Nanobiotix S.A. SEC Filings

Nanobiotix S.A. provides clinical and pipeline updates for its radioenhancer JNJ-1900 (NBTXR3) and Curadigm Nanoprimer platform in connection with an underwritten offering. The Phase 2 CONVERGE trial in unresectable stage 3 NSCLC reported early Part 1 data in seven patients, with an 85.7% objective response rate, 57.1% complete response rate and 100% disease control after chemoradiotherapy, JNJ-1900 and durvalumab, though the company cautions these preliminary results from a small cohort should not be seen as predictive.

The pivotal Phase 3 NANORAY-312 head and neck cancer trial, sponsored by Johnson & Johnson, was amended to remove an interim analysis and bring forward the final analysis at 335 events, with maintained endpoints and improved statistical power for progression-free survival at 92% and overall survival at 80%. Nanobiotix notes it may receive up to approximately $200 million in development and regulatory milestones from J&J over the next few years if head and neck and lung programs meet specified goals.

The company also highlights Curadigm Nanoprimer preclinical data showing that pretreatment in a mouse model increased systemic exposure and reduced liver clearance of lipid nanoparticle DNA immunotherapies, while decreasing hepatic toxicity and inflammatory responses. These findings, along with multiple ongoing collaborations and new patent filings, support further exploration of Curadigm with advanced intravenously delivered therapeutics.

Nanobiotix S.A. is conducting a global offering of securities targeting €75,000,000 in ordinary shares and pre-funded warrants, delivered in the U.S. as ADSs and outside the U.S. as ordinary shares and pre-funded warrants.

The supplement describes ADSs listed as NBTX on Nasdaq and ordinary shares listed as NANO on Euronext Paris, pre-funded warrants exercisable for one ordinary share at an exercise price of €0.03, transfer and exercisability limits tied to a Beneficial Ownership Limitation, and an underwriter option to purchase additional shares. The company reported €52.8M cash and cash equivalents and a net tangible book deficit of €(84.5M) as of December 31, 2025. Use of proceeds is stated as accelerating development of JNJ-1900 (NBTXR3), advancing the Curadigm Nanoprimer platform, and general corporate purposes.

Nanobiotix S.A. reported early Part 1 results from the Johnson & Johnson-sponsored CONVERGE randomized Phase 2 trial of nanoradioenhancer JNJ-1900 (NBTXR3) in stage 3 inoperable non-small cell lung cancer. In seven patients completing concurrent chemoradiotherapy, JNJ-1900, and durvalumab, the overall response rate was 85.7% (6/7) and the complete response rate was 57.1% (4/7), compared with historically very low complete response rates under current standard of care. Disease control rate reached 100% (7/7), with no progressive disease and responses deepening over time, suggesting potential for durable benefit. JNJ-1900 is a one-time intratumoral hafnium oxide nanoparticle injection activated by radiotherapy, being developed across multiple solid tumors, including a global Phase 3 head and neck cancer trial and supported by a global co-development and commercialization agreement with Johnson & Johnson.

Nanobiotix S.A. reports that the FDA has accepted a protocol amendment for the pivotal NANORAY-312 global Phase 3 study in head and neck cancer, sponsored by Johnson & Johnson. The amendment removes the planned interim analysis and changes the final analysis to be based on fewer events and to occur earlier than originally designed. Nanobiotix believes this could accelerate and broaden the global registration path for its radiotherapy-activated nanoparticle candidate JNJ-1900 (NBTXR3), potentially allowing earlier revenue generation from its licensing deal. The company notes it is eligible for hundreds of millions in aggregate milestone payments over the next few years, contingent on development and regulatory achievements in head and neck and lung cancer programs.

Nanobiotix S.A. reported new preclinical results from its Nanoprimer platform combined with lipid nanoparticle-delivered recombinant DNA (LNP-DNA) immunotherapy in a mouse model. Pre-treatment with Nanoprimer before intravenous LNP-DNA reduced liver uptake and toxicity, increased circulating LNP-DNA, and lessened cGAS-STING pathway inflammation.

The findings, presented at the 2026 American Association for Cancer Research meeting, suggest Nanoprimer may help advanced LNP systems designed for extrahepatic delivery achieve better systemic bioavailability and tolerability. The company is advancing Nanoprimer through external collaborations and an internal pipeline as a companion platform for complex therapeutics.

Nanobiotix S.A. reports its share capital and voting rights as of March 31, 2026. The company had 48,517,630 shares outstanding, corresponding to 50,165,132 theoretical voting rights and 50,143,014 exercisable voting rights. These figures are provided under French market transparency rules.

Nanobiotix S.A. reported full-year 2025 revenue and other income of €32.6 million, driven mainly by an amendment to its global licensing agreement for JNJ-1900 (NBTXR3) with Janssen and related product sales and services. Research and development expenses fell 43% to €23.1 million, reflecting the removal of most funding obligations for the NANORAY-312 study and lower development costs. Selling, general and administrative expenses were stable at €20.4 million. Net loss narrowed to €24.0 million, or €0.50 per share, compared with a net loss of €68.1 million, or €1.44 per share, in 2024.

The company closed a non-dilutive royalty financing agreement with HealthCare Royalty for up to $71 million, receiving $50 million in December 2025, and ended 2025 with €52.8 million in cash and cash equivalents. Based on its current plan and assuming receipt of the remaining $21 million from HealthCare Royalty, Nanobiotix expects this cash to fund operations into early 2028. Operationally, development of JNJ-1900 (NBTXR3) advanced across multiple tumor types, and the Curadigm Nanoprimer platform saw new patents, data, and CMC activities supporting both internal and external programs.

Nanobiotix S.A., a French oncology company listed on Euronext Paris and via ADSs on Nasdaq, files its Form 20-F for the year ended December 31, 2025. The company develops physics-based nanotechnology cancer treatments, led by JNJ-1900 (NBTXR3), now globally licensed to Janssen and in a Phase III trial called NANORAY-312.

Nanobiotix highlights extensive risk factors, including heavy reliance on Janssen for development and commercialization, complex manufacturing and technology transfer, clinical and regulatory uncertainty, and dependence on third-party CROs, CMOs and raw-material suppliers. As of December 31, 2025, it reports accumulated losses of €400.8 million, a 2025 net loss of €24.0 million and cash and cash equivalents of €52.8 million, meaning further funding will be needed. Ordinary shares outstanding were 48,410,068 as of December 31, 2025.

Nanobiotix S.A. furnished a press release highlighting first data from the Johnson & Johnson–sponsored randomized Phase 2 CONVERGE study of JNJ-1900 (NBTXR3) in stage 3 inoperable non-small cell lung cancer. Investigators reported an acceptable safety profile with no serious treatment-emergent adverse events and no impact on patients’ ability to continue planned therapy.

Among 7 patients evaluated after concurrent chemoradiotherapy and before anti-PD-L1 treatment, initial efficacy signals were encouraging, with an objective response rate of 71.4% and disease control rate of 100%, compared with an estimated 45–50% response benchmark. JNJ-1900 (NBTXR3) is a one-time intratumoral hafnium oxide nanoparticle radioenhancer activated by radiotherapy and is being developed across multiple solid tumors, including a global Phase 3 head and neck cancer trial and a global co-development agreement with Janssen.