CHARLOTTE, N.C., Nov. 13, 2007 (PRIME NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) reported financial results for the quarter and nine months ended September 30, 2007, presented a quarterly update on the Company's development progress and will host a conference call this morning at 11:00 AM EDT to discuss these results.
Financial Results:
* Net loss of $3.2 million, or ($0.14) per share, for the three months ended September 30, 2007 compared to $2.1 million, or ($0.11) per share, for the comparable quarter in 2006. Net loss for the nine months ended September 30, 2007 was $10.2 million or ($0.47) per share compared to a net loss of $6.3 million or ($0.34) per share for the prior year period. * Cash used for operations was $1.9 million in the third quarter 2007 and $6.5 million for the nine months ending September 30, 2007. * Chelsea ended the quarter with $21 million in cash and short-term investments, compared to $15.9 million at December 31, 2006. Earlier this month, Chelsea completed a registered direct offering resulting in gross proceeds of $48.9 million. As a result, Chelsea expects to end the year with cash and cash equivalents of approximately $60 million and anticipates that this will fund the company's current development programs into 2009.
Third Quarter Highlights:
* Resolved CH-1504 bioavailability issue and reported greater than 10-fold improvement in relative bioavailability with the new formulation * Secured two orphan medicinal product designations for Droxidopa from the EMEA * Reached agreement with the U.S. FDA on the clinical protocol for its Phase III trials of Droxidopa in neurogenic orthostatic hypotension * Submitted Investigational New Drug (IND) application to the FDA
"During the third quarter, we met several critical goals including the confirmation of the improved bioavailability of our new CH-1504 formulation, demonstration of bioequivalence and determination of the final doses for our Phase II trial in rheumatoid arthritis," commented Dr. Simon Pedder, President and CEO of Chelsea Therapeutics. "We are further pleased to have now also met all the regulatory requirements necessary to commence our pivotal program in NOH including acceptance by the FDA of our Phase III protocol and approval of our IND. With these accomplishments in hand, we look forward to starting the clinical trials that should allow for the U.S. approval of Droxidopa and provide clear proof of concept for CH-1504."
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 877-340-7912 (domestic) or 719-325-4845 (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 9074511 when prompted. Participants may also access both the live and archived webcast of the conference call through the events 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.
To view the Notes to the Company's Financial Statements and Management's Discussion and Analysis, please see the Company's SEC Filings available on Chelsea's website at www.chelseatherapeutics.com
CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the three months For the nine months
ended September 30, ended September 30,
-------------------------- --------------------------
2007 2006 2007 2006
---- ---- ---- ----
Operating expenses:
Research and
development $ 2,652,206 $ 1,745,319 $ 7,975,042 $ 4,874,971
Sales and
marketing 235,775 150,137 1,055,195 460,668
General and
administrative 662,325 458,481 2,034,431 1,551,634
------------ ------------ ------------ ------------
Total operating
expenses 3,550,306 2,353,937 11,064,668 6,887,273
------------ ------------ ------------ ------------
Operating loss (3,550,306) (2,353,937) (11,064,668) (6,887,273)
Interest
income 307,490 243,149 822,545 636,600
Interest
expense -- -- -- --
------------ ------------ ------------ ------------
Net loss $ (3,242,816) $ (2,110,788) $(10,242,123) $ (6,250,673)
============ ============ ============ ============
Net loss per
basic and
diluted share
of common
stock $ (0.14) $ (0.11) $ (0.47) $ (0.34)
============ ============ ============ ============
Weighted average
number of
basic and
diluted
common shares
outstanding 22,512,364 19,707,129 21,639,903 18,468,414
============ ============ ============ ============
See accompanying notes to condensed consolidated financial
statements.
Chelsea Pharmaceuticals International, Ltd.
Condensed Consolidated Balance Sheet Data
(unaudited)
September 30, December 31,
2007 2006
---- ----
(in thousands)
Cash and cash equivalents $ 21,081 $ 15,897
Total assets 21,389 16,171
Total liabilities 4,567 2,034
Deficit accumulated during the development
stage (29,846) (19,604)
Stockholders' equity 16,822 14,137
To view the Notes to the Company's Financial Statements and
Management's Discussion and Analysis, please see the Company's SEC
Filings available on Chelsea's website at www.chelseatherapeutics.com