PARIS & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Regulatory news:
NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ”Company”), a late-stage biotechnology company pioneering physics-based approaches to expand treatment options for cancer patients, today announced that it has reached an agreement in principle to restructure 30.7 million euros of outstanding debt related to the Company’s 2018 loan agreement with the European Investment Bank (“EIB”).
“The European Investment Bank has demonstrated an unwavering commitment to supporting potentially disruptive healthcare innovation in the European Union and this agreement in principle demonstrates its strength as a strategic partner,” said said Bart Van Rhijn, CFO of Nanobiotix. “Given the macroeconomic volatility and the impact on the biotechnology industry as a whole, Nanobiotix continues to prioritize major 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 cancers. The restructuring of existing debts to extend the maturity of the loan will allow Nanobiotix to pilot priority development programs in 2023 by extending the operating track by an additional quarter. Combined with committed access to capital available through our existing capital line, this gives Nanobiotix the opportunity to extend its operating track through Q1 2024.”
The financing contract and the royalty agreement concluded with the EIB in July 2018 consisted of a first tranche of 16.0 million euros drawn down in October 2018 and repayable in one installment maturing in 2023 and a second tranche of 14 .0 million granted in March 2019 and repayable 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 royalties annually over a six-year period beginning in January 2021.
The agreement in principle is structured around the cash inflows expected by Nanobiotix from future non-dilutive value drivers, including the planned commercialization1 of NBTXR3 and potential partnerships. The agreement in principle allows the deferral of approximately €25.3 million of principal repayments until June 2029 and of approximately €5.4 million of interest-in-kind (PIK) payments until in October 2024. It also includes an additional payment of €20.0 million with a maturity in 2029 which could be accelerated depending on potential cash inflows. Outstanding debt securities will continue to bear interest until the new maturity dates. The six-year royalty period included in the 2018 agreement is also being revised to begin upon commercialization.
The signature by the Company and the EIB of a definitive amendment, expected in the fourth quarter of 2022, is subject to the finalization of the necessary documents and agreements.
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 is leveraging its proprietary nanoparticle platform, including its lead product candidate, radiation-activated NBTXR3, to develop a pipeline of therapeutic options designed to improve local and systemic control of solid tumors with an initial focus on the treatment of head and neck cancers.
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 may be identified by words such as “at this time”, “anticipate “, “believe”, “expect”, “intend”, “on track”, “plan”, “intended”, and “will”, or the negative of these and other expressions similar. These forward-looking statements, which are based on our management’s current expectations and assumptions and information currently available to management, include statements regarding the timing and progress of clinical trials, the timing of our data presentation, results of our preclinical and clinical studies and their potential implications. These forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix believes are reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including with respect to the risk that subsequent studies and ongoing or future clinical trials may not generate favorable data despite positive early clinical results and the risks associated with the evolving nature of the duration and severity of the COVID-19 pandemic and the governmental and regulatory measures put in place to respond to it, the risk that the Company and the EIB may not reach a definitive agreement regarding the restructuring of the loan; the risk that the EIB may accelerate lending under the Financing Agreement and its modification upon the occurrence of customary events of default; the risk that the Company may not be able to obtain additional capital on attractive terms, if at all. In addition, numerous 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 (the SEC) on April 8, 2022 under “Item 3 .D. Risk factors” and those appearing in Nanobiotix’s universal registration document filed with the 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 be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we undertake no obligation to update publicly these forward-looking statements or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information become available in the future.
1 any commercialization of NBTXR3 is subject to the granting of a marketing authorization by a health authority, such as the FDA