Nanobiotix (NANO) Status Update summary

Strategic partnership and license agreement amendment

• Amended global license agreement with Johnson & Johnson reduces deal value from $2.7B (€2.7B) to $2.6B (€2.6B), with J&J assuming nearly all costs for the pivotal NANORAY-312 phase 3 trial, significantly reducing Nanobiotix's cash burn and extending cash runway to mid-2026.

• Milestones worth €105M were exchanged for J&J's direct funding of the trial, with Nanobiotix remaining eligible for $1.77B in milestones for lead programs, $650M for additional indications, and $220M per new indication developed with J&J.

• Tiered royalties from the low teens to low twenties remain unchanged, with additional milestone payments for new indications developed by either party.

• The amendment removes significant liabilities and aligns financial impact with operational responsibilities, supporting a sustainable financing outlook if key milestones and regulatory approvals are achieved.

• Janssen has consolidated global rights, including Greater China, and will duplicate manufacturing capabilities.

Financial outlook and capital allocation

• Cash runway is extended to mid-2026, with no milestones included in current guidance; achieving interim analysis milestones could extend runway into 2027.

• Focus remains on non-dilutive financing options, such as royalty deals, debt, grants, or additional partnerships, to avoid expensive equity financing.

• Cash burn is expected to be in the double-digit millions for 2024 and 2025, with significant reduction post-2026 as phase 3 trial costs are removed.

• The Phase 3 study previously represented a significant portion of operating costs, now largely assumed by Johnson & Johnson.

Clinical development and pipeline progress

• Lead programs include phase 3 in head and neck cancer and phase 2 in non-small cell lung cancer, targeting a combined addressable population of 100,000 in North America and EU5, with a potential $10B market.

• NBTXR3 is a novel oncology product activated by radiotherapy, with proof-of-concept in soft tissue sarcomas and a CE mark in Europe.

• NBTXR3 received FDA Fast Track designation for locally advanced HNSCC in patients not eligible for platinum-based chemotherapy.

• Multiple value inflection points and clinical readouts are expected in 2025, including updates from the 1100 trial, phase 1 lung cancer studies, pancreatic cancer, melanoma, and esophageal cancer.

• Nanobiotix maintains a broad pipeline leveraging nanophysics, with ongoing efforts to expand indications and maximize product value in collaboration with J&J.