0001193125-12-241793.txt : 20120521 0001193125-12-241793.hdr.sgml : 20120521 20120521162308 ACCESSION NUMBER: 0001193125-12-241793 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20120515 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120521 DATE AS OF CHANGE: 20120521 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Cardium Therapeutics, Inc. CENTRAL INDEX KEY: 0000772320 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 840635673 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33635 FILM NUMBER: 12859075 BUSINESS ADDRESS: STREET 1: 12255 EL CAMINO REAL STREET 2: SUITE 250 CITY: SAN DIEGO STATE: CA ZIP: 92130 BUSINESS PHONE: (858) 436-1000 MAIL ADDRESS: STREET 1: 12255 EL CAMINO REAL STREET 2: SUITE 250 CITY: SAN DIEGO STATE: CA ZIP: 92130 FORMER COMPANY: FORMER CONFORMED NAME: Cadium Therapeutics, Inc. DATE OF NAME CHANGE: 20060118 FORMER COMPANY: FORMER CONFORMED NAME: CARDIUM THERAPEUTICS, INC DATE OF NAME CHANGE: 20060118 FORMER COMPANY: FORMER CONFORMED NAME: ARIES VENTURES INC DATE OF NAME CHANGE: 20000523 8-K 1 d356736d8k.htm FORM 8-K FORM 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

CURRENT REPORT

pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

DATE OF REPORT (Date of earliest event reported): May 15, 2012

001-33635

(Commission file number)

CARDIUM THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   27-0075787
(State of incorporation)   (IRS Employer Identification No.)

12255 El Camino Real, Suite 250

San Diego, California 92130

  (858) 436-1000
(Address of principal executive offices)   (Registrant’s telephone number)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


ITEM 8.01 OTHER EVENTS.

On May 15, 2012, Cardium Therapeutics, Inc. (“Cardium”) issued a press release announcing the its first quarter 2012 financial results and recent developments. On May 15, 2012, Cardium announced an agreement with UK-based Angel Biomedical Limited for Excellagen supply and planned European market expansion. On May 16, 2012, Cardium announced that certain catheter-based methods increased cardiac gene delivery as reported in a late-breaking presentation at the 2012 American Society of Gene & Cell Therapy Meeting. On May 17, 2012, Cardium announced an upcoming presentation at the Sachs Associates 2012 Science, Partner, and Investment Forum. Copies of the press releases are attached hereto as Exhibit 99.1, Exhibit 99.2, Exhibit 99.3 and 99.4, respectively, and incorporated by reference herein.

 

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.

(d) Exhibits.

 

99.1    Press Release of Cardium issued on May 15, 2012
99.2    Press Release of Cardium issued on May 15, 2012
99.3    Press Release of Cardium issued on May 16, 2012
99.4    Press Release of Cardium issued on May 17, 2012


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    CARDIUM THERAPEUTICS, INC.
Date: May 21, 2012     By:  

/s/ Christopher J. Reinhard

      Christopher J. Reinhard
      Chief Executive Officer
EX-99.1 2 d356736dex991.htm PRESS RELEASE PRESS RELEASE

Exhibit 99.1

 

LOGO

Press / Investor Contact:

Bonnie Ortega

Director, Investor/Public Relations

Cardium Therapeutics, Inc.

Tel: (858) 436-1018

Email: InvestorRelations@cardiumthx.com

CARDIUM PRESENTS FIRST QUARTER 2012 FINANCIAL RESULTS

AND RECENT DEVELOPMENTS

SAN DIEGO, CA – May 15, 2012 – Cardium Therapeutics (NYSE Amex: CXM) today presented its financial results for the first quarter ended March 31, 2012, and other recent developments.

In addition to the announcement of first quarter 2012 financial results, Cardium reported its goals for 2012, which were outlined in the year-end report, and include (1) plans to advance commercialization of its new Excellagen® advanced, physician-use wound care product through strategic partners in the U.S., as well as internationally; (2) develop new product extensions based on Excellagen’s formulated collagen product platform for additional wound healing applications; (3) advance of its ASPIRE Generx® clinical study at leading medical centers in the Russian Federation for patients with advanced coronary disease; (4) introduce additional product line extensions and broaden national distribution of the Company’s MedPodium® healthy lifestyle product platform; and (5) continue 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.

First Quarter 2012 Financial Highlights

The Company’s research and development costs for the three months ended March 31, 2012 totaled $1.2 million and selling, general and administrative expenses were $1.5 million, compared to $492,000 and $1.3 million, respectively, for the same period last year. The increase in expenses related to development costs associated with testing and validation of our Excellagen product, the initiation of the Generx ASPIRE study, and marketing efforts for the new FDA-cleared Excellagen product and the MedPodium Nutra-Apps® product line. Revenue for the three months ended March 31, 2012 totaled $20,000 and was generated from the initial distribution of MedPodium Nutra-Apps products.

For the first quarter ended March 31, 2012, the Company reported a loss from operations of $2.7 million, compared to a loss from operations of $1.8 million for the same period in 2011. The increase in net cash used in operating activities was due primarily to testing and validation costs for the initial inventory of the Company’s Excellagen product. For the first quarter ended March 31, 2012, the Company reported a net loss of $2.6 million, or $(0.02) per share, compared to a net loss


of $1.7 million, or $(0.02) per share for the same period in 2011. As of March 31, 2012, the Company had a total of $9.1 million in cash compared to $4.7 million at the end of December 31, 2011. As of March 31, 2012, 119.6 million shares of Cardium’s common stock were outstanding.

Excellagen Commercialization Plans

In the first quarter 2012, the Company announced the U.S. introduction of Excellagen and a logistics and cold chain agreement with Smith Medical Partners. Cardium’s new and unique Excellagen product is a high molecular weight, sterile, professional use, Type-I bovine collagen topical gel supplied in ready-to-use, prefilled, single-use syringes. Cardium received FDA 510(k) clearance for marketing and sales in the U.S. of its Excellagen professional-use, sterile, syringe-based wound care product for the management of diabetic foot ulcers, pressure ulcers and other dermal wounds in fourth quarter 2011. Excellagen is intended for physician use following debridement procedures, and is engineered to support a favorable wound healing environment for non-healing lower extremity ulcers in diabetic patients. Excellagen’s viscosity optimized biocompatible gel formulation requires application at only one or two week intervals. It is recommended that Excellagen be applied following debridement in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors. Cardium’s market research indicates that physicians seek easy-to-use products to reduce preparation time and facilitate product application, and Excellagen’s syringe-based collagen gel requires no thawing or mixing. Because of its specialized formulation, only a thin layer needs to be applied over the wound area, and one syringe containing 0.5 cc of Excellagen covers wounds up to 5 cm2 in size using the supplied 24-gauge sterile, single-use flexible applicator tip. To learn more about Excellagen and for product ordering information, please visit http://www.excellagen.com and view the informational video, Excellagen: A New Wound Care Pathway for Diabetic Foot Ulcers, at http://www.youtube.com/watch?v=D2GYCYc_8JE.

Consistent with Cardium’s business strategy (and similar to the business strategy for the Company’s InnerCool operating unit, which was sold to Philips Electronics), Cardium does not plan to establish an extensive sales force, but rather, following Excellagen’s initial market introduction, to look to strategic commercialization partners with existing sales and marketing forces in the U.S., as well as internationally. In line with this strategy, during first quarter 2012, the Company announced an agreement for the sale and distribution of Excellagen in South Korea, which represents the first of what Cardium plans to be a series of marketing and distribution agreements with commercialization partners in the U.S. and other markets. Initial market introduction includes educating physicians and wound care clinics about Excellagen through direct mailing, advertising in trade publications, building a network of key opinion leaders, web outreach to both physicians and patients, and exhibiting at medical trade shows. During the first quarter, the Company exhibited Excellagen at the APWCA (American Professional Wound Care Association) 2012 Meeting and this month exhibited Excellagen at the SAWC Symposium on Advanced Wound Care Meeting in Atlanta, GA.

Generx Commercial Development Plans

During first quarter 2012, Cardium announced the initiation of the ASPIRE Phase 3 registration study to evaluate the therapeutic effects of its lead product candidate, Generx (Ad5FGF-4) in patients with myocardial ischemia due to coronary artery disease. The ASPIRE study, a 100-patient, randomized and controlled multi-center study to be conducted at up to six leading cardiology centers in the Russian Federation, is designed to further evaluate the safety and


effectiveness of Cardium’s Generx DNA-based angiogenic product candidate, which has already been tested in clinical studies involving 650 patients at more than one hundred medical centers in the U.S., Europe and elsewhere. The efficacy of Generx will be quantitatively assessed using rest and stress SPECT myocardial imaging (Single-Photon Emission Computed Tomography) to sensitively measure improvements in microvascular cardiac perfusion following a one-time, non-surgical, catheter-based administration of Generx. The Russian Health Authority has assigned Generx the therapeutic drug trade name of Cardionovo™ for marketing and sales in Russia. Additional information about the Generx ASPIRE study is available at http://clinicaltrials.gov/ct2/show/NCT01550614?term=cardium&rank=1.

Preclinical research conducted at Emory University provides further support for the apparent safety and effectiveness of Generx as a potential one-time non-surgical approach to the treatment of coronary heart disease. This important study demonstrated that induced transient ischemia, using a standard angioplasty balloon catheter, combined with the intracoronary co-infusion of nitroglycerin, substantially enhanced adenovector-mediated gene expression in the heart. Use of these newly applied gene transfer techniques increased the efficiency of gene transfer in preclinical studies by more than two orders of magnitude (p<0.001). These findings have been incorporated into the protocol for the ASPIRE study and the new data underscore the expected benefit of Cardium’s improved adenovector administration methods. Use of combined non-surgical, percutaneous balloon catheter-based delivery with transiently-induced ischemia and nitroglycerin to enhance uptake is expected to lead to improved microvascular circulation in the heart. By increasing gene transfer efficiency, this modified delivery approach allows maximizing targeted expression of FGF-4 protein within the ischemic heart of all treated patients, where the resulting angiogenesis or blood vessel growth can bring about improved blood flow. Traditional interventional approaches such as coronary artery bypass surgery (CABG) or angioplasty and stenting (PCI), not only require invasive and costly surgical procedures but they can only directly target selected vulnerable spots in larger vessels that are susceptible to treatment and reachable through mechanical intervention.

Additional information about Generx and the ASPIRE study is available in a Company presentation titled, Generx Angiogenic Therapy: Regenerative Medicine for Interventional Cardiology, at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-presentations and by viewing, “Cardium Generx Cardio-Chant” at http://www.youtube.com/watch?v=pjUndFhJkjM.

MedPodium’s Healthy Lifestyle Brand

During first quarter 2012, Cardium partnered with Nutritional Productions International (NPI) and InHealth Media to market the MedPodium brand and distribute Nutra-Apps products to retail and online outlets across the U.S. MedPodium’s Neo-Energy® is a dietary supplement capsule that provides a customized blend of natural caffeine, green tea leaf extract and Vitamin B3 (Niacin). Each of Neo-Energy’s small, easy-to-use capsules provides an amount of caffeine comparable to commonly-sold energy shots or a premium coffee, or multiple cans (about 20 ounces) of various energy drinks. A pocket-sized pack containing four Neo-Energy capsules will be sold for approximately the same retail price as a single liquid energy shot or beverage. In addition, Neo-Energy capsules have no sugar, no calories, and no aftertaste as commonly found in various drinks.*

MedPodium’s new Neo-Carb Bloc® is a dietary supplement that features a custom formulation of maximum strength Phase 2™, a white kidney bean extract that has been clinically studied and shown to reduce the enzymatic digestion of dietary starches contained in many carbohydrate-rich foods such as pastas, rice, crackers, breads, pastries, potato chips, and donuts.*


Sold in convenient, pocket-sized packages of two small, easy-use capsules, Neo-Carb Bloc is designed to selectively reduce the uptake of the types of carbohydrates found in many starchy foods, without blocking the absorption of “good” simple carbohydrates such as those derived from vegetables and whole grains.* For information about MedPodium’s healthy lifestyle products, please visit www.medpodium.com. A new Nutra-Apps video, “Nutra-Apps: Fuel your Lifestyle”, is at http://www.youtube.com/watch?v=BtGqfI0Vfvs.

Financial Highlights

In first quarter 2012, Cardium reported that it had received notice from NYSE Regulation that the Company is now considered to have resolved the listing deficiencies referenced in the NYSE Amex LLC’s letter dated November 26, 2010, as previously reported, and that it had regained compliance with the corresponding requirements of the Exchange. The Exchange indicated that as with all listed issuers, the Company’s continued listing eligibility will continue to be assessed on an ongoing basis and that the Company is subject to the provisions of Section 1009(h) of the NYSE Amex Company Guide, which may be accessed at www.nyse.com/regulation.

During first quarter 2012, the Company completed a registered direct equity financing with three institutional and accredited investors for net proceeds of approximately $4.5 million, after deducting placement agent’s fees and estimated offering expenses. The investors purchased an aggregate of 17.9 million shares of the Company’s common stock for a price of $0.28 per share with no warrant coverage. In addition, during the first quarter, the Company sold 5.2 million shares of common stock in at-the-market transactions for net proceeds of $1.9 million. Under the terms of the Securities Purchase Agreement dated February 12, 2012, Cardium cannot issue common stock for cash consideration involving a variable rate transaction or issue common stock under its at-the-market sales agreement with Brinson Patrick Securities for a period of six months from the date of the agreement or until the date which our average stock price has exceeded $0.40 for 20 consecutive trading days.

About Cardium

Cardium is a health sciences and regenerative medicine company focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering and other economic monetizations. Cardium’s current medical opportunities portfolio, which is focused on health sciences and regenerative medicine, includes the Tissue Repair Company, Cardium Biologics, and the Company’s in-house MedPodium Health Sciences healthy lifestyle product platform. The Company’s lead commercial product Excellagen™ topical gel for wound care management recently received FDA clearance for marketing and sale in the United States. 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 artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. 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


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 in actual use; that new clinical studies will be successful or will lead to approvals or clearances from health regulatory authorities, or that approvals in one jurisdiction will help to support studies or approvals elsewhere; that the company can attract suitable commercialization partners for our products or that we or partners can successfully commercialize them; that our product 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 or blocked by third party proprietary rights or other means; that the products and product candidates referred to in this report or in our other reports will be successfully commercialized or will enhance our market value; that new product opportunities or commercialization efforts will be successfully established; that third parties on whom we depend will perform as anticipated; that we can raise sufficient capital from partnering, monetization or other fundraising transactions to maintain our stock exchange listing or adequately fund ongoing operations; or that we will not be adversely affected by these or other risks and uncertainties that could impact our operations, business or other matters, as described in more detail in our filings 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 2012 Cardium Therapeutics, Inc. All rights reserved.

For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics, Generx®, Cardionovo, Tissue Repair, Gene Activated Matrix, GAM, Excellagen™, Excellarate, Osteorate, MedPodium, Appexium, Linée, Alena, Cerex, D-Sorb, Neo-Energy®, Neo-Carb Bloc®, Neo-Chill, and Nutra-Apps® are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.

*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.

- Continued -


Cardium Therapeutics, Inc.

Selected Condensed Consolidated Results of Operations

As of March 31, 2012

 

   

    Three Months Ended March 31,    

 
        2012     2011  

Revenues

        $ 20,478                   $ —          

Cost of goods sold

      5,455                 —          
   

 

 

   

 

 

 

Gross profit

      15,023                 —          
   

 

 

   

 

 

 

Research and development

      (1,164,599)                (491,574)       

Selling, general and administrative

      (1,509,761)                (1,287,885)       
   

 

 

   

 

 

 

Loss from operations

      (2,659,337)                (1,779,459)       
   

 

 

   

 

 

 

Interest income (expense), net

      1,144                 2,649        
Change in fair value of derivative liabilities       64,157                 88,170        
   

 

 

   

 

 

 

Net loss

      $ (2,594,036)               $ (1,688,640)        
   

 

 

   

 

 

 
Net loss per common share – basic and diluted       $ (0.02)               $ (0.02)       
   

 

 

   

 

 

 
Weighted average common shares outstanding – basic and diluted       109,279,152                 83,097,967       

Selected Condensed Consolidated Balance Sheet Data

 

            March 31,        
2012
        December 31,    
2011
 

Cash and cash equivalents

    $ 9,070,522                $ 4,721,279           

Restricted cash

    50,000                200,000           

Accounts receivable

    17,546                —            

Inventory

    521,657                434,130           

Prepaid expenses and other current assets

    111,266                68,204           

Property and equipment, net

    111,701                135,581           

Other long-term assets

    1,910,433                1,944,035           
 

 

 

   

 

 

 

Total assets

    $ 11,793,125                $ 7,503,229           
 

 

 

   

 

 

 

Accounts payable and accrued liabilities

    $ 1,690,399                $ 1,214,480           

Derivative liabilities

    —                85,506           

Long-term liabilities

    105,353                118,313           
 

 

 

   

 

 

 

Total liabilities

    1,795,752                1,418,299           
 

 

 

   

 

 

 

Stockholder’s equity

    9,997,373                6,084,930           
 

 

 

   

 

 

 

Total liabilities and stockholder’s equity

    $ 11,793,125                $ 7,503,299           
 

 

 

   

 

 

 


Cardium Therapeutics, Inc.

Reconciliation of Non-GAAP Measure

As of March 31, 2012

 

    Three Months Ended March 31,  
    2012     2011  

Net Loss

      $  (2,594,036)                $ (1,688,640)     

Add (subtract)

   

Stock-based compensation expense

    43,239               33,915        

Change in fair value of derivative liabilities

    (64,157)              (88,170)       
 

 

 

   

 

 

 

Non-GAAP net loss

     $   (2,614,954)               $   (1,742,895)     
 

 

 

   

 

 

 
Non-GAAP net loss per common share – basic and diluted     $ (0.02)              $ (0.02)     
 

 

 

   

 

 

 
Weighted average common shares outstanding – basic and diluted     109,279,152            83,097,967     

Non-GAAP Financial Measure

To 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 non-cash items: stock-based compensation, change in fair value of derivative liabilities and gain on exchange of warrants.

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.

EX-99.2 3 d356736dex992.htm PRESS RELEASE PRESS RELEASE

Exhibit 99.2

 

LOGO

 

Press / Investor Contact:

 

Sales/Marketing Contact:

Bonnie Ortega

 

Sarah Dennison

Director, Investor/Public Relations

 

Director, Marketing and Sales

Cardium Therapeutics, Inc.

 

Cardium Therapeutics, Inc.

Tel: (858) 436-1018

 

Tel: (858) 436-1005

Email: InvestorRelations@cardiumthx.com

 

Email: SDennison@cardiumthx.com

CARDIUM ANNOUNCES AGREEMENT WITH UK-BASED ANGEL BIOMEDICAL FOR EXCELLAGEN SUPPLY AND PLANNED EUROPEAN MARKET EXPANSION

SAN DIEGO, CA – May 15, 2012 – Cardium Therapeutics (NYSE Amex: CXM) today announced an agreement with UK-based Angel Biomedical Limited, a subsidiary of Angel Biotechnology Holdings plc (AIM: ABH), a global biopharmaceutical contract manufacturer, covering the manufacture of formulated collagen for Cardium’s Excellagen® product, which was recently cleared for marketing by the U.S. Food and Drug Administration (FDA). Excellagen is a professional-use high molecular weight fibrillar bovine Type I topical gel (2.6%) specifically engineered as an adjunct to debridement for the management of diabetic foot ulcers and other dermal wounds.

In addition to the manufacturing of Excellagen’s formulated collagen, Angel Biomedical Ltd will assist Cardium to facilitate filing for a CE Mark of Excellagen for marketing and sale in the European Union and in other countries recognizing CE Mark approval. Additionally, Angel Biomedical will assist Cardium in establishing its own Device Master File with the FDA’s Center for Devices and Radiological Health covering the process for manufacturing the Company’s Excellagen formulated fibrillar collagen gel.

“We are pleased to announce the agreement with Angel following Angel’s recent asset purchase of our current collagen manufacturing facility located in Glasgow, Scotland. This new agreement is a logical next step that provides for ongoing and future supply of the specialized formulated collagen used to support Excellagen’s commercialization activities, and also positions Cardium for the planned expansion of Excellagen commercialization into European and other markets,” stated Christopher J. Reinhard, Chairman and CEO of Cardium Therapeutics.

“The team at Angel is excited by this new partnership to provide Cardium’s formulated high molecular weight collagen. We look forward to the commercial manufacture of Cardium’s Excellagen advanced wound care product and to facilitate its CE marking to assist Cardium expand its global distribution opportunities,” stated Dr. Stewart White, Acting Chief Executive Officer of Angel Biotechnology.


About Excellagen

Excellagen is an FDA-cleared highly-refined fibrillar collagen-based topical gel (2.6%) designed to support favorable wound care management. Excellagen’s unique high molecular weight sterile collagen formulation is topically applied through easy-to-control, pre-filled, single use syringes. Excellagen is intended for physician use following surgical debridement procedures, and is engineered to support a favorable wound healing environment for non-healing lower extremity ulcers in diabetic patients. Excellagen’s viscosity-optimized biocompatible gel formulation requires application at only one or two week intervals. It is recommended that Excellagen be applied following surgical debridement in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors.

Cardium’s market research indicates that physicians seek easy-to-use products to reduce preparation time and facilitate product application - and Excellagen’s unique, ready-to-use syringe-based collagen gel requires no thawing or mixing. Because of its specialized formulation, only a thin layer needs to be applied over the wound area, and one syringe containing 0.5 cc of Excellagen covers wounds up to 5cm2 in size using the supplied 24-gauge sterile, single-use flexible applicator tip. To learn more about new Excellagen and for product ordering information, please visit http://www.excellagen.com/physician-purchase-information.html and view the information video, Excellagen: A New Wound Care Pathway for Diabetic Foot Ulcers, at http://www.excellagen.com/excellagen-video.html.

About Angel Biotechnology/Angel Biomedical

Angel Biotechnology Holdings plc (AIM: ABH), is a full service contract bio-manufacturing partner to biotechnology and pharmaceutical companies worldwide. Angel specializes in advanced biologics including biopharmaceutical proteins and cell therapies, such as cellular vaccines and stem cells.

Angel has three U.K. facilities: Pentlands Science Park near Edinburgh, Cramlington, near Newcastle-upon-Tyne, and Angel Biomedical Limited encompassing its new collagen manufacturing operation in Glasgow, Scotland. More information is available at www.angelbio.com.

About Cardium

Cardium is a health sciences and regenerative medicine company focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering and other economic monetizations. Cardium’s current medical opportunities portfolio, which is focused on health sciences and regenerative medicine, includes the Tissue Repair Company, Cardium Biologics, and the Company’s in-house MedPodium Health Sciences healthy lifestyle product platform. The Company’s lead commercial product Excellagen® topical gel for wound care management, has recently received FDA clearance for marketing and sale in the United States. 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 artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. 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 Angel can effectively and efficiently manufacture collagen to support Excellagen commercialization; that we can successfully introduce Excellagen into wound care markets for the treatment of diabetic foot ulcers or other dermal wounds; that we can obtain a CE Mark for marketing and sale in the European Union and other countries recognizing CE Mark approval; that we can establish our own Device Master File with the FDA’s Center for Devices and Radiological Health covering the Company’s process for manufacturing Excellagen; that we can attract suitable commercialization partners for our products or that such partners will successfully commercialize our products; that our exchange listing compliance can be maintained; that our product or product candidates will not be unfavorably compared to other competitive products that may be regarded as safer, more effective, easier to use or less expensive; that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures or in actual use; that clinical studies and regulatory clearances even if successful will lead to product advancement or partnering; that that FDA or other regulatory clearances or other certifications, or other commercialization efforts 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; that new collaborative partners will be found; that additional product opportunities will be established; or that 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.

Copyright 2012 Cardium Therapeutics, Inc. All rights reserved.

For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics, Generx®, Cardionovo, Tissue Repair, Gene Activated Matrix, GAM, Excellagen®, Excellarate, Osteorate, MedPodium®, Appexium®, Linée, Alena, Cerex®, D-Sorb, Neo-Energy®, Neo-Carb Bloc®, Neo-Chill®, and Nutra-Apps® are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.

EX-99.3 4 d356736dex993.htm PRESS RELEASE PRESS RELEASE

Exhibit 99.3

 

LOGO

Press / Investor Contact:

Bonnie Ortega

Director, Investor/Public Relations

Cardium Therapeutics, Inc.

Tel: (858) 436-1018

Email: InvestorRelations@cardiumthx.com

CARDIUM REPORTS NEW CATHETER-BASED METHODS SIGNIFICANTLY

BOOST CARDIAC GENE DELIVERY IN LATE-BREAKING PRESENTATION

AT 2012 AMERICAN SOCIETY OF GENE & CELL THERAPY MEETING

SAN DIEGO, CA – May 16, 2012 – Cardium Therapeutics (NYSE MKT: CXM) today announced a late-breaking poster presentation at the American Society of Gene & Cell Therapy (ASGCT) 15th Annual Meeting being held May 16-19, 2012 at the Pennsylvania Convention Center in Philadelphia, PA.

The new research findings demonstrate that cardiac ischemia plays an important role in adenovector gene transfection (delivery) in mammalian hearts. Based on this understanding, using a standard balloon angioplasty catheter, researchers have developed and tested a new method to induce transient ischemia during a non-surgical interventional cardiac procedure, which when coupled with the infusion of nitroglycerin, boosts the delivery (cell transfection) of an adenovector gene construct into heart cells. The increase in adenovector-based gene transfection with the new technique is over two orders of magnitude (>100 fold).

Cardium’s new method of adenovector delivery takes advantage of the findings that transient ischemia appears to alter the permeability barrier of the vascular endothelium and may expose the blood to the coxsackie-adenovirus receptor mediating adenovector uptake by the heart. Balloon angioplasty catheters have been used for many years to dilate blocked coronary arteries, sometimes with use of a stent, and these catheters have also been used safely by cardiologists in patients with coronary artery disease to study the effects of brief ischemia. Cardium’s new technique inflates the balloon in non-narrowed areas, and only enough to briefly interrupt flow using inflation pressure that is less than that used for performing angioplasty.

Cardium’s recently initiated Russian-based ASPIRE Phase 3 / registration clinical study uses transient ischemia techniques during non-surgical percutaneous catheterization with a standard angioplasty catheter together with the intracoronary infusion of nitroglycerin with the Generx® [Ad5FGF-4] product candidate for the treatment of patients with myocardial ischemia and stable angina pectoris. These patients have atherosclerotic coronary artery disease, and the Company’s Generx product candidate is intended to stimulate the growth of new or additional collateral blood vessels to bypass blockages.


These studies were conducted at Emory University School of Medicine, led by Jakob Vinten-Johnasen, PhD., and co-sponsored by a Small Business Innovative Research grant from the National Institutes of Health (Cardium Therapeutics) and the Carlyle Fraser Heart Center (Emory). At the conference Gabor M. Rubanyi, MD, PhD, Cardium’s Chief Scientific Officer, will present the late-breaking poster entitled “Transient Ischemia is Necessary for Efficient Adenovector Gene Transfer in the Heart”, on May 17, 2012 from 3:00 to 5:30 p.m. in Exhibit Hall A. The poster presentation can be viewed at http://www.cardiumthx.com/pdf/Generx-ASGCT-Poster-Presentation-May-2012.pdf.

In addition, Dr. Rubanyi will also make an oral presentation titled: “New Perspectives for Angiogenic Gene Therapy to Treat Myocardial Ischemia in Patients with Coronary Disease” to attendees at the ASGCT Meeting today, May 16. The presentation will provide a historical overview of the Generx clinical development program and how these new and important preclinical findings have been incorporated into the protocol for the 100-patient Generx ASPIRE Phase 3 registration study which was recently initiated in the Russian Federation for patients with myocardial ischemia and stable angina pectoris. The presentation is now available for viewing at http://www.cardiumthx.com/pdf/Generx-ASGCT-May-2012-Rubanyi.pdf.

About Generx and the ASPIRE Study

Generx (Ad5FGF-4) is a disease-modifying regenerative medicine biologic that is being developed to offer a one-time, non-surgical option for the treatment of myocardial ischemia in patients with stable angina due to coronary artery disease, who might otherwise require surgical and mechanical interventions, such as coronary artery by-pass surgery or balloon angioplasty and stents. Similar to surgical/mechanical revascularization approaches, the goal of Cardium’s Generx product candidate is to improve blood flow to the heart muscle – but to do so non-surgically, following a single administration from a standard balloon angioplasty catheter. The video “Cardium Generx Cardio-Chant” provides an overview Generx and can be viewed at http://www.youtube.com/watch?v=pjUndFhJkjM.

In March 2012, Cardium reported on the ASPIRE Phase 3 registration study to evaluate the therapeutic effects of its lead product candidate, Generx in patients with myocardial ischemia due to coronary artery disease. The ASPIRE study, a 100-patient, randomized and controlled multi-center study to be conducted at up to eight leading cardiology centers in the Russian Federation, is designed to further evaluate the safety and effectiveness of Cardium’s Generx DNA-based angiogenic product candidate, which has already been tested in clinical studies involving 650 patients at more than one hundred medical centers in the U.S., Europe and elsewhere. The efficacy of Generx will be quantitatively assessed using rest and stress SPECT (Single-Photon Emission Computed Tomography) myocardial imaging to sensitively measure improvements in microvascular cardiac perfusion following a one-time, non-surgical, catheter-based administration of Generx.

The Cedars-Sinai Medical Center Nuclear Cardiology Core Laboratory in Los Angeles, California, will serve as the central core lab for the ASPIRE study and will be responsible for the analysis of SPECT myocardial imaging data electronically transmitted from the Russian medical centers participating in the ASPIRE study. Advanced Biosciences Research, an affiliate of bioRASI which is a global clinical research organization, is Cardium’s Russian sponsor and development partner and is responsible for the ASPIRE program management and regulatory


compliance. The Russian Health Authority has assigned Generx the therapeutic drug trade name of Cardionovo™ for marketing and sales in Russia. Information about the ASPIRE study is available at http://clinicaltrials.gov/ct2/show/NCT01550614?term=cardium&rank=1.

About Cardium

Cardium is a health sciences and regenerative medicine company focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering and other economic monetizations. Cardium’s current medical opportunities portfolio, which is focused on health sciences and regenerative medicine, includes the Tissue Repair Company, Cardium Biologics, and the Company’s in-house MedPodium Health Sciences healthy lifestyle product platform. The Company’s lead commercial product Excellagen™ topical gel for wound care management recently received FDA clearance for marketing and sale in the United States. 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 artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. 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 enhancements in the uptake of adenovectors can be successfully applied to improve the uptake or therapeutic effects of Generx in human patients; that Generx can be successfully advanced in clinical studies outside of the U.S.; 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 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 regulatory or commercialization activities of Generx in the U.S. or other markets; that the ASPIRE clinical study will be successful or will lead to approval of Generx by the Russian Health Authority for marketing and sales in Russia or lead to approvals in other countries of the Commonwealth of Independent States; that additional clinical evidence regarding the safety and effectiveness of Generx that might be obtained in Russia would be useful for optimizing and broadening commercial development pathways in other industrialized countries; 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; that 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.

Copyright 2012 Cardium Therapeutics, Inc. All rights reserved.

For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics, Generx®, Cardionovo, Tissue Repair, Gene Activated Matrix, GAM, Excellagen®, Excellarate, Osteorate, MedPodium®, Appexium®, Linée, Alena, Cerex®, D-Sorb, Neo-Energy®, Neo-Carb Bloc®, Neo-Chill, and Nutra-Apps® are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.

EX-99.4 5 d356736dex994.htm PRESS RELEASE PRESS RELEASE

Exhibit 99.4

 

LOGO

Investor Contact:

Bonnie Ortega

Director, Investor/Public Relations

Cardium Therapeutics, Inc.

Tel: (858) 436-1018

Email: InvestorRelations@cardiumthx.com

CARDIUM TO PRESENT AT SACHS ASSOCIATES 2012 SCIENCE, PARTNER, AND INVESTMENT FORUM: GATEWAY FOR THE GLOBAL LIFE SCIENCES

SAN DIEGO, CA – May 17, 2012 – Cardium Therapeutics (NYSE MKT: CXM) today announced that Christopher J. Reinhard, Chairman & CEO will present a corporate overview and participate in a Regenerative Medicine Panel being held at the Sachs Associates 2012 Science, Partner, and Investment Forum: Gateway for the Global Life Sciences in West Palm Beach, FL May 21 – 22, 2012. The Regenerative Medicine Panel, chaired by Bernard Siegel, Executive Director, Genetics Policy Institute and Jeffrey Cohen, Director, Ladenburg Thalmann & Co, Inc., will take place on May 22 at 9:15 a.m. ET and Cardium’s investor presentation is scheduled for 10:40 a.m. ET on the same day in Ballroom B.

An updated investor presentation is now available on Cardium’s website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-presentations.

About Cardium

Cardium is a health sciences and regenerative medicine company focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering and other economic monetizations. Cardium’s current medical opportunities portfolio, which is focused on health sciences and regenerative medicine, includes the Tissue Repair Company, Cardium Biologics, and the Company’s in-house MedPodium Health Sciences healthy lifestyle product platform. The Company’s lead commercial product Excellagen™ topical gel for wound care management recently received FDA clearance for marketing and sale in the United States. 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 artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. 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 or the referenced investor presentation 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 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 in actual use; that new clinical studies will be successful or will lead to approvals or clearances from health regulatory authorities, or that approvals in one jurisdiction will help to support studies or approvals elsewhere; that the company can attract suitable commercialization partners for our products or that we or partners can successfully commercialize them; that our product 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 or blocked by third party proprietary rights or other means; that the products and product candidates referred to in this report or in our other reports will be successfully commercialized or will enhance our market value; that new product opportunities or commercialization efforts will be successfully established; that third parties on whom we depend will perform as anticipated; that we can raise sufficient capital from partnering, monetization or other fundraising transactions to maintain our stock exchange listing or adequately fund ongoing operations; or that we will not be adversely affected by these or other risks and uncertainties that could impact our operations, business or other matters, as described in more detail in our filings 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 2012 Cardium Therapeutics, Inc. All rights reserved.

For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics, Generx®, Cardionovo, Tissue Repair, Gene Activated Matrix, GAM, Excellagen®, Excellarate®, Osteorate, MedPodium®, Appexium®, Linée, Alena, Cerex®, D-Sorb, Neo-Energy®, Neo-Carb Bloc®, Neo-Chill, and Nutra-Apps® are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.

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