Cardium Therapeutics News
Cardium Reports on Recent Highlights and Financial Results
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO) Highlights and Recent Developments — Initiation of Phase 2b MATRIX clinical trial to evaluate the safety and efficacy of Excellarate(TM) for the potential treatment of non-healing diabetic foot ulcers. Excellarate is a DNA-based topical gel that is being developed to be administered once or twice to stimulate wound healing. The MATRIX study, a randomized, double-blind, placebo-controlled, comparator arm clinical trial is expected to enroll approximately 210 patients at about 30 U.S. sites. Top line safety and efficacy data from the trial is expected to be announced in late 2008. — Initiation of Phase 3 AWARE trial for Generx(TM), a randomized, placebo-controlled, double-blind clinical trial that is expected to enroll approximately 300 women at an estimated 50 U.S. medical centers. Generx is being evaluated as a potential treatment for myocardial ischemia (insufficient blood flow within the heart muscle) which gives rise to angina associated with coronary heart disease. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Generx for myocardial ischemia in view of the large unmet medical need for effective new therapies to treat coronary heart disease. — Launch of InnerCool's new CoolBlue(TM) surface temperature modulation system, which is designed to provide effective patient temperature control in less acute patients or in clinical settings best suited to prolonged temperature management. — Completion of development of InnerCool's next-generation RapidBlue(TM) endovascular cooling system, including an enhanced console and disposable catheter, which is designed to cool patients rapidly and controllably, and provide effective rewarming as well as cooling. — Publication in the Journal of American College of Cardiology of positive findings from a pooled by-patient analysis of the AGENT-3 and AGENT-4 Phase 2b/3 clinical trials for Generx. Among the findings reported, a pre-specified analysis showed significant improvements in multiple clinical measures of heart disease among women who received Generx(TM) as compared to women in the placebo control group. — Completion of a $21.5 million equity financing with institutional and other accredited investors and listing on the American Stock Exchange (AMEX) under the new trading symbol CXM. — Licensing agreement with the University of Texas Health Science Center at Houston for the clinical research, development and commercialization of Caffeinol as a potential therapeutic for use in acute ischemic stroke patients. A Phase 2a study has been proposed to the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health (NIH), to assess the safety and efficacy of induced hypothermia and Caffeinol, both individually and in combination, in an estimated 400 patients presenting within three hours of an acute stroke. — Initiation of pre-clinical studies supported by an NIH Small Business Innovation Research (SBIR) grant, which are designed to further establish the therapeutic potential of Corgentin(TM) (Ad5IGF-1) to preserve heart tissue and cardiac function following a heart attack (acute myocardial infarction). Corgentin is a DNA therapeutic based on the localized and sustained cardiac production of insulin-like growth factor-1 (IGF-1) following a single intracoronary administration in an acute care setting immediately after percutaneous coronary intervention in heart attack patients. Financial Report
For the year ended
2008 Objectives — Complete our Phase 2b MATRIX clinical study and announce top line safety and efficacy data for Excellarate. — Continue patient recruitment in our Phase 3 AWARE clinical study for Generx, which is expected to be completed in 2009. — Secure FDA clearance for InnerCool's next-generation RapidBlue endovascular cooling system. — Accelerate the commercialization of InnerCool's surface and endovascular temperature modulation systems in the U.S.. — Conduct additional pre-clinical studies supported by Tissue Repair's SBIR grant to evaluate Corgentin as a potential one-time biologic treatment for heart attack patients. — Continue to consider opportunistic acquisitions of innovative product candidates, and evaluate potential sales or strategic partnering opportunities for existing products and candidates.
Cardium also reported that the audit opinion accompanying its consolidated financial statements for the year ended
This announcement is made in compliance with Section 610(b) of the American Stock Exchange Company Guide, which requires listed companies to make a public announcement of the receipt of an audit opinion that contains a going concern qualification. This announcement does not reflect any change or amendment to the consolidated financial statements as filed. More information about the going concern qualification is contained in Cardium's Annual Report on Form 10-K for the year ended
About Cardium
Cardium Therapeutics, Inc. and its subsidiaries, InnerCool Therapies, Inc. and the Tissue Repair Company, are medical technology companies primarily focused on the development, manufacture and sale of innovative therapeutic products and devices for cardiovascular, ischemic and related indications. Cardium's lead product candidate, Generx (alferminogene tadenovec, Ad5FGF-4), is a DNA-based growth factor therapeutic being developed for potential use by interventional cardiologists as a one-time treatment to promote and stimulate the growth of collateral circulation in the hearts of patients with ischemic conditions such as recurrent angina. For more information about Cardium Therapeutics and its businesses, products and therapeutic candidates, please visit http://www.cardiumthx.com or view its 2006 Annual Report at http://www.cardiumthx.com/flash/pdf/2006CardiumAnnualReport.pdf.
Cardium's InnerCool Therapies subsidiary is a San Diego-based medical technology company in the emerging field of temperature modulation therapy to rapidly and controllably cool the body in order to reduce cell death and damage following acute ischemic events such as cardiac arrest or stroke, and to potentially lessen or prevent associated injuries such as adverse neurological outcomes. For more information about Cardium's InnerCool subsidiary and therapeutic hypothermia, including InnerCool's Celsius Control System(TM), which has received regulatory clearance in the U.S.,
Cardium's Tissue Repair Company subsidiary (TRC) is a San Diego-based biopharmaceutical company focused on the development of growth factor therapeutics for the treatment of severe chronic diabetic wounds. TRC's lead product candidate, Excellarate(TM), is a DNA-activated collagen gel for topical treatment formulated with an adenovector delivery carrier encoding human platelet-derived growth factor-BB (PDGF-BB). Excellarate(TM) is initially being developed to be administered once or twice for the potential treatment of non-healing diabetic foot ulcers. Other potential applications for TRC's Gene Activated Matrix(TM) (GAM) technology include therapeutic angiogenesis (cardiovascular ischemia, peripheral arterial disease) and orthopedic products, including hard tissue (bone) and soft tissue (ligament, tendon, cartilage) repair. For more information about Cardium's Tissue Repair Company subsidiary, please visit http://www.t-r-co.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that human clinical trials can be conducted and completed in an efficient and successful manner, that product modifications or launches will be successful or that the resulting products will be favorably received in the marketplace, that results or trends observed in one clinical study will be reproduced in subsequent studies, that our products or proposed products will prove to be sufficiently safe and effective, that necessary regulatory approvals will be obtained, that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive, that having a shelf registration statement in place will allow the Company to take advantage of favorable market conditions or that the Company will be effectively able to sell additional common stock or otherwise raise additional funds on favorable terms or at all. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and the conduct of human clinical trials, including the timing, costs and outcomes of such trials, and our ability to obtain necessary regulatory approvals and expected qualifications, our limited experience in the development, testing and marketing of therapeutic hypothermia devices and whether our efforts to accelerate the commercialization of such devices and launch new devices will be successful or completed within the timeframes contemplated, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2008 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com. Cardium Therapeutics(TM), Corgentin(TM) and Generx(TM) are trademarks of Cardium Therapeutics, Inc. Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM) and Excellarate(TM) are trademarks of the Tissue Repair Company. InnerCool Therapies(R), InnerCool(R), Celsius Control System(TM), Accutrol(TM), CoolBlue(TM) and RapidBlue(TM) are trademarks of InnerCool Therapies, Inc. Selected Consolidated Operational Results Annual Financial Data Three Months Ended Twelve Months Ended December 31, December 31, Statements of 2007 2006 2007 2006 Operations Data: Total Revenues $683,386 $373,295 $1,586,519 $756,137 Cost of goods sold (524,659) (509,262) (1,348,335) (954,194) Gross profit (loss) 158,727 (135,967) 238,184 (198,057) Research and development 3,216,762 4,699,159 13,117,849 8,384,324 Selling, general and administrative 3,778,059 2,096,760 12,134,557 10,053,530 Amortization - Intangibles 197,414 219,664 789,656 673,230 Loss from operations (7,033,508) (7,151,550) (25,803,878) (19,309,141) Interest, Net 20,737 111,334 482,108 715,976 Net loss (7,012,771) (7,040,216) (25,321,770) (18,593,165) Net loss per common share - basic and diluted (0.16) (0.22) (0.64) (0.59) Weighted average shares outstanding - basic and diluted 40,950,074 31,750,482 39,311,359 31,308,650 December 31, Selected Consolidated 2007 2006 Balance Sheet Data Cash and cash equivalents $7,722,816 $5,931,123 Accounts receivable, net 565,613 275,590 Inventory 1,037,164 857,034 Prepaid expenses and other current assets 522,067 654,448 Property and equipment, net 1,650,632 791,277 Patented technology and intangibles, net 4,766,330 5,555,986 Other long-term assets 661,067 51,965 Total assets 16,925,689 14,117,423 Total current liabilities 5,255,392 2,964,068 Long-term liabilities 3,241,992 - Stockholder's equity 8,428,305 11,153,355
SOURCE Cardium Therapeutics
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