NEW YORK, Aug. 12, 2014 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX), a late stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad spectrum, topical antibiotic peptide, today reported its financial results for the second quarter ended June 30, 2014 and provided an update on operational progress.
"The first half of 2014 has been an exciting period for Dipexium. We are very pleased with the progress achieved since the completion of our Initial Public Offering in March," stated David P. Luci, President & Chief Executive Officer of Dipexium. "Importantly, we remain on our stated timeline to complete enrollment in the OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials in the first quarter of 2015 and file a New Drug Application (NDA) for Locilex® in the second half of 2015."
Financial Results for the Second Quarter of 2014For the three months ended June 30, 2014, Dipexium reported a net loss of approximately $3.9 million, compared to $0.4 million for the three months ended June 30, 2013, an increase of $3.5 million, primarily due to a $2.5 million increase in research and development expenses and a $1.0 million increase in general and administrative expenses. The increased research and development expenses were primarily due to an increase of $1.9 million in research and development consulting-related expenses for the planning and execution of Locilex®'s Phase 1 and 3 clinical trials and a $0.6 million increase in research and development manufacturing costs related to manufacturing Locilex® for clinical trials. The increase in general and administrative expenses is primarily attributable to an increase of $0.7 million for compensation related expenses and an increase in $0.3 million in professional fees and office expenses.
For the six months ended June 30, 2014, Dipexium reported a net loss of approximately $6.5 million, compared to $0.8 million for the six months ended June 30, 2013, an increase of $5.7 million, primarily due to a $4.3 million increase in research and development expenses and a $1.4 million increase in general and administrative expenses. The increased research and development expenses were primarily due to an increase of $3.5 million in research and development consulting related expenses for the planning and execution of the clinical trials and a $0.8 million increase in research and development manufacturing costs related to making the product for the clinical trials. The increase in general and administrative expenses is primarily attributable to an increase of $0.9 million for compensation related expenses and an increase in $0.4 million in professional fees and a $0.1 million increase in office expenses.
Net cash used in operating activities for the six months ended June 30, 2014 was $5.7 million.
At June 30, 2014, the Company had a cash balance of approximately $32.6 million, as compared to approximately $3.9 million at December 31, 2013. The increase in cash was due to the consummation of the Company's Initial Public Offering in March, which provided net proceeds of approximately $34.5 million. The Company's cash balance is currently anticipated to fund operations through the first half of 2016.
Operational UpdateIn July, Dipexium announced the initiation of patient enrollment in OneStep-1 and OneStep-2, the Company's pivotal Phase 3 trials of Locilex® for the treatment of patients with mild infections of diabetic foot ulcers (Mild DFI). These trials remain on track to complete enrollment in the first quarter of 2015. Also in July, the company reported the successful completion of DPX-110, a Phase 1 skin irritation study of Locilex® in healthy adult volunteers. Results demonstrated that Locilex® is not a topical irritant. There was no statistical difference between Locilex®, vehicle cream, and the negative control on intact or abraded skin.
In the second quarter, the company initiated DPX-120, a Phase 1 skin sensitization study of Locilex®. Patient enrollment in the study was completed in July, and the Company expects to complete the study in the fourth quarter of 2014. Finally, during the second quarter, the Company initiated activities related to the preparation of a New Drug Application (NDA) for Locilex®.
Upcoming Locilex® Poster Presentation at ICAAC Today, Dipexium also announced that the Company will present new microbiology data at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C. on September 6th. Data to be presented will highlight the potent and broad spectrum in vitro activity of pexiganan, the active pharmaceutical ingredient in Locilex®, against contemporary Gram-negative and Gram-positive bacteria from isolates that include those that commonly cause diabetic foot infections and other select antibiotic resistant bacteria. Details of the poster presentation are as follows:
"In Vitro Spectrum of Pexiganan Against Pathogens from Diabetic Foot Infections and with Selected Resistance Mechanisms." [C-105a] Saturday, September 6, 2014, 12:00 p.m. - 2:00 p.m. Poster Session 009 (Exhibit Hall B).
About Dipexium Pharmaceuticals, Inc.Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) is a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad spectrum, topical antibiotic peptide. Initially, Locilex® is targeted for the treatment of Mild DFI. Based on a compilation of available clinical and microbiology data, Locilex® is also considered a promising product candidate to treat other mild and moderate skin and skin structure infections, including infected decubitus ulcers, infected burns, infected surgical wounds and nasal colonization of methicillin-resistant staphylococcus aureus (MRSA).
Cautionary Note on Forward-Looking StatementsThis press release and any statements of representatives and partners of Dipexium Pharmaceuticals, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission and those that relate to the Company's ability to leverage the expertise of employees and partners to assist the Company in the execution of its strategy. Actual results (including, without limitation, the timing for and results of the clinical trials and proposed NDA submission for Locilex®) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
DIPEXIUM PHARMACEUTICALS, INCCONDENSED STATEMENTS OF OPERATIONS (Unaudited)Three Months Ended June 30, Six Months Ended June 30,2014201320142013REVENUES$
-EXPENSESOPERATING EXPENSESResearch and Development Expenses2,592,91733,7754,409,607156,476General and Administrative Expenses1,327,196329,4112,054,345613,298TOTAL OPERATING EXPENSES3,920,113363,1866,463,952769,774LOSS FROM OPERATIONS(3,920,113)(363,186)(6,463,952)(769,774)NET LOSS$
(769,774)LOSS PER SHAREBasic and diluted net loss per common share/units$
(0.17)Wtd avg common shares/units outstanding basic and diluted
DIPEXIUM PHARMACEUTICALS, INCCONDENSED BALANCE SHEETSJune 30,December 20142013ASSETS(unaudited)CURRENT ASSETSCash $
3,861,145Prepaid Expenses165,21446,094TOTAL CURRENT ASSETS32,808,6053,907,239OTHER ASSETSDeferred Initial Public Offering costs-122,826Security Deposit49,385-TOTAL OTHER ASSETS49,385122,826TOTAL ASSETS$
4,030,065LIABILITIES AND MEMBERS' AND SHAREHOLDERS' EQUITYCURRENT LIABILITIESAccounts Payable and Accrued Expenses$
823,834TOTAL LIABILITIES667,355823,834COMMITMENTS AND CONTINGENCIESMEMBERS' AND SHAREHOLDERS' EQUITY Members' Equity-3,206,231Common Stock : $.001 par value, 30,000,000 shares authorized, 8,537,877 shares issued and outstanding at June 30 20148,538-Additional paid-in capital47,383,814-Accumulated deficit(15,201,717)---TOTAL MEMBERS' AND SHAREHOLDER'S EQUITY 32,190,6353,206,231TOTAL LIABILITIES AND MEMBERS' AND SHAREHOLDERS' EQUITY
Company Contacts:David P. Luci
President & Chief Executive Officer
Dipexium Pharmaceuticals, Inc.
Vice President, Finance & Corporate Development
Dipexium Pharmaceuticals, Inc.
© 2014 Dipexium Pharmaceuticals, Inc. All rights reserved.
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