UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2013March 31, 2014

or

 

¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number: 001-33635

 

 

TAXUS CARDIUM THERAPEUTICS,PHARMACEUTICALS GROUP INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 27-0075787
(State of incorporation) 

(IRS Employer

Identification No.)

11750 Sorrento Valley Rd, Suite 250

San Diego, California 92121

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

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that Cardiumthe registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer¨ Accelerated filer  ¨  Non-acceleratedAccelerated filer¨ ¨
Non-accelerated filer¨Smaller reporting companyx

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.):    Yes  ¨    No  x

As of November 10, 2013,May 14, 2014, the registrant had 8,175,67411,982,988 shares of common stock outstanding.


TABLE OF CONTENTS

Page

EXPLANATORY NOTE

1

SPECIAL NOTE ABOUT FORWARD-LOOKING STATEMENTS

1
PART 1FINANCIAL INFORMATION

Item 1.

Financial Statements (Unaudited)

Condensed Consolidated Balance Sheets

3

Condensed Consolidated Statements of Operations

4

Condensed Consolidated Statements of Cash Flows

5

Notes to Condensed Consolidated Financial Statements

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations15

Item 3.

Quantitative and Qualitative Disclosures About Market Risk20

Item 4.

Controls and Procedures20
PART IIOTHER INFORMATION20

Item 1.

Legal Proceedings20

Item 1A.

Risk Factors20

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds22

Item 3

Defaults Upon Senior Securities22

Item 4.

Mine Safety Disclosures22

Item 5.

Other Information22

Item 6.

Exhibits23

SIGNATURES

24


EXPLANATORY NOTE

Unless the context requires otherwise, all references in this report to the “Company,” “Taxus Cardium,” “Cardium,” “we,” “our,” and “us” refer to Taxus Cardium Pharmaceuticals Group Inc. (formerly Cardium Therapeutics, Inc.) and, as applicable, its wholly ownedwholly-owned subsidiaries Activation Therapeutics, Inc. (formerly Tissue Repair Company), Angionetics Biologics, Inc.,Company, To Go Brands, Inc. and LifeAgain Insurance Solutions, Inc.

OnEffective July 18, 2013 we affectedeffected a 1 for 20 reverse split of our outstanding common stock, par value $0.0001 per share. The informationshare, in a ratio of 1 for 20. All common stock and per share amounts included in this report hashave been retroactively adjusted to give retroactive effect to thereflect a 1 for 20 reverse stock split.split, as if such split had been effective at the beginning of the period reported.

SPECIAL NOTE ABOUT FORWARD-LOOKING STATEMENTS

Certain statements in this report, including information incorporated by reference, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect current views about future events and financial performance based on certain assumptions. They include opinions, forecasts, intentions, plans, goals, projections, guidance, expectations, beliefs or other statements that are not statements of historical fact. Words such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “believes,” “anticipates,” “intends,” “estimates,” “approximates,” “predicts,” or “projects,” or the negative or other variation of such words, and similar expressions may identify a statement as a forward-looking statement. Any statements that refer to projections of our future financial performance, our anticipated growth and trends in our business, our goals, strategies, focus and plans, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results and the development of our products, are forward-looking statements. Forward-looking statements in this report may include statements about:

 

our ability to fund operations and business plans, and the timing of any funding or corporate development transactions we may pursue;

 

planned development pathways and potential commercialization activities or opportunities;

 

the timing, conduct and outcome of discussions with regulatory agencies, regulatory submissions and clinical trials, including the timing for completion of clinical studies;

 

our ability to increase revenues, raise sufficient financing and to regain the listing of our common stock on a national exchange;

our beliefs and opinions about the safety and efficacy of our products and product candidates and the anticipated results of our clinical studies and trials;

 

our ability to enter into acceptable relationships with one or more contract manufacturers or other service providers on which we may depend, and the ability of such contract manufacturers or other service providers to manufacture biologics, devices, nutraceuticals or other key products or components, or to provide other services, of an acceptable quality on a timely and cost-effective basis;

 

our ability to enter into acceptable relationships with one or more development or commercialization partners to advance the commercialization of new products and product candidates and the timing of any product launches;

 

our growth, expansion and acquisition strategies, the success of such strategies, and the benefits we believe can be derived from such strategies;

 

our ability to pursue and effectively develop new product opportunities and acquisitions and to obtain value from such product opportunities and acquisitions;

 

our ability to maintain the listing of our common stock on a national exchange;

our intellectual property rights and those of others, including actual or potential competitors;

 

the outcome of litigation matters;

 

the anticipated activities of our personnel, consultants and collaborators;

 

expectations concerning our operations outside the United States;

 

current and future economic and political conditions;

 

overall industry and market performance;

 

the impact of new accounting pronouncements;

 

management’s goals and plans for future operations; and

 

other assumptions described in this report underlying or relating to any forward-looking statements.

The forward-looking statements in this report speak only as of the date of this report and caution should be taken not to place undue reliance on any such forward-looking statements. Forward-looking statements are subject to certain events, risks, and uncertainties that may be outside of our control. When considering forward-looking statements, you should carefully review the risks, uncertainties and other cautionary statements in this report as they identify certain important factors that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. These factors include, among others, the risks described under Item 1A and elsewhere in this report, as well as in other reports and documents we file with the United States Securities and Exchange Commission (the “SEC”).


TABLE OF CONTENTS

Page
PART 1

FINANCIAL INFORMATION

1
Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations

2

Condensed Consolidated Statements of Cash Flows

3

Notes to Condensed Consolidated Financial Statements

4
Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

15
Item 3.

Quantitative and Qualitative Disclosures About Market Risk

19
Item 4.

Controls and Procedures

20
PART II

OTHER INFORMATION

21
Item 1.

Legal Proceedings

21
Item 1A.

Risk Factors

21
Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

22
Item 3

Defaults Upon Senior Securities

22
Item 4.

Mine Safety Disclosures

22
Item 5.

Other Information

22
Item 6.

Exhibits

23
SIGNATURES24


PART I – FINANCIAL INFORMATION

ITEM 1.FINANCIAL STATEMENTS

TAXUS CARDIUM THERAPEUTICS,PHARMACEUTICALS GROUP, INC. AND SUBSIDIARIES

(a development stage company)

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

  March 31, December 31, 
  2014 2013 
  (unaudited)   
  September 30,
2013
 December 31,
2012
 

Assets

      

Current assets:

      

Cash and cash equivalents

  $585,201   $2,328,074    $163,492   $22,489  

Restricted cash

   0    50,000  

Accounts receivable

   105,174    328,953  

Inventory, net

   823,235    1,174,323     134,831   159,831  

Prepaid expenses and other assets

   332,682    407,389     438,870   309,200  
  

 

  

 

   

 

  

 

 

Total current assets

   1,846,292    4,288,739     737,193    491,520  

Property and equipment, net

   65,010    97,582     26,640    30,196  

Investment

   435,000    435,000     1,699,672    1,699,672  

Technology licenses, net

   1,097,511    1,198,318  

Intangible assets, net

   904,766    1,019,692  

Goodwill

   584,711    584,711  

Deposit on investment option

   435,000    435,000  

Other long term assets

   195,920    184,836     69,989    129,989  
  

 

  

 

   

 

  

 

 

Total assets

  $5,129,210   $7,808,878    $2,968,494   $2,786,377  
  

 

  

 

 
  

 

  

 

 

Liabilities and Stockholders’ Equity

      

Current liabilities:

      

Accounts payable

  $802,365   $777,861    $1,101,098   $990,279  

Accrued liabilities

   364,547    614,857     739,644    611,007  

Advances for payables from officer

   417,484    0  
  

 

  

 

   

 

  

 

 

Current liabilities

   1,166,912    1,392,718  

Deferred rent

   11,813    50,370  

Total current liabilities

   2,258,226    1,601,286  
  

 

  

 

   

 

  

 

 

Total liabilities

   1,178,725    1,443,088     2,258,226    1,601,286  
  

 

  

 

   

 

  

 

 

Commitments and contingencies

      

Stockholders’ equity:

      

Series A Convertible Preferred stock, $0.0001 par value; 40,000,000 shares authorized; issued and outstanding 2,580.9 at September 30, 2013 and 0 at December 31, 2012, with liquidation preferences of $1,000

   0    0  

Common stock, $0.0001 par value; 200,000,000 shares authorized; issued and outstanding 7,747,228 at September 30, 2013 and 6,460,915 at December 31, 2012

   12,956    12,922  

Series A Convertible Preferred stock, $0.0001 par value; 40,000,000 shares authorized; issued and outstanding 1,386 at March 31, 2014 and 1,500 at December 31, 2013, with liquidation preferences of $1,000

   0    0  

Common stock, $0.0001 par value; 200,000,000 shares authorized; issued and outstanding 9,652,710 at March 31, 2013 and 8,810,624 at December 31, 2013

   13,028    12,956  

Additional paid-in capital

   106,500,753    102,767,193     107,464,346    106,500,753  

Deficit accumulated during development stage

   (102,563,224  (96,414,325   (106,767,106  (105,328,618
  

 

  

 

   

 

  

 

 

Total stockholders’ equity

   3,950,485    6,365,790     710,268    1,185,091  
  

 

  

 

   

 

  

 

 

Total liabilities and stockholders’ equity

  $5,129,210   $7,808,878    $2,968,494   $2,786,377  
  

 

  

 

   

 

  

 

 

See accompanying notes, which are an integral part of these condensed consolidated financial statements.

-1-


TAXUS CARDIUM THERAPEUTICS,PHARMACEUTICALS GROUP, INC. AND SUBSIDIARIES

(a development stage company)

Condensed Consolidated Statements of OperationsCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)(unaudited)

 

  Three Months Ended
September 30,
 Nine Months Ended
September 30,
 Period from
December 22, 2003
(Inception) to
September 30,
2013
   Three Months Ended
March 31,
 (Inception) to
March 31, 2014
 
  2013 2012 2013 2012   2014 2013 

Revenues

          

Product sales

  $471,566   $5,589   $1,655,342   $39,241   $2,440,660    $0   $47,400   $894,518  

Grant revenues

   0    0    0    0    1,623,160     0   0   1,623,160  
  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total revenues

   471,566    5,589    1,655,342    39,241    4,063,820     0    47,400    2,517,678  

Cost of goods sold

   288,522    3,640    977,912    15,191    (1,414,977   0    (30,020  (506,225
  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Gross profit

   183,044    1,949    677,430    24,050    2,648,843     0    17,380    2,011,453  
  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Operating expenses

          

Research and development

   315,178    508,342    1,566,988    2,097,675    45,573,715     243,544    724,876    46,287,642  

Selling, general and administrative

   1,636,871    1,389,731    5,258,129    4,358,706    48,811,487     1,194,945    1,267,757    49,657,222  
  

 

  

 

  

 

  

 

 ��

 

   

 

  

 

  

 

 

Total operating expenses

   1,952,049    1,898,073    6,825,117    6,456,381    94,385,202     1,438,489    1,992,633    95,944,864  
  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Loss from operations

   (1,769,005  (1,896,124  (6,147,687  (6,432,331  (91,736,360   (1,438,489  (1,975,253  (93,933,411
  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Change in fair value of derivative liabilities

   0    0    0    64,157    10,395,709     0    0    10,395,709  

Gain on warrant exchange

   0    0    0    0    473,872     0    0    473,872  

Interest income

   0    1,204    217    5,885    1,583,855     0    217    1,583,855  

Interest expense

   (0  0    (1,438  (2,114  (7,127,692   0    (771  (7,127,025
  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Net loss from continuing operations

   (1,769,005  (1,894,920  (6,148,908  (6,364,403  (86,410,616  $(1,438,489 $(1,975,807 $(88,607,000

Net loss from discontinued operations

   0    0    0    0    (22,561,220   0    (286,548  (24,568,710

Gain on sale of business unit

   0    0    0    0    6,408,603     0    0    6,408,603  
  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Net loss

  $(1,769,005 $(1,894,920 $(6,148,908 $(6,364,403 $(102,563,233  $(1,438,489 $(2,262,355 $(106,767,107
  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Deemed dividend on preferred stock

   (172,861  0    (405,872  0    (0
  

 

  

 

  

 

  

 

  

 

 

Net loss applicable to common stockholders

  $(1,941,866 $(1,894,920 $(6,554,780 $(6,364,403 $(0
  

 

  

 

  

 

  

 

  

 

 

Basic and diluted loss per common share

  $(0.28 $(0.32 $(0.99 $(1.10 

Weighted average common shares outstanding

   6,995,494    5,952,237    6,595,209    5,774,671   

Net loss per share—basic and diluted

    

Net loss from continued operations

  $(0.16 $(0.31 

Net Loss from discontinued operations

   (0.00  (0.04 

Net loss per share—basic and diluted

  $(0.16 $(0.35 

Weighted average number of common shares outstanding

   9,037,771    6,377,538   

See accompanying notes, which are an integral part of these condensed consolidated financial statements.

-2-


TAXUS CARDIUM THERAPEUTICS,PHARMACEUTICALS GROUP, INC. AND SUBSIDIARIES

(a development stage company)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)(unaudited)

 

  For The Nine Months Ended
September 30,
 December  22,
2003
(Inception)
To
September 30,
2013
   Three Months Ended
March 31,
 

December 22,
2003

(Inception)

To

 
  2013 2012  2014 2013 March 31, 2014 

Cash Flows From Operating Activities

        

Net loss

  $(6,148,908 $(6,364,403 $(102,563,233  $(1,438,489 $(2,262,355 $(106,767,107

Adjustments to reconcile net loss to net cash used in operating activities:

        

Gain on sale of discontinued operation

   0    0    (6,408,603   0   0   (6,408,603

Gain on sale of warrants

   0    0    (518,622   0   0   (518,622

Loss on abandonment of leaseholds

   0    0    135,344     0   0   135,344  

Depreciation

   60,224    73,408    2,171,352     3,556   20,594   2,187,041  

Amortization—intangibles

   114,926    0    2,849,427     0   38,308   2,857,781  

Amortization—debt discount

   0    0    5,291,019     0   0   5,291,019  

Amortization—deferred financing costs

   0    0    925,859     0   0   925,859  

Amortization—technology and licenses

   100,807    100,806    337,489     0   33,602   337,489  

Write-off of technology licenses

   0   0   1,097,511  

Provision for obsolete inventory

   (62,431  0    96,717     25,000   39,574   121,666  

Reserve for product returns

   (27,646  0    48,354     0   (4,328 (0

Change in fair value of warrants

   0    (64,157  (10,395,709   0   0   (10,395,709

Common stock and warrants issued for services and reimbursement of expenses

   0    0    203,882     0   0   203,882  

Stock based compensation expense

   40,750    128,996    7,638,571     506,165   40,750   8,144,736  

In-process purchased technology

   0    0    2,027,529     0   0   2,027,529  

Deferred rent

   (38,557  (49,615  11,813     0   (18,328 (0

Changes in operating assets and liabilities

        

Accounts receivable

   223,779    (3,621  120,092     0   134,213   118,423  

Inventories

   413,519    (296,098  (2,132,373   0   43,592   (1,925,194

Prepaid expenses and other assets

   74,707    (165,426  (438,552   (129,670 30,750   (552,799

Deposits

   (11,084  0    (196,064   60,000   (1,853 (70,133

Payables advance from officer

   417,484   0   417,484  

Accounts payable

   24,504    (377,298  1,729,000     110,819   (109,964 2,332,805  

Accrued liabilities

   (222,664  (50,916  (685,692   128,638   (58,751 (196,601
  

 

  

 

  

 

   

 

  

 

  

 

 

Net cash used in operating activities

   (5,458,074  (7,068,324  (99,752,400   (316,497  (2,074,196  (100,636,199
  

 

  

 

  

 

   

 

  

 

  

 

 

Cash Flows From Investing Activities

        

In-process technology purchased from Tissue Repair Company

   0    0    (1,500,000   0    0    (1,500,000

Cash acquired in acquisitions

   0    288,151    1,839,951  

Fee paid to list shares issued for technology and product license

   0    0    (65,000   0    0    (65,000

Purchases of property and equipment

   (27,652  (15,866  (2,860,069   0    (4,599  (2,855,470

Cash acquired in acquisitions

   0    0    1,839,951  
  

 

  

 

  

 

   

 

  

 

  

 

 

Net cash used in investing activities

   (27,652  272,285    (2,585,118

Net cash provided by (used in) investing activities

   0    (4,599  (2,580,519
  

 

  

 

  

 

   

 

  

 

  

 

 

Cash Flows From Financing Activities

        

Proceeds from officer loan

   0    0    62,882  

Restricted cash – collateral for letter of credit

   50,000    150,000    0  

Restricted cash – proceeds placed in escrow from sale of business

   0    0    0  

Payables advance from officer

   0    0    62,882  

Restricted cash—collateral for letter of credit

   0    50,000    0  

Proceeds from the exercise of warrants, net

   0    764    1,259,212     0    0    1,259,212  

Proceeds from debt financing agreement, net of debt issuance costs of $871,833

   0    0    14,378,167     0    0    14,378,167  

Proceeds from the sale of business unit

   0    0    11,250,000     0    0    11,250,000  

Repayment of debt

   0    0    (15,750,000   0    0    (15,750,000

Proceeds from sales of preferred and common stock, net of issuance costs of $198,086

   3,692,853    6,396,127    91,722,458  

Proceeds from sales of preferred and common stock, net of issuance costs of $42,500

   457,500    65,744    92,179,949  
  

 

  

 

  

 

   

 

  

 

  

 

 

Net cash provided by financing activities

   3,742,853    6,546,891    102,922,719     457,500    115,744    103,380,210  
  

 

  

 

  

 

   

 

  

 

  

 

 

Net (decrease) increase in cash

   (1,742,873  (249,148  585,201  

Net increase (decrease) in cash

   141,003    (1,963,051  163,492  

Cash and cash equivalents at beginning of period

   2,328,074    4,721,279    0     22,489    2,328,074    0  
  

 

  

 

  

 

   

 

  

 

  

 

 

Cash and cash equivalents at end of period

  $585,201   $4,472,131   $585,201    $163,492   $365,023   $163,492  
  

 

  

 

  

 

   

 

  

 

  

 

 

Supplemental Disclosures of Cash Flow Information:

    

Cash paid for interest

  $1,438   $2,114   $1,394,487  

Cash paid for income taxes

  $3,200   $2,400   $31,762  

Non-Cash Activity:

    

Subscription receivable for common shares

  $0   $0   $17,000  

Common stock issued for repayment of loans

  $0   $0   $62,882  

Stock issued for technology license fee

  $0   $0   $1,870,000  

Net assets acquired for the issuance of common stock (exclusive of cash acquired)

  $0   $1,727,849   $7,551,849  

Warrants exchanged for stock

  $0   $0   $(901,139

Reclassification of derivative liabilities with expired price protection provisions

  $0   $(21,349 $(4,045,702

   Three Months Ended
March 31,
   

December 22,
2003

(Inception)

To

 
  2014   2013   March 31, 2014 

Supplemental Disclosures of Cash Flow Information:

      

Cash paid for interest

  $0    $910    $1,394,487  

Cash paid for income taxes

  $0    $3,200    $31,762  

Non-Cash Activity:

      

Warrants issued in settlement of Accounts Payable

  $75,000      $75,000  

Subscription receivable for common shares

  $0    $0    $17,000  

Common stock issued for repayment of loans

  $0    $0    $62,882  

Stock issued for technology license fee

  $0    $0    $1,870,000  

Net assets acquired for the issuance of common stock (exclusive of cash acquired)

  $0    $0    $7,551,849  

Warrants exchanged for stock

  $0    $0    $(901,139

Reclassification of derivative liabilities with expired price protection provisions

  $0    $0    $(4,045,702

Issuance of note for accrued milestone payment

  $0    $0    $500,000  

Sale of To Go Brands for preferred stock

  $0    $0    $1,699,672  
  

 

 

   

 

 

   

 

 

 

See accompanying notes, which are an integral part of these condensed consolidated financial statements.

-3-


TAXUS CARDIUM THERAPEUTICS,PHARMACEUTICALS GROUP, INC. AND SUBSIDIARIES

(a development stage company)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

Note 1 -1. Organization and Liquidity

Organization

Taxus Cardium Therapeutics,Pharmaceuticals Group, Inc. (the “Company,” “Cardium,” “we,” “our” and “us”) was incorporated in Delaware in December 2003. We are a medical technology company primarilydevelopment-stage regenerative medicine biotechnology company. We are focused on the development of advanced regenerative therapeutics designed to promote the activation and commercializationgrowth of (1) microvascular circulation to enhance perfusion of ischemic cardiac tissue as a portfolio of novelpotential treatment for heart disease; and (2) granulation tissue as a treatment for chronic non-healing wounds. We have a commercial FDA-cleared wound care product, a late clinical stage cardiovascular gene therapy product candidate and corresponding technology platforms as outlined below. We also own non-core interests in the Healthy Brands Collective, a health products and devices.

We are currently operating in four primary business lines through our four operating subsidiaries: Activation Therapeutics, Inc., Angionetics Biologics, Inc., To Go Brands, Inc.company, and LifeAgain Insurance Solutions, Inc. We report in two business segments. Our Pharmaceutical Products segment includes the operations of our Activation Therapeutics, Inc. and Angionetics Biologics, Inc. subsidiaries. Activation Therapeutics, Inc. is developing and commercializing, a late-stage line of regenerative medicine product candidates. Angionetics Biologics, Inc. is developing innovative cardiovascular products. Our Nutraceutical Products segment includes the operations of our To Go Brands, Inc. subsidiary and is developing and marketing a line of nutraceuticals and other healthy lifestyle products. Our LifeAgain Insurance Solutions, Inc. subsidiary is a life insurance business focused on medical data analysis and is advancing toward commercialization. We anticipate that LifeAgain Insurance Solutions business will be reported as a separate segment, once it establishes material operations.analytics business.

The significant transactions in the development of our current product portfolio are as follows:

In October 2005, we acquired a portfolio of biologic growth factors and related delivery techniques from the Schering AG Group (now part of Bayer AG) for potential use in treating ischemic and other cardiovascular conditions. This was the inception of our Angionetics Biologics business.

In March 2006, we acquired the technologies and products of InnerCool Therapies, Inc., a medical technology company in the emerging field of therapeutic hypothermia, or patient temperature modulation, whose systems and products are designed to rapidly and controllably cool the body to reduce cell death and damage following acute ischemic events such as cardiac arrest and stroke, and to potentially lessen or prevent associated injuries such as adverse neurologic outcomes.

In August 2006, we acquired rights to assets and technologies of Activation Therapeutics, Inc. (formerly Tissue Repair Company),Company, a company focused on the development of growth factor therapeutics for the potential treatment of tissue wounds such as chronic diabetic wounds, and whose FDA 510(k) cleared product candidate, Excellagen is designedinitially being developed as a single administration therapeutic for the treatment of non-healing, neuropathic diabetic foot ulcers and other wounds,ulcers. Tissue Repair Company is operated as a wholly-owned subsidiary of Cardium.

On July 24, 2009, we sold all of the assets and liabilities of our InnerCool Therapies business to Philips Electronics North America Corporation for $11.25 million, as well as the transfer of approximately $1.5 million in trade payables.

On September 28, 2012 we acquired substantially all of the business assets and product portfolio of privately-held To Go Brands, Inc. To Go Brands develops, markets and sells a portfolio of products, including nutraceutical powder mixes, supplements and chews intended to support healthy lifestyles. These products are sold through food, drug and mass channels at retailers including Whole Foods®, CVS®, Kroger®, GNC®, Jewel-Osco®, Ralph’s Supermarkets®, Meijer®, and the Vitamin Shoppe® and from the Company’s web-based store.

On September 28, 2012 we acquired substantially all of the business assets and product portfolio of privately-held To Go Brands, Inc. To Go Brands develops, markets, and sells a portfolio of products, including nutraceutical powder mixes, supplements and chews intended to support healthy lifestyles. These products are sold through food, drug and mass channels at retailers including Whole Foods®, Kroger®, GNC®, Jewel-Osco®, Ralph’s Supermarkets®, Meijer®, and the Vitamin Shoppe® and from the Company’s web-based store.

On November 15, 2013, we sold our To Go Brands® business to Healthy Brands Collective® in exchange for an equity stake in Healthy Brands preferred stock which, at the time of the transaction, was convertible into approximately 4% of their fully-diluted common stock, and the assumption of approximately $370,000 of liabilities. Healthy Brands Collective® is a fast growing private company that has acquired a portfolio of eight independent brand product platforms (prior to To Go Brands).

Our business is focused on the acquisition and strategic development and partnering or other monetization of product opportunities or businesses having the potential to address significant unmet medical needs, and having definable pathways to commercialization. We intend to consider various corporate development transactions designed to place our product candidates into larger organizations or with partners having existing commercialization, sales and marketing resources, and a need for innovative products. Such transactions could involve the sale, partnering or other monetization of particular product opportunities or businesses.

We are a development stage company. We have yet to generate positive cash flows from operations, and are essentially dependent on debt and equity funding or sale or other monetization of product opportunities or businesses, to finance our operations.

Reverse Stock Split

On July 17, 2013, pursuant to board and stockholder approval, we filed a Certificate of Amendment to our Restated Certificate of Incorporation with the State of Delaware to effectaffect a reverse split of our outstanding common stock, par value $0.0001 per share, in a ratio of 1:1 for 20. The effective date of the reverse stock split was July 18, 2013.

-4-


On that date, every 20 shares of outstanding common stock were reclassified and combined into one share of common stock. No fractional shares were issued as a result of the reverse stock split. Instead, each resulting fractional share of common stock was rounded down to one whole share. The reverse stock split reduced the number of shares of common stock outstanding from 134,366,340 to 6,718,317.

All common stock and per share amounts contained in the consolidated financial statements included in this report have been retroactively adjusted to reflect the 1 for 20 reverse stock split, as if such split had been effective at the beginning of the period reportedreported.

Liquidity and Going ConcernCapital Resources

As of September 30, 2013March 31, 2014, we had $585,201approximately $163,492 in cash and cash equivalents and ourequivalents. Our working capital deficit at March 31, 2014 was $679,380.approximately $1,521,000.

Net cash used in operating activities was $5,458,000$316,497 for the ninethree months ended September 30, 2013March 31, 2014 compared to $7,068,000$2,074,196 for the ninethree months ended September 30, 2012.March 31, 2013. The decrease in net cash used in operating activities was due primarily to an increasespending and headcount reductions in product sales,the second half of 2013 and decreases in testingearly 2014 and process validation costs for the initial inventory foradvances against payables made by our Activation Therapeutics business, including our Excellagen topical treatment gel.CEO. Since inception, our operations have consumed substantial amounts of cash and we have had only limited revenues. From inception (December 22, 2003) to September 30, 2013,March 31, 2014, net cash used in operating activities amountedhas been $100,636,199.

We had no net cash used in investing activities for the three months ended March 31, 2014. Net cash used in investing activities since inception has been approximately $2,580,519. At March 31, 2014 we did not have any significant capital expenditure requirements.

During the during the three months ended March 31, 2014, cash flows from financing activities include the sale of 714,286 shares of common stock in transactions for net proceeds of $457,500.

During the period subsequent to $99,752,000.March 31, 2014, cash flows from financing activities include the sale of 2,330,278 shares of common stock in transaction with net proceeds of approximately $1,477,000.

Our primary source of liquidity has been cash flows from financing activities and in particular proceeds from sales of our debt and equity securities. Net cash provided by financing activities was $3,743,000$457,500 for the ninethree months ended September 30, 2013.March 31, 2014. This includedwas the saleresult of 4,012a common stock equity financing with our strategic investor of 714,286 shares of Series A Convertible PreferredCommon Stock priced at $0.70 per share with net proceeds of $3,692,000, and 343,749 shares of common stock in at-the-market transactions in the first quarterno warrant coverage for net proceeds of $65,743. See Note 7.$457,500. From inception (December 22, 2003) to September 30,March 31, 2013 net cash provided by financing activities amounted to $102,923,000.

Net cash used in investing activities for the nine months ended September 30, 2013 was $28,000. Net cash used in investing activities since inception amounted to $2,585,000. At September 30, 2013 we did not have any significant capital expenditure requirements.

Our business model is designed to develop a diversified portfolio of product opportunities and businesses, leveraging our skills in late-stage product development in order to bridge the critical gap between promising new technologies and readiness for commercialization – and then to partner or monetize such product opportunities or businesses with established organizations capable of advancing their commercialization. Consistent with our business model and long-term strategy, we have already advanced and monetized a first business unit, Innercool Therapies, Inc., which was sold to Philips Electronics North America Corporation.

We now have four additional business units in our portfolio: (1) Angionetics Biologics, which includes Cardium’s late-stage DNA-based Generx® cardiovascular biologic product candidate; (2) Activation Therapeutics, which includes the Company’s regenerative medicine wound healing technology platform, including its Excellagen® advanced wound care product; (3) To Go Brands®, which includes the Company’s health sciences and nutraceutical business; and (4) LifeAgain Insurance Solutions, Inc. which is focused on building the Company’s medical data analytics technology platform.has been $103,380,210.

We intend to consider additional corporate development transactions designed to place our product candidates or businesses into larger organizations or with partners having existing commercialization, sales and marketing resources, and a need for innovative products. Such transactions could involve the sale, partnering or other monetization of particular product opportunities or businesses. In parallel, as our businesses are advanced and corresponding valuations established, we plan to pursue new product opportunities and acquisitions with strong value enhancement potential.

-5-


While we intend to partner or monetize one or more of our product opportunities or businesses consistent with our business model, the timing and success of those transactions cannot be assured andanticipate that negative cash flow from operations are expected towill continue for the foreseeable future. In order to maintain operations and liquidity,We do not have any unused credit facilities. As long as any shares of our Series A Convertible Preferred Stock are outstanding, we expecthave agreed that we will neednot, without the consent of the holders of two-thirds of the Series A Convertible Preferred Stock, incur indebtedness other than specified “Permitted Indebtedness”, incur any liens other than specified “Permitted Liens”. We intend to complete a monetizationsecure additional working capital through sales of oneadditional debt or more product opportunities or business units, and/or complete a financing, before end of year.equity securities to finance our operations. Our principal business objective in the near term is to complete an additional strategic licensing agreement to advance sales of the Excellagen product family enter into a distribution arrangement to advance sales of our To Go Brands nutraceuticals business, and/or another corporate transaction. If we fail to receive sufficient proceeds from the partnering, sale, or other monetization of product opportunities or businesses,enter into an additional strategic licensing arrangement or generate sufficient product salescash from financing activities we will not generate sufficient cash flows to cover our operating expenses.

If needed, we intent to secure additional financings in the form of sale of equity securities. Based on recently-issued amendments to Rule 506 and Rule 144A under the Securities Act of 1933 that were implemented under Section 201(a) of the Jumpstart Our Business Startups Act (the “JOBS Act”), and since we do not anticipate raising additional funds under our shelf registration statement or as debt within the next 12 months, such financings may be through the sale of private equity interests to Qualified Investors or strategic partners based on the JOBS Act amendments, and/or through other private placements or a public offering of securities, which could potentially be made in the parent company or independently in one or more of our subsidiary business units.

Our history of recurring losses and uncertainties as to whether our operations will become profitable raise substantial doubt about our ability to continue as a going concern. Our condensed consolidated financial statements do not include any adjustments related to the recoverability of assets or classifications of liabilities that might be necessary should we be unable to continue as a going concern.

Note 2 – 2—Summary of Significant Accounting Policies

Basis of Presentation

The accompanying financial statements have been prepared in accordance with authoritative guidance for development stage enterprises. The condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial statements and with Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not contain all information and footnotes required by accounting principles generally accepted in the United States of America for annual financial statements. In the opinion of the Company’s management, the accompanying unaudited condensed consolidated financial statements contain all the adjustments necessary (consisting only of normal recurring accruals) to present the financial position of the Company as of September 30, 2013March 31, 2014 and the results of operations and cash flows for the periods presented. The results of operations for the ninethree months ended September 30, 2013March 31, 2014 are not necessarily indicative of the operating results for the full fiscal year or any future period.

These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012.2013. The Company’s accounting policies are described in the Notes to Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2012,2013, and updated, as necessary, in this Quarterly Report on Form 10-Q.

Fair Value of Financial Instruments

The carrying amounts of cash and cash equivalents, accounts receivable, inventories, accounts payable, and accrued liabilities approximate fair value due to the short term maturities of these instruments.

Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. The most significant estimates include reserve for product returns, reserve for inventory, and valuing options and warrants using option pricing models.

Fair Value of Financial Instruments

The carrying amounts of cash and cash equivalents, accounts receivable, inventories, accounts payable, and accrued liabilities approximate fair value due to the short term maturities of these instruments.

Principles of Consolidation

The consolidated financial statements include the accounts of Taxus Cardium Therapeutics,Pharmaceuticals Group, Inc. and its wholly-owned subsidiaries, Activation Therapeutics, Inc. (formerly Tissue Repair Company),Company, To Go Brands, Inc. (a business that is presented as a discontinued operation as described in Note 3) and LifeAgain Insurance Solutions, Inc., and To Go Brands, Inc. (collectively, the “Company”). All significant inter-company transactions and balances have been eliminated in consolidation.

-6-


Cash and Cash Equivalents

We consider all highly liquid investments with maturities of three months or less when purchased to be cash equivalents.

Concentration of Credit Risk

Financial instruments that potentially subject us to significant concentrations of credit risk consist of cash and cash equivalents. At times, our cash and cash equivalents may be uninsured or in deposit accounts that exceed the Federal Deposit Insurance Corporation (“FDIC”) insurance limits. As of September 30, 2013, we had cash and cash equivalent balances of approximately $335,000 in excess of the federally insured limit of $250,000.

Accounts Receivable

Accounts receivable are stated at cost less an allowance for doubtful accounts, which reflects our estimate of balances that will be not collected. The allowance is based on the history of past write-offs, the aging of balances, collections experience and current credit conditions. Additions to the allowance for doubtful accounts include provisions for bad debt and deductions to the allowance for doubtful accounts include customer write-offs. We have a low occurrence of credit losses and therefore do not believe an allowance for doubtful accounts is necessary at this time.

Long-Lived Assets

Long-lived assets to be held and used, including property, plant, and equipment as well as intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable such as:

a significant decline in the observable market value of an asset;

a significant change in the extent or manner in which an asset is used; or

a significant adverse change that would indicate that the carrying amount of an asset or group of assets is not recoverable.

Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their estimated fair values. Long-lived assets to be disposed of are carried at fair value less costs to sell. We do not believe there was any impairment of long-lived assets at September 30, 2013 or December 31, 2012.

Preferred Stock

We apply the accounting standards for distinguishing liabilities from equity when determining the classification and measurement of our preferred stock. Shares that are subject to mandatory redemption (if any) are classified as liability instruments and are measured at fair value. We classify conditionally redeemable preferred shares, which includes preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control, as temporary equity. At all other times, preferred shares are classified as stockholders’ equity.

Revenue Recognition

OurThe Company’s revenues principally consist of sales of nutritional products. We applyExcellagen product. The Company applies the revenue recognition principles set forth under the Securities and Exchange Commission’s Staff Accounting Bulletin (“SAB”) 104. Accordingly, revenue from product sales is recognized when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred, (iii) the sales price is fixed or determinable, and (iv) collectability is reasonably assured. These criteria are met when the risk of ownership and title passes to ourthe Company’s customers.

Net sales represent products at gross selling price, less (i) estimatedResearch and Development

In accordance with ASC Topic 730 research and development costs are expensed as incurred. Research and development expenses consist of purchased technology, purchased research and development rights and outside services for research and development activities associated with product returnsdevelopment. In accordance with ASC Topic 730, the cost to purchase such technology and (ii) certain other discounts, allowancesresearch and sales incentives. Wedevelopment rights are required to be charged to expense if there is currently no alternative future use various types of sales incentivesfor this technology and, promotions in marketing our products; including, price reductions, coupons, rebate offers, slotting fees and free product. The cost of these sales incentives and promotions are accounted for as a direct reduction of sales. The cost of free product is classified as cost of goods sold.therefore, no separate economic value.

We sell certain products with rights of return. If the amount of future returns can be reasonably estimated, we recognize revenue when the products are shipped, net of allowance for estimated returns, provided that all other criteria for revenue recognition have been met. A reserve for product returns is recorded based upon historical experience. At September 30, 2013 and December 31, 2012, the reserve for product returns amounted to $48,000 and $76,000, respectively.

-7-


Income Taxes

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period enacted. A valuation allowance is provided when it is more likely than not that a portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income and the reversal of deferred tax liabilities during the period in which related temporary differences become deductible. The benefit of tax positions taken or expected to be taken in ourthe Company’s income tax returns isare recognized in the condensed consolidated financial statements if such positions are more likely than not to be sustained upon examination.

Common Stock Purchase Warrants

We account for the issuance of common stock purchase warrants issued in connection with capital financing transactions in accordance with the provisions of ASC Topic 815. Based upon the provisions of ASC Topic 815, we classify as equity any contracts that (i) require physical settlement or net-share settlement or (ii) gives the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). We classify as assets or liabilities any contracts that (i) require net-cash

settlement (including a requirement to net-cash settle the contract if an event occurs and if that event is outside the control of the Company) or (ii) gives the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement).

Loss Per Common Share

We compute loss per share, in accordance with ASC Topic 260 which requires dual presentation of basic and diluted earnings per share.

Basic income or loss per common share is computed by dividing net income or loss by the weighted average number of common shares outstanding during the period. Diluted income or loss per common share is computed by dividing net income or loss by the weighted average number of common shares outstanding, plus the issuance of common shares, if dilutive, that could result from the exercise of outstanding stock options and warrants. These potentially dilutive securities were not included in the calculation of loss per common share for the three months and nine months ended September 30,March 31, 2014 or 2013 or 2012 because their effect would be anti-dilutive.

As of September 30, 2013March 31, 2014 potentially dilutive securities consist of preferred stock convertible into 50,777,475 shares of common stock and outstanding stock options and warrants to acquire 1,276,1122,500,165 shares of our common stock. As of September 30, 2012,March 31, 2013, potentially dilutive securities consisted of outstanding stock options and warrants to acquire 1,624,9511,495,643 shares of our common stock.

Stock-Based Compensation

Stock-based compensation costs are recognized on a straight-line basis over the requisite service period of the award, which is generally the vesting term of the award. At September 30, 2013 we had no unamortized stock option expense.

Total stock-based compensation expense included in the condensed consolidated statements of operations was allocated to research and development and general and administrative expenses as follows:

 

                            
  For the Three Months Ended
September 30
   March 31, 
  2013   2012   2014   2013 

Research and development

  $0    $5,999    $51,409    $5,997  

General and administrative

   0     36,152     454,756     34,753  
  

 

   

 

   

 

   

 

 

Total stock-based compensation

  $0    $42,151    $506,165    $40,750  
  

 

   

 

   

 

   

 

 
   For the Nine Months Ended  September
30,
 
  2013   2012 

Research and development

  $5,997    $17,886  

General and administrative

   34,753     111,110  
  

 

   

 

 

Total stock-based compensation

  $40,750    $128,996  
  

 

   

 

 

Investment

On November 15, 2013, we closed the sale of our To Go Brands, Inc. business unit to Healthy Brands Collective. The purchase price was 33,441 shares of preferred stock (representing approximately 4% of the outstanding shares of common stock of Healthy Brands collective on a fully diluted basis) of Cell-nique (parent company of Healthy Brands). Since Cell-nique Corporation is a private company we have recorded the value of those shares of preferred stock on our balance sheet as an investment in Cell-nique Corporation, at the net asset value of the net assets transferred (cost) to Cell-nique Corporation. The Company periodically reviews the carrying amount of its investment in Cell-nique to determine whether the value is impaired or a write down may be necessary for an other than temporary decline in value.

Recent Accounting Pronouncements

We do not believe that any recently issued accounting standards, if adopted, would have a material impact on our condensed consolidated financial statements.

NOTE 3—Disposal of Long-Lived Assets

-8-


Note 3 - Business Combinations

On September 28, 2012 we completedIn accordance with the provisions of ASC topic 360 (formerly SFAS No. 144), “Accounting for the Impairment or Disposal of Long-Lived Assets,” the disposal of our acquisition of the assets of privately-held To Go Brands Inc., business segment is presented as a Nevada corporation. To Go Brands develops, markets and sells a portfolio of products, including nutraceutical powder mixes, supplements and chews intended to support healthy lifestyles. We acquired substantially all ofdiscontinued operation in the assets, properties, goodwill and rights related to the business, including without limitation, accounts receivable, inventory, furniture and fixtures, patents, trademarks, and other intellectual property rights. The product line includes drink mixes in stick packs designed to be poured directly into a water bottle, packaged mixes for home use and capsule-based dietary supplements. These products are sold through food, drug and mass channels at retailers including Whole Foods®, Kroger®, GNC®, Jewel-Osco®, Ralph’s Supermarkets®, Meijr®, and the Vitamin Shoppe® and from the Company’s web-based store.

Pursuant to the terms of the asset purchase agreement, we issued 480,000 shares of our common stock, which were unregistered and restricted shares. We issued 420,000 unregistered shares of common stock into an escrow account, to be held for 6 months and then released in tranches over the following one year period ending 18 months following the closing of the transaction. As of September 30, 2013 245,000 shares of common stock have been released from the escrow account. An additional 60,000 shares of common stock were issued into escrow to be held for an 18-month period as security for indemnification claims that may arise in connection with the asset purchase transaction or the related business.

We accounted for the acquisition of To Go Brands in accordance with ASC 805 “Business Combinations”.accompanying consolidated financial statements.

The unaudited pro forma consolidated financial information for the three months and nine months ended September 30, 2012 is as follows:

Pro Forma Combined for the Acquisitionfollowing results of operations of To Go Brands, Inc. and the expense associated with the write-off of the remaining recorded value of the technology licenses associated with the nutraceutical business are presented as a loss from a discontinued operation in the consolidated statements of operations:

 

   For The Three Months Ended
September 30, 2012
  For The Nine Months Ended
September 30, 2012
 

Net Sales

  $410,582   $2,134,868  

Net (loss)

   (2,160,729  (6,924,110

Net (loss) per common share - basic and diluted

  $(0.34 $(1.12

Weighted average common shares outstanding - basic and diluted

   6,372,237    6,194,671  
   For the three
months ended
March 31, 2013
  Period from
December 22,
2003
(Inception) to
March 31, 2014
 

Revenues

   

Product sales

  $551,805   $2,454,086  

Cost of goods sold

   320,221    1,384,978  
  

 

 

  

 

 

 

Gross profit

   231,584    1,069,108  

Operating expenses

   

Research and development

   37,566    168,442  

Selling, general and administrative

   480,427    1,905,971  
  

 

 

  

 

 

 

Total operating expenses

   517,993    2,074,413  
  

 

 

  

 

 

 

Loss from operation

   (286,409)  (1,005,305)
  

 

 

  

 

 

 

Interest, net

   (139  (870
  

 

 

  

 

 

 

Net loss from discontinued operations of To Go Brands, Inc.

  $(286,548) $(1,006,175)

Write-off of technology licenses associated with the nutraceutical product lines

   0    (1,097,511

Net loss from discontinued operations

  $(286,548 $(2,103,686
  

 

 

  

 

 

 

Unaudited pro forma condensed consolidated financial information is presented above as if the To Go Brands acquisition had occurred at the beginning of the period shown. The results have been adjusted to account for the amortization of acquired intangibles and other pro forma adjustments. The pro forma information presented does not purport to present what actual results would have been had the acquisition occurred at the beginning of such periods, nor does the information project results for any future period. The pro forma information includes net sales of To Go Brands for the three and nine months ended September 30, 2012 totaling $404,993 and $2,095,627 respectively. Net (loss) for To Go Brands for the three and nine months ended September 30, 2012 was $(227,501), and $(444,783) respectively.

Note 4 - 4—Inventories

Inventories consisted of the following:

 

  September 30,
2013
 December 31,
2012
   March 31,
2014
 December 31,
2013
 

Raw materials

  $648,859   $515,244    $183,398   $183,398  

Finished goods

   201,553    748,687     0   0  
  

 

  

 

   

 

  

 

 
   850,412    1,263,931     183,398    183,398  

Less provision for obsolete inventory

   (27,177  (89,608   (48,567  (23,567
  

 

  

 

   

 

  

 

 

Inventories, net

  $823,235   $1,174,323    $134,831   $159,831  
  

 

  

 

   

 

  

 

 

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Note 5 –Intangible assets and strategic investment

Technology license fees and intangible assets consisted of the following:

   September 30, 2013 
   Cost   Accumulated
Amortization
   Net Asset 

Technology and product license fee

  $1,435,000    $337,489    $1,097,511  

Brands

   385,000     38,500     346,500  

Product formulas

   596,000     99,334     496,666  

Customer database

   77,000     15,400     61,600  
  

 

 

   

 

 

   

 

 

 
  $2,493,000    $490,723    $2,002,277  
  

 

 

   

 

 

   

 

 

 
   December 31, 2012 
   Cost   Accumulated
Amortization
   Net Asset 

Technology and product license fee

  $1,435,000    $236,682    $1,198,318  

Brands

   385,000     9,625     375,375  

Product formulas

   596,000     24,833     571,167  

Customer database

   77,000     3,850     73,150  
  

 

 

   

 

 

   

 

 

 
  $2,493,000    $274,990    $2,218,010  
  

 

 

   

 

 

   

 

 

 

Amortization expense for the three month period ended September 30, 2013 and September 30, 2012 was $71,910 and $33,602, respectively. Amortization expense for the nine month period ended September 30, 2013 and September 30, 2012 was $215,733 and $100,806, respectively.

Based on the carrying amount of the intangible assets as of September 30, 2013 the amortization expense for the next five years and thereafter is estimated as follows:

Year Ending December 31,

  Amount 

2013

  $71,909  

2014

   287,642  

2015

   287,643  

2016

   287,643  

2017

   283,792  

Thereafter

   783,648  
  

 

 

 

Total

  $2,002,277  

Note 6 - 5—Accrued Liabilities

Accrued Liabilities consisted of the following:

 

  March 31,   December 31, 
  September 30,
2013
   December 31,
2012
   2014   2013 

Payroll and benefits

  $315,716    $454,337    $655,809    $511,098  

Other

   48,831     160,520     83,835     99,909  
  

 

   

 

   

 

   

 

 

Total

  $364,547    $614,857    $739,644    $611,007  
  

 

   

 

   

 

   

 

 

Note 6—Stockholders’ Equity

Common Stock

-10-On September 28, 2010, we entered into a Sales Agreement (“Sales Agreement”) with Brinson Patrick Securities Corporation to enable us to use Brinson Patrick as a sales manager to sell shares of our common stock from time to time in “at-the-market” transactions pursuant to our shelf registration statement on a best efforts basis. During the first quarter of 2013, we raised net proceeds of $65,743 through the sale of 17,187 shares of common stock under at-the-market transactions under our sales agreement with Brinson Patrick Securities Corporation.


On February 28, 2014, the Company entered into a strategic collaboration and funding arrangement with Shanxi Taxus Pharmaceuticals Co., Ltd., which is based in the Peoples Republic of China (PRC) and is affiliated with Shenzhen Forntsea Taxus Industry Capital Management (“Shanxi Taxus”), to support the worldwide clinical and commercial development of Cardium’s advanced regenerative medicine therapeutics products, including the Generx product candidate and Excellagen. In connection with the agreement, Shanxi Taxus acquired an initial tranche of $0.5 million in unregistered common stock by purchasing 714,286 shares of common stock at $0.70 per share.

Note 7 - The second tranche of funding was delayed while Chinese currency clearance procedures were completed. On May 12, 2014, Shanxi Taxus acquired the second tranche of $1.5 million by purchasing 2,330,278 shares of common stock at $0.6437 per share.

After completion of the second tranche, Shanxi Taxus held approximately 25% of the outstanding common stock of the Company without giving effect to the shares of common stock obtainable upon conversion of preferred shares held by Sabby Healthcare—or approximately 22% of the common stock giving effect to the shares of common stock obtainable by Sabby Healthcare.

While Shanxi Taxus had the right to complete a third tranche of $1.0 million of common stock at a 10% premium above the trailing market price by April 30, 2014, with funding delayed for currency clearance, they closed on the second tranche for $1.5 million (which amount has been received), and committed to promptly provide a minimum of $0.3 million toward the third tranche (which is expected to be cleared shortly), each at a 10% premium above the trailing market price.

Although Shanxi Taxus originally had a right to purchase fourth and fifth tranches of $1.0 million each, with the third tranche not timely closed for the full amount, they will no longer have a contractual right to purchase additional shares pursuant to the terms of the February stock purchase agreement. While we and Shanxi Taxus could mutually agree to effect additional share purchases pursuant to the February agreement or otherwise, they would be at the Company’s discretion with terms to be determined.

The common stock issued to Shanxi Taxus is unregistered, but under the terms of the Stock Purchase Agreement, we agreed to grant the investor piggyback registration rights in the event that the Company files a registration statement for other shares of common stock after the exclusive financing period with the strategic investor ends. No warrants were issued in connection with the transaction.

Preferred Stock Transaction

In April 2013, we entered into a securities purchase agreement with Sabby Healthcare, one of our institutional investors pursuant to which we agreed to sell to the investor an aggregate of 4,012 shares of our newly authorized Series A Convertible Preferred Stock, for a total purchase price of $4.0 million. No warrants will bewere issued in connection with this offering, other than 44,087 placement agent warrants with an exercise price of $2.275 per share and an expiration date of August 27, 2015. The securities purchase agreement provided for the sale of Series A Convertible Preferred Stock in two closings. The initial closing under the securities purchase agreement took place in April 2013, at which we sold 2,356 shares of Series A Convertible Preferred Stock for aggregate net proceeds of $2,160,000. A second closing for the remaining 1,656 shares of Series A Convertible Preferred Stock for aggregate net proceeds of $1,532,000 took place promptly after shareholder approval of the offering of the Series A Convertible Preferred Stock and the 1 for 20 reverse stock split of our outstanding common stock. That closing took place on July 18, 2013. Prior to September 30, 2013March 31, 2014 the investor had converted 1,4312,626 shares of Series A Convertible Preferred Stock into 1,269,1262,460,652 shares of common stock. As a result of the conversion, 2,580.91,386 shares of Series A Convertible Preferred Stock were outstanding at September 30, 2013.March 31, 2014.

The holders of our Series A Convertible Preferred Stock are entitled, on an as-converted basis, to dividends equal to and in the same form as any dividends declared and issued on our common stock. Except as required by law, holders of Series A Convertible Preferred Stock are not entitled to voting rights. Upon any liquidation, dissolution or winding up, holders of the Series A Convertible Preferred Stock will be entitled to a liquidation preference above the holders of common stock or any other junior stock in an amount equal to the original purchase price of $1,000, plus any fees, damages or dividends arising. The Series A Convertible Preferred Stock is convertible into shares of our common stock at the option of the holder, subject to a beneficial ownership limitation of 9.99%. The initial conversion price was $1.82 per share after giving effect to the reverse stock split, but was subsequently reset and is currently $0.6437 per share; the conversion price is subject to $1.02 per share.downward adjustment if we issue common stock or common stock equivalents at a price less than the then effective conversion price. We have the right to force conversion if the volume weighted average price for our common stock exceeds $12.00 per share for 25 trading days during a 30 consecutive trading day period and certain other equity conditions are met.

As long as any shares of Series A Convertible Preferred Stock are outstanding, we have agreed that we will not, without the consent of the holders of two-thirds of the Series A Convertible Preferred Stock, incur indebtedness other than specified “Permitted Indebtedness”, incur any liens other than specified “Permitted Liens”, amend our Certificate of Incorporation in any manner that adversely affects the Series A Convertible Preferred Stock, repurchase or redeem any common stock or common stock equivalents, pay dividends on our common stock, or enter into any related party transactions.

In connection with the convertible preferred stock, the Company determined the instrument contained a beneficial conversion feature at the date of issuance. This beneficial conversion feature amounted to $233,011 for the April transaction and was recorded as a deemed preferred dividend in April 2013. The beneficial conversion feature on the July transaction amounted to $172,861 and was recorded as a deemed preferred dividend in July 2013.

Note 8 - Stock Option ActivityOptions and Other Equity Compensation Plans

We have an equity incentive plan that was established in 2005 under which 283,292 shares of our common stock options have been reserved for issuance to our employees, non-employee directors and consultants.consultants of the Company.

On February 28, 2014 the Company issued 1,457,100 common stock warrants to directors, officers and our chief medical advisor. The warrants were approved by the Board of Directors, have a ten year term and an exercise price of $0.80 per share, which represents a 57% premium to the closing stock price on the date of issuance.

At March 31, 2014 the following shares were outstanding and available for future issuance under the option plan:

Plan

  Shares Outstanding   Shares Available
for Issuance
 

2005 Equity Incentive Plan

   144,000     139,058  

The following is a summary of stock option and warrant activity under our equity incentive plan and warrants issued outside of suchthe plan to our employees and consultants, during the ninethree months ended September 30, 2013. At September 30, 2013March 31, 2014:

   Number of
Options or
Warrants
  Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Life
(in years)
 

Balance outstanding, December 31, 2013

   144,000   $31.80     2.1  

Granted

   1,457,100   $0.80     9.9  

Exercised

     

Cancelled

   (0 $00.00     0  

Cancelled (unvested)

   (0 $00.00     0  

Expired (vested)

     
  

 

 

  

 

 

   

 

 

 

Balance outstanding, March 31, 2014

   1,601,100   $3.58     9.2  
  

 

 

  

 

 

   

 

 

 

Balance exercisable, March 31, 2014

   1,601,100   $3.58     9.2  
  

 

 

  

 

 

   

 

 

 

As of March 31, 2014 there was no intrinsic value into the outstanding options.and exercisable options and warrants.

   Number of
Options or
Warrants
  Weighted Average
Exercise Price
   Weighted
Average
Remaining
Contractual
Life
(in years)
 

Balance outstanding, January 1, 2013

   177,750   $33.40     2.3  

Granted

   0    0.00     0  

Exercised

   0    0.00     0  

Expired (vested)

   (20,750  41.18     0  

Cancelled (unvested)

   (2,844  14.80     0  
  

 

 

  

 

 

   

 

 

 

Balance outstanding, September 30, 2013

   154,156   $32.75     2.25  
  

 

 

  

 

 

   

 

 

 

Exercisable, September 30, 2013

   153,479    32.83     2.25  
  

 

 

  

 

 

   

 

 

 

At September 30, 2013 we had no unamortized stock option expense.

Warrants

-11-


Note 9 - Common Stock Purchase Warrants

In connection with various financing transactions we have issued common stock purchase warrants to investors. The following table summarizes warrant activity issued with financing transactions for the ninethree months ended September 30, 2013:March 31, 2014:

 

  Number of
Warrants
 Weighted Average
Exercise Price
   Weighted
Average
Remaining
Contractual
Life
(in years)
   Number of
Warrants
 Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Life
(in years)
 

Balance outstanding, January 1, 2013

   1,369,321   $19.00     2.1  

Balance outstanding, December 31, 2013

   978,830   $19.82     1.9  

Warrants issued

   44,087    2.28     2.2       

Warrants exercised

   0    0.00     0       

Warrants expired

   (291,452  16.42     0     (79,765 $40.00    

Warrants cancelled

   0    0.00     0       
  

 

  

 

   

 

   

 

  

 

   

 

 

Balance outstanding, September 30, 2013

   1,121,956   $19.20     1.9  

Balance outstanding, March 31, 2014

   899,065   $18.03     1.77  
  

 

  

 

   

 

   

 

  

 

   

 

 

Warrants exercisable at September 30, 2013

   1,077,868   $19.80     1.9  

Warrants exercisable at March 31, 2014

   899,065   $18.03     1.77  
  

 

  

 

   

 

   

 

  

 

   

 

 

The following table summarizes warrant by exercise price range asAs of September 30, 2013:March 31, 2014 there was no intrinsic value to the outstanding and exercisable options.

   Number of
Warrants
   Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Life
(in years)
 

Warrants by Price Range

      

Warrants priced between $2.28 and $12.80

   670,938    $11.79     2.2  

Warrants priced between $18.00 and $44.00

   451,018    $30.46     1.34  
  

 

 

   

 

 

   

 

 

 

Balance outstanding, September 30, 2013

   1,121,956    $19.20     1.9  
  

 

 

   

 

 

   

 

 

 

Note 10 - Segment Information7—Subsequent Events

Effective October 1, 2012, we commenced reportingUnder the resultsterms of our operations in two segments; Pharmaceutical Products and Nutraceutical Products. We established these two segments following our acquisition of To Go Brands, which presented us with a turn-key opportunityStock Purchase Agreement, Shanxi Taxus agreed to acquire a limited but established portfolio of nutritional supplement or “nutraceutical” products. We manage these two segments separately due to inherent differences in the nature of pharmaceutical and nutraceutical products. Pharmaceutical products are subject to significantly more stringent regulatory approval standards than nutraceutical products; there are material differences in the cost, time and effort we must expend to develop and test pharmaceutical products, each of these product categories have distinctly different marketing channels and the initial sales ramp is much slower for our products in the Pharmaceutical segment.

The Nutraceutical segment of our business includes the purchasing, packaging, selling and distributionpurchase shares of the To Go Brands portfolio of products that we acquired on September 28, 2012. The Pharmaceutical segment of our business, which is our core and planned principal operation, includes the development, testing and clinical trials of Generx and Excellagen products. We do not have an internal sales force for our pharmaceutical products and will rely on strategic partnerships and distribution agreementsCompany’s unregistered common stock in the U.S. and internationally. We have distributed samples and made initial sales of Excellagen and have entered into distribution agreements for future sales growth.

-12-


The following ismultiple tranches, each at a summary of certain financial data for each of our business segments:

   Three Months
Ended September 30,
2013
   Three Months
Ended September 30,
2012
   Nine Months
Ended September 30,
2013
   Nine Months
Ended September 30,
2012
 

Net Sales

      

Pharmaceutical

  $19,200    $5,589    $109,200    $39,241  

Nutraceutical

   452,366     0     1,546,142     0  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

   471,566     5,589     1,655,342     39,241  
  

 

 

   

 

 

   

 

 

   

 

 

 
   Three Months
Ended September 30,
2013
   Three Months
Ended September 30,
2012
   Nine Months
Ended September 30,
2013
   Nine Months
Ended September 30,
2012
 

Operating Loss

      

Pharmaceutical

   1,527,288     1,896,124     5,358,770     6,432,331  

Nutraceutical

   241,717     0     788,917     0  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

   1,769,005     1,896,124     6,147,687     6,432,331  
  

 

 

   

 

 

   

 

 

   

 

 

 

   September 30,
2013
   December 31,
2012
 

Identifiable Assets

    

Pharmaceutical

   2,965,139     7,167,478  

Nutraceutical

   2,164,071     641,400  
  

 

 

   

 

 

 

Total

  $5,129,210    $7,808,878  

-13-


Note 11 - Subsequent Events:

On November 15th 2013, subsequent10% premium to the period covered by this report,then-current trailing average market prices of the Company sold its To Go Brands® business to Healthy Brands Collective® in exchange for an equity stake in Healthy Brands preferred stock which convertible intoCompany’s common stock currently represents approximately 4%at the time of their fully-dilutedeach closing. We closed the second tranche of funding on May 12, 2014 by selling 2,330,278 shares of common stock and the assumptionat $0.6437 per share, based on a trailing average price, resulting in net cash proceeds of approximately $300,000 of liabilities. Healthy Brands Collective® is a fast growing private company that has acquired a portfolio of eight independent brand product platforms (prior to To Go Brands) including Cell-nique®, Cherrybrook Kitchen®, Yumnuts®, Living Harvest/Tempt®, Bites of Bliss®, High Country Kombucha® drinks and Organics European Gourmet Bakery (formerly Dr. Oetker) natural and organic baking mixes. Healthy Brands expects to make additional brand acquisitions and has previously reported plans to move forward as a public company as its business advances. Cardium, through its health sciences unit, will retain the trademarks and technology relating to the MedPodium nutra-apps and nutraceutical product line and will retain its investment interest in SourceOne, a leading nutraceutical and health sciences ingredient supplier. A Form 8-K will be filed within four days of the sale which will include the required pro forma financial statements.$1,477,000.

-14-


ITEM 2.ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis is intended to help you understand our financial condition and results of operations for the three and nine months ended September 30, 2013.March 31, 2014. You should read the following discussion and analysis together with our unaudited condensed consolidated financial statements and the notes to the condensed consolidated financial statements included under Item 1 in this report, as well as the risk factors and other information included Part II, Item 1A, in our annual report on Form 10-K for our year ended December 31, 20122013 (our “2012“2013 Annual Report”), and other reports and documents we file with the United States Securities and Exchange Commission (“SEC”). Our future financial condition and results of operations will vary from our historical financial condition and results of operations described below.

Executive Overview

The following overview does not address all of the matters covered in the other sections of this Item 2 or other items in this report or contain all of the information that may be important to our stockholders or the investing public. This overview should be read in conjunction with the other sections of this Item 2 and this report.

We are a medical technology company primarilydevelopment-stage regenerative medicine biotechnology company. We are focused on the development of advanced regenerative therapeutics designed to promote the activation and commercializationgrowth of novel(1) microvascular circulation to enhance perfusion of ischemic cardiac tissue as a potential treatment for heart disease; and (2) granulation tissue as a treatment for chronic non-healing wounds. We have a commercial FDA-cleared wound care product, a late clinical stage cardiovascular gene therapy product candidate and corresponding technology platforms as outlined below. We also own non-core interests in the Healthy Brands Collective, a health products and devices. We are currently operating in four primary business lines through our four operating subsidiaries: Activation Therapeutics, Inc., Angionetics Biologics, Inc., To Go Brands, Inc.company, and LifeAgain Insurance Solutions, Inc. We report in two business segments. Our Pharmaceutical Products segment includes the operations of our Activation Therapeutics, Inc. and Angionetics Biologics, Inc. subsidiaries. Activation Therapeutics, Inc. is developing and commercializing late-stage line of regenerative medicine product candidates including Excellagen®. Angionetics Biologics, Inc. is developing innovative cardiovascular products including Generx® Our Nutraceutical Products segment includes the operations of our To Go Brands, Inc. subsidiary and is developing and marketing a line of nutraceuticals and other healthy lifestyle products. Our LifeAgain Insurance Solutions, Inc. subsidiary is a life insurance business focused on, an advanced medical data analytics and is advancing toward commercialization.business.

Our business is focused on the acquisition and strategic development and partnering or other monetization of product opportunities or businesses having the potential to address significant unmet medical needs, and having definable pathways to commercialization, and on partnering or other monetization following the achievement of corresponding development objectives. Consistent with the Company’s long-term business strategy, as previously reported, Taxus Cardium does not plan to build inventory or establish an internal marketing and sales force to directly support the commercialization of Excellagen, but continues to credentialize Excellagen in preparation for the completion of strategic partnerings for various vertical channel market opportunities or asset monetization. The Company has continued to pursue a CE mark certification for Excellagen, has fully responded to all information requested by the notified body, and looks forward to completing this process. Consistent with our overall business strategy, as our product opportunities and businesses are advanced and corresponding valuations established, we intend to consider various corporate development transactions designed to place our product candidates into larger organizations or with partners having existing commercialization, sales and marketing resources, and a need for innovative products. Such transactions could involve the sale, partnering or other monetization of particular product opportunities or businesses.

Recent Developments

During the nine months ended September 30, 2013, we continued our efforts to advance the clinicaldevelopment of Generx, continued the commercialization of Excellagen, sold To Go Brands, Inc. and completed development of our biologicfirst LifeAgain product Generx, commercialize our wound healing product Excellagen, integrateoffering. During the three months ended March 31, 2014, we entered into a strategic cooperation agreement and expand the business from our recent acquisition of To Go Brands, Inc., and develop our LifeAgain insurance product in conjunctionfinancing arrangement with strategic partners. Highlights for the first nine months of 2013Shanxi Taxus Pharmaceuticals Ltd. Recent highlights include the following:

Angionetics Biologics, Inc.—Generx Development

Generx (Ad5FGF-4)® (alferminogene tadenovec/CardioNovo®) is a disease-modifying regenerative medicine biologic that isan innovative DNA-based angiogenic therapy being developed to offer a one-time, non-surgical option for the potential treatment of myocardial ischemia in patients with stable angina due to advanced coronary artery disease, who might otherwise require surgicaldisease. Generx is designed to stimulate and mechanical interventions, such as coronary artery by-pass surgery or balloon angioplasty and stents. Similarpromote the growth of supplemental collateral vessels to surgical/mechanical revascularization approaches, the goal of our Generx product candidate is to improveenhance myocardial blood flow to the heart muscle – but to do so non-surgically,(perfusion) following a singleone-time intracoronary administration from a standard balloon angioplasty catheter. Thecardiac infusion catheter in patients who have insufficient blood flow due to atherosclerotic plaque build-up in the coronary arteries. Developments with respect to Generx include:

Continued our Generx ASPIRE Phase 33/ registration isstudy, a 100-patient, randomized and controlled multi-center study currently being conductedenrolling patients at up to nine leading cardiology centers in the Russian Federation to evaluate the therapeutic effects of Generx infor patients with myocardial ischemia due to coronary artery disease. For additional information aboutThe ASPIRE study 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 the ASPIRE clinical study, please visit www.cardiumthx.com/generx.html. Recent developments with respectelsewhere. The efficacy of Generx is being quantitatively assessed using rest and stress SPECT (Single-Photon Emission Computed Tomography) myocardial imaging to Generx include: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,

 

Advanced forward our Generx ASPIRE Phase 3/ registration study, a 100-patient, randomized and controlled multi-center study currently enrolling patients at up to nine leading cardiology centers in the Russian Federation for patients with myocardial ischemia due to coronary artery disease. The ASPIRE study is designed to further evaluate the safety and effectiveness of our 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 is being quantitatively assessed using rest and stress SPECT (Single-Photon Emission Computed Tomography) myocardial imaging to 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, is the central core lab for the study and is responsible for the analysis of SPECT myocardial imaging data electronically transmitted from the Russian medical centers participating in the ASPIRE study. The Russian Health Authority has assigned Generx the therapeutic drug trade name of Cardionovo® for marketing and sales in Russia.

 

Published important Generx findings in the peer-reviewed journalHuman Gene Therapy Methods that demonstrate that Cardium’s innovative technique employing transient cardiac ischemia can be used to dramatically enhance gene delivery and transfection efficiency after one-time intracoronary administration of adenovector in mammalian hearts. These finding have been incorporated into the treatment protocols of the Generx ASPIRE Phase 3 study.

-15-

Presented at the 2013 Phacilitate Annual Cell & Gene Therapy Forum in Washington, DC,, “Optimizing Phase III Trial Design for Generx® (Ad5FGF-4)” reporting on adaptive coronary collateral growth, the biological processes to be targeted by therapeutic angiogenesis, and discussed the lessons learned during the past decade of the Company’s Generx clinical development program.

Commercialization of Excellagen


PublishedOn October 3, 2011, our Tissue Repair Company subsidiary received a 510(k) premarket notification from the article, “Mechanistic, Technical,U.S. Food and Clinical Perspectives in Therapeutic Stimulation of Coronary Collateral Development by Angiogenic Growth Factors, authored by Gabor M. Rubanyi, M.D., Ph.D., Cardium’s Chief Scientific Officer, in the April issue of Molecular Therapy publication. The publication outlines current scientific knowledge about the mechanistic basis of adaptive coronary collateral growth, the biological processes to be targeted by therapeutic angiogenesis, and the optimization of clinical trial designs, including the Generx ASPIRE Phase 3 / registration study.

Activation Therapeutics, Inc.—Excellagen Commercialization

Excellagen is a syringe-based, professional-use, pharmaceutically-formulated 2.6%Drug Administration (FDA) for its fibrillar Type I bovine collagen homogenate that functions as an acellular biological modulator to activate thecollagen-based Excellagen® topical gel for wound healing processof diabetic foot ulcers and significantly accelerate the growth of granulation tissue.other dermal wounds. Our 510(k) filing covers Excellagen’s FDA clearance providesuse as a wound care management medical device for very broad labeling including partial and full-thicknesstopical application by health care professionals for patients with dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence),and trauma wounds, (abrasions, lacerations, second-degreesecond degree burns, and skin tears) and drainingother types of wounds. Developments with respect to Excellagen is intended for professional use following standard debridement procedures in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors. Excellagen’s unique fibrillar Type I bovine collagen homogenate formulation is topically applied through easy-to-control, pre-filled, sterile, single-use syringes and is designed for application at only one-week intervals. For more information, visitwww.excellagen.com.

Distribution agreement with Kasiak Holdings AG for the marketing and sale of Excellagen in Germany and Switzerland.

Distribution agreement with AvKARE Inc., the Company’s new sales and distribution partner for Excellagen in Veterans Hospitals and other governmental medical facilities throughout the United States. The new agreement and commercialization arrangement with AvKARE effectively replaces an earlier arrangement with Academy Medical, LLC. Cardium elected to transfer the Excellagen distribution responsibilities to AvKARE, which provides five direct wound care experts and allows Cardium’s 25 distributor representatives access to all government accounts. AvKARE services a diverse customer base that includes government (federal, state and municipal) and commercial sectors

New FDA 510(k) clearance submission for the Company’s current FDA-cleared Excellagen to reflect additional and specific structural and functional properties based on the Company’s supplemental research and development activities.

Collaboration agreement with researchers at Boston Children’s Hospital, to assess the medical utility of Excellagen as a delivery scaffold to seed autologous mesenchymal fetal stem cells for ex-vivo engineering of tissue grafts for transplantation into infants to repair prenatally diagnosed birth defects.

Agreement with Orbsen Therapeutics Ltd and the National University of Ireland, Galway, to utilize Excellagen as a delivery agent for Orbsen’s proprietary stromal cell therapy in pre-clinical studies for the potential treatment of diabetic foot ulcers.

Presentation at the Symposium on Advanced Wound Care Spring 2013 Meeting highlighting Excellagen’s capability of promoting rapid granulation and complete wound dehiscence and healing in three difficult and complex post-surgical wounds, including Mohs surgery.

ISO 13485:2003 certification (a requirement for CE marking) for Excellagen by BSI, one of the world’s leading certification bodies, was received in first quarter 2013. With the completion of ISO certification, the Company reported that it had completed its initial submission of required documentation, including the technical file and design dossier for its CE mark application. The Company recently reported that since the initial submission, it has received requests for supplemental information from BSI. Based on the current status, all information requested has been provided to BSI and the Company believes this process should lead to CE mark certification for Excellagen.

To Go Brands—Integration and Expansion

Since 2007, To Go Brands has been making healthy, great tasting and anti-oxidant-rich phytonutrients and nutraceutical supplements in an array of easy use formats, including drink mixes, chews, powders and capsules, to empower busy lifestyles in today’s fast-paced, tech-driven world. The Go Active! product line includes High Octane®, Green Tea Energy Fusion™, Acai Natural Energy Boost™, and Neo-Energy®. The Go Healthy! product line includes Greens to Go®, Extreme Berries to Go®, Healthy Belly®, VitaRocks®, and Neo-Chill™. Go Trim! products include Smoothie Complete®, Trim Energy Green Coffee Bean™, Trim Energy®, and Neo-Carb Bloc®. To Go Brands products are sold through mass, food and drug channels at retailers including Target, Whole Foods, Sprouts, Kroger, GNC, RiteAid, Jewel-Osco, Ralph’s Supermarkets, Vitamin World, Meijer, Fred Meyer, King Soopers, and the Vitamin Shoppe, as well as directly from the company’s web-based store. To learn more about To Go Brands, visit www.togobrands.com.include:

 

  

We announced that To Go BrandsExcellagen® expanded its VitaRocks® kids vitamins product line and that retail distribution flowable dermal matrix in combination with Orbsen Therapeutics’ mesenchymal stromal stem cell therapy Cyndacel-M™ has been selected for clinical evaluation in a Phase 1b safety study for the potential treatment of chronic diabetic wounds to be funded by the newly-designed productsEuropean Union under EU Framework 7 (FP7). The project, known by the acronym “REDDSTAR” (Repair of Diabetic Damage by Stromal Cell Administration), is being broadenedcoordinated by Professor Timothy O’Brien, Dean of Medicine and Director of Ireland’s Regenerative Medicine Institute (REMEDI) at National University of Ireland Galway (NUI). The REDDSTAR preclinical studies evaluated the use of Taxus Cardium’s Excellagen® and an alternative collagen-based product to promote the maintenance of stem cell viability. The combination of Cyndacel-M™ and Excellagen® improved wound closure and neo-vascularization in a diabetic dermal wound healing model. Based on those results, Excellagen® was selected to be used with Cyndacel-M™ in a human clinical study.

Introduced FDA-cleared Excellagen® professional-use wound care product in March 2012 and entered into select nationwide Target stores.

a logistics and cold chain services agreement with Smith Medical Partners, a subsidiary of H. D. Smith.

 

Awarded ISO 13485 Certification for Excellagen, State of California manufacturing license and state clearances to market and sell Excellagen in the U.S., and advancement of other international registrations for Excellagen, including CE Mark registration, which we expect to receive approval within the next several weeks.

We also announced that because

Excellagen selected as one of the Top Ten Podiatry Innovations in 2012 byPodiatry Today publication, and awarded by the American Podiatric Medical Association’s Seal of Approval for Excellagen’s contributions to better foot health and mobility.

Formed the Excellagen Medical Advisory Board comprising leading practitioners, clinicians and researchers with diversified expertise in the field of advanced wound care, and Excellagen presentations and case studies at the Desert Foot 2012 High Risk Diabetic Foot Conference.

Advanced applications to support the reimbursement process for Excellagen with the Centers for Medicare & Medicaid Services and private insurance providers, and broadened marketing and sales efforts into markets with established CPT® codes for surgical debridement procedures and in-hospital surgical markets covered under DRG reimbursement systems.

Planned partner-enabled pilot Phase 2b/3 clinical study for Genedexa™ (Ad5PDGF-B) (previously referred to as the Excellarate™ product candidate). Genedexa’s initial clinical development focus will be for the treatment of chronic, non-healing diabetic foot ulcers. The Company has completed the MATRIX-1 (Phase 1/2) and MATRIX-2 (Phase 2b) clinical studies and the planned Genedexa pilot study represents an important next step forward towards FDA registration of Cardium’s advanced DNA biologic wound care product. Genedexa represents the first product candidate based on the Company’s Excellagen product platform and is comprised of the unique manufacturing processFDA-cleared Excellagen collagen matrix gel (6%) topical gel and an adenovector gene therapy with DNA encoding for PDGF-B protein. PDGF-B is believed to promote wound healing by directly stimulating cells involved in wound repair and also by eliciting the production of other growth factors. Genedexa, a DNA-based biologic, requires data from clinical studies demonstrating patient safety and efficacy prior to filing for a Biologic License Application.

Consistent with the Company’s long-term business strategy, as previously reported, Taxus Cardium does not plan to build inventory or establish an internal marketing and sales force to directly support the commercialization of Excellagen, but continues to credentialize Excellagen in preparation for the completion of strategic partnerings for various vertical channel market opportunities or asset monetization. The Company has continued to pursue a CE mark certification for Excellagen, has fully responded to all information requested by the certification body, and looks forward to completing this process.

Sale of To-Go Brands, Inc.

On November 15, 2013, the Company sold its To Go Brands® business to Healthy Brands Collective® in exchange for an equity stake in Healthy Brands preferred stock which, at the time of the transaction, was convertible into approximately 4% of their fully-diluted common stock, and Healthy Brands Collective’s assumption of approximately $370,000 of liabilities. Healthy Brands Collective® is a fast growing private company that has acquired a portfolio of eight independent brand product platforms (prior to To Go Brands) including Cell-nique® , Cherrybrook Kitchen® , Yumnuts® , Living Harvest/Tempt® , Bites of Bliss® , High Country Kombucha® drinks and Organics European Gourmet Bakery™ (formerly Dr. Oetker) natural and organic baking mixes. Healthy Brands expects to make additional brand acquisitions and has previously reported plans to move forward as a public company as its business advances. As a result of the sale, management determined it appropriate to discontinue the nutraceutical operations which led to the sale of To Go Brands’ VitaRocksBrands Inc., and to write off the unamortized balance of our technology licenses which was focused on that product line. Accordingly, the activities of To Go Brands, Inc. are reflected in the accompanying financial statements as discontinued operations.

The purchase price was 33,441 shares of preferred stock (representing approximately 4% of the outstanding shares of common stock of Cell-nique Corporation in a fully diluted basis) of Cell-nique (parent company of Healthy Brands). Since Cell-nique Corporation is a private company we have recorded the value of those shares of preferred stock on our balance sheet as an investment in Cell-nique Corporation, at the net asset value of the net assets transferred (cost) to Cell-nique Corporation. The Company periodically reviews the carrying amount of its investment in Cell-nique to determine whether the value is impaired or a write down may be necessary for an other than temporary decline in value.

LifeAgain Insurance Solutions

During 2013, we completed the initial product development of LifeAgain™, a medical analytics and social media-driven enabled e-commerce platform we now have the flexibility to expand the product line into formulas that could include enzymes, electrolytes, amino acids, vitamins and minerals, as well as nutrients, and into other applications including OTC drugs.

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LifeAgain™ Insurance Solutions—Product Development

During the third quarter, LifeAgain Insurance Solutions, Inc., Cardium’s newly-formed advanced medical data analytics businessis focused on the development, marketing and saledirect sales of “survivable risk”new and innovative survivable risk, multi-year, non-convertible level term life insurance programs and AgencyONE, its commercialization partner, entered into agreements to marketother insurance products, that are currently non-accessible and sell termunaffordable for certain sub-groups of highly motivated buyers considered “uninsurable” based on traditional underwriting standards by U.S. life insurance issued by Symetra Life Insurance Company under LifeAgain’s BlueMetric Select termcompanies. Traditional life insurance program for men with active localized prostate cancer. The BlueMetric Select program washas become over-optimized web-marketed, undifferentiated, low priced commodity largely marketed to healthy people. LifeAgain is being developed based on LifeAgain’s Advanced Medical Data Analytics Platform Technology (ADAPT)improvements in relative mortality in certain sub-group populations, including cancer patients and was specifically designedpatients with chronic medical diseases, as a result of the success of early diagnostic screening, public education, the introduction of advanced drugs and biologics, improved and optimized therapies, and expanding access to provide eligible menhealthcare. We released the first product aimed at individuals with term life insurance coverage following a prostate cancer diagnosis or uponin 2013. The Company plans to potentially support the completiongrowth and development of a prostate cancer surgery, without the traditional multi-year waiting periodsthis non-core business and additional medical re-qualifications generally required by most life insurance companies.

The BlueMetric Select program has been designed for men aged 45-65, who are in otherwise good health and who have low- to medium-risk active localized prostate cancer, which has been confirmed by a recent biopsy, and for men who have recently completed prostate cancer surgery. This program seeks to provide term life insurance coverage and may include an automatic renewal option (following the initial ten-year term), the right to convert into universal life insurance, and an accelerated benefit in the event of a terminal illness. The BlueMetric Select Program is designed to offer substantial coverage levels, ranging from $100,000 to $1,000,000, without waiting periods, so an individual can begin the application process on the day of his prostate cancer diagnosis, or immediately following completion of prostate cancer surgery. Additional information is at www.lifeagain.com.

LifeAgain’s proprietary Advanced Medical Data Analytics Platform Technology enables a scalable, actuarial-based risk assessment based on a diagnostic histological biopsy or a prostate cancer surgery. Together with an applicant’s overall health, these factors may be used to support favorable underwriting decisions and to establish appropriate premium pricing based on the level of prostate cancer progression of each applicant. LifeAgain is developing additional new and innovative insurance solutions for other medical conditions currently considered uninsurable by traditional underwriters.

In April 2013 we entered into a financing transaction involvingtechnology platform through the sale of newly authorized Series A Convertible Preferred Stock. Details of the financing transaction are discusseda minority stake in “Liquidity and Capital Resources” below.our LifeAgain business to a strategic partner or financial investors.

Cooperation Agreement with Shanxi Taxus Pharmaceuticals Ltd.

On November 15th 2013, subsequent toFebruary 28, 2014, after the period covered by this report, we sold ourentered into a collaboration and financing arrangement with Shanxi Taxus Pharmaceuticals Co., Ltd. (“Shanxi Taxus”), a strategic corporate investor based in China, pursuant to Go Brands® businesswhich the parties agreed to Healthy Brands Collective®collaborate on the advancement of the Company’s product opportunities in exchange for a $2.5 million equity stake in Healthy Brands preferred stockChina, and the assumptioninvestor’s product opportunities in the United States. The arrangement is reflected in two definitive agreements, each dated as of approximately $300,000February 21, 2014, which were concluded and delivered on February 28, 2014, in connection with the first tranche of liabilities. Detailsfunding under the financing arrangement. Under the terms of a collaboration agreement, Shanxi Taxus agreed to apply commercially reasonable efforts to assist Cardium to develop and refine a plan or plans pursuant to which Cardium products, particularly its Generx® and Excellagen® product opportunities, could be commercialized in China; and Cardium agreed that it will, upon request, apply commercially reasonable efforts to assist Shanxi Taxus to develop and refine a plan or plans pursuant to which Shanxi Taxus’ oncology-related products and product opportunities could be commercialized in the United States. As part of the sale transaction areagreement the Company changed its name to Taxus Cardium Pharmaceuticals Group, Inc. In addition, the Company agreed to grant Shanxi Taxus certain board rights based on the level of its financing pursuant to the financing arrangement discussed in “Liquidity and Capital Resources”.below.

Critical Accounting Policies and Estimates

Our condensed consolidated financial statements included under Item 1 in this report have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of our financial statements in accordance with GAAP requires that we make estimates and assumptions that affect the amounts reported in our financial statements and their accompanying notes.

The preparationWe have identified certain policies such as derivative liabilities and stock option compensation expense that are calculated using the Binomial and Black-Scholes Option Model that we believe are important to the portrayal of our financial statements in conformity with accounting principles generally accepted in the United Statescondition and results of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. The most significant estimates include reserve for product returns, reserve for inventory, and valuing options and warrants using option pricing models.operations. These policies require the application of significant judgment by our management. We base our estimates on our historical experience, industry standards, and various other assumptions that we believe are reasonable under the circumstances.

Actual results could differ from these estimates under different assumptions or conditions. An adverse effect on our financial condition, changes in financial condition, and results of operations could occur if circumstances change that alter the various assumptions or conditions used in such estimates or assumptions. If we were to undervalue our derivative liabilities or stock option compensation expense we would understate the expense recognized in our consolidated statements of operation. Conversely if we were to overvalue our derivative liabilities and stock option compensation expenses we would overstate the expense recognized in our consolidated statements of operations. Our significant accounting policies are described in the notes to our financial statements.

Results of Operations

For the Three Months Ended March 31, 2014 compared to the Three Months Ended March 31, 2013

The Company generated $47,400 in revenue from the sale of Excellagen products associated with the introduction of the product to the market in the three months ended September 30,March 31, 2013, comparedbut did record any revenue for the same period in 2014. Consistent with the Company’s long-term business strategy, Taxus Cardium does not plan to September 30, 2012.build inventory or establish an internal marketing and sales force to directly support the commercialization of Excellagen, but continues to credentialize Excellagen in preparation for the completion of strategic partnerings for various vertical channel market opportunities or asset monetization.

RevenuesThere were no costs of goods sold for the three months ended September 30, 2013 were $471,566, primarily from sales of our To Go Brands product lines, along with salesMarch 31, 2014. Costs of Excellagen as further describedproduct sold in Note 10 to our consolidated financial statements. For the three months ended September 30, 2012 sales were $5,589 and were attributable to our initial distribution of our Medpodium Nutra-Apps nutraceutical products. The increase of $465,977March 31, 2013 was principally attributable to the purchase of To Go Brands in September 2012.$30,020.

Research and development expenses for the three months ended September 30, 2013March 31, 2014 were $315,178$243,544 compared to $508,342$724,876 for the same three month period last year.in 2013. The decrease of $193,164$481,332 was the result of decreases in in three expense categories: decreased costs associated withrelated to our Generx ASPIREAspire study, reductions in Russia based on timing of milestone paymentsproduction and reduced developmenttesting costs associated with Excellagen.for Excellagen, and a reduction in personnel costs.

Selling, general and administrative expenses for the three months ended September 30, 2013March 31, 2014 were $1,636,871$1,194,945 compared to $1,389,731$1,267,757 for the three months ended September 30, 2012.March 31, 2014. The $247,140 increase was primarily due toCompany implemented a number of cash savings initiatives during the inclusionsecond half of $370,000 of2013 which decreased certain expenses by approximately $493,000, including an overall 29% headcount reduction and salary reductions as well as savings in facility costs associated with the relocation of our corporate headquarters. These expense reductions were offset in the first quarter of 2014 by a non-cash expense of $454,756 associated with stock based compensation expense based on the Black-Scholes value of warrants issued during the period.

Net loss from continuing operations for the three months ended March 31, 2013 was $1,438,489 (including the $506,165 non cash stock based compensation expense $454,756 included in selling, general and administrative and $51,409 included in research and development expense) compared to $1,975,807 for the same period last year (which included only $40,750 of non-cash stock based compensation expense). The decrease in net loss was primarily a result of the decrease in operating expenses described above.

Net loss from discontinued operations for the three months ended March 31, 2013 was $286,548 as a result of the losses incurred by To Go Brands Inc. operations acquired in September 2012, offset by decreases in advertising, and professional fees.during that period.

Net loss for the three months ended September 30, 2013March 31, 2014 was $1,769,005,$1,438,489 (including the $506,165 non cash stock based compensation expense) compared to a net loss of $1,894,920$2,262,355 for the same period in the prior year. The decrease in net loss was primarily attributable to the decreases in Excellagen development costs and spending controls put in place partially offset by losses generated by To Go Brands.of 2013.

Nine months ended September 30, 2013 compared to September 30, 2012.

Revenues for the nine months ended September 30, 2013 were $1,655,342, primarily from sales of our To Go Brands product lines, along with sales of Excellagen as further described in Note 10 to our consolidated financial statements. For the nine months ended September 30, 2012 sales were $39,241 attributable to our distribution of our MedPodium Nutra-Apps nutraceutical products. The increase of $1,616,100 was principally attributable to the purchase of To Go Brands in September 2012.

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Research and development expenses for the nine months ended September 30, 2013 were $1,566,988 compared to $2,097,675 for the same nine month period last year. The decrease of $530,687 was the result of decreases in expenses related to the development of our Excellagen product candidates, savings in travel and consulting costs offset by increased costs associated with our Generx ASPIRE study in Russia. Research and development expenses for the nine months ended September 30, 2013 included $350,000 associated with milestone payments and out of pocket costs of ASPIRE study and $100,000 of product and testing costs used to validate a production volume and cost efficiency improvement for Excellagen.

Selling, general and administrative expenses for the nine months ended September 30, 2013 were $5,258,129 compared to $4,358,706 for the nine months ended September 30, 2012. The $899,423 increase was primarily due to the inclusion of $1,176,000 of costs associated with To Go Brands, Inc. operations offset by decreases in advertising, insurance, investor relations and professional fees.

We derive interest income from the investment of our available cash in various short-term obligations, such as certificates of deposit, commercial paper and money market funds. Interest income for the nine months ended September 30, 2013 was $217 compared to $5,885 for the same nine month period last year. Interest expense for the nine months ended September 30, 2013 was $1,438 and $2,114 at September 30, 2012.

Net loss for the nine months ended September 30, 2013 was $6,148,908, roughly unchanged from a net loss of $6,364,403 in the same period for the prior year.

Liquidity and Capital Resources

As of September 30, 2013March 31, 2014, we had $585,201approximately $163,492 in cash and cash equivalents and ourequivalents. Our working capital deficit at March 31, 2014 was $679,380.approximately $1,521,000.

Net cash used in operating activities was $5,458,000$316,497 for the ninethree months ended September 30, 2013March 31, 2014 compared to $7,068,000$2,074,196 for the ninethree months ended September 30, 2012.March 31, 2013. The decrease in net cash used in operating activities was due primarily to an increasespending and headcount reductions in product sales,the second half of 2013 and decreases in testingearly 2014 and process validation costs for the initial inventory ofadvances against payables made by our Excellagen topical treatment gel.CEO. Since inception, our operations have consumed substantial amounts of cash and we have had only limited revenues. From inception (December 22, 2003) to September 30, 2013,March 31, 2014, net cash used in operating activities amountedhas been $100,636,199.

We had no net cash used in investing activities for the three months ended March 31, 2014. Net cash used in investing activities since inception has been approximately $2,580,519 million. At March 31, 2014 we did not have any significant capital expenditure requirements.

During the three months ended March 31, 2014, cash flows from financing activities include the sale of 714,286 shares of common stock in transactions for net proceeds of $457,500. During the period subsequent to $99,752,000.March 31, 2014, cash flows from financing activities include the sale of 2,330,278 shares of common stock in transaction with net proceeds of approximately $1,477,000.

Our primary source of liquidity has been cash flows from financing activities and in particular proceeds from sales of our debt and equity securities. Net cash provided by financing activities was $3,743,000$457,500 for the ninethree months ended September 30, 2013.March 31, 2014. This includedwas the saleresult of 4,012a common stock equity financing with our strategic investor of 714,286 shares of Series A Convertible PreferredCommon Stock priced at $0.70 per share with net proceeds of $3,692,000, and 343,749 shares of common stock in at-the-market transactions in the first quarterno warrant coverage for net proceeds of $65,743.$457,500. From inception (December 22, 2003) to September 30, 2013March 31, 2014 net cash provided by financing activities amounted to $102,923,000.has been $103,380,210.

Net cash used in investing activities for the nine months ended

On September 30, 2013 was $28,000. Net cash used in investing activities since inception amounted to $2,585,000. At September 30, 2013 we did not have any significant capital expenditure requirements.

In April 2013,28, 2010, we entered into a securities purchase agreementSale Agreement with one of our institutional investors pursuantBrinson Patrick Securities Corporation which enables us to which we agreeduse Brinson Patrick as a sales manager to sell to the investor an aggregate of 4,012 shares of our newly authorizedcommon stock on a best efforts basis from time to time in “at-the-market” transactions pursuant to our shelf registration statement. During the year ended December 31, 2013 we raised $65,744 under this agreement, the majority of which was raised during the first quarter of 2013. The Sale Agreement required that we register the sale of our shares to Brinson Patrick Securities Corporation on a shelf registration statement on Form S-3. Because our common stock is no longer listed on a national exchange, we are not eligible to use a Form S-3 registration statement. Accordingly we do not anticipate additional sales under the Sales Agreement unless and until we regain listing on a national exchange.

On February 28, 2014, the Company entered into a strategic collaboration and funding arrangement with Shanxi Taxus Pharmaceuticals Co., Ltd., “Shanxi Taxus” which is based in the Peoples Republic of China (PRC) and is affiliated with Shenzhen Forntsea Taxus Industry Capital Management, to support the worldwide clinical and commercial development of Cardium’s advanced regenerative medicine therapeutics products, including the Generx product candidate and Excellagen. In connection with the agreement, Shanxi Taxus acquired an initial tranche of $0.5 million in unregistered common stock by purchasing 714,286 shares of common stock at $0.70 per share.

The second tranche of funding was delayed while Chinese currency clearance procedures were completed. On May 12, 2014, Shanxi Taxus acquired the second tranche of $1.5 million by purchasing 2,330,278 shares of common stock at $0.6437 per share.

After completion of the second tranche, Shanxi Taxus held approximately 25% of the outstanding common stock of the Company without giving effect to the shares of common stock obtainable upon conversion of preferred shares held by Sabby Healthcare—or approximately 22% of the common stock giving effect to the shares of common stock obtainable by Sabby Healthcare.

While Shanxi Taxus had the right to complete a third tranche of $1.0 million of common stock at a 10% premium above the trailing market price by April 30, 2014, with funding delayed for currency clearance, they closed on the second tranche for $1.5 million (which amount has been received), and committed to promptly provide a minimum of $0.3 million toward the third tranche (which is expected to be cleared shortly), each at a 10% premium above the trailing market price.

Although Shanxi Taxus originally had a right to purchase fourth and fifth tranches of $1.0 million each, with the third tranche not timely closed for the full amount, they will no longer have a contractual right to purchase additional shares pursuant to the terms of the February stock purchase agreement. While we and Shanxi Taxus could mutually agree to effect additional share purchases pursuant to the February agreement or otherwise, they would be at the Company’s discretion with terms to be determined.

Cardium and Shanxi Taxus are moving forward with plans to explore the commercialization of Cardium’s advanced regenerative medicine therapeutic products for the emerging and rapidly growing advanced healthcare market in China, and Shanxi Taxus oncology-focused product opportunities for the U.S. market; and for Mr. Jiayue Zhang, who is the Chairman of Shanxi Taxus, and an additional individual with U.S. corporate and financial experience, to join Cardium’s Board of Directors.

We believe that if we complete the $5.0 million funding under this financing arrangement or an alternative financing we will have sufficient capital to fund our operations until December 31, 2014.

We anticipate that negative cash flow from operations will continue for the foreseeable future. We do not have any unused credit facilities. As long as any shares of our Series A Convertible Preferred Stock for a total purchase price of $4.0 million. No warrants were issued in connection with this offering, other than placement agent warrants. The securities purchase agreement provided forare outstanding, we have agreed that we will not, without the sale of Series A Convertible Preferred Stock in two closings. Upon consummationconsent of the financing, which was subject to exchange and other approvals, the initial closing under the securities purchase agreement took place in April 2013. At that closing we sold 2,356 sharesholders of Series A Convertible Preferred Stock for net proceeds of $2,160,000. A second closing for the remaining 1,656 shares was completed following the shareholder approval of the offeringtwo-thirds of the Series A Convertible Preferred Stock, and the reverse stock split on July 18, 2013 with net proceeds of $1,532,000.

Our business model is designed to develop a diversified portfolio of product opportunities and businesses, leveraging our skills in late-stage product development in order to bridge the critical gap between promising new technologies and readiness for commercialization – and then to partner or monetize such product opportunities or businesses with established organizations capable of advancing their commercialization. Consistent with our business model and long-term strategy, we have already advanced and monetized a first business unit, InnerCool Therapies, Inc.incur indebtedness other than specified “Permitted Indebtedness”, which was sold to Philips Electronics North America Corporation.

We now have four additional business units in our portfolio: (1) Angionetics Biologics, which includes Cardium’s late-stage DNA-based Generx® cardiovascular biologic product candidate; (2) Activation Therapeutics, which includes the Company’s regenerative medicine wound healing technology platform, including its Excellagen® advanced wound care product; (3) To Go Brands®, which includes the Company’s health sciences and nutraceutical business; and (4) LifeAgain Insurance Solutions, Inc. which is focused on building the Company’s medical data analytics technology platform.

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These portfolio companies and their business, lead product or product candidate, and current commercial status are outlined on the schedule below.

Portfolio Company

Business Summary

Lead Product

Status

Activation Therapeutics Inc.Advanced Tissue Regeneration for Wounds & Biological Delivery PlatformExcellagen®Initial Product FDA-Cleared
Angionetics Biologics Inc.Cardiovascular Growth Factor TherapeuticsGenerx® Product CandidatePhase 3 Registration Study
To Go Brands Inc.Nutrition & Health SciencesPortfolio of 30 ProductsNationwide Commercial Sales at 15,000 Retail Locations
LifeAgain Insurance Solutions Inc.National Life Insurance Business Focused on Medical Data AnalyticsBlueMetric Select™ Term Life InsuranceAdvancing toward commercialization

During the three months ended September 30, 2013, we instituted a series of cost reduction actions that include relocation the corporate offices, reduced employee headcount and made across the board salary reductions. These measures are designed to reduce overall operating expenses. The impact of these measures will be reflected in the fourth quarter.

On November 15th 2013, subsequent to the period covered by this report, we sold our To Go Brands® business to Healthy Brands Collective®incur any liens other than specified “Permitted Liens”. The transaction was structured as an asset sale in exchange for a $2.5 million equity stake in Healthy Brands preferred stock and the assumption of approximately $300,000 of liabilities. Healthy Brands Collective® is a fast growing private company that has acquired a portfolio of eight independent brand product platforms including Cell-nique®, Cherrybrook Kitchen®, Yumnuts®, Living Harvest/Tempt®, Bites of Bliss®, High Country Kombucha® drinks and Organics European Gourmet Bakery (formerly Dr. Oetker) natural and organic baking mixes. Healthy Brands expects to make additional brand acquisitions and has previously reported plans to move forward as a public company as its business advances. Cardium will retain the trademarks and technology relating to the MedPodium nutra-apps and nutraceutical product line and will retain its investment interest in SourceOne, a leading nutraceutical and health sciences ingredient supplier.

The sale of the To Go Brands is intended to monetize that business by positioning it with a diversified, fast growing platform. Cardium’s preferred stock position in Cell-nique is convertible into common stock currently representing approximately 4% of the fully-diluted common stock, it accrues an 8% annual dividend, and it comes with certain rights and preferences described in Cell-nique’s articles of incorporation. Cardium could also elect to sell or otherwise monetize its preferred stock position in Cell-nique in one or more transactions. The transaction also includes the transfer of certain operating expenses and liabilities to Health Brands Collective, which will further reduce the Company’s operating expenses. A Form 8-K will be filed within four days of the sale which will include the required pro forma financial statements reflecting the impact of the transaction.

We intend to considersecure additional corporate development transactions designedworking capital through sales of additional debt or equity securities to placefinance our product candidates or businesses into larger organizations or with partners having existing commercialization, sales and marketing resources, and a need for innovative products. Such transactions could involve the sale, partnering or other monetization of particular product opportunities or businesses. In parallel, as our businesses are advanced and corresponding valuations established, we plan to pursue new product opportunities and acquisitions with strong value enhancement potential.

While we may partner or monetize one or more of our product opportunities or businesses consistent with our business model, the timing and success of those transactions cannot be assured and negative cash flow from operations are expected to continue for the foreseeable future. In order to maintain operations and liquidity, we expect we will need to complete a monetization of one or more product opportunities or business units, and/or complete a financing, before end of year.operations. Our principal business objective in the near term is to complete an additional strategic licensing agreement to advance sales of the Excellagen product family enter into a distribution arrangement to advance sales of our To Go Brands nutraceuticals business, and/or another corporate transaction. If we fail to receive sufficient proceeds from the partnering, sale or other monetization of product opportunities or businessesenter into an additional strategic licensing arrangement or generate sufficient product sales, we will not generate sufficient cash flows to cover our operating expenses.

        If needed, we intend to secure any additional financings in the form of sale of equity securities. Based on recently-issued amendments to Rule 506 and Rule 144A under the Securities Act of 1933 that were implemented under Section 201(a) of the Jumpstart Our Business Startups Act (the “JOBS Act”), and since we do not anticipate raising additional funds under our shelf registration statement or as debt within the next 12 months, such financings may be through the sale of private equity interests to Qualified Investors or strategic partners based on the JOBS Act amendments, and/or through other private placements or a public offering of securities, which could potentially be made in the parent company or independently in one or more of our subsidiary business units.

Our history of recurring losses and uncertainties as to whether our operations will become profitable raise substantial doubt about our ability to continue as a going concern. Our condensed consolidated financial statements do not include any adjustments related to the recoverability of assets or classifications of liabilities that might be necessary should we be unable to continue as a going concern.

Off-Balance Sheet Arrangements

As of September 30, 2013,March 31, 2014, we did not have any significant off-balance sheet arrangements.debt nor did we have any transactions, arrangements, obligations (including contingent obligations) or other relationships with any unconsolidated entities or other persons that have or are reasonably likely to have a material current or future effect on financial condition, changes in financial condition, results of operations, liquidity, capital expenditures, capital resources, or significant components of revenue or expenses material to investors.

ITEM 3.ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Under the rules and regulations of the SEC, as a smaller reporting company we are not required to provide the information required by this item.

 

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ITEM 4.ITEM 4.CONTROLS AND PROCEDURES

We maintain certain disclosure controls and procedures. They are designed to help ensure that material information is: (i) gathered and communicated to our management, including our principal executive and financial officers, on a timely basis; and (ii) recorded, processed, summarized, reported and filed with the SEC as required under the Securities Exchange Act of 1934, as amended.

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2013.March 31, 2014. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective for their intended purpose described above.

There were no changes to our internal control over financial reporting during the quarterly period ended September 30, 2013March 31, 2014 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.

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PART II – OTHER INFORMATION

 

ITEM 1.ITEM 1.LEGAL PROCEEDINGS

As of September 30, 2013March 31, 2014 neither Cardium nor its subsidiaries were a party to any material pending legal proceeding nor was any of their property the subject of any material pending legal proceeding. In the course of our business, however, we could become engaged in various intellectual property, product-related, and other matters in connection with the technology we develop or license and the products we develop or sell. To the extent we are not successful in defending against any adverse claims concerning our technology, business relationships or products, we could be compelled to seek licenses from one or more third parties who could be direct or indirect competitors and who might not make licenses available on terms that we find commercially reasonable or at all, or to pay other forms of compensation or expenses. In addition, any such proceedings, even if decided in our favor, involve lengthy processes, are subject to appeals, and typically result in substantial costs and diversion of resources. In the course of our business, we are also routinely involved in proceedings such as disputes involving goods or services provided by various third parties to us,Cardium or its subsidiaries, which we do not consider likely to be material to us,Cardium, but which can nevertheless result in costs and diversions of resources to pursue and resolve.

 

ITEM 1A.ITEM 1A.RISK FACTORS

In addition to the risk factors described below, a number of risk factors that could materially affect our business, product candidates, financial condition and results of operations are disclosed and described in our 20122013 Annual Report. You should carefully consider the risks described below and under Item 1A of our 20122013 Annual Report, as well as the other information in our 20122013 Annual Report, this report and other reports and documents we file with the SEC, when evaluating our business and future prospects. If any of the identified risks actually occur, our business, financial condition and results of operations could be seriously harmed. In that event, the market price of our common stock could decline and you could lose all or a portion of the value of your investment in our common stock. Information about our products are available through the additional website addresses,www.excellagen.com;www.lifeagain.com; andwww.healthbrandsco.com.

Risks Related to Our Business and Industry

Our products and product candidates are subject to ongoing regulatory requirements or require regulatory approvals, and in some cases additional prior development or testing, before marketing. We will need substantial additional capitalmay be unable to develop, obtain or maintain regulatory approval or market any of our product candidates or expand the market of our existing products and fortechnology. If our futureproduct candidates are delayed or fail, we will not be able to generate revenues and cash flows from operations, in the near term. If we are unable to obtain such funds when needed,and we may have to delay, scale backcurtail or terminatecease our product development or our business.operations.

Conducting the costly and time consuming research, pre-clinical and clinical testing necessary to obtain regulatory approvals and bring our products to market will require a commitment of substantial funds in excess of our current capital. Our future capital

requirements will depend on many factors, including, among others: the progress of our current and new product development programs; the progress, scope and results of our pre-clinical and clinical testing; the time and cost involved in obtaining regulatory approvals; the cost of manufacturing our products and product candidates; the cost of prosecuting, enforcing and defending against patent claims and other intellectual property rights; competing technological and market developments; and our ability and costs to establish and maintain collaborative and other arrangements with third parties to assist in potentially bringing our products to market and/or to monetize the economic value of our product portfolio. We expect we will need to raise additional funds in the future. The audit opinion accompanying our consolidated financial statements, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, includes an explanatory paragraph indicating substantial doubt about our ability to continue as a going concern.

We will need substantial additional capital to develop our products and for our future operations in the near term. If we are unable to obtain such funds when needed, we may have to delay, scale back or terminate our product development or our business.

We will need to raise substantial additional capital to fund our future operations from the sale or other monetization of product opportunities or businesses and/or from additional financing.operations. We cannot be certain that product opportunities or businesses can be sold or otherwise monetized or that additional financing will be available on acceptable terms, or at all. In recent years, it has been difficult for companies to raise capital due to a variety of factors. To the extent we raise additional capital through the sale of equity securities or we issue securities in connection with another transaction, the ownership position of existing stockholders could be substantially diluted. Anti-dilution adjustments into our securities currently outstanding securities would cause further dilution. If additional funds are raised through the issuance of preferred stock or debt securities, these securities are likely to have rights, preferences and privileges senior to our common stock and may involve significant fees, interest expense, restrictive covenants and the granting of security interests in our assets. Fluctuating interest rates could also increase the costs of any debt financing we may obtain. Raising capital through a licensing or other transaction involving our intellectual property could require us to relinquish valuable intellectual property rights and thereby sacrifice long term value for short-term liquidity. If we sell or otherwise monetize one or more of our product opportunities or businesses, it could lower or actual or perceived value.

Our failure to successfully address ongoing liquidity requirements would have a substantially negative impact on our business. If we are unable to obtain additional capital on acceptable terms when needed, we may need to take actions that adversely affect our business, our stock price and our ability to achieve cash flow in the future, including possibly surrendering our rights to some technologies or product opportunities, delaying our clinical trials or curtailing or ceasing operations.

Risks Related to Our Common Stock

The issuance of our Series A Convertible Preferred Stock may result in substantial dilution to holders of our common stock and may restrict our access to additional financing.

On April 4, 2013 we entered into a securities purchase agreement with an institutional investor to purchase up to 4,012 shares of our newly authorized Series A Convertible Preferred Stock for maximum proceeds of $4.0 million. The Series A Convertible Preferred Stock is convertible into shares of our common stock at an initiala current conversion price of $1.82$0.6437 per share. TheIn addition, the conversion price was subsequently resetis subject to downward adjustment if we issue common stock or common stock equivalents at $1.02 per share.

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The offering ofa price less than the Series A Convertible Preferred Stock used all of our current availability under our shelf registration statement for the next 12 months, unless the value of our unaffiliated public float rises from current levels.then effective conversion price. In connection with the offering of the Series A Convertible Preferred Stock we granted the investor certain rights of participation in future equity financings. WeAt March 31, 2014, there were 1,386 shares of Series A Convertible Preferred Stock outstanding. As long as the Series A Convertible Preferred Stock is outstanding, we have also agreed not to incur specified indebtedness without the consent of the holders of the Series A Convertible Preferred Stock as long as these securities remain outstanding.Stock. These factors couldmay restrict our ability to raise capital through equity offerings or debt offerings in the future,future.

Our Company could be difficult to acquire due to anti-takeover provisions in our charter, our stockholder rights plan and Delaware law.

Our board of directors has adopted a stockholder rights plan in which preferred stock purchase rights were distributed as a dividend. These provisions may make it more difficult for stockholders to take corporate actions and may have the effect of delaying or preventing a change in control. These provisions also could require usdeter or prevent transactions that stockholders deem to seek equity financing throughbe in their interests. In addition, we are subject to the anti- takeover provisions of Section 203 of the Delaware General Corporation Law. Subject to specified exceptions, this section provides that a new registration statement, to sell, partnercorporation may not engage in any business combination with any interested stockholder during the three-year period following the time that such stockholder becomes an interested stockholder. This provision could have the effect of delaying or otherwise monetize assets, to seek alternative sourcespreventing a change of funding, or to furthercontrol of our company. The foregoing factors could reduce expenses.

A delisting from the NYSE MKT could adversely affect the price of our common stock and restrict our accessthat investors or an acquirer might be willing to capital.

Our common stock is currently listed onpay in the NYSE MKT (the “Exchange”). In order to maintain that listing, we must continue to comply with various listing standards of the Exchange, as set forth in Part 10 of the Exchange’s Company Guide

Based on our quarterly report on Form 10-Qfuture for the period ended September 30, 2012, NYSK MKT issued correspondence noting noncompliance with respect to the requirement of section 1003(a)(iv) of its Company Guide in connection with our financial condition and corresponding access to capital, based on our having reported cash and cash equivalents of $4.5 million at quarter end, and reporting that we did not have any unused credit or other capital facilities in place at the time. The Exchange indicated that in order to maintain our NYSE MKT listing, we needed to submit a plan by December 31, 2012 outlining plans to regain compliance with Section 1003(a)(iv) of the Company Guide by March 31, 2013, which deadline was subsequently extended to June 30, 2013. Additional information and provisions regarding the NYSE MKT requirements are found in Part 10 of its Company Guide. We disputed the staff’s basis for its determination of deemed noncompliance, but we submitted a plan designed to re-establish compliance with the listing requirement. On January 16, 2013 we reported that our listing compliance plan had been accepted by NYSE MKT; on April 5, 2013, we reported that the compliance period had been extended to June 30, 2013; on July 2, 2013, we reported that the compliance period had been extended to September 30, 2013; and on October 7, 2013 we reported that the compliance period had been extended to December 31, 2013.

The Exchange’s notification had no current effect on the listing of our shares. Rather, we were afforded the opportunity to submit a plan pursuant to which we would seek to establish compliance with the requirements of Section 1003(a)(iv) of the Company Guide by the extended deadline of December 31, 2013. Failure to make progress consistent with the plan or to regain compliance with the continued listing standards by the end of the applicable extension periods could result in our shares being delisted from the Exchange.

If our common stock was not traded on the NYSE MKT, it would be expected to trade on the OTCMarket, an alternative regulated quotation service that provides quotes, sale prices and volume information in over-the-counter equity securities. The Company’s common stock was traded on the OTC until July 2007, when the Company elected to instead list its shares on the American Stock Exchange (the predecessor to the NYSE MKT). Stock traded on the OTCMarket generally have limited trading volume and exhibit a wider spread between bid and ask prices as compared to stocks traded on the NYSE MKT.

We have relied on a universal shelf registration statement for a significant portion of the sales of our equity securities for cash over the past few years. We have a registration statement on Form S-3 on file with the SEC, and that registration statement automatically incorporates by reference our future periodic reports that we file with the SEC. Under the terms of this registration statement, we can sell shares of our common stock, or other securities linked to our common stock, at transactions from time to time. We have used the registration statement to issue shares of common stock, and recently preferred stock, from time to time in registered direct offerings. We are required to maintain our listing on a national exchange as a condition to the continued use of the shelf registration statement for primary offerings of our common stock. The OTC market is not considered a national exchange. If our listing with the NYSE MKT terminates, we will not be able to renew our shelf registration statement on Form S-3. If that were to occur, we would still be able to sell securities in registered offerings or private placements, but we would lose access to the simplified registration process that the shelf registration statement on Form S-3 provides. We expect that registration statements would to take longer to get effective, and would be more costly to secure and maintain.

ITEM 1B.UNRESOLVED STAFF COMMENTS

None.

 

ITEM 2.ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

 

ITEM 3.ITEM 3.DEFAULTS UPON SENIOR SECURITIES

None.

 

ITEM 4.ITEM 4.MINE SAFETY DISCLOSURES

Not applicable.

 

ITEM 5.ITEM 5.OTHER INFORMATION

None.

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ITEM 6.ITEM 6.EXHIBITSEXHIBITS

The following exhibit index shows those exhibits filed with this report and those incorporated by reference:

EXHIBIT INDEX

 

Exhibit
Number

  

Description

  

Incorporated By Reference To

    3.1  

Certificate of DesignationOwnership and Merger as filed with the Delaware Secretary of Preferences Rights and

Limitations of Series A Convertible Preferred Stock.

State On March 14, 2014.
  

Exhibit 3.1 of the registrant’sour Current Reportreport on

Form 8-K, filed with the SECCommission on April 5, 2013.

March 18, 2014.
    4.1Form of Warrant Agreement issued to directors and officers in February 2014.Filed herewith.
  10.1  

Securities PurchaseStrategic Cooperation Agreement dated April 4, 2013 for the

purchase of Series A Convertible Preferred Stock.

February 21, 2014 between Cardium Therapeutics, Inc. and Shanxi Taxus Pharmaceuticals Co., Ltd
  

Exhibit 10.1 of the registrant’sour Current Report on

Form 8-K filed with the SECCommission on April 5, 2013.

March 4, 2014.
  10.2Securities Purchase Agreement dated February 21, 2014 between Cardium Therapeutics, Inc. and Shaanxi Taxus Pharmaceuticals Co., LtdExhibit 10.2 of our Current Report on Form 8-K filed with the Commission on March 4, 2014.
  31.1  

Rule 13a-14(a)/15d-14(a) Certification of Chief Executive

Officer

  Filed herewithherewith.
  31.2  

Rule 13a-14(a)/15d-14(a) Certification of Chief Financial

Officer

  Filed herewithherewith.
  32  Section 1350 Certification  Filed herewith.
101  

The following financial statements and footnotes from the

Taxus Cardium Therapeutics,Pharmaceuticals Group, Inc. Quarterly Report on Form 10-Q

for the quarter ended September 30, 2013March 31, 2014 formatted in

eXtensible Business Reporting Language (XBRL): (i)

Condensed Consolidated Balance Sheets; (ii) Condensed

Consolidated Statements of Operations; (iii) Condensed

Consolidated Statements of Cash Flows; and (iv) the Notes

to Condensed Consolidated Financial Statements.

  Filed herewith.

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, Taxus Cardium Therapeutics,Pharmaceuticals Group, Inc., the registrant, has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date: November 19, 2013

Date: May 15, 2014
TAXUS CARDIUM THERAPEUTICS,PHARMACEUTICALS GROUP, INC.
By: 

/s/    DENNIS M. MULROY

 Dennis M. Mulroy,
 Chief Financial Officer

 

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