Data show a favorable safety profile and early efficacy signals in a heavily pre-treated population whose cancer progressed after multiple prior lines of therapy including anti-PD-1Recommended phase 2 dose (RP2D) established at 33% of gross tumor volume (GTV)47.4% (9/19) best observed objective response rate (ORR) in all lesions per RECIST 1.178.9% (15/19) best observed disease control rate (DCR) in all lesions per RECIST 1.114.6 months median Overall Survival (mOS) in all patients treated (n=21)Investigato ...

Summary of Nanobiotix Conference Call Company Overview - **Company**: Nanobiotix - **Product**: NBTXR3, a radioenhancer composed of hafnium oxide nanoparticles designed to enhance the effects of radiotherapy on tumor cells [1][2] Industry Insights - **Biotech/Pharma Industry**: The industry faces uncertainties in targeting specific biological entities for treatment, which can affect the predictability of treatment outcomes [2][3] - **Radiation Therapy**: Contrary to perceptions, radiation therapy is increasingly utilized as a frontline treatment for cancer, with a growing number of patients due to an aging population [8][9] Core Product Insights - **Market Opportunity**: Over 12 million patients receive radiation therapy annually, representing 60% of all cancer patients, indicating a vast market potential for NBTXR3 [5][6] - **Treatment Timing**: NBTXR3 is positioned as a first-line treatment, potentially leading to long-term benefits and reduced need for systemic therapies [5][6] - **Clinical Data**: Initial trials show promising results, with an 80%+ response rate in head and neck cancer patients, significantly higher than the typical 35% response rate [14] Strategic Partnerships - **Collaboration with Janssen Pharmaceuticals**: A significant agreement valued at nearly $3 billion was established, emphasizing the strategic fit in early treatment of tumors [11][12] - **Royalty Structure**: Nanobiotix will receive royalties and has incentives to expand clinical development, fostering a symbiotic relationship with Janssen [15][18] Clinical Development and Future Indications - **Ongoing Trials**: Current focus includes head and neck cancer and lung cancer, with plans to expand into additional solid tumors based on established safety and feasibility [19][20] - **Upcoming Data Releases**: Anticipated clinical data readouts include trials for head and neck cancer, melanoma, and esophageal cancer, with key milestones expected in 2025 and 2026 [22][25] Financial Position - **Cash Reserves**: As of the end of 2024, the company reported a cash balance of approximately €50 million, providing a runway into mid-2026 [28] Additional Developments - **New Platforms**: Nanobiotix is developing two new platforms, Curiline and Oocuity, aimed at addressing multiple indications and CNS diseases, with updates expected by the end of the year [27]

Core Insights - Nanobiotix, a late-stage clinical biotechnology company, is focused on pioneering nanoparticle-based approaches to enhance treatment options for cancer and other significant diseases [1][2]. Company Overview - Nanobiotix was incorporated in 2003 and is headquartered in Paris, France. The company has been listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market since December 2020. It also has subsidiaries in Cambridge, Massachusetts, among other locations [3]. - The company owns over 25 patent families related to three nanotechnology platforms, which have applications in oncology, bioavailability and biodistribution, and disorders of the central nervous system [3]. Upcoming Events - Company management will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 9:00 am EDT / 3:00 pm CEST in New York, NY. Presenters will include Laurent Levy, CEO, and Bart van Rhijn, Chief Financial & Business Officer [1]. - The event will be webcast live, and a replay will be available afterward [1].

Core Insights - Nanobiotix announced significant developments regarding JNJ-1900 (NBTXR3), a potential first-in-class radioenhancer for cancer treatment, which is licensed by Janssen Pharmaceutica NV, a Johnson & Johnson company [1][4] Regulatory Developments - Health authorities in major European countries have reclassified JNJ-1900 (NBTXR3) from a medical device to a drug, aligning its regulatory status with that in the United States and other major markets [2][9] - This reclassification supports a unified global regulatory classification, facilitating future global strategies and filings [9] Intellectual Property - Nanobiotix has filed a new composition of matter patent for JNJ-1900 (NBTXR3) to strengthen the intellectual property foundation supporting the product candidate [3][9] Clinical Development - JNJ-1900 (NBTXR3) is undergoing a comprehensive global clinical development program across multiple tumor types, including a pivotal Phase 3 trial in head and neck cancer [4][6] - The product candidate has shown proof-of-concept in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018 [5] Mechanism of Action - JNJ-1900 (NBTXR3) consists of functionalized hafnium oxide nanoparticles, administered via one-time intratumoral injection and activated by radiotherapy, designed to induce significant tumor cell death and trigger an adaptive immune response [5] Collaboration and Strategy - Nanobiotix has engaged in a collaboration strategy to expand the development of JNJ-1900 (NBTXR3), including a partnership with The University of Texas MD Anderson Cancer Center for several Phase 1 and Phase 2 studies [7]

Core Viewpoint - Nanobiotix is making significant progress in its clinical development programs, particularly with JNJ-1900 (NBTXR3), and is optimistic about upcoming milestones in cancer treatment [2][5]. Operational Highlights - The company is advancing the NANORAY-312 program in head and neck cancer and has expanded development into lung cancer through the CONVERGE study [2][6]. - The first patient has been dosed in the Phase 2 randomized CONVERGE study for unresectable stage 3 non-small cell lung cancer (NSCLC) [6][7]. - Clinical data presented at major conferences supports the expansion of JNJ-1900 into additional cancer indications, including lung cancer and locally advanced pancreatic cancer [2][6][7]. Financial Updates - As of March 31, 2025, Nanobiotix reported cash and cash equivalents of €39.8 million, which is expected to fund operations into mid-2026 [5][6]. - An amendment to the global licensing agreement for JNJ-1900 has extended the cash runway and reduced operational cash burn [6][7]. Product Overview - JNJ-1900 (NBTXR3) is a novel oncology product utilizing hafnium oxide nanoparticles, designed to induce tumor cell death when activated by radiotherapy [8][9]. - The product is being evaluated across multiple solid tumor indications and has received Fast Track designation from the FDA for specific cancer treatments [9][10]. Collaboration and Strategy - Nanobiotix has engaged in collaborations to expand the development of JNJ-1900, including a partnership with MD Anderson Cancer Center for various clinical studies [10][11].

PARIS and CAMBRIDGE, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ''Company''), a late-clinical stage biotechnology company pioneering nanoparticle- based approaches to expand treatment possibilities for patients with cancer and other major diseases, announced today that Company management will participate in fireside chats at following conference: H.C. Wainwright 3rd Annual BioConnect Investor Conference at NASDAQ Date: Tuesday, May 20, 2025 Time: 5:00 pm EDT / 1 ...

PARIS and CAMBRIDGE, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ''Company''), a late-clinical stage biotechnology company pioneering nanoparticle- based approaches to expand treatment possibilities for patients with cancer and other major diseases, announced today that Company management will participate in fireside chats at following conference: Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches ...

Core Insights - Nanobiotix presented full results from a Phase 1 study of JNJ-1900 (NBTXR3) for locally advanced or borderline resectable pancreatic cancer at the 2025 ESTRO Annual Meeting [1][3] - The study showed promising safety and efficacy outcomes, indicating a potential new treatment option for patients with high unmet needs in this area [5][9] Company Overview - Nanobiotix is a late-stage clinical biotechnology company focused on innovative nanotherapeutic approaches to enhance cancer treatment outcomes [15][16] - The company is headquartered in Paris, France, and is listed on Euronext Paris and NASDAQ [16] Study Details - The Phase 1 study evaluated JNJ-1900 (NBTXR3) activated by radiotherapy in patients with locally advanced or borderline resectable pancreatic cancer, replacing standard concurrent chemoradiation [3][6] - The study was conducted by The University of Texas MD Anderson Cancer Center, with Dr. Eugene Koay as the principal investigator [1][3] Key Results - The study involved 22 patients, with a median overall survival of 23 months from diagnosis and a median local progression-free survival of 13.3 months from completion of radiation [5][6] - Notable findings included a 59% normalization rate of CA19-9, a biomarker associated with overall survival, and an association between increased circulating tumor mutational burden (cTMB) and improved survival outcomes [5][12] Future Directions - Investigators concluded that further evaluation of JNJ-1900 (NBTXR3) is warranted in a randomized study, with ongoing recruitment for a new cohort combining JNJ-1900 with standard-of-care concurrent chemotherapy [8][9] - The collaboration with MD Anderson aims to explore innovative treatment approaches for patients with high unmet needs in pancreatic cancer [9][14]

Core Viewpoint - Nanobiotix announced the presentation of full results from a Phase 1 study evaluating JNJ-1900 (NBTXR3) for locally advanced or borderline resectable pancreatic cancer, highlighting the potential of its nanoparticle-based therapeutic approach in oncology [1][6]. Group 1: Study Details - The Phase 1 study was conducted by The University of Texas MD Anderson Cancer Center and will be presented by Dr. Eugene Koay at the ESTRO 2025 conference on May 4, 2025 [1][6]. - The study includes both dose escalation and dose expansion phases, focusing on patients who have undergone induction chemotherapy [6]. Group 2: Product Information - NBTXR3 is a novel oncology product made of functionalized hafnium oxide nanoparticles, administered via a one-time intratumoral injection and activated by radiotherapy [4]. - The mechanism of action is designed to induce significant tumor cell death and trigger an adaptive immune response, potentially applicable across various solid tumors treated with radiotherapy [4]. Group 3: Regulatory and Collaboration Efforts - NBTXR3 received a European CE mark in 2019 for soft tissue sarcomas and has been granted Fast Track designation by the FDA for use in locally advanced head and neck squamous cell cancers [5]. - Nanobiotix has engaged in a collaboration with MD Anderson Cancer Center to sponsor multiple studies evaluating NBTXR3 across different tumor types and therapeutic combinations [7]. Group 4: Company Overview - Nanobiotix is a late-stage clinical biotechnology company focused on innovative therapeutic approaches to improve treatment outcomes for cancer patients [8]. - The company was incorporated in 2003 and is headquartered in Paris, France, with additional locations including Cambridge, Massachusetts [9].

Financial Data and Key Metrics Changes - The company reported negative revenue of €7.2 million for 2024, a significant decrease from €36.2 million in 2023, primarily due to the transfer of NanoRay 312 study sponsorship to Johnson & Johnson [36][37] - The net loss attributable to shareholders increased by 72% year-over-year to €68.1 million, or €1.44 per share, compared to a net loss of €39.7 million, or €1.08 per share, in 2023 [40][41] - Cash and cash equivalents decreased to €49.7 million as of December 31, 2024, down from €75.3 million at the end of 2023, but are expected to fund operations into mid-2026 [42] Business Line Data and Key Metrics Changes - The company signed a licensing agreement with Johnson & Johnson, which includes a $20 million milestone payment related to NanoRay 312 progress [28] - R&D expenses totaled €40.5 million for 2024, up from €38.4 million in 2023, driven by increased clinical development activities [39] - Selling, general, and administrative expenses decreased to €20.5 million in 2024 from €22 million in 2023, mainly due to one-off fees incurred in 2023 [40] Market Data and Key Metrics Changes - The collaboration with Johnson & Johnson is expected to address over 100,000 patients in the US and EU5 for lung and head and neck cancers, representing a potential market of €10 billion [11] - The company is actively exploring further financing options, preferably non-dilutive, to extend cash visibility into 2027 [30][88] Company Strategy and Development Direction - The company is focused on advancing its collaboration with Johnson & Johnson and developing its new platform, Curadime, which is expected to be applicable across multiple therapeutic areas [10][22] - The amended licensing agreement with Johnson & Johnson is designed to reduce cash burn and extend the company's cash runway to mid-2026 [29][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for positive data readouts in the near future, particularly for the NanoRay 312 and lung cancer studies [44][48] - The company is in a "de-risked situation" regarding the NBT-XR3 program, with significant progress made in partnerships and clinical development [93] Other Important Information - The company has added two new board observers to its board, indicating ongoing governance improvements [25] - The company is working on its internal pipeline and has signed multiple Material Transfer Agreements (MTAs) with biotech and pharma companies [97] Q&A Session Summary Question: Details on the phase two CONVERGE study by J&J - Management stated that the trial has started and is progressing well, but specific timelines for initial data are not yet available [54][55] Question: Upcoming pancreatic cancer data presentation - The upcoming data will include full efficacy and safety results, as well as potential biomarkers, which were not detailed in the previous press release [58][59] Question: Remaining costs for the NanoRay study - The remaining costs are relatively immaterial, with the majority now covered by Johnson & Johnson, and any future payments expected to be in the single-digit millions [65][69] Question: Recent communication with the FDA - Management reported no delays in meetings or interactions with the FDA, indicating that the program is well engaged [67] Question: Long-term R&D initiatives beyond NBT-XR3 - Management highlighted the Curadime platform as a key area for future development, alongside ongoing work on the NBT-XR3 program [73][76]