20-F: Nanobiotix 2025 Annual Report: Strategic Shifts & Royalty Financing

Nanobiotix's 2025 annual report highlights a significant revenue increase driven by a Janssen agreement amendment, new royalty financing, and ongoing clinical trial advancements for its lead product candidate, NBTXR3.

Summary

• Net loss for 2025 was EUR 24.0 million, a significant improvement from EUR 68.1 million in 2024.
• Total revenues and other income increased to EUR 32.6 million in 2025 from a negative EUR 7.2 million in 2024, primarily due to a one-time positive impact of EUR 21.8 million from a contract modification to the Janssen Agreement in H1 2025.
• Other sales, mainly clinical product supplies to Janssen, contributed EUR 7.0 million in 2025.
• Research and development expenses decreased by 42.9% to EUR 23.1 million in 2025, largely due to the transfer of NANORAY-312 funding obligations to Janssen.
• Selling, General and Administrative (SG&A) expenses remained stable at EUR 20.4 million in 2025.
• Net financial loss increased to EUR 13.1 million in 2025 from a EUR 0.4 million income in 2024, mainly due to unfavorable foreign exchange changes and higher interest expenses.
• Cash and cash equivalents stood at EUR 52.8 million as of December 31, 2025, up from EUR 49.7 million in 2024.
• The company secured a royalty financing agreement with HCRx for up to $71 million, with an initial $50 million gross installment received on December 2, 2025.
• The EIB finance contract was amended, requiring 2% of Royalty Financing proceeds towards a EUR 20.0 million milestone payment, of which EUR 0.9 million was prepaid in 2025, leaving EUR 18.1 million outstanding.
• Global sponsorship of the NANORAY-312 Phase 3 trial for head and neck cancer was transferred to Johnson & Johnson Enterprise Innovation (JJEI) in 2025, with J&J assuming nearly all remaining costs.
• Clinical trials for NBTXR3 are ongoing in head and neck, lung, pancreatic, and esophageal cancers, with positive safety and efficacy signals observed across tumor types.
• The company continues to develop its Nanoprimer (Curadigm) and Neurological disease (OOcuity) platforms, which are in preclinical and discovery stages, respectively.

Sentiment

Score: 8

Explanation: StockSavvy.ai views this as a strong positive report, primarily driven by the significant financial restructuring and de-risking of the NANORAY-312 trial through the Janssen agreement amendment and the new HCRx royalty financing, which substantially improved the company's liquidity and reduced R&D burden. Promising clinical data across multiple indications for NBTXR3 further reinforces its potential, despite the ongoing net losses typical for a late-stage biotech.

Positives

• Significant reduction in net loss to EUR 24.0 million in 2025 from EUR 68.1 million in 2024.
• Total revenues and other income increased substantially to EUR 32.6 million in 2025, from a negative EUR 7.2 million in 2024.
• A one-time positive revenue impact of EUR 21.8 million was recognized from the Janssen Agreement amendment.
• Secured a royalty financing agreement with HCRx for up to $71 million, with an initial $50 million received, strengthening liquidity.
• Transfer of NANORAY-312 Phase 3 trial sponsorship and most financial responsibility to Janssen, significantly reducing R&D expenses for Nanobiotix.
• Positive safety and efficacy signals observed for NBTXR3 in various tumor types, including head and neck, lung, pancreatic, and esophageal cancers.
• JNJ-1900 (NBTXR3) was granted Fast Track designation from the FDA for locally advanced head and neck cancers.
• Preliminary efficacy responses in the CONVERGE Phase 2 NSCLC trial showed an Objective Response Rate (ORR) of 71.4% and Disease Control Rate (DCR) of 100% in 7 patients, compared to an estimated benchmark of 45%-50%.
• Favorable safety profile and feasibility confirmed in Phase 1 NSCLC reirradiation trial (Study 2020-0123), with 12-month Local Progression-Free Survival (LPFS) of 64% and Overall Survival (OS) of 83%.
• Favorable safety and feasibility in Phase 1 pancreatic cancer trial (Study 2019-1001), with 2 patients achieving R0 surgical resection and an association between increased circulating tumor mutational burden (cTMB) and improved LPFS/OS.
• Positive initial clinical response in Phase 1 esophageal cancer trial (Study 2020-0122) with DCR of 85% and ORR of 69%, including 6 biopsy-confirmed complete responses.
• Long-term follow-up data for Act.In.Sarc (soft tissue sarcoma) reinforced a favorable benefit-risk ratio for JNJ-1900 (NBTXR3) plus radiotherapy.
• The company's cash and cash equivalents of EUR 52.8 million are expected to be sufficient for operations beyond the next twelve months.
• Women represent 50% of the Supervisory Board, 25% of the Executive Board, and 54% of total employees, reflecting a commitment to equality.

Negatives

• Net financial loss increased to EUR 13.1 million in 2025 from a EUR 0.4 million income in 2024, primarily due to unfavorable foreign exchange results and higher interest expenses.
• Research tax credit decreased by EUR 0.5 million in 2025 due to lower tax credit recognized in Nanobiotix Corp and Nanobiotix SA, partly from French regulatory changes.
• The EIB loan's PIK interest prepayment requirement could be triggered if the cash balance exceeds $150 million for 60 days, starting June 30, 2027.
• The Royalty Financing agreement's contractual multiple increases from 175% to 250% of the subscription price if not repaid by December 31, 2030, increasing total repayment obligation.
• The second installment of $21 million from HCRx is contingent on no clinical hold or termination of NANORAY-312 and/or CONVERGE clinical trials for 60+ days in the 12 months following December 1, 2025.
• The company has a history of operating losses and negative cash flows from operations since inception, with cumulative losses totaling EUR 400.8 million.
• The company does not expect to generate revenue from product sales in the near future and will require additional funding to pursue preclinical and clinical activities.
• The regulatory transfer process for NANORAY-312 is still ongoing in the Philippines and expected to be finalized by Q3 2026.

Risks

• Difficulty in evaluating current business and future prospects due to being a late-stage clinical development company pioneering disruptive, physics-based therapeutic approaches.
• Anticipation of continued significant losses for the foreseeable future.
• Need to obtain additional funding, which may not be available on acceptable terms or at all, potentially forcing delays, limits, or termination of product development.
• Lead product candidate JNJ-1900 (NBTXR3) is in various phases of development and may be unsuccessful.
• Initial, interim, and preliminary clinical data may change as more patient data becomes available and is subject to audit and verification.
• Substantial delays in clinical trials of JNJ-1900 (NBTXR3), including NANORAY-312, or failure to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
• Even if clinical trials are successfully completed, JNJ-1900 (NBTXR3) may not be successfully commercialized for other reasons.
• Issues in the complex manufacturing process for JNJ-1900 (NBTXR3) could adversely affect technology transfer to Janssen, business, financial position, or prospects.
• Difficulty enrolling patients could delay timelines or prevent clinical studies.
• Failure to achieve projected development milestones and commercialization in expected timeframes could adversely impact milestone payments and harm the business.
• Product candidates beyond JNJ-1900 (NBTXR3) are in early stages and may be unsuccessful or cause undesirable side effects.
• Future profitability depends on Janssen's ability to penetrate global markets, subject to additional regulatory burdens and risks.
• Heightened risk due to reliance on Janssen for JNJ-1900 (NBTXR3) development and commercialization, including potential termination of agreements.
• Third parties relied upon for development programs may not perform satisfactorily.
• Access to raw materials and starting materials for clinical trials and manufacturing is not guaranteed.
• Need to develop and expand the company, with potential difficulties in managing growth.
• Product liability lawsuits could divert resources, result in substantial liabilities, and reduce commercial potential.
• Future material weaknesses in internal control over financial reporting could adversely affect financial reporting and investor confidence.
• Internal computer systems or those of third-party contractors may fail or suffer security breaches, including cybersecurity breaches, leading to disruption or loss of data.
• Consolidated financial statements rely on estimates and assumptions, so actual results may vary significantly.
• Rigorous, complex, and evolving regulatory framework results in significant compliance costs and unpredictable development/approval.
• Fast Track, Breakthrough Therapy, Priority Review, or Accelerated Approval designations may not lead to faster development or approval.
• Government restrictions on pricing and reimbursement, and other cost-containment initiatives, may negatively impact revenue generation.
• Ability to compete may decline if proprietary rights are not adequately protected.
• Inability to protect confidentiality of trade secrets would harm business and competitive position.
• Patents and patent applications involve complex legal and factual questions, which could negatively impact competitive position if determined adversely.
• Disputes concerning infringement or misappropriation of proprietary rights could be time-consuming and costly.
• Dependence on key management personnel and ability to attract/retain qualified personnel.
• Rights of shareholders under French corporate law differ from U.S. corporations.
• By-laws and French corporate law provisions may delay or discourage takeover attempts, and investments may require governmental authorization.
• Failure to maintain certain tax benefits applicable to French technology companies may adversely affect results.
• Potential classification as a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes.
• Exemption from certain U.S. securities laws as a foreign private issuer and following home country corporate governance practices.
• Holders of ADSs do not directly hold ordinary shares and may not be able to exercise voting rights.
• Right of ADS holders to participate in preferential subscription rights or elect dividends in shares may be limited, causing dilution.
• Limitations on transfer of ADSs and withdrawal of underlying ordinary shares.
• Market price for ADSs may be volatile or decline regardless of operating performance.
• Share ownership concentrated in principal shareholders and management, who can exercise substantial influence.

Future Outlook

The company expects its future cash operating expenses to remain stable or decrease modestly in the near future due to reduced financial obligations for the NANORAY-312 study. However, significant R&D expenses are anticipated as clinical development advances beyond NANORAY-312. Additional funding will be required to pursue preclinical and clinical activities, obtain regulatory approval, and commercialize product candidates. The company plans to finance operating activities through existing cash, the second installment of the HCRx Royalty deal (expected December 2026), equity offerings, debt and other non-dilutive financings, research tax credits, government subsidies, capital allocation optimization, and potential upfront fees and milestone payments under third-party collaborations. Management believes current cash and cash equivalents are sufficient to fund operations beyond the next twelve months. The company also intends to file amended tax returns in 2026 for 2022-2024 to exercise retroactive elections for R&D cost deductibility, which is expected to result in higher Net Operating Losses (NOLs) available to offset future taxable income. Development of the Curadigm and OOcuity platforms is being pursued for long-term growth.

Management Comments

• We believe we are solidifying our foundation for long term growth.
• We believe we are a pioneer and leader in the field of nanomedicine.
• We believe JNJ-1900 (NBTXR3) could significantly improve the prognosis for up to 12 million patients receiving radiation therapy each year and capture one of the largest untapped markets in oncology.
• Nanobiotix believes that this collaboration will accelerate the realization of JNJ-1900 (NBTXR3) promise for patients in need.
• Nanobiotix believes that JNJ-1900 (NBTXR3)s physical mode of action could make it broadly applicable across a multitude of solid tumor indications.
• We believe that the Curadigm technology could have broad implications across the healthcare system by increasing the efficacy of therapeutics at their current dose or lowering the necessary dose in order to decrease toxicity and cost, while preserving the same efficacy, thus allowing for novel therapeutic approaches.

Industry Context

StockSavvy.ai notes that Nanobiotix's focus on physics-based nanotherapeutics, particularly NBTXR3, positions it in a highly competitive oncology market characterized by intense R&D and rapid innovation. The strategic collaboration with Janssen and MD Anderson aligns with industry trends of large pharmaceutical companies partnering with biotech firms to de-risk and accelerate novel drug development. The pursuit of immuno-oncology combinations for NBTXR3 also reflects the broader industry shift towards enhancing immune responses in cancer treatment, especially for 'cold tumors' that are unresponsive to current checkpoint inhibitors. The company's exploration of Nanoprimer and Neurological disease platforms indicates a strategy to diversify beyond oncology, tapping into unmet needs in drug delivery and neurological conditions, which are also areas of significant industry investment and research.

Comparison to Industry Standards

• In the CONVERGE Phase 2 NSCLC trial, initial efficacy responses (ORR = 71.4%; DCR = 100%) in 7 patients were promising relative to the estimated benchmark (ORR = 45%-50%) from published literature (Hung, M. Et al. Medicine (Baltimore). 2019;98(27):e16167; Antonia SJ, et al. N Engl J Med. 2017;377(20):1919).
• In the Study 102 LA-HNSCC trial, median Progression-Free Survival (mPFS) of 11.4 months and median Overall Survival (mOS) of 18.1 months in the All treated population were prolonged compared with historical data (PFS ~9 months; OS ~12 months) from Moye et al. Oncologist (2015); Amini A, et al. Cancer (2016); and Shia et al. Cancers (2020).
• In the Phase 1 pancreatic cancer trial (Study 2019-1001), median OS of 16.3 months from start of radiotherapy (23 months from diagnosis) compares favorably to a historical review at MD Anderson of 144 LAPC patients treated with induction chemotherapy followed by radiotherapy, which reported a median OS of 19.2 months.
• Normalization of CA19-9, a surrogate marker for overall survival benefit, was observed in 59% of patients in the pancreatic cancer trial, compared to approximately 17% in a historical review at MD Anderson of 243 LAPC patients treated with standard of care.
• In the Act.In.Sarc (soft tissue sarcoma) Phase 2/3 trial, 16.1% of patients in the JNJ-1900 (NBTXR3) arm achieved pathological complete response compared to 7.9% in the control arm (p-value of 0.0448), demonstrating superior efficacy. R0 resection margin was 77% in the NBTXR3 arm vs. 64% in the control arm (p-value of 0.0424).

Management Changes

Corporate Governance

Legal Proceedings

• The company is not currently a party to any legal proceedings that, in the opinion of management, are likely to have a material adverse effect on its business.

Related Party Transactions

• Janssen Pharmaceutica NV is deemed to possess significant influence but not control, as the exclusive and worldwide licensee of JNJ-1900 (NBTXR3).
• Transactions with Janssen in 2025 included EUR 13,196 thousand in collections from Janssen (receivables EUR 2,136 thousand) and EUR 5,486 thousand in payments to Janssen (payables EUR 5,431 thousand).
• The company has a related-party transaction policy requiring supervisory board review and approval for transactions exceeding $120,000 or falling under French Commercial Code Article L. 225-86.

Stakeholder Impact

• Shareholders: Potential for dilution from future equity raises; impact of share price volatility on equity incentives; influence of principal shareholders on corporate actions.
• Employees: Equity incentive instruments (stock options, free shares) are used to attract and retain personnel; potential for severance pay in case of change of control.
• Customers (Patients): Development of NBTXR3 aims to transform cancer treatment and expand life for millions of patients; potential for improved local control and immune response in various cancers.
• Partners (Janssen, MD Anderson, HCRx): Collaboration agreements are critical for development and commercialization; financial terms and milestone payments are significant for company operations.
• Creditors (EIB, HCRx): Repayment obligations under loan and royalty financing agreements; potential for early repayment triggers or increased repayment multiples based on company performance and cash levels.

Next Steps

• Complete the regulatory transfer process for NANORAY-312 in the Philippines by Q3 2026.
• Receive the additional $21 million installment from HCRx in December 2026, subject to clinical trial conditions.
• Continue advancing the ongoing clinical trial of JNJ-1900 (NBTXR3) with Study 1100.
• Initiate, conduct, or fund additional clinical trials of JNJ-1900 (NBTXR3), including those with MD Anderson.
• Continue research and development of other product candidates, including the Curadigm and OOcuity platforms.
• Maintain and expand the intellectual property portfolio.
• Add operational, financial, and management information systems and personnel.
• Nanobiotix Corp intends to file amended tax returns in 2026 for 2022, 2023, and 2024 fiscal years to exercise retroactive elections for R&D cost deductibility.

Key Dates

Recommendation

Nanobiotix's 2025 annual report shows a significant improvement in financial health due to strategic agreements with Janssen and HCRx, which de-risk its lead product development and provide substantial funding. The positive clinical data for NBTXR3 across multiple cancer types is encouraging. However, the company remains in a pre-revenue stage from product sales, with continued reliance on external funding and milestone payments. While the long-term potential is strong, the inherent risks of late-stage biotech development, including regulatory hurdles and market acceptance, suggest a 'hold' position for seasoned investors, awaiting further definitive clinical outcomes and commercialization clarity.

Keywords

NBTXR3, JNJ-1900, Nanobiotix, Janssen, Oncology, Radiotherapy, Clinical Trials, Biotechnology, Nanomedicine, Drug Development, Head and Neck Cancer, Lung Cancer, Pancreatic Cancer, Esophageal Cancer, Soft Tissue Sarcoma, Immuno-oncology, Royalty Financing, SEC Filing, Financial Results, Pharmaceuticals, Medical Device, Curadigm, OOcuity, MD Anderson