SARASOTA, Fla., Nov. 10, 2014 /PRNewswire/ -- Rock Creek
Pharmaceuticals, Inc., (RCPI), a drug development company focused
on chronic inflammatory disease and neurologic disorders, announced
today its financial results for the third quarter ended
September 30, 2014 and provided a
business update. The Company's Form 10-Q was filed with the
Securities Exchange Commission.
Michael J. Mullan, MBBS (MD),
PhD, Rock Creek Pharmaceuticals' Chairman and CEO, remarked, "We
are advancing the development of our lead drug candidate in the
U.S. and the E.U. Consistent with our recent disclosures, we are
looking forward to achieving upcoming milestones and commencing
Phase I clinical trials in 2015."
Business Update
Additional pre-clinical studies have been completed in support
of both the Company's Investigational New Drug (IND) application
and Clinical Trial Application (CTA). The Company is evaluating the
additional data both in direct response to FDA's comments on the
Company's IND and for incorporation into the Company's CTA.
Drug formulations are currently being prepared in line with
regulatory standards for clinical trials to begin under the
CTA.
The basic science associated with anatabine citrate continues to
be validated and expanded. As previously disclosed, abstracts
outlining four separate preclinical studies evaluating anatabine
were recently accepted for poster and nano symposium presentations
at the upcoming annual meeting of the Society for Neuroscience,
taking place November 15-19 in
Washington, DC. The presentations
specifically will focus on anatabine's beneficial activity in
animal models of Traumatic Brain Injury, Gulf War Illness and
Alzheimer's Disease. All of these studies were independently
conducted and presented by the Roskamp Institute, a not-for-profit
research organization devoted to understanding neurodegenerative
diseases, disorders and addictions. The studies were funded by
either the Roskamp Foundation or by awards through the
Congressionally Directed Medical Research Program.
Researchers from the Roskamp Institute recently published a
manuscript in "Brain Disorders & Therapy," May 2014, entitled "Anatabine Attenuates Tau
Phosphorylation and Oligomerization in P301S Tau Transgenic
Mice." The article described how anatabine attenuated tau
phosphorylation in vivo animal models which included the molecular
activation inhibition of GSK3b, STAT3 and NF-kb as a proposed
mechanism of action.
Rock Creek Pharmaceuticals recently retained a major, national
intellectual property advisory and investment bank, as a strategic
advisor, to monitor, value and evaluate the growth of the Company's
intellectual property (IP) portfolio. Concurrently, the Company
continues to take measures to protect existing IP as well as
enhancing and developing additional IP.
On November 3, 2014, the Company
disclosed through an 8-K filing that it had received a notice from
the NASDAQ Stock Market indicating a failure for the Company to
attain the $1.00 minimum bid price
requirement and was subject to delisting. The Company has appealed
the delisting and is taking appropriate steps in pursuit of
maintaining NASDAQ listing. The Company has been granted a hearing
in December 2014 with a NASDAQ
Hearings Panel and will advance a plan to remedy the deficiency and
request an additional period of time to implement it.
Third Quarter 2014 Results
The Company recorded a net loss of approximately $10.0 million for the three months ended
September 30, 2014, compared to a net
loss of approximately $3.4 million
for the same period in 2013. The increased net loss for the three
months ended September 30, 2014 was
primarily due to a discontinued operations charge, increases in
stock based compensation, severance costs, directors' and officers'
insurance, legal expenditures and research and development
expenditures; and was partially offset by decreased loss from the
dietary supplement business.
General and administrative expenses were approximately
$4.3 million for the three months
ended September 30, 2014, an increase
of approximately $1.5 million from
approximately $2.8 million for the
same period in 2013. This level of general and administrative
expenses was primarily caused by elevated legal expenses, severance
agreements, increased Director and Officer insurance, and expenses
related to the corporate transition. In the near term, the Company
expects decreased G&A expenses as it implements its office
consolidation plan and other measures to reallocate resources to
the drug development plans.
The Company expended approximately $1.7
million on research and development in the three months
ended September 30, 2014, compared to
approximately $0.4 million in the
comparable period in 2013. The research and development costs in
the three months ended September 30,
2014 were directed principally towards additional studies
enhancing the Company's clinical regulatory submissions (the IND
and CTA), as well as overall drug development expenses associated
with consultants, contract research organizations and activities
directly in support of the Company's new strategic direction.
For the three months ended September 30,
2014, the Company had a basic and diluted loss per share of
$(0.05), compared to a basic and
diluted loss per share of $(0.02) for
the comparable period in 2013.
On September 12, 2014, the Company
announced that it would no longer market or sell its dietary
supplements and cosmetic products in the
United States. Accordingly, the Company is primarily focused
on drug development in the U.S. and Europe. As a result of
this decision, all sales, cost of sales and sales and marketing
expenses related to these consumer products, encompassing all of
its commercial products on the market, were reclassified to
discontinued operations. For the three months ended September 30, 2014, this was a loss of
$0.4 million, compared to a loss of
$1.5 million in the comparable period
for 2013. The decreased loss of $1.1
million was primarily attributable to the reduced promotion
of Anatabloc® dietary supplement in response to the FDA warning
letter received in December 2013. For the three months ended
September 30, 2014, the Company also
took a charge of $3.6 million
consisting of inventory, specialized packaging machinery and other
assets specifically related to the dietary supplement business.
For a detailed review of the Company's financial disclosures,
please refer to the company's current Form 10-Q.
About Anatabine Citrate:
Rock Creek Pharmaceutical's anatabine citrate is a small
molecule, cholinergic agonist which exhibits anti-inflammatory
pharmacological characteristics. The Company has sponsored
extensive pre-clinical (in vitro and in vivo) studies resulting in
peer reviewed and published scientific journal articles, covering
models of Multiple Sclerosis, Alzheimer's Disease, and Auto-Immune
Thyroiditis. All these studies demonstrated the anti-inflammatory
effects of anatabine. In addition, the company's compilation of
human exposure, safety and tolerability data, derived primarily
from human clinical studies and post-marketing data collection of
the previously marketed nutraceutical product, has provided
important insights for clinical development.
About Rock Creek Pharmaceuticals, Inc.:
Rock Creek Pharmaceuticals, Inc. is an emerging drug development
company focused on the discovery, development and commercialization
of new drugs, formulations and compounds that provide therapies for
chronic inflammatory disease, neurologic disorders and behavioral
health.
For more information, visit:
http://www.rockcreekpharmaceuticals.com
Forward Looking Statements:
Certain statements contained in this release constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to statements identified by words such as
"believes," "expects," "anticipates,\" "estimates," "intends,"
"plans," "targets," "projects" and similar expressions. The
statements in this release are based upon the current beliefs and
expectations of our company's management and are subject to
significant risks and uncertainties. Actual results may differ from
those set forth in the forward-looking statements. Numerous factors
could cause or contribute to such differences, including, but not
limited to, results of clinical trials and/or other studies, the
challenges inherent in new product development initiatives,
including the continued development and approval of
anti-inflammatory drug candidates, the effect of any competitive
products, our ability to license and protect our intellectual
property, our ability to raise additional capital in the future
that is necessary to maintain our business, changes in government
policy and/or regulation, potential litigation by or against us,
any governmental review of our products or practices and the
outcome of the ongoing investigations as well as other risks
discussed from time to time in our filings with the Securities and
Exchange Commission, including, without limitation, our annual
report on Form 10-K for the fiscal year ended December 31, 2013 filed on March 17, 2014 and our latest 10-Q Report filed
on August 11, 2014. We undertake no
duty to update any forward-looking statement or any information
contained in this press release or in other public disclosures at
any time.
CONTACT:
Ted Jenkins
Vice President, Corporate Strategy, Development, Investor
Relations
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL 34243
Direct: 941-251-0488
tjenkins@rockcreekpharmaceuticals.com
Stephanie Carrington/
Bo Park
Investors/Media
Integrated Corporate Relations, Inc. (ICR): Redefining Strategic
Communications
685 Third Avenue, 2nd Floor,
New York, NY 10017
(646) 277-1282/(646) 277-1222
stephanie.carrington@icrinc.com
bo.park@icrinc.com
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SOURCE Rock Creek Pharmaceuticals, Inc.