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."
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.
Vice President, Corporate Strategy, Development, Investor Relations
Rock Creek Pharmaceuticals
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Stephanie Carrington/ Bo Park
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SOURCE Rock Creek Pharmaceuticals, Inc.