Nanobiotix(US:NBTX)2022-03-31 14:50Financial Data and Key Metrics Changes - Total revenue for 2021 was approximately €10,000, a decrease from €50,000 in 2020 [17] - Other income increased from €1.9 million in 2020 to €2.5 million in 2021 due to higher research and development expenses [18] - Research and development expenses rose to €30.4 million in 2021 from €24.3 million in 2020, reflecting increased clinical trial costs [19] - Selling, general and administrative expenses increased to €19.4 million in 2021 from €14.6 million in the prior year, with a significant decrease in SG&A during the second half of 2021 [20] - Net loss for 2021 was €47 million, compared to a net loss of €33.6 million in 2020 [21] - Cash, cash equivalents, and investments totaled €83.9 million at the end of 2021, down from €119 million at the end of 2020 [22] Business Line Data and Key Metrics Changes - The company is focusing on two lead programs: NBTXR3 as a single agent activated by radiation in head and neck cancer, and a follow-on checkpoint inhibitor combination program [9] - A new strategic partnership with LianBio was established to advance NBTXR3 development in Asia, with LianBio expected to enroll 20% of the 500 patients in the pivotal study [12][13] Market Data and Key Metrics Changes - The company anticipates patient enrollment in the pivotal study to begin in the second half of 2022, with ongoing collaborations expected to enhance development capabilities [13][34] Company Strategy and Development Direction - The company aims to optimize capital allocation and enhance operational efficiency while focusing on the development of NBTXR3 [11][23] - The strategic priority is to advance the Phase III trial in head and neck cancer and explore registration pathways for the immune checkpoint inhibitor combination [50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of NBTXR3 to provide survival benefits in patients intolerant to standard chemotherapy [26] - The company is actively working with the FDA to define a registration path for NBTXR3 in combination with immune checkpoint inhibitors, with encouraging preliminary feedback [44][60] Other Important Information - The company has strengthened its leadership team with key appointments to drive execution and foster a culture of innovation [15][16] - Ongoing collaborations with MD Anderson have generated significant preclinical data supporting the combination potential of NBTXR3 with immune checkpoint inhibitors [14] Q&A Session Summary Question: What is the status of the 312 study? - The 312 study is progressing well, with sites initiated in Europe and patient injections beginning in January [48] Question: What is the status of non-priority pathways, including liver and prostate studies? - The priority remains on the Phase III trial in head and neck cancer, with other trials opening new growth opportunities [50] Question: What is the company's cash position and financing prospects? - The company is evaluating options for sufficient capital and has initiated cost optimization programs [55][56] Question: What are the key upcoming data releases? - Key data releases include updates from the rectal cancer and head and neck chemotherapy studies expected in Q2 [58] Question: What is the expected timeline for discussions with the FDA regarding immunotherapy? - Discussions with the FDA are ongoing, focusing on clarifying endpoints and population for market entry [65] Question: What is the status of the Curadigm and CNS platforms? - Development of Curadigm is ongoing in collaboration with Sanofi, while CNS platform development is progressing at a preclinical stage [68]