August 11, 2008, San Diego --
Cardium Therapeutics (Amex: CXM) today reported recent highlights
and developments, as well as financial results for its second
quarter ended June 30, 2008.
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.
Financial Report
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.
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
patient temperature modulation, including InnerCool's Celsius
Control System™ and its CoolBlue™ 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™, 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 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.
Cardium Therapeutics™ Corgentin™ and Generx™ are trademarks
of
Cardium Therapeutics,
Inc.
Tissue Repair ™, Gene Activated Matrix™, GAM™ and Excellarate™
are
trademarks of 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
June 30,
(Unaudited)
Selected Condensed Consolidated 2008 2007
Operational Results
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
(Unaudited) (Audited)
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
