Regulatory News:
NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the “ Company “), a French biotechnology company in late-stage clinical development, a pioneer in physics-based approaches to expand treatment options for cancer patients, today announces the filing of its Universal Reference Document for the fiscal year ended December 31, 2021 with the Autorité des marchés financiers (AMF), as well as the filing of the annual report “Form 20-F” for the fiscal year ended December 31, 2021 with the US Securities and Exchange Commission (SEC ) in the USA.
These documents are available on the Nanobiotix website at https://ir.nanobiotix.com/financial-information/annual-reports. The 2021 Universal Registration Document is also available on the AMF website (www.amf-france.org) and the 2021 annual report “Form 20-F” on the SEC website (www.sec. gov).
The 2021 Universal Registration Document includes in particular:
– the 2021 annual financial report,
– the management report, including the report on corporate governance,
– the reports of the statutory auditors and information relating to their fees, and
– information relating to the description of the share buyback program.
Financial diary 2022
May 10, 2022 – Update of the operational and financial situation for the first quarter of 2022
June 21, 2022 – Annual General Meeting, Paris, France
September 7, 2022 – Update of the operational and financial situation for the first half of 2022
November 9, 2022 – Update of the operational and financial situation for the third quarter of 2022
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About NBTXR3
NBTXR3 is a new product in oncology, potentially the first in its class, composed of crystallized and sterile hafnium oxide nanoparticles in aqueous suspension. NBTXR3 is administered by single intratumor injection and activated by radiotherapy. The product candidate’s physical mechanism of action is designed to induce tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering an adaptive immune response and anticancer long-term memory. Considering the physical mechanism of action, Nanobiotix believes that NBTXR3 could be suitable for all solid tumors that can be treated by radiotherapy and for all therapeutic combinations, in particular checkpoint inhibitors.
NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as a primary pathway of development. The company-sponsored phase I dose escalation and expansion study produced favorable safety data and early signs of efficacy; and a global registrational Phase III study began recruiting in 2022. In February 2020, the United States Food and Drug Administration granted Fast Track regulatory designation for the study of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy – the same population being evaluated in the planned phase III study.
Nanobiotix has also prioritized a development program in immuno-oncology, beginning with a company-sponsored Phase I clinical study evaluating radiation therapy-activated NBTXR3 in combination with anti-PD-1 checkpoint inhibitors. for patients with recurrent or recurrent/metastatic locoregional HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.
Given the company’s areas of interest and the evolutionary potential of NBTXR3, Nanobiotix has embarked on a strategy of strategic collaboration with world-class partners to expand the development of the product candidate alongside its priority development pathways. In line with this strategy, in 2019 Nanobiotix entered into a broad and comprehensive clinical research collaboration with the University of Texas MD Anderson Cancer Center to sponsor several Phase I and Phase II studies aimed at evaluating NBTXR3 across types tumors and therapeutic combinations.
About NANOBIOTIX
Nanobiotix is a late-stage clinical biotechnology company developing innovative physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; it is supported by people who are 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.
Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (USA), France, Spain and Germany. 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 devoted to the development of its lead product candidate – NBTXR3 – which is the product of its proprietary oncology platform and which has already obtained marketing authorization in Europe for the treatment of patients with sarcoma. soft tissue 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 the present time”, “anticipate”, “believe”, “expect”, “intend”, “on track”, “plan”, “planned”, and “will”, or the negative of these and other expressions similar expressions. These forward-looking statements, which are based on our management’s current expectations and assumptions and information currently available to them, include statements about the timing and progress of clinical trials, the timing of our data presentation, the results of our preclinical and clinical studies and their potential implications, the development and commercialization of NBTXR3, the Company’s expected financial visibility and the execution of the Company’s development and commercialization strategy. 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 preclinical or 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 implemented in response thereto. Particular caution should be exercised when interpreting results relating to a small number of patients or to individual clinical cases, which may not be replicated in larger cohorts.. In addition, numerous other important factors, including those described in the Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 8, 2022 under the heading “Item 3D. Risk Factors” and those set forth in the Nanobiotix’s universal registration document filed with the Autorité des marchés financiers on April 8, 2022 (a copy of which is available at www.nanobiotix.com), as well as other known and unknown risks and uncertainties, may have an adverse effect on these 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 becomes available in the future.
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