The following excerpt is from the company's SEC filing.
Management to Host Conference Call Today, November 16, 2015, at 8:30 a.m. ET
NEW YORK, November 16, 2015 /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 financial results for the quarter ended September 30, 2015.
Our OneStep Phase 3, placebo-controlled, pivotal clinical trials of Locilex in the treatment of patients with mild infections of diabetic foot ulcers are approximately 62% enrolled, said David P. Luci, President and CEO of Dipexium Pharmaceuticals, Based on the current pace of enrollment, we expect to complete enrollment in early 2016. We intend to file a New Drug Application with the Food and Drug Administration by the end of 2016, followed soon thereafter by a Marketing Authorization Application with the European Medicines Agency.
Financial Results for the Third Quarter of 2015
For the three months ended September 30, 2015, Dipexium reported a net loss of $5.0 million, compared to a net loss of $3.8 million for the three months ended September 30, 2014, an increase of $1.2 million. The change was primarily due to a $0.9 million increase in research and development expenses associated with increased number of sites participating in our OneStep clinical trials, advancement of clinical trial enrollment and manufacturing scale-up activities, as well as a $0.3 million increase in selling, general and administrative expenses associated with marketing related professional fees and non-cash stock-based compensation expenses.
For the nine months ended September 30, 2015, Dipexium reported a net loss of $13.2 million, compared to a net loss of $10.3 million for the nine months ended September 30, 2014, an increase of $2.9 million. This change was primarily due to a $2.4 million increase in selling, general and administrative expenses, and a $0.5 million increase in research and development expenses. The increase in general and administrative expenses is primarily attributable to an increase of $1.8 million for non-cash stock-based compensation expenses and $0.2 million increase in marketing related professional fees. Research and development expenses increased slightly due to clinical trial related expenses.
Net cash used in operating activities for the nine months ended September 30, 2015 was $10.6 million. At September 30, 2015, the Company had cash and short-term investments of $36.2 million, compared to $27.0 million at December 31, 2014. The increase in cash was due to the Companys common stock offering in June 2015, which provided net proceeds of $19.7 million. The Companys cash balance is currently anticipated to fund operations through 2017.
Conference Call & Webcast Information
Dipexium will host a conference call today beginning at 8:30 a.m. Eastern Time, during which management will discuss Dipexiums financial results and recent developments. Access to the live call is available by dialing 877-407-8012 (U.S. & Canada) or 412-902-1013 (international) five minutes prior to the start of the call. A live and archived audio webcast of the conference call can be accessed through
the Investor Relations section of the Companys website at www.dipexiumpharmaceuticals.com, under the IR Calendar tab. The archived webcast will remain available on the Companys website for 30 days following the call.
About Dipexium Pharmaceuticals
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 infections of diabetic foot ulcers. Based on a compilation of available clinical and microbiology data, Dipexium also considers Locilex to be 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). For more information, visit www.dipexiumpharmaceuticals.com.
This press release may contain, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include statements relating to our anticipated clinical and regulatory development of our product candidate, including development for the European market and development of an intravenous formulation; our cash position; cash flows; business strategies and initiatives; and other matters. We have based these forward-looking statements on the assumptions, expectations and projections about future events that we hold at the time the statements are made. We use words like believe, anticipate, intend, estimate, expect, project and similar expressions to identify forward-looking statements, although not all forward-looking statements contain these words. These forward-looking statements are necessarily estimates reflecting the best judgment of our senior management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements.
Investors should consider the information contained in our filings with the U.S. Securities and Exchange Commission (the SEC), including our Annual Report on Form 10-K, especially in the Managements Discussion and Analysis of Financial Condition and Results of Operations and Risk Factors sections, our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Other unknown or unpredictable factors also could have material adverse effects on our future results, performance or achievements. In light of these risks, uncertainties, assumptions and factors, the forward-looking events discussed in this press release may not occur. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our beliefs at the time the statements are made. We do not undertake any obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, nor any other information provided in a conference call, webcast, news release, SEC filing or website.
DIPEXIUM PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
TOTAL CURRENT ASSETS
TOTAL OTHER ASSETS
LIABILITIES AND SHAREHOLDERS EQUITY
Accounts Payable and Accrued Expenses
COMMITMENTS AND CONTINGENCIES
Common Stock: $.001 par value, 30,000,000 shares authorized, 10,301,114 and 8,538,329 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively
Additional paid-in capital
TOTAL SHAREHOLDERS EQUITY
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY
CONDENSED STATEMENTS OF OPERATIONS
Three Months Ended September 30,
Nine Months Ended September 30,
Research and Development Expenses
Selling, General and Administrative Expenses
TOTAL OPERATING EXPENSES
LOSS FROM OPERATIONS
LOSS PER SHARE
Basic and diluted net loss per common share
Weighted average common shares/units outstanding basic and diluted
President & Chief Executive Officer
Vice President, Finance & Corporate Development
© 2015 Dipexium Pharmaceuticals, Inc. All rights reserved.
The above information was disclosed in a filing to the SEC. To see this filing in its entirety, click here. Dipexium Pharmaceuticals, Inc. next reports earnings on November 16, 2015.
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Other recent filings from the company include the following:
Regulation FD - Jan. 8, 2018