Nanobiotix S.A. Q4 FY2023 earnings call

Partnerships

• Entered into a $2.5 billion license agreement with Johnson Pharmaceutical (a Johnson & Johnson company) for NBTXR3, a potential first-in-class radioenhancer. LianBio assigned rights in China and other Asian markets to Janssen, consolidating global development and commercialization rights with Janssen, bringing potential milestones of up to $205 million.

Clinical Progress

• Positive final safety and efficacy data from Study 102, a Phase 1 trial in head and neck cancer, with a 64% complete response rate and 82% overall response rate. Initial data from a Phase 1b study in pancreatic cancer with MD Anderson showed promising durable antitumor efficacy.
• Collaboration with Janssen focuses on head and neck and lung cancer initially, with expansion potential to other solid tumor indications. Ongoing clinical trials with MD Anderson in various solid tumors, including lung, liver metastasis, head and neck, non-small cell lung, esophageal, and pancreatic cancer.

Financials

• Secured $140 million in funding in June 2023, strengthening the balance sheet and extending the cash runway to Q3 2025. The license agreement with J&J has a total potential value of $2.5 billion, including milestones and royalties.

Leadership

• Welcomed Dr. Louis Kayitalire as Chief Medical Officer, bringing industry experience in oncology development and commercialization.

Nanobiotix reported total revenue of EUR36.2 million for 2023, a significant increase from EUR4.8 million in 2022, primarily driven by revenue from the Janssen agreement. Research and development (R&D) expenses were EUR38.4 million, up from EUR32.6 million in 2022, and selling, general, and administrative (SG&A) expenses were EUR22 million, up from EUR17.8 million in 2022. As of December 31, 2023, the company had EUR75.3 million in cash and cash equivalents, providing a cash runway extending into the third quarter of 2025.

Clinical Readouts

• Expect multiple clinical readouts in 2024, including immunotherapy combination data from Study 1100 and new data from the collaboration with MD Anderson.

Cash Runway

• Current cash and cash equivalents, combined with milestones, provide a cash runway extending into the third quarter of 2025, supporting near-term milestones and development efforts.

Uncertainties

• Clinical trial outcomes are subject to variability, with no guarantee of positive results. Regulatory approvals for NBTXR3 are uncertain and could delay commercialization. Dependence on successful achievement of milestones and the timing of payments from partnerships like Janssen could impact the company's financial trajectory.

Q: Provide context for what to expect regarding vision numbers, duration of follow-up, and potential readouts in the upcoming ASCO update for Study 1100?

A: Study 1100 is evaluating safety and efficacy of NBTXR3 with checkpoint inhibitor in head and neck cancer. Expect data on response rates, survival, and efficacy in patients naive to or refractory to PD-1 therapy. Baseline compared to trials like CheckMate 141 or KEYNOTE 040.

Q: Details on lung cancer trial start, Janssen relationship, NANORAY-312 recruitment?

A: Working closely with Janssen on development priorities, including head and neck and lung cancer. In-kind contributions from Janssen for NANORAY-312 do not affect cash runway. Interim analysis of NANORAY-312 expected in mid-2025 with cash runway supporting progress. Recruitment for NANORAY-312 is ongoing.

Q: Impact of multiple looks on NANORAY-312 statistical calculation, Janssen's appetite for other indications?

A: Trial design accounts for multiple looks, with statistical considerations built in. Janssen's appetite for other indications is part of ongoing discussions, with potential to explore beyond initial focuses like head and neck cancer.

Q: Color on other platforms, Sanofi collaboration, J&J discussions?

A: Two other platforms (CNS disorder and Nanoprimer) in development. Sanofi collaboration on gene therapy ongoing. No current discussions with J&J on other platforms, focusing on NBTXR3 development.

Q: Next steps for lung cancer, esophageal cancer trials?

A: Lung cancer trial recruitment moving well, with potential updates soon. Esophageal cancer trial is being reshaped with MD Anderson, with updates expected in coming quarters as recruitment and data collection progress