SARASOTA, Fla., Aug. 11, 2014 /PRNewswire/ -- Rock Creek
Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug development company
focused on chronic inflammatory disease and neurologic disorders,
announced today that it filed with the Securities Exchange
Commission its Form 10-Q for the second quarter ended June 30, 2014. The company has also announced a
clinical and regulatory update.
Second Quarter, 2014:
For the three months ended June 30,
2014, the company reported net sales of $0.7 million (gross sales less cash
discounts, product discounts and product return allowance) compared
to $2.5 million for the same period
in 2013. The decrease of 71% was attributable exclusively to
decreased Anatabloc® sales volume driven by significantly
reduced promotion and marketing expenditures associated with the
administrative status of Anatabloc® during the period.
The company also reported positive gross profits of $0.4 million for second-quarter 2014, compared to
a gross profit of $1.0 million for
the same period in 2013. The decreased gross profit is
attributable exclusively to the decreased Anatabloc® sales volume
discussed above.
The company had a net loss of approximately $12.7 million for the three months ended
June 30, 2014, compared to a net loss
of approximately $8.7 million for the
same period in 2013. The increase in net loss for the three months
ended June 30, 2014 was primarily due
to increases in stock-based compensation and severance costs,
offset by lower sales and marketing expenses and legal
expenditures.
For the three months ended June 30,
2014, the company had a basic and diluted loss per share of
$(0.07), compared to a basic and
diluted loss per share of $(0.05) for
the comparable period in 2013.
For a detailed review of the company's financial disclosures,
please refer to the company's current Form 10-Q.
Subsequent to the second quarter, on August 8, 2014, the company closed on a
$6.0 million private placement
financing transaction resulting in net proceeds of $4.25 million from the sale of common stock and
common stock warrants and an additional $1.75 million credit facility with one of the
Company's largest stockholders. The company believes that, with
this financing transaction, it has sufficient funding to support
operations through the second quarter of 2015.
Clinical Update:
The company has announced that it has received written comments
from the U.S. Food and Drug Administration (FDA) indicating that
the company's Investigational New Drug (IND) application is being
placed on clinical hold until the company submits additional detail
regarding the pre-clinical submissions. The company is coordinating
with the FDA and working diligently at attaining an effective IND
so as to begin clinical safety trials as soon as
practicable. In the interim, the company will continue
to prosecute a parallel clinical development program in the
United Kingdom under a Clinical
Trial Application (CTA) currently anticipated to be filed by the
end of the third quarter of 2014. Upon CTA approval, the company
expects to conduct European clinical safety trials shortly
thereafter. Assuming a timely CTA approval, the company
currently expects to launch Phase II clinical trials in 2015 for
specific inflammatory diseases and potentially for nicotine
addiction
With regard to the nutritional supplement business, the company
filed a New Dietary Ingredient Notification (NDIN) in June 2014 as a measure to address certain
provisions in the December 2013 FDA
warning letter. Although the company does not believe that an
NDIN is a prerequisite to the lawful marketing of the nutritional
supplement, the NDIN was voluntarily submitted to provide the FDA
with preclinical and clinical data concerning the supplement.
In addition, the company is also voluntarily suspending its sale of
CigRx® and Anatabloc® until such time as the company can complete
its review of the FDA's response to the company's pending NDIN,
which has not yet been received, as well as a review of how the
nutritional supplement business may affect the company's drug
development program. However, the company does anticipate these
actions will bring the FDA warning letter matter to a close.
Michael J. Mullan MBBS (MD) PhD, Rock Creek Pharmaceutical's
Chairman and CEO, said, "We continue to execute on our previously
disclosed initiatives including office consolidation, personnel and
expense reductions, and realignment of third party resources. Most
significantly, we are fully engaged in the drug development process
and will meet regulatory and scientific hurdles as they arise in
the normal course of such development."
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
inflammatory models of Multiple Sclerosis, Alzheimer's Disease, and
Auto-Immune Thyroiditis. In addition, the company's compilation of
human exposure, safety and tolerability data, provides important
insights for future clinical pathway progression.
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.rockcreekpharma.com
CONTACT:
Ted Jenkins
Vice President, Corporate Strategy, Development, Investor
Relations
Rock Creek Pharmaceuticals
941-251-0488
tjenkins@rockcreekpharma.com
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 market acceptance of our
nutraceutical dietary supplements products, 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.
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SOURCE Rock Creek Pharmaceuticals, Inc.