NANOBIOTIX Provides Third Quarter 2024 Update and Progress on Nanotherapeutics Platforms

Transferred US sponsorship of global Phase 3 NANORAY-312 head and neck cancer study, a key step in the preparation for potential NBTXR3 regulatory submission

Added expert industry leaders to Supervisory Board, further strengthening support for the Company's long-term growth strategy

NBTXR3 program update from pancreatic cancer study and lung cancer study with MD Anderson expected 4Q 2024 and 1H 2025, respectively

Update on expansion of product portfolio to include disruptive nanotherapeutic platform Curadigm expected 4Q 2024

€53.2 million in cash and cash equivalents as of September 30, 2024 with cash runway into 4Q 2025

PARIS and CAMBRIDGE, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering nanoparticle-based approaches to expand treatment possibilities for patients with cancer and other major diseases, provided an update on operational progress and reported financial results for the third quarter of 2024.

"Our strong momentum continues as we further execute across initiatives designed to advance our potentially first-in-class nanoparticle-based therapeutic platforms for millions of patients worldwide. In the NBTXR3 program, we began sponsorship transfer of our global, pivotal NANORAY-312, which is a key step for the potential regulatory submission of NBTXR3 and the promise of our lead candidate to help address the unmet needs of 12 million patients with solid tumors globally who receive radiotherapy each year," said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. "We were also pleased to expand our Supervisory Board to include leading experts in both the scientific and financial communities to help foster sustainable long-term growth across our platforms. In the fourth quarter, we expect updated dose escalation data for NBTXR3 in pancreatic cancer from our MD Anderson collaboration, as well as an update to our Curadigm program, which is the next-wave of nanoparticle-based platforms from Nanobiotix."

Third Quarter 2024 Operational Highlights

In an important step forward for the potential NBTXR3 regulatory pathway, Nanobiotix and Janssen Pharmaceutica NV, a Johnson & Johnson Company ("Janssen"), have initiated the planned sponsorship transfer of NANORAY-312, a global Phase 3 study evaluating radiotherapy-activated NBTXR3 for patients with head and neck cancer ineligible for cisplatin, from Nanobiotix to Janssen. Nanobiotix has transferred the sponsorship of the study in the United States to Janssen as planned. The process of transferring the remaining global regions is ongoing. Nanobiotix estimates this process will require several quarters to complete. Janssen is the global licensee for NBTXR3 co-development and commercialization. Accountability for the NANORAY-312 sponsorship will enable the licensee to submit NBTXR3 for global registration in the event of positive trial results.

The Company strengthened its Supervisory Board with the nominations of Dr. Margaret A. Liu and Ms. Anat Naschitz as board observers, two key additions intended to further equip the Company for sustainable long-term growth. Dr. Liu brings a wealth of experience in US and international academia, pharmaceuticals, biotechnology and public policy, and Ms. ...