SAN DIEGO, March 14 /PRNewswire-FirstCall/ -- Cardium Therapeutics today reported highlights and financial results for its fiscal year ended December 31, 2007, and other important recent developments.
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For the year ended December 31, 2007, Cardium reported net operating losses totaling $25.3 million, or a loss of $(0.64) per share compared to $18.6 million, or $(0.59) per share in 2006. Research and development costs in 2007 were $13.1 million compared to $8.4 million for fiscal year 2006, and selling, general and administrative expenses were $12.1 million in 2007 compared to $10.1 million in 2006. Total revenue for the year ended December 31, 2007 was $1,587,000 compared to $756,000 for the previous year. The increase in 2007 product revenues was in large part a result of an increase in InnerCool sales resulting from our expanded sales and marketing efforts, as well as the launch of the new CoolBlue surface cooling system. Cardium ended the year with cash and cash equivalents totaling $7.7 million compared to $5.9 million the previous year. On February 1, 2008, the Company reported closing a registered direct financing of $5.3 million, before placement agent fees and other expenses. Total shares of common stock outstanding at December 31, 2007 were 41.0 million compared to 32.2 million at December 31, 2006. The total number of shares of common stock outstanding as of March 10, 2008 was 43.6 million shares.
Cardium also reported that the audit opinion accompanying its consolidated financial statements for the year ended December 31, 2007, which statements were included in its Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 14, 2008, contained a going concern qualification from its independent registered public accounting firm, Marcum & Kliegman LLP. Consistent with its business strategy, Cardium plans to raise additional funds through the strategic sale or monetization of its operating units, entering into strategic licensing agreements, and/or as appropriate, may also consider the sale of securities in registered direct transactions under its effective shelf registration statement.
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 December 31, 2007, which is available free of change on Cardium’s website at http://www.cardiumthx.com.
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., Europe and Australia, and its CoolBlue(TM) surface-based system, which is currently being marketed in the U.S., please visit http://www.innercool.com.
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.
http://www.cardiumthx.com
CONTACT: Bonnie Ortega, Director, Investor-Public Relations of Cardium
Therapeutics, Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
Web site: http://www.cardiumthx.com/
http://www.innercool.com/
http://www.t-r-co.com/