Regulatory News:
NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the
‘‘Company’’), a clinical-stage biotechnology company
pioneering physics-based approaches to expand treatment
possibilities for patients with cancer, today announced that the
Company has reached an agreement with PharmaEngine, Inc.
(“PharmaEngine”) to terminate the License and Collaboration
agreement that the Company and PharmaEngine entered into in August
2012.
As previously disclosed in the Nanobiotix prospectus filed with
the U.S. Securities and Exchange Commission on December 11, 2020,
in November 2020, Nanobiotix notified PharmaEngine of a material
breach of the terms of the License and Collaboration agreement. In
a letter dated December 1, 2020, PharmaEngine responded to the
Company’s notification of material breach, denying a material
breach of the License and Collaboration agreement, and asserting
certain material breaches of that agreement by Nanobiotix. After
discussion between the two parties, this agreement to terminate the
License and Collaboration agreement represents a full resolution of
outstanding disagreements over a number of issues with respect to
the development of NBTXR3 in the Asia-Pacific region.
The License and Collaboration agreement provided PharmaEngine
exclusive rights to further the development of NBTXR3 in the
Asia-Pacific region. While both Nanobiotix and PharmaEngine believe
in the potential of NBTXR3 to improve treatment outcomes for
patients with cancer, the parties have had disagreements regarding
the optimal strategy for development in the Asia-Pacific region. As
such, Nanobiotix and PharmaEngine have mutually agreed to
discontinue the collaboration.
Pursuant to their Termination and Release agreement, Nanobiotix
will retain all rights to the development and commercialization of
NBTXR3 in the Asia-Pacific region. PharmaEngine is to receive
payments, not to exceed $5 million in total, upon the completion of
various administrative steps in connection with the winding-up of
the collaboration.
In the future, PharmaEngine will be entitled to receive a
payment of $7.5 million upon a second regulatory approval of NBTXR3
in any jurisdiction of the world for any indication, unless the
Company announces a collaboration with a new partner for the
Asia-Pacific region within 6 months of the effective date of the
agreement. If that occurs, PharmaEngine will be entitled to an
immediate $2.5 million payment and will be eligible to receive a
payment of the remaining $5 million upon such second regulatory
approval of an NBTXR3-containing product. The Company has also
agreed to pay royalties to PharmaEngine at low-single digit royalty
rates with respect to sales of NBTXR3 in the Asia-Pacific region
for a 10-year period commencing on the corresponding first date of
sales in the region.
Retention of all rights regarding NBTXR3 will open new near- and
long-term possibilities for the Company, and Nanobiotix will
evaluate the Asia-Pacific region for potential inclusion in its
upcoming global phase III registration trial in head and neck
cancer.
About NBTXR3
NBTXR3 is a first-in-class radioenhancer composed of sterile,
functionalized, crystalline hafnium oxide nanoparticles. The
product candidate is designed to increase the radiotherapy energy
deposit inside tumor cells through the nanoparticles’ high atomic
number core packaged in the space for interaction with ionizing
radiation, and subsequently increase of tumor cell death when
compared to radiotherapy alone—without adding toxicity to adjacent
healthy tissues. NBTXR3 requires a single, intratumoral
administration before the first radiotherapy treatment session, and
has the ability to fit into current worldwide standards of
radiation care. The primary physical mechanism of action of NBTXR3
activated by radiotherapy could be universal, making it potentially
applicable across any solid tumor indication where radiotherapy is
a part of standard of care including head and neck, lung, prostate,
liver, colorectal, and esophageal cancers. The biological secondary
mechanism of action of NBTXR3 activated by radiotherapy has been
shown in preclinical studies to prime adaptive immune response,
which would potentially bring a new dimension to cancer
immunotherapies.
About NANOBIOTIX: www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a clinical-stage
biotechnology company pioneering physics-based approaches to expand
treatment possibilities for patients with cancer and other major
diseases.
The Nanobiotix philosophy is rooted in bringing highly
effective, generalized solutions to address unmet medical needs and
challenges.
The Company’s first-in-class, proprietary lead technology,
NBTXR3, is being evaluated in an expansive global development
program both as a single agent activated by radiotherapy and in
combination with other anti-cancer therapies including chemotherapy
and immune checkpoint inhibitors.
Nanobiotix is listed on the regulated market of Euronext in
Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP)
and on the Nasdaq Global Select Market (Nasdaq: NBTX). The
Company’s headquarters are in Paris, France, with a U.S. affiliate
in Cambridge, MA, and European affiliates in France, Spain and
Germany.
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 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 challenges associated
with developing NBTXR3 in the Asia-Pacific region or identifying a
suitable collaboration partner for such development activities, the
risk that subsequent studies and clinical trials may not generate
favorable data notwithstanding positive preclinical result 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 prospectus
filed with the U.S. Securities and Exchange Commission on December
11, 2020 under the caption “Risk Factors” and those set forth in
the universal registration document of Nanobiotix registered with
the French Financial Markets Authority (Autorité des Marchés
Financiers) under number R.20-010 on May 12, 2020 (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/20210304005958/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 France – Ulysse Communication
Pierre-Louis Germain +33 (0) 6 64 79 97 51
plgermain@ulysse-communication.com
US – Porter Novelli Stefanie Tuck +1 (917) 390-1394
Stefanie.tuck@porternovelli.com
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