Ocata Therapeutics Approved for Listing on NASDAQ
February 26 2015 - 9:02AM
Business Wire
Trading under Ticker “OCAT” to Begin Today,
February 26, 2015
Ocata Therapeutics, Inc. (“Ocata”; NASDAQ Global Market: OCAT),
a clinical stage biotechnology company developing regenerative
ophthalmology therapeutics, today announced that it has received
notice that the NASDAQ Listing Qualifications Department has
approved its application to list the Company’s common stock on the
NASDAQ Global Market, effective with the opening of trading today,
February 26, 2015, under the ticker symbol “OCAT”.
“This is a significant step in the Company’s evolution and
crucial to our long-term corporate strategy,” stated Ted Myles,
Chief Operating Officer and Chief Financial Officer, of Ocata. “The
NASDAQ Global Market is the right place for a biotechnology company
like Ocata, with an advanced clinical stage pipeline, to be listed
and we are pleased to become part of this prestigious
exchange.”
Following meetings with various regulatory bodies, Ocata expects
to initiate both its Pivotal program for Stargardt’s disease
(“SMD”) and Phase 2 age-related macular degeneration (“AMD”) trials
in the near term, using retinal pigment epithelium (“RPE”) cells.
The purpose of the pivotal SMD trial is to determine efficacy and
safety, as well as to assess relevant functional and anatomical
parameters of cell transplantation using an untreated control
group, with the intent of bringing a product to market potentially
as early as 2019.
“Following publication of our Phase 1 data in The Lancet in
October 2014 and given continuing safety data from ongoing studies,
we are excited by the prospect of initiating these controlled
clinical trials,” said Paul K. Wotton, Ph.D., President and Chief
Executive Officer, of Ocata. “We continue to believe that our RPE
therapy may provide breakthrough treatments for both SMD and dry
AMD and we are committed to help patients with these potentially
devastating diseases where no current therapy exists.”
About Ocata Therapeutics, Inc.
Ocata Therapeutics, Inc. is a clinical stage biotechnology
company focused on the development and commercialization of
Regenerative Ophthalmology therapeutics. Ocata’s most advanced
products are in clinical trials for the treatment of Stargardt’s
macular degeneration, dry age-related macular degeneration, and
myopic macular degeneration. Ocata’s intellectual property
portfolio includes pluripotent stem cell platforms – hESC and
induced pluripotent stem cell (iPSC) – and other cell therapy
research programs. For more information, visit www.ocata.com.
About Age-related Macular Degeneration
Age-related macular degeneration is the leading cause of vision
loss in people over the age of 50. Every year in the USA there are
1.8 million patients newly diagnosed with dry AMD which occurs when
light-sensitive photoreceptor cells in the macula, located in the
center of the retina, slowly break down, causing vision loss as a
result. Photoreceptor breakdown is a consequence of loss or damage
to the RPE layer. As the disease progresses, patients may have
difficulty reading and recognizing faces. There is currently no
proven medical therapy for dry AMD and the projected number of
people worldwide with age-related macular degeneration in 2020 is
196 million, increasing to 288 million in 2040 underscoring the
urgent need for new treatments.
About Stargardt’s Disease
Stargardt’s macular degeneration is a form of juvenile macular
degeneration that affects vision in children and young adults
between the ages of six and 20, with a prevalence of approximately
one in 10,000 people in the United States. It is an orphan disease
and loss of vision is an inevitable aspect of SMD, with more than
half of the patients experiencing vision loss in the range of
20/200-20/400. Like dry AMD, it occurs as a result of damage to the
RPE layer and there are no treatments currently approved to prevent
or slow the vision loss associated with SMD.
Forward-Looking Statements
All statements, other than historical facts, contained in this
news release, including statements regarding the expected timing of
the commencement of Ocata' Pivotal program for SMD and Phase 2 AMD
trials, potential timing of commercial launch of a therapeutic
product, potential efficacy of Ocata’s RPE therapy for both SMD and
dry AMD and any other statements about Ocata’s future expectations,
beliefs, goals, plans, results or prospects expressed by management
constitute forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Any statements
that are not statements of historical fact (including statements
containing the words “will,” “believes,” “plans,” “anticipates,”
“expects,” “estimates,” and similar expressions) should also be
considered to be forward-looking statements. There are a number of
important factors that could cause actual results or events to
differ materially from those indicated by such forward-looking
statements, including: the fact that Ocata has no product revenue
and no products approved for marketing; Ocata’s limited operating
history; the need for and limited sources of future capital; the
unknown nature of the regulatory approval process for Ocata’s novel
therapeutics such as those being developed by Ocata; potential
failures or delays in obtaining regulatory approval of products;
risks inherent in the development and commercialization of
potential products; reliance on new and unproven technology in the
development of products; the need to protect Ocata’s intellectual
property; the challenges associated with conducting and enrolling
clinical trials; the risk that the results of clinical trials may
not support the Company’s product candidate claims; even if
approved, the risk that physicians and patients may not accept or
use Ocata’s products; Ocata’s reliance on third parties to conduct
its clinical trials and to formulate and manufacture its product
candidates; and economic conditions generally. Additional
information on potential factors that could affect our results and
other risks and uncertainties are detailed from time to time in
Ocata’s periodic reports, including the Quarterly Report on Form
10-Q for the three and nine months ended September 30, 2014.
Forward-looking statements are based on the beliefs, opinions, and
expectations of Ocata’s management at the time they are made, and
Ocata does not assume any obligation to update its forward-looking
statements if those beliefs, opinions, expectations, or other
circumstances should change. Forward-looking statements are based
on the beliefs, opinions, and expectations of Ocata’s management at
the time they are made, and Ocata does not assume any obligation to
update its forward-looking statements if those beliefs, opinions,
expectations, or other circumstances should change. There can be no
assurance that Ocata’s future clinical trials will be successful or
that the results of previous clinical studies will lead to
commercialization or products or therapies.
Investors:Westwicke PartnersJohn Woolford,
443-213-0506john.woolford@westwicke.comorPress:Russo PartnersDavid
Schull, 858-717-2310david.schull@russopartnersllc.com
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