PARIS & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Regulatory News:
NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ”company”), a late-stage clinical-stage biotechnology company developing breakthrough physics-based approaches to expand the treatment options for cancer patients, today announced that it has entered into a €30.7 million agreement in principle to restructure outstanding European Investment Bank (“EIB”) debt.
“The European Investment Bank has been steadfast in supporting potentially disruptive innovations in healthcare across the European Union, and this agreement in principle is a testament to its strength as a strategic partner,” said Bart Van Rhijn, Chief Financial Officer of Nanobiotix. “Given the macroeconomic volatility and the impact on the entire biotechnology industry, Nanobiotix continues to prioritize leading registration programs for NBTXR3 as a single agent activated by radiation therapy and in combination with checkpoint inhibitors for the treatment of head and neck cancer. The restructuring of existing debt obligations to extend the maturity of the loan will position Nanobiotix to advance priority development programs in 2023 by adding an additional quarter of operating distance. This, combined with the committed access to capital available through our existing equity line, provides Nanobiotix with the opportunity to extend its operating route into Q1 2024.”
The financing agreement and royalty agreement signed with the EIB in July 2018 consisted of a first tranche of EUR 16.0m in semi-annual installments of principal and interest after a two-year grace period. The 2018 agreement also included a commitment to pay low-single-digit annual royalties for a six-year period beginning in January 2021.
The agreement is structured principally around Nanobiotix’s expected cash inflow from future non-dilutive value drivers, including planned commercialization1 of NBTXR3 and potential partnerships. The agreement generally provides for a deferral of principal payments of approximately €25.3 million until June 2029 and interest payments of approximately €5.4 million in kind (PIK) until October 2024. It also includes an additional payment of €20.0 million due in 2029, which could be accelerated due to the potential cash inflow. The outstanding debt obligations continue to accrue interest until the new due dates. The six-year license period included in the 2018 agreement will also be revised to begin commercialization.
The implementation of a final change by the Company and the EIB, which is expected in Q4 2022, is subject to the completion of the necessary documents and agreements.
Nanobiotix is a late-stage clinical biotechnology company developing pioneering physics-based therapeutic approaches to revolutionize patient outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company is leveraging its proprietary nanoparticle platform, including its lead product candidate, radiotherapy-activated NBTXR3, to develop a pipeline of therapeutic options aimed at improving local and systemic control of solid tumors, with an initial focus on the treatment of head and neck cancer lies.
For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter
This press release contains certain “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as “as of this date”, “anticipate”, “believe”, “expect”, “intend”. ‘, ‘in plan’, ‘plan’, ‘scheduled’ and ‘will’ or the negation of these and similar expressions. These forward-looking statements, which are based on management’s current expectations and assumptions and information currently available to management, include statements about the timing and progress of clinical studies, the timing of our presentation of data, the results of our preclinical and clinical studies Studies and their possible implications. Such forward-looking statements are made in light of information currently available to us and are based on assumptions that Nanobiotix believes to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including the risk that subsequent trials and ongoing or future clinical trials may fail despite positive early clinical results and the risks associated with evolving the duration and severity of the COVID-19 pandemic and in response official and regulatory measures taken, the risk that the Company and the EIB will not reach final agreement on the restructuring of the loan; the risk that the EIB may accelerate loans under the Finance Agreement and its modification should normal default events occur; the risk that the company is unable or unable to raise additional capital on attractive terms. In addition, many other important risk factors and uncertainties, including those described in our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission on April 8, 2022, under “Item 3.D. Risk Factors” and those listed in Nanobiotix’s universal registration document filed with the French Financial Markets Authority (Autorité des Marchés Financiers – AMF) on April 8, 2022 (a copy of which is available at www.nanobiotix.com). , may adversely affect such forward-looking statements and cause our actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Except as required by law, we undertake no obligation to publicly update these forward-looking statements or to update the reasons why actual results may differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
1 Any commercialization of NBTXR3 is subject to obtaining marketing approval from a health authority such as the FDA