Summary of Nanobiotix Conference Call Company Overview - **Company**: Nanobiotix (NasdaqGS:NBTX) - **Industry**: Healthcare, specifically focused on oncology and CNS disorders through nanophysics-based therapeutics [1][2] Core Points and Arguments Nanobiotix's Unique Approach - Nanobiotix is pioneering nanophysics for healthcare, developing small objects that can trigger physical effects at the cellular level, impacting treatments for oncology and CNS disorders [2][3] - The company has three platforms: one for oncology, one for rethinking drug development, and one for CNS disorders [3] NBTXR3 Program - NBTXR3 is the most advanced program, currently in a Phase 3 study for head and neck cancer, with a partnership with Johnson & Johnson (J&J) [4] - The focus is on early-stage cancer treatment, where the majority of patients have local disease, representing a significant market opportunity [5][6] - NBTXR3 aims to enhance radiation therapy by improving the dose delivered to tumors while minimizing damage to surrounding healthy tissue [6][7] Market Opportunity - Approximately 60% of all cancer patients receive radiation therapy, with significant potential for NBTXR3 to impact around 160,000 patients in the EU5 and US for the initial indications [7][8] - The potential market size for NBTXR3 is estimated between $5 billion and $10 billion based on addressing 20% of the patient population [8] Partnership with J&J - The deal with J&J includes $2.6 billion in milestones and royalties ranging from low teens to low twenties percentage [8] - J&J is responsible for running three trials for NBTXR3, with the aim of broad commercialization [7][8] Clinical Data and Efficacy - In a Phase 1 study, NBTXR3 showed an 81% overall response rate and a 63% complete response rate among treated patients, with a median overall survival of 23 months [17][18] - The ongoing Phase 3 trial aims to improve progression-free survival (PFS) from nine months to 13 months, which could serve as registration data for the FDA [25] Future Directions - J&J has initiated a Phase 1 study for cisplatin-eligible head and neck cancer patients, indicating confidence in expanding the use of NBTXR3 [26] - The company is also exploring the use of NBTXR3 in lung cancer, where radiation therapy is widely used [29][30] Additional Important Content Other Platforms - Nanobiotix is developing Curadigm, a technology aimed at improving the delivery of various therapies by preventing their capture by the liver, thus enhancing systemic distribution [39][40] - The company is positioned to leverage its nanophysics-based approach beyond oncology, indicating potential for significant business development opportunities [39][40] Regulatory and Market Readiness - The transfer of the Phase 3 trial to J&J was completed in September 2025, with expected interim data in H1 2027 [24] - The company anticipates significant revenue from the J&J partnership, with plans for commercialization and recurrent revenue from royalties [38] This summary encapsulates the key points discussed during the Nanobiotix conference call, highlighting the company's innovative approach, market potential, partnership dynamics, and future directions in research and development.

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 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].

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].

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - Edmund Ingham, a biotech consultant with over five years of experience, leads the investing group Haggerston BioHealth and has compiled detailed reports on more than 1,000 companies [1]

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Core Insights - Nanobiotix presented new data from the third cohort of its Phase I 1100 study in melanoma at the Immunorad conference in Paris [2] Company Overview - The conference call was led by Joanne Choi, Head of U.S. Investor Relations, and included participation from Laurent Levy, Co-Founder and CEO [3] Research and Development - The call discussed forward-looking statements regarding the company's research and clinical development, highlighting the potential for significant risks and uncertainties that may affect actual results [3]

Summary of Nanobiotix Conference Call on Melanoma Study Results Company and Industry - **Company**: Nanobiotix - **Industry**: Oncology, specifically focused on melanoma treatment Core Points and Arguments 1. **Study Overview**: The conference call discussed new data from the third cohort of the Phase I 1100 study in melanoma, presented at the ImmunoRad Conference in Paris [2][4] 2. **Product Focus**: NBTXR3 is designed for patients receiving radiation therapy, which constitutes around 60% of cancer patients. The product aims to address unmet medical needs in patients who have failed multiple lines of treatment [4][5] 3. **Patient Recruitment**: A total of 21 patients were recruited for the study, with 19 evaluable for efficacy. The majority of these patients were advanced stage III and IV melanoma patients who had failed PD-1 and other treatments [6][8] 4. **Efficacy Results**: The study reported an overall response rate of 47%, with 9 out of 19 patients achieving complete response (CR) or partial response (PR). The disease control rate (DCR) was noted to be 78% [9][15] 5. **Safety Profile**: No grade four or five adverse events were reported related to NBTXR3, and the safety profile was consistent with previous trials [7][15] 6. **Overall Survival**: The median overall survival (OS) was reported at 14.6 months, with a confidence interval ranging from 11.6 months to non-reach [11][12] 7. **Immune Response**: There is a potential for NBTXR3 to prime an immune response, particularly in patients who have exhausted other treatment options. This was suggested by the correlation between injected irradiated lesions and systemic responses [11][20] 8. **Future Development Plans**: The company is considering further development of NBTXR3 in earlier treatment settings for melanoma and potentially in combination with other therapies [25][27] Additional Important Content 1. **Regulatory Considerations**: Future trials will need to be discussed with regulatory agencies like the FDA, especially regarding the control arm for randomized trials [21][22] 2. **Comparative Context**: The median OS of 14.6 months compares favorably to historical data for similar patient populations, where median OS after failure of PD-1 treatments is around 6.8 months [44][45] 3. **Pipeline Strategy**: Nanobiotix is exploring multiple indications for NBTXR3, with ongoing trials in head and neck cancer and lung cancer being run by Janssen [27][49] 4. **Patient Characteristics**: The study did not find significant baseline characteristics that influenced treatment outcomes, indicating a broad applicability of NBTXR3 across different patient profiles [33][39] This summary encapsulates the key findings and discussions from the Nanobiotix conference call, highlighting the potential of NBTXR3 in treating advanced melanoma and the company's strategic direction moving forward.

Immunorad September 2025 Data on Phase 1 Trial Safety and preliminary efficacy of NBTXR3/SBRT in combination with Immune Checkpoint Inhibitors in anti-PD-1 resistant patients with melanoma treated in the phase I trial Study 1100 Cohort 3 – Melanoma Subgroup Analysis Jason W. Chan, MD, Ari Rosenberg, MD, Alexander Lam, MD, James Lee, MD, Adil Daud, MD, William A. Stokes, MD,Nabil F. Saba, MD, Frances Collichio, MD, Hyeon Yu, MD, Priya Mody, MD, Jared Weiss, MD, Stergios Moschos, MD,Steven Powell, MD, Shannon ...

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]