Nanobiotix(US:NBTX)2022-09-29 18:08Financial Data and Key Metrics Changes - The operating costs for the first half of 2022 decreased from €31.1 million in 2021 to €27.2 million in 2022, reflecting a reduction in SG&A expenses and an increase in R&D expenses due to the initiation of a global Phase 3 study [28] - The net loss attributable to common shareholders for the first half of 2022 was €26.4 million, or €1.76 per share, compared to a net loss of €30.4 million for the same period in 2021 [29] Business Line Data and Key Metrics Changes - Significant progress was made in the clinical program, particularly with the initiation of patient enrollment in NANORAY-312, which is now actively recruiting patients across Europe, the U.S., and Asia [10][12] - Enrollment was completed in Study 102, which provided valuable information regarding the activity of NBTXR3 in head and neck cancer, leading to a decision to pursue registration in this area [14] Market Data and Key Metrics Changes - Approximately 50 clinical sites have been activated across 13 countries for NANORAY-312, with recruitment ongoing in key territories [9][10] - The company is facing challenges due to the COVID-19 pandemic, including staffing shortages in the U.S. and a recent surge in cases in China, but has adapted its strategies accordingly [12] Company Strategy and Development Direction - The company is focused on advancing the development of NBTXR3, particularly for patients with local events and treatment-resistant recurrent and metastatic cancer [7][8] - Plans include leveraging existing data to support the development of a Phase 3 protocol submission to the FDA by Q1 2023 [20][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate challenges and emphasized the importance of the NANORAY-312 study as a key operational priority [31] - The company anticipates that it will take approximately four to six months of global recruitment to provide data-driven validation of study timelines [13] Other Important Information - The company has implemented cost control initiatives aimed at achieving a double-digit reduction in SG&A expenses and has restructured existing debt obligations to align repayment schedules with anticipated commercial timelines [22][23] - As of June 30, 2022, the company reported €63 million in cash and cash equivalents, expected to support clinical development programs into Q1 2024 [26] Q&A Session Summary Question: Efforts to extend cash runway - Management acknowledged the progress made in extending the cash runway potentially into 2024 and discussed ongoing internal and external initiatives to drive efficiency [34][35] Question: Data readouts for Study 1100 - Management confirmed that results from the dose escalation part of Study 1100 will be presented at the SITC conference, with 28 patients injected and evaluable for safety [37] Question: Pathway for developing further indications - The company is currently focused on the head and neck franchise but sees potential for further development in collaboration with MD Anderson [40][41] Question: Timelines for NBTXR3 market entry - Management indicated that if interim readouts are positive, there may be a pathway for accelerated approval, with potential market entry around 2025 [46] Question: Study 1100 data benchmarks - Management provided benchmarks based on previous studies, indicating expected response rates for naive and refractory patients [52][54] Question: Registration pathway for immunotherapy combination trial - The company plans to submit a protocol to the FDA in Q1 2023, focusing on PD-1 resistant patient populations [58][61] Question: Collaboration with MD Anderson for pancreatic cancer - Management expects to receive data from the Phase 1 part of the pancreatic cancer trial by the end of the year, which will inform the next steps [64]