CHARLOTTE, N.C., May 9, 2007 (PRIME NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the first quarter 2007 and presented a quarterly update on the Company's development progress.
Financial Results:
* Net loss of $3.8 million, or ($0.19) per share, for the three months ended March 31, 2007 compared to $2.3 million, or ($0.14) per share, for the comparable quarter in 2006 * Cash used for operations was $2.0 million in the first quarter 2007 * Chelsea ended the quarter with $25.4 million in cash and cash equivalents and short-term investments, compared to $15.9 million at December 31, 2006
First Quarter Highlights:
* Announced results of European Phase IIb Trial of Droxidopa for the treatment of orthostatic hypotension in patients with multiple system atrophy or Parkinson's Disease * Granted Orphan Drug Status for Droxidopa by the FDA for the treatment of symptomatic neurogenic orthostatic hypotension * Reported improved pharmacokinetics of disodium salt of CH-1504 from primate study indicating significant improvement in peak plasma levels and systemic exposure compared to the original free acid formulation * Elected Kevan Clemens, Ph.D., as Chairman of the Board * Completed $12.5 million equity financing with several existing institutional and accredited investors
"The solid achievements in both our Droxidopa and CH-1504 programs during the first quarter have allowed us not only to move forward in our clinical development of these compounds as intended, but also provided the foundation from which to further define and refine our long-term development strategy," commented Dr. Simon Pedder, President and CEO of Chelsea Therapeutics. "With receipt of FDA Orphan designation for Droxidopa in the U.S. and a clear path in the EU, we secured the necessary exclusivity to move aggressively ahead in our initial indication of NOH and were able to subsequently begin more serious consideration of how best to manage the long-term value of the compound through additional indications such as intradialytic hypotension and hypotension associated with disautonomias such as Fibromyalgia and Chronic Fatigue Syndrome. In parallel to this progress, we were pleased to report the pharmacokinetic improvements in our new disodium salt of CH-1504 and confirm our intent to continue our clinical program in rheumatoid arthritis by first initiating bioequivalence studies in the second quarter followed by global Phase II trials in the fourth quarter of this year."
Conference Call Today at 11:00 AM EDT
Chelsea management will host a conference call and live webcast to discuss these financial results along with recent developments this morning at 11:00 AM EDT. Interested investors may participate in the conference call by dialing 866-290-0916 (domestic) or 913-312-1226 (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 4097067 when prompted. Participants may also access both the live and archived webcast of the conference call through the investor relations section of 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. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea's lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea's antifolate program is complemented by a strategic partnership with Active Biotech AB for the joint development of a portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.
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 reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.
CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months
ended March 31,
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2007 2006
----------- -----------
(unaudited) (unaudited)
Operating expenses:
Research and development $ 3,167,289 $ 1,694,771
Sales and marketing 216,615 244,139
General and administrative 649,412 502,870
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Total operating expenses 4,033,316 2,441,780
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Operating loss (4,033,316) (2,441,780)
Interest income 197,436 145,821
Interest expense -- --
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Net loss $(3,835,880) $(2,295,959)
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Net loss per basic and diluted share
of common stock $ (0.19) $ (0.14)
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Weighted average number of basic and
diluted common shares outstanding 19,975,135 16,049,827
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Chelsea Pharmaceuticals International, Ltd.
Condensed Consolidated Balance Sheet Data
(unaudited)
March 31, December 31,
----------------------------
2007 2006
----------- -----------
(in thousands)
Cash and cash equivalents $ 25,374 $ 15,897
Total assets 25,821 16,171
Total liabilities 3,409 2,034
Deficit accumulated during the
development stage (23,440) (19,604)
Stockholders' equity 22,412 14,137
To view the Notes to the Company's Financial Statements and Management's Discussion and Analysis, please see the Company's 2006 Annual Filings available on Chelsea's website at www.chelseatherapeutics.com