Core Insights - Nanobiotix announced poster presentations from two Phase 1 studies evaluating JNJ-1900 (NBTXR3) for lung cancer at the 2025 European Lung Cancer Conference [1] Group 1: Study Presentations - The first study focuses on reirradiation with NBTXR3 for inoperable locoregional recurrent non-small cell lung cancer (NSCLC) [2] - The second study evaluates NBTXR3 activated by stereotactic body radiotherapy (SBRT) in combination with immune checkpoint inhibitors for lung metastases from NSCLC or other solid tumors [3] Group 2: Product Overview - 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 product aims 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 Development Strategy - NBTXR3 is being evaluated in multiple solid tumor indications, including a global Phase 3 study in head and neck squamous cell cancers [5] - The FDA granted Fast Track designation for NBTXR3 activated by radiation therapy for patients with locally advanced head and neck squamous cell carcinoma [5] Group 4: Collaboration and Licensing - Nanobiotix has engaged in a collaboration with The University of Texas MD Anderson Cancer Center to expand the development of NBTXR3 [6] - In 2023, a license agreement for global co-development and commercialization of NBTXR3 was established with Janssen Pharmaceutica NV, a Johnson & Johnson company [7] Group 5: Company Background - Nanobiotix is a late-stage clinical biotechnology company focused on innovative therapeutic approaches to improve treatment outcomes for patients [8] - The company was incorporated in 2003 and is headquartered in Paris, France, with listings on Euronext Paris and Nasdaq [9]

Core Viewpoint - Nanobiotix (NBTX) shares increased approximately 13% in pre-market trading following the initiation of dosing in a mid-stage study for JNJ-1900, a potential first-in-class radioenhancer for lung cancer treatment, in collaboration with Johnson & Johnson [1][2] Company Developments - The first patient has been dosed in the phase II CONVERGE study targeting Stage 3 unresectable non-small cell lung cancer (NSCLC), with eligibility criteria including patients receiving standard chemoradiation followed by AstraZeneca's Imfinzi [2] - Nanobiotix's pipeline currently includes only JNJ-1900, which is being evaluated for multiple solid tumor indications, both as a single agent and in combination with anti-PD-1 immune checkpoint inhibitors [4] - The candidate is also being assessed in a registrational phase III NANORAY-312 study for locally advanced head and neck squamous cell cancers, with Fast Track designation from the FDA [5] Recent Study Results - An early-stage study for JNJ-1900 in locally advanced pancreatic cancer showed a median overall survival of 23 months in treated patients, compared to 19.2 months based on historical data, indicating promising results [6][7] - Following positive outcomes, a new study cohort has been launched to evaluate JNJ-1900 in combination with standard chemoradiation for pancreatic cancer, with enrollment currently ongoing [7] Market Performance - Over the past three months, NBTX shares have decreased by 40.2%, contrasting with a 10.6% decline in the industry [3]

Core Insights - Nanobiotix has initiated the CONVERGE study, a Phase 2 clinical trial for JNJ-1900 (NBTXR3) targeting Stage 3 unresectable non-small cell lung cancer, marking a significant step in its development pipeline [1][2] - The company emphasizes the potential of JNJ-1900 to meet the needs of patients undergoing radiotherapy, with a clear path to registration in head and neck cancer established through the NANORAY-312 study [2] - NBTXR3 is a novel oncology product utilizing hafnium oxide nanoparticles, designed to enhance tumor cell death when activated by radiotherapy, and has received a European CE mark for soft tissue sarcomas [3][4] Company Overview - Nanobiotix is a late-stage clinical biotechnology company focused on innovative therapeutic approaches to improve cancer treatment outcomes [6] - The company was founded in 2003 and is headquartered in Paris, France, with listings on Euronext Paris and Nasdaq [7] - Nanobiotix holds over 25 patents related to nanotechnology applications in oncology, bioavailability, and central nervous system disorders [8] Product Development - NBTXR3 is being evaluated in various solid tumor indications, both as a standalone treatment and in combination with anti-PD-1 immune checkpoint inhibitors [4] - The FDA granted Fast Track designation for NBTXR3 in the treatment of locally advanced head and neck squamous cell carcinoma [4] - Nanobiotix has established collaborations, including a partnership with The University of Texas MD Anderson Cancer Center, to expand the clinical development of NBTXR3 [5]

Core Insights - Nanobiotix is advancing its NBTXR3 program, with a key step being the transfer of sponsorship for the global Phase 3 NANORAY-312 study to Janssen, which is crucial for potential regulatory submission [1][3] - The company has strengthened its Supervisory Board by adding industry experts to support long-term growth strategies [1][4] - Upcoming updates on clinical studies for pancreatic and lung cancers are expected in Q4 2024 and H1 2025, respectively [1][5] Operational Highlights - The sponsorship transfer of NANORAY-312 for head and neck cancer is underway, with Janssen taking over in the U.S. and plans for global regions to follow [3] - The company anticipates interim analysis for NANORAY-312 in H1 2026 after the required patient events [5] - Updated dose escalation data for pancreatic cancer from the collaboration with MD Anderson is expected in Q4 2024 [5] Financial Updates - As of September 30, 2024, Nanobiotix reported €53.2 million in cash and cash equivalents, providing a cash runway into Q4 2025 [6][7] Product Development - The Curadigm program, which focuses on next-generation nanoparticle-based therapies, is expected to provide updates in Q4 2024 [6] - NBTXR3, a novel oncology product, is designed to induce tumor cell death when activated by radiotherapy, with potential applications across various solid tumors [8][9] Strategic Collaborations - Nanobiotix has engaged in a collaboration with MD Anderson to evaluate NBTXR3 across multiple tumor types and therapeutic combinations [10] - The company has a license agreement with Janssen for the global co-development and commercialization of NBTXR3 [10] Company Overview - Nanobiotix is a late-stage clinical biotechnology company focused on innovative therapeutic approaches to improve treatment outcomes for cancer patients [11][12] - The company is headquartered in Paris, France, and is listed on Euronext Paris and Nasdaq [12]

Core Viewpoint - Nanobiotix is actively participating in several upcoming healthcare conferences to showcase its innovative approaches in biotechnology, particularly in cancer treatment and other major diseases [1][2]. Company Overview - Nanobiotix is a late-stage clinical biotechnology company focused on pioneering physics-based therapeutic approaches to improve treatment outcomes for patients [2]. - The company is headquartered in Paris, France, and has been listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market since December 2020 [3]. - Nanobiotix owns over 25 patent families related to three nanotechnology platforms, which have applications in oncology, bioavailability and biodistribution, and central nervous system disorders [3]. Upcoming Conferences - Nanobiotix will participate in the following conferences: - **Guggenheim's Inaugural Healthcare Innovation Conference** - Date: November 11, 2024 - Time: 4pm ET / 10pm CET - Location: Boston, MA - Presenters: Laurent Levy (CEO) and Bart van Rhijn (CFO) [1] - **Stifel Healthcare Conference** - Date: November 18, 2024 - Time: 4:45pm ET / 10:45pm CET - Location: New York, NY - Presenter: Bart van Rhijn (CFO) [1] - **Jefferies London Healthcare Conference** - Date: November 20, 2024 - Time: 1pm GMT / 8am ET / 2pm CET - Location: London, UK - Presenters: Laurent Levy (CEO) and Bart van Rhijn (CFO) [1] Communication and Investor Relations - For further information, Nanobiotix provides contact details for its communications and investor relations departments, emphasizing its commitment to transparency and engagement with stakeholders [4].

Financial Performance - Revenue and other income for the six-month period ended June 30, 2024, was €9.3 million, a significant increase from €3.3 million in the same period of 2023, primarily due to the Janssen Agreement[12]. - Total revenues of €6.2 million for the first half of 2024 included €2.7 million from services linked to the Janssen license, €1.1 million from technology transfer, and €2.4 million from other sales[12]. - The net loss for the six-month period ended June 30, 2024, was €21.9 million, an improvement from a net loss of €28.1 million in the same period of 2023[16]. - The financial result for the first half of 2024 showed a loss of €1.9 million, an improvement from a loss of €2.7 million in the same period of 2023[16]. - For the six months ended June 30, 2024, the company reported a net loss of €21.9 million, compared to a net loss of €28.1 million for the same period in 2023, representing a 22.5% improvement[30]. - The company experienced a net cash outflow of €5.8 million from operating activities in the first half of 2024, compared to €17.3 million in the same period of 2023[24]. - The company recorded total operating expenses of €32.9 million for the six months ended June 30, 2024, compared to €28.7 million for the same period in 2023, marking a 14.5% increase[34]. - The basic loss per share for the six months ended June 30, 2024, was €0.46, compared to €0.80 for the same period in 2023[34]. - The company incurred operating losses since its inception in 2005 and expects to continue incurring significant losses in the near term[105]. Research and Development - The overall response rate (ORR) in evaluable anti-PD-1 naïve patients was 48%, while the disease control rate (DCR) was 76% in a Phase 1 study evaluating NBTXR3[9]. - The Company aims to replicate the NBTXR3 model across any solid tumor indication treated by radiotherapy alone or with immunotherapy[9]. - The Company is focusing on expanding the use of NBTXR3 in head and neck cancers and non-small-cell lung cancer (NSCLC) through collaborations with Janssen and MD Anderson[9]. - The company is focused on advancing the development of NBTXR3 while also exploring two additional nanoparticle-based therapy platforms, Curadigm and OOcuity[18]. - Research and development expenses increased to €22.0 million for the six months ended June 30, 2024, compared to €17.8 million for the same period in 2023, reflecting a 23.9% rise[34]. - The company has not recognized deferred tax assets related to tax losses carry forwards due to insufficient reliable income projections[56]. Collaborations and Agreements - Nanobiotix received a $20 million milestone payment from Janssen in Q2 2024 following the achievement of operational requirements in the NANORAY-312 study[9]. - The collaboration with Janssen includes a protocol amendment to remove the planned futility analysis for the NANORAY-312 trial[9]. - The Janssen collaboration continues to progress, with the FDA issuing a Study May Proceed Letter for a Phase 2 study evaluating NBTXR3 for stage 3 unresectable NSCLC[11]. - The company entered into a master services agreement with Janssen, receiving purchase orders totaling €4.7 million for clinical manufacturing and technical assistance services[155]. - The company received purchase orders from Janssen for raw materials and clinical batches amounting to €3.8 million and technology transfer services of €0.9 million[155]. Assets and Liabilities - Cash and cash equivalents decreased to €66.3 million as of June 30, 2024, down from €75.3 million as of December 31, 2023[30]. - The company's total assets decreased to €86.7 million as of June 30, 2024, from €93.9 million as of December 31, 2023[31]. - Current liabilities increased to €56.5 million as of June 30, 2024, compared to €49.9 million as of December 31, 2023, indicating a 13.2% rise[31]. - Total liabilities as of June 30, 2024, amounted to €68.3 million, an increase from €66.8 million in the previous period[104]. - The company’s total shareholders' equity as of June 30, 2024, was negative €21.8 million, a decline from negative €1.8 million as of December 31, 2023[31]. Cash Flow and Financing - The company expects to finance its operating activities through equity offerings, debt financings, and government subsidies until sufficient revenue is generated[27]. - The company reported a favorable variance in cash flows used in operating activities of €11.5 million, primarily driven by the recognition of €6.2 million in revenues during the first half of 2024[25]. - Cash flows from operating activities after tax and before changes in working capital were negative €18.1 million for the six months ended June 30, 2024, compared to negative €22.9 million in the prior year, indicating a 21% reduction in cash outflows[41]. - The company has reduced its consolidation scope, with four wholly owned subsidiaries as of June 30, 2024, reflecting strategic adjustments in its operational structure[51]. Employee and Shareholder Information - The average headcount increased to 105 employees as of June 30, 2024, compared to 98 in the previous year[122]. - Total compensation to related parties increased to €2.7 million for the six-month period ended June 30, 2024, compared to €1.8 million in 2023, reflecting higher salaries and share-based payments[156]. - The total number of BSPCEs authorized ranges from 450,000 to 500,000 across various grants, with a total number of shares likely to be subscribed varying from 50,000 to 129,250[130]. - The total number of shares available for subscription as of June 30, 2024, is not specified for several BSAs[132]. Financial Instruments and Market Conditions - The company does not use financial instruments for speculative purposes and has no derivative financial instruments[105]. - The dollar-to-euro exchange rate as of June 30, 2024, was $1.0705, compared to $1.0866 as of June 30, 2023[53]. - The estimated fair value of the debt as of June 30, 2024, is €35.4 million, with an estimated fair market rate of 22.4% due to increased spreads[90].

Core Viewpoint - Nanobiotix's lead candidate NBTXR3 shows promising safety and efficacy in cancer treatment, particularly in combination with anti-PD-1 therapy, with several clinical milestones anticipated in the next 12-18 months [1][2]. Company Updates - Nanobiotix has strengthened its Supervisory Board with the addition of Dr. Margaret A. Liu and Ms. Anat Naschitz, enhancing the company's capacity for sustainable growth [3]. - The company achieved a significant operational milestone in its collaboration with Janssen Pharmaceutica NV, receiving a $20 million payment as part of their licensing agreement [4]. Clinical Trials and Milestones - NBTXR3 is being evaluated in multiple clinical trials, including a Phase 3 trial (NANORAY-312) for locally advanced head and neck squamous cell carcinoma, with interim analysis expected by 1H2026 [4]. - A Phase 2 study for non-small cell lung cancer (NSCLC) is underway, with the first patient randomized as the next milestone [5]. - Study 1100 has shown a 48% overall response rate in anti-PD-1 naïve patients and a 28% response rate in resistant patients, indicating the potential of NBTXR3 to prime immune responses [5]. Financial Performance - For the first half of 2024, revenue increased to €9.3 million from €3.3 million in the same period of 2023, primarily due to the licensing agreement with Janssen [7]. - Research and development expenses rose to €22.0 million, driven by increased clinical activities, compared to €17.8 million in the previous year [8]. - The net loss for the first half of 2024 was €21.9 million, an improvement from €28.1 million in the same period of 2023 [10]. Cash Position - As of June 30, 2024, the company reported €66.3 million in cash and cash equivalents, extending its cash runway into Q4 2025 [11].

Core Insights - NANOBIOTIX has announced the nominations of Dr. Margaret A. Liu and Ms. Anat Naschitz as observers to its Supervisory Board, aiming to enhance its strategic initiatives in oncology and expand development opportunities [1][2][4]. Company Overview - NANOBIOTIX is a late-stage clinical biotechnology company focused on pioneering nanoparticle-based therapeutic approaches for cancer and other major diseases [1][6]. - The company is headquartered in Paris, France, and is listed on Euronext Paris and the Nasdaq Global Select Market [7]. Key Personnel - Dr. Margaret A. Liu is a global expert in vaccines, gene therapy, and cancer immunotherapy, currently serving as CEO of PAX Therapeutics and holding various board positions [2][3]. - Ms. Anat Naschitz is a life science investor and entrepreneur with over three decades of experience in biotech and pharmaceuticals, currently co-founder and CEO of 9xchange [3][4]. Strategic Goals - The company aims to leverage the expertise of Dr. Liu and Ms. Naschitz to drive the development of nanophysics-based therapies and enhance collaboration opportunities beyond its current focus on NBTXR3 [2][4]. Future Actions - The nominations of Dr. Liu and Ms. Naschitz will be submitted for ratification at the next shareholders' meeting [5].

Core Insights - Nanobiotix is a late-stage clinical biotechnology company focused on innovative physics-based approaches to enhance cancer treatment options for patients [1][3][4] - The company will participate in the H.C. Wainwright 26th Annual Global Investment Conference, scheduled for September 11, 2024, in New York City [2] Company Overview - Founded in 2003, Nanobiotix is headquartered in Paris, France, and has been listed on Euronext Paris since 2012 and on Nasdaq since December 2020 [4] - The company holds over 25 patent families related to three nanotechnology platforms, which are applicable in oncology, bioavailability and biodistribution, and central nervous system disorders [4] Event Details - The fireside chat at the conference will feature Laurent Levy, co-founder and chairman, and Bart Van Rhijn, CFO of Nanobiotix [2] - The event will be webcast live, with a replay available afterward [2]

Company Overview - Nanobiotix is a late-stage clinical biotechnology company focused on physics-based approaches to cancer treatment, headquartered in Paris, France, and listed on Euronext Paris since 2012 and on Nasdaq since December 2020 [3][7] - The company has subsidiaries in Cambridge, Massachusetts, among other locations [3] Upcoming Event - Nanobiotix will host a virtual Key Opinion Leader (KOL) event on June 18, 2024, from 9:00-10:30 AM EDT / 3:00-4:30 PM CEST [1] - The event will feature KOLs including Dr. Colette Shen, Dr. Ari Rosenberg, and Dr. Jeffrey Bockman, who will discuss NBTXR3 and its role in treating recurrent/metastatic head and neck cancer [11] Research Focus - The KOL event will cover topics such as the mechanisms of action of NBTXR3, its local and systemic responses, and the treatment landscape for head and neck cancer patients, highlighting unmet needs [12][11] - Recent data presented at the 2024 Annual Meeting of the American Society for Clinical Oncology (ASCO) will be reviewed, showing disease control and tumor response in patients treated with radiotherapy-activated NBTXR3 followed by anti-PD-1 therapy [11]