Nanobiotix (NANO) Stifel 2024 Healthcare Conference summary

Strategic partnerships and development focus

• Lead asset R3 is a nanophysics-based, tumor-agnostic oncology product in phase III for head and neck cancer, with broad applicability across multiple tumor types and a unique universal mode of action.

• R3 is being co-developed with J&J, which has committed to a $2.5 billion deal, including royalties and milestone payments, and is duplicating manufacturing capabilities for commercialization.

• Clinical development is also pursued with MD Anderson for challenging indications, with ongoing studies in lung, pancreatic, and esophageal cancers.

• The phase III interim analysis for R3 was delayed to H1 2026 due to a dual trigger design, aligning with J&J's regulatory standards and potentially accelerating commercialization.

• Current cash runway extends into Q4 2025, slightly short of the interim analysis readout, with confidence in addressing the gap through partnership dynamics.

Clinical data and pipeline progress

• Phase I data for R3 in elderly, frail head and neck cancer patients showed a median PFS of 16.9 months, OS of 23.1 months, and high response rates, supporting advancement to phase III.

• Phase III allows lymph node injection and includes less frail patients, with high statistical power and management confidence in meeting endpoints.

• R3 demonstrated strong local and systemic control, including immune response activation, in both anti-PD-1 naive and resistant head and neck cancer patients.

• Additional data from a third cohort with liver-lung metastasis is expected at a medical congress next year.

• Studies with MD Anderson have shown promising results in PDAC, with a median OS of 23 months, and further updates are expected before year-end.

Platform expansion and future outlook

• Beyond oncology, the Curadigm platform aims to improve bioavailability by occupying the liver, enhancing therapeutic agent efficacy; it is currently in preclinical development.

• A CNS program is in discovery, targeting neuronal conduction for diseases like Alzheimer's and Parkinson's, with plans to advance toward preclinical stages.

• The company remains 85% focused on R3 but expects to bring Curadigm to the clinic within a few years.

• R3 pricing is expected to align with typical oncology drugs, reflecting its impact on survival and quality of life.

• Long-term safety profile of R3 remains favorable, with no significant concerns observed to date.