NEW YORK, Nov. 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 Company’s common stock offering in June 2015, which provided net proceeds of $19.7 million. The Company’s 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 Dipexium’s 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 Company’s website at www.dipexiumpharmaceuticals.com, under the IR Calendar tab. The archived webcast will remain available on the Company’s 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.
Forward-Looking Statements
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.
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