Financial Data and Key Metrics Changes - The company reported an unaudited cash balance of €58.9 million for Q1 2024, reaffirming a cash runway into Q3 2025, which includes a $20 million milestone received [18][21][64]. Business Line Data and Key Metrics Changes - The NBTXR3 program is the primary focus, with ongoing pivotal Phase 3 trials for head and neck cancer and a Phase 2 study for non-small cell lung cancer, both of which are expected to yield significant data in the near future [49][55]. - The company is also exploring new indications for NBTXR3 beyond head and neck and lung cancer, indicating a robust pipeline [14][30]. Market Data and Key Metrics Changes - The collaboration with Janssen Pharmaceutica is expected to expand the market potential of NBTXR3, with a deal valued at over $2.5 billion plus royalties [21][22]. - The company aims to leverage its nanoparticle technology to treat a wide range of cancers, potentially impacting millions of patients globally [6][21]. Company Strategy and Development Direction - The company is focused on executing its partnership with Janssen to maximize the value of NBTXR3 and is also exploring next-generation nanoparticle therapies [9][30]. - The strategic shift includes transferring the sponsorship of the NANORAY-312 trial to Janssen to optimize the path to market and enhance the product's value [50][63]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing collaboration with Janssen and the potential for NBTXR3 to significantly improve patient outcomes [7][22]. - The company is optimistic about the upcoming data readouts and the potential for new indications, which could further validate its technology and expand its market reach [55][92]. Other Important Information - The company has made significant operational progress, including the activation of joint working teams with Janssen and the replication of manufacturing processes to increase product availability [26][53]. - The expected interim analysis for the NANORAY-312 trial is now anticipated to be reported after the last patient is recruited in H1 2026 [12][44]. Q&A Session Summary Question: Strategies to extend the company's cash runway - Management discussed shifting focus from rapid interim readouts to expanding indications, which could lead to a more secure path forward [37][38]. - CFO noted that there are multiple options available to extend the cash runway and expressed confidence in navigating financing needs [40]. Question: Timing for the transfer of sponsorship and its impact on cash runway - Management confirmed that the transfer of sponsorship is expected to be completed before the interim readout, which could help extend the cash runway [42][86]. - The transfer is intended to be neutral initially but may become positive in the future as it allows for more focused resource allocation [87]. Question: Updates on Phase 2 in lung cancer and new platforms - Management indicated that the Phase 2 trial for lung cancer is progressing, with FDA approval received for the protocol design [92]. - Updates on the Curadigm and Oocuity platforms are expected in H2 2024, focusing on building a sustainable business model around these technologies [93][94].
Nanobiotix(NBTX) - 2024 Q1 - Earnings Call Transcript