Japan Cell Therapy Transaction Yields $3MM
April 23 2019 - 8:05AM
Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”)
today announced a transaction to divest certain cell therapy assets
to Seijirō Shirahama of Tokyo, Japan yielding $3MM in non-dilutive
funding to the Company, before related transaction expenses.
“This cell therapy asset sale strengthens the company’s ability
to achieve a number of important objectives including – enabling us
to focus on our clinical stage oncology pipeline while bringing in
additional non-dilutive capital,” said Dr. Marc Hedrick, Cytori
President & Chief Executive Officer.
This announcement follows an April 1, 2019 announcement stating
that Cytori was to divest certain cell therapy assets to Lorem
Vascular of Melbourne, Australia yielding $4MM in non-dilutive
funding to the Company, before related transaction expenses.
Building our clinical stage oncology
business
Our lead clinical stage asset, ATI-0918, is an important
potential therapy for breast and ovarian cancer, multiple myeloma
and Kaposi’s sarcoma. Our current development program is focused in
Europe where we believe there is a potential market opportunity of
$120 million annually. In Q1 2019, Cytori submitted a letter of
intent to file a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) for ATI-0918. ATI-0918 is being
developed as a generic version of Janssen’s Caelyx pegylated
liposomal doxorubicin. The Company continues to evaluate potential
development and commercialization partnering opportunities for
ATI-0918 with a focus on Europe and China. European approval and
launch of ATI-0918 is projected to be in late 2020.
Our second clinical stage oncology focused asset is ATI-1123, a
phase II ready, patented, albumin-stabilized pegylated liposomal
docetaxel. In 2018, the Company received an orphan drug designation
from the U.S. FDA for the indication of small cell lung cancer and
is pursuing a 505(b)(2) new drug application (NDA) pathway in the
U.S. which may offer an accelerated clinical timeline and lower
development cost. The Company is exploring near term development
strategies and intends to advance this program aggressively in
2019.
About Cytori
Cytori is developing, manufacturing, and commercializing
nanoparticle-delivered oncology drugs within its Nanomedicine™
franchise. Cytori Nanomedicine™ is focused on the liposomal
encapsulation of anti-neoplastic chemotherapy agents, which may
enable the effective delivery of the agents to target sites while
reducing systemic toxicity. The Cytori Nanomedicine™ product
pipeline consists of ATI-0918, a pegylated liposomal doxorubicin
hydrochloride for breast cancer, ovarian cancer, multiple myeloma,
and Kaposi’s sarcoma, a complex/hybrid generic drug, and ATI-1123
patented albumin-stabilized pegylated liposomal docetaxel for
multiple solid tumors. For more information, visit
www.cytori.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release includes forward-looking statements that
involve known and unknown risks and uncertainties. All statements,
other than historical facts, are forward looking statements. Such
statements, including, without limitation, statements regarding
anticipated commercial launch of our ATI-0918 drug candidate (and
timing thereof); completion of manufacturing activities necessary
to submit an MAA to the EMA for our ATI-0918 drug candidate; are
subject to risks and uncertainties that could cause our actual
results and financial position to differ materially. Some of these
risks include clinical, pre-clinical and regulatory uncertainties,
such as those associated with conduct and completion of the
Company-sponsored RELIEF thermal burn trial, as well as the
Company’s anticipated submission of data to the EMA from the
previously completed bioequivalency trial for ATI-0918. We
also face the risk that we will be unable to time successfully
manufacture our ATI-0918 drug candidate in time to meet our
projected timeline for submission of an MAA to the EMA, or at
all. Some of these risks also include risks relating to
regulatory challenges the Company faces (including the U.S., EU,
China, Japan and its other key geographies) due to a number of
factors including novelty of the Company’s technology and product
offerings, changes in and /or evolution of regulatory approaches to
cellular therapeutics like the Company’s in its key geographies,
and similar matters. It is possible that the Company could face
unexpected revenue shortfalls, expense increases or other
occurrences that adversely affect our cash burn and cash management
strategies. Further the Company face risks pertaining to
dependence on third party performance and approvals (including the
outcome of BARDA’s review of the Company’s proposed burn wound
trial pursuant to its contract with BARDA, and outcome of the EMA’s
review of our ATI-0918 MAA); performance and acceptance of the
Company’s products in clinical studies/trials and in the
marketplace; material changes in the marketplace that could
adversely impact revenue projections (including changes in market
perceptions of the Company’s products, and introduction of
competitive products); unexpected costs and expenses that could
adversely impact liquidity and shorten the Company’s current
liquidity projections (which could in turn require the Company to
seek additional debt or equity capital sooner than currently
anticipated); the Company’s reliance on key personnel; the
Company’s ability to identify and develop new programs or assets to
expand the Company’s clinical pipeline; the right of the U.S.
government (BARDA) to cut or terminate further support of the
thermal burn injury program (including any decision by BARDA not to
proceed with our proposed thermal burn trial); the Company’s
abilities to capitalize on its internal restructuring and achieve
break-even or profitability (or to continue to reduce our operating
losses); and other risks and uncertainties described under the
"Risk Factors" in Cytori's Securities and Exchange Commission
Filings, included in the Company’s annual and quarterly
reports.There may be events in the future that the Company is
unable to predict, or over which it has no control, and its
business, financial condition, results of operations and prospects
may change in the future. The Company assumes no responsibility to
update or revise any forward-looking statements to reflect events,
trends or circumstances after the date they are made unless the
Company has an obligation under U.S. Federal securities laws to do
so.
CYTORI THERAPEUTICS CONTACTGary TitusChief Financial
Officer+1.858.458.0900ir@cytori.com
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