Nanobiotix SA
Nanobiotix SA Q3 FY2022 earnings call
November 11, 2022 · fiscal period ended 2022-09
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2022-11-11
Management highlights
• Laurent discussed the global Phase 3 trial in head and neck cancer, including the 1,100 trial details, safety and efficacy of NBTXR3 in combination with radiation and immune checkpoint inhibitors. • Highlighted that the product is well-tolerated, feasible in combination with immune checkpoint inhibitors, and shows efficacy signals with objective responses in a significant portion of patients. • Bart mentioned cash and cash equivalents were €53.5 million as of September 30, 2022, and the execution of a debt restructuring with the European Investment Bank to extend the operating runway. • Formation of the Scientific Advisory Board to help develop the product and spread its use across cancer indications.
Segment performance
No specific product segment financial performance with revenue contribution % discussed as the transcript focuses on clinical trials and overall company updates.
Guidance
• Intend to submit the protocol of the trial for head and neck patients refractory to PD-1 to the FDA in Q1 2023. • Phase 3 futility analysis expected in H2 2023 and interim PFS analysis in H2 2024. • Expect to reach the recommended Phase 2 dose (RP2D) in the pancreatic cancer Phase 1 trial and see first results in esophageal cancer Phase 1 next year, followed by first results in non-small cell lung cancer Phase 1 later.
Risks
• Forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ from expectations, as detailed in filings with the AMF in France and SEC in the United States.
Q&A highlights
Q: Given the study 1100 results where ORR decreased from 50% at ASTRO last year to 31% this year, are you more or less confident in the ability to have the study prove valuable in attracting additional capital and pulling through NANORAY-312 in 2024?
A: Laurent stated the data from the Phase 1 is the first step in immuno-oncology development, and the signal seen is strong, working on defining the right population for the Phase 3 trial. Bart mentioned the company has extended runway through debt restructuring and remains opportunistic in BD efforts and financings.
Q: About categorization of core and control arm for head and neck cancer patients resistant to Anti-PD-1, how will you deal with the FDA?
A: Laurent said control arm options are under discussion, and the company will get final feedback from the FDA when submitting the protocol in Q1 2023, as control arm for patients failing PD-1 needs to be different from continuing PD-1 treatment.
Key numbers
Reported versus consensus
Earnings calendar feed
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Transcript
November 11, 2022Full transcript unavailable for redistribution
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