Nanobiotix(NBTX) - 2025 Q2 - Quarterly Report

Clinical Development - Nanobiotix reported ongoing clinical development for JNJ-1900 (NBTXR3) in head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) as strategic priorities[24]. - The Phase 3 NANORAY-312 trial is progressing with sponsorship transferred to Janssen Pharmaceutica NV, enhancing financial support for the trial[24][30]. - In the first quarter of 2025, the first patient was dosed in the CONVERGE trial, a randomized global Phase 2 study for JNJ-1900 (NBTXR3) in Stage III unresectable NSCLC[26]. - Preliminary results from a Phase 1 trial showed a 12-month local progression-free survival (LPFS) of 64% and overall survival (OS) of 83% for JNJ-1900 (NBTXR3) in previously irradiated NSCLC patients[27]. - Full data from a Phase 1 trial in pancreatic cancer indicated that JNJ-1900 (NBTXR3) may enhance local tumor control after induction chemotherapy[28][29]. Financial Performance - Total revenue for the six-month period ended June 30, 2025, reached €24.9 million, a significant increase from €6.2 million in the same period of 2024, primarily driven by the Janssen Agreement contract modification[32][36]. - Operating expenses decreased to €25.8 million in the first half of 2025 from €32.9 million in the first half of 2024, with R&D expenses comprising 56% and SG&A expenses 44% of total operating expenses[37][41]. - The operating result for the six-month period ended June 30, 2025, was an income of €0.8 million, compared to a loss of €23.7 million for the same period in 2024[42]. - The net loss for the six-month period ended June 30, 2025, was €5.4 million, a reduction from a net loss of €21.9 million in the same period of 2024[44][65]. - Total revenues and other income for the six-month period ended June 30, 2025, increased to €26,638 thousand, up from €9,289 thousand for the same period in 2024, marking a growth of approximately 187%[81]. Cash Flow and Liquidity - Cash flows used in operating activities amounted to €17.4 million for the six months ended June 30, 2025, compared to €5.8 million in the same period of 2024, reflecting a negative change of €11.6 million[58]. - The company had €28.8 million in available cash and cash equivalents as of June 30, 2025, consisting of liquid cash and short-term bank deposits[66]. - The company estimates it will require additional liquidity in the range of €8 to €10 million to meet its obligations over the next 12 months[68]. - As of June 30, 2025, the company's cash and cash equivalents decreased to €28,818 thousand from €49,737 thousand as of December 31, 2024, representing a decline of approximately 42%[78]. - The company is in active discussions regarding non-dilutive financing to extend its cash runway beyond the next 12 months[70]. Shareholder Equity and Assets - The company’s total shareholders' equity as of June 30, 2025, was negative €68,952 thousand, compared to negative €65,704 thousand as of December 31, 2024[78]. - The company's total assets decreased to €45,174 thousand as of June 30, 2025, down from €67,418 thousand as of December 31, 2024, reflecting a decline of about 33%[78]. - Total liabilities decreased to €114,126 thousand as of June 30, 2025, from €133,122 thousand as of December 31, 2024, a reduction of approximately 14%[78]. Research and Development - Research and development expenses for the six-month period ended June 30, 2025, decreased to €14,529 thousand from €21,987 thousand in 2024, a reduction of about 34%[81]. - Clinical trial expenses are estimated quarterly, with provisions recognized accordingly, reflecting ongoing investment in research and development[134]. - The company expects to require substantial additional capital to continue its clinical development activities and potentially engage in commercialization activities[196]. Agreements and Collaborations - An amendment to the License Agreement with J&J transferred almost full financial responsibility for the NANORAY-312 study to J&J, with limited future milestone obligations reduced[30]. - The global licensing agreement with J&J includes a framework for potential co-development of new indications, with immediate priorities in locally-advanced head and neck squamous cell carcinoma and stage 3 NSCLC[46]. - An amendment to the Janssen agreement has reduced total expected payments from approximately $2.7 billion to $2.6 billion, with potential milestone payments of $105 million over the next 2-3 years[1]. Financial Risks - The principal financial risks include liquidity, foreign currency exchange, interest rate, and credit risks[193]. - The company may need to significantly curtail or delay its research or development programs if it cannot obtain necessary funding in a timely manner[71].