Nanobiotix (NASDAQ:NBTX) executives said the company made “a very rich” set of operational and financial moves in 2025, highlighting progress in its Johnson & Johnson collaboration around NBTXR3/JNJ-1900, a continued pivot toward its Curadigm nanoprimer platform, and an extended cash runway into early 2028.
Johnson & Johnson collaboration: head and neck Phase III and lung cancer Phase II
Co-founder and CEO Laurent Levy said the company’s strategy remains centered on advancing its radioenhancer NBTXR3—licensed to Johnson & Johnson—while building new platforms. Levy framed the opportunity around earlier-stage disease, noting that “more than 70% of patients” are diagnosed with local disease and that “more than 60% of all cancer patients are getting radiation.” He said the product fits “this existing market with almost no competition,” and described a broad development program across multiple tumor types.
On clinical execution, Levy said Johnson & Johnson now has full operational and financial responsibility for the ongoing Phase III head and neck trial (NANORAY-312), which Nanobiotix transferred last year. He said the study is progressing well and reiterated expectations for “the first readout of this trial the first half of next year,” later characterizing Phase III results as expected in the first half of 2027. He also noted Johnson & Johnson has initiated a Phase Ib trial in another head and neck population receiving radiation plus cisplatin.
Levy also discussed the CONVERGE study, a randomized Phase II trial in unresectable stage III non-small cell lung cancer. He said the trial includes a completed safety lead-in followed by a randomized portion comparing standard chemoradiation plus durvalumab versus the same regimen plus JNJ-1900 at two dose levels in a 1:1:1 design, targeting 120 patients. Levy said Johnson & Johnson has indicated the randomized readout is expected in early 2027.
CONVERGE safety lead-in: early response signals and questions on durability
Management highlighted data presented from the CONVERGE safety lead-in (seven patients). Levy said the dataset showed a “good safety profile with no serious adverse events linked to the treatment or the procedure,” and that injection was feasible in every patient. He added that five of seven patients responded and that the cohort showed 100% disease control, meaning all patients went on to durvalumab—contrasting that with what he described as exclusions seen in the PACIFIC trial following chemoradiation.
In response to analyst questions about benchmarking response rates, Levy pointed to nuances in how PACIFIC response rates are presented, including the impact of patients who did not proceed to durvalumab. He said Nanobiotix used “40%-50%” as context based on radiation plus chemotherapy in other papers and PACIFIC regimen optimization, while emphasizing that the key question is how responses evolve over time and whether improved local control alters outcomes.
Levy said the randomized part of CONVERGE has been enrolling since last year and confirmed the safety lead-in is completed. When asked whether Phase II data could support a regulatory filing or a Phase III “go” decision, Levy repeatedly emphasized that decisions and disclosure timing sit with Johnson & Johnson. “If the data are excellent, everything is open,” he said, while noting it was too early to speculate on filing strategy.
MD Anderson investigator-sponsored studies and upcoming data
Levy said Nanobiotix continues to complete follow-up for Study 1100, which has finished recruitment, and that the MD Anderson Cancer Center collaboration remains active. Several MD Anderson trials have completed recruitment, and Levy said the company expects to see data in 2026, while also exploring potential new trials with MD Anderson.
Levy singled out an MD Anderson lung re-irradiation study as one to watch, calling it “very important” and potentially a “surrogate” for what could be observed in CONVERGE, despite being a different patient population. He said the company has filed multiple abstracts and that if the first is accepted, timing “should be around December.”
On questions about immune-mediated “abscopal” effects, Levy said the company has observed distant effects in non-irradiated, non-injected lesions in melanoma, head and neck, and some lung patients in metastatic settings. However, he emphasized that for the “vast majority” receiving radiation—those with local or locoregional disease—“local control is much more important than any potential immune response.”
Curadigm platform: patents, manufacturing start, and MTAs
Levy said the company is “pivoting” toward new platforms, led by Curadigm, which he described as a nanoprimer approach designed to transiently occupy the liver before administering a second therapy, potentially reducing liver capture, improving pharmacokinetics, and/or reducing liver toxicity. He argued that increasingly complex therapeutics can be “captured” by the liver after IV administration, limiting systemic delivery, and said Curadigm is intended to address that challenge using a two-object strategy.
Operationally, Levy said Nanobiotix filed four new patent applications, presented positive in vivo preclinical combinations, initiated CMC activities, started GMP manufacturing, and began preclinical studies aimed at an IND filing. He also said the company has signed “more than 20” material transfer agreements (MTAs) with pharma and biotech companies spanning oncology, rare disease, and CNS disorders, with partners testing Curadigm alongside their own assets. Levy said the company expects to begin converting some MTAs into deals “in a not-too-distant future,” and expects more Curadigm data before the end of the summer.
Asked about whether an IND might come from Nanobiotix’s internal program or from partners first, Levy said the company is “pushing both,” with internal development intended to establish initial safety and feasibility in humans and broaden combination opportunities.
Financial results: revenue swing, lower R&D, and runway into early 2028
Chief Financial and Business Officer Bart Van Rhijn said 2025 initiatives “materially strengthened the company’s financial foundation.” He highlighted an amended global licensing agreement with Janssen that removed “the vast majority” of Nanobiotix’s funding obligations for the Phase III NANORAY-312 study while preserving potential milestone upside that “could total hundreds of millions EUR over the next 24-36 months.”
Van Rhijn also detailed a non-dilutive royalty financing with Healthcare Royalty Partners for up to $71 million, which he said extends projected cash runway into early 2028, excluding potential milestone inflows. He described the construct as capped “from a time and amount perspective” and said it aligns incentives with the success of JNJ-1900.
For full-year 2025, the company reported:
- Revenue: EUR 32.6 million, compared with negative EUR 7.2 million in 2024. Van Rhijn attributed the 2025 figure primarily to a “one-time accounting impact” of EUR 21.8 million tied to the March 2025 licensing amendment, and said the 2024 negative revenue reflected a one-time net liability recognition following transfer of NANORAY-312 sponsorship.
- R&D expenses: EUR 23.1 million, down from EUR 40.5 million in 2024, driven largely by the removal of NANORAY-312 costs after transfer to Janssen.
- SG&A expenses: EUR 20.4 million, compared with EUR 20.5 million in 2024.
- Net loss attributable to shareholders: EUR 24.0 million (EUR 0.50 per share), versus EUR 68.1 million (EUR 1.44 per share) in 2024, reflecting the non-cash revenue recognition and reduced R&D expense.
- Cash and cash equivalents: EUR 52.8 million as of Dec. 31, 2025, compared with EUR 49.7 million a year earlier.
Van Rhijn said the Dec. 31, 2025 cash balance is expected to fund operations into early 2028, assuming receipt of the remaining $21 million from Healthcare Royalty Partners in Q4 2026. When asked about steady-state cash burn, he said the company does not provide year-by-year guidance, but added that following the Janssen transfer, investors should expect development costs to shift toward the newer platforms.
Levy closed by pointing to multiple upcoming clinical data readouts over the next 12 to 18 months, continued Curadigm progress, and the anticipated Phase III head and neck and Phase II lung cancer readouts in 2027 as key potential value inflection points.
About Nanobiotix (NASDAQ:NBTX)
Nanobiotix is a clinical-stage biotechnology company headquartered in Paris, France, specializing in the development of novel nanopharmaceuticals to improve cancer treatment. The company’s lead product, NBTXR3, is a first-in-class radioenhancer composed of hafnium oxide nanoparticles designed to amplify the effect of radiotherapy on tumor cells while sparing surrounding healthy tissue. Nanobiotix has established clinical programs across multiple cancer indications, including soft tissue sarcoma, head and neck cancer, and hepatocellular carcinoma.
Since its inception, Nanobiotix has advanced NBTXR3 through pivotal trials and secured CE Mark approval in Europe for the treatment of soft tissue sarcoma.
