J&J-sponsored NANORAY-312 updates will be delivered by Johnson & Johnson

PARIS and CAMBRIDGE, Mass., Oct. 24, 2025 (GLOBE NEWSWIRE) -- 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, today announced updates to the JNJ-1900 (NBTXR3) clinical development program.

Nanobiotix has completed the transfer of NANORAY-312 sponsorship, initiated in 3Q2024, in the majority of regions along with the transfer of full operational control of the Phase 3 clinical trial to Johnson & Johnson (“J&J”). Following the transfer and Nanobiotix analysis of the latest information, Nanobiotix estimates that NANORAY-312 interim data will be analyzed and reported, after both the requisite number of events have been observed and the last patient has been recruited, in 1H2027.

Future guidance related to NANORAY-312 and other JNJ-1900 (NBTXR3)-related J&J-sponsored studies will be communicated by J&J. Nanobiotix will continue to provide JNJ-1900 (NBTXR3) clinical development updates and guidance related to Nanobiotix-sponsored studies as well as studies sponsored by The University of Texas MD Anderson Cancer Center.

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.

About NANOBIOTIX

Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations.

Nanobiotix is the owner of more than 25 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system.

For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

Disclaimer

This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 2, 2025 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2024 universal registration document filed with the AMF on April 2, 2025 under “chapter 1.5 Risk Factors”, and subsequent filings Nanobiotix makes with the SEC and AMF from time to time, including the Half-Year Report at June 30, 2025 which are available on the SEC’s website at www.sec.gov and on the AMF's website at www.amf.org, The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly.

Contacts

Nanobiotix
Communications Department Brandon Owens VP, Communications +1 (617) 852-4835 contact@nanobiotix.com	Investor Relations Department Joanne Choi VP, Investor Relations (US) +1 (713) 609-3150 investors@nanobiotix.com Ricky Bhajun Director, Investor Relations (EU) +33 (0) 79 97 29 99 investors@nanobiotix.com
Media Relations
France – HARDY Caroline Hardy +33 06 70 33 49 50 carolinehardy@outlook.fr	Global – uncapped Communications Becky Lauer +1 (646) 286-0057 nanobiotixteam@uncappedcommunications.com

Attachment

• 2025-10-24 -- NBTX -- Update to NBTXR3 Clinical Program -- FINAL

FAQ

What did NANOBIOTIX (NBTX) announce about the NANORAY-312 Phase 3 trial on October 24, 2025?

Nanobiotix announced completion of sponsorship transfer in the majority of regions and transfer of full operational control to Johnson & Johnson.

When does NANOBIOTIX expect NANORAY-312 interim data to be analyzed and reported for NBTX?

Nanobiotix estimates interim data will be analyzed and reported in 1H2027 after required events and last patient recruitment.

Who will provide future guidance for JNJ-1900 (NBTXR3) J&J-sponsored studies affecting NBTX?

Johnson & Johnson will communicate future guidance for JNJ-1900 (NBTXR3) studies it sponsors.

Will NANOBIOTIX continue clinical updates for NBTX after the transfer?

Yes; Nanobiotix will continue to provide updates and guidance for Nanobiotix-sponsored studies and MD Anderson-sponsored trials.

What operational change for the NBTX NANORAY-312 trial occurred in 3Q2024 and was completed by October 24, 2025?

The transfer of NANORAY-312 sponsorship, initiated in 3Q2024, was completed in the majority of regions by the announcement date.