|
Cardium Reports Financial Results: Narrower Fourth Quarter Loss; Doubled Annual Revenues
|
 |
March 15, 2008 --
San Diego --
Cardium Therapeutics (Amex: CXM), currently in development
of several innovative medical therapies, yesterday
reported
a narrower fourth quarter loss, helped by more than double the
revenues in 2007 from the previous year.
|
|
Of particular interest
to the cardiology community is the Phase 3 AWARE trial, a
randomized, placebo-controlled, double-blind clinical trial
of Cardium's
catheter-based delivery of Generx™ angiogenetic material.
A potential new treatment
for myocardial ischemia, AWARE is testing the only therapy
for angiogenesis in the coronaries that has reached a Phase
3
trial and that has
been
given Fast
Track status by the U.S. Food and Drug Administration. |
|
Following are the highlights
and
financial results that Cardium released 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™ 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™, 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™ 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™ 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™ 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™ (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 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.
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 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™, which has received regulatory clearance in the U.S., Europe and
Australia, and its CoolBlue™ 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™, 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™ 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™ (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.
Cardium Therapeutics™, Corgentin™ and Generx™ are trademarks of
Cardium Therapeutics, Inc.
Tissue Repair™, Gene Activated Matrix™, GAM™ and Excellarate™
are trademarks of the Tissue Repair Company.
InnerCool Therapies®, InnerCool®, Celsius Control System™,
Accutrol™, CoolBlue™ and RapidBlue™
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, Inc. with additional reporting
by Angioplasty.Org |
