- Preparing to File Northera New Drug Application in Third Quarter 2011
- Opening Enrollment into High Dose Arms of Phase II Trial of CH-405 for Treatment of Rheumatoid Arthritis and On Track to Report Un-blinded Interim Efficacy Data in Third Quarter 2011
- Company to Host Conference Call at 4:30 PM ET
CHARLOTTE, N.C., May 9, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the first quarter 2011 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 ET to discuss these results.
Recent Highlights:
- Demonstrated sustained symptomatic benefit of Northera in neurogenic orthostatic hypotension (NOH) over 12-Month treatment period in Study 303;
- Reported 60% reduction in falls in Parkinson's disease patients with NOH treated with Northera in Study 306A;
- Confirmed new falls endpoint for Northera Study 306B and announced plans to seek supplemental claim for the reduction in falls associated with NOH in patients with Parkinson's disease post-approval;
- Announced acceptance of 306A data for late breaking poster presentation and plans to host symposium on NOH at MDS 15th International Congress of Parkinson's Disease and Movement Disorders June 5-9, 2011;
- Opened enrollment into high dose groups in Phase II trial of CH-4051 following favorable safety review and recommendation from independent data safety monitoring board; and
- Raised net proceeds of $8.4 million through the conversion of expiring warrants and $37.8 million through a public offering in February 2011.
"While we began to ramp up our pre-launch initiatives during the first quarter in anticipation of Northera approval early next year, we continued to seek to strengthen our pipeline through several ongoing trials," commented Dr. Simon Pedder, President and CEO of Chelsea. "In the coming months, we expect to report what we believe will be compelling data from our Phase II trial of CH-4051 in rheumatoid arthritis, establish proof of concept for droxidopa in multiple norepinephrine related disorders and potentially expand the claims for Northera to include the reduction of falls."
Financial Results for the First Quarter
Chelsea reported a net loss for the quarter ended March 31, 2011 of $13.9 million or ($0.25) per share versus a net loss of $6.2 million or ($0.18) per share for the comparable period in 2010.
Research and development (R&D) expenses for the quarter ended March 31, 2011 were $11.5 million, compared to $4.9 million for the first quarter of 2010. The increase in first quarter R&D expenses primarily reflects increases in costs associated with our planned registration and anticipated launch of Northera. Specifically, first quarter 2011 R&D expense included approximately $2.2 million related to manufacturing of and process validation for commercial drug product and approximately $1.3 million related to the initiation of a Northera QTc study. Additionally, the ongoing costs related to Study 306 along with corresponding increases in expenses associated with extension Study 304 and costs for preparation of our NDA filing contributed to the increase.
During the first quarter, Chelsea's selling, general and administrative expenses increased approximately $1.1 million from the prior year period to $2.4 million for the three months ended March 31, 2011 as the Company added personnel and increased promotional activities such as conference sponsorship to support the planned commercialization of Northera, increased market research initiatives and incurred increased legal expenses related to our intellectual property.
Chelsea ended the quarter with $83.0 million in cash, cash equivalents and short-term investments. This reflects a net increase of $35.4 million from December 31, 2010 resulting from the conversion of warrants expiring in February 2011 and the completion of a public offering in March 2011.
2011 Financial Guidance
Chelsea anticipates 2011 R&D expense to peak during the second quarter with full year R&D expenses of approximately $46 million and SG&A expenses continuing to ramp through commercialization with a 2011 total of approximately $17 million. The Company anticipates that available cash, cash equivalents and short-term investments should fund the company's current development programs and launch initiatives through anticipated commercialization of Northera in the second quarter of 2012.
Conference Call Today at 4:30 PM EDT
Chelsea will discuss its first 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 63469192 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, NORTHERA™ (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, | ||
| 2011 | 2010 | |
| (unaudited) | (unaudited) | |
| Operating expenses: | ||
| Research and development | $ 11,458,942 | $ 4,880,473 |
| Sales and marketing | 1,111,131 | 410,547 |
| General and administrative | 1,332,716 | 975,587 |
| Total operating expenses | 13,902,789 | 6,266,607 |
| Operating loss | (13,902,789) | (6,266,607) |
| Interest income | 34,582 | 67,551 |
| Interest expense | -- | (32,953) |
| Net loss | $ (13,868,207) | $ (6,232,009) |
| Net loss per basic and diluted share of | ||
| common stock | $ (0.25) | $ (0.18) |
| Weighted average number of basic and diluted | ||
| common shares outstanding | 54,860,538 | 35,435,962 |
| CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY | ||
| Condensed Consolidated Balance Sheet Data | ||
| (unaudited) | ||
| March 31, | December 31, | |
| 2011 | 2010 | |
| (in thousands) | ||
| Cash and cash equivalents | $ 37,919 | $ 47,593 |
| Short-term investments | 45,129 | -- |
| Total assets | 84,339 | 48,374 |
| Total liabilities | 16,120 | 13,186 |
| Deficit accumulated during the development stage | (146,742) | (132,873) |
| Stockholders' equity | 68,219 | 35,188 |
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 costs of drug development, risk of regulatory approvals, risks and uncertainties include our need to raise operating capital, our history of losses, 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, reliance on key personnel including specifically Dr. Pedder.