Core Insights - Nanobiotix is advancing its corporate strategy to enable long-term growth, focusing on the co-development and commercialization of its lead therapeutic candidate NBTXR3, a nanoparticle-based radioenhancer for cancer treatment [1][3][11] Development of NBTXR3 - NBTXR3 is being developed in collaboration with Janssen Pharmaceutica NV, aiming to leverage expected sustainable revenue from its commercialization to support further development of additional nanoparticle therapy platforms [2][11] - The current development program includes a pivotal Phase 3 study (NANORAY-312) for elderly patients with locally advanced head and neck cancer and a Phase 2 study for stage 3 non-small cell lung cancer (NSCLC) [5][13] Regulatory and Operational Updates - Nanobiotix and Janssen have aligned to transfer the global sponsorship of the NANORAY-312 trial, with ongoing support from Nanobiotix during the transition [6][9] - A protocol amendment has been made to remove the planned futility analysis for NANORAY-312, based on positive data from a related Phase 1 study [7][8] - The FDA has granted a "Study May Proceed" letter for the Phase 2 NSCLC study, indicating regulatory support for the ongoing research [9][11] Financial and Strategic Collaborations - The collaboration with Janssen has resulted in a $20 million milestone payment to Nanobiotix following the achievement of the first operational milestone in NANORAY-312 [12] - Nanobiotix is exploring options to extend its cash runway beyond the current expectation of Q3 2025, indicating proactive financial management [10][11] Future Directions - The company plans to provide updates on its development plans for NBTXR3 and other nanoparticle-based therapies in the second half of 2024 [19] - Nanobiotix is also focusing on expanding its nanoparticle therapy platforms, including Curadigm and OOcuity, to enhance treatment outcomes in various healthcare settings [16][17][18]

PARIS and CAMBRIDGE, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ''Company''), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, announced today that it will report its financial and operational results for the first quarter of 2024 on May 22, 2024, before the US and EU markets open. This release will be followed by a conference call and webcast on May 22, 2024 at 8:00 am EDT ...

PARIS and CAMBRIDGE, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering nanoparticle-based therapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced that the U.S. Food and Drug Administration ("US FDA") issued a Study May Proceed Letter for a randomized Phase 2 study evaluating NBTXR3 for the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCL ...

EXHIBIT 99.1 NANOBIOTIX Provides Business Update and Reports Full Year 2023 Financial Results Conference call and webcast scheduled for April 25, 2024 at 8:00 A.M. EDT / 2:00 P.M. CEST PARIS and CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the "Company"), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, provided an update on operational progress and reported financia ...

Global licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV ("Janssen") expands worldwide potential of novel radioenhancer NBTXR3Prolonged survival in Study 102 reinforces pivotal NANORAY-312 trial design in head and neck cancer; initial efficacy and favorable safety profile supports potential of NBTXR3 in pancreatic cancer; determined RP2D for MD Anderson lung studyMultiple clinical readouts expected in 2024 including immunotherapy combination data from Study 1100, and d ...

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, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the transition period from __________ to _ ...

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 o SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report __________ Commission File Number: 001-39777 ________________________ NANOBIOTIX S.A. (Exact name of registrant as specified ...

Nanobiotix S.A. (NASDAQ:NBTX) Q3 2022 Earnings Call Transcript November 10, 2022 8:00 AM ET Company Participants Kate Mcneil - Senior Vice President, Investor Relations Laurent Levy - Co-Founder & Chief Executive Officer Bart Van Rhijn - Chief Financial Officer Conference Call Participants Mike DiFiore - Evercore Cl??ment Bassat - BNP Paribas Kate Mcneil Thank you, operator. Good afternoon and good morning, and welcome to Nanobiotix Conference Call to discuss our Third Quarter 2022 Financial and Operational ...

Financial 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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ________________________ FORM 6-K ________________________ REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of report: September 28, 2022 Commission File Number: 001-39777 ________________________ NANOBIOTIX S.A. (Exact name of registrant as specified in its charter) _________________________ Nanobiotix S.A. 60 rue de Wattignies 75012 Paris, France (Address of principal ex ...