SAN DIEGO, March 14 /PRNewswire-FirstCall/ -- Cardium Therapeutics
(Amex: CXM) today reported highlights and financial results for its fiscal
year ended December 31, 2007, and other important recent developments.
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
-- 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.
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
-- 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 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.
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.
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.
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
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
- 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
Selected Consolidated 2007 2006
Balance Sheet Data
Cash and cash
equivalents $7,722,816 $5,931,123
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
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
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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