Hensify (crystalline hafnium oxide) / Nanobiotix, LianBio, J&J - LARVOL DELTA

NANORAY-312: JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Johnson & Johnson Enterprise Innovation Inc. | Trial completion date: Dec 2027 ➔ Jun 2028

Trial completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

LUMIRAY: A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Johnson & Johnson Enterprise Innovation Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

NBTXR3 and Radiation Therapy for the Treatment of Inoperable Recurrent Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting | N=24 ➔ 34

Enrollment change • Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=40 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study 1100: NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy (clinicaltrials.gov) - P1 | N=145 | Active, not recruiting | Sponsor: Nanobiotix | Recruiting ➔ Active, not recruiting | Trial completion date: May 2028 ➔ Aug 2027

Enrollment closed • Trial completion date • Bladder Cancer • Breast Cancer • Cervical Cancer • Dermatology • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Endoscopic Ultrasound-Guided Injection of NBTXR3 Activated by Radiotherapy With Concurrent Chemotherapy for Esophageal Adenocarcinoma: Interim Analysis of Feasibility and Safety (ACG 2025) - "Only one patient each was treated at 15% and 22%, with 7 treated at 33% of the GTV, a total of 9 patients were enrolled (Table 1). There were no periprocedural adverse events (AEs) during EUS-FNI. All patients completed CRT without any toxicity that could be specifically attributable to R3."

Clinical • Esophageal Adenocarcinoma • Esophageal Cancer • Oncology • Solid Tumor

NANOBIOTIX Announces Strategic Royalty Monetization Agreement With Healthcare Royalty for up to $71 Million and Extends Cash Runway Toward Long-Term Growth (The Manila Times) - "$71 million in funding would extend Nanobiotix cash visibility into early 2028....HealthCare Royalty (HCRx) will receive a capped portion of milestones and royalties on sales of JNJ-1900 (NBTXR3) payable to Nanobiotix under its global licensing agreement....The Company continues to expect to receive the first potential milestone payments related to clinical development in head and neck cancer (NANORAY-312) and lung cancer (CONVERGE) within this timeframe, and has thereby established the financial foundation for self-sustaining long-term growth."

Financing • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Johnson & Johnson Enterprise Innovation Inc.

New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Oct 2025 ➔ Oct 2027 | Trial primary completion date: Oct 2025 ➔ Oct 2027

Trial completion date • Trial primary completion date • Cervical Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • Thoracic Cancer

NANOBIOTIX Announces First Data From Phase 1 Study Evaluating JNJ-1900 (NBTXR3) for Patients With Esophageal Cancer (GlobeNewswire) - "Treatment was well-tolerated and injection feasibility was confirmed in 13 patients with locally advanced adenocarcinoma of the esophagus. 85% (11/13) disease control rate (DCR). 69% (9/13) objective response rate (ORR); 6 complete responses and 3 partial responses. Recruitment of 17 additional patients is ongoing as planned. Data presented at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO) on October 1st."

P1 data • Esophageal Cancer

NANOBIOTIX Announces Updated Phase 1 Results Continuing to Support JNJ-1900 (NBTXR3) Plus Anti-PD-1 as a Potential New 1L or 2L+ Option in Anti-PD-1 Naïve or Resistant R/M-HNSCC (GlobeNewswire) - "Data presented as a 'Top-rated Abstract in Head and Neck Cancer' at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO)....63% (26/41) disease control rate ('DCR') and 37% (15/41) objective response rate ('ORR') in evaluable anti-PD-1 naïve patients per RECIST 1.1; 74% (37/50) DCR and 32% (16/50) ORR in evaluable anti-PD-1 resistant patients per RECIST 1.1; 15.5 months median Overall Survival ('mOS') in evaluable anti-PD-1 naïve patients."

P1 data • Squamous Cell Carcinoma of Head and Neck

Endoscopic Ultrasound Fine Needle Injection of NBTXR3 Activated by Radiotherapy with Concurrent Chemotherapy for Adenocarcinoma of the Esophagus: Feasibility and Safety of the Phase I Dose Escalation Part for the Photon-Based Cohort (ASTRO 2025) - "In this first cohort of 9 photon treated patients with EADC, the RP2D is 33%, without safety concerns, and no periprocedural or delayed adverse events were noted. Initial clinical response and outcomes are promising. The study continues accrual for the proton cohort."

Clinical • P1 data • Esophageal Adenocarcinoma • Esophageal Cancer • Oncology • Squamous Cell Carcinoma

Phase I Dose Escalation/Dose Expansion Trial of NBTXR3/SBRT in Combination with Nivolumab or Pembrolizumab for the Treatment of anti-PD-1 Naïve or Resistant Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (ASTRO 2025) - P1 | "Use of NBTXR3 when combined with SBRT and anti PD-1 was both feasible and well tolerated in patients with R/M HNSCC. These data compare favorably to historical controls and merit further investigation in randomized trials in this population."

Clinical • Combination therapy • Metastases • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

NANOBIOTIX Announces New Results From a Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Combination With Immune Checkpoint Inhibitors as a 2L+ Therapy for Patients With Primary Cutaneous Melanoma Resistant to Anti-PD-1 (GlobeNewswire) - "Recommended phase 2 dose (RP2D) established at 33% of gross tumor volume (GTV). 47.4% (9/19) best observed objective response rate (ORR) in all lesions per RECIST 1.1. 78.9% (15/19) best observed disease control rate (DCR) in all lesions per RECIST 1.1. 14.6 months median Overall Survival (mOS) in all patients treated (n=21)....Data presented on September 17 at the 2025 Immunorad Conference."

P1 data • Cutaneous Melanoma

NANORAY-312: JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Johnson & Johnson Enterprise Innovation Inc. | Trial completion date: Jun 2027 ➔ Dec 2027

Trial completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

NANOBIOTIX Announces Regulatory Harmonization and New Composition of Matter Patent Filed for JNJ-1900 (NBTXR3) (GlobeNewswire) - "NANOBIOTIX...announced two important developments that aim to reinforce the global positioning of potential first-in-class radioenhancer JNJ-1900 (NBTXR3), which is licensed by Janssen Pharmaceutica NV....Health authorities in major European countries have agreed to formally reclassify JNJ-1900 (NBTXR3) from a medical device to a drug, completing a process initiated by Johnson & Johnson to harmonize the product candidate’s regulatory status with classifications already in place in the United States and other major markets. The reclassification follows updated insights into the product candidate’s mechanism of action. In parallel, Nanobiotix has filed a new composition of matter patent for JNJ-1900 (NBTXR3) that aims to reinforce the intellectual property foundation supporting the product candidate."

Patent • Regulatory • Solid Tumor

NBTXR3, Radiation Therapy, and Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Cancer (clinicaltrials.gov) - P2 | N=14 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | N=60 ➔ 14 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • IO biomarker • Head and Neck Cancer • Lung Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Nanobiotix Provides First Quarter 2025 Operational and Financial Update (Nanobiotix Press Release) - "Strengthened financial position through an amendment to the global licensing agreement for JNJ-1900 (NBTXR3) which extended cash runway into mid-2026 and permanently reduced operational cash burn €39.8 million in cash and cash equivalents as of March 31, 2025"

Commercial • Non Small Cell Lung Cancer

Nanoray-312: phase III study of NBTXR3 + radiotherapy ± cetuximab in elderly, platinum-ineligible locally advanced HNSCC. (PubMed, Future Oncol) - P3 | "https://clinicaltrials.gov identifier is NCT04892173; EudraCT Number: 2021-002163-22."

Journal • P3 data • Head and Neck Cancer • Squamous Cell Carcinoma of Head and Neck

Nanoray Pancreas: A Phase I Study of NBTXR3 activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Cancer (LAPC or BRPC) (ESTRO 2025) - "NBTXR3/RT is safe for patients with LAPC and BRPC with an RP2D of 42% of GTV. Oncologic outcomes are encouraging and warrant further investigation in a phase 2 trial, with incorporation of cTMB and CA19-9 as correlative biomarkers."

Metastases • P1 data • Tumor mutational burden • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CA 19-9 • TMB

Nanobiotix Announces Full Results From Completed Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Pancreatic Cancer (GlobeNewswire) - P1 | N=24 | NCT04484909 | "NANOBIOTIX...announced the presentation of full results from the completed dose escalation and dose expansion phases of a Phase 1 study evaluating JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer....Median overall survival ('mOS'): 23 months from diagnosis [95% CI; 17 months – not reached]; For context, an MD Anderson historical review of 144 patients with LAPC treated at the same center showed a mOS of 19.2 months. Patients in the historical review received induction chemotherapy followed by RT with or without concurrent or maintenance chemotherapy (80% received RT with concurrent chemotherapy); Median local progression-free survival ('mLPFS'): 13.3 months from completion of radiation; Two LAPC patients achieved R0 surgical resection."

P1 data • Pancreatic Ductal Adenocarcinoma

Nanobiotix Announces Presentation of Full Results From Completed Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Pancreatic Cancer Followed by a Conference Call (GlobeNewswire) - "NANOBIOTIX...announced the presentation of full results from the completed dose escalation and dose expansion parts of a Phase 1 study evaluating JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer."

P1 data • Pancreatic Cancer

Results of phase Ib/II trial of PEP503 (NBTXR3, radioenhancer) with chemoradiotherapy in patients with rectal cancer. (PubMed, Nanomedicine (Lond)) - P1/2 | "A single administration of intratumor injection of PEP503 (NBTXR3) (multiple punctures) was applied, followed by radiotherapy in combination with capecitabine or 5-fluorouacil (5-FU)...The strong safety profile and encouraging efficacy of PEP503 (NBTXR3) in combination with neoadjuvant CCRT in locally advanced or unresectable rectal cancer warrant further examination in clinical studies. This study was registered on ClinicalTrials.gov Identifier: NCT02465593."

Journal • P1/2 data • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

NBTXR3 activated by SBRT in combination with nivolumab or pembrolizumab for the treatment of patients with lung metastases from NSCLC or other solid tumours in the phase I trial study 1100 (ELCC 2025) - P1 | "NBTXR3/RT in lung lesions was feasible and well tolerated in combination with anti-PD1. Promising early signs of efficacy were observed. These results support further evaluation of NBTXR3/RT in combination with ICI in pts with lung metastases."

Clinical • Combination therapy • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

NANOBIOTIX Provides Business Update and Reports Full Year 2024 Financial Results (GlobeNewswire) - "Clinical data readouts in 2025 from Phase 1 and 2 studies in RM-HNSCC, pancreatic cancer, NSCLC amenable to re-irradiation, melanoma and esophageal cancer."

P1 data • P2 data • Esophageal Cancer • Melanoma • Non Small Cell Lung Cancer • Pancreatic Cancer • Squamous Cell Carcinoma of Head and Neck