8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 29, 2010

CHELSEA THERAPEUTICS INTERNATIONAL, LTD.

(Exact name of registrant as specified in its charter)

Delaware	000-51462	20-3174202
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer ID Number)

3530 Toringdon Way, Suite 200, Charlotte, North Carolina 28277

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code (704) 341-1516

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02. Results of Operations and Financial Condition.

On April 29, 2010, Chelsea Therapeutics International, Ltd. issued a press release reporting unaudited financial results for the quarter ended March 31, 2010. A copy of this press release is attached hereto as Exhibit 99.1.

The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press release dated April 29, 2010 reporting unaudited financial results for the quarter ended March 31, 2010.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	CHELSEA THERAPEUTICS INTERNATIONAL, LTD.
Date: April 29, 2010	/s/ J. Nick Riehle
	J. Nick Riehle, Chief Financial Officer

EX-99.1

Exhibit 99.1

Chelsea Therapeutics Reports First Quarter 2010 Results

• Full Enrollment of Study 301 on Track for Completion by End of Second Quarter; Data Expected in Third Quarter 2010

• Study 306 On Track to Begin Enrollment in Second Quarter; Data Expected in Second Quarter 2011

• Company to Host Conference Call at 5:00 PM EDT

Charlotte, NC, April 29, 2010 – Chelsea Therapeutics International, Ltd. (NASDAQ: CHTP) today reported financial results for the first 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 5:00 PM EDT to discuss these results.

Recent Highlights:

• Began enrolling additional patients in NORTHERA™ (droxidopa) Study 301 to reach new target enrollment of 150 patients by the end of the second quarter 2010;

• Received FDA approval on protocol for Northera Study 306, a pivotal Phase III trial in Parkinson’s disease patients with symptomatic neurogenic orthostatic hypotension;

• Finalized protocol for Phase II trial of CH-4051 in rheumatoid arthritis;

• Supported the initiation of investigator-led Phase II trial of droxidopa in combination with carbidopa for the treatment of adult attention deficit hyperactivity disorder;

• Reported results from Northera Study 305 demonstrating consistent improvements in blood pressure without evidence of sustained high blood pressure during the night when patients are most likely to be in the supine position and most susceptible to hypertension; and

• Raised net proceeds of $16.8 million through registered direct offering.

“During the first quarter, we made substantial progress in advancing our Northera registration program in neurogenic orthostatic hypotension and are on track to have pivotal Phase III data from Study 301 in the third quarter,” commented Dr. Simon Pedder, President and CEO of Chelsea. “As we prepare to complete enrollment in Study 301 in

June, we also look forward to beginning patient enrollment this quarter in both our Northera Study 306 and CH-4051 Phase II trial in rheumatoid arthritis. Combined with ongoing studies in fibromyalgia and adult attention deficit hyperactivity disorder, Chelsea is well-positioned to benefit from multiple, value-creating clinical milestones over the next several quarters.”

Financial Results for the First Quarter

Chelsea reported a net loss for the quarter ended March 31, 2010 of $6.2 million or ($0.18) per share versus a net loss of $7.4 million or ($0.25) per share for the comparable period in 2009.

Research and development (R&D) expenses for the quarter ended March 31, 2010 were $4.9 million, compared to $6.5 million for the first quarter of 2009. First quarter 2010 R&D expenses reflect an overall decrease in the number of active clinical trials relative to the comparable prior year period and the temporary reduction in costs related to the conduct of the Chelsea’s Phase III registration program for Northera as changes to the company’s ongoing Study 301 were implemented and the design of Study 306 was finalized.

During the first quarter 2010, relative increases in sales and marketing expense were largely offset by a reduction in general and administrative expense. As a result, Chelsea’s selling, general and administrative expenses of $1.4 million for the three months ended March 31, 2010 remained flat year over year.

Chelsea ended the quarter with $31.6 million in cash and cash equivalents. This reflects a net increase of $9.3 million from December 31, 2009 resulting from the completion of a registered direct offering in March 2010, which, after deducting related expenses, generated net proceeds of $16.8 million.

2010 Financial Guidance

Chelsea anticipates 2010 R&D expense to peak during the third quarter with full year R&D expenses of approximately $30 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 5:00 PM EDT

Chelsea will discuss its first quarter results and provide an update on its clinical development programs in a conference call today at 5:00 PM Eastern Time. Interested investors may participate in the conference call by dialing 877-638-9567 (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 70972823 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).

CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY

(A Development Stage Company)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

	For the three months ended March 31,
	2010			2009
	(unaudited)			(unaudited)
Operating expenses:
Research and development	$	4,880,473		$	6,506,906
Sales and marketing		410,547			305,300
General and administrative		975,587			1,042,473
Total operating expenses		6,266,607			7,854,679
Operating loss		(6,266,607	)		(7,854,679	)
Interest income		67,551			115,674
Interest expense		(32,953	)		(26,754	)
Other income (expense)		—			337,492
Net loss	$	(6,232,009	)	$	(7,428,267	)
Net loss per basic and diluted share of common stock	$	(0.18	)	$	(0.25	)
Weighted average number of basic and diluted common shares outstanding		35,435,962			30,111,479

CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY

Condensed Consolidated Balance Sheet Data

(unaudited)

	March 31,			December 31,
	2010			2009
	(in thousands)
Cash and cash equivalents	$	31,597		$	22,295
Short-term investments		11,400			11,450
Total assets		43,756			34,349
Line of credit payable		11,400			11,466
Total liabilities		19,865			21,497
Deficit accumulated during the development stage		(101,775	)		(95,543	)
Stockholders’ equity		23,891			12,852

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.

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Investors & Media:

Kathryn McNeil

Chelsea Therapeutics

718-788-2856

mcneil@chelseatherapeutics.com