Chelsea Therapeutics Reports Second Quarter 2010 Results

• Top-line Data from Pivotal Phase III Northera Study 301 in Neurogenic Orthostatic Hypotension Expected In September 2010
  
• Full Enrollment of Northera Study 306 on Track for Completion by Year End 2010; Data Expected in Second Quarter 2011
  
• Company to Host Conference Call at 4:30 PM EDT

CHARLOTTE, N.C., July 27, 2010 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the second quarter 2010 and presented a quarterly update on the Company's development progress. Chelsea's management team will host a conference call this afternoon at 4:30 PM EDT to discuss these results.

Recent Highlights:

• Reported results from Study 303 in which patients maintained statistically significant 3.2 unit improvement in orthostatic hypotension questionnaire (OHQ) composite scores following long-term NORTHERA™ (droxidopa) treatment in neurogenic orthostatic hypotension (NOH) (p<0.001);
• Initiated Northera Study 306, a pivotal Phase III trial in Parkinson's disease patients with symptomatic neurogenic orthostatic hypotension;
• Completed enrollment in Northera Study 301, a pivotal Phase III trial in neurogenic orthostatic hypotension, bringing final enrollment to 167 patients and further increasing the power of the study to 90%;
• Reported positive interim analysis of Phase II study of droxidopa in fibromyalgia by independent data monitoring committee supporting efficacy of novel droxidopa/carbidopa combination therapy; and
• Submitted additional CH-4051 preclinical data and revised protocol for Phase II trial in rheumatoid arthritis to the U.S. Food and Drug Administration (FDA).

"The significant progress made since January, both in enrolling more than 40 additional patients into Study 301 and getting a robust start to our enrollment into Study 306, reflect not only the successful efforts of our clinical team but also the growing interest in Northera and support of clinicians seeking a safe and effective treatment option for symptomatic neurogenic orthostatic hypotension," commented Dr. Simon Pedder, President and CEO of Chelsea. "Having increased the total number of patients and implemented a new endpoint that previously demonstrated a statistically significant symptomatic improvement in this patient population, we eagerly look forward to the results of Study 301 in September."

Financial Results for the Second Quarter

Chelsea reported a net loss for the quarter ended June 30, 2010 of $9.9 million or ($0.25) per share versus a net loss of $5.3 million or ($0.18) per share for the same period in 2009. Chelsea's net loss for the second quarter 2009 was favorably impacted by the recovery of previously recorded impairments against its holdings in auction rate securities (ARS) that resulted in a gain totaling approximately $4.1 million. Excluding the recovery 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 2010, Chelsea reported a net loss of $16.2 million or ($0.43) per share compared to a net loss of $12.7 million or ($0.42) per share for the first half of 2009. Excluding the gain associated with ARS in 2009, Chelsea's 2009 net loss, on a non-GAAP basis, for the first six months was $17.1 million or ($0.57) per share.

Research and development (R&D) expenses for the second quarter 2010 were $8.4 million, compared to $8.1 million for the same period in 2009. For the six months ended June 30, 2010, research and development expenses were $13.3 million versus $14.6 million for the comparable prior-year period. While R&D expense for the quarter was relatively flat year-over-year, R&D expense for the first half of the year reflects a slight decrease from 2009 resulting from an overall decrease in the number of active clinical trials and the temporary reduction in costs related to the conduct of Chelsea's Phase III registration program for Northera during the first quarter of 2010.

Selling, general and administrative (SG&A) expenses of $1.6 million for the three months ended June 30, 2010 increased from $1.3 million for the same period in 2009. This increase in SG&A is primarily related to increased costs for promotional activities, including conference sponsorships and presentations, and legal and patent filing expenses related to our intellectual property. Similarly, for the six months ended June 30, 2010, SG&A expenses of $3.0 million reflect an increase from $2.7 million for the prior-year period.

Chelsea ended the quarter with $23.0 million in cash and cash equivalents compared to $22.3 million at December 31, 2009.

2010 Financial Guidance

Chelsea anticipates 2010 R&D expense to peak during the third quarter with full year R&D expenses of approximately $33 million. The Company anticipates that available cash and cash equivalents should fund the Company's current and planned development programs as well as increased commercialization activity into the first quarter of 2011.

Conference Call Today at 4:30 PM EDT

Chelsea will discuss its second quarter results and provide an update on its clinical development programs in a conference call today at 4:30 PM Eastern Time. Interested investors may participate in the conference call by dialing 877-331-4219 (domestic) or 720-545-0009 (international). A replay will be available for one week following the call by dialing 800-642-1687 for domestic participants or 706-645-9291 for international participants and entering passcode 89512948 when prompted. Participants may also access both the live and archived webcast of the conference call on Chelsea's web site at www.chelseatherapeutics.com.

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).

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 our need to raise operating capital, our history of losses, risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates Droxidopa and CH-4051, reliance on collaborations and licenses, intellectual property risks, competition, market acceptance for our products if any are approved for marketing and reliance on key personnel including specifically Dr. Pedder. We refer you to documents we file from time to time with the Securities and Exchange Commission.

CONTACT:  Chelsea Therapeutics
          Investors & Media:
          Kathryn McNeil
          704-973-4231
          mcneil@chelseatherapeutics.com

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