Swayampakula Ramakanth

Lucy-Emma Codrington-Bartlett

Clément Bassat

Clement Sears

Elliott Bosco

Jonathan Chang

Lucy Codrington

Michael Schmidt

Shan Hama

Xiaochuan Dai

Yen-Der Li

Yihan Li

- **Nanobiotix S.A.** has completed the transfer of sponsorship and full operational control of the **NANORAY-312 Phase 3 clinical trial** for JNJ-1900 (NBTXR3) to Johnson & Johnson, a process initiated in **3Q2024**.  **[1760854_0001171843-25-006647_exh_991.htm:0]** 
- Following this transfer, Nanobiotix estimates that **interim data for NANORAY-312 will be analyzed and reported in the first half of 2027**.  **[1760854_0001171843-25-006647_exh_991.htm:0]** 
- Future guidance for JNJ-1900 (NBTXR3)-related studies sponsored by J&J will be communicated by J&J, while Nanobiotix will continue to provide updates for its own and The University of Texas MD Anderson Cancer Center-sponsored studies.  **[1760854_0001171843-25-006647_exh_991.htm:0]**

Nanobiotix Updates JNJ-1900 (NBTXR3) Clinical Program

- Nanobiotix announced **first data** from a Phase 1 study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced adenocarcinoma of the esophagus on **October 1, 2025**.  **[1760854_0001171843-25-006226_exh_991.htm:0]** 
- The treatment was **well-tolerated**, and injection feasibility was confirmed in **13 patients**.  **[1760854_0001171843-25-006226_exh_991.htm:0]** **[1760854_0001171843-25-006226_exh_991.htm:1]** 
- Key efficacy signals included an **85% disease control rate** and a **69% objective response rate**, with 6 complete responses and 3 partial responses.  **[1760854_0001171843-25-006226_exh_991.htm:0]** **[1760854_0001171843-25-006226_exh_991.htm:2]** 
- Recruitment of **17 additional patients** for the study is ongoing as planned.  **[1760854_0001171843-25-006226_exh_991.htm:0]**

Nanobiotix Announces First Data from Phase 1 Study of JNJ-1900 (NBTXR3) for Esophageal Cancer

- Nanobiotix reported a significant increase in revenue and other income to **€26.6 million** for the first half of 2025, up from €9.3 million in H1 2024, primarily driven by a **€21.2 million** one-off positive impact from an amendment to the Janssen Agreement.  **[1760854_0001628280-25-043232_nbx-20250630.htm:7]** **[1760854_0001628280-25-043232_nbx-20250630.htm:34]**  The company achieved an **operating income of €0.8 million** for H1 2025, a substantial improvement from a €23.7 million operating loss in H1 2024, and reduced its net loss to **€5.4 million** from €21.9 million in the prior year.  **[1760854_0001628280-25-043232_nbx-20250630.htm:7]** 
- In March 2025, Nanobiotix and Janssen Pharmaceutica NV (J&J) amended their License Agreement, transferring almost full financial responsibility for the ongoing Phase 3 NANORAY-312 trial to J&J and adjusting total expected payments from **$2.7 billion to $2.6 billion**.  **[1760854_0001628280-25-043232_nbx-20250630.htm:5]** **[1760854_0001628280-25-043232_nbx-20250630.htm:16]** 
- As of June 30, 2025, Nanobiotix held **€28.8 million** in cash and cash equivalents  **[1760854_0001628280-25-043232_nbx-20250630.htm:15]** **[1760854_0001628280-25-043232_nbx-20250630.htm:32]**  and projects it can finance its activities into **mid-2026**.  **[1760854_0001628280-25-043232_nbx-20250630.htm:33]**  Net cash flows used in operating activities for the six-month period ended June 30, 2025, increased to **€(17.4) million** compared to €(5.8) million in the same period of 2024, mainly due to lower cash inflows from Janssen.  **[1760854_0001628280-25-043232_nbx-20250630.htm:9]** 
- The company advanced its JNJ-1900 (NBTXR3) clinical program, with J&J dosing the first patient in the CONVERGE randomized global Phase 2 trial for NSCLC in Q1 2025.  **[1760854_0001628280-25-043232_nbx-20250630.htm:4]**  Additionally, Phase 1 results for recurrent NSCLC showed promising early efficacy signals with a 12-month LPFS of **64%** and 12-month OS of **83%**, while full Phase 1 data for pancreatic cancer demonstrated a median overall survival of **23.0 months** and CA19-9 normalization in **59%** of patients.  **[1760854_0001628280-25-043232_nbx-20250630.htm:5]**

Nanobiotix Reports Improved H1 2025 Financials Driven by Amended Janssen Agreement and Clinical Progress

- Nanobiotix S.A. reported **half year 2025 revenue and other income of €26.6 million**, a significant increase from €9.3 million in the prior year, primarily due to a **€21.2 million positive non-cash revenue impact** from an amendment to the J&J agreement, which also contributed to a reduced **net loss of €5.4 million** for the period ended June 30, 2025.  **[1760854_0001171843-25-006189_exh_991.htm:1]** 
- As of June 30, 2025, **cash and cash equivalents stood at €28.8 million**.  **[1760854_0001171843-25-006189_exh_991.htm:1]**  An amendment to the J&J global licensing agreement has extended the company's **cash visibility to mid-2026**.  **[1760854_0001171843-25-006189_exh_991.htm:0]** 
- However, Nanobiotix anticipates its current cash will be **insufficient to fund operations over the next twelve months**, leading to a material uncertainty regarding its ability to continue as a going concern, although it is actively discussing non-dilutive financing.  **[1760854_0001171843-25-006189_exh_991.htm:1]** **[1760854_0001171843-25-006189_exh_991.htm:2]** 
- Operationally, the company achieved milestones including the **first patient dosed in the J&J-sponsored CONVERGE study** for JNJ-1900 (NBTXR3) in NSCLC and the **regulatory reclassification of JNJ-1900 (NBTXR3) from a medical device to a drug** in major European countries.  **[1760854_0001171843-25-006189_exh_991.htm:0]**

Nanobiotix S.A. Reports Half Year 2025 Financial Results and Business Update

- Nanobiotix announced updated **Phase 1 results** for JNJ-1900 (NBTXR3) in combination with anti-PD-1 for recurrent/metastatic head and neck squamous cell carcinoma (R/M-HNSCC) on **September 29, 2025**.  **[1760854_0001171843-25-006152_exh_991.htm:0]** 
- The treatment demonstrated a **well-tolerated safety profile** and **consistent injection feasibility** in **103 heavily pre-treated patients**.  **[1760854_0001171843-25-006152_exh_991.htm:0]** **[1760854_0001171843-25-006152_exh_991.htm:1]** 
- Efficacy signals included a **63% Disease Control Rate (DCR)** and **37% Objective Response Rate (ORR)** in evaluable anti-PD-1 naive patients, and a **74% DCR** and **32% ORR** in evaluable anti-PD-1 resistant patients.  **[1760854_0001171843-25-006152_exh_991.htm:0]** **[1760854_0001171843-25-006152_exh_991.htm:2]** 
- Median Overall Survival (mOS) was **15.5 months** in evaluable anti-PD-1 naive patients and **11.4 months** in evaluable anti-PD-1 resistant patients.  **[1760854_0001171843-25-006152_exh_991.htm:0]** **[1760854_0001171843-25-006152_exh_991.htm:3]** 
- Investigators concluded that these promising results **warrant further exploration in randomized controlled trials**.  **[1760854_0001171843-25-006152_exh_991.htm:0]** **[1760854_0001171843-25-006152_exh_991.htm:3]**

Nanobiotix Announces Updated Phase 1 Results for JNJ-1900 (NBTXR3)

- Nanobiotix announced new data from the **third cohort of its Phase I 1100 study** for NBTXR3 in patients with **refractory melanoma** who had failed multiple prior treatments, including PD-1.  **[1760854_2147060_0]** **[1760854_2147060_1]** **[1760854_2147060_2]** 
- The study demonstrated an **overall response rate of 47%** (9 out of 19 evaluable patients achieved CR or PR) and a **disease control rate of 78%**.  **[1760854_2147060_2]** **[1760854_2147060_3]** 
- The median overall survival was **14.6 months**, with a confidence interval from 11.6 months to non-reach.  **[1760854_2147060_2]** **[1760854_2147060_3]** **[1760854_2147060_8]** 
- The safety profile showed **no grade four or five adverse events** related to the product or injection, and no serious adverse events were observed.  **[1760854_2147060_1]** **[1760854_2147060_8]** 
- The company views these results as supportive for advancing NBTXR3 into a **randomized trial** for this patient population, with ongoing discussions with partner Janssen regarding next steps for development.  **[1760854_2147060_3]** **[1760854_2147060_5]** **[1760854_2147060_9]**

Nanobiotix Presents Positive Phase I Data for NBTXR3 in Refractory Melanoma

- Nanobiotix S.A. reported new Phase 1 study results for **JNJ-1900 (NBTXR3)** in combination with immune checkpoint inhibitors for patients with primary cutaneous melanoma resistant to anti-PD-1, demonstrating a **favorable safety profile** and **early efficacy signals**.  **[1760854_0001171843-25-005941_exh_991.htm:0]** 
- As of the **August 21, 2025**, data cutoff, the study showed a **47.4% (9/19) objective response rate (ORR)** and a **78.9% (15/19) disease control rate (DCR)** in all lesions for evaluable patients.  **[1760854_0001171843-25-005941_exh_991.htm:0]** **[1760854_0001171843-25-005941_exh_991.htm:1]** 
- The median Overall Survival (mOS) for all **21 treated patients** was **14.6 months**, with investigators concluding the data warrant further investigation in randomized clinical trials.  **[1760854_0001171843-25-005941_exh_991.htm:0]** **[1760854_0001171843-25-005941_exh_991.htm:1]**

Nanobiotix (NBTX)