SAN DIEGO, Aug. 15, 2011 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) today presented its financial results for the second quarter ended June 30, 2011. In addition to the announcement of second quarter 2011 financial results, Cardium reported on the Company's near-term goals and milestones including the following:(1)
Clearance from international health authorities to initiate a planned Phase 3 registration ASPIRE 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;(2)
Submission of supplemental information related to the process for manufacturing the "market ready" Excellagen™ product candidate (conducted by Scotland-based Devro Medical Limited and U.S.-based fill/finish providers), which was a key requirement for FDA 510(k) clearance; and initiation of production of commercial supplies for its Excellagen formulated bovine Type I collagen topical gel product candidate at Devro and fill/finish providers; (3)
Expansion of the Company's development-stage MedPodium health and wellness brand platform through the introduction of two new nutraceutical products: Cerex™ (to support cognitive function) and Alena™ (a carbohydrate blocker); and(4)
Consistent with Cardium's long-term business strategy, the Company continued to identify and review potential new innovative and capital-efficient companies, products, strategic partnerships and commercialization opportunities. (Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)
Second Quarter 2011 Financial HighlightsFor the second quarter ended June 30, 2011, the Company reported a loss from operations of $2.0 million, compared to a loss from operations of $2.0 million for the same period in 2010. For the six months ended June 30, 2011, net loss from operations totaled $3.8 million compared to $3.5 million for the same six month period in 2010. The second quarter 2011 financial results also include a $212,000 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 $1.3 million favorable adjustment recorded in the second quarter of 2010.
Research and development costs for the three months ended June 30, 2011 totaled $804,000 and general and administrative expenses were $1.2 million, compared to $613,000 and $1.4 million, respectively, for the same period last year. For the six month period ended June 30, 2011, research and development costs were $1.3 million and general and administrative expenses were $2.5 million, compared to $1.1 million and $2.3 million, respectively, for the same six month period of 2010.
For the second quarter ended June 30, 2011, the Company reported a net loss of $1.8 million, or $(0.02) per share, compared to a net loss of $690,000, or $(0.01) per share for the same period in 2010. For the six months ended June 30, 2011, the Company reported a net loss of $3.5 million, or $(0.04) per share, compared to a net loss for the same six month period of $1.7 million, or $(0.03) per share.
As of June 30, 2011, the Company had a total of $4.5 million in cash ($3.2 million in cash and $1.3 million in restricted cash), compared to cash of $8.0 million ($6.6 million in cash and $1.4 million in restricted cash) at December 31, 2010. As of June 30, 2011, 83.0 million shares of Cardium's common stock were outstanding.
Generx® Angiogenic Therapy During the second quarter 2011, Cardium announced that the Russian Ministry of Health provided clearance to commence a Phase 3 registration study (the ASPIRE Study) of Generx® (alferminogene tadenovec/Ad5FGF-4) at up to seven major medical centers in the Russian Federation. 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 the new therapeutic drug trade name of Cardionovo™ for marketing and sales in the Russian Federation. Generx® 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. The YouTube video "Cardium Generx Cardio-Chant" provides an overview at http://www.youtube.com/watch?v=pjUndFhJkjM.
The Generx clinical program includes four randomized placebo-controlled studies that enrolled over 650 patients at more than 100 medical centers in the U.S. and Western Europe. With published studies reflecting more than a decade of clinical experience, the ongoing clinical program and protocols have been modified to take advantage of certain key findings related to the Company's understanding of the mechanism of action of Generx and the most appropriate patient population and clinical endpoint for evaluating its role in treating myocardial ischemia. Considering the overall clinical dossier as a whole, and in view of what has been learned from the prior studies, it is expected that the ASPIRE study would confirm that Generx is highly effective for the treatment of myocardial ischemia, using SPECT imaging of blood flow under conditions of stress – which is the accepted clinical endpoint in Russia.
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.
Excellagen™ Formulated Fibrillar Collagen GelCardium recently provided an update on the status of its pending FDA 510(k) application seeking clearance from the U.S. Food and Drug Administration (FDA) to market the Company's Excellagen™ formulated bovine Type I collagen topical gel for the treatment of dermal wounds. In addition to diabetic foot ulcers, dermal wounds for which Excellagen is intended include partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.
During the second quarter 2011, Cardium submitted supplemental information related to the process for manufacturing the "market ready" Excellagen product candidate (conducted by Scotland-based Devro Medical Limited and U.S.-based fill/finish providers), which was a key requirement for clearance. Cardium also reported that it has initiated production of commercial supplies for its Excellagen product candidate at Devro and fill/finish providers. Following initial market launch, Cardium intends to transfer the final steps for formulated collagen manufacturing to a U.S.-based operation while continuing to utilize key starting materials (collagen in solution) produced and supplied by Devro. In connection with that process, the Company also expects to eventually establish its own Device Master File with the FDA's Center for Devices and Radiological Health (CDRH) covering the Company's process for manufacturing its finished 2.6% formulated fibrillar collagen gel.
The Company continues to be in discussions with potential commercialization partners for the sale of Excellagen in the U.S. and internationally and is working with potential new collaborative partners for additional product opportunities for its Excellagen formulation.
MedPodium Healthy Lifestyles Platform
During second quarter 2011, Cardium announced 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. In addition, the Company also announced the commercial launch of Alena™ (Phase 2® Extra-Strength and ChromeMate®), 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*.
Cardium 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.
Acquisition Plans Cardium continues to identify and evaluate other companies and businesses, as well as licenses covering product opportunities and technologies to acquire on favorable economic terms consistent with its long-term business strategy. The Company recently announced plans to acquire substantially all of Transdel Pharmaceuticals' business assets in connection with a proposed asset purchase with expedited review under Section 363 of the Bankruptcy Code. Transdel's major creditor had filed a declaration in favor of Cardium's proposed purchase, but subsequently opposed the sale, potentially to offer a plan of its own, which led to the court denying Transdel's motion for expedited approval. Cardium is continuing to evaluate its options with respect to the Transdel transaction and to other business opportunities currently under consideration, which is consistent with the Company's strategy of acquiring businesses with favorable valuations and clearly defined pathways to commercialization or other monetization.
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 there can be no assurance that business transactions under consideration will be completed or that our stockholder's equity can be increased and maintained to a sufficient level to satisfy ongoing compliance with the requirements of our listing stock exchange; 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 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.
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 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. *Note: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.Copyright 2011 Cardium Therapeutics, Inc. All rights reserved.
Cardium Therapeutics®, Generx®, Cardionovo™, Tissue Repair™, Gene Activated Matrix™, GAM™, Excellagen™, Excellarate™, Osteorate™, MedPodium™, Appexium™, Linee™, Alena™, Cerex™ and Nutra-Apps™ are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.
(Cereboost™ is a trademark of Naturex Inc.)
(Phase 2® is used with permission and covered by U.S. Patent # 6900174 and #6797287.)
(ChromeMate® is a registered trademark of InterHealth Nutraceuticals, Inc.)
Cardium Therapeutics, Inc.Selected Condensed Consolidated Results of OperationsThree months ended June 30,Six months ended June 30,2011201020112010Revenues$
__Research and development(803,858)(613,199)(1,295,432)(1,133,161)Selling, general and administrative(1,173,536)(1,358,870)(2,461,421)(2,319,495)Loss from operations(1,977,394)(1,972,069)(3,756,853)(3,452,656)Interest income (expense), net1,68712,1354,33615,536Change in fair value of derivative liabilities212,4011,269,610300,5711,706,980Net loss $ (1,763,306)$
(690,324)$ (3,451,946)$(1,730,140)Net loss per common share – basic and diluted$
(0.03)Weighted average common shares outstanding – basic and diluted83,097,96777,852,15483,097,96768,959,510*Please refer to the reconciliation of Non-GAAP measures included in this release.Selected Condensed Consolidated Balance Sheet DataJune 30,
2010Cash and cash equivalents$
,644,054Restricted cash1,325,0001,425,000Prepaid expenses and other current
assets146,383134,044Property and equipment, net183,718234,942Other long-term assets1,028,5811,074,035Total assets$
9,512,075Accounts payable and accrued liabilities$
,392,045$ 1,345,981Derivative liabilities272,502573,073Deferred rent144,232164,782Total liabilities1,808,7792,083,836Stockholder's equity 4,057,8227,428,239Total liabilities and stockholder's equity$
9,512,075Cardium Therapeutics, Inc.Reconciliation of Non-GAAP Measure As of June 30, 2011Three months ended June 30,Six months ended June 30,2011201020112010Net loss$
(690,324)$(3,451,946)$(1,730,140)Add (subtract)Stock based compensation expense59,009114,31381,529234,792Change in fair value of derivative liabilities(212,401)(1,269,610)(300,571)(1,706,980)Loss from discontinued operations________Non-GAAP net loss $
(1,916,698)$ (1,845,621)$ (3,675,988)$ (3,202,328)Non-GAAP net loss per common share – basic and diluted$
(0.04)Weighted average common shares outstanding – basic and diluted83,097,96777,852,15483,097,96768,959,510Non-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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