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Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP), Charlotte, N.C., has reported financial results for the third quarter 2010 and presented a quarterly update on the company's development progress.

Recent Highlights:

-- Reported Study 301, a pivotal Phase III trial in neurogenic orthostatic hypotension (NOH), demonstrated NORTHERA(TM) (droxidopa) provided statistically significant symptomatic improvement over placebo on composite orthostatic questionnaire score (p=0.003) and showed statistically significant benefits in all 3 composite scores and 8 out of 10 individual items of the orthostatic hypotension questionnaire;

-- Initiated Northera Study 306, a pivotal Phase III trial in Parkinson's disease patients with symptomatic neurogenic orthostatic hypotension;

-- Initiated head-to-head Phase II trial comparing CH-4051 to methotrexate (MTX) in rheumatoid arthritis patients who are experiencing an inadequate response to MTX treatment;

-- Reported positive interim analysis of Phase II study of droxidopa in fibromyalgia by an independent data monitoring committee supporting the efficacy and safety of a novel droxidopa/carbidopa combination therapy; and

-- Raised approximately $37.8 million through a successful public offering.

"The last few months have been momentous for Chelsea as we reported highly favorable findings from Study 301 demonstrating that Northera provided significant symptomatic relief of neurogenic orthostatic hypotension, continued to enroll patients into Study 306 at a better than expected pace, and substantively strengthened our balance sheet," commented Dr. Simon Pedder, president and CEO of Chelsea. "While collectively these accomplishments should put us in a strong position to complete our first NDA filing in 2011, we believe they are only just the beginning of a transformative period for Chelsea. Over the next several quarters, we eagerly anticipate reporting data from five on-going clinical trials including: our Phase III trial of Northera in NOH associated with Parkinson's disease; our Phase II trial of CH-4051 in rheumatoid arthritis; our Phase II trial of droxidopa/carbidopa combination therapy in fibromyalgia; as well as from the investigator-led Phase II trials of droxidopa/carbidopa combination therapy in adult attention deficit hyperactivity disorder and droxidopa monotherapy in chronic fatigue syndrome."

Financial Results for the Third Quarter

Chelsea reported a net loss for the quarter ended September 30, 2010 of $8.8 million or ($0.22) per share versus a net loss of $7.1 million or ($0.22) per share for the same period in 2009.

For the first nine months of 2010, Chelsea reported a net loss of $24.9 million or ($0.65) per share compared to a net loss of $19.8 million or ($0.64) per share for the nine months ended September 30, 2009. Excluding the gain associated with student loan backed auction rate securities in 2009, Chelsea's 2009 net loss, on a non-GAAP basis, for the first nine months was $24.2 million or ($0.78) per share.

Research and development (R&D) expenses for the third quarter 2010 were $7.4 million, compared to $5.4 million for the same period in 2009. The increase in third quarter R&D expense year-over-year reflects an increase in costs related to the conduct of Chelsea's Phase III registration program for Northera as the program was expanded to include Study 306 and participation in the program's safety extension studies increased. Third quarter 2010 R&D also included expense associated with the initiation of a Phase II clinical trial of CH-4051 in rheumatoid arthritis. For the nine months ended September 30, 2010, R&D expenses were $20.7 million versus $20.0 million for the comparable prior-year period.

Selling, general and administrative (SG&A) expenses of $1.4 million for the three months ended September 30, 2010 decreased from $1.7 million for the same period in 2009. SG&A expenses of $4.4 million for the nine months ended September 30, 2010 remained flat year-over-year.

Chelsea ended the quarter with $18.2 million in cash and cash equivalents compared to $22.3 million at December 31, 2009. Additionally, in October 2010, Chelsea completed a public offering resulting in net proceeds of $37.8 million.

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, Droxidopa, is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).

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Publication:Biotech Financial Reports
Article Type:Financial report
Date:Dec 1, 2010

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