Thursday, July 5, 2012

Cardium Therapeutics, Inc. (CXM): Gearing Up For Growth

Cardium Therapeutics is a small biotech company focused on the acquisition and strategic development of new and innovative bio medical opportunities that have the potential to address unmet medical needs. Since Cardium was initially funded in October 2005, the Company has made three strategic acquisitions, sold one business unit, and developed an in-house nutraceutical product line. Cardium continues to identify and evaluate businesses, product opportunities and technologies for potential acquisition on favorable economic terms consistent with the Company’s long-term business strategy.

Cardium currently operates in three primary business lines:

(1) Biologics business that develops innovative cardiovascular product candidates. Generx has advanced to a late-stage Phase 3 registration study for patients with coronary artery disease.

(2) Tissue Repair Company is a subsidiary that is developing and commercializing a late-stage line of regenerative medicine product candidates. Excellagen is the FDA cleared lead product for this business.

(3) MedPodium Health Sciences is a subsidiary that is developing a line of nutraceuticals and other healthy lifestyle products. MedPodium Nutra-Apps were launched in December 2011. Nutra-Apps are small, pharmaceutically-sealed, easy-use capsules in pocket-sized packaging designed for the spontaneous and multi-tasking lifestyles of Millennials.

As of March 31, 2012, Cardium had $9.1 million in cash and cash equivalents and no outstanding debt. Working capital, which is defined as total current assets less total current liabilities, was $8.1 million. As of March 31, 2012, 119.6 million shares of Cardium’s common stock were outstanding. For the three months ended March 31, 2012, Cardium reported a loss from operations primarily due to research and development costs of $1.2 million, and selling, general and administrative expenses of $1.5 million.

Following the FDA clearance of Excellagen, Cardium entered into agreements with international partners to manufacture, sell, market, and distribute the product in South Korea and Russia and the nine additional member countries comprising the Commonwealth of Independent States. Cardium also plans for the expansion of Excellagen into the European Union consisting of 27 member countries through the CE Mark registration process. Cardium does not plan to establish an extensive sales force, but rather, will partner with entities that have existing sales and marketing forces. Cardium introduced Excellagen to the U.S. market in late March 2012; and with cold chain logistics in place with Smith Medical Partners, Excellagen can begin to provide a benefit to a growing patient population.

Excellagen topical wound gel for wound care management is used for diabetic foot ulcers and other dermal wounds. Foot ulcers from diabetes can lead to amputation of the feet and legs. For doctors, the product is simple and easy to use since it comes in pre-filled syringes and requires no thawing or mixing, and requires no sutures or staples. Following FDA clearance, Cardium conducted additional studies showing that Excellagen can activate human platelets to trigger the release of Platelet-Derived Growth Factor (PDGF), which is recognized as an important wound healing facilitator.

In addition, Cardium recently entered into a national distribution agreement that will expand the availability of MedPodium Nutra-Apps across the U.S. The MedPodium Nutra-Apps products are also available on RevNutrition.com, a website that many consumers turn to for the premium vitamins and supplements. The Nutra-Apps that are currently available include: Neo-Energy, a dietary supplement capsule that provides an amount of caffeine comparable to commonly-sold energy shots or a premium coffee; Neo-Carb Bloc, a dietary supplement has been shown to reduce the enzymatic digestion of dietary starches; and Neo-Chill, a dietary supplement capsule that promotes an alert state of relaxation.

Cardium’s lead clinical development product candidate, Generx, is a DNA-based angiogenic biologic intended for the treatment of patients with myocardial ischemia due to coronary heart disease. Generx is currently being developed for international markets outside the United States as a treatment alternative for patients who may not have access to costly and invasive advanced care revascularization procedures, including coronary artery bypass surgery and angioplasty/stents, or may not be optimal candidates for these procedures. In early 2012, Cardium initiated its ASPIRE Phase 3 registration study at leading medical centers in the Russian Federation for patients with advanced coronary disease.

Cardium is dedicated to building on its core products and product candidates to continually create new opportunities for greater success. Leveraging the advantages of its capital-efficient, asset-based business strategy, the company provides a diversified and more balanced portfolio of risk/return opportunities with the chief objective of providing long-term shareholder value.

Key Investment Highlights

Diversified Portfolio of Medical Products with Large Market Potentials
Phase 3 Registration Study Underway for DNA-based Generx Product Candidate
U.S. and International Commercialization Agreements for FDA-Cleared Excellagen Product
Roll out of MedPodium Nutra-Apps Products across the U.S.
Company Continues to Evaluate New Products and Technologies to Expand Portfolio


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