NEW YORK, Nov. 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 third quarter ended September 30, 2014 and provided an update on operational progress.
“We have made progress this quarter on our operating plan and hope to continue that progress moving forward,” stated David P. Luci, President & Chief Executive Officer of Dipexium. “Importantly, we remain on our stated timeline to file a New Drug Application (NDA) for Locilex® in the second half of 2015.”
Financial Results for the Third Quarter of 2014
For the three months ended September 30, 2014, Dipexium reported a net loss of approximately $3.8 million, compared to $1.0 million for the three months ended September 30, 2013, an increase of $2.8 million, primarily due to a $1.9 million increase in research and development expenses and a $0.9 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 3 clinical trials, as well as Locilex’s now complete skin irritation and skin sensitization 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 $0.2 million in professional fees and office expenses.
For the nine months ended September 30, 2014, Dipexium reported a net loss of approximately $10.3 million, compared to $1.8 million for the nine months ended September 30, 2013, an increase of $8.5 million, primarily due to a $6.1 million increase in research and development expenses and a $2.4 million increase in general and administrative expenses. The increased research and development expenses were primarily due to an increase of $5.4 million in research and development consulting related expenses for the planning and execution of the clinical trials and a $0.7 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 $1.6 million for compensation related expenses and an increase in $0.6 million in professional fees and a $0.2 million increase in office expenses.
Net cash used in operating activities for the three months ended September 30, 2014 was $2.7 million.
At September 30, 2014, the Company had a cash balance of approximately $29.9 million, as compared to approximately $32.6 million at June 30, 2014. The Company’s cash balance is currently anticipated to fund operations through the first half of 2016.
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 Statements
This 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, INC | |||||||||
CONDENSED STATEMENTS OF OPERATIONS | |||||||||
(Unaudited) | |||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||
2014 | 2013 | 2014 | 2013 | ||||||
REVENUES | $ - | $ - | $ - | $ - | |||||
EXPENSES | |||||||||
OPERATING EXPENSES | |||||||||
Research and Development Expenses | 2,529,457 | 636,301 | 6,939,063 | 792,778 | |||||
General and Administrative Expenses | 1,313,697 | 354,678 | 3,368,044 | 967,975 | |||||
TOTAL OPERATING EXPENSES | 3,843,154 | 990,979 | 10,307,107 | 1,760,753 | |||||
LOSS FROM OPERATIONS | (3,843,154) | (990,979) | (10,307,107) | (1,760,753) | |||||
NET LOSS | $ (3,843,154) | $ (990,979) | $ (10,307,107) | $ (1,760,753) | |||||
LOSS PER SHARE | |||||||||
Basic and diluted net loss per common share/units | $ (0.45) | $ (0.21) | $ (1.35) | $ (0.39) | |||||
Wtd avg common shares/units outstanding basic and diluted | 8,537,877 | 4,771,911 | 7,618,540 | 4,525,713 | |||||
DIPEXIUM PHARMACEUTICALS, INC | |||||
CONDENSED BALANCE SHEETS | |||||
September 30, | December 31, | ||||
2014 | 2013 | ||||
ASSETS | (unaudited) | ||||
CURRENT ASSETS | |||||
Cash | $ 29,892,515 | $ 3,861,145 | |||
Prepaid Expenses | 133,443 | 46,094 | |||
TOTAL CURRENT ASSETS | 30,025,958 | 3,907,239 | |||
OTHER ASSETS | |||||
Deferred Initial Public Offering costs | - | 122,826 | |||
Security Deposit | 49,385 | - | |||
TOTAL OTHER ASSETS | 49,385 | 122,826 | |||
TOTAL ASSETS | $ 30,075,343 | $ 4,030,065 | |||
LIABILITIES AND MEMBERS’ AND SHAREHOLDERS’ EQUITY | |||||
CURRENT LIABILITIES | |||||
Accounts Payable and Accrued Expenses | $ 1,298,923 | $ 823,834 | |||
TOTAL LIABILITIES | 1,298,923 | 823,834 | |||
COMMITMENTS AND CONTINGENCIES | |||||
MEMBERS’ AND SHAREHOLDERS’ EQUITY | |||||
Members’ Equity | - | 3,206,231 | |||
Common Stock : $.001 par value, 30,000,000 shares authorized, 8,537,877 | |||||
shares issued and outstanding at September 30, 2014 | 8,538 | - | |||
Additional paid-in capital | 47,812,754 | - | |||
Accumulated deficit | (19,044,872) | - | |||
TOTAL MEMBERS’ AND SHAREHOLDERS’ EQUITY | 28,776,420 | 3,206,231 | |||
TOTAL LIABILITIES AND MEMBERS’ AND SHAREHOLDERS’ EQUITY | $ 30,075,343 | $ 4,030,065 | |||
Company Contacts:
David P. Luci
President & Chief Executive Officer
Dipexium Pharmaceuticals, Inc.
212-269-2834
davidluci@dipexium.com
David Garrett
Vice President, Finance & Corporate Development
Dipexium Pharmaceuticals, Inc.
212-269-2834
davidgarrett@dipexium.com
© 2014 Dipexium Pharmaceuticals, Inc. All rights reserved.
SOURCE Dipexium Pharmaceuticals, Inc.
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