Data show favorable safety and feasibility in 68 heavily pre-treated patients with R/M-HNSCC (Intention-to-Treat population; "ITT") who received RT-activated NBTXR3 followed by anti-PD-1 as a second-or-later line treatment 48% ORR in evaluable anti-PD-1 naïve patients (n=25); 28% ORR in evaluable anti-PD-1 resistant patients (n=25) as per RECIST 1.1 76% DCR in evaluable naïve patients; 68% DCR in evaluable resistant patients as per RECIST 1.1 Preliminary review of survival data in ITT anti-PD-1 naïve patien ...

New data from the completed dose escalation part and ongoing expansion part of Study 1100, an ongoing US Phase 1 study evaluating NBTXR3 followed by anti-PD-1 in patients with recurrent or metastatic head and neck cancer (n=68) to be presented by Coordinating Investigator Colette Shen, MD, PhD, at ASCO 2024 Following the ASCO presentation, Nanobiotix will host an investor event on Sunday, June 2nd at 12:00 PM EDT / 6:00 PM CEST to review the presented results PARIS and CAMBRIDGE, Mass., May 28, 2024 (GLOBE ...

Core Insights - Nanobiotix is presenting updated data from Study 1100, a Phase 1 trial evaluating NBTXR3 followed by anti-PD-1 in patients with recurrent or metastatic head and neck cancer, at ASCO 2024 [1][2] - The company will host an investor event on June 2, 2024, to discuss the results presented at ASCO [1][3] Study Details - Study 1100 includes 68 patients, with early signs of efficacy observed in both anti-PD-1 naïve (n=33) and anti-PD-1 resistant (n=35) head and neck squamous cell carcinoma (HNSCC) [2] - NBTXR3 is a novel oncology product composed of functionalized hafnium oxide nanoparticles, administered via intratumoral injection and activated by radiotherapy [4] Product Development - NBTXR3 is being evaluated across multiple solid tumor indications, including a global Phase 3 study in locally advanced HNSCC [5] - The FDA granted Fast Track designation for NBTXR3 activated by radiation therapy for patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy [5] Collaboration and Strategy - Nanobiotix has engaged in a collaboration strategy to expand the development of NBTXR3, including a partnership with The University of Texas MD Anderson Cancer Center for several Phase 1 and Phase 2 studies [6] - In 2023, the company announced a license agreement for global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV [6] Company Overview - Nanobiotix is a late-stage clinical biotechnology company focused on innovative therapeutic approaches to improve treatment outcomes for cancer patients [7] - The company is headquartered in Paris, France, and is listed on Euronext Paris and NASDAQ [8]

Financial Data and Key Metrics Changes - The company reported an unaudited cash balance of €58.9 million for Q1 2024, reaffirming a cash runway into Q3 2025, which includes a $20 million milestone received [18][21][64]. Business Line Data and Key Metrics Changes - The NBTXR3 program is the primary focus, with ongoing pivotal Phase 3 trials for head and neck cancer and a Phase 2 study for non-small cell lung cancer, both of which are expected to yield significant data in the near future [49][55]. - The company is also exploring new indications for NBTXR3 beyond head and neck and lung cancer, indicating a robust pipeline [14][30]. Market Data and Key Metrics Changes - The collaboration with Janssen Pharmaceutica is expected to expand the market potential of NBTXR3, with a deal valued at over $2.5 billion plus royalties [21][22]. - The company aims to leverage its nanoparticle technology to treat a wide range of cancers, potentially impacting millions of patients globally [6][21]. Company Strategy and Development Direction - The company is focused on executing its partnership with Janssen to maximize the value of NBTXR3 and is also exploring next-generation nanoparticle therapies [9][30]. - The strategic shift includes transferring the sponsorship of the NANORAY-312 trial to Janssen to optimize the path to market and enhance the product's value [50][63]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing collaboration with Janssen and the potential for NBTXR3 to significantly improve patient outcomes [7][22]. - The company is optimistic about the upcoming data readouts and the potential for new indications, which could further validate its technology and expand its market reach [55][92]. Other Important Information - The company has made significant operational progress, including the activation of joint working teams with Janssen and the replication of manufacturing processes to increase product availability [26][53]. - The expected interim analysis for the NANORAY-312 trial is now anticipated to be reported after the last patient is recruited in H1 2026 [12][44]. Q&A Session Summary Question: Strategies to extend the company's cash runway - Management discussed shifting focus from rapid interim readouts to expanding indications, which could lead to a more secure path forward [37][38]. - CFO noted that there are multiple options available to extend the cash runway and expressed confidence in navigating financing needs [40]. Question: Timing for the transfer of sponsorship and its impact on cash runway - Management confirmed that the transfer of sponsorship is expected to be completed before the interim readout, which could help extend the cash runway [42][86]. - The transfer is intended to be neutral initially but may become positive in the future as it allows for more focused resource allocation [87]. Question: Updates on Phase 2 in lung cancer and new platforms - Management indicated that the Phase 2 trial for lung cancer is progressing, with FDA approval received for the protocol design [92]. - Updates on the Curadigm and Oocuity platforms are expected in H2 2024, focusing on building a sustainable business model around these technologies [93][94].

PARIS and CAMBRIDGE, Mass., May 22, 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, today provided an update on operational progress and reported financial results for the first quarter of 2024. First Quarter Financial Updates Cash and Cash Equivalents: Based on the current operating plan and financial projections, Nanobiotix ant ...

PARIS and CAMBRIDGE, Mass., May 22, 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, today provided an update on operational progress and reported financial results for the first quarter of 2024. First Quarter Financial Updates Cash and Cash Equivalents: Based on the current operating plan and financial projections, Nanobiotix ant ...

PARIS and CAMBRIDGE, Mass., May 21, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ''Company''), 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 updates to its corporate strategy designed to enable long-term growth in view of significant progress in the Company's collaboration for the co-development and global commercialization of ...

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 ...