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 millioncredit 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.
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