Summary of Nanobiotix FY Conference Call Company Overview - **Company**: Nanobiotix (NasdaqGS:NBTX) - **Focus**: Development of innovative cancer therapies using physics-based approaches, particularly through the use of nanoparticles Key Technologies - **Platforms**: Nanobiotix has developed three different platforms aimed at treating cancer through physical mechanisms rather than traditional biological or chemical methods [3][4] - **NBTXR3**: A nanoparticle designed to enhance radiation therapy by being injected directly into tumors, allowing for higher doses of radiation to be delivered specifically to cancer cells while minimizing damage to surrounding healthy tissue [9][10] Market Opportunity - **Local Disease Focus**: Approximately 77% of cancer patients present with local disease at diagnosis, highlighting the importance of local treatment options [8] - **Radiation Therapy**: About 60% of all cancer patients receive radiation therapy, which has limitations due to damage to healthy tissue surrounding tumors [8][9] - **Head and Neck Cancer**: Initial focus on head and neck cancers due to 90% of patients having local disease at diagnosis, making it a critical area for intervention [14][15] - **Potential Patient Population**: Estimated 30,000 patients in the EU-5 and North America for head and neck cancer, with a total of 160,000 patients when including lung stage III and cisplatin-eligible populations [16][17] Strategic Partnerships - **Johnson & Johnson (J&J)**: Partnered for the commercial development of NBTXR3, aligning with J&J's interventional oncology strategy [12][13] - **Phase III Study**: J&J is conducting a Phase III study for head and neck cancers and a Phase II study for lung stage III cancer [15][28] Financial Aspects - **Royalty Financing**: Recently secured $71 million in royalty financing, extending the company's financial runway into 2028 [32][33] - **Reimbursement Terms**: The financing will be reimbursed at 1.75 to 2.5 times the amount, depending on the timing of reimbursement [35] Clinical Development - **PFS Interim Analysis**: The interim analysis for the Phase III study has been pushed to 2027 due to the complexity of transferring the trial to J&J [26][27] - **Response Rates**: Previous trials showed an 81% overall response rate and a 63% complete response rate in frail populations, indicating strong potential for improving patient outcomes [27] Future Milestones - **Upcoming Data Releases**: Anticipated updates on the second platform, interim readout of the Phase III study, and results from various trials including lung stage III and pancreatic cancer [38] Additional Insights - **Material Choice**: Hafnium oxide was selected for NBTXR3 due to its stability and effectiveness as a super X-ray absorber, minimizing systemic toxicity [11] - **Universal Application**: Data from trials in various cancers (e.g., esophageal, melanoma) support the hypothesis that NBTXR3 could be applicable across many solid tumors [37] This summary encapsulates the key points discussed during the Nanobiotix FY Conference Call, highlighting the company's innovative approach to cancer treatment, strategic partnerships, market opportunities, and future clinical developments.

Core Insights - Nanobiotix, a late-stage clinical biotechnology company, is focused on pioneering nanotherapeutic approaches to enhance treatment options for cancer and other significant diseases [1][3][4]. Conference Participation - The company management will participate in several upcoming conferences, including: - UBS Global Healthcare Conference on November 10, 2025, at 5pm ET in Palm Beach Gardens, FL, presented by Bart van Rhijn, Chief Financial & Business Officer [1]. - Guggenheim's Annual Healthcare Innovation Conference on November 10, 2025, at 4:30pm ET in Boston, MA, presented by Laurent Levy, Chief Executive Officer [2]. - Stifel Healthcare Conference on November 13, 2025, at 8am ET in New York, NY, presented by Laurent Levy and Bart van Rhijn [2]. Company Overview - Nanobiotix, incorporated in 2003 and headquartered in Paris, France, is 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, focusing on oncology, bioavailability and biodistribution, and central nervous system disorders [4].

Core Insights - Nanobiotix has entered into a royalty-based financing agreement with HealthCare Royalty, providing up to $71 million in non-dilutive capital to support its growth and development of nanotherapeutic platforms [1][2][5]. Financing Agreement Details - The agreement includes an upfront payment of $50 million, with an additional $21 million expected one year post-closing, contingent on certain conditions [7]. - The financing extends Nanobiotix's cash runway into early 2028, allowing the company to advance through critical milestones towards self-sustainability [5][6]. - HealthCare Royalty will receive a capped portion of milestones and royalties on sales of JNJ-1900 (NBTXR3), with repayment obligations structured around a defined portion of royalties on the first $1 billion of net sales [7][6]. Product Overview - JNJ-1900 (NBTXR3) is a novel oncology product utilizing functionalized hafnium oxide nanoparticles, administered via intratumoral injection and activated by radiotherapy [6][8]. - The product has shown promise in clinical trials, particularly in soft tissue sarcomas, and is being evaluated for multiple solid tumor indications [9][8]. Strategic Partnerships - 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 various clinical studies [10]. - In 2023, a global co-development and commercialization license agreement was established with Janssen Pharmaceutica NV, a Johnson & Johnson company [10]. Company Background - Nanobiotix is a late-stage clinical biotechnology company focused on innovative, physics-based therapeutic approaches to improve cancer treatment outcomes [11][12]. - The company is headquartered in Paris, France, and is listed on Euronext Paris and the Nasdaq Global Select Market [12].

Core Insights - Nanobiotix has announced updates to the clinical development program for JNJ-1900 (NBTXR3), a late-stage clinical biotechnology product aimed at expanding treatment options for cancer patients [1][2]. Group 1: Clinical Development Updates - The transfer of NANORAY-312 sponsorship to Johnson & Johnson has been completed, along with the operational control of the Phase 3 clinical trial [2]. - Nanobiotix estimates that interim data for NANORAY-312 will be analyzed and reported in the first half of 2027, following the observation of the requisite number of events and recruitment of the last patient [2]. - Future guidance related to NANORAY-312 and other JNJ-1900 (NBTXR3)-related studies will be communicated by Johnson & Johnson, while Nanobiotix will continue to provide updates on its sponsored studies [3]. Group 2: Product Overview - JNJ-1900 (NBTXR3) is a novel oncology product utilizing functionalized hafnium oxide nanoparticles, administered via a one-time intratumoral injection and activated by radiotherapy [4]. - The product's mechanism of action is designed to induce significant tumor cell death in the injected tumor, triggering an adaptive immune response and long-term anti-cancer memory [4]. - The product is being evaluated across multiple solid tumor indications, with a focus on locally advanced head and neck squamous cell cancers in the NANORAY-312 Phase 3 study [5]. Group 3: Strategic Collaborations - Nanobiotix has engaged in a collaboration strategy to expand the development of JNJ-1900 (NBTXR3), including a comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center [6]. - In 2023, a license agreement was announced for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a subsidiary of Johnson & Johnson [6]. Group 4: Company Background - Nanobiotix is a late-stage clinical biotechnology company founded in 2003, headquartered in Paris, France, and listed on Euronext Paris and Nasdaq [8]. - The company holds over 25 umbrella patents associated with three nanotechnology platforms, focusing on oncology, bioavailability, and disorders of the central nervous system [9].

Market Overview - U.S. stock futures are higher, with Dow futures gaining approximately 0.2% on Monday [1] Company-Specific Movements - Olema Pharmaceuticals Inc (NASDAQ:OLMA) shares fell 18.3% to $7.64 in pre-market trading following the announcement of new data from the Phase 1b/2 trial of palazestrant plus ribociclib in ER+/HER2- metastatic breast cancer at ESMO 2025 [1] - Concord Medical Services Hldgs Ltd (NYSE:CCM) experienced a decline of 24.4% to $4.15 in pre-market trading after a 6% drop on Friday [3] - Addex Therapeutics Ltd – ADR (NASDAQ:ADXN) dipped 15.6% to $9.23 in pre-market trading after a significant gain of 28% on Friday [3] - Exelixis Inc (NASDAQ:EXEL) shares fell 8.3% to $36.00 after announcing detailed results from the Phase 3 STELLAR-303 pivotal trial evaluating zanzalintinib in combination with an immune checkpoint inhibitor in metastatic colorectal cancer, presented at ESMO 2025 and published in The Lancet [3] - Cellectis SA (NASDAQ:CLLS) shares declined 7.3% to $3.69 in pre-market trading [3] - Alumis Inc (NASDAQ:ALMS) saw a decline of 6.7% to $4.19 in pre-market trading [3] - Nanobiotix SA – ADR (NASDAQ:NBTX) fell 6.3% to $23.98 in pre-market trading after a 4% decline on Friday [3] - Genmab A/S – ADR (NASDAQ:GMAB) declined 4.1% to $31.81 in pre-market trading, with Rinatabart Sesutecan achieving a 50% objective response rate and two complete responses in advanced endometrial cancer [3] - Taysha Gene Therapies Inc (NASDAQ:TSHA) fell 4% to $4.53 in pre-market trading [3]

Group 1 - U.S. stock futures are lower, with Dow futures falling more than 350 points [1] - Orion SA expects third-quarter adjusted EBITDA to be around $55 million and full-year adjusted EBITDA in the range of $220-$235 million, leading to an 18.6% drop in shares to $5.56 in pre-market trading [1] Group 2 - ENDRA Life Sciences Inc shares fell 19.4% to $6.54 after a previous 25% increase due to $4.9 million in funding commitments [4] - Canaan Inc shares tumbled 11.8% to $1.34 after a 39% jump, despite a maintained Buy rating and $4 price target from Rosenblatt analyst [4] - DBV Technologies SA shares fell 11.8% to $14.48 after gaining around 10% previously [4] - Nanobiotix SA shares tumbled 10.2% to $27.23 after a previous increase of over 28% [4] - Draganfly Inc shares dipped 9.4% to $12.47 after filing for a mixed shelf of up to $200 million [4] - Bitdeer Technologies Group shares fell 9% to $18.61 after a 15% gain [4] - Diginex Ltd shares fell 9% to $23.40 [4] - HIVE Digital Technologies shares dipped 8.1% to $6.21, despite a maintained Buy rating and $10 price target [4] - Oatly Group AB shares fell 7.8% to $13.29 after a 5% gain [4] - Bit Digital Inc shares declined 7.7% to $3.69 after a previous gain of over 6% [4] - Upexi Inc shares fell 7.7% to $5.98 [4] - Sharplink Gaming Inc shares declined 7.1% to $14.98 after adding 5% previously [4] - Nio Inc shares fell 5% to $6.82, influenced by new port fees affecting US-listed Chinese stocks [4] - Alibaba Group Holding Ltd shares declined 4% to $160.20, also impacted by new port fees [4]

Core Insights - Nanobiotix (NBTX) is a clinical-stage nanomedicine company valued at $1.3 billion, focusing on innovative cancer treatment approaches with proprietary technology including NBTXR3 [1] Stock Performance - NBTX has shown exceptional price momentum, gaining 440% over the past year and 200.78% since a "Buy" signal was issued on August 27 [2][6] - The stock reached an all-time high of $27.77 in intraday trading on October 8 [4] - NBTX has made 13 new highs and gained 198.02% in the last month, with a Relative Strength Index (RSI) of 82.55 [7] Technical Indicators - Barchart indicates a 100% "Buy" opinion for NBTX, with a Weighted Alpha of +470.88 [7] - The stock has a technical support level around $25.96 [7] Revenue and Earnings Projections - Revenue is projected to grow by 643.31% this year and an additional 89.01% next year [7] - Earnings are estimated to increase by 79.86% this year and 235.61% next year [7]

Core Insights - NANOBIOTIX announced promising initial data from a Phase 1 study evaluating JNJ-1900 (NBTXR3) combined with chemoradiation for patients with locally advanced esophageal adenocarcinoma (EADC) [1][4][6] Company Overview - NANOBIOTIX is a late-stage clinical biotechnology company focused on physics-based therapeutic approaches to improve treatment outcomes for cancer patients [10][12] - The company is headquartered in Paris, France, and is listed on Euronext Paris and NASDAQ [12] Study Details - The study is sponsored by The University of Texas MD Anderson Cancer Center and involves a dose escalation and expansion study of JNJ-1900 (NBTXR3) [1][2] - The study includes two cohorts: cohort 1 with photon chemoradiation and cohort 2 with proton chemoradiation [1] Efficacy and Safety Results - The treatment was well-tolerated in the study population of 13 patients, with an 85% disease control rate (DCR) and a 69% objective response rate (ORR) [4][11] - Six patients underwent surgery post-treatment, with two achieving pathological complete response (pCR) [11] Mechanism of Action - JNJ-1900 (NBTXR3) consists of functionalized hafnium oxide nanoparticles that induce tumor cell death when activated by radiotherapy, potentially enhancing local control and reducing the need for invasive surgeries [7][3] Future Development - The study's results support further investigation of JNJ-1900 (NBTXR3) in combination with proton radiation therapy, which could open new indications for the product [6] - NANOBIOTIX has engaged in collaborations to expand the development of JNJ-1900 (NBTXR3) across various tumor types and therapeutic combinations [9]

Clinical Development - Nanobiotix reported ongoing clinical development for JNJ-1900 (NBTXR3) in head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) as strategic priorities[24]. - The Phase 3 NANORAY-312 trial is progressing with sponsorship transferred to Janssen Pharmaceutica NV, enhancing financial support for the trial[24][30]. - In the first quarter of 2025, the first patient was dosed in the CONVERGE trial, a randomized global Phase 2 study for JNJ-1900 (NBTXR3) in Stage III unresectable NSCLC[26]. - Preliminary results from a Phase 1 trial showed a 12-month local progression-free survival (LPFS) of 64% and overall survival (OS) of 83% for JNJ-1900 (NBTXR3) in previously irradiated NSCLC patients[27]. - Full data from a Phase 1 trial in pancreatic cancer indicated that JNJ-1900 (NBTXR3) may enhance local tumor control after induction chemotherapy[28][29]. Financial Performance - Total revenue for the six-month period ended June 30, 2025, reached €24.9 million, a significant increase from €6.2 million in the same period of 2024, primarily driven by the Janssen Agreement contract modification[32][36]. - Operating expenses decreased to €25.8 million in the first half of 2025 from €32.9 million in the first half of 2024, with R&D expenses comprising 56% and SG&A expenses 44% of total operating expenses[37][41]. - The operating result for the six-month period ended June 30, 2025, was an income of €0.8 million, compared to a loss of €23.7 million for the same period in 2024[42]. - The net loss for the six-month period ended June 30, 2025, was €5.4 million, a reduction from a net loss of €21.9 million in the same period of 2024[44][65]. - Total revenues and other income for the six-month period ended June 30, 2025, increased to €26,638 thousand, up from €9,289 thousand for the same period in 2024, marking a growth of approximately 187%[81]. Cash Flow and Liquidity - Cash flows used in operating activities amounted to €17.4 million for the six months ended June 30, 2025, compared to €5.8 million in the same period of 2024, reflecting a negative change of €11.6 million[58]. - The company had €28.8 million in available cash and cash equivalents as of June 30, 2025, consisting of liquid cash and short-term bank deposits[66]. - The company estimates it will require additional liquidity in the range of €8 to €10 million to meet its obligations over the next 12 months[68]. - As of June 30, 2025, the company's cash and cash equivalents decreased to €28,818 thousand from €49,737 thousand as of December 31, 2024, representing a decline of approximately 42%[78]. - The company is in active discussions regarding non-dilutive financing to extend its cash runway beyond the next 12 months[70]. Shareholder Equity and Assets - The company’s total shareholders' equity as of June 30, 2025, was negative €68,952 thousand, compared to negative €65,704 thousand as of December 31, 2024[78]. - The company's total assets decreased to €45,174 thousand as of June 30, 2025, down from €67,418 thousand as of December 31, 2024, reflecting a decline of about 33%[78]. - Total liabilities decreased to €114,126 thousand as of June 30, 2025, from €133,122 thousand as of December 31, 2024, a reduction of approximately 14%[78]. Research and Development - Research and development expenses for the six-month period ended June 30, 2025, decreased to €14,529 thousand from €21,987 thousand in 2024, a reduction of about 34%[81]. - Clinical trial expenses are estimated quarterly, with provisions recognized accordingly, reflecting ongoing investment in research and development[134]. - The company expects to require substantial additional capital to continue its clinical development activities and potentially engage in commercialization activities[196]. Agreements and Collaborations - An amendment to the License Agreement with J&J transferred almost full financial responsibility for the NANORAY-312 study to J&J, with limited future milestone obligations reduced[30]. - The global licensing agreement with J&J includes a framework for potential co-development of new indications, with immediate priorities in locally-advanced head and neck squamous cell carcinoma and stage 3 NSCLC[46]. - An amendment to the Janssen agreement has reduced total expected payments from approximately $2.7 billion to $2.6 billion, with potential milestone payments of $105 million over the next 2-3 years[1]. Financial Risks - The principal financial risks include liquidity, foreign currency exchange, interest rate, and credit risks[193]. - The company may need to significantly curtail or delay its research or development programs if it cannot obtain necessary funding in a timely manner[71].

Core Insights - NANOBIOTIX reported significant operational progress and financial results for the first half of 2025, highlighting a strong increase in revenue and a reduction in net loss compared to the previous year [1][6]. Operational Highlights - The clinical development program for JNJ-1900 (NBTXR3) is gaining momentum, with the first patient dosed in the CONVERGE study for Stage 3 unresectable non-small cell lung cancer [4]. - Regulatory harmonization has been achieved, reclassifying JNJ-1900 (NBTXR3) from a medical device to a drug in major European countries [4]. - The company is actively pursuing non-dilutive financing to extend its cash runway beyond mid-2026 [4][11]. Financial Results - Revenue and other income for the six months ended June 30, 2025, increased to €26.6 million from €9.3 million in the same period of 2024, largely due to a positive non-cash revenue impact of €21.2 million from a J&J amendment [2]. - R&D expenses decreased to €14.5 million from €22.0 million year-over-year, primarily due to reduced clinical development activities following the transfer of the NANORAY-312 study sponsorship to J&J [3]. - SG&A expenses remained stable at €11.3 million compared to €10.8 million in the previous year [5]. Net Loss and Cash Position - The net loss attributable to common shareholders for the first half of 2025 was €5.4 million, a significant reduction from €21.9 million in the same period of 2024 [6]. - Cash and cash equivalents as of June 30, 2025, were €28.8 million, down from €49.7 million at the end of 2024 [6][9]. Financial Guidance - The company anticipates that its cash and cash equivalents will fund operations into mid-2026, consistent with prior guidance [7].