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.
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