On Monday morning, Cardium Therapeutics (Amex: CXM) reported that it had submitted a modified compliance plan designed to reestablish compliance with its exchange listing requirements in view of ongoing plans related to the acquisition of a revenue-generating nutraceutical business designed to expand the Company's MedPodium product line.
In a related matter, the Company announced the incorporation of MedPodium Health Sciences, Inc., a new wholly-owned subsidiary established to develop the Company's nutraceutical and healthy lifestyle products, and to acquire complementary business assets having existing revenues and channels of distribution. The Company also announced that MedPodium Health Sciences would handle sales and distribution of Cardium's Excellagen™ product candidate pending FDA marketing clearance for its commercialization in the United States.
As reported previously, Amex officials told the company that it was considered to be noncompliant with the exchange's listing requirements based on its quarterly report for the period ended September 30, 2010, and provided that the company should submit a plan that would reestablish compliance by adding minimum "stockholders' equity" of $6.0 Million by August 26, 2011. Unlike stocks listed on the NASDAQ, the NYSE Amex does not base compliance on stock price.
Consistent with their business model, and with the recent expansion of its portfolio of science-based, easy-to-use Nutra-Apps™ lifestyle supplements known as MedPodium, Cardium has reviewed a number of potential strategic acquisitions, which would not only build stockholders' equity, but would at the same time broaden and accelerate the development of its MedPodium business as a means of enhancing near-term revenues. The Company's modified plan and request for an extension of the compliance period relates to such a proposed strategic acquisition. In the event the modified plan and request were not accepted and the exchange elected instead to initiate the next stage of procedures related to a potential delisting, then the Company would still be provided with an additional period of time in which to appeal any such determination in order to establish compliance.
"We look forward to the acquisition of new products and businesses as we expand our MedPodium product line, and we believe these have the potential to bring additional near-term revenues to complement the expected launch of our Excellagen product candidate," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium.
Officials say the company's stock will continue to trade on the exchange while these matters are considered, and throughout the period of time under which any appeal is under consideration and/or the Company is able to reestablish compliance through the completion of its proposed strategic acquisition or alternative paths for increasing stockholders' equity. The company's common stock was traded on the OTC Bulletin Board until July 2007, when the company elected to instead list its shares on the American Stock Exchange.
The BioMedReports Complete Biotech Trade Catalyst Calendar, which tracks news, SEC filings and milestones for thousands of companies in the healthcare sector shows one upcoming milestone for Cardium. The company reported a forward looking news entry on our calendar as a result of an 8K filing dated 3/26/2009. At the time of that filing, the company stated that with the completion of a Phase IIb 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.
The Excellarate™ product candidate was developed to facilitate wound closure in non-healing diabetic foot ulcers. A collagen-based topical gel, Excellarate™ employs TRC’s Gene Activated Matrix technology to locally stimulate the release of platelet-derived growth factor-B protein (PDGF-B), an important key in the human body’s wound healing process. Sustained, localized micro-release of PDGF-B by a patient’s own cells directly at the wound site is believed to stimulate angiogenesis and granulation tissue formation through the recruitment and proliferation of cells such as monocytes, fibroblasts and endothelial cells. Cardium’s Excellarate™ product candidate is initially being developed to facilitate wound closure in non-healing diabetic foot ulcers.
The Company recently reported data from the multi-center Matrix Phase 2b clinical trial of Excellarate™ for the potential treatment of patients with chronic non-healing diabetic foot ulcers. The study evaluated patients treated with the Excellarate product candidate (combination of Ad5PDGF-B and 2.6% collagen) or 2.6% collagen alone compared to patient who received only the protocol specified standard of care.
Nearly half of patients (48%) receiving a one-time Excellarate treatment had complete wound closure by 12 weeks, compared to a 31% wound closure rate for standard of care. Among combined one and two dose groups of Excellarate approximately 41% of patients achieved complete closure by 12 weeks. In addition to overall wound closures by 12 weeks, the Phase 2b study also evaluated wound closure rates and trajectories following product administration in order to assess the timing and extent of bioactivity. The data revealed that patients receiving Excellarate exhibited early and rapid wound healing responses as evidenced by substantial reductions in wound radius over the first several weeks following product administration, which responses were both greater and faster than those observed among patients that had received standard of care. For example, a 108% relative improvement (decrease in ulcer radius) compared to standard of care was observed over the first week following administration of Excellarate, and a 50% relative improvement was observed as an average over the first four weeks.
On August 18, Cardium Therapeutics announced that, it had received funds corresponding to the final USD 1.1 million payment from Royal Philips Electronics in connection with Philips' acquisition of Innercool Therapies from Cardium. The release of funds from restricted cash represents the receipt of all amounts escrowed in connection with the Innercool acquisition by Philips, less an adjustment of approximately USD 50,000 to correct for working capital revisions and costs in connection with the closing of the USD 11.25 million transaction.
Christopher J. Reinhard, Chairman and Chief Executive Officer, was scheduled to present at the Southern California Investor Conference on Monday, August 29, 2011, at 9:30 a.m. (Pacific) at the Island Hotel in Newport Beach, California. The slide presentation will be available at the Company's website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-presentations.
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