U.S. Stem Cell, Inc. - Quarter Report: 2015 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
__________
FORM 10-Q
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the quarterly period ended June 30, 2015 | ||
OR | ||
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the transition period from ____ to ____ | ||
Commission File Number: 001-33718 |
BIOHEART,
INC.
(Exact name of registrant as specified in its
charter)
__________
Florida | |
(State or other jurisdiction of | 65-0945967 |
incorporation or organization) | (I.R.S. Employer Identification No.) |
13794 NW
4th Street,
Suite 212, Sunrise, Florida 33325
(Address of principal executive offices) (Zip Code)
(954) 835-1500
(Registrants telephone number, including area code)
Securities registered
under Section 12(b) of the Exchange Act:
None
Securities registered
under Section 12(g) of the Exchange Act:
Common Stock, $0.001 par value per
share
(Title of Class)
__________
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 the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ 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 (§232.045 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ 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 definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ | |
Non-accelerated filer | ☐ | Smaller reporting company | ☒ | |
(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒.
As of August 3, 2015, there were 838,164,633 outstanding shares of the Registrants common stock, par value $0.001 per share. Transitional Small Business Disclosure Format Yes ☐ No ☒
BIOHEART, INC.
INDEX
TO FORM 10-Q FILING
JUNE
30, 2015
TABLE OF CONTENTS
Page | ||||
Number | ||||
PART I | Financial Information | |||
Item 1. | Financial Information | 3 | ||
Condensed Balance Sheets June 30, 2015 (Unaudited) and December 31, 2014 | 4 | |||
Unaudited Condensed Statements of Operations (Unaudited) Three and Six Months Ended June 30, 2015 and 2014 | 5 | |||
Unaudited Condensed Statements of Stockholders Deficit (Unaudited) Six Months Ended June 30, 2015 | 6 | |||
Unaudited Condensed Statements of Cash Flows (Unaudited) Six Months Ended June 30, 2015 and 2014 | 7 | |||
Notes to Unaudited Condensed Financial Statements | 8 | |||
Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations | 26 | ||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 36 | ||
Item 4. | Controls and Procedures | 36 | ||
PART II | Other Information | |||
Item 1. | Legal Proceedings | 36 | ||
Item 1A. | Risk Factors | 37 | ||
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 37 | ||
Item 3. | Defaults Upon Senior Securities | 37 | ||
Item 4. | Mine Safety Disclosures | 37 | ||
Item 5. | Other Information | 37 | ||
Item 6. | Exhibits | 38 | ||
SIGNATURES | 44 | |||
EX-31.1 | Management Certification | |||
EX-32.1 | Sarbanes-Oxley Act | |||
2 |
PART I FINANCIAL INFORMATION
Item 1.
Interim Condensed Financial Statements and Notes to Interim Financial Statements
General
The accompanying reviewed condensed interim financial unaudited statements have been prepared in accordance with the instructions to Form 10-Q. Therefore, they do not include all information and footnotes necessary for a complete presentation of financial position, results of operations, cash flows, and stockholders equity in conformity with generally accepted accounting principles. Except as disclosed herein, there has been no material change in the information disclosed in the notes to the financial statements included in the Companys annual report on Form 10-K for the year ended December 31, 2014. In the opinion of management, all adjustments considered necessary for a fair presentation of the results of operations and financial position have been included and all such adjustments are of a normal recurring nature. Operating results for the three and six months ended June 30, 2015 are not necessarily indicative of the results that can be expected for the year ending December 31, 2015.
3
BIOHEART,
INC.
CONDENSED BALANCE
SHEETS
June 30, | December 31, | ||||||
2015 | 2014 | ||||||
(unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 93,534 | $ | 36,674 | |||
Accounts receivable, net | 98,504 | 95,409 | |||||
Prepaid and other | 1,783 | 9,255 | |||||
Total current assets | 193,821 | 141,338 | |||||
Property and equipment, net | 10,961 | 12,686 | |||||
Other assets | |||||||
Investments | 62,905 | 40,597 | |||||
Deposits | 10,160 | 10,160 | |||||
Total assets | $ | 277,847 | $ | 204,781 | |||
LIABILITIES AND STOCKHOLDERS' DEFICIT | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 2,056,274 | $ | 1,991,979 | |||
Accrued expenses | 611,342 | 2,373,615 | |||||
Advances, related party | 155,363 | 148,759 | |||||
Deferred revenue | 37,100 | - | |||||
Deposits | 478,286 | 478,286 | |||||
Promissory note, short term portion, net of debt discount of $82,645 and $-0-, | |||||||
respectively | 67,355 | 1,500,000 | |||||
Notes payable, related party | 2,242,262 | 2,333,059 | |||||
Notes payable, net of debt discount | 1,582,477 | 1,531,812 | |||||
Derivative liabilities | 938,752 | 741,271 | |||||
Total current liabilities | 8,169,211 | 11,098,781 | |||||
Long term debt: | |||||||
Promissory note, long term portion, net of debt discount of $279,225 | 1,268,537 | - | |||||
Total liabilities | 9,437,748 | 11,098,781 | |||||
Commitments and contingencies | - | - | |||||
Stockholders' deficit: | |||||||
Preferred stock, par value $0.001; 20,000,000 shares authorized, 20,000,000 | |||||||
issued and outstanding | 20,000 | 20,000 | |||||
Common stock, par value $0.001; 2,000,000,000 shares authorized, 803,720,019 | |||||||
and 581,433,153 shares issued and 795,376,819 and 581,433,153 outstanding as | |||||||
of June 30, 2015 and December 31, 2014, respectively | 803,720 | 581,433 | |||||
Additional paid in capital | 110,662,768 | 108,939,061 | |||||
Treasury stock, 8,343,200 shares outstanding as of June 30, 2015 | (50,272 | ) | - | ||||
Accumulated deficit | (120,596,117 | ) | (120,434,494 | ) | |||
Total stockholders' deficit | (9,159,901 | ) | (10,894,000 | ) | |||
Total liabilities and stockholders' deficit | $ | 277,847 | $ | 204,781 |
See the accompanying notes to these financial statements
4
BIOHEART,
INC.
CONDENSED STATEMENTS
OF OPERATIONS
(unaudited)
Three months ended June 30, | Six months ended June 30, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
Revenue: | |||||||||||||||
Products | $ | 342,773 | $ | 353,624 | $ | 628,122 | $ | 587,260 | |||||||
Services | 222,534 | 225,622 | 426,742 | 384,160 | |||||||||||
Total revenue | 565,307 | 579,246 | 1,054,864 | 971,420 | |||||||||||
Cost and operating expenses: | |||||||||||||||
Cost of sales | 223,592 | 189,331 | 471,216 | 353,379 | |||||||||||
Research and development | 130,373 | 15,478 | 180,518 | 25,335 | |||||||||||
Marketing, general and administrative | 690,248 | 831,362 | 1,688,381 | 1,669,691 | |||||||||||
Depreciation and amortization | 1,318 | 1,123 | 2,619 | 1,986 | |||||||||||
Total operating expenses | 1,045,531 | 1,037,294 | 2,342,734 | 2,050,391 | |||||||||||
Net loss from operations | (480,224 | ) | (458,048 | ) | (1,287,870 | ) | (1,078,971 | ) | |||||||
Other income (expenses): | |||||||||||||||
Gain on settlement of debt | 1,979,180 | 93,422 | 2,038,610 | 2,187,054 | |||||||||||
(Loss) gain on change of fair value of | |||||||||||||||
derivative liability | (236,455 | ) | 311,414 | (113,731 | ) | (177,957 | ) | ||||||||
Income from equity investment | 8,343 | - | 12,309 | - | |||||||||||
Other income | - | - | 3,151 | - | |||||||||||
Interest expense | (384,250 | ) | (398,194 | ) | (814,092 | ) | (704,092 | ) | |||||||
Total other income (expenses) | 1,366,818 | 6,642 | 1,126,247 | 1,305,005 | |||||||||||
Net income (loss) before income taxes | 886,594 | (451,406 | ) | (161,623 | ) | 226,034 | |||||||||
Income taxes (benefit) | - | - | - | - | |||||||||||
NET INCOME (LOSS) | $ | 886,594 | $ | (451,406 | ) | $ | (161,623 | ) | $ | 226,034 | |||||
Net income (loss) per common share, basic | $ | 0.001 | $ | (0.001 | ) | $ | (0.000 | ) | $ | 0.001 | |||||
Net income (loss) per common share, diluted | $ | 0.001 | $ | (0.001 | ) | $ | (0.000 | ) | $ | 0.000 | |||||
Weighted average number of common shares | |||||||||||||||
outstanding, basic | 741,090,932 | 471,842,494 | 684,183,630 | 436,892,204 | |||||||||||
Weighted average number of common shares | |||||||||||||||
outstanding, diluted | 936,144,349 | 471,842,494 | 684,183,630 | 553,719,873 |
See the accompanying notes to these financial statements
5
BIOHEART, INC.
CONDENSED
STATEMENT OF STOCKHOLDERS'
DEFICIT
SIX MONTHS ENDED JUNE 30, 2015
(unaudited)
Additional | ||||||||||||||||||||||||
Preferred stock | Common stock | Paid in | Treasury | Accumulated | ||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Stock | Deficit | Total | |||||||||||||||||
Balance, December 31, 2014 | 20,000,000 | $ | 20,000 | 581,433,153 | $ | 581,433 | $ | 108,939,061 | $ | - | $ | (120,434,494 | ) | $ | (10,894,000 | ) | ||||||||
Common stock issued in settlement | ||||||||||||||||||||||||
of accounts payable and accrued expenses and interest | - | - | 13,015,750 | 13,016 | 99,751 | - | 112,767 | |||||||||||||||||
Common stock issued in settlement | ||||||||||||||||||||||||
of guarantor fees | - | - | 24,353,285 | 24,354 | 145,747 | - | 170,101 | |||||||||||||||||
Common stock issued in | ||||||||||||||||||||||||
connection with settlement of other | ||||||||||||||||||||||||
debt | - | - | 93,803,679 | 93,803 | 706,227 | - | 800,030 | |||||||||||||||||
Proceeds from issuance of common | ||||||||||||||||||||||||
stock | - | - | 84,464,152 | 84,464 | 449,481 | - | 533,945 | |||||||||||||||||
Common stock issued in settlement | ||||||||||||||||||||||||
of litigation | - | - | 6,650,000 | 6,650 | 53,200 | - | 59,850 | |||||||||||||||||
Purchase of 8,343,200 shares of | ||||||||||||||||||||||||
Company's common stock at | ||||||||||||||||||||||||
average cost of $0.006 per share | - | - | - | - | - | (50,272 | ) | - | (50,272 | ) | ||||||||||||||
Stock based compensation | - | - | - | - | 269,301 | - | - | 269,301 | ||||||||||||||||
Net loss | - | - | - | - | - | - | (161,623 | ) | (161,623 | ) | ||||||||||||||
Balance, June 30, 2015 | 20,000,000 | $ | 20,000 | 803,720,019 | $ | 803,720 | $ | 110,662,768 | $ | (50,272 | ) | $ | (120,596,117 | ) | $ | (9,159,901 | ) |
See the accompanying notes to these financial statements
6
BIOHEART,
INC.
CONDENSED STATEMENTS
OF CASH FLOWS
(unaudited)
Six months ended June 30, | |||||||
2015 | 2014 | ||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||
Net (loss) income | $ | (161,623 | ) | $ | 226,034 | ||
Adjustments to reconcile net (loss) income to net cash used in operating activities: | |||||||
Depreciation and amortization | 2,619 | 1,986 | |||||
Bad debt expense | - | 28,732 | |||||
Discount on convertible debt | 425,629 | 201,615 | |||||
Change in fair value of derivative liability | 113,731 | 177,957 | |||||
Gain on settlement of debt | (2,038,611 | ) | (2,187,054 | ) | |||
Common stock issued in settlement of litigation | 59,850 | ||||||
Non-cash interest expense | 188,303 | 280,876 | |||||
Warrants issued in connection with joint venture agreement | - | 112,070 | |||||
Income on equity investments | (12,308 | ) | - | ||||
Stock based compensation | 269,301 | 282,119 | |||||
(Increase) decrease in: | |||||||
Receivables | (3,095 | ) | (114,391 | ) | |||
Prepaid and other current assets | 7,472 | (3,048 | ) | ||||
Increase (decrease) in: | |||||||
Accounts payable | 242,956 | 255,392 | |||||
Accrued expenses | 221,950 | 230,653 | |||||
Deferred revenue | 37,100 | - | |||||
Net cash used in operating activities | (646,726 | ) | (507,059 | ) | |||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||
Payments for investments | (10,000 | ) | - | ||||
Purchase of treasury stock | (50,272 | ) | - | ||||
Acquisitions of property and equipment | (894 | ) | (6,366 | ) | |||
Net cash used by investing activities | (61,166 | ) | (6,366 | ) | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||
Proceeds from issuance of common stock, net | 533,945 | 371,000 | |||||
Proceeds (repayments) from related party advances | 6,604 | (13,241 | ) | ||||
Proceeds from exercise of stock options and warrants | - | 136,000 | |||||
Proceeds from notes payable | 315,000 | 288,000 | |||||
Repayments of notes payable | (90,797 | ) | (223,340 | ) | |||
Net cash provided in financing activities | 764,752 | 558,419 | |||||
Net increase in cash and cash equivalents | 56,860 | 44,994 | |||||
Cash and cash equivalents, beginning of period | 36,674 | 46,227 | |||||
Cash and cash equivalents, end of period | $ | 93,534 | $ | 91,221 | |||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION | |||||||
Interest paid | $ | 191,773 | $ | 161,532 | |||
Income taxes paid | $ | - | $ | - | |||
Non-cash financing activities: | |||||||
Common stock issued in settlement of notes payable, and accrued interest | $ | 388,259 | $ | 787,289 | |||
Common stock issued in settlement of accounts payable, and accrued expenses and interest | $ | 112,767 | $ | 549,448 | |||
Common stock issued in settlement of guarantor fees | $ | 170,101 | $ | - | |||
Promissory note issued in exchange for subordinated debt and accrued expenses | $ | 1,697,762 | $ | - | |||
Common stock issued in settlement of related party notes and advances payable | $ | - | $ | 728,806 |
See the accompanying notes to these financial statements
7
NOTE 1 SIGNIFICANT ACCOUNTING POLICIES
A summary of the significant accounting policies applied in the presentation of the accompanying unaudited condensed financial statements follows:
General
The accompanying unaudited condensed financial statements of Bioheart, Inc., (the Company), have been prepared in accordance with the rules and regulations (Regulation S-X) of the Securities and Exchange Commission (the SEC) and with the instructions to Form 10-Q. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.
In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. The results from operations for the three and six month periods ended June 30, 2015 are not necessarily indicative of the results that may be expected for the year ended December 31, 2015. The unaudited condensed financial statements should be read in conjunction with the December 31, 2014 financial statements and notes thereto included in the Companys Annual Report on Form 10-K.
Basis and business presentation
Bioheart, Inc. (the Company) was incorporated under the laws of the State of Florida in August, 1999. The Company is in the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Our business includes the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine/cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. To date, the Company has not generated significant sales revenues in that they remain less than their total operating expenses, has incurred expenses, and has sustained losses. Consequently, its operations are subject to all the risks inherent in the establishment of a research and development business enterprise.
Revenue Recognition
The Company recognizes revenue in accordance with Accounting Standards Codification subtopic 605-10, Revenue Recognition (ASC 605-10) which requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred; (3) the selling price is fixed and determinable; and (4) collectability is reasonably assured. Determination of criteria (3) and (4) are based on managements judgments regarding the fixed nature of the selling prices of the products delivered and the collectability of those amounts. Provisions for discounts and rebates to customers, estimated returns and allowances, and other adjustments are provided for in the same period the related sales are recorded.
At the time of each transaction, management assesses whether the fee associated with the transaction is fixed or determinable and whether or not collection is reasonably assured. The assessment of whether the fee is fixed or determinable is based upon the payment terms of the transaction. Collectability is assessed based on a number of factors, including past transaction history with the client and the creditworthiness of the client.
8
Revenues for test kits and equipment sold are not recorded until test kits are delivered. The Company has revenue sharing arrangements for the sale of goods whereby the Company is the primary obligor, sets pricing with the customers and bears all associated credit risks with the customers. Sales under revenue share arrangements are recorded as gross sales and any portion shared with third parties under such arrangements are classified as selling expense due to the nature of the marketing activities performed by the third party. Revenues from trainings are not recorded until the completion of the training. Any cash received as a deposit for trainings are recorded by the company as a liability.
Patent treatments and laboratory services revenue are recognized when those services have been completed or satisfied.
Revenues for bank sales are accounted for as Multiple-Element Arrangements under ASC 605-10 which incorporates Accounting Standards Codification subtopic 605-25, Multiple-Element Arrangements (ASC 605-25). ASC 605-25 addresses accounting for arrangements that may involve the delivery or performance of multiple products, services and/or rights to use assets.
At June 30, 2015 and December 31, 2014, the Company had deferred revenues of $37,100 and $-0-, respectively.
Accounts Receivable
Trade receivables are carried at their estimated collectible amounts. Trade credit is generally extended on a short-term basis; thus trade receivables do not bear interest. Trade accounts receivable are periodically evaluated for collectability based on past credit history with customers and their current financial condition.
Allowance for Doubtful Accounts
Any changes to the allowance for doubtful accounts on accounts receivable are changed to operations in amounts sufficient to maintain the allowance for uncollectible accounts at a level management believes is adequate to cover any probable losses. Management determines the adequacy of the allowance based on historical write-off percentages and the current status of accounts receivable. Accounts receivable are charged off against the allowance when collectability is determined to be permanently impaired. As of June 30, 2015 and December 31, 2014, allowance for doubtful accounts was $-0-.
Investments
The Company has adopted Accounting Standards Codification subtopic 323-10, Investments-Equity Methods and Joint Ventures (ASC 323-10) which requires the accounting for investments where the Company can exert significant influence, but not control of a joint venture or equity investment. The Company accounted for its 33 percent ownership of U.S. Stem Cell Clinic, LLC utilizing the equity method of accounting.
Comprehensive Income
The Company does not have any items of comprehensive income in any of the periods presented.
9
Net Loss per Common Share, basic and diluted
The Company has adopted Accounting Standards Codification subtopic 260-10, Earnings Per Share (ASC 260-10) specifying the computation, presentation and disclosure requirements of earnings per share information. Basic loss per share has been calculated based upon the weighted average number of common shares outstanding. Shares issuable upon conversion of convertible debt, stock options and warrants have been excluded as common stock equivalents in the diluted loss per share for the six months ended June 30, 2015 and three months ended June 30, 2014 because their effect is anti-dilutive on the computation. Fully diluted shares outstanding were 936,144,349 and 588,670,163 for the three months ended June 30, 2015 and 2014, respectively and 879,237,047 and 553,719,873 for the six months ended June 30, 2014 and 2013, respectively.
Stock based compensation
The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. For employees and directors, the fair value of the award is measured on the grant date and for non-employees, the fair value of the award is generally re-measured on vesting dates and interim financial reporting dates until the service period is complete. The fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. Stock-based compensation expense is recorded by the Company in the same expense classifications in the statements of operations, as if such amounts were paid in cash. As of June 30, 2015, there were outstanding stock options to purchase 73,900,497 shares of common stock, 33,001,632 shares of which were vested.
Concentrations of Credit Risk
The Companys financial instruments that are exposed to a concentration of credit risk are cash and accounts receivable. Generally, the Companys cash and cash equivalents in interest-bearing accounts does not exceed FDIC insurance limits. The financial stability of these institutions is periodically reviewed by senior management.
As of June 30, 2015, four customers represented 13%, 7%, 6% and 16% respectively for an aggregate of 42% of the Companys accounts receivable. As of December 31, 2014, two customers represented 38% and 17%, for an aggregate of 55%, of the Companys accounts receivable.
For the three months ended June 30, 2015, the Companys revenues earned from the sale of products and services were $565,307, of which two customers represented 5% and 6% of the Companys revenues. For the three months ended June 30, 2014, the Companys revenues earned from the sale of products and services were $579,246, of which two customers represented 11% and 12% of the Companys revenues.
For the six months ended June 30, 2015, the Companys revenues earned from the sale of products and services were $1,054,864, of which two customers represented 6% and 7% of the Companys revenues. For the six months ended June 30, 2014, the Companys revenues earned from the sale of products and services were $971,420, of which one customer represented 13% of the Companys revenues.
10
Research and Development
The Company accounts for research and development costs in accordance with Accounting Standards Codification subtopic 730-10, Research and Development (ASC 730-10). Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved as defined under the applicable agreement. Company-sponsored research and development costs related to both present and future products are expensed in the period incurred. The Company incurred research and development expenses of $130,373 and $180,518 for the three and six months ended June 30, 2015, respectively; and $15,478 and $25,335 for the three and six months ended June 30, 2014, respectively.
Fair Value
Accounting Standards Codification subtopic 825-10, Financial Instruments (ASC 825-10) requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, accounts payable and accrued liabilities, and short-term borrowings, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments. All other significant financial assets, financial liabilities and equity instruments of the Company are either recognized or disclosed in the financial statements together with other information relevant for making a reasonable assessment of future cash flows, interest rate risk and credit risk. Where practicable the fair values of financial assets and financial liabilities have been determined and disclosed; otherwise only available information pertinent to fair value has been disclosed.
The Company follows Accounting Standards Codification subtopic 820-10, Fair Value Measurements and Disclosures (ASC 820-10) and Accounting Standards Codification subtopic 825-10, Financial Instruments (ASC 825-10), which permits entities to choose to measure many financial instruments and certain other items at fair value.
Derivative Instrument Liability
The Company accounts for derivative instruments in accordance with ASC 815, which establishes accounting and reporting standards for derivative instruments and hedging activities, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value, regardless of hedging relationship designation. Accounting for changes in fair value of the derivative instruments depends on whether the derivatives qualify as hedge relationships and the types of relationships designated are based on the exposures hedged. At June 30, 2015 and December 31, 2014, the Company did not have any derivative instruments that were designated as hedges.
At June 30, 2015 and December 31, 2014, the Company had outstanding convertible notes that contained embedded derivatives. These embedded derivatives include certain conversion features and reset provisions. (See Note 7 and Note 9)
Reliance on Key Personnel and Consultants
The Company has four full-time employees and one part-time employees. The Company is heavily dependent on the continued active participation of its two current executive officers, one employee and key consultants. The loss of any of the senior management or key consultants could significantly and negatively impact the business until adequate replacements can be identified and put in place.
11
Reclassification
Certain reclassifications have been made to prior periods data to conform with the current years presentation. These reclassifications had no effect on reported income or losses.
Recent Accounting Pronouncements
There were various updates recently issued, most of which represented technical corrections to the accounting literature or application to specific industries and are not expected to a have a material impact on the Companys financial position, results of operations or cash flows.
NOTE 2 GOING CONCERN MATTERS
The accompanying unaudited condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying unaudited condensed financial statements, during six months ended June 30, 2015, the Company incurred an operating loss of $1,287,870 and used $646,726 in cash for operating activities. As of June 30, 2015, the Company had a working capital deficit (current liabilities in excess of current assets) of approximately $8.0 million. These factors among others may indicate that the Company will be unable to continue as a going concern for a reasonable period of time.
The Companys existence is dependent upon managements ability to develop profitable operations and to obtain additional funding sources. There can be no assurance that the Companys financing efforts will result in profitable operations or the resolution of the Companys liquidity problems. The accompanying statements do not include any adjustments that might result should the Company be unable to continue as a going concern.
NOTE 3 INVESTMENTS
Investment is comprised of a 33% ownership of U.S. Stem Cell Clinic, LLC, accounted for using the equity method of accounting. The initial investment in 2014 and 2015 of cash and expenses paid on U.S. Stem Cell Clinic, LLCs behalf was an aggregate of $59,714. The Companys 33% income earned by U.S. Stem Cell Clinic, LLC of $8,343 and $12,309 for the three and six months ended June 30, 2015, respectively, (inception to date income of $3,191) was recorded as other income/expense in the Companys Statement of Operations in the appropriate periods and increased the carrying value of the investment to $62,905.
NOTE 4 PROPERTY AND EQUIPMENT
Property and equipment as of June 30, 2015 and December 31, 2014 summarized as follows:
June 30, | December 31, | ||||||
2015 | 2014 | ||||||
Laboratory and medical equipment | $ | 353,252 | $ | 352,358 | |||
Furniture, fixtures and equipment | 125,634 | 125,634 | |||||
Computer equipment | 47,647 | 47,647 | |||||
Leasehold improvements | 362,046 | 362,046 | |||||
888,579 | 887,685 | ||||||
Less accumulated depreciation and amortization | (877,618 | ) | (874,999 | ) | |||
$ | 10,961 | $ | 12,686 |
12
Property and equipment are
recorded on the basis of cost. For financial statement purposes, property, plant
and equipment are depreciated using the straight-line method over their
estimated useful lives.
Expenditures for repair and maintenance which do
not materially extend the useful lives of property and equipment are charged to
operations. When property or equipment is sold or otherwise disposed of, the
cost and related accumulated depreciation are removed from the respective
accounts with the resulting gain or loss reflected in operations. Management
periodically reviews the carrying value of its property and equipment for
impairment in accordance with the guidance for impairment of long lived assets.
NOTE 5 ACCRUED EXPENSES
Accrued expenses consisted of the following as of June 30, 2015 and December 31, 2014:
June 30, | December 31, | ||||
2015 | 2014 | ||||
Amounts payable to the Guarantors of the Companys loan agreement with Bank of America | |||||
and Seaside Bank, including fees and interest | $ | 17,090 | $ | 1,533,217 | |
Interest payable on notes payable | 415,073 | 685,575 | |||
Vendor accruals and other | 134,896 | 120,836 | |||
Employee commissions, compensation, etc. | 44,283 | 33,987 | |||
$ | 611,342 | $ | 2,373,615 |
During the six months ended June 30, 2014, the Company issued an aggregate of 31,052,689 shares of its common stock in settlement of outstanding accounts payable and accrued expenses. In connection with the issuance, the Company incurred $190,966 loss in settlement of debt.
During the six months ended June 30, 2015, the Company issued an aggregate of 11,652,719 shares of its common stock in settlement of outstanding accounts payable. In connection with the issuance, the Company incurred $78,528 gain in settlement of debt.
During the six months ended June 30, 2015, the Company issued an aggregate of 24,353,285 shares of its common stock in settlement of accumulative outstanding accounts payable due to Guarantors of the Company of $961,124. In connection with the issuance, the Company incurred a $791,024 gain in settlement of debt.
During the six months ended June 30, 2015, the Company settled an outstanding subordinated debt, related accrued interest and accounts payable due to the guarantor by issuing a five year, non-interest bearing note payable. (See Note 7). In connection with the note issuance, the Company settled $624,737 of outstanding guarantor fees.
NOTE 6 STOCK PURCHASE AGREEMENT
On October 23, 2014, the Company, entered into a common stock purchase agreement (the Purchase Agreement) with Magna Equities II, LLC, a New York limited liability company (the Investor). The Purchase Agreement provides that, upon the terms and subject to the conditions set forth therein, the Investor is committed to purchase up to $3,000,000 (the Total Commitment) worth of the Companys common stock, $0.001 par value (the Shares), over the 24-month term of the Purchase Agreement.
13
From time to time over the term of the Purchase Agreement, commencing on the trading day immediately following the date on which the initial registration statement is declared effective by the Securities and Exchange Commission (the Commission), the Company may provide the Investor with a draw down notice to purchase a specified dollar amount of Shares, with each draw down subject to certain limitations. The Company may not deliver any Draw Down Notice to the Investor if the Initial Purchase Price with respect to the Shares subject to such Draw Down Notice is less than $0.0025 as of the date the applicable Draw Down Notice is received by the Investor (the Draw Down Exercise Date).
The applicable Initial Purchase Price, the Initial Purchase Price, is defined as a price equal to 93% of the lowest of (i) the arithmetic average of the three lowest daily volume weighted average prices for the Companys common stock (the VWAP) during the 10 consecutive trading days ending on the trading day immediately preceding the applicable Draw Down Exercise Date, (ii) the arithmetic average of the three lowest closing sale prices for the Companys common stock during the 10 consecutive trading days ending on the trading day immediately preceding the applicable Draw Down Exercise Date and (iii) the closing sale price for the Companys common stock on the trading day immediately preceding the applicable Draw Down Exercise Date.
In 2014, the Company paid to the Investor as a commitment fee for entering into the Purchase Agreement equal an aggregate of to 12,000,000 shares of the Companys common stock.
During the six months ended June 30, 2015, the Company issued an aggregate of 76,612,184 shares of its common stock in exchange for $472,675 under the stock Purchase Agreement. (See note 10)
NOTE 7 NOTES PAYABLE
Notes payable were comprised of the following as of June 30, 2015 and December 31, 2014:
June 30, | December 31, | ||||||
2015 | 2014 | ||||||
Seaside Bank note payable | $ | 980,000 | $ | 980,000 | |||
Hunton & Williams notes payable | 384,972 | 384,972 | |||||
Asher notes payable | 180,000 | 151,000 | |||||
Daniel James Management note payable | 75,000 | 75,000 | |||||
Fourth Man, LLC note payable | 75,000 | 75,000 | |||||
Magna Group | 130,000 | 205,000 | |||||
Total notes payable | 1,824,972 | 1,870,972 | |||||
Less unamortized debt discount | (242,495 | ) | (339,160 | ) | |||
Total notes payable net of unamortized debt discount | $ | 1,582,477 | $ | 1,531,812 |
Seaside Bank
On October 25, 2010, the Company entered into a Loan Agreement with Seaside National Bank and Trust for a $980,000 loan at 4.25% per annum interest that was used to refinance the Companys loan with Bank of America. The obligation is guaranteed by certain shareholders of the Company. The Company renewed the loan with Seaside National Bank and Trust during the first quarter of 2014 to extend the maturity date to December 23, 2015.
Hunton & Williams Notes
At June 30, 2015 and December 31, 2014, the Company has two outstanding notes payable with interest at 8% per annum due at maturity. The two notes, $61,150 and $323,822, are payable in one balloon payment upon the date the Noteholder provides written demand, however the Company is not obligated to make payments until the Northstar (or successor) Loan is paid off.
14
Asher Notes (During this period)
During the six months ended June 30, 2015, the Company entered into Securities Purchase Agreements with Asher Enterprises, Inc. (Asher) or affiliates, for the sale of 8% convertible notes in aggregate principal amount of $180,000 (the Asher Notes). The Company incurred legal fees in the amount of $15,000 which were deducted from the proceeds of the notes.
The Asher Notes bear interest at the rate of 8% per annum. As of the six months ended June 30, 2015, all interest and principal must be repaid nine months from the issuance date, with the last note being due February 6, 2016. The Asher Notes are convertible into shares of common stock, at Ashers option, at a 45% discount to the average of the three lowest closing bid prices of the shares of common stock during the 10 trading day period prior to conversion. The Company has identified the embedded derivatives related to the Asher Notes.
These embedded derivatives included certain conversion features and reset provision. The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date of Asher Notes and to fair value as of each subsequent reporting date, which at June 30, 2015 was $307,285. At the inception of the Asher Notes, the Company determined the aggregate fair value of $211,575 of the embedded derivatives.
During the six months ended June 30, 2015, $151,000 of notes that were outstanding at December 31, 2014, plus accrued interest, were converted into shares of the Companys common stock (see Note 10).
The remaining aggregate Asher Notes unconverted principle balance as of June 30, 2015 was $180,000.
Daniel James Management (During this period)
During the six months ended June 30, 2015, the Company entered into Securities Purchase Agreements with Daniel James Management (Daniel) for the sale of 9.5% convertible note in aggregate principal amount of $75,000 (the Daniel Note).
The Daniel Notes bear interest at the rate of 9.5% per annum. As of the six months ended June 30, 2015, all interest and principal must be repaid one year from the issuance date, with the last note being due June 28, 2016. The Daniel Notes are convertible into common stock, at holders option, at a 47% discount to the average of the three lowest closing bid prices of the common stock during the 10 trading day period prior to conversion. The Company has identified the embedded derivatives related to the Daniel Notes. These embedded derivatives included certain conversion features and reset provision.
The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date of Daniel Notes and to fair value as of each subsequent reporting date which at June 30, 2015 was $151,894. At the inception of the Daniel Notes, the Company determined the aggregate fair value of $137,578 of the embedded derivatives.
During the six months ended June 30, 2015, $75,000 of notes that were outstanding at December 31, 2014, plus accrued interest were converted into shares of the Companys common stock (see Note 10).
The remaining aggregate Daniel Notes unconverted principle balance as of June 30, 2015 was $75,000.
15
Fourth Man, LLC (During this period)
During the six months ended June 30, 2015, the Company entered into Securities Purchase Agreements with Fourth Man, LLC. (Fourth Man), for the sale of a 9.5% convertible notes in the aggregate principal amount of $75,000 (the Note).
The Notes bears interest at the rate of 8% to 9.5% per annum. As of the six months ended June 30, 2015, all interest and principal must be repaid one year from the issuance date, with the last note being due May 31, 2016. The Notes are convertible into shares of common stock, at Fourth Mans option, at a 47% discount to the lowest closing bid price of the common stock during the 10 trading day period prior to conversion. The Company has identified the embedded derivatives related to the Fourth Man Notes. These embedded derivatives included certain conversion features and reset provision.
The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date of Fourth Man Notes and to fair value as of each subsequent reporting date which at June 30, 2015 was $150,554. At the inception of the Fourth Man Notes, the Company determined the aggregate fair value of $143,097 of the embedded derivatives.
During the six months ended June 30, 2015, $75,000 of notes that were outstanding at December 31, 2014, plus accrued interest, were converted into shares of the Companys common stock (see Note 10).
The remaining aggregate Fourth Man, LLC Notes unconverted principle balance as of June 30, 2015 was $75,000.
Magna Group (During this period)
During the six months ended June 30, 2015, $75,000 of notes that were outstanding at December 31, 2014, plus accrued interest, were converted into shares of the Companys common stock (see Note 10). The remaining aggregate Magna notes unconverted principle balance as of June 30, 2015 was $130,000.
The Company has identified the embedded derivatives related to the Magna notes. The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date of Magna notes and to fair value as of each subsequent reporting date which at June 30, 2015 was $217,540. The fair value of the embedded derivatives of the Asher, Daniel and Fourth Man Notes, was determined using the Binomial Option Pricing Model based on the following assumptions: (1) dividend yield of 0%, (2) expected volatility of 111.98% to 147.97%, (3) weighted average risk-free interest rate of 0.17% to 0.27%, (4) expected lives of 0.75 to 1.00 years, and (5) estimated fair value of the Companys common stock from $0.0058 to $0.0127 per share. The initial fair value of the embedded debt derivative of $492,249 was allocated as a debt discount up to the proceeds of the notes ($313,964) with the remainder ($178,285) charged to current period operations as interest expense. For the three and six months ended June 30, 2015, the Company amortized an aggregate of $193,834 and $425,629 of debt discounts to current period operations as interest expense, respectively.
Promissory note
At December 31, 2014, the Companys former officers and directors have provided notes in aggregate of $1,500,000. As of December 31, 2014, these notes were not considered as related party. The notes range from 4.75% to 8% per annum and are due upon payoff of the Northstar note payable described in Note 8.
On June 1, 2015, the Company issued an amended and restated promissory note of $1,697,762 in settlement of the $1,500,000 outstanding subordinated debt (See Note 12), related accrued interest of $373,469 and accumulated and unpaid guarantor fees of $624,737 (See Note 5).
16
The note is unsecured and non-interest bearing with four semi-annual payments of $75,000 beginning on December 31, 2015 with the remaining unpaid balance due June 1, 2020.
The Company imputed an interest rate of 5% and discounted the promissory note accordingly. The imputed debt discount of $368,615 is amortized to interest expense using the effective interest method.
In connection with the settlement, the Company recorded a gain on settlement of debt of $1,169,058.
For the three and six months ended June 30, 2015, the Company amortized $6,745 of debt discounts to current period operations as interest expense.
NOTE 8 RELATED PARTY TRANSACTIONS
Advances
As of June 30, 2015 and December 31, 2014, the Companys officers and directors have provided advances in the aggregate of $155,363 and $148,759, respectively, for working capital purposes. The advances are unsecured, due on demand and non-interest bearing.
Notes payable-related party
Northstar Biotechnology Group, LLC
On February 29, 2012, a note issued to BlueCrest Master Fund Limited was assigned to Northstar Biotechnology Group, LLC (Northstar), owned partly by certain directors and existing shareholders of the Company, including Dr. William P. Murphy Jr., Dr. Samuel Ahn and Charles Hart. At the date of the assignment, the principal amount of the BlueCrest note was $544,267.
On March 30, 2012, the Company and Northstar agreed to extend until May 1, 2012 the initial payment date for any and all required monthly under the Note, such that the first of the four monthly payments required under the Note will be due and payable on May, 2012 and all subsequent payments will be due on a monthly basis thereafter commencing on June 1, 2012, and to waive any and all defaults and/or events of default under the Note with respect to such payments. The Company did not make the required payment, and as a result, was in default of the revised agreement The Company renegotiated the terms of the Note and Northstar agreed to suspend the requirement of principal payments by the Company and allow payment of interest-only in common stock.
On September 21, 2012, the Company issued 5,000,000 common stock purchase warrants to Northstar that was treated as additional interest expense upon issuance.
On October 1, 2012, the Company and Northstar entered into a limited waiver and forbearance agreement providing a recapitalized new note balance comprised of all sums due Northstar with a maturity date extended perpetually. The Company agreed to issue 5,000,000 shares of Series A Convertible Preferred Stock and 10,000,000 of common stock in exchange for $210,000 as payment towards outstanding debt, default interest, penalties, professional fees outstanding and due Northstar. In addition, the Company executed a security agreement granting Northstar a lien on all patents, patent applications, trademarks, service marks, copyrights and intellectual property rights of any nature, as well as the results of all clinical trials, know-how for preparing Myoblasts, old and new clinical data, existing approved trials, all right and title to Myoblasts, clinical trial protocols and other property rights.
17
In addition, the Company granted Northstar a perpetual license on products as described for resale, relicensing and commercialization outside the United States. In connection with the granted license, Northstar shall pay the Company a royalty of up to 8% on revenues generated.
Effective October 1, 2012, the effective interest rate was 12.85% per annum. The parties agreed, as of February 28, 2013, to reduce the interest rate to 7% per annum.
In connection with the consideration paid, Northstar waived, from the effective date through the earlier of termination or expiration of the agreement, satisfaction of the obligations as described in the forbearance agreement.
In 2012, 5,000,000 shares of Series A Convertible Preferred Stock were approved to be issued, which was subsequently increased to 20,000,000 shares of preferred stock as Series A Convertible Preferred Stock. In addition, the Company is obligated to issue additional preferred stock equal in lieu of payment of cash of accrued and unpaid interest on each six month anniversary of the effective date (October 1, 2012). In lieu of the initial two payments in preferred stock, the parties have determined to modify the voting rights of the Series A Convertible Preferred Stock from 20 votes per share on matters to be voted on by the common stock holders to 25 votes per share on matters to be voted on by the common stock holders and all prior and subsequent payments of interest will be in common stock. The Company is required to issue additional shares of its common stock (as amended), in lieu of cash, each six month anniversary of the effective date for any accrued and unpaid interest.
As described above, during the year ended December 31, 2013, the Company issued the 5,000,000 shares of Series A Convertible Preferred Stock and the 10,000,000 of common stock described above in exchange for the $210,000 as payment towards outstanding principle of the debt. In addition, the Company issued 15,000,000 shares of Series A Convertible Preferred Stock as a penalty in settlement of the terms of the forbearance agreement. The fair value of the Preferred Stock of $274,050 was included in interest expense for the year ended December 31, 2013.
On September 30, 2013, the Company issued 8,771,929 shares of its common stock as payment of $100,000 towards cash advances.
On December 24, 2013, the Company issued 3,915,662 shares of its common stock as payment of accrued interest through June 30, 2013 of $85,447.
On April 2, 2014, the Company issued 274,681 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,635 due April 1, 2014 per the forbearance agreement.
On September 17, 2014, limited waiver and forbearance agreement entered into on October 1, 2012 to provide that the perpetual license on products as described for resale, relicensing and commercialization outside the United States was amended as such to condition upon NorthStar providing certain financing, which financing the Company, in its sole discretion, could decline and retain the license.
On October 3, 2014, the Company issued 514,886 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2014 per the forbearance agreement.
On April 3, 2015, the Company issued 1,363,031 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,635 due April 1, 2015 per the forbearance agreement.
As of June 30, 2015 and December 31, 2014, the principle of this note was $362,000.
18
Officer and Director Notes
June 30, | December 31, | ||||
2015 | 2014 | ||||
Notes payable, Dr. Murphy | $ | 465,240 | $ | 465,240 | |
Note payable, Mr. Tomas | 252,250 | 331,354 | |||
Note payable, Mr. Tomas | 375,000 | 375,000 | |||
Note payable, Mr. Tomas | 500,000 | 500,000 | |||
Note payable, Ms. Comella | 287,772 | 299,465 | |||
Total | $ | 1,880,262 | $ | 1,971,059 |
Notes payable, Dr. Murphy
At June 30, 2015 and December 31, 2014, the Company has outstanding notes payable to Dr. Murphy with interest at 8% per annum due at maturity in aggregate $465,240. Of the outstanding balance, certain subordinated notes totaling $100,000 and $140,000 were previously due on November 30, 2012 and June 4, 2011 respectively, and are unsecured. The Company is not obligated to make payment until Northstar (or successor) Loan is paid off.
Notes payable, Mr. Tomas
In 2013, the Company issued a promissory note payable for previous advances and accrued compensation. The promissory note bears interest of 5% per annum and due on demand. During the six months ended June 30, 2015, the Company paid off $79,104 of the outstanding promissory note. The principle outstanding balance of this note as of June 30, 2015 is $252,250.
On August 1, 2013, the Company issued a $375,000 promissory note due on demand in settlement of accrued compensation. The promissory note bears interest of 5% per annum and is due on demand. The principle outstanding balance of this note as of June 30, 2015 is $375,000.
On July 1, 2014, the Company issued a $500,000 promissory note in settlement of accrued compensation. The promissory note bears interest of 5% per annum and was due on January 1, 2015. The principle outstanding balance of this note as of June 30, 2015 is $500,000.
Notes payable, Ms. Comella
On July 1, 2014, the Company issued a $300,000 promissory note in settlement of accrued compensation. The promissory note bears interest of 5% per annum and due on January 1, 2015. During the six months ended June 30, 2015, the Company paid off $11,693 of the outstanding promissory note. The principle outstanding balance of this note as of June 30, 2015 is $287,772.
During the three and six months ended June 30, 2015, the Company purchased $80,504 and $172,298 lab kits, respectively, from Pavillion, Inc., a related party, whose owner is related to an officer of the Company.
NOTE 9 DERIVATIVE LIABILITIES
Reset warrants
On October 1, 2012, in connection with the forbearance agreement with Northstar as discussed in Note 8 above, the Company issued an aggregate of 15,000,000 common stock purchase warrants to purchase the Companys common stock with an exercise price of $0.014 per share for ten years with anti-dilutive (reset) provisions.
19
The Company has identified embedded derivatives related to the issued warrants. These embedded derivatives included certain and anti-dilutive (reset) provisions. The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date and to fair value as of each subsequent reporting date.
At June 30, 2015, the fair value of the reset provision related to the embedded derivative liability of $82,511 was determined using the Binomial Option Pricing model with the following assumptions: dividend yield: 0%; volatility: 113.63%; risk free rate: 2.07%; and expected life: 7.26 years. The Company recorded a gain on change in derivative liabilities of $31,837 and $67,409 during the three and six months ended June 30, 2015, respectively.
Convertible notes
In 2014 and the six months ended June 30, 2015, the Company issued convertible notes (see Note 7 above).
These notes are convertible into common stock, at holders option, at a discount to the market price of the Companys common stock. The Company has identified the embedded derivatives related to these notes relating to certain anti-dilutive (reset) provisions. These embedded derivatives included certain conversion features. The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date of these notes and to fair value as of each subsequent reporting date.
The fair value of the embedded derivatives at June 30, 2015, in the amount of $856,241, was determined using the Binomial Option Pricing Model based on the following assumptions: (1) dividend yield of 0%; (2) expected volatility of 113.63%, (3) weighted average risk-free interest rate of 0.01 to 0.28%, (4) expected lives of 0.10 to 0.92 years, and (5) estimated fair value of the Companys common stock of $0.0066 per share. The Company recorded a loss on change in derivative liabilities of $268,292 and $181,140 during the three and six months ended June 30, 2015, respectively.
Based upon ASC 840-15-25 (EITF Issue 00-19, paragraph 11) the Company has adopted a sequencing approach regarding the application of ASC 815-40 to its outstanding convertible notes. Pursuant to the sequencing approach, the Company evaluates its contracts based upon earliest issuance date.
NOTE 10 STOCKHOLDERS EQUITY
During the six months ended June 30, 2015, the Company issued an aggregate of 11,652,719 shares of its common stock in the amount of $100,132 for the settlement of outstanding accounts payable and accrued expenses. In connection with the issuance of the shares the Company recognized a gain on settlement of accounts payable and accrued expenses in the amount of $78,528 (see Note 5).
During the six months ended June 30, 2015, the Company issued 6,650,000 shares of common stock in settlement of litigation. In connection with the issuances, the Company recognized a loss in the amount of $59,850, which is included in the marketing, general and administration expense in the Statement of Operations (see Note 12).
On April 3, 2015, the Company issued 1,363,031 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,635 due April 1, 2015 per the forbearance agreement on Northstar note (See Note 8).
During the six months ended June 30, 2015, the Company issued an aggregate of 93,803,679 shares of its common stock for the conversion of $388,258 of notes payable and related accrued interest. Upon conversion of the notes, the Company recorded an adjustment to the derivative liability in the amount of $411,772 (see Note 13).
20
During the six months ended June 30, 2015, the Company purchased 8,343,200 shares of the Companys common stock in the open market at an average cost of $0.006 per share.
During the six months ended June 30, 2015, the Company issued an aggregate of 76,612,184 shares of common stock in exchange for $472,675 under the stock purchase agreement with Magna Equities II, LLC (see Note 6), and issued an aggregate of 7,851,968 shares of common stock in exchange for $61,270. In connection with the stock sale, the Company issued an aggregate of 1,443,656 warrants to purchase the Companys common stock (see Note 11).
During the six months ended June 30, 2015, the Company issued an aggregate of 24,353,285 shares of its common stock in settlement of accumulative outstanding accounts payable due to Guarantors of the Company of $961,125. In connection with the issuance, the Company incurred a $791,024 gain in settlement of debt.
NOTE 11 STOCK OPTIONS AND WARRANTS
Stock Options
In December 1999, the Board of Directors and shareholders adopted the 1999 Officers and Employees Stock Option Plan, or the Employee Plan, and the 1999 Directors and Consultants Stock Option Plan, or the Director Plan. The Employee Plan and the Director Plan are collectively referred to herein as the Plans. The Plans are administered by the Board of Directors and the Compensation Committee. The objectives of the Plans include attracting and retaining key personnel by encouraging stock ownership in the Company by such persons. In February 2010, the Directors & Consultants Plan was amended to extend the termination date of the Plan to December 1, 2011.
On April 1, 2013, the Board of Directors approved, subject to shareholder approval, the establishment of the Bioheart 2013 Omnibus Equity Compensation Plan, or the 2013 Omnibus Plan. The 2013 Omnibus Plan reserves up to fifty million shares of common stock for issuance. On August 4, 2014, the Board of Directors approved to set the reserve to one hundred million shares of common stock for issuance and to close the 1999 Officers and Employees Stock Option Plan. On February 2, 2015, at the annual meeting of shareholders, the majority of shareholders approved the 2013 Omnibus Equity Compensation Plan.
A summary of options at June 30, 2015 and activity during the three months then ended is presented below:
Weighted- | |||||||
Average | |||||||
Weighted- | Remaining | ||||||
Average | Contractual | ||||||
Shares | Exercise Price | Term (in years) | |||||
Options outstanding at January 1, 2014 | 23,912,943 | $ | 0.15 | 9.0 | |||
Granted | 43,148,487 | $ | 0.023 | 10.0 | |||
Exercised | | $ | |||||
Forfeited/Expired | (136,221 | ) | $ | 5.2 | |||
Options outstanding at December 31, 2014 | 66,925,209 | $ | 0.056 | 8.9 | |||
Granted | 7,000,000 | $ | 0.01116 | 10.0 | |||
Exercised | | ||||||
Forfeited/Expired | (24,712 | ) | $ | 0.71 | |||
Options outstanding at June 30, 2015 | 73,900,497 | $ | 0.05147 | 8.5 | |||
Options exercisable at June 30, 2015 | 33,001,632 | $ | 0.08939 | 8.5 | |||
Available for grant at June 30, 2015 | 89,500,000 |
21
The following information applies to options outstanding and exercisable at June 30, 2015:
Options Outstanding | Options Exercisable | |||||||||||
Weighted- | ||||||||||||
Average | Weighted- | Weighted- | ||||||||||
Remaining | Average | Average | ||||||||||
Contractual | Exercise | Exercise | ||||||||||
Shares | Term | Price | Shares | Price | ||||||||
$0.00 $0.70 | 73,438,487 | 8.6 | $ | 0.024 | 32,539,622 | $ | 0.03 | |||||
$0.71 $1.28 | 125,218 | 4.0 | $ | 0.828 | 125,218 | $ | 0.83 | |||||
$5.25 $5.67 | 312,080 | 1.1 | $ | 5.53 | 312,080 | $ | 5.53 | |||||
$7.69 | 24,712 | 1.1 | $ | 7.69 | 24,712 | $ | 7.69 | |||||
73,900,497 | 8.5 | $ | 0.05147 | 33,001,632 | $ | 0.08939 |
On February 2, 2015, the Company issued an aggregate 7,000,000 options to purchase the Companys common stock at $0.01116 per share to members of the Board of Directors, vesting immediately and exercisable over 10 years. The aggregate fair value of $121,735, determined using the Black Scholes option pricing model with the following assumptions: Dividend yield: 0%; Volatility: 142.65% and Risk free rate: 1.68%.
The fair value of all options vesting during the three and six months ended June 30, 2015 of $75,275 and $272,241, respectively, was charged to current period operations. The fair value of all options vesting during the three and six months ended June 30, 2014 of $48,805 and $243,370, respectively, was charged to period operations.
Warrants
A summary of common stock purchase warrants at June 30, 2015 and activity during the period then ended is presented below:
Weighted- | |||||||
Average | |||||||
Weighted- | Remaining | ||||||
Average | Contractual | ||||||
Exercise | Term (in | ||||||
Shares | Price | years) | |||||
Outstanding at January 1, 2014 | 118,078,856 | $ | 0.22 | 6.3 | |||
Issued | 57,582,469 | $ | 0.02 | 8.2 | |||
Exercised | (11,918,181 | ) | $ | 0.01 | |||
Expired | (13,178,145 | ) | $ | 0.08 | |||
Outstanding at December 31, 2014 | 150,564,999 | $ | 0.17 | 6.6 | |||
Issued | 1,443,656 | $ | 0.01127 | 10.0 | |||
Exercised | $ | ||||||
Expired | (10,325,002 | ) | $ | 0.0240 | |||
Outstanding at June 30, 2015 | 141,683,653 | $ | 0.1783 | 6.6 | |||
Exercisable at June 30, 2015 | 134,695,547 | $ | 0.10 | 6.6 |
22
The following information applies to common stock purchase warrants outstanding and exercisable at June 30, 2015:
Warrants Outstanding | Warrants Exercisable | |||||||||||
Weighted- | ||||||||||||
Average | Weighted- | Weighted- | ||||||||||
Remaining | Average | Average | ||||||||||
Contractual | Exercise | Exercise | ||||||||||
Shares | Term | Price | Shares | Price | ||||||||
$0.01 $0.50 | 135,434,520 | 6.7 | $ | 0.02 | 129,990,864 | $ | 0.02 | |||||
$0.52 $0.68 | 2,699,675 | 3.8 | $ | 0.58 | 2,699,675 | $ | 0.58 | |||||
$0.70 $1.62 | 848,176 | 4.5 | $ | 0.71 | 848,176 | $ | 0.71 | |||||
$5.67 $7.69 | 2,701,282 | 7.4 | $ | 7.55 | 1,156,832 | $ | 7.35 | |||||
141,683,653 | 6.6 | $ | 0.1783 | 134,695,547 | $ | 0.10 |
In conjunction with the authorized issuance of common stock, the Company granted 1,443,656 common stock purchase warrants during the six months ended June 30, 2015. The warrants are exercisable at an exercise price of approximately $0.01127 per share for ten years.
NOTE 12 COMMITMENTS AND CONTINGENCIES
Litigation
On March 19 2015, the Company settled a prospective dispute with a third party over the use of proprietary information through the issuance of 6,650,000 shares of common stock. (See Note 10)
On November 10, 2014, the Company was served with a lawsuit by an alleged assignee and a guarantor to a Loan Guarantee, Payment and Security Agreement. These parties claim breach of that Agreement and damages of approximately $2.3 Million plus interest. The assignor and assignee also sued the Companys directors and two past directors and an affiliate shareholder for breach of fiduciary duty, claiming damages as alleged creditors arising out of these parties alleged participation in Northstar Biotech Group, LLC, a secured creditor of the Company. On June 1, 2015, the Company settled the lawsuit. As part of the settlement, the Company recorded a gain of $1,169,058. The Company provided a note to the original guarantor in the amount of $1,697,762, to be paid over a five year period with a 0% interest rate.
The Company is subject to other legal proceedings that arise in the ordinary course of business. In the opinion of management, as of June 30, 2015, the amount of ultimate liability with respect to such matters, if any, in excess of applicable insurance coverage, is not likely to have a material impact on the Companys business, financial position, results of operations or liquidity. However, as the outcome of litigation and other claims is difficult to predict significant changes in the estimated exposures could exist.
NOTE 13 FAIR VALUE MEASUREMENT
The Company adopted the provisions of Accounting Standards Codification subtopic 825-10, Financial Instruments (ASC 825-10) on January 1, 2008. ASC 825-10 defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required or permitted to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and considers assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of nonperformance. ASC 825-10 establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 825-10 establishes three levels of inputs that may be used to measure fair value:
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Level 1 Quoted prices in active markets for identical assets or liabilities.
Level 2 Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 Unobservable inputs to the valuation methodology that are significant to the measurement of fair value of assets or liabilities.
All items required to be recorded or measured on a recurring basis are based upon level 3 inputs.
To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is disclosed and is determined based on the lowest level input that is significant to the fair value measurement.
Upon adoption of ASC 825-10, there was no cumulative effect adjustment to beginning retained earnings and no impact on the financial statements.
The carrying value of the Companys cash and cash equivalents, accounts receivable, accounts payable, short-term borrowings (including convertible notes payable), and other current assets and liabilities approximate fair value because of their short-term maturity.
As of June 30, 2015 or December 31, 2014, the Company did not have any items that would be classified as level 1 or 2 disclosures.
The Company recognizes its derivative liabilities as level 3 and values its derivatives using the methods discussed in notes 7 and 9. While the Company believes that its valuation methods are appropriate and consistent with other market participants, it recognizes that the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different estimate of fair value at the reporting date. The primary assumptions that would significantly affect the fair values using the methods discussed in Notes 7 and 9 are that of volatility and market price of the underlying common stock of the Company.
As of June 30, 2015 and December 31, 2014, the Company did not have any derivative instruments that were designated as hedges.
The derivative liability as of June 30, 2015, in the amount of $938,752 has a level 3 classification.
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The following table provides a summary of changes in fair value of the Companys Level 3 financial liabilities as of June 30, 2015:
Warrant | Debt | ||||||
Liability | Derivative | ||||||
Balance, December 31, 2013 | 146,855 | $ | 256,956 | ||||
Total (gains) losses | |||||||
Initial fair value of debt derivative at note issuance | | 1,443,708 | |||||
Initial fair value of derivative relating to reset warrants | | | |||||
Mark-to-market at December 31, 2014: | 3,065 | (429,018 | ) | ||||
Transfers out of Level 3 upon increase in authorized shares | | | |||||
Transfers out of Level 3 upon conversion and settlement of | |||||||
notes | | (680,295 | ) | ||||
Balance, December 31, 2014 | $ | 149,920 | $ | 591,351 | |||
Total (gains) losses | |||||||
Initial fair value of debt derivative at note issuance | | 495,522 | |||||
Mark-to-market at June 30, 2015: | (67,409 | ) | 181,140 | ||||
Transfers out of Level 3 upon conversion or payoff of notes | |||||||
payable | | (411,772 | ) | ||||
Balance, June 30, 2015 | $ | 82,511 | $ | 856,241 | |||
Net Gain (loss) for the period included in earnings relating to | |||||||
the liabilities held at June 30, 2015 | $ | 67,409 | $ | (181,140 | ) |
Fluctuations in the Companys stock price are a primary driver for the changes in the derivative valuations during each reporting period. The Companys stock price decreased approximately 37% from December 31, 2014 to June 30, 2015. As the stock price decreases for each of the related derivative instruments, the value to the holder of the instrument generally decreases.. Additionally, stock price volatility is one of the significant unobservable inputs used in the fair value measurement of each of the Companys derivative instruments.
The estimated fair value of these liabilities is sensitive to changes in the Companys expected volatility. Increases in expected volatility would generally result in a higher fair value measurement.
NOTE 14 SUBSEQUENT EVENTS
Subsequent stock issuances
In July 2015, the Company issued 19,948,340 shares of its common stock in settlement of $51,250 of outstanding convertible note payable and $1,520 accrued interest; 6,782,873 shares of its common stock in settlement of services of approximately $38,000. 6,368,040 shares of its common stock in exchange of $33,954 drawn down on the Magna debt and issued 1,345,364 shares of its common stock in settlement as true up shares pursuant to the draw down on the equity line.
Subsequent financing
In July 2015, the Company borrowed an aggregate of $180,000 under unsecured revenue based factoring agreements at an annual interest rate of 5% to 15% with aggregate daily payments of $1,464, including interest, over the term of the loan (189 days).
On August 1, 2015, the Company entered into a Securities Purchase Agreement with Fourth Man, LLC., for the sale of a 9.5% convertible note in the principal amount of $25,000 (the Note).
The Note bears interest at the rate of 9.5% per annum. All interest and principal must be repaid on July 31, 2016. The Note is convertible into common stock, at Fourth Man LLCs option, at a 47% discount to the lowest daily closing trading price of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal at 150%, interest and any other amounts.
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Unless otherwise indicated, references in this Quarterly Report on Form 10-Q to we, us, and our are to the Company, unless the context requires otherwise. The following discussion and analysis by our management of our financial condition and results of operations should be read in conjunction with our unaudited condensed interim financial statements and the accompanying related notes included in this quarterly report and our audited financial statements and related notes and Managements Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2014 filed with the Securities and Exchange Commission.
Cautionary Statement Regarding Forward-Looking Statements
This report may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and we intend that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements are based on our managements beliefs and assumptions and on information currently available to our management. Any such forward-looking statements would be contained principally in Managements Discussion and Analysis of Financial Condition and Results of Operations and Risk Factors. Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities and the effects of regulation. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as anticipates, believes, could, estimates, expects, hopes, intends, may, plans, potential, predicts, projects, should, will, would or similar expressions.
Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We discuss many of these risks in greater detail in Risk Factors. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our managements beliefs and assumptions only as of the date of this report. You should read this report and the documents that we reference in this report and have filed as exhibits to the report completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
Additional information concerning these and other risks and uncertainties is contained in our filings with the Securities and Exchange Commission, including the section entitled Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2014.
Unless otherwise indicated or the context otherwise requires, all references in this Form 10-Q to we, us, our, our company, Bioheart or the Company refer to Bioheart, Inc. and its subsidiaries.
Our Ability to Continue as a Going Concern
Our independent registered public accounting firm has issued its report dated March 16, 2015, in connection with the audit of our annual financial statements as of December 31, 2014, that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern and Note 2 to the unaudited financial statements for the period ended June 30, 2015 also describes the existence of conditions that raise substantial doubt about our ability to continue as a going concern.
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Overview
We are an emerging enterprise in the regenerative medicine/cellular therapy industry. We are focused on the discovery, development and commercialization of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. Our business includes the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic.
US Stem Cell Training, (SCT), an operating division of our company, is a content developer of regenerative medicine/cell therapy informational and training materials for physicians and patients. SCT also provides in-person and online training courses which are delivered through in-person presentations at SCTs state of the art facilities and globally at university, hospital and physicians office locations as well as through online webinars. Additionally, SCT provides hands-on clinical application training for physicians and health care professionals interested in providing regenerative medicine / cell therapy procedures.
Vetbiologics, (VBI), an operating division of our company, is a veterinary regenerative medicine company committed to providing veterinarians with the ability to deliver the highest quality regenerative medicine therapies to dogs, cats and horses. VBI provides veterinarians with extensive regenerative medicine capabilities including the ability to isolate regenerative stem cells from a patients own adipose (fat) tissue directly on-site within their own clinic or stall-side.
US Stem Cell Clinic, LLC, (SCC), a partially owned investment of our company, is a physician run regenerative medicine/cell therapy clinic providing cellular treatments for patients afflicted with neurological, autoimmune, orthopedic and degenerative diseases. SCC is operating in compliance with the FDA 1271s which allow for same day medical procedures to be considered the practice of medicine. We isolate stem cells from bone marrow and adipose tissue and also utilize platelet rich plasma.
Biohearts comprehensive map of products and services:
Regenerative medicine is defined as the process of replacing or regenerating human cells, tissues or organs to restore normal function. Among the categories of therapeutic technology platforms within this field are cell therapy; tissue engineering; tools, devices and diagnostics, and aesthetic medicine. Our business model is focused on two of these areas: first, cell therapy, in which we introduce cells (adult, donor or patient, stem cell or differentiated) into the body to prevent and treat disease; and second, we are a provider of services and products to physicians and veterinaries who provide or seek to provide cellular therapies and direct patient care for individuals and animals who may benefit from cellular therapy.
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All living complex organisms start as a single cell that replicates, differentiates(matures) and perpetuates in an adult organism through its lifetime. Cellular therapy is the process that uses cells to prevent, treat or cure disease, or regenerate damaged or aged tissue. To date, the most common type of cell therapy has been the replacement of mature, functioning cells such as through blood and platelet transfusions. Since the 1970s, first bone marrow and then blood and umbilical cord-derived stem cells have been used to restore bone marrow, as well as blood and immune system cells damaged by the chemotherapy and radiation that are used to treat many cancers. These types of cell therapies are standard of practice world-wide and are typically reimbursed by insurance.
Within the field of cell therapy, research and development using stem cells to treat a host of diseases and conditions has greatly expanded. Stem cells (in either embryonic or adult forms) are primitive and undifferentiated cells that have the unique ability to transform into or otherwise affect many different cells, such as white blood cells, nerve cells or heart muscle cells. Our cell therapy development efforts are focused on the use of adult stem cells; those cells which are found in the muscle, fat tissue and peripheral blood.
There are two general classes of cell therapies: Patient Specific Cell Therapies ("PSCTs") and Off-the-Shelf Cell Therapies ("OSCTs"). In PSCTs, cells collected from a person (donor) are transplanted, with or without modification, to a patient (recipient). In cases where the donor and the recipient are the same individual, these procedures are referred to as autologous. In cases in which the donor and the recipient are not the same individual, these procedures are referred to as allogeneic. Autologous cells offer a low likelihood of rejection by the patient and we believe the long-term benefits of these PSCTs can best be achieved with an autologous product. In the case of OSCT, donor cells are expanded many fold in tissue culture, and large banks of cells are frozen in individual aliquots that may result in treatments for as many as 10,000 people from a single donor tissue. By definition, OSCTs are always allogeneic in nature.
Various adult stem cell therapies are in clinical development for an array of human diseases, including autoimmune, oncologic, neurologic and orthopedic, among other indications. While no assurances can be given regarding future medical developments, we believe that the field of cell therapy holds the promise to better the human experience and minimize or ameliorate the pain and suffering from many common diseases and/or from the process of aging.
According to Robin R. Youngs Stem Cell Summit Executive Summary-Analysis and Market Forecasts 2014-2024, the United States stem cell therapy market is estimated to grow from an estimated $237 million in 2013 to more than $5.7 billion in 2020.
Specific to cellular therapy, we are focused on the discovery, development and commercialization of autologous cellular therapies for the treatment of chronic and acute heart damage as well as vascular and autoimmune diseases.
In our pipeline, we have multiple product candidates for the treatment of heart damage, including MyoCell and Myocell SDF-1. MyoCell and MyoCell SDF-1 are autologous muscle-derived cellular therapies designed to populate regions of scar tissue within a patients heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.
MyoCell SDF-1 is intended to be an improvement to MyoCell. MyoCell SDF-1 is similar to MyoCell but the myoblast cells to be injected for use in MyoCell SDF-1 are modified prior to injection by an adenovirus vector or non-viral vector so that they will release extra quantities of the SDF-1 protein, which expresses angiogenic factors.
AdipoCell is a patient-derived cell therapy proposed for the treatment of lower limb ischemia and potentially, among other autoimmune diseases, rheumatoid arthritis. We hope to demonstrate that these product candidates are safe and effective complements to existing therapies for chronic and acute heart damage.
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Our Clinical Development Pipeline Chart:
Our mission is to advance to market novel regenerative medicine and cellular therapy products that substantially benefit humankind. Our business strategy is, to the extent possible, finance our clinical development pipeline through revenue (cash in-flows) generated through the marketing and sales of unique educational and training services, animal health products and personalized cellular therapeutic treatments.
A fundamental shift in venture capital investment strategies where, management believes, financial sponsorship is now directed toward commercial or near commercial enterprises has required us to adapt our mission combining immediate revenue generating opportunities with longer-term development programs. Accordingly, we have developed a multifaceted portfolio of revenue generating products and services in our US Stem Cell Training, Vetbiologics, and US Stem Cell Clinic, operating divisions that will, if successful, financially support its clinical development programs. Our goal is to maximize shareholder value through the generation of short-term profits that increase cash in-flows and decrease the need for venture financings a modern biotechnology company development strategy.
Today, our company is a combination of opportunistic business enterprises. We estimate that the products and services we offer through US Stem Cell Training, Vetbiologics, and US Stem Cell Clinics has the potential, although we cannot provide assurances as to if and when it will be accomplished, to drive up to $100 million dollars in cumulative peak annual revenues. What we are establishing is a foundation of value in the products and services we are and plan to sell from US Stem Cell Training, Vetbiologics, and US Stem Cell clinics. Our strategy is to expand the revenues generated from each of these operating divisions and to reinvest the profits we generate into our clinical development pipeline.
On January 29th, 2015 we announced an update and diversification of our clinical development pipeline. Our cardiovascular and vascular product candidates have been streamlined, putting, we believe, our best opportunities at the forefront of our efforts. The MYOCELL and MYOCELL SDF-1 candidates will, in our opinion, advance forward in the treatment of chronic heart failure (CHF). We are in active prospective partnering discussion for the MYOCELL SDF-1 program. Partnering, we contend, will enhance our capabilities, reduce our development cost through cost sharing and potentially accelerate our time to approval and commercialization. We will apply our ADIPOCELL technology to the treatment of critical limb ischemia. Additionally, we have expanded and diversified our clinical development pipeline to include autoimmune disease, specifically applying ADIPOCELL to the treatment of Rheumatoid Arthritis (RA). We believe that updating and diversifying our clinical development programs increases the probability of our success, brings operational and fiscal clarity to our company, and will ultimately enhance shareholder value.
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We will continue to evaluate and act upon opportunities to increase our top line revenue position and that correspondingly increase cash in-flows. These opportunities include but are not limited to the development and marketing of new products and services, mergers and acquisitions, joint ventures, licensing deals and more.
Further, if the opportunity presents itself whereby we can raise additional capital at a reasonable fair market value, our management will do so. Accordingly, we plan to continue in our efforts to restructure, equitize or eliminate legacy balance sheet issues that are obstacles to market capitalization appreciation and capital fund raising.
Results of Operations Overview
We are a research and development company and our MyoCell product candidate has not received regulatory approval or generated any material revenues and is not expected to until 2016, if ever. We have generated substantial net losses and negative cash flow from operations since inception and anticipate incurring significant net losses and negative cash flows from operations for the foreseeable future as we continue clinical trials, undertake new clinical trials, apply for regulatory approvals, make capital expenditures, add information systems and personnel, make payments pursuant to our license agreements upon our achievement of certain milestones, continue development of additional product candidates using our technology, establish sales and marketing capabilities and incur the additional cost of operating as a public company.
Three Months Ended June 30, 2015 as compared to the Three Months Ended June 30, 2014
Revenues
We recognized revenues of $565,307 for the three months ended June 30, 2015, generated from the sales of kits and equipment, services, MyoCath Catheters, AdipoCell, and laboratory services. We recognized revenues of $579,246 for the three months ended June 30, 2014 from the sale of MyoCath catheters, AdipoCell, physician training, patient studies and laboratory services. The differential in revenue reflected a moderate decrease based on the products and services provided.
Cost of Sales
Cost of sales consists of the costs associated with the production of MyoCath, laboratory supplies necessary for laboratory services, production of AdipoCell systems and materials, physician course materials, and clinic supplies required for patient studies.
Cost of sales was $223,592 and $189,331 in the three month periods ended June 30, 2015 and 2014, respectively. Associated gross margins were $341,715 (60.4%) and $389,915 (67.3%) for the three months periods ended June 30, 2015 and 2014, respectively. The decrease in gross margin, quarter over quarter, is attributed to the mix of product sales and the testing of lower pricing models to attempt to increase the volume of certain product and service sales.
Research and Development
Our research and development expenses consist of costs incurred in identifying, developing and testing our products and services. Research and development expenses were $130,373 in the three month period ended in June 30, 2015, an increase of $114,895 from the research and development expenses of $15,478 in the three month period ended in June 30, 2014. Our increase is proportionate to our increase in management focus on research and development and its corresponding ongoing costs. The timing and amount of our planned research and development expenditures is dependent on our ability to obtain additional financing.
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Marketing, General and Administrative
Our marketing, general and administrative costs were $690,248 for the three month period ended June 30, 2015 compared to $831,362 for the three month period ended June 30, 2014, a decrease of $141,114. The decrease in costs primarily due to the reduction of stock based compensation of $63,963 and reduction in commission expense of $74,377.
Our marketing, general and administrative expenses primarily consist of the costs associated with our general management and product and service marketing programs, including, but not limited to, salaries and related expenses for executive, administrative and marketing personnel, rent, insurance, legal and accounting fees, consulting fees, travel and entertainment expenses, conference costs and other clinical marketing and trade program expenses.
Gain on settlement of debt
During the three months ended June 30, 2015, we settled $1,585,862 in guarantor fees, accrued interest of $373,469, and an outstanding note payable of $1,500,000, for a net gain of $1,960,082. In addition, we incurred a gain of $19,098 in open accounts payable during the current period as compared to a net aggregate gain of $93,422 for the same period last year.
Interest Expense
Interest expense during the three months ended June 30, 2015 was $384,250 compared to $398,194 three months ended June 30, 2014. Interest expense primarily consists of interest incurred on the principal amount of the Northstar loan, our former Bank of America loan, the Seaside National Bank loan, accrued fees and interest payable to the Guarantors, the amortization of debt discounts and non-cash interest incurred relating to our issued convertible notes payable. The debt discounts amortization and non-cash interest incurred during the three months ended June 30, 2015 and 2014 was $293,558 and $224,130, respectively.
Six Months Ended June 30, 2015 as compared to the Six Months Ended June 30, 2014
Revenues
We recognized revenues of $1,054,864 for the six months ended June 30, 2015, generated from the sales of kits and equipment, services, MyoCath Catheters, AdipoCell, and laboratory services. We recognize revenues of $971,420 for the six months ended June 30, 2014 from the sale of MyoCath catheters, AdipoCell, physician training, patient studies and laboratory services. The increase in revenue resulted from the growth of the sale of our products and services.
Cost of Sales
Cost of sales consists of the costs associated with the production of MyoCath, laboratory supplies necessary for laboratory services, production of AdipoCell systems and materials, physician course materials and clinic supplies required for patient studies.
Cost of sales was $471,216 and $353,379 in the six month periods ended June 30, 2015 and 2014, respectively. Associated gross margins were $583,648 (55.3%) and $618,041 (63.6%) for the six months periods ended June 30, 2015 and 2014, respectively. The decrease in gross margin, period over period, is attributed to the mix of product sales and the testing of lower pricing models to attempt to increase the volume of certain product and service sales.
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Research and Development
Our research and development expenses consist of costs incurred in identifying, developing and testing our products and services. Research and development expenses were $180,518 in the six month period ended in June 30, 2015, an increase of $155,183 from the research and development expenses of $25,335 in the six month period ended in June 30, 2014. Our increase is proportionate to our increase in management focus on research and development and its corresponding ongoing costs. The timing and amount of our planned research and development expenditures is dependent on our ability to obtain additional financing.
Marketing, General and Administrative
Our marketing, general and administrative costs were $1,688,381 for the six month period ended June 30, 2015 compared to $1,669,691 for the six month period ended June 30, 2014, an increase of $18,690 . The increase in costs primarily due to increases in salaries from $325,000 for the six months ended June 30, 2014 to $436,558 for the current period, an increase of $111,558, and our legal and consulting fees decreased by $70,046 and $35,507, respectively, due to services provided.
Our marketing, general and administrative expenses primarily consist of the costs associated with our general management and product and service marketing programs, including, but not limited to, salaries and related expenses for executive, administrative and marketing personnel, rent, insurance, legal and accounting fees, consulting fees, travel and entertainment expenses, conference costs and other clinical marketing and trade program expenses.
Gain on settlement of debt
During the six months ended June 30, 2015, we settled $1,585,862 in guarantor fees, accrued interest of $373,469 and an outstanding note payable of $1,500,000 for a net gain of $1,960,082. In addition, we incurred a gain of $78,528 in open accounts payable. In the six month ended June 30, 2014, we settled outstanding debt and related accrued interest for a net gain of $81,568, licensing fees settled for a gain of $2,122,130, net with a loss on settlement of accounts payable of $16,644.
Interest Expense
Interest expense during the six months ended June 30, 2015 was $814,092 compared to $704,092 six months ended June 30, 2014. Interest expense primarily consists of interest incurred on the principal amount of the Northstar loan, our former Bank of America loan, the Seaside National Bank loan, accrued fees and interest payable to the Guarantors, the amortization of debt discounts and non-cash interest incurred relating to our issued convertible notes payable. The debt discounts amortization and non-cash interest incurred during the six months ended June 30, 2015 and 2014 was $613,932 and $482,491, respectively.
Stock-Based Compensation
Stock-based compensation reflects our recognition as an expense of the value of stock options and other equity instruments issued to our employees and non-employees over the vesting period of the options and other equity instruments. We have granted to our employees options to purchase shares of common stock at exercise prices equal to the fair market value of the underlying shares of common stock at the time of each grant, as determined by our Board of Directors, with input from management.
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The Company follows Accounting Standards Codification subtopic 718-10. Compensation (ASC 718-10) which requires that all share-based payments to both employee and non-employees be recognized in the income statement based on their fair values.
In awarding our common stock, our Board of Directors considered a number of factors, including, but not limited to:
● | our financial position and historical financial performance; |
● | arms length sales of our common stock; |
● | the development status of our product candidates; |
● | the business risks we face; |
● | vesting restrictions imposed upon the equity awards; and |
● | an evaluation and benchmark of our competitors; and |
● | prospects of a liquidity event. |
In April 1, 2013, the Board of Directors authorized, (and approved by our shareholders on February 2, 2015), the establishment of the Bioheart 2013 Omnibus Equity Compensation Plan, or the 2013 Omnibus Plan. The 2013 Omnibus Plan reserves up to fifty million shares of common stock for issuance, subsequently increased to 100,000,000 on November 3, 2014. We currently have 89,500,000 available to future issuances.
Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. While our critical accounting policies are described in Note 1 to our financial statements appearing elsewhere in this report, we believe the following policies are important to understanding and evaluating our reported financial results:
Revenue Recognition
We recognize revenue in accordance with Accounting Standards Codification subtopic 605-10, Revenue Recognition (ASC 605-10) which requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred; (3) the selling price is fixed and determinable; and (4) collectability is reasonably assured. Determination of criteria (3) and (4) are based on managements judgments regarding the fixed nature of the selling prices of the products delivered and the collectability of those amounts. Provisions for discounts and rebates to customers, estimated returns and allowances, and other adjustments are provided for in the same period the related sales are recorded.
At the time of each transaction, management assesses whether the fee associated with the transaction is fixed or determinable and whether or not collection is reasonably assured. The assessment of whether the fee is fixed or determinable is based upon the payment terms of the transaction. Collectability is assessed based on a number of factors, including past transaction history with the client and the creditworthiness of the client.
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Revenues for test kits and equipment sold are not recorded until test kits are delivered. We have revenue sharing arrangements for the sale of goods whereby the Company is the primary obligor, sets pricing with the customers and bears all associated credit risks with the customers. Sales under revenue share arrangements are recorded as gross sales and any portion shared with third parties under such arrangements are classified as selling expense due to the nature of the marketing activities performed by the third party. Revenues from trainings are not recorded until the completion of the training. Any cash received as a deposit for trainings are recorded by the company as a liability.
Patent treatments and laboratory services revenue are recognized when those services have been completed or satisfied.
Revenues for bank sales are accounted for as Multiple-Element Arrangements under ASC 605-10 which incorporates Accounting Standards Codification subtopic 605-25, Multiple-Element Arrangements (ASC 605-25). ASC 605-25 addresses accounting for arrangements that may involve the delivery or performance of multiple products, services and/or rights to use assets.
Research and Development Activities
We account for research and development costs in accordance with Accounting Standards Codification subtopic 730-10, Research and Development (ASC 730-10). Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved as defined under the applicable agreement. Company-sponsored research and development costs related to both present and future products are expensed in the period incurred.
Derivative financial instruments
Accounting Standards Codification subtopic 815-40, Derivatives and Hedging, Contracts in Entitys own Equity (ASC 815-40) became effective for the Company on October 1, 2009. The Company has identified the embedded derivatives related to the issued Notes and anti-dilutive warrants. These embedded derivatives included in our debt contain certain conversion features and reset provision. The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date of Asher Notes and to fair value as of each subsequent reporting date.
Inflation
Our opinion is that inflation has not had, and is not expected to have, a material effect on our operations.
Climate Change
Our opinion is that neither climate change, nor governmental regulations related to climate change, have had, or are expected to have, any material effect on our operations.
Concentrations of Credit Risk
As of June 30, 2015, four customers represented 13%, 7%, 6% and 16%, respectively aggregate of 42% of the Companys accounts receivable. As of December 31, 2014, two customers represented 38% and 17%, aggregate of 55%, of the Companys accounts receivable.
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Liquidity and Capital Resources
In the six months ended June 30, 2015, we continued to finance our considerable operational cash needs with cash generated from financing activities.
Operating Activities
Net cash used in operating activities was $646,726 in the six month period ended June 30, 2015 as compared to $507,059 of cash used in the six month period ended in June 30, 2014.
Our use of cash for operations in the six months ended June 30, 2015 reflected a net loss generated during the period of $161,623, adjusted for non-cash items such as stock-based compensation of $269,301, depreciation of $2,619, amortization of debt discounts of $425,629, and non-cash interest expense of $188,303, loss on change in fair value of derivative liabilities of $113,731, net gain on settlement of debt of $2,038,611 and income from investments of $12,308. In addition we had a net decrease in operating assets of $4,377 and an increase in accrued expenses of $221,950, in accounts payable of $242,956 and deferred revenue of $37,100.
Investing Activities
Net cash used in investing activities was $61,166 for the six months ended June 30, 2015 were to acquire office equipment of $894, additional investment of $10,000 and purchase of treasury stock of $50,272 as compared to $6,366 of cash used for the purchase of equipment for the same period of 2014.
Buy-Back Program
On January 13, 2015, we issued a press release announcing that our Board of Directors approved a share repurchase program authorizing us to repurchase outstanding common stock when beneficially prudent for our company and our shareholders As of June 30, 2015, we have purchased 8,343,200 shares of our common stock pursuant to our share repurchase program.
Financing Activities
Net cash provided by financing activities was an aggregate of $764,752 in the six month period ended June 30, 2015 as compared to $558,419 in the six month period ended in June 30, 2014. In the six month period ended June 30, 2015 we sold, in private placements, shares of common stock and common stock purchase warrants for aggregate net cash proceeds of $533,945 and received proceeds from issuance of note payable of $315,000 net with repayments of related party notes payable of $90,797 and received $6,604 related party advances.
Existing Capital Resources and Future Capital Requirements
Our MyoCell product candidate has not received regulatory approval or generated any material revenues. We do not expect to generate any material revenues or cash from sales of our MyoCell product candidate until commercialization of MyoCell, if ever. We have generated substantial net losses and negative cash flow from operations since inception and anticipate incurring significant net losses and negative cash flows from operations for the foreseeable future. Historically, we have relied on proceeds from the sale of our common stock and our incurrence of debt to provide the funds necessary to conduct our research and development activities and to meet our other cash needs.
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At June 30, 2015, we had cash and cash equivalents totaling $93,534. However our working capital deficit as of such date was approximately $8 million. Our independent registered public accounting firm has issued its report dated March 16, 2015 in connection with the audit of our financial statements as of December 31, 2014 that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern and Note 2 of our unaudited financial statement for the quarter ended June 30, 2015 addresses the issue of our ability to continue as a going concern.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not required under Regulation S-K for smaller reporting companies.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures, which are designed to ensure that information required to be disclosed in the reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commissions rules and forms, and that such information is accumulated and communicated to our management, including our CEO and Chief Accounting Officer, as appropriate, to allow timely decisions regarding required disclosure.
Based on their evaluation, as of June 30, 2015, our management has concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) are effective to provide reasonable assurance that information required to be disclosed by us in reports that we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, summarized, processed and reported within the time periods specified in the SECs rules and forms and to provide reasonable assurance that such information is accumulated and communicated to our management as appropriate to allow timely decisions regarding required disclosure.
Changes In Internal Control Over Financial Reporting
There were no changes in the Companys internal controls over financial reporting during the most recently completed fiscal quarter that have materially affected or are reasonably likely to materially affect the Companys internal control over financial reporting.
PART II OTHER INFORMATION
Item 1. Legal Proceedings
On November 10, 2014, the Company was served with a lawsuit by an alleged assignee and a guarantor to a Loan Guarantee, Payment and Security Agreement. These parties claim breach of that Agreement and damages of approximately $2.3 Million plus interest. The assignor and assignee also sued the Companys directors and two past directors and an affiliate shareholder for breach of fiduciary duty, claiming damages as alleged creditors arising out of these parties alleged participation in Northstar Biotech Group, LLC, a secured creditor of the Company. On June 1, 2015, the Company settled the lawsuit.
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Apart from the above, our Company is not involved in any material litigation pursuant to Item 103 of Regulation S-K. However, the biotechnology and medical device industries have been characterized by extensive litigation regarding patents and other intellectual property rights. In addition, from time to time, we may become involved in litigation relating to claims arising from the ordinary course of our business.
Item 1A. Risk Factors
Not required under Regulation S-K for smaller reporting companies.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
During the six months ended June 30, 2015, the Company sold an aggregate of 7,851,968 shares of the Companys common stock and common stock purchase warrants to purchase 1,443,656 shares of the Companys common stock for aggregate gross cash proceeds of $61,270. The warrants are (i) exercisable solely for cash at an exercise prices of approximately $0.01127 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time during the period commencing on the date that is six months and one day following the date of issuance and ending on the tenth year anniversary of the date of issuance.
The issuance of such shares of our common stock was effected in reliance on the exemptions for sales of securities not involving a public offering, as set forth in Rule 506 promulgated under the Securities Act of 1933, as mended (the Securities Act) and in Section 4(2) of the Securities Act, based on the following: the investors confirmed to us that they were accredited investors, as defined in Rule 501 of Regulation D promulgated under the Securities Act and had such background, education and experience in financial and business matters as to be able to evaluate the merits and risks of an investment in the securities; (b) there was no public offering or general solicitation with respect to the offering; (c) the investors were provided with certain disclosure materials and all other information requested with respect to our company; (d) the investors acknowledged that all securities being purchased were restricted securities for purposes of the Securities Act, and agreed to transfer such securities only in a transaction registered under the Securities Act or exempt from registration under the Securities Act; and (e) a legend was placed on the certificates representing each such security stating that it was restricted and could only be transferred if subsequent registered under the Securities Act or transferred in a transaction exempt from registration under the Securities Act.
Item 3. Defaults Upon Senior Securities
There were no defaults upon senior securities during the period ended June 30, 2015.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None
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Item 6. Exhibits
Exhibit No. | Exhibit Description | |
3.1(6) |
Amended and Restated Articles of Incorporation of the registrant, as amended | |
3.2(9) |
Articles of Amendment to the Articles of Incorporation of the registrant | |
3.3(8) |
Amended and Restated Bylaws | |
4.1(5) |
Loan and Security Agreement, dated as of May 31, 2007 by and between BlueCrest Capital Finance, L.P. and the registrant | |
4.2(12) |
Notice of Event of Default, from BlueCrest Venture Finance Master Fund Limited to the Company, dated January 28, 2009 | |
4.3(12) |
Notice of Acceleration, from BlueCrest Venture Finance Master Fund Limited to the Company, dated February 2, 2009 | |
4.4(13) |
Amendment to Loan and Security Agreement, between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009 | |
4.5(13) |
Grant of Security Interest (Patents), between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009 | |
4.6(13) |
Security Agreement (Intellectual Property), between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009 | |
4.7(13) |
Subordination Agreement, by Hunton & Williams, LLP in favor of BlueCrest Venture Finance Master Fund Limited, entered into and effective April 2, 2009 | |
4.8(13) |
Amended and Restated Promissory Note, dated April 2, 2009, by the Company to BlueCrest Venture Finance Master Fund Limited | |
4.9(13) |
Warrant to purchase 1,315,542 shares of the registrants common stock, dated April 2, 2009, issued to BlueCrest Venture Finance Master Fund Limited | |
4.10(14) |
Warrant to purchase 451,043 shares of the registrants common stock, dated April 2, 2009, issued to Rogers Telecommunications Limited | |
4.11(14) |
Warrant to purchase 173,638 shares of the registrants common stock, dated April 2, 2009, issued to Hunton & Williams, LLP | |
4.12(4) |
Warrant to purchase shares of the registrants common stock issued to Howard J. Leonhardt and Brenda Leonhardt | |
4.12(19) |
10% Convertible Promissory Note Due July 23, 2010, in the amount of $20,000, payable to Dana Smith | |
4.13(19) |
10% Convertible Promissory Note Due July 23, 2010, in the amount of $100,000, payable to Bruce Meyers | |
4.14(19) |
Registration Rights Agreement, dated July 23, 2009 | |
4.15(4) |
Warrant to purchase shares of the registrants common stock issued to the R&A Spencer Family Limited Partnership | |
4.15(19) |
Subordination Agreement, dated July 23, 2009 | |
4.16(19) |
Note Purchase Agreement, dated July 23, 2009 | |
4.17(19) |
Closing Confirmation of Conversion Election, dated July 23, 2009 | |
4.20(6) |
Warrant to purchase shares of the registrants common stock issued to Samuel S. Ahn, M.D. | |
4.23(7) |
Warrant to purchase shares of the registrants common stock issued to Howard and Brenda Leonhardt | |
4.27(11) |
Form of Warrant Agreement for October 2008 Private Placement | |
4.30(19) |
10% Convertible Promissory Note Due July 23, 2010, in the amount of $100,000, payable to Bruce Meyers | |
4.31(34) |
Series A Convertible Preferred Stock |
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4.32(35) | Amendment to the Series A Convertible Preferred Stock | |
10.1**(1) | 1999 Officers and Employees Stock Option Plan | |
10.2**(1) | 1999 Directors and Consultants Stock Option Plan | |
10.3(1) | Form of Option Agreement under 1999 Officers and Employees Stock Option Plan | |
10.4(3) | Form of Option Agreement under 1999 Directors and Consultants Stock Option Plan | |
10.5**(4) | Employment Letter Agreement between the registrant and Scott Bromley, dated August 24, 2006. | |
10.6(1) | Lease Agreement between the registrant and Sawgrass Business Plaza, LLC, as amended, dated November 14, 2006. | |
10.7(1) | Asset Purchase Agreement between the registrant and Advanced Cardiovascular Systems, Inc., dated June 24, 2003. | |
10.8(4) | Conditionally Exclusive License Agreement between the registrant, Dr. Peter Law and Cell Transplants International, LLC, dated February 7, 2000, as amended. | |
10.9(4) | Loan Guarantee, Payment and Security Agreement, dated as of June 1, 2007, by and between the registrant, Howard J. Leonhardt and Brenda Leonhardt | |
10.10(4) | Loan Guarantee, Payment and Security Agreement, dated as of June 1, 2007, by and between the registrant and William P. Murphy Jr., M.D. | |
10.11(4) | Loan Agreement, dated as of June 1, 2007, by and between the registrant and Bank of America, N.A. | |
10.13(4) | Warrant to purchase shares of the registrants common stock issued to Howard J. Leonhardt and Brenda Leonhardt | |
10.14(4) | Warrant to purchase shares of the registrants common stock issued to William P. Murphy, Jr., M.D. | |
10.16(4) | Material Supply Agreement, dated May 10, 2007, by and between the registrant and Biosense Webster | |
10.17(5) | Warrant to purchase shares of the registrants common stock issued to BlueCrest Capital Finance, L.P. | |
10.18(6) | Loan Guarantee, Payment and Security Agreement, dated as of September 12, 2007, by and between the registrant and Samuel S. Ahn, M.D. | |
10.19(6) | Loan Guarantee, Payment and Security Agreement, dated as of September 12, 2007, by and between the registrant and Dan Marino | |
10.21(6) | Loan Guarantee, Payment and Security Agreement, dated as of September 19, 2007, by and between the registrant and Jason Taylor | |
10.22(7) | Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the registrant and Howard and Brenda Leonhardt | |
10.24(7) | Second Amendment to Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the registrant and Howard and Brenda Leonhardt | |
10.25(7) | Second Amendment to Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the registrant and William P. Murphy, Jr., M.D. | |
10.26**(10) | Bioheart, Inc. Omnibus Equity Compensation Plan | |
10.28(11) | Form of Registration Rights Agreement for October 2008 Private Placement | |
10.29(19) | 10% Convertible Promissory Note Due July 23, 2010, in the amount of $20,000, payable to Dana Smith | |
10.31(19) | Registration Rights Agreement, dated July 23, 2009 | |
10.32(19) | Subordination Agreement, dated July 23, 2009 | |
10.33(19) | Note Purchase Agreement, dated July 23, 2009 | |
10.34(19) | Closing Confirmation of Conversion Election, dated July 23, 2009 | |
10.35**(20) | Amended and Restated 1999 Directors and Consultants Stock Option Plan | |
10.36(21) | Preliminary Commitment Letter with Seaside National Bank and Trust, dated September 30, 2010. | |
10.37(22) | Loan Agreement with Seaside National Bank and Trust, dated October 25, 2010. | |
10.38(22) | Promissory Note with Seaside National Bank and Trust, dated October 25, 2010. | |
10.39(22) | Amended and Restated Loan and Security Agreement with BlueCrest Venture Finance Master Fund Limited, dated October 25, 2010. |
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10.40(23) | Form of Subscription Agreement, executed November 30, 2010. | |
10.41(23) | Form of Common Stock Purchase Warrant, issued November 30, 2010. | |
10.42(23) | Form of Registration Rights Agreement, dated November 30, 2010. | |
10.43(24) | Unsecured Convertible Promissory Note for $25,000, with Magna Group, LLC, dated January 3, 2011. | |
10.44(24) | Promissory Note for $139,728.82 with Magna Group, LLC, dated January 3, 2011. | |
10.45(24) | Securities Purchase Agreement with Magna Group, LLC, dated January 3, 2011. | |
10.46(24) | Subordination Agreement, dated January 3, 2011. | |
10.47(24) | Notice of Conversion Election, dated January 3, 2011. | |
10.48(25) | Unsecured Convertible Promissory Note for $34,750, with Magna Group, LLC, dated May 16, 2011. | |
10.49(25) | Promissory Note for $139,728.82 with Magna Group, LLC, dated May 16, 2011. | |
10.50(25) | Securities Purchase Agreement with Magna Group, LLC, dated May 16, 2011. | |
10.51(25) | Subordination Agreement, dated May 16, 2011. | |
10.52(26) | Promissory Note for $139,728.82 with Lotus Funding Group, LLC, dated June 15, 2011. | |
10.53(26) | Partial Assignment and Modification Agreement, dated June 15, 2011. | |
10.54(26) | Subordination Agreement, dated June 15, 2011. | |
10.55(27) | Promissory Note for $140,380.21 with Greystone Capital Partners, dated July 8, 2011. | |
10.56(27) | Partial Assignment and Modification Agreement, dated July 8, 2011. | |
10.57(28) | Subordination Agreement, dated July 8, 2011. | |
10.58(29) | Promissory Note for $139,728.82 with Greystone Capital Partners, dated August 1, 2011. | |
10.59(29) | Partial Assignment and Modification Agreement, dated August 1, 2011. | |
10.60(29) | Subordination Agreement, dated August 1, 2011. | |
10.61(30) | Promissory Note for $139,728.82 with Greystone Capital Partners, dated September 1, 2011. | |
10.62(30) | Partial Assignment and Modification Agreement, dated September 1, 2011. | |
10.63(30) | Subordination Agreement, dated September 1, 2011. | |
10.64(31) | Standby Equity Distribution Agreement dated as of November 2, 2011. | |
10.65(31) | Registration Rights Agreement dated as of November 2, 2011. | |
10.66(32) | Promissory Note for $139,728.82 with Greystone Capital Partners, dated January 3, 2012 | |
10.67(32) | Term Note B Promissory Note for $139,728.82 with Greystone Capital Partners, dated January 3, 2012 | |
10.68(32) | Unsecured Convertible Promissory Note for $63,000, with Asher Enterprises, Inc. dated April 2, 2012 | |
10.69(32) | Unsecured Convertible Promissory Note for $125,000, with IBC Funds LLC., dated January 9, 2013 | |
10.70(32) | Unsecured Convertible Promissory Note for $37,500, with Asher Enterprises, Inc. dated February 20, 2013 | |
10.71(32) | Unsecured Convertible Promissory Note for $42,500, with Asher Enterprises, Inc. dated January 9, 2013 | |
10.80(33) | 2013 Bioheart, Inc. Omnibus Equity Compensation Plan | |
10.81(34) | Securities Purchase Agreement, dated as of October 7, 2014, by and between Magna Holdings I, LLC and Bioheart, Inc. | |
10.82(34) | Registration Rights Agreement, dated as of October 7, 2014, by and between Magna Holdings I, LLC and Bioheart, Inc. | |
10.83(34) | Common Stock Purchase Agreement, dated as of October 23, 2014, by and between Magna Equities II, LLC and Bioheart, Inc. | |
10.84(34) | Registration Rights Agreement, dated as of October 23, 2014, by and between Magna Equities II, LLC and Bioheart, Inc. | |
10.85**(35) | 2013 Omnibus Equity Compensation Plan Amendment One. | |
14.2(2) | Code of Business Conduct and Ethics | |
31.1* | Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
32.1* | Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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* | Filed herewith | |
** | Indicates management contract or compensatory plan. | |
(1) | Incorporated by reference to the Companys Form S-1 filed with the Securities and Exchange Commission (the SEC) on February 13, 2007. | |
(2) | Incorporated by reference to Amendment No. 1 to the Companys Form S-1 filed with the SEC on June 5, 2007. | |
(3) | Incorporated by reference to Amendment No. 2 to the Companys Form S-1 filed with the SEC on July 12, 2007. | |
(4) | Incorporated by reference to Amendment No. 3 to the Companys Form S-1 filed with the SEC on August 9, 2007. | |
(5) | Incorporated by reference to Amendment No. 4 to the Companys Form S-1 filed with the SEC on September 6, 2007. | |
(6) | Incorporated by reference to Amendment No. 5 to the Companys Form S-1 filed with the SEC on October 1, 2007. | |
(7) | Incorporated by reference to Post-effective Amendment No. 1 to the Companys Form S-1 filed with the SEC on October 11, 2007. | |
(8) | Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC on July 3, 2008. | |
(9) | Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC on August 8, 2008. | |
(10) | Incorporated by reference to the Companys Quarterly Report on Form 10-Q filed with the SEC on August 14, 2008. | |
(11) | Incorporated by reference to the Companys Quarterly Report on Form 10-Q filed with the SEC on November 14, 2008. | |
(12) | Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC on February 3, 2009. | |
(13) | Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC on April 8, 2009. | |
(14) | Incorporated by reference to the Companys Annual Report on Form 10-K filed with the SEC on April 15, 2009. | |
(15) | Incorporated by reference to the Companys Annual Report on Form 10-K/A filed with the SEC on April 30, 2009. | |
(16) | Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC on May 18, 2009. | |
(17) | Incorporated by reference to the Companys Quarterly Report on Form 10-Q filed with the SEC on May 20, 2009. | |
(18) | Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC on July 9, 2009. |
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(19) | Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC on August 3, 2009. | |
(20) | Incorporated by reference to Exhibit 4.6 to the Companys Post-Effective Amendment to Registration Statement on Form S-8/A, filed with the SEC on June 2, 2010. | |
(21) | Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed with the SEC on October 6, 2010. | |
(22) | Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC on October 29, 2010. | |
(23) | Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC on December 6, 2010. | |
(24) | Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC on January 12, 2011. | |
(25) | Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on May 25, 2011 | |
(26) | Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on June 21, 2011 | |
(27) | Incorporated by reference to the Companys Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 15. 2011 | |
(28) | Incorporated by reference to the Companys Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2011 | |
(29) | Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on January 13, 2012 | |
(30) | Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on January 30, 2012 | |
(31) | Incorporated by reference to the Company Registration Statement on Form S-1/A filed with the SEC on February 8, 2012 | |
(32) | Incorporated by reference to the Company Annual Report on Form 10-K filed with the SEC on March 29, 2013 | |
(33) | Incorporated by reference to the Company Quarterly Report on Form 10-Q filed with the SEC on May 9, 2013 | |
(34) | Incorporated by reference to the Companys Registration Statement on Form S-1/A filed with the SEC on December 12, 2014. | |
(35) | Incorporated by reference to the Companys Definitive Proxy Statement on Schedule 14A filed with the SEC on December 19, 2014. |
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Exhibit No. | Exhibit Description | |
31.1* | Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
32.1* | Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
101.INS | XBRL Instance Document | |
101.SCH | XBRL Taxonomy Extension Schema Document | |
101.CAL | XBRL Taxonomy Calculation Linkbase Document | |
101.LAB | XBRL Taxonomy Labels Linkbase Document | |
101.PRE | XBRL Taxonomy Presentation Linkbase Document | |
101.DEF | XBRL Definition Linkbase Document |
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Bioheart, Inc. | ||
Date: August 3, 2015 | By: | /s/Mike Tomas |
Mike Tomas | ||
Chief Executive Officer & | ||
President and Principal Financial | ||
and Accounting Officer |
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