NANOBIOTIX Announces Filing of the 2021 Universal Registration Document and the 2021 Annual Report on Form 20-F
April 08 2022 - 5:57PM
Business Wire
Regulatory News:
NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the
‘‘Company’’), a late-stage clinical biotechnology
company pioneering physics-based approaches to expand treatment
possibilities for patients with cancer and other major diseases,
today announced the filing of its universal registration document
for the financial year ended December 31, 2021 with the French
financial market authority (Autorité des marchés financiers or
AMF), as well as of the Annual Report on Form 20-F for the
financial year ended December 31, 2021 with the U.S. 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).
In particular, the Company’s 2021 universal registration
document includes its: - 2021 annual financial report, - Management
report including the report on corporate governance - Reports from
the Company’s statutory auditors and information on their fees -
Required information in relation to the Company’s share buyback
program
2022 Financial Agenda
- May 10, 2022 - First Quarter 2022 Corporate and Financial
Update
- June 21, 2022 - Annual General Meeting, Paris, France
- September 7, 2022 - 2022 Half-Year Corporate and Financial
Update
- November 9, 2022 - Third Quarter 2022 Corporate and Financial
Update
***
About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product,
composed of functionalized hafnium oxide nanoparticles that is
administered via one-time 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 radiotherapy, subsequently
triggering adaptive immune response and long-term anti-cancer
memory. Given the MoA, Nanobiotix believes that NBTXR3 could be
scalable across any solid tumor that can be treated with
radiotherapy and across any therapeutic combination, particularly,
with immune checkpoint inhibitors.
NBTXR3 is being evaluated in locally advanced head and neck
squamous cell carcinoma (HNSCC) as the primary development pathway.
The company-sponsored phase I dose escalation and dose expansion
study has produced favorable safety data and early signs of
efficacy. In February 2020, the United States Food and Drug
Administration granted regulatory Fast Track 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 for platinum-based
chemotherapy.
Nanobiotix has also prioritized an Immuno-Oncology development
program—beginning with a Company sponsored phase I clinical study,
evaluating NBTXR3 activated by radiotherapy in combination with
anti-PD-1 checkpoint inhibitors for patients with locoregional
recurrent or recurrent/metastatic HNSCC and for patients with lung
or liver metastases from any primary cancer eligible for anti-PD-1
therapy, either naïve or resistant to prior PD-1 (either primary or
secondary as per SITC criteria).
Given the Company’s focus areas, and balanced against the
scalable potential of NBTXR3, Nanobiotix has engaged in strategic
collaborations to expand development of the product candidate in
parallel with its priority development pathways. Pursuant to 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 I and phase II
studies to evaluate NBTXR3 across tumor types 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 along with four future
registrational 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’s philosophy is rooted in the concept of pushing past
the boundaries of what is known to expand possibilities for human
life.
Incorporated in 2003, Nanobiotix is headquartered in Paris,
France. The company also has subsidiaries in Cambridge,
Massachusetts (United States), France, Spain, Germany and
Switzerland.
Nanobiotix has been listed on the regulated market of Euronext
in Paris since 2012 and on the Nasdaq Global Select Market in New
York City since December 2020.
Nanobiotix is the owner of more than 30 umbrella patents
associated with three (3) nanotechnology platforms with
applications in 1) oncology; 2) bioavailability and
biodistribution; and 3) disorders of the central nervous system.
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 has already achieved market
authorization in Europe for the treatment of patients with soft
tissue sarcoma under the brand name Hensify®.
For more information about Nanobiotix, visit us at
www.nanobiotix.com or follow us on LinkedIn and Twitter.
Disclaimer
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,”
“scheduled,” and “will,” or the negative of these and similar
expressions. These forward-looking statements, which are based on
our management’s current expectations and assumptions and on
information currently available to management, include statements
about the timing and progress of clinical trials, the timing of our
presentation of data, the results of our preclinical and clinical
studies and their potential implications. Such forward-looking
statements are made in light of information currently available to
us and based on assumptions that Nanobiotix considers to be
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 notwithstanding positive early
clinical results and the risks associated with the evolving nature
of the duration and severity of the COVID-19 pandemic and
governmental and regulatory measures implemented in response to it.
Furthermore, many other important factors, including those
described in our Annual Report on Form 20-F filed with the U.S.
Securities and Exchange Commission (the SEC) on April 8, 2022 under
“Item 3.D. Risk Factors” and those set forth in the universal
registration document of Nanobiotix filed with the French Financial
Markets Authority (Autorité des Marchés Financiers – the 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 on www.nanobiotix.com), as well as other known
and unknown risks and uncertainties 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 assume 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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version on businesswire.com: https://www.businesswire.com/news/home/20220408005595/en/
Nanobiotix
Communications Department Brandon Owens VP,
Communications +1 (617) 852-4835 contact@nanobiotix.com
Investor Relations Department Kate McNeil SVP, Investor
Relations +1 (609) 678-7388 investors@nanobiotix.com
Media Relations
FR – Ulysse Communication Pierre-Louis Germain + 33 (0) 6
64 79 97 51 plgermain@ulysse-communication.com
US – Porter Novelli Dan Childs +1 (781) 888-5106
Dan.childs@porternovelli.com
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