NANOBIOTIX Provides Business Update and Reports Full Year 2024 Financial Results
Global development program for JNJ-1900 (NBTXR3) proceeding as planned, with opportunity to address one of the largest untapped markets in oncology through lead programs in head and neck cancer and lung cancer
Disciplined financial strategy toward long-term sustainability and growth continues to strengthen financial position through focused allocation of capital, the receipt of a planned milestone payment, the transfer of sponsorship for NANORAY-312, and an amendment to the global licensing agreement for JNJ-1900 (NBTXR3)
Curadigm, a next generation nanotherapeutic platform designed to reshape drug design and development across multiple therapeutic classes and disease areas, has launched
Cash runway extended into mid-2026 and reduction of operational cash burn expected beyond mid-2026 with €49.7 million in cash and cash equivalents as of December 31, 2024
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
Conference call and webcast scheduled for April 3, 2025 at 8:00 A.M. EDT / 2:00 P.M. CEST
PARIS and CAMBRIDGE, Mass., April 02, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, provided an update on operational progress, reported financial results for the year ended December 31, 2024, and announced the filing of its universal registration document (URD) for the financial year ended December 31, 2024 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, 2024 with the U.S. Securities and Exchange Commission (SEC).
Operational Highlights
Addressing One of the Largest Untapped Markets in Oncology with JNJ-1900 (NBTXR3)1
Lead programs in head and neck cancer and lung cancer proceeding as planned
Ongoing Pivotal Phase 3 LA-HNSCC Study (NANORAY-312)
Aligned on intent to transfer the global NANORAY-312 sponsorship from Nanobiotix to Janssen Pharmaceutica NV, a Johnson & Johnson Company ("Johnson & Johnson") in 2Q2024 to begin preparations for interim analysis.
Completed the NANORAY-312 US sponsorship transfer from Nanobiotix to Johnson & Johnson, in 4Q2024, with intent to transfer NANORAY-312 globally to Johnson & Johnson by 3Q2025.
Ongoing Randomized Phase 2 Study in Unresectable Stage 3 NSCLC (CONVERGE)
First patient dosed in the Johnson & Johnson-sponsored Phase 2 randomized CONVERGE study evaluating JNJ-1900 (NBTXR3) for patients with unresectable stage 3 non-small cell lung cancer ("NSCLC") in 1Q2025
Multiple early-stage studies across solid tumor types beyond the lead programs continue to progress
RM-HNSCC (Phase 1 Study 1100 sponsored by Nanobiotix)
Presented new data showing disease control and tumor response in patients treated with JNJ-1900 (NBTXR3) followed by anti-PD-1 as a second-or-later line (2L+) therapy for patients with recurrent or metastatic ("RM") head and neck squamous cell carcinoma ("HNSCC") in 2Q2024
Locally Advanced or Borderline Resectable Pancreatic Cancer (Phase 1 Study MDA 2019-1001 sponsored by The University of Texas MD Anderson Cancer Center)
Completed a Phase 1 study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced or borderline resectable pancreatic cancer in 4Q2024 and investigators recommended that the encouraging oncologic outcomes coupled with a favorable safety profile warrant further exploration in a randomized study
US FDA approved a protocol amendment to the completed Phase 1 pancreatic cancer study in 4Q2024 enabling the launch of a new cohort designed to evaluate JNJ-1900 (NBTXR3) combined with standard-of-care concurrent chemoradiation ("CCRT") and recruitment is ongoing
NSCLC Amenable to Re-irradiation (Phase 1 Study MDA 2020-0123 sponsored by MD Anderson)
Completed the dose escalation part of a Phase 1 study evaluating JNJ-1900 (NBTXR3) for patients with inoperable, recurrent NSCLC amenable to re-irradiation ("reRT") and established the recommended Phase 2 dose (RP2D) at 33% of gross tumor volume in 4Q2024
Presented first data from the Phase 1 NSCLC reRT study showing a favorable safety profile and early signals of efficacy in 1Q2025
Disciplined Financial Strategy Toward Long-Term Sustainability and Growth
Received $20M first milestone payment related to NANORAY-312 from Johnson & Johnson in May 2024
Executed amendment to global licensing agreement for JNJ-1900 (NBTXR3) in 1Q2025, removing the vast majority Nanobiotix funding obligation for NANORAY-312 and releasing Johnson & Johnson from select future potential milestone payments, while safeguarding Nanobiotix's path to sustainable cashflow through hundreds of millions in potential milestone payments related to lead programs expected in the coming years
Extended cash runway to mid-2026 with a meaningful reduction in cash burn expected immediately and moving forward through and beyond mid-2026
Actively exploring preferably non-dilutive financing options to further extend cash visibility into 2027
Other Operational Highlights
Strengthened Supervisory Board with the nominations of Dr. Margaret A. Liu and Ms. Anat Naschitz as board observers in 3Q2024, 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
Ms. Naschitz brings world-class expertise in raising and deploying capital to support disruptive innovation for the benefit of patients, healthcare professionals and investors
Launched the Curadigm Nanoprimer Platform, the Company's next lever for growth, in 4Q2024
The platform consists of nanoparticles designed with specific physico-chemical properties that allow temporary occupation of the liver cells responsible for therapeutic clearance. This mechanism is intended to increase the blood bioavailability and subsequent accumulation of therapeutics in the targeted tissues, potentially providing the opportunity to increase the efficacy or decrease the toxicity of intravenously administered medicines. As such, it is a potentially ideal technology to be used by both Nanobiotix and potential partners.
____________________1 Potential first-in-class radioenhancer "NBTXR3" was licensed to Johnson & Johnson by Nanobiotix in 2023 and renamed "JNJ-1900" for the purposes of Johnson & Johnson-led clinical development.
"2024 was a productive year focused on strong clinical execution and establishing a foundation for the next stage of growth. We expanded into lung cancer with the dosing of the first patient in the CONVERGE Phase 2 trial evaluating the potential of JNJ-1900 (NBTXR3) to enhance the treatment of first-line Stage III lung cancer patients." said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. "Conviction in the broad potential of JNJ-1900 (NBTXR3) was further bolstered by the prolonged survival and well-tolerated safety reported across three key programs including Phase 1 data from Study 1100 evaluating NBTXR3 in combination with an anti-PD-1 in recurrent or metastatic head and neck cancer, as well as initial data supporting expansion potential in pancreatic and lung cancer as part of our MD Anderson collaboration. We also introduced our next generation first-in-class nanotherapeutic platform, Curadigm, late in 2024, which we expect to drive additional long-term value. With our financial position strengthened and new data this year in head and neck, lung, pancreatic, and esophageal cancer, we believe Nanobiotix is strongly positioned for impact in 2025 and beyond."
Full Year 2024 Financial Results
Revenue and Other Income: Negative Revenues of €7.2 million were recognized in 2024, compared to €36.2 million for the year ended December 31, 2023, in which year significant revenue was recorded in connection with the execution of the license agreement with Janssen as well as the recognition of a development milestone. The negative non-cash revenue impact recognized in 2024 results from the transfer of NANORAY-312 study sponsorship to Janssen, signed at the end of 2024, which amounts to negative €19.3 million and is driven by a one-time recognition of a net liability towards Janssen to reflect this new situation. This one-off, non-cash negative revenue item, that results from application of IFRS 15 revenue recognition accounting principles, is partially offset by Other Revenues that do positively impact Nanobiotix's cash position including: Sales of Clinical Products and goods to Janssen for €5.9 million, Technology Transfer Services billed to Janssen for €1.8 million, Research Tax Credit for €3.3 million and other income related to collaboration and supply services agreement in Asian territory for €1.0 million.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of preclinical, clinical, and manufacturing expenses related to the development of NBTXR3 (JNJ-1900) and totaled €40.5 million for the twelve-month period ended December 31, 2024, as compared to €38.4 million for the twelve months ended December 31, 2023, a year over year increase of 5%. The increase in net R&D expenses was primarily due to an increase of clinical development activities, driven by the costs related to NANORAY-312 and of its Phase 1 multi-cohort trial of RT-activated NBTXR3 followed by anti-PD-1 checkpoint inhibitors (Study 1100), and the full-year impact of R&D positions that were recruited in 2023.
Selling, General and Administrative ("SG&A") Expenses: ...
https://www.benzinga.com/pressreleases/25/04/g44615457/nanobiotix-provides-business-update-and-reports-full-year-2024-financial-results
