Nanobiotix S.A. American Depositary Shares - NBTX STOCK NEWS

Nanobiotix announced new data from Study 1100, showing disease control and tumor response in patients treated with RT-activated NBTXR3 followed by anti-PD-1 therapy for second-line or later recurrent/metastatic head and neck squamous cell carcinoma (R/M-HNSCC). The study involved 68 heavily pre-treated patients. Results indicated a 48% overall response rate (ORR) and 76% disease control rate (DCR) in anti-PD-1 naïve patients, and a 28% ORR and 68% DCR in anti-PD-1 resistant patients. For the naïve patients, median progression-free survival (mPFS) was 7.3 months, and median overall survival (mOS) was 26.2 months. For resistant patients, mPFS was 4.2 months, and mOS was 7.8 months. The treatment showed favorable safety and feasibility, with serious Grade 3+ adverse events occurring in 8.8% of patients. These promising early efficacy signals were presented at ASCO 2024, and Nanobiotix plans further exploration in randomized trials.

NANOBIOTIX (Euronext: NANO, NASDAQ: NBTX) has announced the presentation of new data from its US Phase 1 Study 1100 at the 2024 Annual Meeting of the American Society for Clinical Oncology (ASCO). The study evaluates NBTXR3 combined with anti-PD-1 therapy in patients with recurrent or metastatic head and neck cancer. Coordinating Investigator Colette Shen, MD, PhD, will present early efficacy signs, involving 68 patients (33 anti-PD-1 naive and 35 anti-PD-1 resistant). Following the ASCO presentation on June 2nd, 2024, Nanobiotix will host an investor conference call. The data from the dose escalation part and the ongoing expansion part demonstrate promising early results, particularly in a challenging patient population.

NANOBIOTIX (Euronext: NANO, NASDAQ: NBTX), a biotechnology company in its late-clinical stage, is set to participate in the Jefferies Global Healthcare Conference. This event is scheduled for June 5, 2024, at 5:00 PM EDT in New York, NY. Bart Van Rhijn, the CFO of Nanobiotix, will be leading a fireside chat that will be webcast live on the company's website. The webcast will also be available for replay post-event.

NANOBIOTIX (Euronext: NANO, NASDAQ: NBTX), a late-clinical stage biotech company, released its Q1 2024 operational and financial update on May 22, 2024. The company reported cash and cash equivalents of €58.9 million as of March 31, 2024, which, along with a $20 million milestone payment, is projected to fund operations into Q3 2025. NANOBIOTIX will hold a conference call and webcast to discuss these updates and take questions. The CEO, Laurent Levy, will lead the session.

Nanobiotix has announced significant progress in its global collaboration with Janssen to develop and commercialize its radioenhancer NBTXR3. This collaboration aims to expand the application of NBTXR3 in treating cancer patients who undergo radiotherapy. Key updates include the removal of a planned futility analysis for the ongoing Phase 3 head and neck cancer trial, with interim analysis results expected in 1H2026. Additionally, the company received FDA approval to proceed with a new Phase 2 study for lung cancer. These advancements are part of a broader strategy to leverage NBTXR3’s potential to fund the development of other nanoparticle-based therapies. Nanobiotix is also aligning with Janssen on global manufacturing and operational strategies, including a transfer of trial sponsorship to Janssen and a focus on expanding indications beyond head and neck and lung cancer.

Nanobiotix has disclosed updated information on its share capital and voting rights in compliance with French regulations. As of April 30, 2024, the company has 47,133,328 outstanding shares. The total number of theoretical voting rights is 48,903,298, while exercisable voting rights stand at 48,881,180. This update follows Articles L.233-8 II of the French Commercial Code and 223-16 of the General Regulation of the French Financial Markets Authority. Nanobiotix will continue to publish monthly updates if there are changes in these figures.

NANOBIOTIX (Euronext: NANO, NASDAQ: NBTX), a late-clinical stage biotechnology company, will announce its Q1 2024 financial and operational results on May 22, 2024, before US and EU markets open.

The announcement will be followed by a conference call and webcast at 8:00 am EDT / 2:00 pm CEST, featuring CEO Laurent Levy and CFO Bart van Rhijn, who will review the results and provide a business update.

The company's next Annual General Meeting (AGM) is scheduled for May 28, 2024, at its Paris headquarters. Meeting details and related documents are available on NANOBIOTIX's website.

NANOBIOTIX has announced that the US FDA has issued a Study May Proceed Letter for a new Phase 2 study evaluating NBTXR3 in patients with stage 3, unresectable non-small cell lung cancer (NSCLC). The study is sponsored by Johnson & Johnson Enterprise Innovation Inc., a subsidiary of Johnson & Johnson. This progress is part of Nanobiotix's global licensing agreement with Janssen Pharmaceutica NV, aimed at expanding the application of NBTXR3 to new cancer indications. The acceptance of this protocol by the FDA is seen as a significant step towards potentially providing improved treatment outcomes for a new group of cancer patients.

NANOBIOTIX provided a business update and reported full-year 2023 financial results. The company entered into a global agreement with Janssen for its radioenhancer NBTXR3, saw positive clinical trial results in head and neck cancer and pancreatic cancer, and expects multiple clinical readouts in 2024. The company reported €75.3 million in cash and cash equivalents as of December 31, 2023, with a cash runway into Q3 2025. The 2023 Universal Registration Document was filed with the French financial market authority and the 2023 Annual Report on Form 20-F was filed with the U.S. Securities and Exchange Commission. Nanobiotix also announced a conference call and webcast scheduled for April 25, 2024, to discuss these updates.