Rock Creek Pharmaceuticals Announces European Patent

Allowance for the Administration of Anatabine to Treat Autism Spectrum and Seizure Disorders and Third Quarter Results

Nov 09, 2015, 17:05 ET from Rock Creek Pharmaceuticals, Inc.

SARASOTA, Fla., Nov. 9, 2015 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (OTCPK: RCPI), a clinical stage drug development company focused on the application of its lead compound being developed to treat chronic inflammatory conditions, announced today its third quarter results. The Company also disclosed the Notification of Intent to Grant by the European Patent Office of a European patent for the administration of Anatabine to treat autism spectrum and seizure disorders.

Autism Spectrum Disorders

Autism spectrum disorders (ASDs) are pervasive neurodevelopmental disorders diagnosed in early childhood when acquired skills are lost or the acquisition of new skills become delayed. ASDs onset in early childhood and are associated with varying degrees of dysfunctional communication and social skills, in addition to repetitive and stereotypic behaviors. In many cases (25%-50%), a period of seemingly normal development drastically shifts directions as acquired skills are lost or the acquisition of new skills becomes delayed. Examples of ASDs include "classical" autism, Asperger's syndrome, Rett syndrome and other pervasive developmental disorders.

Previous research has suggested that there is excess inflammation in the colon, esophagus and duodenum of some patients with autism and postmortem studies have also shown an increase in the expression of several markers of neuro-inflammation. There is also evidence that nicotinic acetylcholine receptor (nAChR) agonists, especially those that target the alpha-7 subtype, may be useful in treating ASD.  For instance, it has been suggested that activating the alpha-7 nAChR may provide symptomatic relief in ASD by reducing chronic inflammation and providing pro-cognitive effects.  Anatabine has been shown in a variety of preclinical models to activate alpha-7 nAChRs, reduce inflammation in several animal models and to normalize social behavior in transgenic models of Alzheimer's disease.

As previously disclosed, the Company believes that isolated forms of Anatabine could be particularly useful for treating diseases or disorders with an inflammatory component characterized by excessive NF-kB mediated transcription. Although the Company is focusing its resources and clinical development program on dermatological diseases, the Company is communicating with the scientific and medical community for potential collaborative and independent, investigative study for autism spectrum and related disorders.

Dr. Michael Mullan, (MBBS, PhD), Chairman and Chief Executive Officer of Rock Creek Pharmaceuticals, remarked, "Given our experience with neurodegenerative diseases, it has been hypothesized that our compound may have applicability for autism spectrum and seizure disorders. Although autism spectrum is not an indication we will be developing internally, I am pleased that the Company has secured intellectual property in this area, and it is just one of many initiatives aimed at enhancing the Company's patent portfolio and broadening the potential clinical uses of our compound."

Third Quarter Results 2015

The Company recorded a net loss of approximately $2.8 million for the three months ended September 30, 2015, compared to a net loss of approximately $10.0 million for the same period in 2014. The decreased net loss for the three months ended September 30, 2015 was primarily due to cost savings in relation to restructuring, a decrease in non-cash expenditures related to stock based compensation, and recognition of a gain on derivatives and the sale of equipment related assets.

General and administrative expenses were approximately $2.2 million for the three months ended September 30, 2015, a 48.8% decrease of approximately $2.1 million, from approximately $4.3 million for the same period in 2014. For the three months ended September 30, 2015, compared to the same period the prior year, there were decreased legal expenses of $0.2 million; a decrease of non-cash charges of $0.6 million related to stock based compensation; and a decrease in the number of employees which translated into lower salaries, consolidation of offices which reduced rents, and lower travel, phone, computer expenses of $1.1 million, due to completion of the restructuring that was undertaken in 2014; and a net decrease in various other expenses in the amount of $0.2 million .

Since 2014, the Company has managed significant cost savings due to the restructuring. During the nine months ended September 30, 2015 General and administrative expenses have declined by approximately $17.3 million or 70.5% for the nine months ended September 30, 2015 compared to the same period in 2014, primarily due to a reduction of overhead of $6.5 million, a reduction of legal expenditure of $2.1 million and a reduction of non-cash stock compensation of $8.7 million.

The Company invested approximately $1.3 million in research and development in the three months ended September 30, 2015, compared to approximately $1.7 million in the comparable period in 2014. The research and development costs in the three months ended September 30, 2015 were directed principally toward completing the Company's Phase I Clinical Trial, formulating dermatological preparations of the Company's lead compound, and preparing ongoing initiatives and strategies for advancing a dermatological clinical development program.

Additional financial information can be found in the Company's Form 10Q filed November 9, 2015.

About Anatabine Citrate:
Rock Creek Pharmaceuticals' compound is a small molecule, cholinergic agonist that 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 the Company's compound. In addition, the Company's compilation of human exposure, safety and tolerability data, has provided important insights for ongoing clinical and regulatory pharmaceutical 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 and acute inflammatory diseases.

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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.


Ted Jenkins
Vice President, Corporate Strategy & Development
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL  34243
Direct: 941-251-0488 

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SOURCE Rock Creek Pharmaceuticals, Inc.