SAN DIEGO, May 16, 2011 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) today presented its financial results for the first quarter ended March 31, 2011.
In addition to the announcement of first quarter 2011 financial results, Cardium reported on the Company's near-term goals and milestones including the following: (1) commercialization plans and efforts to support Cardium's Excellagen™ wound management medical device which is pending clearance of an FDA 510(k) application for marketing and sales in the U.S.; (2) clearance from international health authorities to initiate a planned Phase 3 / Registration clinical trial for Generx® (alferminogene tadenovec/Cardionovo™) as a non-surgical, angiogenic treatment option for patients with advanced coronary artery disease who are considering balloon angioplasty and stents or open heart bypass surgery; and (3) expanding the Company's development-stage MedPodium health and wellness brand platform with two new nutraceutical products: Cerex™ (to support cognitive function) and Alena™ (a carbohydrate blocker).
First Quarter 2011 Financial HighlightsFor the first quarter ended March 31, 2011, the Company reported a loss from operations of $1.8 million, compared to a loss from operations of $1.5 million for the same period in 2010. The first quarter 2011 financial results also include an $88,000 favorable adjustment to results of operations for the non-cash change in fair value of certain common stock warrants recorded as "Change in Fair Value of Derivative Liabilities", compared to a $437,000 favorable adjustment recorded in the first quarter of 2010. Research and development costs for the three months ended March 31, 2011 totaled $492,000 and general and administrative expenses were $1.3 million, compared to $520,000 and $961,000, respectively, for the same period last year. For the first quarter ended March 31, 2011, the Company reported a net loss of $1.7 million, or $(0.02) per share, compared to a net loss of $1.0 million, or $(0.02) per share for the same period in 2010. As of March 31, 2011, the Company had a total of $6.3 million in cash ($5 million in cash and $1.3 million in restricted cash) compared to cash of $8.1 million ($6.7 million in cash and $1.4 million in restricted cash) at December 31, 2010. As of March 31, 2011, 83.1 million shares of Cardium's common stock were outstanding.
Excellagen™ Formulated Fibrillar Collagen GelCardium's Excellagen™ wound management medical device candidate, which is pending FDA 510(k) clearance, is a custom formulated fibrillar collagen gel being developed for the management of dermal wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds, and other types of wounds.
During first quarter 2011, positive findings from the Company's Matrix Phase 2b clinical study were published in the journal, Wound Repair and Regeneration. The clinical paper titled, "Formulated Collagen Gel Accelerates Healing Rate Immediately after Application in Patients with Diabetic Neuropathic Foot Ulcers", is available at www.cardiumthx.com/pdf/ExcellagenPaper_WoundRepair.pdf.
The Company has continued to progress forward with the Excellagen FDA 510(k) clearance for marketing and sales in the U.S. and is in discussions with potential partners for the commercialization of Excellagen in the U.S. and internationally.
Generx® Angiogenic Therapy Generx® (alferminogene tadenovec/Cardionovo™) is an innovative DNA-based angiogenic therapy being developed for the potential treatment of myocardial ischemia due to advanced coronary artery disease. Generx is designed to stimulate and promote the growth of supplemental collateral vessels to enhance myocardial blood flow (perfusion) following a one-time intracoronary administration from a standard cardiac infusion catheter in patients who have insufficient blood flow due to atherosclerotic plaque build-up in the coronary arteries. Cardium plans to commence a Phase 3 / Registration study (the Aspire Study) at three major medical centers in the Russian Federation pending final clearance from the Russian health authority. The study's planned primary endpoint would be the improvement in reversible perfusion defect size as measured by SPECT imaging. The Russian Ministry of Health and Social Development has recently assigned Generx (alferminogene tadenovec/Ad5FGF-4) the new therapeutic drug trade name of Cardionovo™ for marketing and sales in the Russian Federation. The Aspire study is being undertaken in connection with a plan to initially commercialize Generx in the Russian Federation, and to advance forward with applications and submissions seeking approval for marketing and sales in certain other countries of the Commonwealth of Independent States, comprising former republics under the Soviet Union. The Aspire study could also provide additional clinical evidence regarding the safety and effectiveness of Generx that would be useful for optimizing and broadening commercial development pathways in other industrialized countries, including the United States. The new YouTube video "Cardium Generx Cardio-Chant" provides an overview of Generx at http://www.youtube.com/watch?v=pjUndFhJkjM.
Cerex™ Supports Cognitive Performance*
Cardium is planning for the commercial launch of non-prescription Cerex™ (Panax quinquefolius) easy use 200 mg capsules, a plant-based dietary supplement to support cognitive performance for healthy people of all ages.* The addition of Cerex represents another important step toward broadening the Company's MedPodium healthy lifestyles platform to address neuro-cognitive function. Cerex is a ginsenoside-based nutritional supplement intended to support cognitive functions including focus, memory, and attention. Based on data from a recently completed clinical study published in Psychopharmacology 212(3): 345-56 (2010), taking the primary ingredient of a Cerex 200 mg capsule once or twice (approximately six hours following the initial dose) was reported to increase attention, focus and mental alertness.* The key ingredient of Cerex is Cereboost™, a bio-available North American-sourced ginsenoside, which was developed and clinically-studied by Naturex Inc., a French-based international manufacturer of natural specialty ingredients for the food & beverage, nutrition & health and personal care industries. Cereboost™ received the dietary supplement industry's 2010 NutrAward for Best New Ingredient.
Alena™ Clinical Strength Carbohydrate Blocker* In addition to Cerex™, the Company also plans to commercially launch Alena™ (Phase 2® Extra-Strength and ChromeMate®), an all-natural, non-stimulant carbohydrate blocker to further expand its MedPodium product portfolio. Alena™ is a non-prescription dietary supplement intended to be taken before carbohydrate-rich meals (including junk food snacks and fast food meals) to help reduce the digestion of dietary starches and assist in weight control when used in conjunction with a sensible diet and exercise program*. The key ingredient of Alena is a custom-formulated white bean extract (Phase 2®), which represents the first carbohydrate blocker shown in multiple studies to slow or delay the digestion and absorption of carbohydrates and to help control blood glucose after eating certain starch-laden foods*. MedPodium's Alena™ has also been formulated to include ChromeMate® brand chromium polynicotinate that helps to metabolize fat, turn protein into muscle and convert sugar into energy. Researchers have shown that ChromeMate's oxygen-coordinated niacin-bound chromium complex provides a safe and effective form of chromium available in a dietary supplement.*
Alena is formulated using a highly concentrated Phase 2® extract that is approximately four times more potent than other generally available Phase 2® products and was specifically manufactured for Cardium for use in MedPodium's easy-to-swallow pharmaceutical grade capsules. Alena temporarily inhibits the alpha-amylase enzyme from digesting complex carbohydrates commonly found in modern diets, thus slowing their absorption and reducing their caloric impact. Alena works selectively on the types of carbohydrates found in starchy foods, and does not block the absorption of "good" simple carbohydrates such as those derived from vegetables and whole grains*. A complete dossier of Phase 2® clinical studies can be accessed at http://www.phase2info.com/pdf/phase2-product-overview.pdf.
MedPodium Brand PlatformCardium plans to identify and evaluate additional key ingredients and formulations from around the world for use in its MedPodium healthy lifestyle brand platform, and is currently developing a selection of science-based, easy-to-use lifestyle nutraceutical supplements called Nutra-Apps™, which are expected to be marketed to the tech-focused millennial generation for promoting health and well-being. Products selected for the MedPodium portfolio are expected to be substantiated with scientific data supporting an understanding of the mechanism of action, have well-defined manufacturing standardizations, and allow for easy to use formulation and dosage. MedPodium products are now available for sale through the web-based boutique at www.medpodium.com and the Company plans to initiate formal advertising and promotional programs once it has assembled a more complete portfolio of healthy lifestyle products.
About CardiumCardium is focused on the acquisition and strategic development of innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications, and its MedPodium health and wellness brand platform. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at www.cardiumthx.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 results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that the U.S. Food and Drug Administration (the "FDA") will grant marketing clearance of the Excellagen product candidates or that we or a partner can successfully introduce these or additional products into advanced wound care markets; that international health regulatory authorities will approve planned clinical studies of Generx; that we can successfully build and commercialize our MedPodium healthy lifestyle portfolio; that Excellagen, Generx or our other candidates will prove to be sufficiently safe and effective, or that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that the Excellagen or Generx product candidates offer the potential for simpler or more cost-effective treatment for physicians and patients than other products that currently are or will be on the market; that improvements in the formulation or use of Generx will be commercially practicable, or that Generx could be successfully advanced as a therapeutic in developing markets or that the results of studies in such markets could be used to advance or broaden the commercialization of Generx in the U.S. or other markets; that our 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 our clinical study programs can be conducted and completed in an efficient and successful manner; that the FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; or that third parties on whom we depend will perform as anticipated.
Cardium Therapeutics, Inc.Selected Condensed Consolidated Results of OperationsAs of March 31, 2011Three Months Ended March 31,20112010 Revenues
-Research and development
(491,574)(519,962)General and administrative
(1,287,885)(960,625)Loss from operations
(1,779,459)(1,480,587)Interest income (expense), net
2,6493,401Change in fair value of derivative liabilities
$ (1,688,640)$ (1,039,816)Net loss per common share – basic and diluted
(0.02)Weighted average common shares outstanding – basic and diluted
83,097,96759,968,059*Please refer to the reconciliation of Non-GAAP measures included in this release.Selected Condensed Consolidated Balance Sheet Data March 31, 2011
2010Cash and cash equivalents$
,644,054Restricted cash1,325,0001,425,000Total cash6,259,2998,069,054Prepaid expenses and other current assets144,776134,044Property and equipment, net209,665234,942Other long-term assets1,051,3081,074,035Total assets$
9,512,075Accounts payable and accrued liabilities$
,345,981Derivative liabilities484,903573,073Long-term liabilities157,191164,782Total liabilities1,902,9302,083,836Stockholder's equity 5,762,1187,428,239Total liabilities and stockholder's equity$
9,512,075Cardium Therapeutics, Inc.Reconciliation of Non-GAAP MeasureAs of March 31, 2011Three Months Ended March 31, 20112010Net Loss$ (1,688,640)$ (1,039,816)Add (subtract)Stock-based compensation expense22,519120,479Change in fair value of derivative liabilities(88,170)(437,370)Non-GAAP net loss$
(1,356,707)Non-GAAP Financial MeasureTo supplement our condensed consolidated financial statements, which statements are prepared and presented in accordance with accounting principles generally accepted in the United States of America (GAAP), we use a non-GAAP financial measure called non-GAAP earnings or loss per share. We define non-GAAP earnings or loss per share as net income or loss not including the impact of:
It should be noted that basic and diluted weighted average shares are determined on a GAAP basis and the resulting share count is used for computing both GAAP and non-GAAP basic and diluted earnings per share.
With the adoption of ASC 815 and its very substantial impact on our total liabilities including certain non-cash derivative liabilities and corresponding reported net gains and losses arising from changes in the underlying market value of our common stock, we believe that non-GAAP earnings or loss per share provides meaningful supplemental information regarding our performance by excluding certain expenses that may not be indicative of the core business operating results and may help in comparing current-period results with those of prior periods as well as with our peers. We present this information to investors as an additional tool for evaluating our financial results in a manner that reflects ongoing operations and facilitates comparisons with operating results from prior periods. The presentation of this additional non-GAAP information is intended to provide investors with additional incremental tools for their review of our results and is not meant to be considered in isolation or as a substitute for financial information presented in accordance with GAAP.
|SOURCE Cardium Therapeutics|
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