Nanobiotix SA Q4 FY2022 earnings call

• Initiated NANORAY-312 global Phase 3 trial for locally advanced head and neck cancer ineligible for platinum-based chemo, with over 104 sites activated in 25 countries by year-end.
• Completed enrollment in Study 102 (head and neck) expansion phase, planning to present top-line safety/efficacy data in second half of 2023.
• Progressed IO combination program (Study 1100), completing dose escalation phase, with encouraging data from SITC Conference 2022.
• Collaborated with MD Anderson on various trials, including pancreatic cancer (recommended Phase 2 dose determined), lung cancer (expected recommended Phase 2 dose in second half of 2023), and esophageal cancer (progressing toward recommended Phase 2 dose).
• Implemented cost control measures, reduced SG&A expenses, restructured debt with EIB, and secured equity line for future capital access.

Nanobiotix did not report traditional product segment revenue. The focus was on the NBTXR3 program. Key activities included initiation of NANORAY-312 global Phase 3 trial in head and neck cancer, enrollment in Study 102 (head and neck), progress in IO combination program (Study 1100), and collaboration with MD Anderson on various cancer trials. Financials showed R&D expense increased ~EUR2M, SG&A expense decreased EUR1.6M, total income increased to EUR4.8M, net loss was EUR57M, and cash and cash equivalents were EUR41.4M as of Dec 31, 2022.

• Interim efficacy and safety analysis for NANORAY-312 pivotal trial expected in second half of 2024 after 67% of planned events; futility analysis after 25% of planned events anticipated in first half of 2024.
• Cash and cash equivalents will fund operations into third quarter of 2023, shorter than previous guidance to first quarter of 2024.
• Anticipated addition of new Chief Medical Officer and head of regulatory in 2023 to strengthen clinical development program.

• Geopolitical unrest and ongoing pandemic impacting clinical trial enrollment and site activation.
• Complex and changing regulatory framework affecting trial rollout.
• Cash runway constraints, with projected cash balances expected to decline below required levels, raising concerns about debt covenant compliance.
• Uncertainty around the timing and success of clinical trial readouts and regulatory approvals.

Q: Could you give more color on the protocol amendment for NANORAY-312 to increase enrollment rates and impact on timeline?

A: Minor protocol amendments to ease patient eligibility, including better definition of cisplatin eligibility, T&M definition, and using background record data to facilitate recruitment; expect recruitment to accelerate with more sites recruiting and protocol amendments taking effect in next two months.

Q: Elaborate on regulatory challenges for NANORAY-312 and strategy for partnerships?

A: Regulatory challenges in Europe due to medical device status reshaping, COVID lockdowns in Asia, and COVID tail in US; strategy to explore collaborations/industrial partnerships as key option to move forward and create value for shareholders.

Q: Any clinical data presentations at ASCO and plans for pancreatic cancer trial?

A: Expect data presentations at ASCO and other conferences for second half of year, including final data from Study 102 and updates on other programs; MD Anderson's pancreatic cancer trial expansion expected to conclude by end of year, with data to inform next steps for the indication.

Q: Relationship with EIB and STS program?

A: EIB extended waiver on cash balance requirement, but condition is finding a partner; strategy is to start with head and neck cancer indication using CE mark from STS, rather than commercializing STS first, to maximize value for shareholders.