UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): August 10, 2015
ROCK CREEK PHARMACEUTICALS, INC.
(Exact name of registrant as specified
in its charter)
Delaware
(State or other jurisdiction of incorporation) |
000-15324
(Commission File Number) |
52-1402131
(IRS Employer Identification No.) |
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2040 Whitfield Avenue, Suite 300
Sarasota, Florida 34243
(Address of principal executive offices,
including zip code)
844-727-0727
(Registrant’s telephone number,
including area code)
Not Applicable
(Former name or former address, if changed
since last report) |
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Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 2.02. | Results of Operations
and Financial Condition. |
On August 10, 2015, Rock Creek Pharmaceuticals,
Inc. (the “Company”) issued a press release announcing its financial results for the three months ended June 30, 2015.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information furnished in this Item
2.02, including Exhibit 99.1, is not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section. This information will
not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act,
except to the extent that the registrant specifically incorporates it by reference.
| Item 7.01. | Regulation FD Disclosure. |
On August 10, 2015, the Company announced
information about its clinical and regulatory strategy, which information was included in the above-mentioned press release attached
hereto as Exhibit 99.1 and incorporated herein by reference.
The information in this item shall not be
deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of Section 18,
nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended
or the Exchange Act, except to the extent, if any, expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit No. |
Description |
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99.1 |
Press Release, dated August 10, 2015 |
SIGNATURE
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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ROCK CREEK PHARMACEUTICALS, INC. |
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By: |
/s/ Michael J. Mullan |
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Michael J. Mullan Chairman of the Board and
Chief Executive Officer |
Date: August 10, 2015
Exhibit 99.1
Rock Creek
Pharmaceuticals Announces Targeting of
Dermatological
Disease, Updated Clinical and Regulatory
Strategy and Second Quarter Results
SARASOTA,
Fla., August 10, 2015 – Rock
Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a clinical stage, drug development company
which has focused on the application of its lead compound to chronic inflammatory conditions, announced today its second quarter
results. The Company also disclosed 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 in a July 1, 2015
press release, 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.
Scientific Research Update
The transcription factors, NF-κB
and STAT3, are known causative regulators of inflammation and are regarded as therapeutic targets in certain dermatological conditions
including psoriasis. Our lead compound attenuates the activity of these factors in a variety of experimental conditions and is
therefore suited to targeting dermatological conditions where NF-κB and STAT3 activity is increased. Given other advantages
of dermatological trial designs and timelines, the Company is formulating Anatabine Citrate for clinical trials of human inflammatory
skin diseases. The Company has been unifying its scientific, clinical, regulatory and consultancy resources to plan a Phase IB,
proof-of-concept trial with patients diagnosed with mild to moderate psoriasis in Europe, which is expected to commence in the
first quarter of 2016.
Second Quarter 2015 Results
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.
General and administrative expenses were
approximately $1.6 million for the three months ended June 30, 2015 compared to approximately $11.2 million for the comparable
period in 2014, a decrease of $9.6 million or 85.7%. The expense reductions were attributed to a $1.7 million decrease in legal
expenses as a result of the completion of the Department of Justice (DOJ) investigation and settlement of the securities class
action litigation; a decrease in non-cash charges of $3.7 million related to stock based compensation over the same period in the
prior year; a reduction of approximately $4.1 million as compared to the three months ended June 30, 2014 due to the completion
of the 2014 restructuring. This restructuring consolidated all of the Company’s offices into one and substantially reduced
the number of employees, thus lowering payroll and related expenses, reducing rent expense, and lowering administrative operating
expenses such as travel and communication.
The Company invested approximately $0.4
million on research and development in the three months ended June 30, 2015 compared to approximately $0.8 million in the comparable
period in 2014. The research and development costs in the three months ended June 30,
2015 were directed principally toward generating preclinical data, testing safety in the human phase I trial and formulating dermatological
preparations of the Company’s lead compound.
Dr. Michael Mullan, (MBBS, PhD), Chairman
and Chief Executive Officer of Rock Creek Pharmaceuticals, remarked, “We are pleased to be executing our clinical development
plan, gathering the necessary human safety data in healthy volunteer subjects prior to studies in patients suffering from dermatological
conditions. Additional preclinical data continue to affirm the novel anti-inflammatory mechanism of action of the lead compound
which we seek to harness for the benefit of patients. It is also of importance that we have managed to effect a major corporate
restructuring which has resulted in substantial cost savings and an overall repositioning of the Company in preparation for the
next steps in clinical development.”
About Anatabine Citrate:
Rock Creek Pharmaceuticals’ compound
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 the Company’s compound. 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 and acute inflammatory diseases and neurologic disorders.
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
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL 34243
Direct: 941-251-0488
tjenkins@rockcreekpharmaceuticals.com
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