Chelsea Therapeutics Reports Second Quarter 2009 Results

Chelsea Therapeutics Reports Second Quarter 2009 Results

Company to Host Conference Call at 11:00 AM EDT

CHARLOTTE, N.C., Aug. 5, 2009 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) reported financial results for the second quarter 2009. Chelsea's management team will host a conference call this morning to discuss these results and present a quarterly update on the Company's development programs at 11:00 AM EDT.

Second Quarter Operational Highlights

  *  Reported Phase I data demonstrating CH-4051was safe and well
     tolerated up to a maximally tolerated dose of 7.5mg
  *  Presented positive Phase II data for Droxidopa in
     intradialytic hypotension at the World Congress of Nephrology
  *  Presented preclinical data demonstrating efficacy of CH-4051
     in rat collagen-induced arthritis model at EULAR 2009
  *  Achieved target enrollment in Study 302, the first of
     Chelsea's two Phase III trials of Droxidopa in neurogenic
     orthostatic hypotension
  *  Added to Russell 3000 and Russell 2000 Indexes

"The robust activity and strong clinical results achieved during the first six months of 2009 provided the opportunity to clearly demonstrate the considerable breadth and value of Chelsea's pipeline. We clearly established proof-of-concept for our portfolio of metabolically inert antifolates, generated compelling safety and efficacy data on our second compound from this portfolio, and demonstrated the significant symptomatic benefit of Droxidopa for the treatment of intradialytic hypotension in a Phase II trial," commented Dr. Simon Pedder, President and CEO of Chelsea. "Having completed enrollment in our first pivotal study in June and recently strengthened our balance sheet, we are focusing our attention on several significant value drivers in the second half of the year including data from both pivotal studies in neurogenic orthostatic hypotension, initiation of our first NDA filing, and the launch of our commercialization strategy for Droxidopa in this indication."

Financial Results for the Second Quarter

Chelsea reported a net loss for the three months end June 30, 2009 of $5.3 million or ($0.18) per share versus a net loss of $7.3 million or ($0.24) per share for the same period in 2008. Chelsea's net loss for the second quarter 2009 was favorably impacted by the recovery of previously recorded impairments against it holdings in auction rate securities (ARS) that resulted in a gain totaling approximately $4.1 million. Excluding the recapture of this impairment, Chelsea's net loss on a non-GAAP basis for the second quarter 2009 was $9.3 million or ($0.31) per share.

For the first six months of 2009, Chelsea reported a net loss of $12.7 million or ($0.42) per share compared to a net loss of $16 million or ($0.53) per share for the first half of 2008. Excluding the 2008 ARS impairment charges and the associated gain in 2009, Chelsea's net loss, on a non-GAAP basis, of $17.1 million for the first six months of 2009 was up approximately $2.7 million from the net loss of $14.4 million for the prior-year period.

Research and development expenses for the second quarter 2009 were $8.1 million, compared to $6.4 million for the same period in 2008. For the six months ended June 30, 2009, research and development expenses were $14.6 million versus $12.9 million for the comparable prior-year period. Total research and development expenses increased primarily as a result of increased clinical activity compared to the prior year including the Droxidopa pivotal registration program in neurogenic orthostatic hypotension, the Phase II trials of Droxidopa in intradialytic hypotension and fibromyalgia as well as the Phase II evaluation of CH-1504 versus methotrexate in rheumatoid arthritis.

Selling, general and administrative expenses of $1.3 million for the three months ended June 30, 2009 were in line with $1.4 million for the same period in 2008. For the six months ended June 30, 2009, selling, general and administrative expenses of $2.7 remained flat year-over-year.

Chelsea ended the quarter with $24.3 million in cash and cash equivalents after using $15.9 million to fund operations through the first six months of the year. This reflects a net increase of $2.8 million from December 31, 2008 resulting from the favorable ARS settlements.

Financial Guidance

Chelsea anticipates that the cash and cash equivalents as of June 30 combined with net proceeds from the registered direct offering completed in July, which collectively total nearly $37 million, will fund the company's current development programs and recently expanded commercialization initiatives into the third quarter of 2010. Chelsea expects to end the year with cash and cash equivalents of approximately $16 to 18 million.

Conference Call Today at 11:00 AM EDT

Chelsea will discuss its second quarter results and provide an update on its clinical development programs in a conference call today at 11:00 AM Eastern Time. Interested investors may participate in the conference call by dialing 877-440-5788 (domestic) or 719-325-4894 (international). A replay will be available for one week following the call by dialing 888-203-1112 for domestic participants or 719-457-0820 for international participants and entering passcode 8641255 when prompted. Participants may also access both the live and archived webcast of the conference call on Chelsea's web site at

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. Currently approved and marketed in Japan for the treatment of symptomatic orthostatic hypotension, freezing gait in Parkinson's disease and intradialytic hypotension, Droxidopa has accumulated over 15 years of proven safety and efficacy in Japan. 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 suggests superior safety and tolerability, as well as increased potency versus methotrexate (MTX), currently the leading antifolate treatment and standard of care for a broad range of abnormal cell proliferation diseases including RA.

This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risks relating to the use of the proceeds from our registered direct offering, our need to raise additional operating capital in the future, our history of losses, risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates droxidopa and CH-1504, reliance on collaborations and licenses, intellectual property risks, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder and other risks set forth in our public filings made with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K.