NANOBIOTIX announces the filing of the 2021 Universal Registration Document and the 2021 Annual Report on Form 20-F

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PARIS & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Regulatory news:

NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ”Company”), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment options for patients with cancer and other major diseases, today announces the filing of its Universal Registration Document for the financial year ended December 31, 2021 with the Autorité des Marchés Financiers (Financial Markets Authority or AMF), as well as the annual report on Form 20-F for the year ended December 31, 2021 with the United States Securities and Exchange Commission (SEC).

These documents are available on the Nanobiotix website at https://ir.nanobiotix.com/financial-information/annual-reports. In addition, the 2021 Universal Registration Document is available on the AMF website (www.amf-france.org) and the 2021 Annual Report on Form 20-F is available on the SEC website (www.sec .gov).

The Company’s 2021 Universal Registration Document includes in particular:

– Annual financial report 2021,

– Management report including the report on corporate governance

– Reports of the Company’s statutory auditors and information on their fees

– Information required under the Company’s share buyback program

Financial diary 2022

  • May 10, 2022 – First Quarter 2022 Corporate and Financial Update

  • June 21, 2022 – Annual General Meeting, Paris, France

  • September 7, 2022 – 2022 half-year social and financial update

  • November 9, 2022 – Third Quarter 2022 Corporate and Financial Update

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About NBTXR3

NBTXR3 is a new, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered by single intratumoral injection and activated by radiotherapy. The product candidate’s physics-based mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiation therapy, subsequently triggering an adaptive immune response and anti-cancer memory long-term. Given the MoA, Nanobiotix believes that NBTXR3 could be scalable on any solid tumor that can be treated with radiotherapy and on any therapeutic combination, in particular with immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as a primary developmental pathway. The company-sponsored phase I dose escalation and expansion study has produced favorable safety data and early signs of efficacy. In February 2020, the United States Food and Drug Administration granted Fast Track regulatory designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible to platinum-based chemotherapy.

Nanobiotix has also prioritized a development program in Immuno-Oncology, starting with a Company-sponsored Phase I clinical study evaluating radiotherapy-activated NBTXR3 in combination with anti-PD-1 checkpoint inhibitors for patients with of recurrent or recurrent/metastatic locoregional HNSCC and for patients with lung or liver metastases of any primary cancer eligible for anti-PD-1 treatment, naïve or resistant to a previous PD-1 (primary or secondary according to SITC criteria) .

Given the Company’s focus areas, and balanced against the evolutionary potential of NBTXR3, Nanobiotix has engaged in strategic collaborations to expand the development of the product candidate in parallel with its priority development pathways. In line with this strategy, Nanobiotix entered into a broad and comprehensive clinical research collaboration with the University of Texas MD Anderson Cancer Center in 2019 to sponsor several Phase I and Phase II studies to evaluate NBTXR3 across types tumors and therapeutic combinations. In 2021, the Company entered into an additional strategic collaboration agreement with LianBio to support its global Phase III study in Asia as well as four future registration studies.

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 philosophy is rooted in the concept of pushing the boundaries of what is known to expand the possibilities of human life.

Founded in 2003, Nanobiotix is ​​headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (USA), France, Spain, Germany and Switzerland.

Nanobiotix has been listed on the regulated Euronext market in Paris since 2012 and on the Nasdaq Global Select Market in New York since December 2020.

Nanobiotix owns over 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) central nervous system disorders. The Company’s resources are primarily dedicated to the development of its lead product candidate – NBTXR3 – which is the product of its proprietary oncology platform and has already obtained marketing authorization in Europe for the treatment of patients with soft tissue sarcoma under the Hensify brand®.

For more information about Nanobiotix, visit www.nanobiotix.com or follow us on LinkedIn and Twitter.

Warning

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. In addition, numerous other important factors, 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, each as updated in our half-year financial report filed with the AMF and the SEC on September 8, 2021 (a copy of which is available at www.nanobiotix.com), and other known and unknown risks and uncertainties may adversely affect these forward-looking statements and cause our actual results, performance or achievements to be materially different. of those expressed or implied by the forward-looking statements. Except as required by law, we undertake no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

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