Nanobiotix(NBTX)
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Nanobiotix(NBTX) - 2021 Q4 - Earnings Call Transcript
2022-03-31 14:50
Financial 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]
Nanobiotix(NBTX) - 2020 Q4 - Annual Report
2021-04-07 21:32
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ________________________ FORM 20-F ________________________ (Mark One) o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December, 31 2020 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the transition period from __________ to _ ...