Rock Creek Pharmaceuticals, Inc. announced earnings results for the second quarter ended June 30, 2015. For the quarter, the company recorded a net loss of approximately $0.8 million for the three months ended June 30, 2015, compared to a net loss of approximately $12.7 million, a decrease of approximately $11.9 million attributed primarily to the cost savings from the restructuring, a decrease in non-cash expenditures and a gain on derivatives.

Rock Creek Pharmaceuticals, Inc. announced its dermatological development program in which dermal formulations of its lead compound are being developed for common chronic skin disorders such as psoriasis, eczema (e.g., atopic dermatitis) and rare or orphan skin disorders. Patients and key opinion leaders agree there are unmet medical needs requiring new, safe and effective first-line treatments for dermatological diseases, and the Company believes the novel anti-inflammatory mechanism of action of its lead compound is well suited to meet these needs. The Company is directing its strategy to gain regulatory approval accordingly. Clinical/Regulatory Strategy: Rock Creek Pharmaceuticals has an extensive array of published and non-published preclinical and clinical data which provides compelling evidence that Anatabine Citrate produces anti-inflammatory effects through a unique mechanism of action distinct from steroids, non-steroidal anti-inflammatories, and biologics. Included in such data is the Company's recently reported results from a small pharmacodynamic human trial, entitled ‘Rock Creek Pharmaceuticals Reports Human Proof of Principle Study of Lead Compound Demonstrating Inhibition of Inflammatory Markers In White Blood Cells'. Results from that study showed a statistically significant (p<0.05) reduction in pro-inflammatory protein activation (NF-kB and STAT3) in LPS challenged white blood cells from 10 healthy volunteers after a single oral dose of Anatabine Citrate, with no safety concerns raised by the investigators. The company recently reported initial results of "Part One" of the Phase I clinical study being conducted in the United Kingdom (UK) to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of various modified and immediate release oral formulations of Anatabine Citrate. In Part One, there were no reports of serious adverse events (AEs) or AEs leading to study withdrawal, and there were no safety concerns raised by either the Company's UK contract research organization or its UK based medical monitor for the trial. The Company further announced it would conduct "Part Two", with a protocol amendment that primarily evaluates the effects of food on PK parameters, with dosing expected to commence and be completed within the current quarter 2015. The UK's Medicine and Healthcare products Regulatory Agency (MHRA) and an independent Research Ethics Committee approved the protocol amendment. The Company's previously announced "Part Three", double-blind, placebo-controlled, seven-day multiple dose study of Anatabine Citrate in healthy subjects, will likely overlap with "Part Two" and is expected to be completed with preliminary results in the third quarter 2015. In light of the company's ongoing clinical advances in Europe and the generation of oral phase I safety data, the company has carefully evaluated its regulatory strategy in the United States. As indicated in a Form 8-K filing on April 2, 2015, the Company has remained on an FDA-imposed clinical hold for an oral phase I safety study. Because the US IND Phase I, first-in-human, single ascending dose PK protocol is essentially encompassed by the ongoing MHRA approved, European Phase I safety trial, which is nearing completion, the company has decided to withdraw its current US IND submission. The Company believes this strategy will provide a pathway for subsequent clinical and regulatory development in the United States as the company accumulates human safety and efficacy data in its EU dermatological developmental program.