Dipexium Pharmaceuticals Reports Second Quarter 2016 Financial Results

NEW YORK, Aug. 4, 2016 /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 June 30, 2016. 

"In the second quarter we completed enrollment in the OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials of Locilex in patients with mild infections of diabetic foot ulcers (Mild DFI) and expect to have top-line data in September. Pending the results of these trials, we anticipate submitting a New Drug Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency in the first half of 2017," said David P. Luci, President and CEO of Dipexium Pharmaceuticals. "Based on our market research, there is a significant unmet medical need for a non-invasive, topical treatment for Mild DFI with the target product profile of Locilex. If approved, Locilex, has the potential to be the first product specifically approved in the U.S. for the treatment of patients with Mild DFI."

Financial Results for the Second Quarter of 2016

For the three months ended June 30, 2016, Dipexium reported a net loss of $5.4 million, compared to a net loss of $4.0 million for the three months ended June 30, 2015, an increase of $1.4 million.  The change was primarily due to a $0.9 million increase in Phase 3 clinical trial enrollment and related clinical trial expenses, and $0.5 million of increased manufacturing expenses relating to validation batches.

For the six months ended June 30, 2016, Dipexium reported a net loss of $11.2 million, compared to a net loss of $8.2 million for the six months ended June 30, 2015, an increase of $3.0 million. This change was primarily due to a $3.3 million increase in research and development expenses partially offset by a $0.3 million decrease in selling, general, and administrative expenses. The increase in research and development expenses were due to $2.7 million of increased Phase 3 trial enrollment and related clinical trial expenses, and a $0.6 million increase in manufacturing expenses relating to validation batches. The decrease in general and administrative expenses is primarily attributable to a decrease of $0.2 million for stock-based compensation expenses and a $0.1 million decrease in professional fees.

Net cash used in operating activities for the six months ended June 30, 2016 was $9.7 million versus $6.2 million for the six months ended June 30, 2015.   The increase in cash used in operating activities is primarily attributable to increased research and development expenses associated with increased Phase 3 trial enrollment and related clinical trial expenses.   

At June 30, 2016, the Company had cash and short-term investments of $22.6 million, compared to $32.2 million at December 31, 2015.

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