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]

Financial Performance - The company has incurred losses totaling €380.4 million since inception, with a net loss of €68.1 million for the year ended December 31, 2024[102]. - As of December 31, 2024, the company had cash and cash equivalents of €49.7 million[102]. - The company anticipates continuing to incur significant losses for the foreseeable future due to ongoing clinical studies and development expenses related to its product candidates[103]. - The company has not yet established a source of revenue sufficient to cover its operating costs, relying instead on capital increases and collaboration agreements[104]. - The company expects near-term losses and cash utilization to stabilize or slightly decrease due to amendments in the Janssen Agreement[97]. - The company may face challenges in raising additional funding, which could materially affect its operations and financial position[105]. - The company may face dilution of current ownership interests if additional capital is raised through equity or convertible securities[108]. - Debt financing could lead to increased fixed payment obligations and may impose restrictive covenants affecting operational flexibility[108]. - The company has entered into loan agreements with the European Investment Bank, Bpifrance Financement, and HSBC France, which could impact financial stability if payment defaults occur[110]. - Failure to obtain timely funding may result in significant delays or discontinuation of research and development programs[111]. Competition and Market Risks - The company faces substantial competition from other biotechnology and pharmaceutical companies, many of which have greater resources and experience[99]. - The company may face difficulties in achieving market acceptance for NBTXR3, even if it receives regulatory approval[153]. - The ability to penetrate global markets is crucial for future profitability, dependent on Janssen's commitment and resource allocation[159]. - Legislative and political uncertainties could adversely affect the ability to market products and generate revenues[257]. Clinical Development Challenges - The development of product candidates is subject to high attrition rates, with no assurance of success at any stage[113]. - The complexity of the nanotechnology used in product candidates like NBTXR3 may lead to unpredictable development timelines and costs[125]. - Manufacturing processes for NBTXR3 are highly regulated and subject to risks that could impact production and supply[129]. - Difficulty in patient enrollment for clinical studies could delay regulatory approval and commercialization timelines[136]. - Changes in manufacturing processes may require additional regulatory approvals, potentially delaying product development[135]. - The company faces challenges in patient enrollment for clinical trials due to competition and limited qualified investigators, which may delay or terminate studies[138]. - Delays in patient enrollment could lead to increased costs and affect the timing of clinical trials, potentially hindering product development[140]. - Undesirable side effects from product candidates could interrupt clinical trials and delay regulatory approvals, impacting market acceptance[141]. - The company relies on third parties for various aspects of development, which may lead to risks if these parties do not perform satisfactorily[171]. Regulatory and Compliance Issues - The regulatory landscape for the company's product candidates, particularly NBTXR3, is complex and may lead to unexpected costs or delays in obtaining necessary marketing authorizations[227][228]. - NBTXR3 is classified as a Class III medical device in the EU and as a drug in the U.S., requiring compliance with different regulatory frameworks that may extend the development timeline and increase costs[229]. - The company must provide regulatory authorities with data demonstrating the safety and efficacy of its product candidates before they can be marketed, which adds to the complexity of the approval process[230]. - Delays or failures in obtaining marketing authorization or CE-marking could significantly decrease the company's ability to generate product revenue[231]. - The approval processes for product candidates, including NBTXR3, are lengthy, expensive, and unpredictable, potentially harming the business if regulatory approval is not obtained[232]. - Regulatory authorities may impose limitations on approved products, including restrictions on marketing, labeling, and the need for costly post-marketing clinical trials[237]. - The company received Fast Track designation from the FDA for NBTXR3 in February 2020 for treating locally advanced head and neck squamous cell cancer, but this does not guarantee a faster approval process[244]. - Regulatory compliance is critical post-approval, and failure to meet requirements could lead to significant penalties, including suspension or withdrawal of marketing authorization[239]. - The company is subject to extensive healthcare laws and regulations, which could lead to significant civil, criminal, and administrative penalties if found non-compliant[263]. Strategic Partnerships and Licensing - A global exclusive licensing agreement with Janssen is critical for the commercialization of NBTXR3, with future payments expected to contribute significantly to revenue[165]. - The company transferred the sponsorship of the NANORAY-312 clinical trial to Janssen, increasing reliance on Janssen for successful execution[166]. - The company’s reliance on Janssen limits its ability to pursue additional studies or collaborations in oncology, amplifying associated risks[167]. - The company has strategic licensing agreements, including the Janssen Agreement, which grants worldwide development and commercialization rights for product candidate NBTXR3[180]. - The company faces risks if strategic licensees do not effectively pursue product candidates, potentially impacting revenue streams from milestone and royalty payments[181]. Operational and Management Risks - The company has identified a material weakness in internal control over financial reporting, which could adversely affect investor confidence[204]. - The company identified material weaknesses in internal control over financial reporting for the years ended December 31, 2022, and December 31, 2023, due to insufficient supervisory personnel with appropriate technical accounting experience[206]. - Remediation plans have been implemented to address these material weaknesses, but the effectiveness of these controls cannot be assured for the year ending December 31, 2024[207]. - The company may face limitations in preventing or detecting misstatements in financial statements, which could impact compliance with securities law and investor confidence[208]. - Compliance with Section 404 will incur substantial accounting expenses and management attention, with independent auditors required to attest to the effectiveness of internal controls starting with the annual report for the year ending December 31, 2025[209]. - The company may face difficulties in managing growth and expansion, which could disrupt operations and increase expenses[195]. - The company must share trade secrets with third parties, increasing the risk of unauthorized disclosure or misappropriation[188]. Supply Chain and Manufacturing Risks - The company is dependent on third parties for the supply of materials necessary for product candidates, which could be interrupted, affecting development and commercialization timelines[184]. - The company faces risks related to potential interruptions in supply from approved manufacturers, which could disrupt clinical and commercial supply chains[270]. - The company must ensure that all third-party manufacturers adhere to regulatory requirements to avoid sanctions that could disrupt operations[267]. - The company’s product candidates, including NBTXR3, are subject to rigorous quality control measures to prevent contamination and ensure stability[266]. - Manufacturing facilities, including the in-house facility in Villejuif, France, must comply with stringent cGMP and ISO13485 regulations, which may increase operational costs and complexity[265][269]. Insurance and Liability - The company maintains product liability insurance, but coverage may be insufficient to cover potential claims, impacting financial stability[199]. - Non-compliance with healthcare laws could result in exclusion from government-funded healthcare programs, significantly impacting revenue streams[263].

Core Insights - Nanobiotix, a late-stage clinical biotechnology company, is set to report its financial results for Q4 and the full year of 2024 on April 2, 2025, after the U.S. market closes [1] - A conference call and webcast will follow on April 3, 2025, at 8:00 AM EDT, where the CEO and CFO will discuss year-end results and business updates [2] Company Overview - Nanobiotix is headquartered in Paris, France, and has been listed on Euronext Paris since 2012 and on Nasdaq since December 2020 [5] - The company focuses on nanoparticle-based therapeutic approaches, particularly in oncology, bioavailability, and central nervous system disorders [5] - Nanobiotix holds over 25 patent families related to its three nanotechnology platforms [5]

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].