SARASOTA, Fla., May 12, 2015 /PRNewswire/ -- Rock Creek
Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug development company
focused on chronic inflammatory disease and neurologic disorders,
announced today its financial results for the first quarter ended
March 31, 2015 and provided a
clinical update. The Company's Form 10-Q was filed with the
Securities Exchange Commission.
Michael J. Mullan, MBBS (MD),
PhD, Chairman and CEO of Rock Creek Pharmaceuticals, remarked, "We
advanced several strategic objectives in the first quarter, having
commenced and significantly progressed through our human Phase I
studies in the United Kingdom,
completed our study in New
Zealand, as well as having moved forward with various
corporate development initiatives. The Company significantly slowed
its cash burn, after successfully restructuring into a more
appropriate platform for drug discovery and clinical development of
our compounds. Concurrently the Company is planning for Phase II
trials, exploring potential in-licensing/out-licensing
opportunities, as well as advancing towards achieving a more secure
financial footing."
Phase I Trial Update
The United Kingdom's Medicines
and Healthcare Products Regulatory Agency (MHRA) approved in
January 2015 a Clinical Trial
Application (CTA) to commence a Phase I study of the Company's lead
compound, Anatabine Citrate. As of April
8th, and as previously announced in a recent filing on Form
8-K, the Company completed recruitment, commenced human dosing and
administered three formulations. Part One of the Phase I study is
underway and is assessing the safety and tolerability of a variety
of different drug formulations. With Part Two of the Phase I study
being optional, the Company is currently planning for Part Three of
the Phase I study, utilizing the safety, tolerability,
pharmacokinetic and pharmacodynamic data gathered thus far. Part
Three of the Phase I study will be a double-blind,
placebo-controlled, seven-day multiple dose study of the optimal
formulation in healthy subjects. Study completion with preliminary
interim results is currently on track to be reported by the end of
the second quarter, with planned follow up data analysis in the
third quarter.
New Zealand Study
The Company completed the previously announced New Zealand study of the Company's nutritional
supplement variant of Anatabine Citrate. In December 2014, the Company received
a New Zealand Ministry of Health Ethics Committee approval to
conduct a single-site, single dose, open-label human study,
entitled "Determination of the Blood Pharmacodynamic Effects
following a Single Dose of Oral Anatabine Citrate in Normal,
Healthy Volunteers." The primary outcome measure of the study was a
pharmacodynamic assessment of whether a single dose of orally
administered anatabine citrate can acutely attenuate expression
and/or production of pro-inflammatory mediators in human white
blood cells, thus creating an anti-inflammatory effect. Follow up
analysis is ongoing, and the Company is expected to provide a
formal report before the end of the second quarter.
First Quarter 2015 Results
The Company recorded a net loss of approximately $0.3 million for the three months ended
March 31, 2015, compared to a net
loss of approximately $9.8 million
for the same period in 2014. The decreased net loss for the three
months ended March 31, 2015 was
primarily due to cost savings in relation to the restructuring, a
decrease in non-cash expenditures related to stock based
compensation, and non-recurring other income from insurance
proceeds.
General and administrative expenses were approximately
$3.3 million for the three months
ended March 31, 2015, a decrease of
approximately $5.6 million, or 62.8%,
from approximately $9.0 million for
the same period in 2014. For the three months ended March 31, 2015, legal expenses decreased by
$0.2 million primarily due to the
completion of the Department of Justice investigation and
settlement of the Securities Class Action litigation; non-cash
charges decreased by $4.3 million
related to stock based compensation, salaries, rents, travel,
phone, computer expenses decreased by $1.3
million due to completion of the restructuring that was
undertaken in 2014, and various other net decreases of expenses
were $0.2 million. Business insurance
premiums increased by approximately $0.4
million.
The Company expended approximately $0.5
million on research and development in the three months
ended March 31, 2015, compared to
approximately $0.7 million in the
comparable period in 2014. The research and development costs in
the three months ended March 31, 2015
were directed principally toward ongoing expenses related to the
Company's Phase I trial in the UK, the clinical study in
New Zealand and expenses
associated with overall drug development initiatives.
For the three months ended March 31,
2015, the Company had a total basic and diluted loss per
share of $0.04, compared to a total
net loss per share of $1.41 at
March 31, 2014.
About Anatabine Citrate:
Rock Creek Pharmaceuticals' Anatabine Citrate is a small
molecule, cholinergic agonist which exhibits anti-inflammatory
pharmacological characteristics, distinct from other
anti-inflammatory drugs available such as biologics, steroids and
non-steroidal anti-inflammatories. 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 Citrate. 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, failure to obtain sufficient capital resources to fund
our development program and operations, 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 significant payables, 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, pending litigation matters, 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, 2014 filed on
March 12, 2015. 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
Investors
Integrated Corporate Relations, Inc. (ICR): Redefining Strategic
Communications
685 Third Avenue, 2nd Floor,
New York, NY 10017
(646) 277-1282
stephanie.carrington@icrinc.com
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SOURCE Rock Creek Pharmaceuticals, Inc.