- Presented updated results from priority pathways in head and
neck cancer and immunotherapy for potential first-in-class
radioenhancer NBTXR3 at 2021 Annual Meeting of The American Society
for Clinical Oncology
- Established new strategic partnership with LianBio to develop
and commercialize NBTXR3 across tumor types and therapeutic
combinations in China and other Asian markets
- Strengthened global leadership team through the appointment of
Dr. Gary Phillips as Chairman of the Nanobiotix Supervisory Board
and Bart Van Rhijn as Chief Financial Officer
- Reported €102.3 million in cash, cash equivalents, and
short-term investments as of June 30, 2021
Regulatory News:
NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the
‘‘Company’’) (Paris:NANO) (NASDAQ:NBTX), a late-clinical
stage biotechnology company pioneering physics-based approaches to
expand treatment possibilities for patients with cancer, today
announced operational progress and cash position (unaudited) for
the second quarter of 2021.
Second Quarter Financial Updates
Nanobiotix reported total revenue for the six-month period ended
June 30, 2021 of €9.7k. Revenue for the first half of 2021 was
primarily driven by cross charges related to the Company’s previous
collaboration with PharmaEngine, Inc., during the first quarter
2021. Nanobiotix did not generate any revenue during the second
quarter of 2021. Revenue for the second quarter and first half of
2020 amounted to €13.4k and €36.9k respectively.
Nanobiotix reported cash, cash equivalents, and short-term
investments totaling €102.3 million as of June 30, 2021, compared
to €107.1 million as of March 31, 2021. This amount includes the
€16.5 million ($20.0 million) upfront payment associated with the
LianBio collaboration announced in May 2021. As previously
announced, PharmaEngine was eligible for and received a €2.1
million ($2.5 million) payment following the announcement of
Nanobiotix’s collaboration with LianBio and has received €3.4
million ($4.0 million) in conjunction with the completion of
various administrative steps in connection with the winding-up of
the collaboration. PharmaEngine will be eligible to receive an
additional $1.0 million in administrative fees and a final payment
of $5 million upon a second regulatory approval of an
NBTXR3-containing product.
Nanobiotix plans to report half-year financial results for the
six-months ended June 30, 2021, including condensed consolidated
financial statements for the period, on September 8, 2021.
Second Quarter Operational Highlights
- Presented Updated Results from Priority Pathways in Head and
Neck Cancer and Immunotherapy for Potential First-In-Class
Radioenhancer NBTXR3 at 2021 Annual Meeting of The American Society
for Clinical Oncology (ASCO):
- Local Control as a Single-Agent for
Patients with Head and Neck Cancer: Updated data from Study
102, a phase I study evaluating NBTXR3 as a single agent activated
by radiotherapy in locally advanced head and neck squamous cell
carcinoma (LA- HNSCC) presented at ASCO further support NBTXR3
administration as feasible, and well-tolerated with a favorable
safety profile in highly vulnerable elderly LA-HNSCC patients with
high unmet medical needs and significant burden of disease. At a
median follow up of 8.1 months, evaluable patients (n=40)
demonstrated a high primary tumor ORR of 82.5% and a 62.5% CRR.
These results are consistent with those observed in the dose
escalation part of the study and suggest durability of efficacy.
Nanobiotix plans to launch a pivotal phase III global registration
study evaluating NBTXR3 as a single-agent activated by radiotherapy
for patients with LA-HNSCC in the second half of 2021.
- Priming Immune Response and Immunotherapy
Combination Across Oncology:Updated data from Study 1100, a
phase I basket study evaluating NBTXR3 activated by radiotherapy
(RT) in combination with nivolumab or pembrolizumab in locoregional
recurrent or recurrent metastatic HNSCC, lung metastasis from any
primary tumor and/or liver metastasis from any primary tumor showed
tumor regression in 76.9% of evaluable patients (n=13) regardless
of prior anti-PD-1 exposure. Data from this ongoing study show
NBTXR3 plus radiotherapy could potentially stimulate immune
response and convert anti-PD-1 non-responders into responders.
- Formed Strategic Partnership with LianBio to Develop and
Commercialize NBTXR3 Across Tumor Types and Therapeutic
Combinations in China and other Asian markets:
- LianBio’s cross-border development and
commercialization expertise includes strong capabilities in
oncology: LianBio will participate in the Nanobiotix global
phase III HNSCC registrational study by enrolling 100 patients in
China. In addition to the phase III head and neck cancer study,
LianBio has committed to enrolling patients in four additional
registrational studies conducted by Nanobiotix across indications
and therapeutic combinations. Under the terms of the agreement,
LianBio will obtain exclusive rights to develop and commercialize
NBTXR3 in Greater China, South Korea, Singapore, and Thailand.
Nanobiotix received a $20 million upfront payment and is entitled
to receive up to an aggregate of $220 million in potential
contingent, development and commercialization milestone payments
along with tiered, low double-digit royalties based on net sales of
NBTXR3 in the licensed territories.
- Strengthened Board & Leadership Team to Focus Efforts on
Advancing Its Global Development Strategy:
- Named Gary Phillips, MD, as the new
chairman of the Company’s supervisory board: Dr. Phillips,
who is the president and chief executive officer of OrphoMed, Inc.,
brings decades of experience in the pharmaceutical and healthcare
industries where he has led commercial operations, clinical
medicine, business strategy, and development functions.
- Appointed Bart Van Rhijn, MBA, as chief
financial officer and member of the Company’s executive
board: Mr. Van Rhijn brings extensive experience in
consultancy, technology, and life sciences industries and joins
Nanobiotix after nearly 3 years as chief financial officer at
Servier Pharmaceuticals, LLC (Servier US). Prior to Servier US, he
held leadership roles in prominent organizations in Europe and
North America, including PricewaterhouseCoopers, Philips and
Galderma, including Head of Tax, Senior Director of Mergers and
Acquisitions, and Head of Finance positions.
Updated Financial Agenda
September 8: Half-Year Corporate and Financial Update October
20th: Third Quarter 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 physical 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 physical MoA, Nanobiotix believes that NBTXR3
could be scalable across any solid tumor that can be treated with
radiotherapy and across any therapeutic combination, particularly
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; and a phase III global registrational study is planned to
launch in 2021. 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—the same population being evaluated in the planned
phase III study.
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 lung or liver
metastases from any primary cancer eligible for anti-PD-1
therapy.
Given the Company’s focus areas, and balanced against the
scalable potential of NBTXR3, Nanobiotix has engaged in a strategic
collaboration strategy with world class partners 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 (MD
Anderson) for MD Anderson to sponsor several phase I and phase II
studies to evaluate NBTXR3 across tumor types and therapeutic
combinations.
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, and Germany.
Nanobiotix has been listed on Euronext: 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, the development and
commercialization of NBTXR3, and the execution of the Company’s
development and commercialization strategy. 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
preclinical or early clinical 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 Annual Report on Form 20-F filed with
the U.S. Securities and Exchange Commission on April 7, 2021 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) under number
D.21-0272 on April 7, 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/20210720006149/en/
Nanobiotix Nanobiotix Communications Brandon Owens VP,
Communications +1 (617) 852-4835 contact@nanobiotix.com
Nanobiotix Investor Relations 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 Dan Childs +1 (781) 888 5106
dan.childs@porternovelli.com
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