CHARLOTTE, N.C., Aug. 7, 2007 (PRIME NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) reported financial results for the quarter and six months ended June 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 June 30, 2007 compared to $1.8 million, or ($0.09) per share, for the comparable quarter in 2006. Net loss for the six months ended June 30, 2007 was $7 million or ($0.33) per share compared to a net loss of $4.1 million or ($0.23) per share for the prior year period. * Cash used for operations was $2.6 million in the second quarter 2007 and $4.6 million for the six months ending June 30, 2007. * Chelsea ended the quarter with $23 million in cash and short-term investments, compared to $15.9 million at December 31, 2006
Second Quarter Highlights:
* Completed pharmaceutical enhancements to disodium salt formulation of CH-1504 * Initiated CH-1504 Bioequivalence Study to determine dose range for Phase II trials * Submitted multiple applications to the Committee for Orphan Medicinal Products (COMP) in Europe for orphan designation of Droxidopa * Continued its dialogue with the US FDA regarding Droxidopa Phase III program, including a request for a post-phase II meeting
Following the significant PK improvements demonstrated by the new disodium salt composition of CH-1504 in primates at the onset of the year, Chelsea completed its complementary pharmaceutical enhancements through the addition of various dissolution enhancing excipients including gelucire, a substituted fatty acid ester derivative of polyethylene glycol (PEG). The in-vitro dissolution profile of the gelucire formulation of CH-1504 showed greater than 90% dissolution within 30 minutes compared to only 40% dissolution within 30 minutes and maximum 50% dissolution in 90 minutes for the original free acid formulation.
"The second quarter was the beginning of a very exciting period in our development of CH-1504," commented Dr. Simon Pedder, President and CEO of Chelsea Therapeutics. "The results of our dissolution analysis of the new formulation exceeded our expectations and with the results of the primate PK study suggest that significantly lower doses of CH-1504 can be used to achieve predictable therapeutic levels. We have now begun the process of further quantifying this success by conducting our bioequivalence study and based on the positive results this study has yielded to date, we expect to have a determination on the final doses for our Phase II trials by the end of September."
In addition to progress in its antifolate program, Chelsea continued its dialogue with both the U.S. FDA and EMEA in preparation for the initiation of its pivotal Phase III program in the fourth quarter of 2007. Early in the quarter, Chelsea redirected its application for orphan designation of Droxidopa in the EU as three separate applications each for symptomatic, neurogenic orthostatic hypotension (NOH) associated with multiple systems atrophy (MSA), pure autonomic failure (PAF) and Parkinson's disease (PD) respectively. Shortly following the resubmissions, the COMP issued a favorable opinion regarding its recommendation for orphan designation in MSA and PAF, and requested the Company provide additional epidemiology data prior to a meeting with COMP representatives regarding its PD submission. Given the robust 10-year exclusivity afforded new chemical entities in the EU, strong indications from committee members that a pivotal Phase III program could be inclusive of all these indications to support individual marketing applications in the EU, and the potential for significant use in PD, Chelsea has determined that the most expeditious and efficient course of action is to withdraw its application for EU orphan designation in PD and pursue approval for this indication as a new chemical entity. Chelsea is currently scheduled to meet with the U.S. FDA later this month to review its intended Phase III trial design and, following FDA acceptance, intends to submit this protocol to the EMEA prior to its scheduled meeting in October.
"Chelsea has been working hard with regulatory authorities in both the U.S. and EU to finalize preparations for its pivotal Phase III program," continued Dr. Pedder. "During the second quarter we prepared a comprehensive protocol package and requested a post-phase II meeting with the FDA to review our intended Phase III trial design. That meeting date has now been set for late August and we are confident that following this meeting, we should be able to reach rapid agreement with the FDA regarding trial design, file our IND and initiate our Phase III program in NOH before year-end."
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 800-565-5442 (domestic) or 913-312-1298 (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 7489289 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.
CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months For the six months
ended June 30, ended June 30,
------------------------ ------------------------
2007 2006 2007 2006
----------- ----------- ----------- -----------
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Operating expenses:
Research and
development $ 2,155,547 $ 1,434,881 $ 5,322,836 $ 3,129,652
Sales and
marketing 602,805 66,392 819,420 310,531
General and
administrative 722,694 590,283 1,372,106 1,093,153
----------- ----------- ----------- -----------
Total operating
expenses 3,481,046 2,091,556 7,514,362 4,533,336
----------- ----------- ----------- -----------
Operating loss (3,481,046) (2,091,556) (7,514,362) (4,533,336)
Interest income 317,619 247,630 515,055 393,451
Interest expense -- -- -- --
----------- ----------- ----------- -----------
Net loss $(3,163,427) $(1,843,926) $(6,999,307) $(4,139,885)
=========== =========== =========== ===========
Net loss per basic
and diluted share
of common stock $ (0.14) $ (0.09) $ (0.33) $ (0.23)
=========== =========== =========== ===========
Weighted average
number of basic
and diluted
common shares
outstanding 22,404,328 19,608,096 21,196,442 17,838,791
----------- ----------- ----------- -----------
Chelsea Pharmaceuticals International, Ltd.
Condensed Consolidated Balance Sheet Data
(unaudited)
June 30, December 31,
2007 2006
----------- -----------
(in thousands)
Cash and cash equivalents $ 23,005 $ 15,897
Total assets 23,293 16,171
Total liabilities 3,457 2,034
Deficit accumulated during the development
stage (26,603) (19,604)
Stockholders' equity 19,836 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