Nanobiotix S.A. Q4 FY2024 earnings call

• Collaboration with JNJ: Progressing with NBTXR3 collaboration, including NANORAY-312 Phase 3 study in head and neck cancer and lung Stage III trial started by JNJ.
• Pipeline progress: NANORAY-312 Phase 3 global study with 500 patients, early-stage studies in solid tumors like head and neck, pancreatic, and lung cancer.
• Curadigm platform: New nanotherapeutic platform launched, with potential for multiple partnerships in various therapeutic areas.
• Financial updates: Amended license agreement with JNJ removed majority of Nanobiotix's funding obligation for NANORAY-312, extended cash runway to mid-2026, and explored nondilutive financing to extend cash visibility into 2027.

In 2024, Nanobiotix reported negative revenue of €7.2 million, compared to €36.2 million in 2023. The negative revenue in 2024 was due to the transfer of the NANORAY-312 study sponsorship to Janssen, resulting in a negative €19.3 million revenue impact. R&D expenses totaled €40.5 million in 2024, a 5% increase from €38.4 million in 2023, driven by increased clinical development activities. Selling, general, and administrative expenses were €20.5 million in 2024, a 7% decrease from 2023. Cash runway was extended to mid-2026 based on the amended license agreement with JNJ.

• Expect milestone in 2025: End of recruitment in ongoing Phase 3 in head and neck, with potential registration if data are positive.
• 2024 data readouts: Head and neck refractory PD-1 cohorts data by end of 2025, full pancreatic cancer Phase 1 data, 1100 trial data, and esophageal Phase 1 data by end of 2024.
• Cash runway extended to mid-2026, with exploration of nondilutive financing to extend cash visibility into 2027.

• Manufacturing risks until first randomized data are available.
• Need for JNJ to successfully market and mass-produce the product to ensure commercial success.
• General biotech risks related to regulatory approvals and achieving key milestones despite progress.

Q: Regarding the NANORAY-312 trial, percentage of patients enrolled with and without cetuximab and mechanistic benefit of R3 with PD-1 for metastatic patients?

A: Cetuximab use is stratified, with balanced numbers in both arms. Mechanistically, NBTXR3 provides local control and triggers deeper systemic immune response, contributing to both local and systemic benefit for metastatic patients.

Q: Gating event for Curadigm asset clinical program initiation?

A: Timing is key, with ongoing interaction with biotech and pharma for partnerships, and internal pipeline development progressing.