CHARLOTTE, N.C., Aug. 6, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the second quarter ended June 30, 2013. "Chelsea continues to diligently manage its financial resources, which are projected to fund operating expenses into the third quarter of 2014, as we work to finalize our NDA submission for NORTHERA™ (droxidopa) in the treatment of symptomatic Neurogenic Orthostatic Hypotension (NOH)," said Joseph G. Oliveto, Interim CEO of Chelsea. "We anticipate that this effort will be completed in August, at which point a new PDUFA date, expected in the first quarter of 2014, will be set by the Agency." Recent Highlights
- In early July 2013, Chelsea resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market Northera for the treatment of symptomatic NOH. On July 29, Chelsea reported that the U.S. Food and Drug Administration (FDA) identified certain technical difficulties with the resubmitted New Drug Application (NDA). The Company expects to submit the necessary response in August 2013, at which point a new six month Prescription Drug User Fee Act (PDUFA) review clock is expected to begin.
- In June 2013, Chelsea was added to the Russell 3000® and Russell 2000® Indexes when the Russell Investment Group reconstituted its family of U.S. indexes.
Research and development (R&D) expenses for the quarter ended June 30, 2013 were $1.9 million, compared to $4.7 million for the same period in 2012. For the six months ended June 30, 2013, research and development expenses were $3.9 million versus $13.4 million for the comparable prior-year period. The reduction in R&D costs is primarily due to the completion of multiple studies in both the droxidopa and antifolate development programs reflecting significantly reduced clinical activity in 2013 when compared to 2012. Droxidopa-related research and development costs during the remainder of 2013 are estimated at approximately $7.9 million and include estimated costs for the planned new trial of Northera which the Company expects will begin enrolling patients in the fourth quarter of 2013, costs to prepare for a potential late-year meeting of CRDAC, and operating costs for research and development activities including compensation and related costs.Selling, general and administrative (SG&A) expenses were $1.4 million for the three months ended June 30, 2013, compared to $3.2 million for the same period in 2012. For the six months ended June 30, 2013, SG&A expenses were $3.4 million versus $10.1 million for the comparable prior-year period. With no formalized selling activities or near-term plans for commercialization of any of our drug candidates, sales and marketing expenses decreased significantly for the second quarter when compared to the same period of 2012. Costs incurred in 2013 included compensation and related expenses for our continuing business development efforts and legal fees related to our intellectual property activities. Chelsea ended the quarter with $22.0 million in cash and cash equivalents compared to $28.4 million as of December 31, 2012. Chelsea anticipates that its cash and cash equivalents on hand at June 30 should fund the Company's operations into the third quarter of 2014. This current forecast does not include significant costs related to commercialization or other activities and events that are related to and would follow an NDA approval.
About NortheraNORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, is currently in Phase III development for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure — an indication that includes a significant number of patients with Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd. (DSP), initially received Japanese approval in 1989 for the treatment of frozen gait and dizziness on standing associated with Parkinson's Disease and for the treatment of orthostatic hypotension, syncope or dizziness on standing associated with Shy-Drager syndrome and Familial Amyloid Polyneuropathy. In 2000, Droxidopa received expanded marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients. About Chelsea Therapeutics Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system disorders. Chelsea is currently pursuing FDA approval in the U.S. for Northera™ (droxidopa), a novel, late-stage, orally-active therapeutic agent for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure. For more information about the Company, visit www.chelseatherapeutics.com . This press release contains forward-looking statements regarding future events including our intention to pursue the development of Northera. These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include reliance on key personnel and our ability to attract and/or retain key personnel; the risk that FDA will not agree that our clinical trial results demonstrate the safety and effectiveness of droxidopa; the risk that the FDA will not accept our proposal regarding any trial or other data to support a new drug application; the risk that the FDA will not approve the resubmitted NDA; the risk that our resources will not be sufficient to conduct any study of Northera that will be acceptable to the FDA; the risk that we cannot complete any additional study for Northera without the need for additional capital; the risks and costs of drug development and that such development may take longer or be more expensive than anticipated; our need to raise additional operating capital in the future; our reliance on our lead drug candidate droxidopa; risk that we will not be able to obtain regulatory approvals of droxidopa or our other drug candidates for additional indications; risk of volatility in our stock price, related litigation, and analyst coverage of our stock; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; market acceptance for our products if any are approved for marketing.
|CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY|
|(A Development Stage Company)|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|For the three months ended June 30,||For the six months ended June 30,|
|Research and development||$ 1,904,849||$ 4,695,546||$ 3,861,815||$ 13,394,664|
|Sales and marketing||241,139||1,753,166||600,423||6,721,928|
|General and administrative||1,194,172||1,441,167||2,801,236||3,361,278|
|Total operating expenses||3,340,160||7,889,879||7,263,474||23,477,870|
|Net loss||$ (3,335,884)||$ (7,872,285)||$ (7,253,103)||$ (23,431,502)|
|Net loss per basic and diluted share of common stock||$ (0.05)||$ (0.12)||$ (0.11)||$ (0.35)|
|Weighted average number of basic and diluted common shares outstanding||67,094,460||67,040,569||67,085,171||66,734,874|
|CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY|
|Condensed Consolidated Balance Sheet Data|
|June 30,||December 31,|
|Cash and cash equivalents||$ 22,012||$ 28,425|
|Deficit accumulated during the development stage||(222,315)||(215,061)|
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