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Quotes & Info
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| CAPS > SEC Filings for CAPS > Form 10-Q on 7-May-2009 | All Recent SEC Filings |
7-May-2009
Quarterly Report
The following is management's discussion of significant events in the quarter ended March 31, 2009 and factors that affected our interim financial condition and results of operations. This should be read in conjunction with our "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in our Annual Report on Form 10-K for the year ended December 31, 2008, our "Risk Factors" contained therein and Item 1A. Risk Factors included in Part II of this quarterly report.
Overview of the Business
OrthoLogic, dba Capstone Therapeutics, is a biotechnology company focused on the development and commercialization of the novel synthetic peptides AZX100 and Chrysalin® (TP508).
In 2009 and 2008, our activities included:
· Evaluating AZX100 for medically and commercially significant applications, such as treatment of pulmonary disease, prevention of hypertrophic and keloid scarring and intimal hyperplasia. We are executing a development plan for this peptide which included filing an IND for dermal scarring in 2007 and commencement of Phase 1 safety studies in this indication in the first quarter of 2008. Our Phase 1a study was completed in May 2008. The study's Safety Committee reviewing all safety-related aspects of the Phase 1a trial was satisfied with the profile of AZX100. We initiated a second safety study in dermal scarring (Phase 1b), which was completed in the fourth quarter of 2008. The study's Safety Committee reviewing all safety-related aspects of the Phase 1b trial was satisfied with the profile of AZX100. We commenced AZX100 Phase 2 human clinical trials in keloid scar revision and dermal scarring following shoulder surgery in the first quarter of 2009. We also expect to continue to perform further pre-clinical studies supporting multiple indications for AZX100 in 2009.
· Pre-clinical experiments tying Chrysalin to potential modulation of the health of endothelial tissue in blood vessels and other mechanism-of-action studies to support our strategy to partner our vascular product candidates. We did not perform additional pre-clinical or clinical studies in fracture repair, wound healing, spine fusion, cartilage defect repair, dental bone repair or tendon repair. In 2009, we will continue studies to support our vascular partnering efforts.
Results of Operations Comparing Three-Month Period Ended March 31, 2009 to the Corresponding Period in 2008.
General and Administrative ("G&A") Expenses: G&A expenses related to our ongoing development operations were $807,000 in the first quarter of 2009 compared to $821,000 in the first quarter of 2008. Our administrative expenses during the first quarter of 2009 reflect a comparable level of administrative activity to the same period of 2008.
Research and Development Expenses: Research and development expenses were $2,442,000 for the first three months in 2008 compared to $3,608,000 for the first three months in 2009. Our research and development expenses increased $1,166,000 in the first quarter of 2009 compared to the same period in 2008 primarily due to an increase in AZX100 clinical trial activity and a $600,000 purchase of peptide for pre-clinical studies. Given the overlapping nature of our research efforts it is not possible to clearly separate research expenditures between Chrysalin and AZX100; however, the majority of our research and development expenses in 2009 and 2008 were directed towards AZX100 development efforts.
Interest and Other Income, Net: Interest and other income, net decreased from $606,000 in the first quarter of 2008 to $267,000 in the first quarter of 2009 due to the decrease in interest rates between the two periods and reduction in the amount available for investment.
Net Loss: We incurred a net loss in the first three months of 2009 of $4.1 million compared to a net loss of $2.7 million in the first three months of 2008. The $1.4 million increase in the net loss for the three months ended March 31, 2009 compared to the same period in 2008 resulted primarily from an increase in AZX100 clinical trial activity, purchases of peptide for pre-clinical studies, and reduced interest income, due to the decrease in interest rates between the two periods and reduction in the amount available for investment.
Liquidity and Capital Resources
We historically financed our operations through operating cash flows and the public and private sales of equity securities. However, with the sale of our Bone Device Business in November 2003, we sold all of our revenue producing operations. We received approximately $93.0 million in cash from the sale of our Bone Device Business. On December 1, 2005, we received the additional $7.2 million, including interest, from the escrow balance related to the sale of the Bone Device Business. On February 27, 2006, we entered into an agreement with Quintiles (see Note 15 in our Annual Report on Form 10-K for the year ended December 31, 2007), which provided an investment by Quintiles in our common stock, of which $2,000,000 was received on February 27, 2006 and $1,500,000 was received on July 3, 2006. We also received net proceeds of $4,612,000 from the exercise of stock options during our development stage period. As of March 31, 2009, we had cash and cash equivalents of $20.6 million and short-term investments of $23.0 million.
We announced that we have no immediate plans to re-enter clinical trials for Chrysalin-based product candidates and a strategic shift in our development approach to our Chrysalin product candidates. We currently intend to pursue development partnering or licensing opportunities for our Chrysalin-based product candidates, a change from our previous development history of independently conducting human clinical trials necessary to advance our Chrysalin-based product candidates to market. We will continue to explore Chrysalin's therapeutic value in tissues and diseases exhibiting endothelial dysfunction as well as the science behind and potential of Chrysalin.
For AZX100 in 2009, we will continue research and development expenditures for further pre-clinical studies supporting multiple indications for AZX100 and continue our Phase 2 dermal scarring and keloid revision clinical trials.
Our future research and development expenses may vary significantly from prior periods depending on our decisions on our future Chrysalin and AZX100 development plans.
On March 5, 2008, we announced a stock repurchase program and at March 31, 2009, we had repurchased 1,131,622 shares of our common stock, at a total cost of $1,041,000, and have allocated approximately $1,000,000 to fund possible future stock repurchases.
We anticipate that our cash and short-term investments will be sufficient to meet our presently projected cash and working capital requirements for the next year. However, the timing and amounts of cash used will depend on many factors. To complete the clinical trials and supporting research and production efforts necessary to obtain FDA approval for either AZX100 or Chrysalin product candidates would require us to seek other sources of capital. New sources of funds, including raising capital through the sales of securities, joint venture of other forms of joint development arrangements, sales of development rights, or licensing agreements, may not be available or may only be available at terms that would have a material adverse impact on our existing stockholders' interests.
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