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Cardium Reports on First Quarter 2008 Highlights and Financial Results
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May 9, 2008 -- San Diego -- Cardium
Therapeutics (Amex: CXM) today reported recent highlights and
developments,
as well as financial
results for its first quarter ended March 31, 2008.
Highlights and Recent Developments
- European commercialization agreement
with Euromed Medizinisch GmbH (Euromed) for InnerCool's CoolBlue™
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 March 31, 2008, the Company
reported a net loss of $6.7 million, or $0.16 per share, which
included research and development
costs totaling $3.4 million and selling, general and administrative expenses
of $3.4 million. Non-cash charges relating to stock-based compensation,
depreciation and amortization for the first quarter of fiscal 2008 totaled
$906,000. Total revenue for the first quarter 2008 was $646,000, compared to
$309,000 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. Cash and cash equivalents as of March 31, 2008 were
$6.3 million.
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 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 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.
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.
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. |
