Global licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV ("Janssen") expands worldwide potential of novel radioenhancer NBTXR3 Prolonged survival in Study 102 reinforces pivotal NANORAY-312 trial design in head and neck cancer; initial efficacy and favorable safety profile supports potential of NBTXR3 in pancreatic cancer; determined RP2D for MD Anderson lung study Multiple clinical readouts expected in 2024 including immunotherapy combination data from Study 1100, and data from MD Anderson program €75.3 million in cash and cash equivalents as of December 31, 2023 with cash runway into Q3 2025 including the $20 million first development milestone due from Janssen 2023 Universal Registration Document filed with the French financial market authority and the 2023 Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission Conference call and webcast scheduled for April 25, 2024 at 8:00 A.M. EDT / 2:00 P.M. CEST PARIS and CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, provided an update on operational progress and reported financial results for the year ended December 31, 2023, and announced the filing of its universal registration document (URD) for the financial year ended December 31, 2023 with the French financial market authority (Autorité des marchés financiers or AMF), as well as of the Annual Report on Form 20-F for the financial year ended December 31, 2023 with the U.S. Securities and Exchange Commission (SEC). "2023 was an incredible year of progress for Nanobiotix and our NBTXR3 program. This past summer, we entered into a global licensing, co-development and commercialization agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company, to expand NBTXR3, a potential first-in-class radioenhancer with universal application across solid tumors. NBTXR3 is designed to amplify anti-tumor activity and minimize healthy tissue exposure by directly acting inside the tumor. We continue to see compelling data generated in hundreds of patients to date and across eight different tumor types supporting a well-tolerated safety profile and robust efficacy," said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. "During 2023, we reported prolonged survival from Study 102 in head and neck cancer further reinforcing the design of our ongoing pivotal NANORAY-312 trial. In 2024, we expect immunotherapy combination data from our Study 1100 trial in head and neck cancer, as well as chemotherapy combination data in esophageal cancer from our MD Anderson collaboration." "Since June, we have secured $114 million in gross funding, which includes an equity offering, an investment from Johnson & Johnson Innovation, - JJDC, Inc. ("JJDC"), and a NANORAY-312 operational milestone. With our balance sheet strengthened, cash runway extended, the EIB cash covenant removed, and financial overhang addressed, we are strongly positioned to further advance and maximize the therapeutic potential of NBTXR3 within the solid tumor treatment landscape," said Bart Van Rhijn, chief financial officer of Nanobiotix. 2023 Operational Highlights, Subsequent Events, Pipeline Status and Upcoming Milestones Entered into a global exclusive licensing, co-development, and commercialization agreement with Janssen, for the investigational, potential first-in-class radioenhancer NBTXR3 (announced July 10, 2023) The Company has secured: $30 million upfront cash licensing fee $5 million first equity tranche received post signing $25 million second equity tranche (final payment received December 2023) $20 million for NANORAY-312 operational milestone (due to be received May 2024) The Company remains eligible to receive: Up to $30M in-kind regulatory and development support for study NANORAY-312 provided at Janssen's sole discretion Success-based payments of up to $1.8 billion and tiered double-digit royalties on net sales of NBTXR3 Additional success-based potential development and regulatory milestone payments of up to $650 million, in the aggregate, for five new indications that may be developed by Janssen at its sole discretion And up to $220 million, in the aggregate, per indication that may be developed by Nanobiotix in alignment with Janssen Raised a total of $64 million gross in a recent equity sale (inclusive of first and second equity tranches totaling $30 million from JJDC) LianBio's NBTXR3 rights in Asian markets transferred to Janssen including all rights and responsibilities and the potential for Nanobiotix to receive up to a remaining $205 million in milestones Strengthened global development capabilities with the appointment of industry veteran Louis Kayitalire, MD as Chief Medical Officer (CMO). Dr. Kayitalire brings proven success in the research, development, registration, and commercialization of therapeutics in oncology (September 5, 2023) Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): Local Control as Single Agent Activated by Radiotherapy NANORAY-312, a pivotal, global and randomized Phase 3 trial evaluating RT-activated NBTXR3 ± cetuximab vs RT ± cetuximab in elderly patients ineligible for cisplatin chemotherapy Futility analysis following 25% of planned progression free survival (PFS) events expected in H2 2024 Initial Phase 3 interim efficacy and safety data expected after 67% of planned PFS events in mid-2025 Study 102, a Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 in patients ineligible for cisplatin chemotherapy or intolerant to cetuximab Successfully completed study and presented topline safety and efficacy data as an oral presentation at the 65th Annual Meeting of the American Society for Radiation Oncology (ASTRO) supporting robust anti-tumor efficacy and well-tolerated profile in elderly patients with a high burden of comorbidity (n=56) 64% CR, 82% overall response rate (ORR) in injected-lesion in evaluable population (n=44) and median duration of response in the NBTXR3-injected lesion not yet reached 16.9 months mPFS and 23.1 months mOS in the evaluable population Additional signs of efficacy in an exploratory analysis presented at the 2023 Annual Congress of the European Society for Medical Oncology (ESMO) further support underlying hypotheses for the ongoing registrational Phase 3 NANORAY-312 study design 42.8 months median overall survival (OS) observed in the 82% of evaluable patients who had complete or partial response in the NBTXR3-injected lesion (36/44) compared to 18.1 months in All Patients Treated (n=56) Positive correlation associated with objective response, PFS and OS extension with RT-activated NBTXR3 in the injected lesion Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: Priming Immune Response Followed by an Anti-PD-1 Treatment: Study 1100, a Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 followed by an anti-PD-1 in patients with advanced cancers Phase 1 dose expansion data update anticipated 1H 2024 Pancreatic, Lung and Others: Expanding NBTXR3 Opportunity Through a Strategic Collaboration with The University of Texas MD Anderson Cancer Center to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profiles Five ongoing clinical trials in advanced solid tumors: Pancreatic Cancer: Phase 1b study (NCT04484909) of RT-activated NBTXR3 after cytotoxic chemotherapy for patients with locally advanced pancreatic cancer (LAPC) Feasibility and promising, durable anti-tumor efficacy of RT-activated NBTXR3 supported by preliminary Phase 1b dose escalation safety data (July 30, 2023 cutoff) presented at American Association for Cancer Research (AACR) 2023 Special Conference on Pancreatic Cancer Tolerable safety with local endoscopic injection in 15 patients 92% (12/13) injected tumor disease control rate in evaluable patients 21 months mOS from diagnosis in evaluable patients Additional preliminary signals of promising anti-tumor efficacy from the ongoing Phase 1b study (September 30, 2023 cutoff) presented at ESMO 2023 potentially help inform clinical trial development Favorable safety profile and recommended dose established 23 months mOS observed in 15 patients Four ongoing studies in: Advanced solid tumors with lung or liver metastases, recurrent or metastatic head and neck cancer, inoperable non-small cell lung cancer (NSCLC), and esophageal cancer. Multiple clinical milestones in 2024: Initial Phase 1b/2 data in esophageal cancer Completion of enrollment in Phase 1b dose expansion trial in pancreatic cancer Full Year 2023 Financial Results Revenue ...