SAN DIEGO, Aug. 11 /PRNewswire-FirstCall/ -- Cardium Therapeutics
(Amex: CXM) today reported recent highlights and developments, as well as
financial results for its second quarter ended June 30, 2008.
Highlights and Recent Developments
-- Announcement of CE mark approval and Underwriters Laboratories, Inc. (UL) certification for the new RapidBlue endovascular temperature modulation system. The CE mark will allow InnerCool to begin marketing the Rapid Blue system in Europe and many other countries that recognize the certification. InnerCool expects to begin selling the RapidBlue System through its established distribution network in the third quarter. As previously reported, InnerCool's RapidBlue System is currently completing review for FDA 510(k) clearance.
-- Ongoing patient recruitment for the Company's Phase 2b Excellarate MATRIX clinical trial. The MATRIX Study website at http://www.diabeticfootstudy.com was developed to provide patients, caregivers and physicians with information about the study. 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 up to approximately 210 patients at up to 40 U.S. sites. The study has also been the focus of media attention in multiple regions across the U.S. To view television video clips and newspaper articles, please visit http://www.cardiumthx.com/flash/videos.html. Recruiting MATRIX clinical study sites and additional information can be found at Tissue Repair Company's website at http://www.t-r-co.com/matrix-clinical-study.html.
-- Ongoing patient recruitment of the Phase 3 Generx AWARE clinical Trial. The AWARE study website at http://www.anginaresearchstudy.com was launched to provide information about the study to patients, caregivers and physicians. The AWARE study is evaluating the therapeutic effects of Generx for the potential treatment of myocardial ischemia (insufficient blood flow within the heart muscle) and associated angina due to coronary heart disease. Recruiting AWARE clinical study sites and additional information can be found at Cardium's website at http://www.cardiumthx.com/flash/aware.html.
-- Appointment of Paul A. Foster, M.D. as Chief Medical Officer to lead the Company's MATRIX Phase 2b clinical study and the AWARE Phase 3 clinical study. Dr. Foster has held leadership clinical development and medical affairs positions at Reata Pharmaceuticals, IDEC Pharmaceuticals Corporation, Biogen Idec and Alpha Therapeutic and also has experience in the medical device arena, previously holding director positions at Abbot Laboratories and Dade Behring. Dr. Foster received his M.D. degree and medical training at Duke University.
-- Completion of two follow-on registered direct investments by institutional and other accredited investors with gross proceeds totaling approximately $6.6 million excluding placement agent fees and offering expenses and excluding any future proceeds from the exercise of the warrants issued in the offerings.
For the quarter ended June 30, 2008, the Company reported a net loss of $6.6 million, or $0.15 per share, which included research and development costs totaling $4.0 million and selling, general and administrative expenses of $2.7 million. Non-cash charges relating to stock-based compensation, depreciation and amortization for the second quarter of fiscal 2008 totaled $943,000. Total revenue for the second quarter 2008 was $627,000, compared to $229,000 for the same quarter last year. The increase in revenue was a result of an increase in InnerCool sales resulting from our expanded sales and marketing efforts and an increase in the level of activity on the grant at our subsidiary Tissue Repair Company. Cash and cash equivalents as of June 30, 2008 were $4.1 million. In July 2008, the Company used $3.1 million to pay off the principal balance on its commercial credit facility, thereby retiring its remaining debt obligations to Life Sciences Capital; and completed a registered direct investment resulting in gross proceeds of approximately $3.34 million, before placement agent fees and offering expenses and excluding any future proceeds from the exercise of the warrants issued in the offering.
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 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 patient temperature modulation, including InnerCool's Celsius Control System(TM) and its CoolBlue(TM) System, 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.
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 therapeutic hypothermia devices and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our ability to successfully accelerate the commercialization of our therapeutic hypothermia devices and launch new devices 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.
Cardium Therapeutics(TM), Corgentin(TM) and Generx(TM) are trademarks
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
Cardium Therapeutics, Inc.
Three Months Ended
Selected Condensed Consolidated 2008 2007
Revenues $626,841 $229,472
Cost of goods sold (314,254) (258,177)
Gross profit (loss) 312,587 (28,705)
Research and development 3,969,406 3,415,213
Selling, general and administrative 2,696,559 2,978,448
Amortization - Intangibles 197,414 207,043
Loss from operations (6,550,792) (6,629,409)
Interest income (expense), net (83,670) 228,228
Net loss $(6,634,462) $(6,401,181)
Net loss per common
share - basic and diluted $(0.15) $(0.16)
Weighted average common shares
outstanding - basic and diluted 43,629,975 40,914,902
Selected Condensed Consolidated June 30, December 31,
Balance Sheet Data 2008 2007
Cash and cash equivalents $4,138,989 $7,722,816
Accounts receivable, net 406,963 565,613
Inventories, net 1,741,439 1,037,164
Prepaid expenses and other current assets 537,124 522,067
Property and equipment, net 2,006,735 1,650,632
Patented technology and
intangibles, net 4,371,502 4,766,330
Other long-term assets 600,041 661,067
Total assets $13,802,793 $16,925,689
Current liabilities $9,602,428 $5,255,392
Long-term liabilities 96,420 3,241,992
Stockholder's equity 4,103,945 8,428,305
Total liabilities and
stockholder's equity $13,802,793 $16,925,689
|SOURCE Cardium Therapeutics|
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