Cardium Therapeutics, Inc. News
Cardium Reports on First Quarter 2008 Highlights and Financial Results
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO) Highlights and Recent Developments — European commercialization agreement with Euromed Medizinisch GmbH (Euromed) for InnerCool's CoolBlue(TM) surface temperature modulation system and RapidBlue endovascular system. Euromed, a leading distributor of cardiology medical products will have exclusive marketing, sales and distribution rights in Austria, Germany and Switzerland for InnerCool's portfolio of temperature modulation systems. — Australian distribution agreement with Lifehealthcare Pty Ltd., one of Australia's leading medical device distributors and health service providers. Under the agreement, Lifehealthcare has the exclusive rights to market, sell and distribute InnerCool's CoolBlue and RapidBlue temperature modulation systems in Australia and New Zealand. — Publication by BioMed Central (BMC) Cardiovascular Disorders (2008, 8:7, April 10, 2008) of positive findings from a preclinical study conducted by researchers at Lund University Hospital in Sweden demonstrating a new and expanded benefit of early rapid cooling for the potential treatment of acute myocardial infarction (heart attack). The same researchers are currently recruiting patients for the RAPID-MI-ICE (Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention) clinical study, which is expected to enroll approximately 20 patients who present within six hours of their heart attack and require angioplasty and stent procedures. Patients randomized to the cooling arm (hypothermia) will be infused with one liter of iced saline in addition to endovascular cooling and patients assigned to the normothermia arm will receive routine standard of care without induced hypothermia. Additional information about the study can be found at http://www.clinicaltrials.gov. — Ongoing patient recruitment for the Company's Phase 3 Generx AWARE and Phase 2b Excellarate MATRIX clinical trials. The AWARE clinical trial is evaluating Generx as a potential treatment for myocardial ischemia (insufficient blood flow within the heart muscle) which gives rise to angina and is expected to enroll approximately 300 women at an estimated 50 U.S. medical centers. Additional information about the AWARE study can be found at http://www.cardiumthx.com/flash/aware.html. The MATRIX clinical trial is evaluating the safety and efficacy of Excellarate for the potential treatment of non-healing diabetic foot ulcers and is expected to enroll approximately 210 patients at up to 40 U.S. sites. Additional information about the MATRIX study can be found at http://www.t-r-co.com/images/Website_082407_(3).pdf. — Addition of Richard A. Schatz, M.D. to Cardium's Scientific Advisory Board. Dr. Schatz is a pioneer of coronary stent technology and is Research Director of Cardiovascular Interventions at the Heart, Lung, and Vascular Center at Scripps Clinic in La Jolla, California. — Broadcast of the Science Channel's \"Cool Stuff: How it Works\" series featuring the use of InnerCool's endovascular cooling system during brain surgery at Stanford University. The segment (episode 5) is scheduled to be rebroadcast tonight, May 9, at 8:30 p.m. and 11:30 p.m. (ET/PT). Financial Report
For the quarter 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 2007 Annual Report at http://www.cardiumthx.com/flash/pdf/CardiumAR07_Book_FINAL.pdf.
Cardium's InnerCool Therapies subsidiary is a
Cardium's Tissue Repair Company subsidiary (TRC) is a
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 or procedure will be reproduced in subsequent studies or procedures, that our products or product candidates will prove to be sufficiently safe and effective, that necessary regulatory approvals will be obtained, that third parties on whom we depend will perform as anticipated, or 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. 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 funding, 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.
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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. - Continued - Cardium Therapeutics, Inc. Three Months Ended March 31, (Unaudited) Selected Condensed 2008 2007 Consolidated Operational Results Revenues $646,002 $309,331 Cost of goods sold (370,696) (246,565) Gross profit 275,306 62,766 Research and development 3,372,480 3,242,866 Selling, general and administrative 3,385,566 2,539,101 Amortization - Intangibles 197,414 207,043 Loss from operations (6,680,154) (5,926,244) Interest income (expense), net (53,974) 86,395 Net loss $(6,734,128) $(5,839,849) Net loss per common share - basic and diluted $(0.16) $(0.17) Weighted average shares outstanding - basic and diluted 42,709,247 34,362,080 Selected Condensed March 31, December 31, Consolidated Balance Sheet 2008 2007 (unaudited) (audited) Cash and cash equivalents $6,300,638 $7,722,816 Accounts receivable, net 311,837 565,613 Inventories, net 1,337,870 1,037,164 Prepaid expenses and other current assets 657,820 522,067 Property and equipment, net 1,644,416 1,650,632 Patented technology and intangibles, net 4,568,916 4,766,330 Other long-term assets 748,023 661,067 Total assets $15,569,520 $16,925,689 Total current liabilities $5,545,073 $5,255,392 Long-term liabilities 2,849,334 3,241,992 Stockholder's equity 7,175,113 8,428,305 Total liabilities and stockholder's equity $15,569,520 $16,925,689
SOURCE Cardium Therapeutics, Inc.
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