Nanobiotix S.A. Q3 FY2023 earnings call

Laurent Levy started by highlighting a productive quarter, including a $2.5 billion collaboration with Johnson & Johnson, updates on Head and Neck Phase 1 trial and ESMO/ASTRO data, and MD Anderson's pancreatic cancer trial data showing feasibility, safety, and early efficacy. Bart Van Rhijn discussed the company's strengthened financial position with €37.8 million in cash (before recent financing), removal of EIB cash covenants, and a cash runway extending into Q2 2025. NBTXR3 is a first-in-class radioenhancer combining with radiation therapy, with a pipeline including multiple indications. The Phase 3 global trial in head and neck is ongoing, with an interim analysis expected by mid-2025. MD Anderson's pancreatic trial showed 23 months median overall survival with a good safety profile and potential efficacy signal, while head and neck data showed high response rates and strong PFS/OS correlations.

Ongoing Phase 3 global trial in head and neck cancer expects interim analysis by mid-2025. Cash runway extended into Q2 2025 due to recent financing and removal of EIB covenants. Expect to report NANORAY-312 study interim efficacy results around this timeframe. Need to discuss next steps for pancreatic cancer indication with Johnson & Johnson, MD Anderson, and LianBio, including continuing trials and expanding NBTXR3 development.

Forward-looking statements subject to significant risks and uncertainties. Regulatory and development milestones for new indications carry risks. Dependence on collaborations and partners for development and commercialization. Uncertainty around timing and success of clinical trials, including potential delays in data readouts.

Q: On the pancreatic cancer indication, what is the appetite for J&J to take it forward and how soon could studies start?

A: MD Anderson's data on pancreatic cancer is encouraging. Need to complete the trial, then discuss next steps with J&J, MD Anderson, and LianBio. Focus is currently on head and neck and lung programs, with subsequent discussion on pancreatic cancer.

Q: What is the cadence of data expected from MD Anderson on other indications?

A: Expect RP2D in lung cancer soon, and additional data on pancreatic, esophageal, and lung cancer in 2024-2025.

Q: Regarding NANORAY-312 statistical assumptions and cash runway?

A: Hypothesis for NANORAY-312 is based on literature; a better population in Phase 3 may yield better results. Cash runway extended to mid-2025 including a de-risk milestone from the collaboration.

Q: Comparability of baseline characteristics in pancreatic trial and amplitude of CA19 reduction?

A: Historical control in pancreatic trial, 42% of patients normalized CA19 vs 17% previously seen, with 23 months median overall survival showing potential efficacy.

Q: EIB update and RP2D delay in lung cancer?

A: EIB loan restructured, RP2D in lung cancer delayed slightly but enrollment is good; just a timing issue.