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 March 31, 2019

  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

 

U.S. STEM CELL, INC.

(Exact name of registrant as specified in its charter)

 

Florida

65-0945967

(State or other jurisdiction of 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

(Registrant’s telephone number, including area code)

 

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 every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit 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                

    Emerging growth company 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

 Common Stock

 USRM

OTC

 

As of May 7, 2019, there were 393,694,820 outstanding shares of the Registrant’s common stock, par value $0.001 per share.

 

Transitional Small Business Disclosure Format Yes ☐ No ☒

 

 

 

TABLE OF CONTENTS

 

PART I.

FINANCIAL INFORMATION

 

 

 

 

 

 

ITEM 1.

Financial Statements

3

 

 

 

 

 

 

Condensed balance sheets as of March 31, 2019 (unaudited) and December 31, 2018

4

 

 

 

 

 

 

Condensed statements of operations for the three months ended March 31, 2019 and 2018 (unaudited)

5

 

 

 

 

 

 

Condensed statement of stockholders’ deficit for the three months ended March 31, 2019 (unaudited)

6

 

 

 

 

   

Condensed statement of stockholders’ deficit for the three months ended March 31, 2018 (unaudited)

7

       

 

 

Condensed statements of cash flows for the three months ended March 31, 2019 and 2018 (unaudited)

8

 

 

 

 

 

 

Notes to condensed financial statements (unaudited)

 9-27

 

 

 

 

 

ITEM 2.

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

28-36

 

ITEM 3.

Quantitative and Qualitative Disclosures about Market Risk

36

 

ITEM 4.

Controls and Procedures

36

 

 

 

 

PART II.

OTHER INFORMATION

 

 

 

 

 

 

ITEM 1.

Legal Proceedings

37

 

ITEM 1A.

Risk Factors

37

 

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds

37

 

ITEM 3.

Defaults Upon Senior Securities

38

 

ITEM 4.

Mine Safety Disclosures

38

 

ITEM 5.

Other Information

38

 

ITEM 6.

Exhibits

39

 

 

 

 

 

SIGNATURES

42

 

 

 

 

EX 31.01

Management Certification

 

 

 

 

 

EX 32.01

Sarbanes-Oxley Act

 

 

 

 

 

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’ deficit 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 Company’s annual report on Form 10-K for the year ended December 31, 2018. 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 months ended March 31, 2019 are not necessarily indicative of the results that can be expected for the year ending December 31, 2019.

 

 

 

 

 

 

 

 

U.S. STEM CELL, INC.

CONDENSED BALANCE SHEETS

March 31, 2019 AND December 31, 2018

 

   

March 31,

   

December 31,

 
   

2019

   

2018

 
   

(unaudited)

         

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 749,399     $ 1,357,146  

Accounts receivable, net

    64,238       18,035  

Inventory

    70,906       93,215  

Prepaid and other

    38,128       38,128  

Total current assets

    922,671       1,506,524  
                 

Property and equipment, net

    190,963       242,615  
                 

Right to use assets

    35,812          
                 

Other assets

               

Investments

    93,149       57,790  

Deposits

    10,160       10,160  
                 

Total assets

  $ 1,252,755     $ 1,817,089  
                 

LIABILITIES AND STOCKHOLDERS' DEFICIT

               

Current liabilities:

               

Accounts payable, including $69,325 and $75,714 to related parties, respectively

  $ 1,130,651     $ 1,182,730  

Accrued expenses

    1,152,587       1,155,792  

Advances, related party

    324,901       234,901  

Deferred revenue

    313,566       293,665  

Deferred gain on sale of equipment

    118,108       128,845  

Deposits

    565,286       465,286  

Notes payable, related party

    1,724,236       1,993,104  

Notes and capital leases payable, net of debt discount of $53,067 and $62,240, respectively

    383,695       462,330  

Lease liability

    35,812       -  

Total current liabilities

    5,748,842       5,916,653  
                 

Long term debt:

               

Deferred revenue

    64,750       65,500  

Deferred gain on sale of equipment

    -       21,474  

Long term deposits

    -       100,000  

Promissory note, long term portion, net of debt discount of $81,951 and $99,183, respectively

    1,315,811       1,298,579  

Notes and capital lease payable, long term portion, net of debt discount of $9,012 and $12,413, respectively

    1,218,988       1,297,093  

Total long term debt

    2,599,549       2,782,646  
                 

Total liabilities

    8,348,391       8,699,299  
                 

Commitments and Contingencies:

    -       -  
                 

Stockholders' deficit:

               

Preferred stock, par value $0.001; 20,000,000 shares authorized, -0- issued and outstanding as of March 31, 2019 and December 31, 2018

    -       -  

Common stock, par value $0.001; 2,000,000,000 shares authorized, 389,675,905 and 378,076,976 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively

    389,676       378,077  

Additional paid in capital

    122,976,584       122,528,391  

Accumulated deficit

    (130,461,896 )     (129,788,678 )

Total stockholders' deficit

    (7,095,636 )     (6,882,210 )
                 

Total liabilities and stockholders' deficit

  $ 1,252,755     $ 1,817,089  

 

See the accompanying notes to these unaudited condensed financial statements

 

 

U.S. STEM CELL, INC.

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

 

   

Three months ended March 31,

 
   

2019

   

2018

 

Revenue:

               

Products

  $ 116,700     $ 714,906  

Services

    1,148,778       998,023  

Management fees-related party

    43,332       -  

Total revenue

    1,308,810       1,712,929  
                 

Cost of sales

    522,099       503,838  
                 

Gross profit

    786,711       1,209,091  
                 

Cost and operating expenses:

               

Research and development

    420       1,337  

Marketing, general and administrative

    1,185,392       1,216,526  

Depreciation and amortization

    -       524  

Total operating expenses

    1,185,812       1,218,387  
                 

Loss from operations

    (399,101 )     (9,296 )
                 

Other income (expenses):

               

Loss on settlement of debt

    (12,960 )     (15,059 )

Gain on sale of equipment

    32,211       32,211  

Miscellaneous income

    69       -  

Income from equity investment

    100,944       95,342  

Interest expense

    (394,381 )     (242,357 )

Total other income (expenses)

    (274,117 )     (129,863 )
                 

Net loss before income taxes

    (673,218 )     (139,159 )
                 

Income taxes (benefit)

    -       -  
                 

NET LOSS

  $ (673,218 )   $ (139,159 )
                 

Net loss per common share, basic and diluted

  $ (0.00 )   $ (0.00 )
                 

Weighted average number of common shares outstanding, basic and diluted

    384,669,889       352,977,458  

 

See the accompanying notes to these unaudited condensed financial statements

 

 

U.S. STEM CELL, INC.

CONDENSED STATEMENT OF STOCKHOLDERS' DEFICIT

THREE MONTHS ENDED MARCH 31, 2019

 

                                   

Additional

                 
   

Preferred stock

   

Common stock

   

Paid in

   

Accumulated

         
   

Shares

   

Amount

   

Shares

   

Amount

   

Capital

   

Deficit

   

Total

 

Balance, December 31, 2018

    -     $ -       378,076,976     $ 378,077     $ 122,528,391     $ (129,788,678 )   $ (6,882,210 )

Common stock issued in settlement of accounts payable

    -       -       8,098,929       8,099       180,862       -       188,961  

Common stock issued for services

    -       -       3,500,000       3,500       82,850       -       86,350  

Contribution to equity investment

    -       -       -       -       15,265       -       15,265  

Stock based compensation

    -       -       -       -       169,216       -       169,216  

Net loss

    -       -       -       -       -       (673,218 )     (673,218 )

Balance, March 31, 2019 (unaudited)

    -     $ -       389,675,905     $ 389,676     $ 122,976,584     $ (130,461,896 )   $ (7,095,636 )

 

See the accompanying notes to these unaudited condensed financial statements

 

 

U.S. STEM CELL, INC.

CONDENSED STATEMENT OF STOCKHOLDERS' DEFICIT

THREE MONTHS ENDED MARCH 31, 2018

 

                                   

Additional

   

Common

                 
   

Preferred stock

   

Common stock

   

Paid in

   

Stock

   

Accumulated

         
   

Shares

   

Amount

   

Shares

   

Amount

   

Capital

   

Subscriptions

   

Deficit

   

Total

 

Balance, December 31, 2017

    -     $ -       342,113,098     $ 342,113     $ 120,185,821     $ -     $ (127,628,251 )   $ (7,100,317 )

Common stock issued in settlement of accounts payable

    -       -       3,817,783       3,818       143,895       -       -       147,713  

Common stock issued for services

    -       -       4,366,274       4,366       237,265       -       -       241,631  

Proceeds from issuance of common stock

    -       -       8,428,858       8,429       314,571       -       -       323,000  

Common stock subscription

    -       -       -       -       -       44,700       -       44,700  

Stock based compensation

    -       -       -       -       82,555       -       -       82,555  

Net loss

    -       -       -       -       -       -       (139,159 )     (139,159 )

Balance, March 31, 2018 (unaudited)

    -     $ -       358,726,013     $ 358,726     $ 120,964,107     $ 44,700     $ (127,767,410 )   $ (6,399,877 )

 

See the accompanying notes to these unaudited condensed financial statements

 

 

 

U.S. STEM CELL, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

 

   

Three months ended March 31,

 
   

2019

   

2018

 

CASH FLOWS FROM OPERATING ACTIVITIES:

               

Net loss

  $ (673,218 )   $ (139,159 )

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

               

Depreciation and amortization

    51,652       52,176  

Bad debt (recoveries)

    21,304       9,188  

Amortization of discount on debt

    29,809       69,974  

Loss on settlement of debt

    12,960       15,059  

Gain on sale of equipment

    (32,211 )     (32,211 )

Income on equity investments

    (100,944 )     (95,342 )

Stock based compensation

    255,566       324,186  

Changes in operating assets and liabilities:

               

Receivables

    (67,507 )     (42,111 )

Inventory

    22,309       (6,320 )

Deposits

    -       103,159  

Prepaid and other current assets

    -       (25,000 )

Accounts payable

    123,922       188,198  

Accrued expenses

    (3,205 )     99,941  

Deferred revenue

    19,151       166,913  

Net cash (used in) provided by operating activities

    (340,412 )     688,651  
                 

CASH FLOWS FROM INVESTING ACTIVITIES:

               

Proceeds from equity investments

    80,850       45,000  

Net cash provided by investing activities

    80,850       45,000  
                 

CASH FLOWS FROM FINANCING ACTIVITIES:

               

Proceeds from notes payable

    -       47,907  

Proceeds from sale of common stock

    -       323,000  

Net proceeds from common stock subscriptions

    -       44,700  

Proceeds from related party advances

    90,000       -  

Repayments of related party notes

    (268,868 )     (258,469 )

Repayments of notes payable

    (169,317 )     (159,560 )

Net cash used in financing activities

    (348,185 )     (2,422 )
                 

Net (decrease) increase in cash and cash equivalents

    (607,747 )     731,229  
                 

Cash and cash equivalents, beginning of period

    1,357,146       986,799  

Cash and cash equivalents, end of period

  $ 749,399     $ 1,718,028  
                 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION

         

Interest paid

  $ 324,782     $ 132,036  

Income taxes paid

  $ -     $ -  
                 

Non cash financing activities:

               

Common stock issued in settlement of notes payable

  $ -     $ 147,713  

Equity contributed to investment

  $ 15,265     $ -  

 

See the accompanying notes to these unaudited condensed financial statements

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

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 U.S. Stem Cell, 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 month period ended March 31, 2019 are not necessarily indicative of the results that may be expected for the year ended December 31, 2019. The unaudited condensed financial statements should be read in conjunction with the December 31, 2018 audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K.

 

Basis and business presentation

 

U.S. Stem Cell, Inc. was incorporated under the laws of the State of Florida in August, 1999. The Company is in the sector of the cell technology industry delivering cell therapies and biologics that help address a variety of injuries and diseases such as osteoarthritis, heart failure, lower limb ischemia, neurological conditions, autoimmune diseases and other issues. The primary business includes the development of proprietary cell therapy procedure and products as well as revenue generating physician and patient based regenerative medicine/cell therapy training services, revenues realized from an Asset Sale and Lease Agreement related to the segment of the Company business involving collecting, growing and banking cell cultures 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

 

Effective January 1, 2018, the Company recognizes revenue in accordance with Accounting Standards Codification 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, and most industry-specific revenue recognition guidance throughout the Industry Topics of the Accounting Standards Codification. The updated guidance states that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The guidance also provides for additional disclosures with respect to revenues and cash flows arising from contracts with customers.

 

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.

 

The Company’s primary sources of revenue are from the sale of test kits and equipment, training services, patient treatments, laboratory services and cell banking. 

 

Revenues for kits and equipment sold are not recorded until kits and equipment are received by the customer. Revenues from in-person trainings are recognized when the training occurs and revenues from on demand online trainings are recognized when the customer purchases the rights to the training course. Any cash received as a deposit for trainings are recorded by the Company as a liability.

 

Patient treatments and laboratory services revenue are recognized when those services have been completed or satisfied.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

Revenues for cell banking sales are accounted for as multiple performance obligations as described in ASC 606 and addresses accounting for arrangements that may involve the delivery or performance of multiple products, services and/or rights to use assets. Because the Company sells its services separately, on more than a limited basis and at a price within a narrow range, the Company was able to allocate revenue based on stand-alone pricing. The multiple performance obligations include stem cell banking, dose retrieval and yearly storage fees. Revenues for stem cell banking and dose retrieval is recognized at the point of service and revenues for the yearly storage fees is recognized over the term of the banking contract, which is typically one year with annual renewals.

 

At March 31, 2019 and December 31, 2018, the Company had deferred revenues of $313,566 and $293,665, respectively, which includes $67,750 and $68,500, respectively, to the Intellectual Property Licensing Agreement.

 

Use of Estimates

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the fair value of the Company’s stock, stock-based compensation, debt discounts and the valuation allowance related to deferred tax assets. Actual results may differ from these estimates.

 

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 charges to the allowance for doubtful accounts on accounts receivable are charged 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 March 31, 2019 and December 31, 2018, allowance for doubtful accounts was $21,304 and $30,808, respectively.

 

Inventories

 

Inventories are stated at the lower of cost or market with cost being determined on a first-in, first-out (FIFO) basis. The Company writes down its inventory for estimated obsolescence or unmarketable inventory equal to the difference between the cost of inventory and the estimated market value based upon assumptions about future demand and market conditions. If actual market conditions are less favorable than those projected by management, additional inventory write-downs may be required. During the periods presented, there were no inventory write-downs.

 

Investments

 

The Company follows 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 49.9 percent member interest ownerships of U.S. Stem Cell Clinic, LLC and Regenerative Wellness Clinic, LLC respectively and its 49 percent member interest ownership of U.S. Stem Cell Clinic of the Villages utilizing the equity method of accounting (See Note 3).

 

Property and Equipment

 

Property and equipment are stated at cost. When retired or otherwise disposed, the related carrying value and accumulated depreciation are removed from the respective accounts and the net difference less any amount realized from disposition, is reflected in earnings. For financial statement purposes, property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful lives of 3 to 15 years. Equipment under capital leases are recorded at the estimated present value of the minimum lease payments. Equipment under capital leases are amortized over the term of the lease, which is three years.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

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.

 

Net Loss per Common Share, basic and diluted

 

The Company computes earnings (loss) per share under Accounting Standards Codification subtopic 260-10, Earnings Per Share (“ASC 260-10”). Net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the year.  Diluted earnings per share, if presented, would include the dilution that would occur upon the exercise or conversion of all potentially dilutive securities into common stock using the “treasury stock” and/or “if converted” methods as applicable.

 

The computation of basic and diluted income (loss) per share as of March 31, 2019 and 2018 excludes potentially dilutive securities when their inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during the period.

 

Potentially dilutive securities excluded from the computation of basic and diluted net loss per share are as follows:

 

   

March 31,

2019

   

March 31,

2018

 

Options to purchase common stock

    112,970,670       71,630,763  

Warrants to purchase common stock

    1,114,019       125,591  

Totals

    114,084,689       71,756,354  

 

Concentrations of Credit Risk

 

The Company’s financial instruments that are exposed to a concentration of credit risk are cash and accounts receivable. Generally, the Company’s 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 March 31, 2019, two customers represented 15% and 49%, respectively, representing an aggregate of 64% of the Company’s accounts receivable. As of December 31, 2018, four customers represented 41%, 10%, 16% and 10% respectively, representing an aggregate of 77% of the Company’s accounts receivable.

 

For the three months ended March 31, 2019, the Company’s revenues earned from sale of products and services were $1,308,810, of which one customer, a related party (US Stem Cell Clinic LLC, a partly owned investment in which the Company holds a 49.9% interest) represented 10%.  For the three months ended March 31, 2018, the Company’s revenues earned from sale of products and services did not include any customers representing 10% or more of the Company’s total revenues.  

 

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 $420 and $1,337 for the three months ended March 31, 2019 and 2018, respectively.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

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.

 

Deposits

 

Deposits are comprised of the following:

 

On March 3, 2017, the Company entered into a customer purchase agreement with General American Capital Partners (GACP), whereby the Company agreed to sell, for $50,000, the first 5,000 customers of the cell banking business after the effective date of the equipment sale/leaseback agreement with rights to purchase additional customers at a price of $20 per customer.  There is no reduction in the selling price should the new customers be fewer than 5,000.  The effective date of the sale is upon the expiry or early termination of the related equipment lease transaction (See Notes 4 and 8).

 

On March 3, 2017, the Company entered into an asset purchase agreement of intellectual property with GACP whereby the Company agreed to sell all of the Company’s worldwide rights, title or interest in certain intellectual and other property (as defined) associated with the cell banking business for $50,000. The effective date of the sale is upon the expiry or early termination of the related equipment lease transaction (See Notes 4 and 8).

 

Adoption of Accounting Standards

 

In February 2016, the FASB established ASC Topic 842, Leases (Topic 842), by issuing ASU No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. The new standard establishes a right-of-use (ROU) model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company adopted the new standard on January 1, 2019.

 

The new standard provides a number of optional practical expedients in transition. The Company has elected the ‘package of practical expedients’, which permit it not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter is not applicable to the Company.

 

The new standard had a material effect on the Company’s financial statements. The most significant effects of adoption relate to (1) the recognition of new ROU assets and lease liabilities on its balance sheet for real estate operating leases; and (2) providing significant new disclosures about its leasing activities.

 

Upon adoption, the Company recognized additional operating lease liabilities, net of deferred rent, of approximately $57,000 based on the present value of the remaining minimum rental payments under current leasing standards for existing operating leases. The Company also recognized corresponding ROU assets of approximately $57,000.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

The new standard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, the Company will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. Beginning in 2019, the Company changed to its disclosed lease recognition policies and practices, as well as to other related financial statement disclosures due to the adoption of this standard. See Note 5.

 

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 Company’s financial position, results of operations or cash flows.

 

Subsequent Events

 

The Company evaluates events that have occurred after the balance sheet date but before the consolidated financial statements are issued.  Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the consolidated financial statements, except as disclosed.

 

NOTE 2 – GOING CONCERN AND MANAGEMENT’S LIQUIDITY PLANS

 

The accompanying 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 financial statements during three months ended March 31, 2019, the Company incurred net losses of $673,218 and has a working capital deficit (current liabilities in excess of current assets) of $4,826,171. These factors among others raise substantial doubts about the Company’s ability to continue as a going concern for a reasonable period of time.

 

The Company’s primary source of operating funds in the past has been from revenue generated from sales and cash proceeds from the sale of common stock and the issuance of convertible and other debt. The Company has experienced net losses and negative cash flows from operations since inception, but expects these conditions to improve in 2019 and beyond as it develops its business model. The Company has stockholders’ deficiencies at March 31, 2019 and requires additional financing to fund future operations.

 

The Company’s existence is dependent upon management’s ability to develop profitable operations and to obtain additional funding sources. There can be no assurance that the Company’s financing efforts or revenues realized from the Asset Sale and Lease Agreement will result in profitable operations or the resolution of the Company’s 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

 

U.S. Stem Cell Clinic, LLC

 

The investment in U.S. Stem Cell Clinic, LLC is comprised of a 49.9% (33.3% in 2018) member interest ownership and is accounted for using the equity method of accounting. The Company’s 49.9% (33.3% in 2018) income earned by U.S. Stem Cell Clinic, LLC member interests was $72,672 and $85,647 for the three months ended March 31, 2019 and 2018, respectively (inception to date income of $620,878) which was recorded as other income/expense in the Company’s Statement of Operations in the appropriate periods.  In addition, during the three months ended March 31, 2019 and 2018, the Company received distributions totaling $49,900 and $45,000 from U.S. Stem Cell Clinic, LLC, respectively (inception to date of $648,900).  The carrying value of the investment at March 31, 2019 and December 31, 2018 is $36,128 and $8,921, respectively.

 

At March 31, 2019 and December 31, 2018, accounts receivable for sales of product and services to U.S. Stem Cell Clinic, LLC was $0; revenues earned from sales to U.S. Stem Clinic, LLC for the three months ended March 31, 2019 and 2018 were $131,877 and $167,649, respectively.

 

In January 2019, a member of in U.S. Stem Cell Clinic, LLC contributed 16.6% of his ownership interest to the Company increasing the Company’s member interest from 33.3% to 49.9%. The Company recorded the contribution to equity of $4,435.

 

An affiliate of one of the Company’s officers is a minority investor in the U.S. Stem Cell Clinic, LLC.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

Regenerative Wellness Clinic, LLC

 

The investment in Regenerative Wellness Clinic, LLC is comprised of a 49.9% (33.3% in 2018) member interest ownership and is accounted for using the equity method of accounting. The Company has provided technical expertise, but no cash investment with Regenerative Wellness Clinic, LLC’s startup in 2017. The Company’s 49.9% (33.3% in 2018) income earned by Regenerative Wellness Clinic, LLC member interests was $37,915 and $22,460 for the three months ended March 31, 2019 and 2018, respectively (inception to date income of $81,617) which was recorded as other income/expense in the Company’s Statement of Operations in the appropriate periods.  In addition, during the three months ended March 31, 2019 and 2018, the Company received distributions totaling $30,950 and $0 from Regenerative Wellness Clinic, LLC, respectively (inception to date of $30,950).  The carrying value of the investment at March 31, 2019 and December 31, 2018 is $39,583 and $21,787, respectively.

 

At March 31, 2019 and December 31, 2018, accounts receivable for sales of products and services to Regenerative Wellness Clinic, LLC was $500 and $0, respectively; revenues earned from sales to Regenerative Wellness Clinic, LLC for the three months ended March 31, 2019 and 2018 was $39,611 and $39,534, respectively.

 

In January 2019, a member of in Regenerative Wellness Clinic, LLC contributed 16.6% of his ownership interest to the Company increasing the Company’s member interest from 33.3% to 49.9%. The Company recorded the contribution to equity of $10,830.

 

An affiliate of one of the Company’s officers is an investor in the Regenerative Wellness Clinic, LLC.

 

U.S. Stem Cell of the Villages LLC

 

On January 30, 2018, Greg Knutson, a director of the Company (“Knutson”) and the Company agreed to open and operate a regenerative medicine/cell therapy clinic providing cellular treatments for patients afflicted with neurological, autoimmune, orthopedic and degenerative diseases in Florida.  To that end, U.S. Stem Cell Clinic of The Villages LLC (the “LLC”) was formed on January 30, 2018. Knutson provided the Company with the sum of Three Hundred Thousand Dollars ($300,000) (the “Investment”) to be utilized for the formation and initial operation of the LLC.  Currently, Knutson holds a 51% member interest in the LLC and the Company holds a 49% member interest. The Company will provide operating assistance as well as management services, the latter to be compensated at fee of five percent (5%) of the LLC gross revenues.

 

As of December 31, 2018, upon completion of U.S. Stem Cell of the Villages LLC, the Company was credited with investment equity of $86,750 from Greg Knutson, the holder of the 51% member interest. The Company then recorded the investment equity as contributed capital by the Company. The Company’s 49% income (loss) incurred by U.S. Stem Cell of the Villages LLC member interests was $(9,643) for the three months ended March 31, 2019 (operations had not yet begun as of March 31, 2018). In addition, during the year ended December 31, 2018, the Company received distributions totaling $63,700 from U.S. Stem Cell of the Villages LLC. The carrying value was $17,438 and $27,081 at March 31, 2019 and December 31, 2018, respectively

 

At March 31, 2019 and December 31, 2018, accounts receivable for sales of products and services to U.S. Stem Cell of the Villages LLC was $42,332 and $0, respectively; revenues earned from sales to U.S. Stem Cell of the Villages LLC three months ended March 31, 2019 and 2018 was $91,201 and $22,585, respectively.

 

During the three months ended March 31, 2019, the Company received $43,332 management fees from U.S. Stem Cell of the Villages LLC.

 

NOTE 4 — PROPERTY AND EQUIPMENT

 

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.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

Property and equipment as of March 31, 2019 and December 31, 2018 is summarized as follows:

 

   

March 31,

2019

   

December 31,

2018

 

Laboratory and medical equipment

  $ 5,590     $ 5,590  

Furniture, fixtures and equipment

    125,633       125,633  

Computer equipment

    49,951       49,951  

Equipment under capital lease

    624,602       624,602  

Leasehold improvements

    362,046       362,046  
      1,167,822       1,167,822  

 Less accumulated depreciation and amortization

    (976,859

)

    (925,207

)

    $ 190,963     $ 242,615  

 

On March 3, 2017, the Company entered into an asset sale and lease agreement (sale/leaseback transaction, the “Asset Sale and Lease Agreement”) with GACP, whereby the Company sold certain lab, medical and other equipment relating to the cell banking business for $400,000 and leased back the sold equipment over a three year term.

 

The Company determined that the transaction was a capitalized lease and accordingly recorded the leased assets and liability based on the estimated present value of the minimum lease payments.

 

Included in net property are assets under capital leases of $624,602, less accumulated depreciation of $435,211 as of December 31, 2018 and $624,602, less accumulated depreciation of $383,559 December 31, 2018, respectively.

 

In connection with the sale of the lab, medical and other equipment, the Company realized a gain on sale of equipment of $386,535.  The gain is recognized ratably over the term of the lease to operations. During the three months ended March 31, 2019 and 2018, the Company recognized $32,211 and $32,211, as the gain on sale of equipment, respectively.  As of March 31, 2019 and December 31, 2018, deferred gain on sale of equipment was $118,108 and $150,319, respectively.

 

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. 

 

Depreciation expense was $51,652 and $52,176 of which $51,652 and $51,652 were included in cost of sales for the three months ended March 31, 2019 and 2018, respectively.

 

NOTE 5 — RIGHT TO USE ASSETS AND LEASE LIABILITY

 

The Company leases its headquarters in Sunrise, Florida which consists of 4,860 square feet of space, which it leases at a current rent of approximately $82,620 per year. In September 2013, the Company amended its facility lease to extend the term until July 31, 2016. On February 4, 2016, the Company extended its facility lease to extend the term of the lease until August 31, 2019 at a monthly base rent of $7,306 plus a pro rata share of landlord’s operating expenses.

 

In adopting ASC Topic 842, Leases (Topic 842), the Company has elected the ‘package of practical expedients’, which permit it not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter is not applicable to the Company. In addition, the Company elected not to apply ASC Topic 842 to arrangements with lease terms of 12 months or less. In determining the length of the lease term to its long term lease, the Company determined there was not an option to extend the lease. At lease commencement date, the Company estimated the lease liability and the right of use assets at present value using the Company’s estimated incremental borrowing rate of 8% and determined the initial present value, at inception, of $274,180. On January 1, 2019, upon adoption of ASC Topic 842, the Company recorded right to use assets of $56,734 and lease liability of $56,734.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

Right to use assets is summarized below:

 

   

March 31,

2019

 

Sunrise Facility

  $ 274,180  

Less accumulated depreciation

    (238,368

)

Right to use assets, net

  $ 35,812  

 

During the three months ended March 31, 2019, the Company recorded $36,982 as lease expense to current period operations.

 

Lease liability is summarized below:

 

   

March 31,

2019

 

Los Angeles, Suite 740

  $ 274,180  

Less accumulated depreciation

    (238,368

)

Right to use assets, net

    35,812  

Less: short term portion

    (35,812

)

Long term portion

  $ -  

 

Maturity analysis under these lease agreements are as follows:

 

Nine months ended December 31, 2019

  $ 36,531  

Less: Present value discount

    (719

)

Lease liability

  $ 35,812  

 

Lease expense for the three months ended March 31, 2019 was comprised of the following:

 

Operating lease expense

  $ 36,531  

Variable lease expense

    451  
    $ 36,982  

 

NOTE 6 — ACCRUED EXPENSES

 

Accrued expenses consisted of the following as of March 31, 2019 and December 31, 2018:   

 

   

March 31,

2019

   

December 31,

2018

 

Interest and fees payable to the Guarantors of the Company’s loan agreement with Seaside Bank

  $ 373,713     $ 347,235  

Interest payable on notes payable-related party (See Note 8)

    508,648       482,784  

Vendor accruals and other

    146,420       146,420  

Marketing obligation

    86,046       179,353  

Employee commissions, compensation, etc.

    37,760       -  
    $ 1,152,587     $ 1,155,792  

 

During the three months ended March 31, 2019, the Company issued an aggregate of 8,598,928 shares of its common stock in settlement of outstanding accounts payable and accrued expenses. In connection with the issuance, the Company incurred a $12,960 net loss in settlement of debt.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

NOTE 7 — NOTES AND CAPITAL LEASE PAYABLE

 

Notes and capital lease payable were comprised of the following as of March 31, 2019 and December 31, 2018:

 

   

March 31,

2019

   

December 31,

2018

 

Seaside Bank note payable.

  $ 980,000     $ 980,000  

Hunton & Williams note(s) payable

    408,000       444,000  

Power Up Lending Group notes payable

    66,362       145,476  

Lab and medical equipment capitalized leases

    210,400       264,590  

Total notes payable

    1,664,762       1,834,076  

Less unamortized debt discount

    (62,079

)

    (74,653

)

Total notes payable net of unamortized debt discount

    1,602,683       1,759,423  

Less current portion

    (383,695

)

    (462,330

)

Long term portion

  $ 1,218,988     $ 1,297,093  

 

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 Company’s 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 2019 to extend the maturity date to May 18, 2020.

 

Hunton & Williams Notes

 

At December 31, 2016, the Company had 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 Biotech Group, LLC (or successor) Loan is paid off.

 

On August 31, 2017, the Company and the note holder entered into a Note Forbearance, Modification and Repayment Agreement (“Agreement”). The two notes, $61,150 and $323,822, were payable in one balloon payment upon the date of a written demand and upon certain triggering events occurring. The total of unpaid principal and accumulated interest for both notes as of August 31, 2017 was $747,680 and an accounts payable of $40,596, for an aggregate total of $788,276.

 

The note holder agreed to accept full payment of their obligation of over a four (4) year period in 48 monthly installments on an adjusted debt obligation in aggregate of $624,000 (reducing the outstanding balance), with such payments staggered in amounts such that the Company will pay $10,000 monthly the first year, $12,000 monthly the second year, $14,000 monthly the third year, and $16,000 monthly the final year.  In addition, the note holder agreed to suspend accrual interest on the notes commencing September 1, 2017.

 

The Agreement remains in full force and effect provided the Company continues to make the monthly payments, there is no event of default as defined in the notes and an agreement to a subordination agreement by Northstar Biotech Group, LLC, which has been provided.

 

The Company imputed an interest rate of 5% and discounted the note accordingly. The imputed debt discount of $69,700 is amortized to interest expense using the effective interest method. For three months ended March 31, 2019 and 2018, the Company amortized $5,264 and $7,077 of debt discounts to current period operations as interest expense. The unamortized debt discount at March 31, 2019 is $25,938.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

PowerUp Lending Group, Ltd

 

On November 8, 2018, the Company entered into a revenue based factoring agreement and received an aggregate of $137,200 (less origination fees of $2,800) in exchange for $187,600 of future receipts relating to monies collected from customers or other third party payors. Under the terms of the factoring agreement, the Company is required to make daily payments equal to $1,276 for 147 business days.  The Company received net proceeds of $93,809 along with cancellation of the previous revenue based factoring agreement issued in May 2018.  In connection with the cancellation of the January 2018 revenue based factoring agreement, the Company incurred a loss in settlement of debt of $37,604 in 2018.  

 

The remaining principle balance of the PowerUp Lending Group promissory note payable at March 31, 2019 and December 31, 2018 is $66,362 and $145,486, net of unamortized discount of $36,142 and $43,452, respectively.

 

Lab and Medical Equipment Capitalized Lease

 

On March 3, 2017, the Company entered into an asset sale and lease agreement (sale/leaseback transaction; “Asset Sale and Lease Agreement”) with GACP, whereby the Company sold certain lab, medical and other equipment relating to the cell banking business for $400,000 and leased back the sold equipment over a three year term.  The Company recognized the arrangement as a capital lease.  The Company initially recorded the equipment and the capitalized lease liability at the estimated present value of the minimum lease payments of $619,825. 

 

The lease includes a base monthly rental payment of $20,000, due the first day of each calendar month plus contingent rent equal to 2.3%, 22.5%, and 31.6% of revenues collected on deposits arising from cell banking business for years 1, 2 and 3, respectively.  The contingent rent is recognized as a period expense and as interest expense at the time of collection.  At the expiration of the lease, the Company is required to return all leased equipment and along with any maintenance records, logs, etc. in the Company’s possession to the lessor with no right of repurchase.

 

The Company determined that the present value of the minimum lease payments exceeded 90% of the estimated fair value of the equipment and therefore classified the equipment sale/lease as a capitalized lease. The effective interest rate of the capitalized lease is estimated at 10.00% based on the Company estimated incremental borrowing rate.

 

The following summarizes the assets under capital leases:

 

   

March 31,

2019

   

December 31,

2018

 

Classes of property

               

Lab, medical and other equipment

  $ 619,825     $ 619,825  

Office equipment

    4,777       4,777  

Less: accumulated depreciation

    (435,211

)

    (383,559

)

    $ 189,391     $ 241,043  

 

The following summarizes the current and long-term portion of capital leases:

 

   

March 31,

2019

   

December 31,

2018

 

Current leases payable

  $ 210,400     $ 225,084  

Long-term leases payable

    -       39,506  

Total

  $ 210,400     $ 264,590  

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

The following summarizes total future minimum lease payments at December 31, 2018:

 

Period ending,

       

Year ended December 31, 2019

    181,047  

Year ended December 31, 2020

    40,000  

Total minimum lease payments

    221,047  

Amount representing interest

    (10,647

)

Present value of minimum lease payments

    210,400  

Current portion of capital lease obligations

    210,400  

Capital lease obligation, less current portion

  $ -  

 

Promissory note

 

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, related accrued interest of $373,469 and accumulated and unpaid guarantor fees of $624,737.

 

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. For the three months ended March 31, 2019 and 2018, the Company amortized $17,233 and $17,233 of debt discounts to current period operations as interest expense, respectively.  The unamortized debt discount at March 31, 2019 is $81,951.

 

As of March 31, 2019, the remaining principle due was $1,397,762.

 

NOTE 8 — RELATED PARTY TRANSACTIONS

 

Advances

 

As of March 31, 2019 and December 31, 2018, the Company’s officers and directors have provided advances in the aggregate of $324,901 and $234,901 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 promissory 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 at the time, 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 the (“Note”).

 

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 common stock purchase warrants to Northstar that was treated as additional interest expense upon issuance.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

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 shares 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.

 

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 was 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 agreed to modify the voting rights of the subsequently cancelled 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.

 

On March 1, 2017, Northstar and the Company entered into a settlement agreement (“Settlement Agreement “) related to then pending litigation (See Note 11). Pursuant to the terms and conditions of the Settlement Agreement, Northstar converted its outstanding Series A Convertible preferred stock, into twenty million (20,000,000) shares of common stock according to the original conversion terms. In addition, and separate and apart from the conversion, Northstar received Eleven Million (11,000,000) shares of the Company’s common stock. Northstar will receive ten percent (10%) of all Company international sales (based on a gross sales basis). There was no effect of the 10% obligation as there were no international sales in 2017 or, to date, in 2018 Furthermore, a Northstar designee, Greg Knutson, was appointed as a member of the Board of Directors of the Company and two Company directors, Michael Tomas and Kristin Comella, each exercised their prior Northstar options to each receive a Five percent (5%) Member Interest in Northstar.  The parties agreed to a mutual release and Northstar agreed to terminate any UCC lien on the Company assets previously filed for the benefit of Northstar. On March 9, 2017 and April 1, 2017, the Company issued 30,000,000 and 1,000,000 shares of its common stock, respectively, as described above. In connection with the settlement, the Company recorded a loss on litigation settlement of $316,800.

 

On September 30, 2013, the Company issued 8,772 shares of its common stock as payment of $100,000 towards cash advances.

 

On December 24, 2013, the Company issued 3,916 shares of its common stock as payment of accrued interest through June 30, 2013 of $85,447.

 

On April 2, 2014, the Company issued 275 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, the 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 on the condition that Northstar provide certain financing, which financing the Company, in its sole discretion, could decline and retain the license.

 

On October 3, 2014, the Company issued 515 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.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

On April 3, 2015, the Company issued 1,363 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 October 2, 2015, the Company issued 4,156 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2015 per the forbearance agreement.

 

On October 7, 2015, the Company issued 34,522 shares of its common stock in settlement of $100,000 principal payment towards the outstanding debt.

 

On April 7, 2016, the Company issued 57,778 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due April 1, 2016 per the forbearance agreement.

 

On October 6, 2016, the Company issued 848,490 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2016 per the forbearance agreement.

 

On April 1, 2017, the Company issued 286,315 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,703 due October 1, 2016 per the forbearance agreement.

 

On October 2, 2017, the Company issued 559,187 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2016 per the forbearance agreement.

 

On October 19, 2018, the Company issued 164,523 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $9,195 due October 1, 2016 per the forbearance agreement.

 

As of March 31, 2019 and December 31, 2018, the principal of this note was $262,000.

 

Officer and Director Notes

 

   

March 31,

201 9

   

December 31,

201 8

 

Note payable, Mr. Tomas

  $ 179,256     $ 483,393  

Note payable, Mr. Tomas

    500,000       500,000  

Note payable, Dr. Comella

    182,980       147,711  

Note payable, Dr. Comella

    300,000       300,000  

Note payable, Dr. Comella

    300,000       300,000  

Total

  $ 1,462,236     $ 1,731,104  

 

Notes payable, Mr. Tomas

 

On August 7, 2017, the Company issued a $500,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due one year from date of issuance. During the three months ended March 31, 2019, the Company paid off $304,137 of the outstanding promissory note. The principal outstanding balance of this note as of March 31, 2019 and December 31, 2018 is $179,256 and $483,393, respectively.

 

On May 7, 2018, the Company issued a $500,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due six months from date of issuance. The principal outstanding balance of this note as of March 31, 2019 and December 31, 2018 is $500,000.

 

At March 31, 2019 and December 31, 2018, the Company has recorded accrued interest on the outstanding and past notes to Mr. Tomas in the amount of $352,133 and $340,009, respectively, which is included in the accrued expenses on the balance sheet.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

Notes payable, Dr. Comella

 

On September 6, 2016, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and was due upon demand. During the three months ended March 31, 2019, the Company received $35,269 of previously paid balance of the outstanding promissory note. The principal outstanding balance of this note as of March 31, 2019 and December 31, 2018 is $182,980 and $147,711, respectively.

 

On August 7, 2017, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due one year from date of issuance. The principal outstanding balance of this note as of March 31, 2019 and December 31, 2018 is $300,000.

 

On May 7, 2018, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due six months from date of issuance. The principal outstanding balance of this note as of March 31, 2019 and December 31, 2018 is $300,000.

 

At March 31, 2019 and December 31, 2018, the Company has recorded accrued interest on the outstanding notes to Dr. Comella in the amount of $112,192 and $102,974, respectively, which is included in the accrued expenses on the balance sheet.

 

Transactions with Pavillion

 

On May 1, 2016, the Company entered into a consulting agreement with Pavillion, Inc., whose owner is related to an officer of the Company.  The agreement is for 12 months and renewable for 6 month periods.  Compensation is at $250 per hour or, at the Company’s discretion, in shares of the Company’s common stock. For the three months ended March 31, 2019 and 2018, the Company has incurred $0 and $30,000 of expense under the agreement, respectively. As of March 31, 2019 and December 31, 2018, the Company had $37,909 and $64,909, respectively, in accounts payable owed to Pavillion. On June 1, 2018, effective June 30, 2018, the Company terminated the agreement in accordance with its terms and no further compensation was derived by Pavillion.

 

Transactions with GACP

 

On March 3, 2017, the Company entered into an asset sale and lease agreement (sale/leaseback transaction, the “Asset Sale and Lease Agreement”) with GACP, whereby the Company sold certain lab, medical and other equipment relating to the cell banking business for $400,000 and leased back the sold equipment over a three year term (See “ Lab and Medical Equipment Capitalized Lease ” below). The Company determined that the transaction was a capitalized lease and accordingly recorded the leased assets and liability based on the estimated present value of the minimum lease payments (see Notes 4 and 6).

 

In connection with the asset sale and lease agreement, the Company is obligated to accrue 10% of banking revenue as for marketing, offset by any incurred costs of the Company.  At March 31, 2019 and December 31, 2018, the outstanding accrued marketing obligation is $86,046 and $179,353, respectively (see Note 6).

 

On March 3, 2017, the Company also entered into a customer purchase agreement with GACP, whereby the Company agreed to sell, for $50,000, the first 5,000 customers of the cell banking business after the effective date of the equipment sale/leaseback agreement with rights to purchase additional customers at a price of $20 per customer.  There is no reduction in the selling price should the new customers be fewer than 5,000.  The effective date of the sale is upon the expiry or early termination of the related equipment lease transaction.

 

On March 3, 2017, the Company also entered into an asset purchase agreement of intellectual property with GACP whereby the Company agreed to sell all of the Company’s worldwide rights, title or interest in certain intellectual and other property (as defined) associated with the cell banking business for $50,000. The effective date of the sale is upon the expiry or early termination of the related equipment lease transaction.

 

In connection with the March 3, 2017 asset purchase agreement, the CEO and CSO of U.S. Stem Cell, Inc. were also retained as CEO and CSO of American Stem Cell Centers of Excellence, which is owned by General American Capital Partners (GACP), to help with scientific and successful operational deployment of clinics. Subsequently, the CSO of U.S. Stem Cell, Inc. has vacated her position but retained her positions with U.S. Stem Cell, Inc. and subsidiaries.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

On April 3, 2017, U.S. Stem Cell received a commitment to invest up to $5,000,000 from GACP with the intent for GACP to receive up to 63,873,275 shares of common stock.  To date, GACP has invested, pursuant to this commitment, $250,000 in return for 858,281 shares. Subsequent to this investment, GACP has informed the Company that they will make no further investments pursuant to this agreement and has entered into a new agreement to open their own clinics (branded American Stem Cell) using the US Stem Cell Inc. protocols, procedures, products and technologies. As of March 31, 2019 (effective May 9, 2018), pursuant to an Amendment to Asset Sale and Lease Agreement, dated June 18, 2018, GACP has suspended their obligation to open additional clinics (tolling such obligation to a mutually agreeable date in the future) and has suspended the monthly aggregate number of stem cell kits set forth for purchase in a given month arising from such clinics. All other terms and conditions of the agreements between U.S. Stem Cell, Inc. and GACP remain in full force and effect. As of March 31, 2019 and December 31, 2018, GACP owns 4,021,945 shares of the Company’s common stock.

 

NOTE 9 — STOCKHOLDERS’ EQUITY

 

During the three months ended March 31, 2019, the Company issued an aggregate of 8,598,928 shares of its common stock in settlement of outstanding accounts payable and accrued expenses. In connection with the issuance, the Company incurred a $12,960 net loss in settlement of debt.

 

During the three months ended March 31, 2019, the Company issued 3,000,000 shares of its common stock for services.

 

Stock Options

 

On April 1, 2013, the Board of Directors approved, subject to subsequently received shareholder approval, the establishment of the Bioheart 2013 Omnibus Equity Compensation Plan, or the “2013 Omnibus Plan” (replacing the 1999 Officers and Employees Stock Option Plan, or the Employee Plan, and the 1999 Directors and Consultants Stock Option Plan). The 2013 Omnibus Plan initially reserved up to fifty thousand (50,000) shares of common stock for issuance. On August 4, 2014, the Board of Directors approved to set the reserve to one hundred thousand (100,000) 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. On November 2, 2015, the Board of Directors approved the increase of the reserve under the 2013 Omnibus Plan to five hundred million (500,000,000) shares of common stock for issuance, effective September 16, 2016, approved an addition of twenty five million (25,000,000) shares of common stock to the reserve, effective April 21, 2017, approved an addition of twenty five million (25,000,000) shares of common stock to the reserve, effective August 7, 2017, approved an addition of thirty million (30,000,000) shares of common stock to the reserve and effective May 7, 2018, approved an addition of one hundred million (100,000,000) shares of common stock to reserve.

 

A summary of options at March 31, 2019 and activity during the three months then ended is presented below:

 

   

Shares

   

Weighted-

Average

Exercise Price

   

Weighted-

Average

Remaining

Contractual

Term (in years)

 
                         

Options outstanding at December 31, 2018

    112,970,693     $ 0.03294       8.7  

Granted

                     

Exercised

                     

Forfeited/Expired

    (23

)

  $ 0.15402          

Options outstanding at March 31, 2019

    112,970,670     $ 0.03294       8.4  

Options exercisable at March 31, 2019

    47,139,420     $ 0.02574       8.2  

Available for grant at March 31, 2019

    75,068,070                  

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

The following information applies to options outstanding and exercisable at March 31, 2019:

 

Exercise
Price

   

Number
Outstanding

   

Option Outstanding Options Average Remaining Contractual Life (years)

   

Weighted Average
Exercise price

   

Number
Exercisable

   

Options Exercisable Weighted Average

Exercise price

 
$ 0.0043       16,200,000       7.86     $ 0.0043       8,100,000     $ 0.0043  
  0.0196       22,850,000       7.48       0.0196       15,350,000       0.0196  
  0.02511       9,000,000       9.68       0.02511       9,000,000       0.02511  
  0.02576       2,340,000       9.36       0.02576       -       0.02576  
  0.03626       31,865,000       8.36       0.03626       14,060,000       0.03626  
  0.03680       10,000       8.36       0.03680       2,500       0.03680  
  0.0536       30,000,000       9.11       0.0536       -       0.0536  
  0.15402       705,340       6.50       0.15402       626,590       0.15402  
  19.32       150       5.60       19.32       150       19.32  
  70.00       100       2.42       70.00       100       70.00  
  210.00       40       2.37       210.00       40       210.00  
  680.00       40       0.87       680.00       40       680.00  

Total

      112,970,670       8.42     $ 0.03294       47,139,420     $ 0.02574  

 

The aggregate intrinsic value of the issued and exercisable options of $322,055 and $168,485, respectively, represents the total pretax intrinsic value, based on options with an exercise price less than the Company’s stock price of $0.0215 as of March 31, 2019, which would have been received by the option holders had those option holders exercised their options as of that date.

 

The fair value of all options vesting during the three months ended March 31, 2019 and 2018 of $169,216 and $82,555, respectively, was charged to current period operations.

 

As of March 31, 2019, the Company had approximately $1,803,978 of total unrecognized compensation cost related to non-vested awards granted under the 2013 Omnibus Plan, which the Company expects to recognize over a weighted average period of 1.52 years.

 

Warrants

 

A summary of common stock purchase warrants at March 31, 2019 and activity during the three months ended March 31, 2019 is presented below:

 

   

Shares

   

Weighted-

Average

Exercise

Price

   

Weighted-

Average

Remaining

Contractual

Term (in years)

 

Outstanding at December 31, 2018

    1,114,019     $ 14.735       9.1  

Issued

    -                  

Exercised

    -                  

Expired

    -                  

Outstanding at March 31, 2019

    1,114,019     $ 14.735       8.9  

Exercisable at March 31, 2019

    1,112,474     $ 4.076       8.9  

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

The following information applies to common stock purchase warrants outstanding and exercisable at March 31, 2019:

 

Warrants Outstanding   

   

Warrants Exercisable

         

Exercise
Price

   

Shares

   

Weighted-

Average

Remaining

Contractual

Term

   

Weighted-

Average

Exercise

Price

   

Shares

   

Weighted-

Average

Exercise

Price

 
$ 0.01 – 20.00       1,086,536       9.0     $ 1.267       1,086,536     $ 15.59  
$ 20.01 – 30.00       19,543       4.9     $ 25.06       19,543     $ 25.06  
$ 40.01 - 50.00       2,253       3.5     $ 48.83       2,253     $ 48.83  
$ 50.01 –60.00       543       2.3     $ 60.00       543     $ 60.00  

> $60.00

    $ 5,144       2.5     $ 2,800.69       3,599     $ 701.78  
          1,114,019       8.9     $ 14.74     $ 1,112,474     $ 4.076  

 

The aggregate intrinsic value of the issued and exercisable warrants of $-0- represents the total pretax intrinsic value, based on warrants with an exercise price less than the Company’s stock price of $0.0215 as of March 31, 2019, which would have been received by the warrant holders had those warrants holders exercised their warrants as of that date.

 

NOTE 10 — COMMITMENTS AND CONTINGENCIES

 

Litigation

 

On December 12, 2017, a product liability lawsuit was filed in Broward County, specifically Jeannine Mallard v. U.S. Stem Cell, Inc., US Stem Cell Clinics LLC., Regenestem, LLC., Regenestem Network, LLC., and Kristin C. Comella. The Company will continue to defend it vigorously.

 

On September 17, 2015, a product liability lawsuit was filed in Broward County, specifically Patsy Bade v. Bioheart, Inc. US Stem Cell Clinics LLC, Alejandro Perez, ARNP, and Shareen Greenbaum, M.D., and on November 30, 2015, a product liability lawsuit was filed in Broward County, specifically Elizabeth Noble v. Bioheart, Inc. US Stem Cell Clinics LLC, Alejandro Perez, ARNP, and Shareen Greenbaum, M.D. During the year ended December 31, 2016, both matters settled by the Company’s insurance policy with no additional cost to the Company, excluding the Company payment of the $100,000 insurance company deductible of which $11,000 was paid in fiscal 2017. As a result of the final settlement and determination of insurance coverage, the Company recognized $100,000 of expense due to litigation for the year ended December 31, 2017, of which $89,000 is included in accrued expenses at March 31, 2019 and December 31, 2018.

 

The Company is subject at times to other legal proceedings and claims, which arise in the ordinary course of its business.  Although occasional adverse decisions or settlements may occur, the Company believes that the final disposition of such matters should not have a material adverse effect on its financial position, results of operations or liquidity.  There was no outstanding litigation as of March 31, 2019 other than that described above.

 

SEC Investigation

 

On or about March 1, 2018, the U.S. Securities and Exchange Commission (“Commission”), Miami Regional Office (“Commission Staff”), served a subpoena upon U.S. Stem Cell, Inc., which seeks the production of certain documents and communications. The Commission Staff is conducting a formal, non-public, fact-finding inquiry of U.S. Stem Cell, Inc. (“Investigation”).  The Investigation is neither an allegation of wrongdoing nor a finding that any violation of law has occurred.  The Company is cooperating with, and has provided information and documents to, the Commission Staff.  

 

As part of the Investigation, on or about May 14, 2018, the Commission Staff served subpoenas upon Kristin Comella and Mike Tomas, respectively, seeking the production of certain documents and communications. Ms. Comella and Mr. Tomas responded to the respective subpoenas and provided information and documents to the Commission Staff.

 

At this juncture, the Company is not able to predict the duration, scope, results, or consequences of the Investigation. There can be no assurance that the Investigation will be resolved in a manner that is not adverse to the Company.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

Government Claim

 

On May 9, 2018, the U.S. Department of Justice filed an injunctive action, specifically United States of America v. U.S. Stem Clinic, LLC, U.S. Stem Cell, Inc., Kristin C. Comella, and Theodore Gradel. The Complaint was filed at the request of the U.S. Food and Drug Administration (FDA) and alleges that the respective defendants manufacture “stromal vascular fraction” (SVF) products from patient adipose (fat) tissue, which the companies then market as stem cell-based treatments without first obtaining what the government alleges are necessary FDA approvals. The Company has retained counsel to defend in this action. The Company is not able to predict the duration, scope, results, or consequences of the U.S. Department of Justice actions.  There can be no assurance that this matter will be resolved in a manner that is not adverse to the Company.

 

NOTE 11 — 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:

 

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 Company’s 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 March 31, 2019 and December 31, 2018, the Company did not have any items that would be classified as level 1 or 2 disclosures.

 

As of March 31, 2019 and December 31, 2018, the Company did not have any derivative instruments that were designated as hedges.

 

There were no derivative and warrant liability as of March 31, 2019 and December 31, 2018.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2019

(unaudited)

 

NOTE 12 — SUBSEQUENT EVENTS

 

In April 2019, the Company issued an aggregate of 3,639,774 shares of common stock for services rendered.

 

In April 2019, the Company issued an aggregate of 379,141 shares of common stock as payment of accrued interest.

 

In April 2019, the Company entered into a revenue based factoring agreement and received an aggregate of $137,200 (less origination fees of $2,800) in exchange for $187,600 of future receipts relating to monies collected from customers or other third party payors.

 

 

 

 

Item 2. Management’s 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 Management’s 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, 2017 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 management’s beliefs and assumptions and on information currently available to our management. Any such forward-looking statements would be contained principally in “Management’s 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.

 

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 management’s beliefs and assumptions and on information currently available to our management. Any such forward-looking statements would be contained principally in “Management’s 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 management’s 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, 2018.

 

Unless otherwise indicated or the context otherwise requires, all references in this Form 10-Q to “we,” “us,” “our,” “our company,” “U. S. Stem Cell, Inc.” or the “Company” refer to U.S. Stem Cell, Inc. and its subsidiaries.

 

Our Ability to Continue as a Going Concern

 

Our independent registered public accounting firm has issued its report dated March 13, 2019, in connection with the audit of our annual financial statements as of December 31, 2018, 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 March 31, 2019 also describes the existence of conditions that raise substantial doubt about our ability to continue as a going concern.

 

 

Overview

 

We are an 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, revenues realized from an Asset Sale and Lease Agreement (See Notes 3 and  6 of the Financial Statements and description below) related to the segment of our company business involving collecting, growing and banking cell cultures treatment kits for humans and animals, and the operation of a cell therapy clinic.

 

US Stem Cell Training, Inc. (“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 SCT’s state of the art facilities and globally at university, hospital and physician’s 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.

 

Vet biologics, (“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 patient’s own adipose (fat) tissue directly on-site within their own clinic or stall-side.

 

US Stem Cell Clinic, LLC, (“SCC”), Regenerative Wellness Clinic, LLC, and US Stem Cell Clinic of the Villages, LLC are partially owned investment of our company (in which we have a 49.9%, 49.9% and 49% respectively member interests), are physician run regenerative medicine/cell therapy clinics providing cellular treatments for patients afflicted with neurological, autoimmune, orthopedic and degenerative diseases. They are 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.

 

Our comprehensive map of products and services:

 

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 the November 1, 2016 report, Scalar Market Research Stem Cell Therapy Analysis Global Revenue, Trends, Growth, Share, Size and Forecast to 2022, the stem cell therapy market is worth USD 11.99 billion in 2016 and is expected to reach USD 60.94 billion by 2022, growing at a CAGR (compound annual growth rate) of 31.1% from 2016 to 2022.

 

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 patient’s 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 kit used to isolate a patient-derived cell therapy proposed for the treatment of a variety of degenerative diseases. We hope to demonstrate that these product candidates are safe and effective complements to existing therapies for a variety of diseases.

 

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/Regenerative Wellness 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. 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 November 9, 2016, we executed a Commercial Agency Agreement with High Rising Group Company (General Trading and Construction) and subsequently, on February 10,  2017, we authorized High Rising Group Company as an independent contractor and Licensee for our company for the territories of Kuwait and the Middle East (expressly excluding prohibited countries pursuant to the Patriot Act and The Iran Threat Reduction and Syria Human Rights Act of 2012). The intent of the agreement is for High Rising Group Company to establish clinics specializing in regenerative medicine, stem cell treatment and therapy, including stem cell bank, training, and all related stem cell machines and equipment.  To date, the first clinic in Kuwait City has been completed but has not begun operations as High Rising Group has not yet been able to secure regulatory approvals to operate. With the ongoing construction of the The Sheikha Salwa Sabah Al-Ahmad Center for Stem Cell and Umbilical Cord, a public/private partnership with the government of Kuwait, (see http://news.kuwaittimes.net/website/stem-cell-center-epitomizes-ppp which is expressly not incorporated by reference to this filing), management hopes (but cannot guarantee) that private sector stem cell centers, as described above, will get regulatory approval.

 

On January 29, 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 to a variety of indications. 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.

 

On March 3, 2017, we entered into an asset sale and lease agreement (sale/leaseback transaction; “Asset Sale and Lease Agreement”), with GACP (General American Capital Partners) Stem Cell Bank LLC, a Florida limited liability company (“GACP) whereby we sold certain lab, medical and other equipment relating to the cell banking business for $400,000 and leased back the sold equipment over a three year term.  The lease includes a base monthly rental payment of $20,000, due the first day of each calendar month.  In addition, we are required to pay 2.3%, 22.5% and 31.6% of revenues collected on deposits arising from cell banking business for years 1, 2 and 3, respectively.  At the expiration of the lease, we are required to return all leased equipment and along with any maintenance records, logs, etc. in our possession to the lessor with no right of repurchase. In addition, GACP has contractually agreed to invest an additional Two and a half Million Dollars ($2,500,000) to open ten (10) stem cell clinics in the United States within 3 years--with a penalty provision to our benefit for shortfalls if less than 6 clinics are opened within 24 months. As of March 31, 2019 (effective May 9, 2018), pursuant to an Amendment to Asset Sale and Lease Agreement, dated June 18, 2018, GACP has suspended their obligation to open additional clinics (tolling such obligation to a mutually agreeable date in the future) and has suspended the monthly aggregate number of stem cell kits set forth for purchase in a given month arising from such clinics. All other terms and conditions of the agreements between U.S. Stem Cell, Inc. and GACP remain in full force and effect.

  

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 generate revenues until commercialization  , 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 March 31, 2019 as compared to the Three Months Ended March 31, 2018

 

Revenues

 

We recognized revenues of $1,308,810 for the three months ended March 31, 2019. These revenues were generated from the sales of kits and equipment, services, MyoCath Catheters, AdipoCell, and laboratory services. We recognized revenues of $1,712,929 for the three months ended March 31, 2018 from the sale of MyoCath catheters, AdipoCell, physician training, patient studies and laboratory 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, kits and clinic supplies required for patient studies.

 

Cost of sales were $522,099 and $503,838 in in the three month periods ended March 31, 2019 and 2018, respectively. Associated gross margins were $786,711 (60.11%) and $1,209,091 (70.59%) for the three months periods ended March 31, 2019 and 2018, respectively.

 

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 $420 in the three month period ended March 31, 2019, a decrease of $917 from the research and development expenses of $1,337 in the three month period ended March 31, 2018. Current management focus is towards on sales in addition to 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 $1,148,778 for the three month period ended March 31, 2019 compared to $998,023 for the three month period ended March 31, 2018, an increase of $150,755. The increase in costs are primarily due to increases in consulting and other professional fees, decrease in sales and marketing expenses and stock based and other compensation, as compared to the prior year.

 

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.

 

Loss on settlement of debt

 

During the three months ended March 31, 2019, we incurred a net loss of $12,960 primarily related to accounts payable and debt restructured during the current period as compared to a net aggregate loss of $15,059 for the same period last year.

 

Gain on sale of equipment

 

In March 2017, we entered a sale/leaseback transaction whereby we sold our lab and other medical equipment and re-leased the equipment back for 36 months.  In connection with the sale/leaseback, we realized a gain on sale of equipment of $386,536, which we will recognize to operations over the term of the lease (36 months). During the three months ended March 31, 2019 and 2018, we recognized $32,211 and $32,211 in current period operations.

 

Income from equity investment

 

Our investment of a 49.9% (33.3% in 2018) member interest ownership of U.S. Stem Cell Clinic, LLC and Regenerative Wellness Clinic as well as a 49% interest in U.S. Stem Cell of the Villages LLC are accounted for using the equity method of accounting.  As such, we report our pro rata share of its income or loss for the period.  For the three months ended March 31, 2019 and 2018, our pro rata share of its income was $100,944 and $95,342, respectively

 

 

Interest Expense

 

Interest expenses during the three months ended March 31, 2019 were $394,381 compared to $242,357 for the three months ended March 31, 2018. Interest expenses 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, our capital lease and 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 March 31, 2019 and 2018 was $29,809 and $69,974, 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.

 

We follow 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;

arm’s 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.

 

On April 1, 2013, the Board of Directors approved, subject to subsequently received shareholder approval, the establishment of the Bioheart 2013 Omnibus Equity Compensation Plan, or the “2013 Omnibus Plan”. The 2013 Omnibus Plan initially reserved up to fifty thousand (50,000) shares of common stock for issuance. On August 4, 2014, the Board of Directors approved to set the reserve to one hundred thousand (100,000) 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. On November 2, 2015, the Board of Directors approved the increase of the reserve under the 2013 Omnibus Plan to five hundred million (500,000,000) shares of common stock for issuance, effective September 16, 2016, approved an addition of twenty five million (25,000,000) shares of common stock to the reserve, effective April 21, 2017, approved an addition of twenty five million (25,000,000) shares of common stock to the reserve, effective August 7, 2017, approved an addition of thirty million (30,000,000) shares of common stock to the reserve and effective May 7, 2018, approved an addition of one hundred million (100,000,000) shares of common stock to reserve.

 

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

 

Effective January 1, 2018, the Company recognizes revenue in accordance with Accounting Standards Codification 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, and most industry-specific revenue recognition guidance throughout the Industry Topics of the Accounting Standards Codification. The updated guidance states that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The guidance also provides for additional disclosures with respect to revenues and cash flows arising from contracts with customers.

 

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.

 

The Company’s primary sources of revenue are from the sale of test kits and equipment, training services, patient treatments, laboratory services and cell banking. 

 

Revenues for kits and equipment sold are not recorded until kits and equipment are received by the customer. Revenues from in-person trainings are recognized when the training occurs and revenues from on demand online trainings are recognized when the customer purchases the rights to the training course. Any cash received as a deposit for trainings are recorded by the Company as a liability.

 

Patient treatments and laboratory services revenue are recognized when those services have been completed or satisfied.

 

Revenues for cell banking sales are accounted for as multiple performance obligations as described in ASC 606 and addresses accounting for arrangements that may involve the delivery or performance of multiple products, services and/or rights to use assets. Because the Company sells its services separately, on more than a limited basis and at a price within a narrow range, the Company was able to allocate revenue based on stand-alone pricing. The multiple performance obligations include stem cell banking, dose retrieval and yearly storage fees. Revenues for stem cell banking and dose retrieval is recognized at the point of service and revenues for the yearly storage fees is recognized over the term of the banking contract, which is typically one year with annual renewals.

 

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. Our company-sponsored research and development costs related to both present and future products are expensed in the period incurred.

 

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 March 31, 2019, two customers represented 15% and 49%, respectively, representing an aggregate of 64% of the Company’s accounts receivable. As of December 31, 2018, four customers represented 41%, 10%, 16% and 10% respectively, representing an aggregate of 77% of the Company’s accounts receivable.

 

 

For the three months ended March 31, 2019, the Company’s revenues earned from sale of products and services were $1,308,810, of which one customer, a related party (US Stem Cell Clinic LLC, a partly owned investment in which the Company holds a 49.9% interest) represented 10%.  For the three months ended March 31, 2018, the Company’s revenues earned from sale of products and services did not include any customers representing 10% or more of the Company’s total revenues.  

 

Recent Accounting Policies 

 

There are various other 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 our  financial position, results of operations or cash flows.

 

Liquidity and Capital Resources

 

In the three months ended March 31, 2019, we incurred negative cash flow from operations of $340,412 and will continue to finance our considerable operational cash needs with cash generated from financing activities and revenues.

 

Net cash used in operating activities was $340,412 in the three month period ended March 31, 2019 as compared to $688,651 of cash provided in the three months ended March 31, 2018.

 

Our cash used in for operations in the three months ended March 31, 2019 reflected a net loss generated during the period of $673,218, adjusted for non-cash items such as stock-based compensation of $242,716, depreciation of $51,652, amortization of debt discounts and non-cash interest of $29,809, bad debts of $21,304 and loss on settlement of debt of $12,960, net with gain on sale of property and equipment of $32,211 and income from investments of $100,944. In addition we had a net increase in operating assets of $45,198 and an decrease in accrued expenses of $3,205, increase accounts payable of $136,772 and in deferred revenue of $19,151.

 

Investing Activities

 

Net cash provided by investing activities was $80,850 for the three months ended March 31, 2019 represented proceeds from our equity investment as compared to cash provided by investing activities of $45,000 from our equity investments for the same period last year.

 

Financing Activities

 

Net cash used in financing activities was an aggregate of $348,185 in the three month period ended March 31, 2019 as compared to cash used of $2,422 in the three month period ended in March 31, 2018. In the three month period ended March 31, 2019, we received $90,000 from advances from related party, net with repayments of notes payable of $169,317 and $268,868 related party notes.

 

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.

 

At March 31, 2019, we had cash and cash equivalents totaling $749,399. However our working capital deficit as of such date was approximately $4.8 million.

 

 

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.

 

Subsequent Events

 

Our headquarters are located in Sunrise, Florida and consists of 4,860 square feet of space, which we lease at a current rent of approximately $82,620 per year. On April 23, 2019, our lease was extended from the prior term ending August 31, 2019 until August 31, 2024 with annual base rent increasing from approximately $82,674 per year at the commencement of the extension to approximately $98,678 per year in the final year.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Not required under Regulation S-K for “smaller reporting companies.”

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

As required under Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we carried out an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Accounting Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of March 31, 2019. Based upon that evaluation, the Chief Executive Officer and Chief Accounting Officer concluded that our disclosure controls and procedures as of March 31, 2019 were not effective, for the same reasons as previously disclosed under Item 9A. “Controls and Procedures” in our Annual Report on Form 10-K for our fiscal year ended December 31, 2018. 

 

Changes in Internal Controls over Financial Reporting

 

There have been no changes in our internal controls over financial reporting (as defined in Rule 13a-15(f) and 15d-(f) of the Exchange Act) that occurred during the our last fiscal quarter to which this report relates that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

 

PART II — OTHER INFORMATION

 

Item 1. Legal Proceedings

 

On December 12, 2017, a product liability lawsuit was filed in Broward County, specifically Jeannine Mallard v. U.S. Stem Cell, Inc., US Stem Cell Clinics LLC., Regenestem, LLC., Regenestem Network, LLC., and Kristin C. Comella. The Company will continue to defend it vigorously.

 

On September 17, 2015, a product liability lawsuit was filed in Broward County, specifically Patsy Bade v. Bioheart, Inc. US Stem Cell Clinics LLC, Alejandro Perez, ARNP, and Shareen Greenbaum, M.D., and on November 30, 2015, a product liability lawsuit was filed in Broward County, specifically Elizabeth Noble v. Bioheart, Inc. US Stem Cell Clinics LLC, Alejandro Perez, ARNP, and Shareen Greenbaum, M.D. During the year ended December 31, 2016, both matters settled by the Company’s insurance policy with no additional cost to the Company, excluding the Company payment of the $100,000 insurance company deductible of which $11,000 was paid in fiscal 2017. As a result of the final settlement and determination of insurance coverage, the Company recognized $100,000 of expense due to litigation for the year ended December 31, 2017, of which $89,000 is included in accrued expenses at March 31, 2019 and December 31, 2018.

 

The Company is subject at times to other legal proceedings and claims, which arise in the ordinary course of its business.  Although occasional adverse decisions or settlements may occur, the Company believes that the final disposition of such matters should not have a material adverse effect on its financial position, results of operations or liquidity.  There was no outstanding litigation as of December 31, 2018 other than that described above.

 

SEC Investigation

 

On or about March 1, 2018, the U.S. Securities and Exchange Commission (“Commission”), Miami Regional Office (“Commission Staff”), served a subpoena upon U.S. Stem Cell, Inc., which seeks the production of certain documents and communications. The Commission Staff is conducting a formal non-public, fact-finding inquiry of U.S. Stem Cell, Inc (“Investigation”).  The Investigation is neither an allegation of wrongdoing nor a finding that any violation of law has occurred.  The Company is cooperating with, and has provided information and documents to, the Commission Staff.  

 

As part of the Investigation, on or about May 14, 2018, the Commission Staff served subpoenas upon Kristin Comella and Mike Tomas, respectively, seeking the production of certain documents and communications. Ms. Comella and Mr. Tomas responded to the respective subpoenas and provided information and documents to the Commission Staff. At this juncture, the Company is not able to predict the duration, scope, results, or consequences of the investigation. There can be no assurance that the Investigation will be resolved in a manner that is not adverse to the Company.

 

Government Claim

 

On May 9, 2018, the U.S. Department of Justice filed an injunctive action, specifically United States of America v. U.S. Stem Clinic, LLC, U.S. Stem Cell, Inc., Kristin C. Comella, and Theodore Gradel. The Complaint was filed at the request of the U.S. Food and Drug Administration (FDA) and alleges that the respective defendants manufacture “stromal vascular fraction” (SVF) products from patient adipose (fat) tissue, which the companies then market as stem cell-based treatments without first obtaining what the government alleges are necessary FDA approvals. The Company has retained counsel to defend in this action. The Company is not able to predict the duration, scope, results, or consequences of the U.S. Department of Justice actions.  There can be no assurance that this matter will be resolved in a manner that is not adverse to the Company.

 

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

 

None

 

 

Item 3. Defaults Upon Senior Securities

 

There were no defaults upon senior securities during the period ended March 31, 2019

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

None

 

 

Item 6. Exhibits

 

Exhibit No.

Exhibit Description

 

 

2.1(20)

Asset Sale and Lease Agreement between U.S. Stem Cell, Inc. and GACP Stem Cell Bank LLC., dated March 3, 2017.

2.2(20)

Asset Purchase Agreement between U.S. Stem Cell, Inc. and GACP Stem Cell Bank LLC., dated March 3, 2017.

2.3(20)

Customer Purchase Agreement between U.S. Stem Cell, Inc. and GACP Stem Cell Bank LLC., dated March 3, 2017.

3.1 (1)

Articles of Incorporation

3.2(5)

Amended and Restated Articles of Incorporation

3.3(8)

Articles of Amendment to the Articles of Incorporation

3.4(17)

Articles of Amendment to the Articles of Incorporation

3.5 (7)

Amended and Restated Bylaws

3.6(19)

Amendment to Bylaws

4.1(4)

Loan and Security Agreement, dated as of May 31, 2007 by and between BlueCrest Capital Finance, L.P. and the Registrant

4.2(9)

Amendment to Loan and Security Agreement, between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009

4.3(9)

Grant of Security Interest (Patents), between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009

4.4(9)

Security Agreement (Intellectual Property), between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009

4.5(9)

Subordination Agreement, by Hunton & Williams, LLP in favor of BlueCrest Venture Finance Master Fund Limited, entered into and effective April 2, 2009

4.6(9)

Amended and Restated Promissory Note, dated April 2, 2009, by the Company to BlueCrest Venture Finance Master Fund Limited

4.7(9)

Warrant to purchase shares of the Registrant’s common stock, dated April 2, 2009, issued to BlueCrest Venture Finance Master Fund Limited

4.8(10)

Warrant to purchase shares of the Registrant’s common stock, dated April 2, 2009, issued to Rogers Telecommunications Limited

4.9(10)

Warrant to purchase shares of the Registrant’s common stock, dated April 2, 2009, issued to Hunton & Williams, LLP

4.10 (15)

Series A Convertible Preferred Stock

10.1(1)

Lease Agreement between the Registrant and Sawgrass Business Plaza, LLC, as amended, dated November 14, 2006.

10.2(3)

Loan Guarantee, Payment and Security Agreement, dated as of June 1, 2007, by and between the Registrant, Howard J. Leonhardt and Brenda Leonhardt

10.3(3)

Loan Guarantee, Payment and Security Agreement, dated as of June 1, 2007, by and between the Registrant and William P. Murphy Jr., M.D.

10.4(3)

Loan Agreement, dated as of June 1, 2007, by and between the Registrant and Bank of America, N.A.

10.5(5)

Loan Guarantee, Payment and Security Agreement, dated as of September 12, 2007, by and between the Registrant and Samuel S. Ahn, M.D.

10.6(5)

Loan Guarantee, Payment and Security Agreement, dated as of September 12, 2007, by and between the Registrant and Dan Marino

10.7(5)

Loan Guarantee, Payment and Security Agreement, dated as of September 19, 2007, by and between the Registrant and Jason Taylor

10.8(6)

Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the Registrant and Howard and Brenda Leonhardt

10.9(6)

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

 

 

10.10(6)

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.

10.11(11)

Loan Agreement with Seaside National Bank and Trust, dated October 25, 2010.

10.12(11)

Promissory Note with Seaside National Bank and Trust, dated October 25, 2010.

10.13(11)

Amended and Restated Loan and Security Agreement with BlueCrest Venture Finance Master Fund Limited, dated October 25, 2010.

10.14(12)

Unsecured Convertible Promissory Note for $25,000, with Magna Group, LLC, dated January 3, 2011.

10.15(12)

Promissory Note for $139,728.82 with Magna Group, LLC, dated January 3, 2011.

10.16(13)

Unsecured Convertible Promissory Note for $34,750, with Magna Group, LLC, dated May 16, 2011.

10.17(13)

Promissory Note for $139,728.82 with Magna Group, LLC, dated May 16, 2011.

10.18**(14)

2013 U.S. Stem Cell, Inc. Omnibus Equity Compensation Plan

10.19(16)

Senior Convertible Note with Magna Equities II, LLC, dated October 1, 2015

10.20(16)

Securities Purchase Agreement, dated as of October 1, 2015, by and between Magna Equities II, LLC and U.S. Stem Cell, Inc.

10.21(16)

Registration Rights Agreement, dated as of October 1, 2015, by and between Magna Holdings I, LLC and U.S. Stem Cell, Inc.

10.22(18)

Senior Convertible Note Magna Equities II, LLC, dated December 3, 2015

10.23(18)

Amended and Restated Senior Convertible Note, dated December 3, 2015.

10.24(18)

Securities Purchase Agreement, dated as of December 3, 2015, by and between Magna Equities II, LLC and U.S. Stem Cell, Inc.

10.25(18)

Registration Rights Agreement, dated as of December 3, 2015, by and between Magna Holdings I, LLC and U.S. Stem Cell, Inc.

10.26(20)

Non-Competition and Non-Solicitation Agreement between U.S. Stem Cell, Inc. and GACP Stem Cell Bank LLC., dated March 3, 2017.

10.27(21)

First Amendment to Lease Agreement between the Registrant and Sawgrass Business Plaza, LLC, as amended, dated November 17, 2017.

10.28* Second Amendment to Lease Agreement between the Registrant and Sawgrass Business Plaza, LLC, as amended, dated November 17, 2017.

14.1(2)

Code of Business Conduct and Ethics

31.01*

Certification of Chief Executive Officer and Chief Financial Officer (Principal Accounting Officer) pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.01*

Certifications of Chief Executive Officer and Chief Financial Officer (Principal Accounting Officer) 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 DEF

XBRL Taxonomy Extension Definition Linkbase Document

101 LAB

XBRL Taxonomy Labels Linkbase Document

101 PRE

XBRL Taxonomy Presentation Linkbase Document

 

 

*

Filed herewith 

**

Indicates management contract or compensatory plan.

(1)

Incorporated by reference to the Company’s 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 Company’s Form S-1 filed with the SEC on June 5, 2007.

(3)

Incorporated by reference to Amendment No. 3 to the Company’s Form S-1 filed with the SEC on August 9, 2007.

(4)

Incorporated by reference to Amendment No. 4 to the Company’s Form S-1 filed with the SEC on September 6, 2007.

(5)

Incorporated by reference to Amendment No. 5 to the Company’s Form S-1 filed with the SEC on October 1, 2007.

(6)

Incorporated by reference to Post-effective Amendment No. 1 to the Company’s Form S-1 filed with the SEC on October 11, 2007.

(7)

Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on July 3, 2008.

(8)

Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on August 8, 2008.

(9)

Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on April 8, 2009.

(10)

Incorporated by reference to the Company’s Annual Report on Form 10-K filed with the SEC on April 15, 2009.

(11)

Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on October 29, 2010.

(12)

Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on January 12, 2011.

(13)

Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on May 25, 2011.

(14)

Incorporated by reference to the Company Quarterly Report on Form 10-Q filed with the SEC on May 9, 2013.

(15)

Incorporated by reference to the Company’s Definitive Proxy Statement on Schedule 14A filed with the SEC on April 28, 2014.

(16)

Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on October 2, 2015.

(17)

Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on November 4, 2015.

(18)

Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on December 4, 2015.

(19)

Incorporated by reference to the text of the Company Current Report on Form 8-K filed with the SEC on August 3, 2016.

(20)

Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on March 8, 2017.

(21)

Incorporated by reference to the Company Annual Report on Form 10-K filed with the SEC on April 16, 2018.

 

 

 

SIGNATURES

 

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

 

 

 

U.S. Stem Cell, Inc.

  

Date: May 7, 2019

By:   

/s/ Mike Tomas

 

 

Mike Tomas

 

 

Chief Executive Officer &

 

 

President and Principal Financial

 

 

and Accounting Officer

 

 

 

 

 

 

42

 

 

 

 

EXHIBIT 10.28

 

SECOND AMENDMENT TO LEASE

 

THIS SECOND AMENDMENT TO LEASE (this “Amendment") is entered into this 23 rd day of April, 2019 ("Effective Date") by and between SAWGRASS BUSINESS PLAZA, LLC, a Florida limited liability company ("Landlord"), whose address is c/o Morris Southeast Group, Inc., 13798 N W 4th Street, Suite 310, Sunrise, FL 33325 and U.S. STEM CELL, INC., a Florida corporation ("Tenant"), whose address is 13794 NW 4th Street, Suites 211 -213, Sunrise FL 33325. Landlord and Tenant shall be collectively referred to as the "Parties." Capital ized term(s) used herein and not otherwise defined shall have the meaning ascribed to such term(s) in the Lease (defined below).

 

WHEREAS, Landlord and Tenant entered into that certain Office Lease, dated February 4, 2016, as amended by that certain First Amendment to Lease, between Landlord and Tenant, dated November 17, 2017 (collectively, the "Lease") with respect to that certain premises located at 13794 NW 4th Street, Suites 211 -213, Sunrise, FL 33325 ("Premises");

 

WHEREAS, the term of the Lease is scheduled to expire on August 31 ,2019;

 

WHEREAS, Landlord and Tenant desire to extend the term of the Lease upon the terms and conditions set forth herein; and

 

WHEREAS, Land lord and Tenant desire to modify and/or confirm certain other obligations in the Lease, as set forth in this Amendment.

 

NOW THEREFORE, in consideration of the mutual covenants hereinafter contained and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Landlord and Tenant hereby agree as follows:

 

1 .      Recitals . The above-mentioned recitals are true, correct and incorporated herein by this reference .

 

2.     Term . The term of the Lease shall be extended for an additional period of Sixty (60) months, commencing September 1 , 2019 and expiring on August 31, 2024 (such period shall be hereinafter referred to as the " E xt e n s i o n Ter m "). Therefore, commencing upon execution of this Amendment by both Parties, the expiration date of the Lease shall be August 31 , 2024.

 

 3.      Base Rent . The monthly base rent during the Extension Term shall be as follows:   

 

 

Base Rent

Lease Period

Base Rent Per Sq. Ft.

Annual Base Rent

Monthly Base Rent

9/ I / 1 9 - 8/31120

$18.04

$87,674.40

$7,306.20

9/ l /20 - 8/31/2 I

$18.58

$90,304.63

$7,525.39

9/ I /2 l - 8/31/22

$19.14

$93,013.77

$7,751.15

9/ I /22 -  813   I /23

$19.71

$95,804. 18

$7,983.68

9/ I /23 - 8/3 I /24

$20.30

$98,678.31

$8,223.19

 

  4.      Operating Expenses; Utilities and Sales Taxes . At all times during the Lease, in addition to the monthly base rent, Tenant shall pay its proportionate share of Landlord's monthly Operating Expenses, including, but not limited to, Real Estate Taxes, Insurance Premiums and Common Area Maintenance. The estimated monthly payment of Tenant's proportionate share of Land lord ' s operating expenses for 2019 is $3,349.35 per month (based upon an estimate of $8.27 per rentable square foot). Said amount is an estimate and subject to change in Landlord's sole discretion. Tenant is responsible for all costs associated with the

 

 

 

 

utilities used in the Premises, including, but not limited to, electric. Tenant shall pay sales taxes on all amounts due under the Lease at the time such payments are due. Currently, sales tax is 6.7% in Broward County.

 

5.    Options . The Parties hereby acknowledge that Tenant does not have any options to renew and extend the term of the Lease.

 

6.      Estoppel . Tenant acknowledges and agrees that Land lord is not currently in default of any of Landlord 's obligations pursuant to the Lease as of the date hereof.

 

7.      Ratification of Lease . The Lease, as amended hereby, is in full force and effect, and is ratified and confirmed, and there are no other amendments or modifications therein, except as stated herein. In the event of any conflicts between the terms and conditions of the Lease and the terms and conditions of this Amendment, the terms and conditions of this Amendment shall prevail. All terms and conditions of the Lease not modified by this Amendment shall remain in full force and effect.

 

8.      Applicable Law . This Amendment and the Lease shall be governed by and construed in accordance with the laws of the state of Florida.

 

9.      Counterparts; E-Mail or Facsimile Transmission of Signatures . This Amendment may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute a single integrated document and shall be binding and effective upon each patty. The parties agree that a faxed or electronically transmitted copy or copies of this Amendment and/or the signatures collected herein, shall have the same evidentiary and legal effect as the original(s).

 

IN WITNESS WHEREOF, the parties hereto have executed this Amendment under seal, as of the Effective Date.

 

 

WITNESSED BY:

   

LANDLORD:

       
     

SAWGRASS BUSINESS PLAZA, LLC

Signature: /s/ Alina Carvajal                                     

     

Print Name: Alina Carvajal

   

By: /s/ Michael T. Montero                                    

     

Name: Michael T. Montero

     

Title: Manager

       
       
     

TENANT:

Signature:  /s/ Julieta Radiche                                      

     

Print Name: Julieta Radiche

   

U.S. STEM CELL, INC.

       
     

By: /s/ Mike Tomas                                                

Signature:  /s/ Danique Stewart                                      

Name: Mike Tomas

Print Name: Danique Stewart    

Title: President and CEO

 

 

Exhibit 31.1

 

Certification of Chief Executive Officer and Principal Accounting Officer

 

I, Mike Tomas, certify that:

 

1.

 

I have reviewed this report on Form 10-Q of U.S. Stem Cell, Inc.;

 

2.

     

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

 

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

 

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

   

a.

     

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

   

b.

 

designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

   

c.

 

evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

   

d.

 

disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

 

 

 

 

5.

 

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

 

 

   

a.

 

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

 

 

 

 

 

 

b.

 

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 7, 2019

   
   

/s/ Mike Tomas

 

Name:     

Mike Tomas

 

 

President and Chief Executive Officer

 

 

Chief Financial Officer and Principal

   

Accounting Officer

 

 

 

 

Exhibit 32.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Mike Tomas, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge, U.S. Stem Cell, Inc.’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2019 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that

 

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

(2)  The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

Date: May 7, 2019

   
   

/s/ Mike Tomas

 

Name:     

Mike Tomas

 

 

President and Chief Executive Officer Chief

 

 

Financial Officer and Principal Accounting

   

Officer