CHARLOTTE, N.C., Nov. 1, 2010 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) reported financial results for the third 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:
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Reported Study 301, a pivotal Phase III trial in neurogenic orthostatic hypotension (NOH), demonstrated NORTHERA™ (droxidopa) provided statistically significant symptomatic improvement over placebo on composite orthostatic questionnaire score (p=0.003) and showed statistically significant benefits in all 3 composite scores and 8 out of 10 individual items of the orthostatic hypotension questionnaire;
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Initiated Northera Study 306, a pivotal Phase III trial in Parkinson's disease patients with symptomatic neurogenic orthostatic hypotension;
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Initiated head-to-head Phase II trial comparing CH-4051 to methotrexate (MTX) in rheumatoid arthritis patients who are experiencing an inadequate response to MTX treatment;
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Reported positive interim analysis of Phase II study of droxidopa in fibromyalgia by an independent data monitoring committee supporting the efficacy and safety of a novel droxidopa/carbidopa combination therapy; and
- Raised approximately $37.8 million through a successful public offering.
"The last few months have been momentous for Chelsea as we reported highly favorable findings from Study 301 demonstrating that Northera provided significant symptomatic relief of neurogenic orthostatic hypotension, continued to enroll patients into Study 306 at a better than expected pace, and substantively strengthened our balance sheet," commented Dr. Simon Pedder, President and CEO of Chelsea. "While collectively these accomplishments should put us in a strong position to complete our first NDA filing in 2011, we believe they are only just the beginning of a transformative period for Chelsea. Over the next several quarters, we eagerly anticipate reporting data from five on-going clinical trials including: our Phase III trial of Northera in NOH associated with Parkinson's disease; our Phase II trial of CH-4051 in rheumatoid arthritis; our Phase II trial of droxidopa/carbidopa combination therapy in fibromyalgia; as well as from the investigator-led Phase II trials of droxidopa/carbidopa combination therapy in adult attention deficit hyperactivity disorder and droxidopa monotherapy in chronic fatigue syndrome."
Financial Results for the Third Quarter
Chelsea reported a net loss for the quarter ended September 30, 2010 of $8.8 million or ($0.22) per share versus a net loss of $7.1 million or ($0.22) per share for the same period in 2009.
For the first nine months of 2010, Chelsea reported a net loss of $24.9 million or ($0.65) per share compared to a net loss of $19.8 million or ($0.64) per share for the nine months ended September 30, 2009. Excluding the gain associated with student loan backed auction rate securities in 2009, Chelsea's 2009 net loss, on a non-GAAP basis, for the first nine months was $24.2 million or ($0.78) per share.
Research and development (R&D) expenses for the third quarter 2010 were $7.4 million, compared to $5.4 million for the same period in 2009. The increase in third quarter R&D expense year-over-year reflects an increase in costs related to the conduct of Chelsea's Phase III registration program for Northera as the program was expanded to include Study 306 and participation in the program's safety extension studies increased. Third quarter 2010 R&D also included expense associated with the initiation of a Phase II clinical trial of CH-4051 in rheumatoid arthritis. For the nine months ended September 30, 2010, R&D expenses were $20.7 million versus $20.0 million for the comparable prior-year period.
Selling, general and administrative (SG&A) expenses of $1.4 million for the three months ended September 30, 2010 decreased from $1.7 million for the same period in 2009. SG&A expenses of $4.4 million for the nine months ended September 30, 2010 remained flat year-over-year.
Chelsea ended the quarter with $18.2 million in cash and cash equivalents compared to $22.3 million at December 31, 2009. Additionally, in October 2010, Chelsea completed a public offering resulting in net proceeds of $37.8 million.
Conference Call Today at 4:30 PM EDT
Chelsea will discuss its third 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 877-638-9567 (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 21115133 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 | |||||
| (unaudited) | |||||
| For the three months ended September 30, | For the nine months ended September 30, | ||||
| 2010 | 2009 | 2010 | 2009 | ||
| Operating expenses: | |||||
| Research and development | $ 7,424,682 | $ 5,357,373 | $ 20,699,430 | $ 19,960,065 | |
| Sales and marketing | 424,453 | 714,064 | 1,343,421 | 1,352,486 | |
| General and administrative | 954,540 | 1,014,299 | 3,018,299 | 3,039,234 | |
| Total operating expenses | 8,803,675 | 7,085,736 | 25,061,150 | 24,351,785 | |
| Operating loss | (8,803,675) | (7,085,736) | (25,061,150) | (24,351,785) | |
| Interest income | 19,003 | 32,427 | 188,478 | 263,925 | |
| Interest expense | (2,055) | (40,544) | (70,389) | (108,118) | |
| Other income (expense) | -- | -- | -- | 4,390,487 | |
| Net loss | $ (8,786,727) | $ (7,093,853) | $ (24,943,061) | $ (19,805,491) | |
|
Net loss per basic and diluted share of common stock |
$ (0.22) | $ (0.22) | $ (0.65) | $ (0.64) | |
|
Weighted average number of basic and diluted common shares outstanding |
40,316,699 | 32,428,692 | 38,668,900 | 30,892,371 | |
| Chelsea Therapeutics International, Ltd. | |||
| Condensed Consolidated Balance Sheet Data | |||
| (unaudited) | |||
|
September 30, 2010 |
December 31, 2009 |
||
| (in thousands) | |||
| Cash and cash equivalents | $ 18,190 | $ 22,295 | |
| Short-term investments | -- | 11,450 | |
| Total assets | 18,628 | 34,349 | |
| Line of credit payable | -- | 11,466 | |
| Total liabilities | 9,578 | 21,497 | |
| Deficit accumulated during the development stage | (120,486) | (95,543) | |
| Stockholders' equity | 9,050 | 12,852 | |
| A reconciliation of GAAP to non-GAAP loss per share is as follows: | |||||
|
For the three months ended September 30, |
For the nine months ended September 30, |
||||
| 2010 | 2009 | 2010 | 2009 | ||
| GAAP loss per share | $ (0.22) | $ (0.22) | $ (0.65) | $ (0.64) | |
|
Net other (income) expense related to investments in auction rate securities |
-- | -- | -- | (0.14) | |
| Non-GAAP loss per share | $ (0.22) | $ (0.22) | $ (0.65) | $ (0.78) | |
| A reconciliation of GAAP to non-GAAP net loss is as follows: | |||||
| (in thousands) | |||||
|
For the three months ended September 30, |
For the nine months ended September 30, |
||||
| 2010 | 2009 | 2010 | 2009 | ||
| GAAP net loss | $ (8,787) | $ (7,094) | $ (24,943) | $ (19,805) | |
|
Net other (income) expense related to investments in auction rate securities |
-- | -- | -- | (4,390) | |
| Non-GAAP loss | $ (8,787) | $ (7,094) | $ (24,943) | $ (24,195) | |
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 and costs of drug development, our need to raise operating capital, risk of regulatory approvals, our reliance on our lead drug candidates Droxidopa and CH-4051, reliance on collaborations and licenses, our history of losses, 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.