SAN DIEGO, March 26 /PRNewswire-FirstCall/ -- Cardium Therapeutics
(NYSE Amex: CXM) today reported highlights and financial results
for its fourth quarter and fiscal year ended December 31, 2008, and
other important recent developments and outlook for 2009. (Logo:
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO) Recent
Developments and 2009 Outlook Cardium's business is focused on the
acquisition and strategic development of product opportunities or
businesses having the potential to address significant unmet
medical needs, and definable pathways to commercialization,
partnering or other monetization. As our product opportunities and
businesses are advanced and corresponding valuations established,
we intend to consider various corporate development transactions
designed to place our product candidates into larger organizations
or with partners having existing commercialization, sales and
marketing resources, and a need for innovative products. Such
transactions could involve the sale, partnering or other
monetization of particular product opportunities or businesses. In
November 2008, Cardium reported that it was focusing principal
near-term efforts on its InnerCool Therapies and Tissue Repair
subsidiaries - both of which we believe are nearing completion of
their strategic development programs initiated in 2006. InnerCool
Therapies completed its high-performance endovascular-based cooling
system, RapidBlue(TM), and the system was cleared by the FDA in
late 2008. InnerCool also developed a new class of targeted
organ-specific cooling applications, including its UroCool(TM)
pelvic cooling catheter system, which is designed to induce
localized cooling during surgery for prostate cancer. An
application for FDA 510(k) clearance of the UroCool(TM) system was
submitted in the first quarter of 2009. Tissue Repair Company
successfully advanced its MATRIX Phase 2b clinical study, which is
principally designed to evaluate the ability of Excellarate(TM) to
promote rapid closure of previously non-healing diabetic foot
ulcers, and to gather additional information regarding safety and
clinical use. Enrollment in the MATRIX clinical study is expected
to be completed and select top line data announced shortly. In
keeping with Cardium's business model, we expect to consider
strategic partnering or other transactions designed to further
advance these products to commercialization. InnerCool Therapies
InnerCool was acquired by Cardium in 2006. As a result of Cardium's
efforts, InnerCool is now uniquely positioned with a portfolio of
temperature modulation therapy products and products under
development that include endovascular and surface-based systems
(for cooling and warming) that are easy to use and address a wide
range of care environments, such as emergency vehicles, emergency
rooms and intensive care units, and in operating room settings such
as in neurology, cardiac and urology surgeries. In addition,
through Cardium's investment, InnerCool's product portfolio and
pipeline of new and innovative future products are supported by a
fully-integrated 29,000 square foot cGMP facility with R&D and
manufacturing capabilities. InnerCool is also positioned to benefit
from participation in cutting-edge research efforts with the
potential to broaden the applicability of patient temperature
modulation for advanced therapies. Consistent with Cardium's
business strategy, the Company believes that InnerCool has reached
a significant valuation inflection point within Cardium's
investment portfolio, and with the appropriate strategic
positioning, best-in-class products and a pipeline of innovative
product opportunities, Cardium intends to advance InnerCool's
therapeutic cooling and warming products into corresponding markets
through the strategic sale of the business to a large and
diversified medical device company or through various vertical
partnering opportunities with established companies having existing
sales and marketing organizations but with a continuing need for
innovative, high-value content products. The Company believes this
strategy is more cost-effective than building InnerCool into a
fully integrated manufacturing, sales and marketing organization.
Recent highlights and ongoing product development and clinical
research activities at InnerCool include the following: -- U.S.
Food and Drug Administration (FDA) 510(k) clearance to market the
RapidBlue(TM) System, an endovascular temperature modulation
device. The new RapidBlue System is believed to be the most
powerful easy to use endovascular-based system available. InnerCool
has obtained CE mark approval and Underwriters Laboratories, Inc.
(UL) certification for the new RapidBlue system. The CE mark allows
InnerCool to market the Rapid Blue system in Europe and many other
countries that recognize the certification. -- InnerCool's
establishment of commercialization agreements with leading
distributors of medical products for exclusive marketing, sales and
distribution rights in Austria, Germany, Italy, Switzerland,
Australia and New Zealand for InnerCool's RapidBlue(TM)
endovascular system and CoolBlue(TM) surface temperature modulation
system. During the year, InnerCool was also awarded a new supplier
contract with Novation, LLC, a leading health care contracting
company. -- InnerCool's development of a new class of targeted
organ-specific cooling applications, including UroCool(TM), a
pelvic cooling catheter system designed to induce localized cooling
during surgery for prostate cancer. Researchers at the University
of California, Irvine believe that therapeutic cooling during
prostate surgery (which includes both traditional open surgical
approaches and newer robotic-assisted techniques) can reduce tissue
damage and inflammation and thereby provide a faster return of
bladder control (continence) and possibly erectile function
(potency). The specialized UroCool pelvic cooling catheter is being
integrated with InnerCool's current Celsius Control console which
has been marketed and sold since 2003 and a regulatory application
for FDA 510(k) clearance of the UroCool catheter was submitted in
the first quarter of 2009. -- Positive clinical findings
demonstrating faster recovery of urinary continence using localized
manual cooling techniques during robotic-assisted radical
prostatectomy surgery will be published in the April 2009 issue of
Urology and are now available online at
http://www.goldjournal.net/article/S0090-4295(08)01953-5/abstract.
The Hypothermic Nerve-sparing Radical Prostatectomy: Rationale,
Feasibility, and Effect on Early Continence study conducted by
Thomas E. Ahlering, M.D., David S. Finley, M.D., and colleagues at
the University of California, Irvine, demonstrated that cooling
during robotic-assisted radical prostatectomy surgery resulted in a
statistically significant improvement in early postoperative
continence following surgery. The results reported on 47 patients
receiving hypothermia during robotic-assisted laparoscopic
prostatectomy (hRLP) who were compared with a standard
robotic-assisted laparoscopic prostatectomy (RLP) cohort of 666
controls. Pelvic cooling was achieved using cold irrigation and an
endorectal cooling balloon cycled with 4 degrees Celsius saline.
Urinary continence was defined as requiring no urinary pads. The
return to continence was faster for the hRLP (hypothermia) group
versus the RLP (control) group: median 39 days versus 59 days,
respectively (p=0.002). -- Sponsorship of a pilot study to evaluate
the use of early and rapid cooling in heart attack patients, which
is being co-sponsored and conducted by the interventional
cardiology center at Lund University Hospital, Sweden. The ongoing
clinical study, called RAPID MI-ICE (Rapid Intravascular Cooling in
Myocardial Infarction as Adjunctive to Percutaneous Coronary
Intervention), is expected to enroll approximately 20 patients who
present within six hours of their heart attack and require
angioplasty and stent procedures in order to restore blood flow to
the heart. Preclinical and preliminary clinical data suggest that
rapid patient cooling using intravenous cold saline in combination
with endovascular hypothermia can be initiated without causing
delay of reperfusion therapy and may have the potential to enable
interventional cardiologists to dramatically reduce heart tissue
damage following a heart attack. The Company expects to announce
results of the RAPID MI-ICE clinical study in 2009. --
Co-sponsorship of the Intravascular Cooling in the Treatment of
Stroke - Longer tPA window (ICTuS-L) study, which is a prospective,
randomized, controlled, multi-center study, sponsored by the
National Institute of Neurological Disorders and Stroke (NINDS).
The study is evaluating the safety and feasibility of InnerCool's
endovascular temperature modulation therapy as an adjunctive
treatment for acute ischemic stroke. The Company expects to
announce results of this important safety study in 2009, and is
working with investigators to undertake advanced multi-center
clinical studies in the U.S. and internationally to evaluate
further safety and preliminary efficacy of therapeutic cooling for
ischemic stroke patients. Tissue Repair Company The Tissue Repair
Company (TRC) was also acquired by Cardium in 2006. TRC's product
candidate, Excellarate(TM), is a DNA-based topical gel designed to
be administered once or twice for the potential treatment of
non-healing diabetic foot ulcers. This profile would represent a
dramatic change from current treatment approaches, which are often
not predictably effective and which typically require multiple
clinic visits, or in the case of a protein-based treatment, require
daily wound cleanings and product applications over an extended
period of time. The Company's Phase 2b MATRIX clinical study was
initiated in November 2007 and is principally designed to evaluate
the ability of Excellarate to promote rapid closure of previously
non-healing diabetic foot ulcers and to gather additional
information regarding safety and clinical use. Enrollment in the
MATRIX clinical study is expected to be completed and select top
line data announced shortly. Consistent with Cardium's business
strategy, the Company believes that with the Company's completion
of the Phase 2b MATRIX study, the Tissue Repair Company will have
reached a key valuation inflection point within Cardium's
investment portfolio and in concert with this, Cardium plans to
consider potential development and commercialization partnerships
for Excellarate with large pharmaceutical companies and companies
focused on wound healing. With continued clinical advancement,
Excellarate offers the potential to be commercially available in
late 2011 or early 2012. Cardium also plans to explore additional
clinical opportunities utilizing TRC's Gene Activated Matrix(TM)
(GAM) technology platform. The Company's GAM technology has
potential utility in additional indications in which protein
therapeutics have had limited success, including the treatment of
other dermal wounds (e.g., pressure ulcers) and with orthopedic
products, including those for repair of damaged hard tissue (e.g.,
bone) and soft tissue (e.g., ligament, tendon and cartilage).
Biologics and Stem Cells for Cardiovascular Disease and Other
Indications Cardium has also developed additional biologics for
potential application in cardiovascular disease and other areas of
regenerative medicine. Generx(R) (alferminogene tadenovec,
Ad5FGF-4) is designed to leverage the body's natural healing
processes in response to repeated ischemic stress (insufficient
blood flow and myocardial oxygen supply due to coronary heart
disease) - for potential use in treating ischemic conditions such
as recurrent angina. Corgentin(TM) (Ad5IGF-1) is designed to
enhance myocardial healing in and around the infarct zone when used
as an adjunct to existing vascular-directed pharmacologic and
interventional therapies - for potential use in treating acute
ischemic injury such as that following a heart attack. A
complementary approach to the development of therapeutics for
regenerative medicine involves the use of stem cells that can be
incorporated into injured tissue like the heart as a means of
preventing further damage and promoting healing of the affected
organ. In that regard, filings by Cardium related to Ad5IGF-1 also
described the potential use of stem cells, such as mesenchymal stem
cells or MSCs transfected with an Ad5IGF-1 vector (such as that
used in Corgentin(TM)), for addressing coronary syndromes such as
heart disease or heart attack. With regard to stem cell approaches,
recently reported studies conducted by independent researchers at
the University of Cincinnati showed in a preclinical model of heart
attack that MSCs that had been transfected with Ad5IGF-1 were
particularly effective at promoting angiogenesis within the heart
and that the zone of heart attack related tissue damage (the
infarct zone) was significantly reduced, and cardiac contractile
function significantly improved - further highlighting the
potential value of these therapeutic approaches. Financial Report
For the quarter ended December 31, 2008, the Company reported a net
loss of $5 million, or $(0.11) per share, which included research
and development costs totaling $2 million and selling, general and
administrative expenses of $2.6 million. For the year ended
December 31, 2008, Cardium reported net operating losses totaling
$24.6 million, or a loss of $(0.55) per share compared to $25.3
million, or $(0.64) per share in 2007. Research and development
costs in 2008 were $12.3 million compared to $13.1 million for
fiscal year 2007, and selling, general and administrative expenses
were $11.6 million in 2008 compared to $12.1 million in 2007. The
decrease in research and development costs was primarily due to a
reduction in the development costs for InnerCool's RapidBlue system
as it has moved from development to production, increased expenses
in our efforts to advance our Excellarate product candidate in its
Phase 2b clinical trial, offset by reductions in the AWARE Phase 3
clinical trial costs. Non-cash charges relating to stock-based
compensation, depreciation and amortization for the year ended
December 31, 2008 totaled $4.0 million compared to $3.5 million in
2007. Total revenue for fourth quarter 2008 was $559,000 compared
to $683,000 for fourth quarter 2007. Total revenue for the year
ended December 31, 2008 was $2,417,000 compared to $1,587,000 for
the previous year, representing a 52% year-over-year increase. The
increase in 2008 product revenues was in large part a result of an
increase in InnerCool sales resulting from the launch of the
CoolBlue surface cooling system in late 2007 and the launch of the
RapidBlue in late 2008. Cardium ended the year with cash and cash
equivalents totaling $1.1 million compared to $7.7 million the
previous year. During 2008, the Company completed three follow-on
registered direct investments by institutional and other accredited
investors with gross proceeds totaling approximately $11.9 million,
and the completion of a secured debt financing resulting in gross
proceeds of approximately $6.0 million, before placement agent fees
and offering expenses and excluding any future proceeds from the
exercise of the warrants issued in the financings. On March 5,
2009, the Company reported closing a credit facility in the amount
of $3.5 million, before placement agent fees and other expenses.
The total shares of common stock outstanding at December 31, 2008
were 46.9 million compared to 41.0 million at December 31, 2007.
Cardium also reported that the audit opinion accompanying its
consolidated financial statements for the year ended December 31,
2008, which statements were included in its Annual Report on Form
10-K filed with the Securities and Exchange Commission in March
2009, contained a going concern qualification from its independent
registered public accounting firm, Marcum & Kliegman LLP.
Consistent with its business strategy and as outlined in this press
release, Cardium plans to raise additional funds through the
strategic sale or monetization of its operating units, entering
into strategic licensing agreements, and/or other financing
transactions. This announcement is made in compliance with Section
610(b) of the Company Guide of the NYSE Amex (formerly the American
Stock Exchange), 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, 2008, which is available free of change on
Cardium's website at http://www.cardiumthx.com/. In late December
2008, Cardium received notification from the staff of its current
listing exchange indicating that the Company was considered to be
noncompliant with certain listing requirements of the NYSE Amex. On
January 23, 2009, the Company submitted a proposed plan outlining
how it could establish compliance with the requirements of section
1003(a)(iv) by March 23, 2009, and establish compliance with all
sections, including section 1003(a)(i), by June 23, 2010. Cardium
received notification in late February that its plan had been
accepted by the exchange, but remains subject to continuing review
by the exchange with respect to the carrying out of its plan and
the achievement and maintenance of overall compliance. 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
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 new RapidBlue(TM)
System, which recently received FDA clearance, and its CoolBlue(TM)
System, please visit http://www.innercool.com/. Cardium also has
two biologic candidates in clinical development. Cardium's Tissue
Repair Company subsidiary (TRC) is 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/. Cardium's
Generx(R) product candidate (alferminogene tadenovec, Ad5FGF-4) is
a DNA-based growth factor therapeutic designed for potential
application 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 most recent Annual Report at
http://www.cardiumthx.com/flash/pdf/CardiumAR07_Book_FINAL.pdf.
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 results
or trends observed in pre-clinical studies will be reproduced in
subsequent studies, that human clinical trials can be conducted and
completed in an efficient and successful manner, that partnering,
asset monetization or other strategic development opportunities can
be successfully achieved and that such opportunities will
effectively and efficiently advance commercialization of our
products, that we can raise sufficient capital from partnering,
monetization or other fundraising transactions to maintain our
stock exchange listing or adequately fund ongoing operations, 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 product
candidates will prove to be sufficiently safe and effective, that
necessary regulatory approvals will be obtained, 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 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 2009 Cardium Therapeutics,
Inc. All rights reserved. For Terms of Use Privacy Policy, please
visit http://www.cardiumthx.com/. Cardium Therapeutics(TM),
Generx(R) and Corgentin(TM) are trademarks of Cardium Therapeutics,
Inc. Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM) and
Excellarate(TM) are trademarks of Tissue Repair Company. InnerCool
Therapies(R), InnerCool(R), RapidBlue(TM), CoolBlue(TM),
Accutrol(R), Temperature Control Element(R), TCE(R) and Celsius
Control(R) consol 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 Operations Data: 2008 2007 2008 2007 Total Revenues
$559,121 $683,386 $2,417,385 $1,586,519 Cost of goods sold
(232,381) (524,659) (1,431,574) (1,348,335) Gross profit (loss)
326,740 158,727 985,811 238,184 Research and development 2,025,769
3,216,762 12,315,652 13,117,849 Selling, general and administrative
2,631,901 3,778,059 11,600,115 12,134,557 Amortization -
Intangibles 197,414 197,414 789,656 789,656 Loss from operations
(4,528,344) (7,033,508) (23,719,612) (25,803,878) Interest
(expense) income, net (549,609) 20,737 (878,446) 482,108 Net loss
(5,077,953) (7,012,771) (24,598,058) (25,321,770) Net loss per
common share - basic and diluted $(0.11) $(0.16) $(0.55) $(0.64)
Weighted average shares outstanding - basic and diluted 46,930,439
40,950,074 44,978,169 39,311,359 December 31, Selected Consolidated
Balance Sheet Data 2008 2007 Cash and cash equivalents $1,102,894
$7,722,816 Accounts receivable, net 296,116 565,613 Inventory
2,000,385 1,037,164 Prepaid expenses and other current assets
642,246 522,067 Property and equipment, net 1,706,065 1,650,632
Patented technology and intangibles, net 3,976,674 4,766,330 Other
long-term assets 572,541 661,067 Total assets 10,296,921 16,925,689
Total current liabilities 10,856,362 5,255,392 Long-term
liabilities 195,315 3,241,992 Stockholder's (deficit) equity
(754,756) 8,428,305 Total liabilities and stockholder's (deficit)
equity 10,296,921 16,925,689
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
http://photoarchive.ap.org/ DATASOURCE: Cardium Therapeutics
CONTACT: Press / Investor, Bonnie Ortega, Director, Investor/Public
Relations of Cardium Therapeutics, Inc., +1-858-436-1018, Web Site:
http://www.cardiumthx.com/
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