NANOBIOTIX provides update and progress for Q3 2024 on nanotherapeutic platforms

Transferred US sponsorship of the global Phase 3 NANORAY-312 study in head and neck cancer, a key step in preparation for potential regulatory submission of the NBTXR3
Expert industry leaders have been added to the Supervisory Board, further strengthening support for the company’s long-term growth strategy
NBTXR3 program update from pancreatic cancer research and lung cancer research with MD Anderson expected 4Q 2024 and 1H 2025, respectively
Update on the expansion of the product portfolio with the disruptive nanotherapeutic platform Curadigm expected in the fourth quarter of 2024
€53.2 million in cash and cash equivalents as of September 30, 2024, with cash flow starting in Q4 2025

PARIS and CAMBRIDGE, Massachusetts, November 12, 2024 (GLOBE NEWSWIRE) — NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – de “Company”)a late-stage biotechnology company pioneering nanoparticle-based approaches to expand treatment options for patients with cancer and other serious diseases, provided an update on operational progress and reported financial results for the third quarter of 2024.

“Our strong momentum continues as we continue to execute initiatives designed to advance our potentially first-in-class nanoparticle-based therapeutic platforms to millions of patients worldwide. In the NBTXR3 program, we have initiated the sponsorship transfer of our global, pivotal NANORAY-312 “This is an important 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 worldwide who receive radiotherapy every year,” said Laurent. Levy, co-founder of Nanobiotix and Chairman of the Board of Directors: “We were also pleased to expand our Supervisory Board with leading experts from both the scientific and financial communities to drive long-term sustainable growth on our platforms. help promote. 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, the next wave of nanoparticle-based platforms from Nanobiotix.”

Operational highlights third quarter 2024

In a significant 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 who are not eligible for cisplatin, from Nanobiotix to Janssen. Nanobiotix has transferred sponsorship of the study in the United States to Janssen and is in the process of transferring the other global regions as planned. Nanobiotix estimates that this process will take several quarters. Janssen is the global licensee for the co-development and commercialization of NBTXR3 to submit NBTXR3 for global registration upon positive trial results.

The company has strengthened its Supervisory Board with the appointment of Dr. Margaret A. Liu and Ms. Anat Naschitz as board observers, two key additions intended to further equip the company for long-term sustainable growth. Dr. Liu brings a wealth of experience in US and international academia, pharmaceuticals, biotechnology and public policy, and Ms. Naschitz brings world-class expertise in raising and deploying capital to support disruptive innovation for the benefit of patients, healthcare professionals and investors.

Upcoming milestones

Janssen license agreement

Locally advanced squamous cell carcinoma of the head and neck (LA-HNSCC): Nanobiotix continues to expect the interim analysis for NANORAY-312 after the required number of events and the last patient enrolled in the first half of 2026

MD Anderson Collaboration

Pancreatic cancer: Updated Phase 1b dose escalation data expected in Q4 2024
NSCLC: Data on initial phase 1 dose escalations in unresectable, relapsed NSCLC amenable to re-irradiation expected in the first half of 2025
Esophageal cancer: Presentation of the first Phase 1b/2 data expected in 2025

Preclinical nanoparticle-based platforms

Curadigm Nanoprimer: Program update on Curadigm’s disruptive potential and the platform’s ability to redefine the discovery and design of next-generation therapies, expected in Q4 2024

Financial updates for the third quarter

Nanobiotix reported cash and cash equivalents of €53.2 million (unaudited) as of September 30, 2024.

Based on the current operating plan and financial projections, Nanobiotix expects cash and cash equivalents of €53.2 million as of September 30, 2024 to fund operations through the fourth quarter of 2025.

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product consisting of functionalized hafnium oxide nanoparticles administered via single intratumoral injection and activated by radiotherapy. The proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The physical mechanism of action (MoA) of the product candidate is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy. , which then triggers an adaptive immune response and long-term memory against cancer. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable for any solid tumor treatable with radiotherapy and for any therapeutic combination, especially immune checkpoint inhibitors.

Radiotherapy-activated NBTXR3 is being evaluated in multiple solid tumor indications, as monotherapy or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312 – a global, randomized Phase 3 study of locally advanced squamous cell cells in the head and neck. cancers. In February 2020, the U.S. Food and Drug Administration granted Fast Track regulatory designation to the study of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are ineligible for platinum-based chemotherapy. the same population being evaluated in the phase 3 study.

Given the company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaborative strategy to expand development of the product candidate in parallel with its priority development pathways. In line with this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across different tumor types and therapeutic combinations . In 2023, Nanobiotix announced a licensing agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV.

About NANOBIOTIX

Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The company’s philosophy is rooted in the concept of going beyond the limits of what is known to expand the possibilities for human life.

Founded in 2003, Nanobiotix is headquartered in Paris, France and has been listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The company has subsidiaries in Cambridge, Massachusetts (United States), among others.

Nanobiotix is the owner of more than 25 patent families associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) central nervous system disorders.

To learn more about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

Disclaimer

This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceeds therefrom, and the time period through which the company expects that its financial resources will be sufficient to support operations. Words such as “expects”, “intends”, “may”, “could”, “might”, “could”, “plans”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on the current expectations and assumptions of our management and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance , including the risk that assumptions underlying the company’s cash runway projections are not realized. Further information regarding the risk factors that may affect its business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 24, 2024 under “Item 3.D. Risk Factors”, in the universal registration of Nanobiotix for 2023. document filed with the AMF on April 24, 2024, in Nanobiotix’s 2024 semi-annual report under the heading “Additional Risk Factor” filed with the SEC on Form 6-K and with AMF on September 18, 2024, and subsequent filings that Nanobiotix files with the SEC from time to time and which are available on the SEC’s website at www.sec.gov. The forward-looking statements contained in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to publicly update these forward-looking statements.

Contacts

Appendix