UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

[X]QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 20182019

 

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: 001-36763

 

MEDOVEX CORP.H-CYTE, INC

(Exact Namename of Registrantregistrant as Specifiedspecified in Its Charter)its charter)

 

Nevada 46-3312262
(State or Other Jurisdictionother jurisdiction of (IRS Employer
Incorporationincorporation or Organization)organization) Identification Number)No.)

3060 Royal Boulevard S Ste 150201 East Kennedy Blvd, Suite 700  
Alpharetta, GeorgiaTampa, Florida 3002233602
(Address of Principal Executive Offices)principal executive offices) (Zip Code)

 

(844) 633-6839

(Registrant’s Telephone Number, Including Area Code)

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

Title of each classTicker symbol(s)Name of each exchange on which registered
Common Stock, par value $0.001 per shareHCYTOTC Capital Markets

 

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.

[X] Yes [  ] No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted and posted 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 and post such files.)

[X] 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 or an emerging growth company. See the 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 [X]
 Emerging Growth Company [X]

 

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. [X]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

[  ]Yes [X] No

 

As of November 12, 2018, 24,717,27114, 2019, 99,236,413 shares of the registrant’s common stock were outstanding.

 

 

 

 
 

 

MEDOVEX CORP.H-CYTE, INC AND SUBSIDIARIES

 

TABLE OF CONTENTS

 

  Page
PART I – FINANCIAL INFORMATION
  
Item 1.Financial Statements4
 Condensed Consolidated Balance Sheets as of September 30, 2018 (unaudited) and December 31, 20174
 Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2018 and 2017 (unaudited)5
 Condensed Consolidated StatementStatements of Stockholders’ (Deficit) Equity for the nine months ended September 30, 2018 (unaudited)(Deficit)6
 Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2018 and 2017 (unaudited)7
 Notes to Condensed Consolidated Financial Statements (unaudited)8
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations.Operations2025
Item 3.Quantitative and Qualitative Disclosures About Market Risk.Risks2534
Item 4.Controls and Procedures.Procedures2634
   
PART II – OTHER INFORMATION
   
Item 1.Legal Proceedings.Proceedings2635
Item 1A.Risk Factors.Factors2635
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds.Proceeds2635
Item 3.Defaults Upon Senior Securities.Securities2635
Item 4.Mine Safety Disclosures.Disclosures2635
Item 5.Other Information.Information2635
Item 6.Exhibits.Exhibits2635
   
SIGNATURES2736

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains “forward-looking statements”, as defined under United States federal securities laws. These statements involve known and unknown risks, uncertainties, and other factors that 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. Forward-looking statements include, but are not limited to, statements about:

 

 our ability to market, commercialize and achieve broader market acceptance for our products;
   
 our ability to successfully expand, and achieve full productivity from, our sales, clinical support, and marketing capabilities;
   
 our ability to successfully complete the development of, and obtain regulatory clearance or approval for, our products; and
   
 the estimates regarding the sufficiency of our cash resources, our ability to obtain additional capital or our ability to maintain or grow sources of revenue.

 

In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these words. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. You should also refer to the section of our Annual report on Form 10-K entitled “Risk Factors” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us, or any other person, that we will achieve our objectives and plans in any specified time frame, or at all. We do not undertake to update any of the forward-looking statements after the date of this Quarterly Report, except to the extent required by applicable securities laws.

 

The “Risk Factors” included in the Company’s Annual Report on Form 10-K reflect the “Risk Factors” of H-CYTE (formerly MedoveX) business and do not include information relative to Regenerative Medicine Solutions, LLC, RMS Shareholder, LLC (“Shareholder”), Lung Institute LLC (“LI”), RMS Lung Institute Management LLC (“RMS LI Management”) and Cognitive Health Institute Tampa, LLC (“CHIT”), (collectively “RMS”).

 

MEDOVEX CORP. AND SUBSIDIARIESItem 1. Financial Statements

H-CYTE, INC AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

September 30, 2018

  December 31, 2017  September 30, 2019 (Unaudited)  December 31, 2018 
 (unaudited)         
Assets                
        
Current Assets                
Cash $227,960  $245,026  $367,877  $69,628 
Accounts receivable  141,290   157,069   37,180   15,242��
Other receivables  9,537   86,888   33,868   5,144 
Inventory  206,495   294,714   126,250    
Prepaid expenses  59,068   204,532   198,927   59,678 
Short-term receivable     150,000 
Total Current Assets  644,350   1,138,229   764,102   149,692 
Property and Equipment, net of accumulated depreciation  66,551   87,173 
Deposits  2,751   2,751 
        
Right-of-use asset  859,134    
Property and equipment, net  235,225   266,916 
Intangibles, net  3,128,000    
Goodwill  12,564,401    
Other assets  29,239   38,288 
Total Assets $713,652  $1,228,153  $17,580,101  $454,896 
Liabilities and Stockholders’ (Deficit) Equity        
        
Liabilities and Stockholders’ Equity (Deficit)        
        
Current Liabilities                
Interest payable $80,709  $69,222  $78,328  $158,371 
Accounts payable  688,958   196,171   1,952,500   851,604 
Accounts payable to related parties  69,503   12,319 
Accrued payroll  124,817    
Accrued liabilities  477,413   64,000   543,137   183,183 
Other current liabilities  532,396   462,856 
Short-term note, related party  1,250,000   180,000 
Short-term financing payable  114,123   30,852 
Short-term convertible notes payable  774,615    
Notes payable, current portion  54,363   132,294   71,653    
Short-term convertible notes payable, net of debt discount  533,128    
Dividend payable  30,063      105,389    
Unearned revenue     1,048 
Deferred revenue  1,364,658   326,064 
Lease liability, current portion  481,295    
Total Current Liabilities  2,058,954   475,054   7,268,094   2,192,930 
        
Long-Term Liabilities                
Lease liability, net of current portion  396,424    
Notes payable, net of current portion     38,990   22,920    
Convertible debt to related parties     4,306,300 
Derivative liability - warrants  332,150    
Deferred rent  67   688      22,206 
Total Long-Term Liabilities  67   39,678   751,494   4,328,506 
        
Total Liabilities  2,059,021   514,732   8,019,588   6,521,436 
Stockholders’ (Deficit) Equity        
Series A Preferred stock - $.001 par value: 45,000 shares authorized, no shares issued and outstanding at September 30, 2018 (unaudited), 12,740 shares issued and outstanding at December 31, 2017     13 
Series B Preferred stock - $.001 par value: 10,000 shares authorized, 9,250 shares issued and outstanding at September 30, 2018 (unaudited), no shares issued and outstanding at December 31, 2017  9    
Common stock - $.001 par value: 200,000,000 and 49,500,000 shares authorized as of September 30, 2018 (unaudited) and December 31, 2017 respectively; 23,473,314 and 21,163,013 shares issued and outstanding at September 30, 2018 (unaudited) and December 31, 2017, respectively  23,473   21,163 
        
Commitments and Contingencies (Note 10)        
        
Stockholders’ Equity (Deficit)        
Series A Convertible Preferred Stock - $.001 par value: 500,000 shares authorized, no shares issued and outstanding at September 30, 2019 and December 31, 2018      
Series B Convertible Preferred Stock - $.001 par value: 10,000 shares authorized, 7,000 and 0 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively  7    
Series C Convertible Preferred Stock - $.001 par value: 45,000 shares authorized, no shares issued and outstanding at September 30, 2019 and December 31, 2018      
Common stock - $.001 par value: 199,000,000 and 49,500,000 shares authorized. 99,236,360 and 33,661,388 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively  99,237   33,661 
Additional paid-in capital  35,278,207   33,509,648   25,818,913   3,566,339 
Accumulated deficit  (36,647,058)  (32,817,403)  (15,987,512)  (9,296,408)
Total Stockholders’ (Deficit) Equity  (1,345,369)  713,421 
Total Liabilities and Stockholders’ (Deficit) Equity $713,652  $1,228,153 
Non-controlling interest  (370,132)  (370,132)
Total Stockholders’ Equity (Deficit)  9,560,513   (6,066,540)
        
Total Liabilities and Stockholders’ Equity (Deficit) $17,580,101  $454,896 

 

See accompanying notes to condensedthe unaudited consolidated financial statements

H-CYTE, INC AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
  2019  2018  2019  2018 
Revenues $2,742,442  $1,536,990  $6,498,404  $6,880,794 
Cost of Sales  (550,139)  (503,755)  (1,539,104)  (1,979,128)
Gross Profit  2,192,303   1,033,235   4,959,300   4,901,666 
                 
Operating Expenses                
Salaries and related costs  1,913,845   894,773   7,078,531   3,072,807 
Other general and administrative  2,025,980   809,119   5,309,791   2,482,789 
Advertising  1,467,691   278,942   4,188,087   1,435,784 
Depreciation & amortization  211,885   35,371   631,722   84,259 
Total Operating Expenses  5,619,401   2,018,205   17,208,131   7,075,639 
                 
Operating Loss  (3,427,098)  (984,970)  (12,248,831)  (2,173,973)
                 
Other Income (Expense)                
Other income  --   --   2,153   -- 
Foreign currency transaction gain  --   --   6,837   -- 
Change in fair value of derivative liability - warrants  883,527   --   883,527   -- 
Interest expense  (80,092)  (50,281)  (259,436)  (121,200)
Total Other Income (Expenses)  803,435   (50,281)  633,081   (121,200)
                 
Net Loss $(2,623,663) $(1,035,251) $(11,615,750) $(2,295,173)
                 
Dividend on outstanding Series B Preferred Stock  21,000   --   66,639   -- 
Deemed dividend on adjustment to exercise price on convertible debt and certain warrants  --   --   404,384   -- 
Deemed dividend on beneficial conversion features  --   --   32,592   -- 
Net loss attributable to common stockholders $  (2,644,663) $(1,035,251) $(12,119,365) $(2,295,173)
                 
Loss per share – Basic and Diluted $(0.03) $(0.03) $(0.13) $(0.07)
Weighted average outstanding shares used to compute basic and diluted net loss per share  98,991,805   33,661,388   96,150,811   33,661,388 

See accompanying notes to the unaudited consolidated financial statements

 

45
 

 

MEDOVEX CORP.H-CYTE, INC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSSTOCKHOLDERS’ EQUITY (DEFICIT)

(UNAUDITED)

  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
  2018  2017  2018  2017 
Revenues $208,713  $117,277  $605,058  $117,277 
Less: Discounts Allowed  (2,554)     (6,285)   
Cost of Goods Sold  (122,436)  (96,683)  (425,399)  (96,683)
Gross Profit  83,723   20,594   173,374   20,594 
                 
Operating Expenses                
General and administrative  1,153,966   1,092,084   2,918,251   3,540,500 
Sales and marketing  215,039   216,950   666,092   444,708 
Research and development  46,219   70,151   201,529   461,924 
Depreciation  6,728   7,109   20,622   20,000 
Total Operating Expenses  1,421,952   1,386,294   3,806,494   4,467,132 
                 
Operating Loss  (1,338,229)  (1,365,700)  (3,633,120)  (4,446,538)
                 
Other Expenses                
Foreign currency transaction loss  3,849      15,881    
Interest expense  40,197   1,654   72,957   393,890 
Total Other Expenses  44,046   1,654   88,838   393,890 
                 
Total Loss from Continuing Operations  (1,382,275)  (1,367,354)  (3,721,958)  (4,840,428)
                 
Discontinued Operations                
Loss from discontinued operations           1,163 
Total Loss from Discontinued Operations           (1,163)
                 
Net Loss  (1,382,275)  (1,367,354)  (3,721,958)  (4,841,591)
                 
Dividend on outstanding Series B Preferred stock  (22,354)     (30,063)   
Deemed divided on adjustment to exercise price on certain warrants  (107,697)     (107,697)   
Deemed dividend on beneficial conversion features        (259,350)   
Net loss attributable to common shareholders $(1,512,326) $(1,367,354) $(4,119,068) $(4,841,591)
Loss per share – Basic:                
Continuing Operations $(0.06) $(0.07) $(0.18) $(0.26)
Discontinued Operations            
Net Loss per share $(0.06) $(0.07) $(0.18) $(0.26)
Loss per share – Diluted:                
Continuing Operations $(0.06) $(0.07) $(0.18) $(0.26)
Discontinued Operations            
Net Loss per share $(0.06) $(0.07) $(0.18) $(0.26)
                 
Weighted average outstanding shares used to compute basic net loss per share
  23,473,314   20,504,932   22,786,208   18,332,398 
Weighted average outstanding shares used to compute diluted net loss per share  23,473,314   20,504,932   22,786,208   18,332,398 

See notes to condensed consolidated financial statements

 MEDOVEX CORP. AND SUBSIDIARIES

CONSOLIDATED STATEMENT OF STOCKHOLDERS’ (DEFICIT) EQUITY

For the three and nine months ended September 30, 20182019

(UNAUDITED)(Unaudited)

 

  

Series A Preferred

Stock

  

Series B Preferred

Stock

  Common Stock  

Additional

Paid-in

  

Accumulated

  

Total Stockholders'

(Deficit)

 
  Shares  Amount  Shares  Amount  Shares  Amount  Capital  Deficit  Equity 
Balance – December 31, 2017  12,740  $13         21,163,013  $21,163  $33,509,648  $(32,817,403) $713,421 
Issuance of common stock pursuant to a private placement completed in February 2018, net of offering costs              770,000   770   241,727      242,497 
Issuance of warrants pursuant to a private placement completed in February 2018                    52,003      52,003 
Issuance of warrants in connection with promissory note in March 2018                    25,646      25,646 
Issuance of common stock pursuant to preferred stock conversion in March 2018  (12,740)  (13)        1,274,000   1,274   (1,261)      
Issuance of common stock pursuant to conversion of convertible debt in April 2018              266,301   266   100,928      101,194 
Issuance of preferred stock pursuant to a private placement completed in May 2018, net of offering costs        8,250   8         413,174      413,182 
Issuance of warrants pursuant to a private placement completed in May 2018                    161,206      161,206 
Convertible preferred stock – beneficial conversion feature pursuant to a private
placement completed in May 2018
                    245,612      245,612 
Issuance of preferred stock pursuant to conversion of promissory note in May 2018        1,000   1         68,773      68,774 
Issuance of warrants pursuant to conversion of promissory in May 2018                    17,488      17,488 
Convertible preferred stock – beneficial conversion feature pursuant to conversion of
Promissory note in May 2018
                    13,738      13,738 
Issuance of warrants in connection with short-term convertible debt in August 2018                    192,330      192,330 
Issuance of warrants in connection with short-term convertible debt in September 2018                    52,246      52,246 
Adjustment of exercise price on certain warrants                    107,697   (107,697)   
Dividend payable                    (30,063)     (30,063)
Stock based compensation                    107,315      107,315 
Net loss                       (3,721,958)  (3,721,958)
Balance – September 30, 2018    $   9,250  $9   23,473,314  $23,473  $35,278,207  $(36,647,058) $(1,345,369)
For the Three Months Ended Preferred Stock  Common Stock  Additional Paid-in  Accumulated  Non-controlling  Total Stockholders’
(Deficit)
 
September 30, 2019 Shares  Amount  Shares  Amount  Capital  Deficit  Interest  Equity 
Balances – June 30, 2019  7,000  $7   98,886,360  $98,887  $25,705,975  $(13,480,691) $(370,132) $11,954,046 
Issuance of common stock in connection with private placement offering        200,000   200   77,164         77,364 
Issuance of warrants in connection with private placement offering              22,636         22,636 
Issuance of common stock in exchange for consulting services        150,000   150   43,349         43,499 
Derivative liability adjustment (Note12)              (116,842)  116,842      

 

— 

Issuance of warrants pursuant to extension of maturity date on convertible debt              106,158         106,158 
Stock based compensation              1,473         1,473 
Dividends payable              (21,000)        (21,000)
Net loss                 (2,623,663)     (2,623,663)
Balances - September 30, 2019  7,000  $7     99,236,360  $  99,237  $  25,818,913  $(15,987,512) $(370,132) $9,560,513 

For the Nine Months Ended Preferred Stock  Common Stock  Additional Paid-in  Accumulated  Non-controlling  Total Stockholders’
(Deficit)
 
September 30, 2019 Shares  Amount  Shares  Amount  Capital  Deficit  Interest  Equity 
Balances - December 31, 2018    $   33,661,388  $33,661  $3,566,339  $(9,296,408) $(370,132) $(6,066,540)
Purchase accounting entries due to the purchase transaction  9,250   9   24,717,217   24,717   12,657,182         12,681,908 
Adjustment for assets and liabilities not included in purchase transaction                 5,244,780      5,244,780 
Issuance of common stock in connection with private placement offering        17,700,000   17,700   4,402,087         4,419,787 
Issuance of warrants in connection with private placement offering              2,663,797         2,663,797 
Issuance of common stock pursuant to conversion of short-term debt        500,000   500   125,437         125,937 
Issuance of warrants pursuant for repayment of short-term debt              74,063         74,063 
Issuance of additional exchange shares (Note 3)        17,263,889   17,264   (17,264)         
Issuance of common stock pursuant to conversion of convertible short-term debt        250,000   250   99,750         100,000 
Conversion of Preferred Series B Stock and accrued dividends  (2,250)  (2)  604,167   605   (603)         
Issuance of common stock to pay accrued interest on convertible short-term debt        1,667   2   665         667 
Issuance of common stock in exchange for consulting fees incurred        280,085   280   95,253         95,533 

Adjustment of exercise price on convertible debt 

              287,542   (287,542)      
Issuance of common stock to pay accrued dividends on Preferred Series B stock        32,313   32   12,894         12,926 
Beneficial conversion on Preferred Series B Stock              32,592   (32,592)      
Issuance of common stock per restricted stock award to executive (Note 9)        4,225,634   4,226   1,686,028         1,690,254 
Issuance of warrants pursuant to extension of maturity date on convertible debt              106,158         106,158 
Stock based compensation              93,632         93,632 
Dividends payable              (66,639)        (66,639)
Net loss                 (11,615,750)     (11,615,750)
Balances - September 30, 2019  7,000  $7     99,236,360  $99,237  $  25,818,913  $(15,987,512) $(370,132) $9,560,513 

 

See accompanying notes to the unaudited consolidated financial statements

MEDOVEX CORP.H-CYTE, INC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)(Unaudited)

 

  Nine Months Ended
September 30,
 
  2018  2017 
Cash Flows from Operating Activities        
Net loss $(3,721,958) $(4,841,591)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation  20,622   20,000 
Amortization of debt discount  53,350   31,772 
Debt conversion expense     355,985 
Stock-based compensation  107,315   611,522 
Straight-line rent adjustment  (621)  (196)
Changes in operating assets and liabilities, net of effects of disposition:        
Accounts receivable  15,779   (94,779)
Other receivables  77,351   (23,369)
Prepaid expenses  145,464   224,416 
Inventory  88,219   (164,867)
Accounts payable  492,787   43,106 
Accounts payable to related parties  57,184   671 
Interest payable  11,487    
Unearned revenue  (1,048)   
Accrued payroll  124,817    
Accrued liabilities  413,413   (84,800)
Net Cash Used in Operating Activities  (2,115,839)  (3,922,130)
Cash Flows from Investing Activities        
Payment received from Streamline note receivable  150,000    
Expenditures for property and equipment     (14,808)
Net Cash Provided by (Used in) Investing Activities  150,000   (14,808)
Cash Flows from Financing Activities        
Principal payments under note payable obligations  (215,727)  (112,342)
Proceeds from issuance of common stock and preferred stock, net of offering costs  901,291   3,838,671 
Proceeds from issuance of warrants, net of offering costs  483,431   1,248,575 
Proceeds from issuance of promissory notes  174,354    
Proceeds from issuance of convertible notes  605,424    
Net Cash Provided by Financing Activities  1,948,773   4,974,904 
Net (Decrease)/Increase in Cash  (17,066)  1,037,966 
Cash - Beginning of period  245,026   892,814 
Cash - End of period $227,960  $1,930,780 
Supplementary Cash Flow Information        
Cash paid for interest $4,768  $6,130 
Non-cash investing and financing activities        
Financing agreement for insurance policy $74,672  $66,895 
Conversion of convertible note and accrued interest to common stock  101,194   718,079 
Conversion of short-term loan to common stock     126,720 
Conversion of promissory note to preferred stock and warrants  100,000    
Issuance of warrants for conversion of notes     305,201 
Common stock issued for board fees     240,000 
Issuance of common stock for preferred stock conversion  1,274   931 
Issuance of common stock warrants for placement agent fees     304,183 
Issuance of common stock for consideration of cancellation of warrants     208,000 
Issuance of warrants for promissory note  25,646    
Dividends accrued  30,063    

  Nine Months Ended 
  September 30, 2019  September 30, 2018 
Cash Flows from Operating Activities        
Net loss $(11,615,750) $(2,295,173)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  631,722   84,259 
Amortization of debt discount  151,881   -- 
Interest and penalties on extension of short-term convertible notes  124,615   -- 
Stock-based compensation  1,783,886   -- 
Loss on write-off of inventory  5,205   -- 
Common stock issued for consulting services  95,533   -- 
Income from change in fair value adjustment of derivative liability - warrants  (883,527)  -- 
Issuance of warrants to extend short-term debt  106,158   -- 
Bad debt expense  60,112   -- 
Changes in operating assets and liabilities, net of purchase transaction:        
Accounts receivable  63,707   (6,903)
Other receivables  (28,724)  -- 
Accounts receivable from related parties  --   (8,824)
Prepaid expenses and other assets  (140,304)  89,078 
Interest payable  (25,381)  98,286 
Accounts payable  486,196   207,265 
Accrued liabilities  (102,099)  (96,667)
Other current liabilities  354,340   (57,801)
Dividend payable  (12,928)  -- 
Deferred revenue  1,038,594   (391,938)
         
Net Cash Used in Operating Activities  (7,906,764)  (2,378,418)
         
Cash Flows from Investing Activities        
Purchases of property and equipment  (17,238)  (207,895)
Purchase of business, net of cash acquired  (302,710)  -- 
assets not included in purchase transaction  (69,629)  -- 
Net Cash Used in Investing Activities  (389,577)  (207,895)
         
Cash Flows from Financing Activities        
Payments on short-term related party notes  (180,000)  (4,944)
Proceeds from short-term related party notes  1,250,000   -- 
Payment of dividends  (6,136)  -- 
Proceeds from debt obligations  277,519   50,020 
Payment on debt obligations  (130,377)  -- 
Proceeds from common stock  4,419,787   -- 
Proceeds from warrants  2,663,797   -- 
Proceeds from shareholder contributions  300,000   -- 
Proceeds from convertible debt to a related party  --   2,367,724 
Net Cash Provided by Financing Activities  8,594,590   2,412,800 
         
Net Increase (Decrease) in Cash  298,249   (173,513)
         
Cash - Beginning of period  69,628   251,330 
         
Cash - End of period $367,877  $77,817 
         
Supplementary Cash Flow Information        
Cash paid for interest $132,937  $20,900 
         
Non-cash investing and financing activities        
Common stock issued to pay accrued dividends $12,928  $-- 
Deemed dividends $436,976  $-- 
Conversion of debt obligations to common stock $225,937  $-- 
Conversion of debt obligations to warrants $74,063  $-- 
Issuance of warrants to extend short-term debt $106,158  $-- 
Conversion of short-term related party notes payable to common stock $114,000  $-- 
Conversion of note and accrued interest to common stock and warrants $607  $-- 
Interest and penalties on extension of short-term convertible notes $253,607  $-- 
Dividends accrued $66,639  $-- 
Repurchase of non-controlling interest $--  $33,805 

 

See accompanying notes to condensedthe unaudited consolidated financial statements

 

MEDOVEX CORP.H-CYTE, INC

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Note 1 - Description of the Company

MedoveX Corp. (the “Company” or “MedoveX”) was incorporated in Nevada onOn July 30, 2013 as SpineZ11, 2019, Medovex Corp. (“SpineZ”MedoveX”) and changed its namenamed to MedoveX Corp. on March 20, 2014. MedoveX isH-CYTE, Inc. (“H-CYTE” or the parent company“Company”) by filing a Certificate of Debride Inc. (“Debride”Amendment (the “Amendment”), which was incorporated under to the lawsCompany’s Amended and Restated Certificate of Incorporation (the “Certificate of Incorporation”) with the Secretary of the State of Nevada. The name change and the Company’s new symbol, HCYT, became effective with FINRA on July 15, 2019.

On October 18, 2018, H-CYTE (formerly named MedoveX) entered into an Asset Purchase Agreement (“APA”) with Regenerative Medicine Solutions, LLC, RMS Shareholder, LLC (“Shareholder”), Lung Institute LLC (“LI”), RMS Lung Institute Management LLC (“RMS LI Management”) and Cognitive Health Institute Tampa, LLC (“CHIT”), (collectively “RMS”). On January 8, 2019, the APA was amended, and the Company acquired certain assets and assumed certain liabilities of RMS as reported in the 8-K/A filed in March of 2019. Based on the terms of the APA and its amendment (collectively the “APA”), the former RMS members had voting control of the combined company as of the closing of the RMS acquisition. For accounting purposes, the acquisition transaction has been treated as a reverse acquisition whereby the Company is deemed to have been acquired by RMS and the historical financial statements prior to the acquisition date of January 8, 2019 now reflect the historical financial statements of RMS.

Prior to the merger of H-CYTE and RMS on January 8, 2019 (the “Merger”), the consolidated results for H-CYTE include the financial activities of Regenerative Medicine Solutions, LLC, LI, RMS Nashville, LLC (“Nashville”), RMS Pittsburgh, LLC (“Pittsburgh”), RMS Scottsdale, LLC (“Scottsdale”), RMS Dallas, LLC (“Dallas”), State, LLC (“State”), Cognitive Health Institute of Tampa (“CHIT”), RMS LI Management, and Shareholder, H-CYTE included Lung Institute Dallas, PLLC (“LI Dallas”), Lung Institute Nashville, PLLC (“LI Nashville”), Lung Institute Pittsburgh, PLLC (“LI Pittsburgh”), and Lung Institute Scottsdale, LLC (“LI Scottsdale”), as Variable Interest Entities (“VIEs”).

As of the merger, the consolidated results for H-CYTE include the following wholly-owned subsidiaries: H-CYTE Management, LLC (formerly Blue Zone Health Management, LLC), Cognitive Health Institute, LLC, and Lung Institute Tampa, LLC (formerly Blue Zone Lung Tampa, LLC). Additionally, H-CYTE has consolidated LI Dallas, LI Nashville, LI Pittsburgh, and LI Scottsdale, as VIEs.

The Company’s RMS division is a healthcare medical biosciences company that develops and implements advanced innovative treatment options in regenerative medicine to treat an array of debilitating medical conditions. In addition, the company is the operator and manager of the various Lung Health Institute clinics. Committed to an individualized patient-centric approach, RMS consistently provides oversight and management of the highest quality care while producing positive outcomes. RMS offices are located in Tampa, Florida. The Lung Health Institute located in Tampa, Florida is a wholly owned subsidiary of RMS. RMS also provides oversight and management to the Lung Health Institutes located in Nashville, TN, Scottsdale AZ, Pittsburgh, PA, and Dallas, TX.

On June 21, 2019, H-CYTE entered into an agreement with Rion, LLC (“Rion”) to develop a disruptive cytotherapy technology for chronic obstructive pulmonary disease (“COPD”), the fourth leading cause of death in the U.S. This agreement provides for a 10-year exclusive and extendable supply agreement with Rion to enable H-CYTE to develop proprietary biologics. This will be managed through a new Rion division of H-CYTE.

Rion has established a novel technology to harness the healing power of the body. Rion’s novel exosome technology, based on October 1, 2012. science developed at Mayo Clinic, provides an off-the-shelf platform to enhance healing in soft tissue, musculoskeletal, cardiovascular and neurological organ systems.

With this agreement, Rion will serve as the product supplier and co-develop a proprietary cellular platform with H-CYTE for the treatment of COPD, and H-CYTE will control the commercial development and facilitate clinical trial investigation. After conducting joint research and development of these biologics, H-CYTE intends to pursue submission of an investigational new drug (IND) application for review by the U.S. Food and Drug Administration (“FDA”) for treatment of COPD.

The Company is also in the business of designing and marketing proprietary medical devices for commercial use in the United States and Europe. The Company received CE marking in June 2017 for the DenerveX System, and it is now commercially available throughout the European Union and several other countries that accept CE marking. The Company’s first sale of the DenerveX System occurred in July 2017. The Company plansis presently reevaluating its approaches to revenue generation including the continuing use of its distribution channels, source of manufacturing, and evaluating joint venture opportunities. In July 2019, the Company signed a new engineering feasibility proposal that would confirm a new sterilization process which would be a slightly less expensive option and expand the shelf life of DenerveX from six months to a minimum of one year and potentially up to three years. The longer shelf life will help the distributors reach more end-users as many hospital systems and medical practitioners will not purchase medical products with less than a one-year shelf life. The Company still considers the United States to be a target market and it remains the Company’s goal to seek approval for the DenerveX System from the Food & Drug Administration (“FDA”)FDA approval. The Company anticipates that it will do so once it is back in the United States.production and generating revenue through sales in Europe and other approved countries.

8

 

Note 2 – Basis of presentation and Summary of Significant Accounting Policies

Based on the terms of the APA, the former RMS members had voting control of the combined company as of the closing of the Merger. RMS is deemed to be the acquiring company for accounting purposes and the transaction is accounted for as a reverse acquisition under the acquisition method of accounting for business combinations in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The assets acquired and the liabilities assumed of RMS included as part of the purchase transaction are recorded at historical cost. Accordingly, the assets and liabilities of H-CYTE are recorded as of the merger closing date at their estimated fair values (see Note 3).

The unaudited consolidated balance sheets, consolidated statements of operations, consolidated statements of stockholders’ equity (deficit), and the consolidated statements of cash flows do not reflect the historical financial information related to H-CYTE prior to the Merger as they only reflect the historical financial information related to RMS. For the unaudited consolidated statements of stockholders’ equity (deficit), the common stock, preferred stock, and additional paid in capital reflect the accounting for the stock received by the RMS members as of the Merger as if it was received at the beginning of the periods presented. The unaudited consolidated statements of stockholders’ equity (deficit) reflect the activity from June 30, 2019 to September 30, 2019 and December 31, 2018 to September 30, 2019. For the comparable period from December 31, 2017 to September 30, 2018, the only activity in the unaudited consolidated statement of stockholders’ equity (deficit) were the losses totaling approximately $1,035,251 and $2,295,173 for the three and nine months ended September 30, 2018, respectively.

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States (“U.S.”) generally accepted accounting principles (“GAAP”) GAAP and with the rules and regulations of the Securities and Exchange Commission (“SEC”) that permit reduced disclosure for interim periods. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments which included only normal recurring adjustments, necessary to present fairly the Company’s financial position as of September 30, 2019 and December 31, 2018 and the results of operations for the three and nine months ended September 30, 2019 and 2018 and 2017, andstatements of cash flows for the nine months ended September 30, 20182019 and 2017. 2018.

These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements, and notes thereto for the fiscal year ended December 31, 2017,2018, included in the Company’s Annual Report on Form 10-K. The December 31, 2018 financial information included in the Company’s Annual Report on Form 10-K reflect the historical financial information of the H-CYTE business and do not include the RMS financial information. With the reverse merger, historical financial information for periods prior to the merger on January 8, 2019, presented in the comparative financial information included in the 2019 Form 10-Q, will only reflect the historical financial information related to RMS prior to the merger (see Note 3).

The results for the three and nine months ended September 30, 20182019 are not necessarily indicative of the results to be expected for the year ending December 31, 20182019 or for any other interim period or for any future year.

principlesPrinciples of consolidationConsolidation

 

TheseU.S. GAAP requires that a related entity be consolidated with a company when certain conditions exist. An entity is considered to be a VIE when it has equity investors who lack the characteristics of having a controlling financial interest, or its capital is insufficient to permit it to finance its activities without additional subordinated financial support. Consolidation of a VIE by the Parent would be required if it is determined that the Parent will absorb a majority of the VIE’s expected losses or residual returns if they occur, retain the power to direct or control the VIE’s activities, or both.

The accompanying unaudited condensed consolidated financial statements that presentinclude the Company’s resultsaccounts of operationsthe parent, its wholly-owned subsidiaries, and its VIEs.

Accounts Receivable

Accounts receivable represent amounts due from customers for which revenue has been recognized. Generally, the Company does not require collateral or any other security to support its receivables. Trade accounts receivable are stated net of an estimate made for doubtful accounts, if any. Management evaluates the adequacy of the allowance for doubtful accounts regularly to determine if any account balances will potentially be uncollectible. Customer account balances are considered past due or delinquent based on the contractual agreement with each customer. Accounts are written off when, in management’s judgment, they are considered uncollectible. At September 30, 2019 and December 31, 2018, management believes no allowance is necessary. For the three and nine monthsmonth periods ended September 30, 20182019, the Company recorded bad debt expense of approximately $0 and 2017,$60,000, respectively.

Goodwill And Intangibles

Goodwill is recorded at fair value and cash flowsnot amortized but is reviewed for impairment at least annually or more frequently if impairment indicators arise. Goodwill is evaluated for impairment by first performing a qualitative assessment to determine whether a quantitative goodwill test is necessary. If it is determined, based on qualitative factors, that the fair value is “more likely than not” less than the carrying amount or if significant changes related to the business have occurred that could materially impact fair value, a quantitative goodwill impairment test would be required. The Company can elect to forego the qualitative assessment and perform the quantitative test.

If the carrying amount exceeds its fair value, “Step 1” is performed to determine if goodwill is impaired and to measure the amount of impairment loss to recognize, if any. This step compares the implied fair value of goodwill with the carrying amount of goodwill. If the carrying amount of goodwill exceeds the implied fair value, an impairment loss is recognized in an amount equal to that excess.

The implied fair value of goodwill is determined by assigning the fair value to all the assets and liabilities of that unit (including any unrecognized intangible assets) as if the reporting unit had been acquired in a business combination. The Company has elected to perform the annual impairment assessment for goodwill in the fourth quarter.

Intangibles acquired in a business combination are recorded at fair value using generally accepted valuation methods appropriate for the nine months endedtype of intangible asset. Intangible assets with definite lives are amortized over the estimated useful lives and are reviewed for impairment whenever events or changes in circumstances indicate that the carrying value may be greater than fair value. The Company’s intangible assets are patents and related proprietary technology for the DenerveX System.

Leases

In February 2016, the Financial Accounting Standard Board (“FASB”) established Topic 842, Leases, by issuing Accounting Standards Update (ASU) No. 2016-02 (as amended), which requires lessees to recognize leases on the balance sheet and disclose key information about leasing arrangements. 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 for all leases with a term longer than twelve months. 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 has not entered into significant lease agreements in which it is the lessor. For the lease agreements in which the Company is lessee, under Topic 842, lessees are required to recognize a lease liability and right-of-use asset for all leases (with the exception of short-term leases) at the lease commencement date. Effective January 1, 2019, the Company adopted this guidance, applied the modified retrospective transition method and elected the transition option to use the effective date as the date of initial application. The Company recognized the cumulative effect of the transition adjustment on the consolidated balance sheet as of the effective date and did not provide any new lease disclosures for periods before the effective date. With respect to the practical expedients, the Company elected the package of transitional-related practical expedients and the practical expedient not to separate lease and non-lease components.

Other Receivables

Other receivables totaling approximately $34,000 at September 30, 20182019 include receivables from the non-acquired Lung Institute, LLC due to Lung Institute Tampa, LLC for approximately $19,000, and 2017, include Debride and the accountsapproximately $9,000 reimbursement receivable for reimbursement of expenses from a joint study. The $19,000 receivable was a result of the Lung Institute, LLC being a transitory entity for Lung Institute Tampa, LLC while the merchant services accounts are being transferred.

Revenue Recognition

The Company recognizes revenue in accordance with U.S. GAAP as welloutlined in the FASB ASC 606,Revenue From Contracts with Customers, which requires that five steps be completed to determine when revenue can be recognized: (i) identify the contract with the customer; (ii) identity the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price; and (v) recognize revenue when or as the entity satisfies a performance obligation. The Company records revenue under ASC 606 when control is transferred to the customer, which is consistent with past practice. The adoption of this standard did not have a material impact on the consolidated financial statements.

Biomedical Services

H-CYTE wholly owns the Tampa, Florida Lung Health Institute (LHI) location and manages the other Lung Health Institute locations. The Lung Health Institute uses a standard pricing model for the types of cellular therapy treatments that is offered to its formerly wholly-owned subsidiary, Streamline Inc. (“Streamline”). All intercompanypatients. The transaction price accounts for medical, surgical, facility, and transactions have been eliminatedoffice services rendered by LHI for consented procedures and is recorded as revenue. The company recognizes revenue when the terms of a contract with a patient are satisfied.

The Lung Health Institute locations offer two types of cellular therapy treatments to their patients. The first type of treatment includes medical services rendered typically over a two-day period in consolidation.which the patient receives cellular therapy. For this treatment type, revenue is recognized in full at time of service. LHI also offers a four-day treatment in which medical services are rendered typically over a two-day period and then again, approximately three months later, medical services are rendered for an additional two days of treatment. Payment is collected in full for both service periods at the time the first treatment is rendered. Revenue is recognized when services are performed based on the related professional, facility, and diagnostic services for each session of treatment. The Company has deferred recognition of revenue amounting to approximately $1,365,000 and $326,000 at September 30, 2019 and December 31, 2018, respectively.

 

Use of Estimates

 

In preparing the unaudited consolidated financial statements, U.S. GAAP requires disclosure regarding estimates and assumptions used by management that affect the amounts reported in financial statements and accompanying notes. The Company’s significant estimates include deferred revenue, the deferred income tax asset and the related valuation allowance, andbusiness acquisition accounting, the fair value of its warrant issuances and share-based payment arrangements.

 

For those estimates that are sensitive to the outcome of future events, actual results could differ from those estimates.

 

Change in Accounting EstimatesStock-Based Compensation

 

The Company had three yearsmaintains a stock option incentive plan and accounts for stock-based compensation in accordance with ASC 718,Compensation - Stock Compensation. The Company recognizes share-based compensation expense, net of historical stock price information availablean estimated forfeiture rate, over the requisite service period of the award to employees and directors. As required by fair value provisions of share-based compensation, employee and non-employee share-based compensation expense recognized is calculated over the requisite service period of the awards and reduced for estimated forfeitures.

Income Taxes

From inception to September 30, 2019, the Company has incurred net losses and, therefore, has no current income tax liability. The net deferred tax asset generated by these losses is fully reserved as of September 30, 2018. 2019 and December 31, 2018, respectively, since it is currently likely that the benefit will not be realized in future periods.

As such, onlya result of the Company’s historical information was solely used in calculating annualized volatility utilizedacquisition, the Company is required to file federal income tax returns and state income tax returns in the Black-Sholes valuation method in determining the fair valuestates of warrants issued. In prior periods, annualized volatility was calculated using the historical price of the Company’s stock price information in addition to three comparative companies in an active market.Arizona, Florida, Georgia, Minnesota, Pennsylvania, Tennessee, and Texas. There are no uncertain tax positions at September 30, 2019 or December 31, 2018. The Company has not undergone any tax examinations since inception.

 

Foreign CurrencyNet Loss Per Share

 

The Company’s revenues and expenses transacted in foreign currencies are recorded as they occur at exchange rates in effect at the time of each transaction. Realized gains and losses on foreign currency transactions are recorded as a component of other income or expense, netBasic loss per share is computed on the basis of the weighted average number of shares outstanding for the reporting period. Diluted loss per share is computed on the basis of the weighted average number of common shares plus dilutive potential common shares outstanding using the treasury stock method. Any potentially dilutive securities are antidilutive due to the Company’s consolidated statements of operations. The Company recorded approximately $4,000net losses.

For the periods presented, there is no difference between the basic and $5,600, respectively, in foreign currency transaction expensediluted net loss per share: 32,756,181 warrants and 517,509 common stock options outstanding were considered anti-dilutive and excluded for the three and nine monthsmonth periods ended September 30, 2018. The Company did not incur any foreign currency transaction costs related to revenues and expenses transacted in foreign currencies for2019. For the three and nine months ending September 30, 2017.

Foreign currency denominated monetary assets and liabilities of the Company are measured at the end of each reportingmonth period using the exchange rate as of the balance sheet date and are recorded as a component of other income or expense, net on the Company’s consolidated statements of operations. As ofended September 30, 2018, there were no dilutive securities as the Company recorded a net translation loss of approximately $10,200 in foreign currency denominated monetary assets and liabilities. The Companyaccounting acquirer did not incur any foreign currency translation costs related to foreign currency denominated monetary assets and liabilities for the three and nine months ending September 30, 2017.

Recently Issued Accounting Pronouncements

The Company considers the applicability and impact of all ASUs issued, both effective and not yet effective.

In May 2014, the FASB issued ASU 2014-09, “Revenue Recognition - Revenue from Contracts with Customers” (ASU 2014-09) that requires companies to recognize revenue when a customer obtains control rather than when companieshistorically have transferred substantially all risks and rewards of a good or service. This update is effective for annual reporting periods beginning on or after December 15, 2017 and interim periods therein and requires expanded disclosures. The adoption of this standard did not have a material impact on the consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from leases. ASU 2016-02 is effective for public companies for annual reporting periods beginning after December 15, 2018, and interim periods within those fiscal years. The guidance may be adopted prospectively or retrospectively and early adoption is permitted. The Company is currently assessing the impact the adoption of ASU 2016-02 will have on its consolidated financial statements.

In July 2017, FASB issued ASU No. 2017-11 to provide new guidance for classification and accounting of financial instruments with down round features. The update requires entities to recognize the effect of a down round feature in a freestanding equity-classified financial instrument only when it is triggered. The effect of triggering such a feature should be recognized as a dividend and a reduction to income available to common shareholders in calculating basic EPS. ASU 2017-11 is effective for public companies for annual reporting periods beginning after December 15, 2018, including interim periods therein. The Company adopted the amendments of ASU 2017-11 effective January 1, 2018.stock compensation programs.

 

Note 3 – Accounts ReceivableBusiness Acquisition

 

Accounts receivable primarilyOn January 8, 2019, MedoveX completed its business combination with RMS under which MedoveX purchased certain assets and assumed certain liabilities of RMS, otherwise referred to as the Merger. Pursuant to the terms of the APA, MedoveX issued to the shareholders of RMS 33,661 shares plus 6,111 additional Exchange Shares (based on closing the sale of $2 million of new securities) for a total of 39,772 shares of Series C Preferred Stock where each share of Series C Preferred stock which automatically converted into 1,000 shares of common stock and represent amounts due from customersapproximately fifty-five percent (55%) of the outstanding voting shares of the Company.

Under the terms of the APA, the Company issued additional “Exchange Shares” to the shareholders of RMS to maintain the 55% ownership and not be diluted by the sale of convertible securities (“New Shares Sold”) until MedoveX raised an additional $5.65 million via the issuance of new securities. On the date of closing the Company issued 6,111 additional Exchange Shares to RMS Shareholders as a result of the issuance of additional securities, which are included in the 39,772 shares above. Subsequent to the closing of the purchase transaction, an incremental 11,153 additional Exchange Shares were issued, for which revenuea total of 17,264 additional Exchange Shares. All additional Exchange Shares have been issued to the shareholders of RMS and these Series C Preferred shares converted to 17,263,889 shares of common stock; no additional equity will be issued to RMS.

Because RMS shareholders owned approximately 55% of the voting stock of MedoveX after the transaction, RMS was deemed to be the acquiring company for accounting purposes (the “Acquirer”) and the transaction is accounted for as a reverse acquisition under the acquisition method of accounting for business combinations in accordance with U.S. GAAP. The assets acquired and the liabilities assumed of RMS included as part of the purchase transaction are recorded at historical cost. Accordingly, the assets and liabilities of MedoveX (the “Acquiree”) are recorded as of the Merger closing date at their estimated fair values.

Under the terms of the APA, MedoveX purchased certain assets and assumed certain liabilities of RMS. The assets of RMS reported on the MedoveX consolidated balance sheet as of December 31, 2018 that were excluded in the Merger on January 8, 2019 was cash of approximately $70,000. The Merger included the following: convertible debt to a related party of approximately $4,300,000, interest payable of approximately $158,000, accounts payable of approximately $224,000 and other current liabilities of approximately $285,000. Additionally, there were certain on-going litigation matters that were not assumed as part of the January 8, 2019 RMS reverse acquisition.

Purchase Price Allocation

The purchase price for the acquisition of the Acquiree has been recognized. Generally,allocated to the assets acquired and liabilities assumed based on their estimated fair values. The purchase price allocation herein is preliminary. The final purchase price allocation will be determined after completion of a thorough analysis to determine the fair value of all assets acquired and liabilities assumed but in no event later than one year following completion of the acquisition. Accordingly, the final acquisition accounting adjustments could differ materially from the allocation reflected as of September 30, 2019 presented herein. Any increase or decrease in the fair value of the assets acquired and liabilities assumed, as compared to the information shown herein, could also materially change the portion of purchase price allocated to goodwill and could materially impact the operating results of the Company doesfollowing the acquisition due to differences in purchase price allocation and depreciation and amortization related to some of these assets and liabilities.

The acquisition-date fair value of the consideration transferred is as follows:

Common shares issued and outstanding  24,717,271 
Common shares reserved for issuance upon conversion of the outstanding Series B Preferred Stock  2,312,500 
Total Common shares  27,029,771 
Closing price per share of MedoveX Common stock on January 8, 2019 $0.40 
   10,811,908 
Fair value of outstanding warrants and options  2,220,000 
Cash consideration to RMS  (350,000)
Total consideration $12,681,908 

Just prior to the transaction, MedoveX had 24.5 million shares of common stock outstanding at a market capitalization of $9.8 million. The estimated fair value of the net assets of MedoveX was $8.4 million as of January 8, 2019. Measuring the fair value of the net assets to be received by RMS was readily determinable based upon the underlying nature of the net assets. The fair value of the MedoveX common stock is above the fair value of its net assets. The MedoveX net asset value is primarily comprised of definite-lived intangibles as of the closing and the RMS interest in the merger is significantly related to obtaining access to the public market. Therefore, the fair value of the MedoveX stock price and market capitalization as of the closing date is considered to be the best indicator of the fair value and, therefore, the estimated purchase price consideration. During the three months ended September 30, 2019 the Company revised its purchase price allocation for the acquisition. As a result, the Company recorded a measurement period adjustment of $1,215,677 as an increase to goodwill adjusting the amount recorded as of January 8, 2019. The adjustment resulted in a corresponding increase to a derivative liability (see Note 12).

The following table summarizes the fair values of the assets acquired and liabilities assumed at the date of acquisition on January 8, 2019:

Cash $(302,710)
Accounts receivable  145,757 
Inventory  131,455 
Prepaid expenses  46,153 
Property and equipment  30,393 
Other  2,751 
Intangibles  3,680,000 
Goodwill  12,564,401 
Total assets acquired $16,298,200 
Accounts payable and other accrued liabilities  1,645,399 
Derivative liability  

1,215,677

 
Interest-bearing liabilities and other  755,216 
Net assets acquired $12,681,908 

Intangible assets are recorded as definite-lived assets and amortized over the estimated period of economic benefit. Goodwill is calculated as the difference between the acquisition-date fair value of the consideration transferred and the fair values of the assets acquired and liabilities assumed. Goodwill is not require collateralexpected to be deductible for income tax purposes. Goodwill is recorded as an indefinite-lived asset and is not amortized but tested for impairment on an annual basis or when indications of impairment exist.

Total interest bearing and other liabilities assumed are as follows:

Notes payable $99,017 
Short-term convertible notes payable  598,119 
Dividend payable  57,813 
Deferred rent  267 
Total interest-bearing and other liabilities $755,216 

Notes payable relate to promissory notes assumed by Acquiree in a 2015 acquisition, which was later divested in 2016, with the assumed promissory notes being retained by Acquiree. The Company finalized an eighteen-month extension on the notes extending the maturity date to March 1, 2021. Payments on both of the notes are due in aggregate monthly installments of approximately $5,800 and carry an interest rate of 5%. The promissory notes had outstanding balances of $95,000 as of September 30, 2019. The promissory notes had outstanding balances of approximately $99,000 plus accrued interest of approximately $3,000 at January 8, 2019 (see Note 11).

In the third quarter of 2018, convertible notes were issued pursuant to a securities purchase agreement with select accredited investors, whereby the Acquiree offered up to 1,000,000 units (the “Units”) at a purchase price of $50,000 per Unit. Each Unit consisted of (i) a 12% senior secured convertible note, initially convertible into shares of the Company’s common stock, par value $0.001 per share, at a conversion price equal to the lesser of $0.40 or ninety percent (90%) of the per share purchase price of any other securityshares of common stock or common stock equivalents issued in future private placements of equity and/or debt securities completed by the Company following this offering of Units, and (ii) a three-year warrant to supportpurchase such number of shares of the Company’s common stock equal to one hundred percent (100%) of the number of shares of common stock issuable upon conversion of the notes at $0.40. The warrants are exercisable at a price equal to the lesser of $0.75 or ninety percent (90%) of the per share purchase price of any shares of common stock or common stock equivalents issued in future private placements of the debt and/or equity securities completed by the Company following the issuance of warrants. As a result of the price adjustment feature, the conversion price of the convertible notes was adjusted to $0.36 per share.

In the offering, the Acquiree sold an aggregate of 15 Units and issued to investors an aggregate of $750,000 in principal amount of convertible notes and 1,875,000 warrants to purchase common stock, resulting in total gross proceeds of $750,000 to the Company. If converted at $0.40 the convertible notes sold in the offering are convertible into an aggregate of 1,875,000 shares of common stock. Due to the notes maturing during the third quarter of 2019, the warrants have fully accreted as of September 30, 2019. The Acquiree recorded the proceeds from the notes and the accompanying warrants, which accrete over the period the notes are outstanding, on a relative fair value basis of approximately $505,000 and $245,000, respectively. At acquisition date, the value of the notes was approximately $598,000.

The convertible notes had maturity dates between August and September 2019 and were renegotiated during the third quarter of 2019 (see Note 11).

The following schedule represents the amounts of revenue and net loss attributable to the MedoveX acquisition which have been included in the consolidated statements of operations for the periods subsequent to the acquisition date:

  Three Months Ended  Nine Months Ended 
  September 30, 2019  September 30, 2019 
Revenues $28,405  $63,910 
Net loss attributable to MedoveX  (7,203)  (1,956,705)

The following unaudited pro forma financial information represents the consolidated financial information as if the acquisition had been included in the consolidated results beginning on the first day of the fiscal year prior to its receivables.acquisition date. The pro forma results have been calculated after adjusting the results of the acquired entity to remove any intercompany transactions and transaction costs incurred and to reflect any additional depreciation and amortization that would have been charged assuming the fair value adjustments to property and equipment and intangible assets had been applied on the first day of the fiscal year prior to its acquisition date, together with the consequential tax effects. The pro forma results do not reflect any cost savings, operating synergies or revenue enhancements that the combined entities may achieve as a result of the acquisition; the costs to combine the companies’ operations; or the costs necessary to achieve these cost savings, operating synergies or revenue enhancements. The pro forma results do not necessarily reflect the actual results of operations of the combined companies under the current ownership and operation.

  For the Three Months Ended September 30, 2018 
  RMS  MedoveX  Pro Forma 
Revenues $1,536,990  $206,159  $1,743,149 
Net loss  (1,035,251)  (1,382,275)  (2,417,526)
Net loss attributable to common shareholders  (1,035,251)  (1,512,326)  (2,547,577)
             
Loss per share- basic and diluted $(0.03) $(0.06) $(0.04)

  For the Nine Months Ended September 30, 2018 
  RMS  MedoveX  Pro Forma 
Revenues $6,880,794  $598,773  $7,479,567 
Net loss  (2,295,173)  (3,721,958)  (6,017,131)
Net loss attributable to common shareholders  (2,295,173)  (4,119,068)  (6,414,241)
             
Loss per share- basic and diluted $(0.07) $(0.18) $(0.11)

 

Note 4 – Other Receivables

Other receivables include input and importation value added tax (VAT) paid by the Company for conducting business in the European Union (“EU”) and for importing goods from outside the EU.

Note 5 - Inventory

 

Inventory consists only of finished goods and areis valued at the lower of cost or net realizable value, using the first-in, first-out (FIFO) method. Inventories were acquired in the Merger and therefore there were no inventories prior to January 8, 2019.

Inventory consisted solely of the Pro-40 Generators totaling approximately $126,000 and $0 at September 30, 2019 and December 31, 2018, respectively.

Note 5 – Right-of-use Asset And Lease Liability

 

Inventories consistedUpon adoption of ASU No. 2016-02 (as amended) (See Note 2), additional current liabilities of approximately $475,000 and long-term liabilities of approximately $713,000 with corresponding ROU assets of approximately $1,167,000 were recognized, based on the present value of the following items asremaining minimum rental payments under the new leasing standards for existing operating leases.

The unaudited consolidated balance sheet at September 30, 2019 reflects current lease liabilities of approximately $481,000 and long-term liabilities of $396,000, with corresponding ROU assets of $859,000.

Operating lease expense and cash flows from operating leases for the three and nine months ending September 30, 2019 totaled approximately $140,000 and $389,000, respectively, and are included in the “Other general and administrative” section of the unaudited consolidated statement of operations.

The Company leases corporate office space in Tampa, FL and Atlanta, GA. The Company also leases medical clinic space in Tampa, FL, Nashville, TN, Scottsdale, AZ, Pittsburgh, PA, and Dallas, TX. The leasing arrangements contain various renewal options that are adjusted for increases in the consumer price index or agreed upon rates. Each location has its own expiration date ranging from April 30, 2020 to August 31, 2023. The Company expects to renew each lease upon expiration in order to continue operations.

As of September 30, 2018, and December 31, 2017:2019, the undiscounted minimum future maturities of lease liabilities are as follows:

 

  September 30, 2018  December 31, 2017 
Split Return Electrodes $  $1,868 
Denervex device  71,495   111,596 
Pro-40 generator  135,000   181,250 
Total $206,495  $294,714 
Remainder of 2019 $138,000 
2020  482,000 
2021  155,000 
2022  103,000 
2023  69,000 
  $947,000 

 

Note 6 - Property andAnd Equipment

 

Property and equipment, net, consists of the following:

 

 Useful Life September 30, 2018 December 31, 2017  Useful Life September 30, 2019 December 31, 2018 
Furniture and fixtures  5 years  $67,777  $67,777  5-7 years $147,870  $149,285 
Computers and software  3 years   31,738   31,738  3-7 years  361,986   278,234 
Leasehold improvements  5 years   35,676   35,676  15 years  157,107   156,133 
     135,191   135,191     666,963   583,652 
Less accumulated depreciation     (68,640)  (48,018)    (431,738)  (316,736)
                     
Total    $66,551  $87,173    $235,225  $266,916 

 

Depreciation expense amounted to $6,728was approximately $28,000 and $20,622,$80,000, respectively, for the three and nine months ended September 30, 2018.2019. Depreciation expense amounted to $7,109was approximately $35,000 and $20,000,$84,000, respectively, for the three and nine months ended September 30, 2018.

Note 7 - Intangible Assets

As of September 30, 2019, intangible assets acquired as part of the Merger, net of accumulated amortization of $552,000, totaled approximately $3,128,000. Amortization expense was $184,000 and $552,000 for the three and nine months ended September 30, 2019.

The following is a schedule of expected future amortization of intangible assets as of September 30, 2019:

Remainder of 2019 $184,000 
2020  736,000 
2021  736,000 
2022  736,000 
2023  736,000 
Total $3,128,000 

Note 8 – Related Party Transactions

Consulting Expense

The Company entered into an oral consulting agreement with Mr. Raymond Monteleone, Board Member and Chairman of the Audit Committee, in which Mr. Monteleone receives $10,000 per month for advisory services and $5,000 per quarter as Audit Committee Chair in addition to regular quarterly board meeting fees. This arrangement has no specified termination date. For the three and nine months ended September 30, 2019, the Company has expensed approximately $35,000 and $90,000 in compensation to Mr. Monteleone, respectively.

Board Member Expenses

For the three and nine months ended September 30, 2019, the Company paid $0 and $5,000 each for Board of Director fees to Michael Yurkowsky and to Raymond Monteleone for a total of $0 and $10,000, respectively.

Debt and Other Obligations

The Company had various related party transactions in 2018. For the period of January 1, 2018 to March 13, 2018, the Company received $528,175 from one of its shareholders (RMS members) and $228,175 from its CEO (RMS CEO) as part of a line of credit that was established in 2017. On March 13, 2018, the entire $1,856,350 line of credit received from the Member and the CEO, including contributions from 2017, was transferred to the BioCell Capital, LLC debt instrument, (“BioCell Capital Line of Credit”).

The BioCell Capital Line of Credit also consisted of capital contributions from related parties totaling approximately $4,306,000, inclusive of the aforementioned $1,856,300, to RMS in 2018. The BioCell Capital Line of Credit was converted to RMS members’ equity and was excluded from the APA on January 8, 2019.

The Company also received a short-term advance from one of its shareholders (RMS members), who was also the CEO of H-CYTE, in the amount of $180,000 in December 2018 for working capital needs. Approximately $66,000 of the advance was repaid in January 2019 and approximately $114,000 was converted to equity as part of the APA on January 8, 2019.

Horne Management, LLC, controlled by Chief Executive Officer, William E. Horne, advanced funds for operations totaling $900,000 on July 25, 2019. These loans accrue interest at 5.5% and are due and payable upon demand of the creditor.

In addition, Horne Management, LLC loaned H-CYTE $350,000 on September 26, 2019, for working capital purposes. The terms of the loan as follows:

12% interest rate with a maturity date of March 26, 2020.
If the Company does not pay back the principal and interest by November 26, 2019, the Company shall issue to Lender a three-year warrant to purchase 400,000 shares of the Company’s common stock with a purchase price of $0.75 per share.
If the Company is unable to pay the loan as of March 26, 2020, the interest rate increases to 15%.

 

Note 79 - Equity Transactions

For the consolidated statements of stockholders’ equity (deficit) as of December 31, 2018, the common stock, preferred stock and additional paid in capital reflect the accounting for the stock received by the RMS members as of the Merger as if it was received as of the beginning of the periods presented and the historical accumulated deficit of RMS. As of the closing of the Merger, before the contingent additional exchange shares impact from the sale of new securities, the stock received by RMS was 33,661 shares of Series C Preferred Stock, which was later converted into approximately 33,661,000 shares of common stock, with common stock par value of approximately $33,700 and additional paid-in capital of approximately $3,566,000. The historical accumulated deficit of RMS as of the closing was approximately $9,296,000.

 

Common Stock Issuance

In November 2016,On January 8, 2019, the Company entered into a securities purchase agreement (the “SPA”) with four purchasers (the “Purchasers”) pursuant to which the four Purchasers invested in the Company an aggregate amount of $2,000,000, with $1,800,000 in cash and $200,000 by cancellation of debt as explained below, in exchange for forty (40) units (the “Units”), each consisting of a convertible note (the “Convertible Note”) with the principal amount of $50,000 and a warrant (the “Warrant”) to purchase common stock (the “common stock”) of the Company at a purchase price of $.075 per share. Pursuant to this SPA, the Company initially offered a minimum of $1,000,000 and a maximum of $6,000,000 Units, and subsequently increased the maximum amount to $8,000,000 (the “Maximum Amount”) of Units at a price of $50,000 per Unit until the earlier of i) the closing of the subscription of the Maximum Amount and ii) March 31, 2019 (the “Termination Date”), subject to the Company’s earlier termination at its discretion. The SPA includes the customary representations and warranties from the Company and purchasers. Steve Gorlin, the Company’s former Chairman of the Board, authorizedconverted a $200,000 promissory note owed to him by the issuanceCompany in exchange for four (4) Units on the same terms as all other Purchasers. Mr. Gorlin subsequently converted the promissory note underlying the Units into an aggregate of 500,000 shares of common stock, eliminating the Company’s debt obligation.

Each Convertible Note had an interest rate of 12% per annum, a principal amount of $50,000 maturity date of January 8, 2020, and will be convertible into shares of common stock at a price of $0.40 subject to adjustment as provided for in the Convertible Note. Pursuant to the terms of the Convertible Note, each holder of the Convertible Note shall not own more than 4.99% of the number of shares of common stock outstanding immediately after giving effect to the issuance of common stock issuable upon exercise of such Convertible Note. If defaulted, the penalty interest rate of the Convertible Note shall rise to 18% per annum. In addition, each Warrant is exercisable at a price of $0.75 per share (the “Exercise Price”), subject to adjustments stated therein. The holder of each Warrant may purchase the number of shares of common stock equal to the number of shares of common stock issuable upon conversion of each Convertible Note while the Warrant is exercisable. The Warrants have a term of three years and shall be exercised in cash or on a cashless basis as described in the Warrant agreement. All Convertible Notes have been converted into an aggregate of 18,000,000 shares of common stock.

As reported on Form 8-K filings on January 25, 2019, February 8, 2019, March 15, 2019 and April 5, 2019, the Company entered into other SPA’s with additional purchasers, which brought the aggregate amount of capital raised in all Board members, both current and former, in an amount equivalentthese offerings to $240,000, representing their accrued but unpaid directors’ fees$7,200,000, as of December 31, 2016. that latest date.

As a result of the sales of new securities of at least $5,650,000, the Company issued an additional 17,264 Series C Preferred Stock which automatically converted to 17,263,889 shares of common stock.

All the Convertible Notes from the SPA, as well as the shares of Series C Preferred Stock issued to RMS members, were automatically converted into shares of common stock.

The foregoing description of the SPA, Convertible Note, and Warrant is qualified in its entirety by reference to the respective agreements.

In January 2017,February 2019, 250,000 shares of common stock were issued pursuant to conversion of short-term debt and accrued interest.

In March 2019, the Company issued an aggregate of 173,911130,085 shares of common stock at $1.38$0.40 per share for consulting fees in an amount equivalent to $52,034.

On April 25, 2019, the Company issued 4,225,634 shares of common stock valued at $0.40 per share to Mr. William E. Horne, the Company’s CEO, in a restricted stock award which was 100% vested when issued. The Company recognized approximately $1,690,000 of compensation expense in the average closing pricequarter ended June 30, 2019 related to the restricted stock award. This restricted stock award was issued pursuant to his employment agreement with the Company, which stated that this restricted stock award  (as well as the incentive stock options issued in the quarter ended March 31, 2019) would be fully vested if not issued within fifteen days of the Merger. Neither award was issued within that time frame and both awards became fully vested when issued. The aggregate number of shares of common stock from these two awards is 4,475,634 and was calculated based on 7% of the Company’s issued and outstanding common stock during 2016, to fulfill this obligation. Theas of the closing of the Merger.

During the third quarter of 2019, the Company raised $100,000 by selling 200,000 shares of common stock at $0.50 per share. They also issued the investors 100,000 warrants with an exercise price of the Company’s stock on January 17, 2017, the day the shares were issued, was $1.16$1.00 per share.

 

In August 2017, the Board authorizedthird quarter of 2019, the issuance of 125,000Company issued 150,000 shares of common stock to a certain memberconsultant in consideration of consulting services rendered to the Company. At the time of issuance, the fair market value of the Boardshares was $0.29, and, as a result, $43,500 was expensed in the three and nine months ended September 30, 2019.

During the nine months ended September 30, 2019, 636,480 shares were issued pursuant to conversions of Directorssome of our Series B Convertible Preferred Stock (“Stock B Preferred”) and 175,000accrued dividends thereunder.

Series B Preferred Stock Preferences

Voting Rights

Holders of our Series B Preferred Stock (“Series B Holders”) have the right to receive notice of any meeting of holders of common stock or Series B Preferred Stock and to vote upon any matter submitted to a vote of the holders of common stock or Series B Preferred Stock. Each Series B Holder shall vote on each matter submitted to them with the holders of common stock.

Liquidation

Upon the liquidation, dissolution or winding up of the business of the Company, whether voluntary or involuntary, each Series B Holder shall be entitled to receive, for each share thereof, out of assets of the Company legally available therefore, a preferential amount in cash equal to the stated value plus all accrued and unpaid dividends. All preferential amounts to be paid to the Series B Holders in connection with such liquidation, dissolution or winding up shall be paid before the payment or setting apart for payment of any amount for, or the distribution of any assets of the Company’s to the holders of the Company’s common stock. The Company accrues these dividends as they are earned each period.

On January 8, 2019, the Company completed the issuance of Convertible Notes with a conversion price of $0.40. As a result, the exercise price on all of the warrants issued with the Series B Preferred Stock was adjusted downward to 90% of that conversion price, or $0.36.

The Company recognized a beneficial conversion feature related to the Series B Preferred Stock of approximately $33,000, which was credited to additional paid-in capital, and reduced the income available to common shareholders. Because the Series B Preferred Stock can immediately be converted by the holder, the beneficial conversion feature was immediately accreted and recognized as a deemed dividend to the preferred shareholders.

Series B preferred Stock Conversions

During the nine months ended September 30, 2019, 9,250 shares of Series B Preferred Stock, par value $0.001, and accrued dividends were assumed with the Merger and an aggregate of 2,250 shares of Series B Preferred Stock, and accrued dividends, were subsequently converted into an aggregate of 604,167 shares of the Company’s common stock.

Debt Conversion

Convertible Notes

The $750,000 convertible notes payable assumed in the Merger had a fair value of approximately $598,000 on the acquisition date. Subsequently, on February 6, 2019, $100,000 of the outstanding Convertible Notes was converted into an aggregate of 250,000 shares of common stock, to a certain consultant. At the inceptioneliminating $100,000 of the agreement, 25%Company’s debt obligation. The debt was converted into shares of common stock at $0.40 per share, in accordance with the SPA.

In connection with the APA, on January 8, 2019, Steve Gorlin, the Company’s former Chairman of the shares were issuedBoard, converted a $200,000 promissory note owed to bothhim by the director and the consultant. In December 2017, 50,000 shares were issuedCompany pursuant to the consultant. As of September 30, 2018, the board member and consultant are due to be issued an additional 75,000 shares. The 75,000 shares were valued at the performance completion date, August 16, 2018, at $0.32 per share, which was the closing price on that date. As the shares had not been issued as of September 30, 2018, the fair valuesame terms of the liability atSPA entered into by other investors to consummate the performance completion date $24,000 is in accrued liabilities.acquisition on January 8, 2019. The Company does not expect to issue any remainingpromissory note was converted into an aggregate of 500,000 shares asof common stock, eliminating the board member and the consultant are no longer associated with the Company.Company’s debt obligation.

Stock-Based Compensation Plan

2013Stock Option Incentive Plan

We utilizeThe Company utilizes the Black-Scholes valuation method to recognize stock-based compensation expense over the vesting period. The expected life represents the period that ourthe stock-based compensation awards are expected to be outstanding.

Including the expense of approximately $1,690,000 related to the restricted stock award to the Company’s CEO, total stock-based compensation expense for the three and nine months ended September 30, 2019 was approximately $1,473 and $1,786,500, respectively. The nine months ended September 30, 2019 includes $1,690,000 of compensation expense related to the Company’s CEO restricted stock award which was 100% vested when issued. This restricted stock award was issued pursuant to his employment agreement with the Company, which stated that this option grant would be fully vested if not issued within fifteen days of the reverse merger transaction. The restricted stock award was not issued within that time frame and was fully vested when issued.

Stock Option Activity

 

For the three and nine months ended September 30, 2018,2019, the Company recognized approximately $22,000$1,500 and $107,000,$94,000, respectively, as compensation expense with respect to vested stock options. ForNo compensation expense was recorded prior to the three andMerger. Since these stock options were assumed on January 8, 2019 as part of the Merger, there were no historical costs related to this prior to January 8, 2019. The expense for the nine months ended September 30, 2017,2019 is primarily related to a fully-vested option to purchase 250,000 shares of the Company recognized approximately $111,000Company’s common stock that was issued to the Company’s CEO pursuant to his employment agreement, which stated that this option grant would be fully vested if it was not issued within fifteen days of the Merger. The option was not granted within that time frame and $612,000, respectively, as compensation expense with respect towas fully vested stock options.when issued.

 

Stock Option Activity

As of September 30, 2018,2019, there were 142,8259,501 shares of time-based, non-vestedunvested stock options outstanding. As of September 30, 2018, there wasand unrecognized compensation expense totaled approximately $53,000 of total unrecognized stock-based compensation related to these non-vested stock options. That$2,400. The remaining expense is expected towill be recognized as an expense on a straight-line basis over a remaining weighted average period of 1.39 years.service period.

 

The following is a summary of stock option activity atfor the nine months ending September 30, 2018:2019:

 

  Shares  Weighted
Average
Exercise
Price
  Weighted
Average
Remaining Term
(Years)
 
Outstanding at 12/31/2017  1,314,059  $2.01   8.19 
             
Forfeited  (136,035) $1.69    
Outstanding at 9/30/2018  1,178,024  $2.04   7.45 
Exercisable at 9/30/2018  1,035,200  $2.16   7.37 
  Shares  Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Term
(Years)
 
Outstanding at December 31, 2018    $    
             
Assumed with the RMS merger transaction  557,282  $2.78   6.06 
Other activity since January 8, 2019:            
Granted  250,000  $0.40   9.27 
Cancelled  (289,774) $2.46    
Outstanding at September 30, 2019  517,508  $1.81   7.62 
Exercisable at September 30, 2019  508,007  $1.81   7.62 

 

Note 10 – Commitments & Contingencies

Private PlacementBiotechnology Agreement

 

On February 26, 2018,June 21, 2019, the Company entered into a securities purchase10-year exclusive and extendable product supply agreement with selected accredited investors wherebyRion that will enhance its existing cytotherapy product line, developing a disruptive technology for COPD, the Company sold an aggregatefourth leading cause of 770,000 shares of common stock and 385,000 warrantsdeath in the U.S. Rion has established a unique exosome technology to purchase common stock. The offering resulted in $308,000 in gross proceeds toharness the Company. The warrants have a five-year term commencing six months from issuance with an exercise price of $0.75. The Company allocated $52,003 to the warrants and the remainder to the issuancehealing power of the common stock. The Company incurred $13,500body. Rion’s novel exosome technology, based on science developed at Mayo Clinic, provides an off-the-shelf platform to enhance healing in legal expenses relatedsoft tissue, musculoskeletal, cardiovascular and neurological organ systems. With this agreement, Rion will serve as the product supplier and will co-develop a proprietary cellular platform with H-CYTE for the treatment of COPD. H-CYTE will control the commercial development and facilitate clinical trial investigation. After conducting joint research and development of these biologics, H-CYTE intends to pursue submission of an investigational new drug (IND) application for review by the offering.FDA for treatment of COPD.

 

Sublease Agreement

On May 1, 2018, the

The Company entered into a securities purchasesub-lease agreement for the lease in Alpharetta, Georgia. The period of the lease is from July 1, 2019 to December 31, 2020 and sublessee shall pay to sublessor a minimum rent, of $2,000 per month recognized by the Company as rental income.

Consulting Agreements

The Company has reached a new agreement with selected accredited investors wherebyJesse Crowne, a former Director and Co-Chairman of the Board of the Company, offered up to $1,000,000 in units. Each unit hadprovide business development consulting services for a purchase pricefee of $100,000$5,000 per month. The Company incurred expense of approximately $10,000 and consisted of (i) 1,000 shares$50,000, for the three and nine months ended September 30, 2019, respectively, related to this consulting agreement. Since this agreement was assumed on January 8, 2019 as part of the Company’s 5% Series B Convertible Preferred Stock (the “Series B Shares”)Merger, there were no historical costs related to this prior to January 8, 2019.

The Company entered into a consulting agreement with LilyCon Investments, LLC effective February 1, 2019 for services related to evaluation and (ii) warrants to purchase 250,000 sharesnegotiation of future acquisitions, joint ventures, and site evaluations/lease considerations. The duration of the Company’s common stock, par value $0.001 per share. Each Series B Shareconsulting agreement is convertible at a conversion price of $0.40 per share. The conversion price has a feature that would adjust the conversion price downward if the company issues any common stock or common stock equivalents at a price less than $0.40 per share while the Series B shares are outstanding. The market value of the common stock on the date of the agreement was $0.44. The Series B Shares initially entitled the holders to a 5% adjustable annual dividend. The Series B Shares also have a feature that provides the holder the ability to adopt more favorable terms of subsequent financings while the Series B Shares are outstanding. The Warrants are exercisable for a period of three (3) yearstwelve months in the amount of $12,500 per month with a $15,000 signing bonus which was paid in full during the quarter ending March 31, 2019. The agreement also provides LilyCon Investments with $35,000 in stock (to be calculated using an annual Variable Weighted Average Price from February 2019 through January 2020) to be granted on the dateone-year anniversary of issuance at an initial exercise price of $0.75 per share subject to downward adjustmentthis agreement, if the Company issues any common stockagreement has not been terminated prior to that date. Either party may terminate this agreement with or common stock equivalents at a price less than $0.75 per share whilewithout cause upon 30 days written notice. For the warrants are outstanding.

As a result of the offering,three and nine months ended September 30, 2019, the Company sold an aggregateexpensed a total of 8.25 Units$37,500 and issued$115,000 in compensation to the Investors an aggregate of 8,250 Series B Shares and 2,062,500 warrants to purchase common stock, resulting in total $825,000 gross proceeds to the Company. The Company incurred $5,000 in legal fees related to the offering, which resulted in $820,000 net cash received from the offering. The 8,250 Series B Shares sold in the Offering are initially convertible into an aggregate of 2,062,500 shares of Common Stock.LilyCon Investments, respectively.

 

The net proceedsCompany entered into an oral consulting arrangement with St. Louis Family Office, LLC, controlled by Jimmy St. Louis, former CEO of RMS, in January 2019 in the amount of $10,000 per month plus benefits reimbursement for advisory services. The Company terminated this agreement effective June 30, 2019. For the three and nine months ended September 30, 2019, the Company expensed $0 and $71,000 in consulting fees to St. Louis Family Office, respectively.

The Company entered into a consulting agreement with Strategos Public Affairs, LLC (Strategos) on February 15, 2019 for a period of twelve months, unless otherwise terminated by giving thirty days prior written notice. Strategos will provide information to key policymakers in the legislature and executive branches of government on the benefits of the offeringcellular therapies offered by the Lung Health Institute, advocate for legislation that supports policies beneficial to patient access and oppose any legislation that negatively impacts the Company’s ability to expand treatment opportunities, and position the Company and its related entities as the expert for information and testimony. For the three and nine months ended September 30, 2019, the Company expensed $22,500 and $48,500, respectively.

The Company entered into a consulting agreement with Goldin Solutions, effective August 4, 2019, for media engagement and related efforts, including both proactive public relations and crisis management services. The agreement has a minimum term of $820,000 weresix months, with a $33,000 monthly fee payable each month, with the exception of a first allocatedmonth discount of $12,000. For the three and nine months ended September 30, 2019, the Company expensed $54,000.

Distribution center and logistic services agreement

The Company has a non-exclusive distribution center agreement with a logistics service provider in Berlin, Germany pursuant to which they manage and coordinate the DenerveX System products which the Company exports to the warrants issuedEU through June 2020 The Company paid a fixed monthly fee of €4,500 (approximately $5,000) for all accounting, customs declarations and office support, and a variable monthly fee ranging from €1,900 to investors,€6,900 (approximately $2,300 to $8,300), based off volume of shipments, for logistics, warehousing and customer support services.

Total expenses incurred for the Series B Sharesdistribution center and logistics agreement were approximately $10,080 and $40,080, respectively, for the three and nine months ended September 30, 2019. Since this agreement was assumed on January 8, 2019 as part of the reverse merger transaction, there were no historical costs related to this prior to January 8, 2019.

Patent Assignment and Contribution Agreements

The terms of a Contribution and Royalty Agreement dated January 31, 2013 with Dr. Scott Haufe, M.D was assumed in the Merger as of January 8, 2019. This agreement provides for the Company to pay Dr. Haufe royalties equal to 1% of revenues earned from sales of any and all products derived from the use of the DenerveX technology. Royalties are payable to Dr. Haufe within 30 days after the close of each calendar quarter based on their relative fair value. actual cash collected from sales of applicable products. The royalty period expires on September 6, 2030.

The Company recognizedincurred approximately $0 and $1,100 respectively, in royalty expense under the Contribution and Royalty agreement for the three months and nine months ended September 30, 2019, all of which was included in accounts payable at September 30, 2019. Since this agreement was assumed on January 8, 2019 as part of the Merger, there were no historical costs related to this prior to January 8, 2019.

Litigation

From time to time, the Company may be involved in routine legal proceedings, as well as demands, claims and threatened litigation that arise in the normal course of our business. The ultimate amount of liability, if any, for any claims of any type (either alone or in the aggregate) may materially and adversely affect the Company’s financial condition, results of operations and liquidity. In addition, the ultimate outcome of any litigation is uncertain. Any outcome, whether favorable or unfavorable, may materially and adversely affect the Company due to legal costs and expenses, diversion of management attention and other factors. The Company expenses legal costs in the period incurred. The Company cannot assure that additional contingencies of a beneficial conversion featurelegal nature or contingencies having legal aspects will not be asserted against the Company in the future, and these matters could relate to prior, current or future transactions or events.

Guarantee

The Company has guaranteed payments based upon the terms found in the management services agreements to two affiliated physicians related to LI Nashville, LI Scottsdale, LI Pittsburgh, and LI Dallas. For the three and nine months ending September 30, 2019, payments totaling approximately $42,000 and $105,000 respectively were made to these affiliates.

Note 11 – Short-term Debt

Notes Payable

Short-term financing payable relates to financing arrangements for Directors and Officers and general liability insurance premiums that were financed at various points throughout 2018 and 2019 and two promissory notes assumed in the merger transaction.

These financing arrangements require aggregate monthly payments of approximately $18,000, with interest rates ranging from 7% to 12.8% and are to be paid in full by July 2020. The financing arrangements had balances of approximately $114,000 at September 30, 2019 and $31,000 at December 31, 2018. Interest expense related to these arrangements was approximately $2,000 and $4,300 for the three and nine months ended September 30, 2019, respectively, and was $0 for the three and nine months ended September 30, 2018 respectively.

Two promissory notes payable assumed in the Merger are due in aggregate monthly installments of approximately $5,700 and carry an interest rate of 5%. Each note originally had a maturity date of August 1, 2019. During the third quarter, the Company finalized an eighteen-month extension that extended the maturity date to March 1, 2021. The promissory notes have an aggregate outstanding balance of approximately $95,000 at September 30, 2019. The Company incurred interest expense related to the Series B Shares of approximately $246,000, which was credited to additional paid-in capital. Becausepromissory notes for the Series B Shares can immediately be converted by the holder, the discount recognized by the allocation of proceeds to the beneficial conversion feature was immediately accretedthree and recognized as a dividend to the preferred shareholders.

On August 1, 2018 the annual dividend rate on the Series B Shares was adjusted to 12%, which is equal to the same rate as the convertible debt issued in August andnine months ended September 2018, pursuant to an adjustment provision in the Series B Shares which entitles the holders to receive a more beneficial annual dividend rate offered in any subsequent financings. The Company had accrued unpaid dividends30, 2019 in the amount of approximately $30,000$400 and $2,500, respectively; no interest expense was incurred during 2018 as these notes were assumed on January 8, 2019.

The Company’s interest expense of approximately $50,000 and $121,000 for the three and nine months ended September 30, 2018, respectively, was related to the Series B Shares.

On August 8, 2018, the Company completed the issuance of convertible debt at an initial conversion price of $0.40. Accordingly the exercise price on all of the warrants issued with the Series B Shares were adjusted downward to $0.40. In conjunction with the downward adjustment, the Company recorded a deemed dividend of approximately $108,000 representing the differencenot assumed in the fair valueMerger as of the warrants immediately before and after the adjustment to the exercise price.

preferred Stock Conversion

On March 30, 2018, 12,740 shares of Series A Preferred Stock were converted into an aggregate of 1,274,000 restricted shares of authorized common stock, par value $0.001 per share.January 8, 2019.

 

Convertible Notes

In August and September 2018, the Company entered intoThe Convertible Notes payable represents a securities purchase agreement with select accredited investors, wherebywhich was assumed in the Merger. The debt assumed by the Company offered up to $1,000,000 inconsisted of $750,000 of units at(the “Units”) with a purchase price of $50,000 per unit.Unit. Each Unit consists of (i) a 12% senior secured convertible note, initially convertible into shares of the Company’s common stock, par value $0.001 per share, at a conversion price equal to the lesser of $0.40 or ninety percent (90%) of the per share purchase price of any shares of common stock or common stock equivalents issued in future private placements of equity and/or debt securities completed by the Company following this offering, and (ii) a three-year warrant to purchase such number of shares of the Company’s common stock equal to one hundred percent (100%) of the number of shares of common stock issuable upon conversion of the notes at $0.40. The Warrants arewere initially exercisable at a price equal to the lesser of $0.75 or ninety percent (90%) of the per share purchase price of any shares of common stock or common stock equivalents issued in future private placements of the debt and/or equity securities completed by the Company following the issuance of warrants. The notesConvertible Notes are secured by all of the assets of the Company.

 

ASU 2017-11 provided that when determining whether certain financial instruments should be classified as liability or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. If a down round feature on the conversion option embedded in the note is triggered, the Company will evaluate whether a beneficial conversion feature exists, the Company will record the amount as a debt discount and will amortize it over the remaining term of the debt.

If the down round feature in the warrants is triggered, the Company will recognize the effect of the down found as a deemed dividend which will reduce the income available to common stockholders.

In the offering, the Company sold an aggregate of 15 units and issued to investors an aggregate of $750,000 in principal amount of convertible notes and 1,875,000 warrants to purchase common stock, resulting in total gross proceeds of $750,000 to the Company. If converted at $0.40 the convertible notes sold in the offering are convertible into an aggregate of 1,875,000 shares of common stock. The Company recorded the proceeds from the notes and the accompanying warrants, which accrete over the period the notes are outstanding, on a relative fair value basis of approximately $505,000 and $245,000, respectively. Accretion expense for the three and nine month period ending September 30, 2018 related to these convertible notes was approximately $28,400. The Company recognized $10,700 in unpaid accrued interest expense related to the notes as of September 30, 2018.

Debt Conversion

Convertible Debenture

On April 26, 2018, the Company’s $100,000 5% convertible debenture and unpaid accrued interest was converted into an aggregate of 266,301 shares of common stock, eliminating the Company’s debt obligation. The debt was converted into shares at $0.38 per share, which was 85% of the average closing price of the Company’s stock during the twenty trading days immediately preceding the delivery of the notice of conversion. The market value of the common stock on the date of the conversion was $0.40. This difference noted above lead to an immaterial amount related to a beneficial conversion feature.

Promissory Note

On May 15, 2018, the Company entered into a modification agreement with Steve Gorlin whereby he agreed to convert $100,000 of the $200,000 outstanding promissory note into Series B Shares. The conversion of $100,000 was converted under the terms of the May 1, 2018 securities purchase agreement. The $100,000 conversion was converted into an aggregate of 1,000 shares of the Company’s Series B Shares and 250,000 warrants to purchase common stock, eliminating $100,000 of the Company’s $200,000 debt obligation.

The converted $100,000 was first allocated to the fair value of the warrants issued in conjunction with the conversion, and the Series B Shares based on their relative fair value. The Company recognized a beneficial conversion feature related to the Series B Shares of approximately $14,000, which was credited to additional paid-in capital. Because the Series B Shares can immediately be converted by the holder, the discount recognized by the allocation of proceeds to the beneficial conversion feature was immediately accreted and recognized as a dividend to the preferred shareholders.

On August 21, 2018, the Company paid back the remaining $100,000 plus unpaid accrued interest in the amount of $2,944, eliminating the Company’s debt obligation.

Note 8 – Commitments & Contingencies

Operating Leases

Office Space

The Company pays TAG Aviation, a company owned by its Chief Executive Officer, Jarrett Gorlin (“Mr. Gorlin”) for office space that is currently being used as the Company’s principal business location plus utilities cost (see “Related-Party Transactions”) on a monthly basis. Base annual rent is $2,147 per month. Rent expense and utilities cost paid to TAG Aviation amounted to approximately $9,400 and $28,300, respectively, for the three and nine months ended September 30, 2018. Rent expense and utilities cost paid to TAG Aviation amounted to approximately $9,500 and $25,000 for the three and nine months ended September 30, 2017.

On September 1, 2018, the Company extended the term of the lease agreement for the commercial building which originally commenced on August 1, 2015. The term of the new lease agreement is for two years four months commencing on September 1, 2018 and ending December 31, 2020. Base rent under the old lease agreement was $2,948 and base rent under the new agreement is $3,095. Total lease expense for the three and nine months ended September 30, 2018 was approximately $8,800 and $26,000, respectively related to this lease. Total lease expense for the three and nine months ended September 30, 2017 was approximately $8,600 and $26,000, respectively related to this lease.

Future minimum lease payments under this rental agreement are approximately as follows:

For the year ending:

December 31, 2018 $9,300 
December 31, 2019  37,500 
December 31, 2020  38,600 
  $85,400 

12

Equipment

The Company entered into a non-cancelable 36-month operating lease agreement for equipment on March 23, 2018. The agreement is renewable at the end of the term and requires the Company to maintain comprehensive liability insurance. Total lease expense was approximately $800 and $2,500, respectively, for the three and nine months ended September 30, 2018. Total lease expense was approximately $900 and $2,900, respectively, for the three and nine months ended September 30, 2017.

Future minimum lease payments under this operating lease agreement are approximately as follows:

For the year ending:

December 31, 2018 $500 
December 31, 2019  1,900 
December 31, 2020  1,900 
December 31, 2021  500 
  $4,800 

Consulting Agreements

The Company has an agreement with Jesse Crowne, a Director and Co-Chairman of the Board of the Company, to provide business development consulting services for a fee of $13,333 per month. The Company incurred $39,999 and $120,000, respectively, for the three and nine months ended September 30, 2018 related to this consulting agreement, of which $13,333 was included in accounts payable at September 30, 2018. The monthly consulting fee was increased from a rate of $9,167 beginning in January 2018. The Company incurred approximately $30,000 and $85,000, respectively, for the three and nine months ended September 30, 2017 related to this consulting agreement.

The Company has a consulting agreement with a sales, marketing, and distribution consultant in Latin America at a fee of $7,000 per month through December 31, 2018. The Company incurred $21,000 and $63,000, respectively, for the three and nine months ended September 30, 2018 related to this consulting agreement. The Company incurred $21,000 and $45,000, respectively, for the three and nine months ended September 30, 2017 related to this consulting agreement.

The Company has consulting agreements with a varying team of sales, marketing, and distribution consultants in Europe who provide consulting services for aggregate compensation amounting to approximately €21,000 (approximately $25,000) per month. The consulting agreements, while subject to modifications, commenced at separate dates and will also terminate at separate dates through April 30, 2019. The Company incurred approximately $71,000 and $280,000, respectively, for the three and nine months ended September 30, 2018 related to these consulting agreements. The Company incurred approximately $58,000 and $131,000, respectively, for the three and nine months ended September 30, 2017 related to these consulting agreements.

Generator development agreement

The Company was obligated to reimburse Bovie Medical Corporation (“Bovie”) up to $295,000 for the development of the Pro-40 electrocautery generator. The Company did not incur any expenses to Bovie for the three and nine months ended September 30, 2018 under this agreement. The Company incurred approximately $3,000 and $33,000, respectively, for the three and nine months ended September 30, 2017 under this agreement. Through September 30, 2018, the Company has paid approximately $422,000 to Bovie related to this agreement. The original $295,000 agreement was a based number along the pathway of development. Additional requirements were added as the research and development process progressed and as a result certain prices increased and additional costs were added to further customize the DenerveX System. The Company is currently manufacturing the generator for sales.

Distribution center and logistic services agreement

The Company has a non-exclusive distribution center agreement with a logistics service provider in Berlin, Germany pursuant to which they manage and coordinate the DenerveX System products which the Company exports to the EU through June 2019. The Company originally paid a fixed monthly fee of €2,900 (approximately $3,500) for all accounting, customs declarations and office support, and a variable monthly fee ranging from €1,900 to €6,900 (approximately $2,300 to $8,300), based off volume of shipments, for logistics, warehousing and customer support services. Effective September 1, 2018, the fixed monthly fee was changed to €6,900 (approximately $7,900). Total expenses paid for the distribution center and logistics agreement was approximately $34,000 and $118,000, respectively, for the three and nine months ended September 30, 2018. Total expenses paid for the distribution center and logistics agreement was approximately $37,900 for the three and nine months ended September 30, 2017.

Co-Development Agreement

In September 2013, the Company executed a Co-Development Agreement with James R. Andrews, M.D. (“Dr. Andrews”) to further evaluate, test and advise on the development of products incorporating the use of the patented technology. In exchange for these services the Company is obligated to pay Dr. Andrews a royalty of 2% of revenues earned from applicable product sales over a period of 5 years. If Dr. Andrews is listed as inventor of any Improvement Patent on the DenerveX device during the 5-year term, he would continue to receive a 1% royalty after the 2% royalty expires for the duration of the effectiveness of the Improvement Patent.

The Company incurred approximately $4,500 and $13,100, respectively, in royalty expense under the co-development agreement for the three and nine months ended September 30, 2018, all of which was included in accounts payable at September 30, 2018. The Company incurred approximately $446 in royalty expense under the co-development agreement for the three and nine months ended September 30, 2017.

Patent Assignment and Contribution Agreements

On February 1, 2013, the Company issued 750,108 shares of common stock to Scott Haufe, M.D. (“Dr. Haufe”) pursuant to the terms of a Contribution and Royalty Agreement dated January 31, 2013 between the Company and Dr. Haufe. This agreement provides for the Company to pay Dr. Haufe royalties equal to 1% of revenues earned from sales of any and all products derived from the use of the DenerveX technology. Royalties are payable to Dr. Haufe within 30 days after the close of each calendar quarter based on actual cash collected from sales of applicable products. The royalty period expires on September 6, 2030.

The Company incurred approximately $2,300 and $6,600, respectively, in royalty expense under the Contribution and Royalty agreement for the three and nine months ended September 30, 2018, all of which was included in accounts payable at September 30, 2018. The Company incurred approximately $225 in royalty expense under the patent assignment and contribution agreement for the three and nine months ended September 30, 2017.

Streamline Inc. Asset Sale

The asset sale of Streamline Inc. resulted in the immediate receipt of $500,000 in cash, and a $150,000 note receivable that was due to the Company on January 1, 2018. The $150,000 note receivable represents the non-contingent portion of the receivables due from the sale. The Company received the short-term receivable on January 2, 2018.

The terms of the sale also required that for each of the calendar years ending December 31, 2018 and December 31, 2019 (each such calendar year, a “Contingent Period”), a contingent payment in cash (each, a “Contingent Payment”) equal to five percent (5%) of the total net sales received by the acquiring party from the sale of “IV suspension system” products in excess of 100 units during each Contingent Period. Each such Contingent Payment is payable to the Company by the acquiring party by no later than March 31st of the subsequent year; provided, however, that the total aggregate amount of all Contingent Payments owed by the acquiring party to the Company for all Contingent Periods will not exceed $850,000. The Company is yet to receive any Contingent Payments and has no reason to expect it will receive any Contingent Payments.

The Company did not incur any Streamline related expenses for the three and nine months ended September 30, 2018. The Company recorded a nominal amount in Streamline related expenses for the three and nine months ended September 30, 2017.

Note 9 – Short Term Liabilities

Finance Agreement

The Company entered into a commercial insurance premium finance and security agreement in December 2017. The agreement finances the Company’s annual D&O insurance premium. Payments are due in quarterly installments of approximately $24,000 and carry an annual percentage interest rate of 5.98%.

The Company had paid the yearly premium in full and had no outstanding balance as of September 30, 2018 and 2017 related to the agreement.

Promissory Notes

On March 26, 2018 the Company issued a promissory note to Steve Gorlin, father of Jarrett Gorlin, the Company’s CEO, for the principal amount of $200,000, plus interest, at a rate of five percent per year. The outstanding principal and all accrued but unpaid interest was originally due on May 15, 2018. The Company issued warrants to purchase an aggregate of 133,333 shares of common stock par value $.001 per share in conjunction with the promissory note to Mr. Gorlin. Each warrant has an exercise price of $0.75 and is exercisable for a period of five years commencing from the date of issuance. The Company recorded the proceeds from the promissory note and the accompanying warrants, which accrete over the period the loan is outstanding, on a relative fair basis of approximately $174,000 and $26,000, respectively.

On May 15, 2018, the Company entered into a modification agreement with Steve Gorlin whereby he agreed to convert $100,000 of the outstanding promissory note into Series B Shares. (See Note 7). Additionally, the due date for the remaining $100,000 of the promissory note was extended to August 31, 2018.

On August 21, 2018, the Company paid the remaining $100,000 plus unpaid accrued interest in the amount of $2,944, which was exclusive of the amortization expense recognized in connection with the accompanying warrants issued with the note, eliminating the Company’s debt obligation. (See Note 7)

Notes Payable

In conjunction with the consummation of the Streamline acquisition on March 25, 2015, the Company assumed two notes for approximately $135,000 and $125,000 to the Bank of North Dakota New Venture Capital Program and North Dakota Development Fund, both outside non-related parties. Payments on both notes are due in aggregate monthly installments of approximately $5,700 and carry an interest rate of 5%. Both notes have a maturity date of August 1, 2019. The notes, had outstanding balances of approximately $62,000 and $104,000 at September 30, 2018 and December 31, 2017, respectively.

The Company incurred interest expense related to the notes for the three and nine months ended September 30, 2018 in the amount of approximately $800 and $3,100, respectively. The Company incurred interest expense related to the notes for the three and nine months ended September 30, 2017 in the amount of approximately $1,700 and $5,500, respectively. The Company had unpaid accrued interest in the amount of approximately $70,000 and $69,000 at September 30, 2018 and December 31, 2017, respectively, related to the notes.

Expected future payments related to the notes payable as of September 30, 2018, are approximately as follows:

For the year ending:

December 31, 2018 $17,000 
December 31, 2019  45,000 
  $62,000 

Convertible Debenture

On January 31, 2018, the Company issued a 5% convertible debenture in exchange for $100,000. The debenture accrued interest at 5% per annum. Principal and interest were due on January 30, 2019. The debenture was convertible at the option of the holder into shares of the Company’s common stock at a conversion rate equivalent to 85% of the average closing price of the Company’s common stock for the 20 days preceding the conversion.

On April 26, 2018, the convertible debenture and unpaid accrued interest was converted into an aggregate of 266,301 shares of common stock, eliminating the Company’s debt obligation (Note 7). Prior to the conversion, the Company recognized approximately $400 and $1,200, respectively, in interest expense related to the convertible debenture during the nine months ending September 30, 2018. The market value of the common stock on the date of the conversion was $0.40. This difference lead to an immaterial amount related to a beneficial conversion feature.

Convertible Notes

In August and September 2018, the Company entered into a securities purchase agreement with select accredited investors, whereby the Company offered up to $1,000,000 in units at a purchase price of $50,000 per unit. Each unit consists of a 12% senior secured convertible note and a three-year warrant to purchase shares of the Company’s common stock. The notes are secured by all of the assets of the Company. (See Note 7).

In the offering, the Company sold an aggregate of 15 units and issued to investors an aggregate of $750,000 in principal amount of convertible notes and 1,875,000 warrants to purchase common stock, resulting in total gross proceeds of $750,000 to the Company. The convertible notes sold in the offering are initially convertible into an aggregate of 1,875,000 shares of common stock but could convert into additional shares if the Company completes a down round financing during the term of the convertible notes. The Company recorded the proceeds from the notes and the accompanying warrants, which accrete over the period the notes are outstanding, on a relative fair value basis of $505,424 and $244,576, respectively. AccretionInterest expense related to the discount on these convertible notes for the three and nine month period ending September 30, 20182019 was approximately $28,000.$24,000 and $151,900, respectively. The Company recognized $10,700approximately $19,300 and $60,500, respectively, in unpaid accrued interest expense related to the notes as offor the three and nine months ended September 30, 2018.2019.

 

Note 10 – RevenueThe Convertible Notes sold in the offering were initially convertible into an aggregate of 1,875,000 shares of common stock. The down round feature was triggered on January 8, 2019, and the conversion price of the Convertible Notes was adjusted to $0.36. The Company recognized the down round as a deemed dividend of approximately $288,000 which reduced the income available to common stockholders.

On February 6, 2019, $100,000 of the Company’s $750,000 outstanding Convertible Notes plus accrued interest was converted into an aggregate of 251,667 shares of common stock, eliminating $100,000 of the Company’s debt obligation. The debt was converted into shares at $0.36 per share, which was the conversion price per the SPA subsequent to the trigger of the down round feature. The convertible notes had maturity dates between August and September 2019.

 

The Company sellsnegotiated a short-term extension with two of the DenerveX Systemthree noteholders through a combinationthe expected closing of direct salesthe Series D Security Purchase Agreement (the “Short-term Extension Notes”). As of September 30, 2019, approximately $479,000, which includes the principal balance of $350,000, fees and independent distributors in international markets. The Company recognizes revenue when titlepenalties of approximately $80,000 and accrued interest of approximately $49,000 is due to the goods and risk of loss transfers to customers, provided there are no material remaining performance obligations required of the Company or any matters of customer acceptance. We only record revenue when collectability is reasonably assured.two Short-term Extension Notes noteholders.

 

Revenue recognition occursThe Company also reached an extension with the third noteholder which extended the maturity date of the loan for one year, until September 30, 2020. This note has a principal balance of $300,000 plus penalties of approximately $85,000 and accrued interest of approximately $40,000 for a total amount due of approximately $425,000 (the “New Principal”) as of September 30, 2019. This amount has been rolled into a new note effective September 30, 2019 (the “One Year Extended Note”). Additionally, approximately 424,000 warrants were issued in connection with the One Year Extended Note. The fair market value of the warrants on September 18, 2019, the day the warrants were issued, was approximately $106,000, which the Company recognized as an expense in the three months ended September 30, 2019.

In the aggregate, the new principal balance on these convertible notes as of September 30, 2019 is approximately $775,000 which is comprised of the original principal balance of $350,000 on the Short-term Extension Notes plus $425,000 for the New Principal on the One Year Extended Note.

Note 12 – Derivative Liability Warrants

In connection with the securities purchase agreements executed in May 2018 the Company issued 108,250 shares of the Company’s Series B Convertible Preferred Stock (the “Series B Shares”) and warrants to purchase 2,312,500 shares of the Company’s common stock. The warrants had a three-year term at an exercise price of $0.75. The warrants contain two features such that in the event of a downward price adjustment the Company is required to reduce the strike price of the existing warrants (first feature or “down round”) and issue additional warrants to the award holders such that the aggregate exercise price after taking into account the adjustment, will equal the aggregate exercise price prior to such adjustment (second feature or “additional issuance”).

On January 8, 2019 the Company issued equity securities which triggered the down round and additional issuance warrant features. As a result, the exercise price of the warrants was lowered from $0.75 to $0.40 and 2,023,438 additional warrants were issued. The inclusion of the additional issuance feature caused the warrants to be accounted for as liabilities in accordance with ASC Topic 815.

The fair market value of the warrants, approximately $1,200,000, has been recorded as a derivative liability in the purchase price allocation as a measurement period adjustment during the period ended September 30, 2019 (see Note 3). The derivative liability has been remeasured to fair value at the time product is shipped to customers fromend of each reporting period and the third-party distribution warehouse locatedcumulative change in Berlin, Germany. Our stocking distributors, who sellfair value, approximately $884,000, has been recorded as a component of other income (expense) in the products to their customers or sub-distributors, contractually take title toCompany’s consolidated statement of operations for the productsthree and assume all risksnine month period ended September 30, 2019. The fair value of ownership at the timederivative liability included on the consolidated balance sheet was approximately $332,000 as of shipment. Our stocking distributors are obligated to pay us the contractually agreed upon invoice price within specified terms regardless of when, if ever, they sell the products. Our direct customers do not have any contractual rights of return or exchange other than for defective product or shipping error.September 30, 2019.

Note 11 –13 - Common Stock Warrants

 

Fair value measurement valuation techniques, to the extent possible, should maximize the use of observable inputs and minimize the use of unobservable inputs. The Company’s fair value measurements of all warrants are designated as Level 21 since all of the significant inputs are observable and quoted prices used for volatility were available for the four comparative companies in an active market.

 

A summary of the Company’s warrant issuance activity and related information for the nine months ended September 30, 20182019 is as follows:

 

  Shares  Weighted Average
Exercise
Price
  Weighted
Average
Remaining Contractual Life
 
Outstanding at 12/31/2017  7,194,215  $1.74   3.40 
             
Issued  4,705,833   (1)(2)  2.91 
Outstanding and exercisable at 9/30/2018  11,900,048  $1.28   2.73 
  Shares  Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Contractual
Life
 
Assumed as of the January 8, 2019 merger  12,108,743  $1.38   1.78 
             
Issued  20,647,437  $0.72   2.36 
Outstanding and exercisable at September 30, 2019  32,756,180  $.96(1)(2)  2.15 

 

The fair value of all warrants issued are determined by using the Black-Scholes-MertonBlack-Scholes valuation technique and were assigned based on the relative fair value of both the common stock and the warrants issued.

The inputs used in the Black-Scholes-MertonBlack-Scholes valuation technique to value each of the warrants issued at September 30, 20182019 as of their respective issue dates are as follows:

 

Event
Description
 Date  MDVX
Stock Price
  Exercise Price of Warrant  Grant Date Fair Value  Life
of Warrant
  Risk Free Rate of Return (%)  Annualized Volatility Rate (%) 
Private placement  2/26/18  $0.51  $0.75  $0.20   5 years   2.60   55.91 
Short-term debt  3/26/18  $0.53  $0.75  $0.22   5 years   2.64   56.57 
Private placement  5/1/2018  $0.44   (1) $0.11   3 years   2.66   56.92 
Debt conversion  5/15/2018  $0.39   (1) $0.08   3 years   2.75   57.03 
Convertible notes  8/8/2018  $0.37   (2) $0.19   3 years   2.68   104.37 
Convertible notes  9/28/2018  $0.40   (2) $0.21   3 years   2.88   105.07 
Event
Description
 Date H-CYTE
Stock Price
  Exercise Price of Warrant  Grant Date Fair Value  Life
of Warrant
 Risk Free Rate of Return (%)  Annualized Volatility Rate (%) 
Private placement 1/8/2019 $0.40  $0.75  $0.24  3 years  2.57   115.08 
Antidilution provision(3) 1/8/2019 $0.40  $0.40  $0.28  3 years  2.57   115.08 
Private placement 1/18/2019 $0.40  $0.75  $0.23  3 years  2.60   114.07 
Private placement 1/25/2019 $0.59  $0.75  $0.38  3 years  2.43   113.72 
Private placement 1/31/2019 $0.54  $0.75  $0.34  3 years  2.43   113.47 
Private placement 2/7/2019 $0.57  $0.75  $0.36  3 years  2.46   113.23 
Private placement 2/22/2019 $0.49  $0.75  $0.30  3 years  2.46   113.34 
Private placement 3/1/2019 $0.52  $0.75  $0.33  3 years  2.54   113.42 
Private placement 3/8/2019 $0.59  $0.75  $0.38  3 years  2.43   113.53 
Private placement 3/11/2019 $0.61  $0.75  $0.40  3 years  2.45   113.62 
Private placement 3/26/2019 $0.51  $0.75  $0.32  3 years  2.18   113.12 
Private placement 3/28/2019 $0.51  $0.75  $0.31  3 years  2.18   112.79 
Private placement 3/29/2019 $0.51  $0.75  $0.31  3 years  2.21   112.79 
Private placement 4/4/2019 $0.48  $0.75  $0.29  3 years  2.29   112.77 
Private placement 7/15/2019 $0.53  $1.00  $0.31  3 years  1.80   115.50 
Convertible debt extension 9/18/2019 $0.40  $0.75  $0.25  3 years  1.72   122.04 

 

(1)Warrants issued with the May 2018 private placement and debt conversion had an initial exercise price of $0.75 and contain a contingent feature which would adjust the exercise price of the warrant in the event the Company issues any shares of common stock or common stock equivalents in a private placement of equity or debt securities at a price less than $0.75 per share. On August 8, 2018, the Company completed the issuance of convertible debt at an initial conversion price of $0.40. Accordingly, the exercise price on these warrants was adjusted downward to $0.40.

(2)Warrants issued with the August 8, 2018 and September 28, 2018 convertible notes havehad an initial exercise price of $0.75 and contain a contingent feature which would adjust the exercise price of the warrantwarrants in the event the Company issuesissued any shares of common stock or common stock equivalents in a private placement of equity or debt securities at whichto 90% of the issuance price if it is less than $0.75.

(3)The Company had warrants that triggered the required issuance of an additional 2,023,438 warrants as a result of the Company’s capital raise that gave those new investors a $0.40 per share investment price which required the old warrant holders to receive additional warrants since their price was $0.75 per share.

 

The methods described above may produce a fair value calculation that may not be indicative of net realizable value or reflective of future fair values. Furthermore, while the Company believes its valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different fair value measurement at the reporting date.

Note 12 - Income Taxes

For the period from February 1, 2013 (inception) to September 30, 2018, the Company has incurred net losses and, therefore, has no current income tax liability. The net deferred tax asset generated by these losses is fully reserved as of September 30, 2018 and December 31, 2017, since it is currently more likely than not that the benefit will not be realized in future periods.

The Company is required to file federal income tax returns and state income tax returns in the states of Florida, Georgia and Minnesota. There are no uncertain tax positions at September 30, 2018 or December 31, 2017. The Company has not undergone any tax examinations since inception.

Note 13 - Related-Party Transactions

Patent Assignment and Royalty Agreements

As described in Note 8, the Company has a Contribution and Royalty Agreement with Dr. Haufe, a director of the Company. The agreement provides for the Company to pay Dr. Haufe royalties equal to 1% of revenues received by the Company from sales of all products derived from the use of the DenerveX technology. The Company incurred approximately $2,300 and $6,600, respectively, in royalty expense under the Contribution and Royalty agreement for the three and nine months ended September 30, 2018, all of which was included in accounts payable at September 30, 2018. The Company incurred approximately $225 in royalty expense under the patent assignment and contribution agreement for the three and nine months ended September 30, 2017.

Co-Development Agreement

As described in Note 8, the Company entered into a Co-Development Agreement with Dr. Andrews, a director of the Company, in September 2013. The agreement provides for the Company to pay Dr. Andrews a royalty of 2% of the Company’s net sales earned from applicable product sales for at least 5 years from the effective date of the agreement. The Company incurred approximately $4,500 and $13,100 in royalty expense under the co-development agreement for the three and nine months ended September 30, 2018, all of which was included in accounts payable at September 30, 2018. The Company incurred approximately $446 in royalty expense under the co-development agreement for the three and nine months ended September 30, 2017.

Operating Lease

As described in Note 8, the Company pays TAG Aviation LLC, (“TAG”), a company owned by Mr. Gorlin, for month to month rental of office space at Dekalb-Peachtree Airport in Atlanta Georgia plus cost of utilities. Base rent payments under this arrangement is $2,147 per month. Rent expense and utilities expenses incurred by TAG Aviation amounted to approximately $9,400 and $28,300, respectively, for the three and nine months ended September 30, 2018. Approximately $6,300 was included in accounts payable as of September 30, 2018. Rent expense and utilities expenses paid to TAG Aviation amounted to approximately $9,500 and $25,000, respectively, for the three and nine months ended September 30, 2017.

Consulting expense

As described in Note 8, the Company paid $39,999 and $120,000, respectively, for the three and nine months ended September 30, 2018 to Jesse Crowne, a director and Co-Chairman of the Board of the Company, for business advisory services, of which $13,333 was included in accounts payable at September 30, 2018.

Note 14 - Research and Development

Devicix Prototype Manufacturing Agreement

In November 2013, the Company accepted a proposal from Devicix, a Minneapolis, Minnesota based FDA registered contract designer and developer, to develop a commercially viable prototype of its product that could be used to receive regulatory approval from the FDA and other international agencies for use on humans to relieve pain associated with Facet Joint Syndrome. Through September 30, 2018, the Company has incurred approximately $1,947,000 in fees to Devicix, of which approximately $66,000 and $7,000, respectively, was included in accounts payable as of September 30, 2018 and December 31, 2017.

The development work commenced in December 2013. The total estimated cost of this work at contract signing was $960,000; however, the terms of the proposal allow either the Company or the designer and developer to cancel the development work with 10-days’ notice.

The Company incurred expenses of approximately $42,000 and $98,000, respectively, for the three and nine months ended September 30, 2018. The Company incurred expenses of approximately $34,000 and $273,000, respectively, for the three and nine months ended September 30, 2017.

Denervex Generator Manufacturing Agreement

The DenerveX device requires a custom electrocautery generator for power. As described in Note 8, in November 2014, the Company contracted with Bovie to customize one of their existing electrocautery generators for use with DenerveX Device, and then manufacture that unit on a commercial basis once regulatory approval for the DenerveX is obtained. The Bovie agreement required a base $295,000 development fee to customize the unit, plus additional amounts if further customization was necessary beyond predetermined estimates.

The Company did not incur any expenses to Bovie for the three and nine months ended September 30, 2018. The Company incurred approximately $3,000 and $33,000, respectively, for the three and nine months ended September 30, 2017. Through September 30, 2018, the Company has incurred approximately $422,000 to Bovie related to this agreement. The manufacturing agreement is complete as of September 30, 2018, and the Company does not expect to incur any more expenses related to the agreement.

Nortech Manufacturing Agreement

In November 2014, the Company selected Nortech Systems Inc. (“Nortech”), a Minneapolis, Minnesota based FDA registered contract manufacturer, to produce 315 DenerveX devices from the prototype supplied by Devicix for use in final development and clinical trials. The agreement with Nortech includes agreed upon per unit prices for delivery of the devices. Actual work on development of the final units began in November 2014.

The Company incurred fees of approximately $0 and $107,000, respectively, to Nortech for the three and nine months ended September 30, 2018 related to the manufacturing agreement. The Company incurred fees of approximately $7,400 and $147,000, respectively, to Nortech for the three and nine months ended September 30, 2017. Through September 30, 2018, the Company has incurred expenses of approximately $997,000 to Nortech related to the manufacturing agreement.

 

Note 15–14 - Liquidity, Going Concern and Management’s Plans

 

The Company incurred net losses of approximately $3,721,000$11,616,000 and $4,842,000$2,295,000 for the nine months ended September 30, 2019 and 2018, respectively.

The Biomedical products and 2017, respectively.services division will incur losses until sufficient revenue volume and geographical coverage is attained utilizing the infusion of capital resources to expand marketing and sales initiatives.

In April 2019, the Company determined that their contract manufacturer was not able to meet the quality and quantity requirements for producing the DenerveX product. As a result, the manufacture of the DenerveX product has been temporarily suspended while the Company sources alternative manufacturing options. Additionally, in the Company’s review and evaluation of its current distribution channels, the Company has determined that many of these channels were not cost effective. As a result of the above evaluations, certain European distributor agreements were terminated, and all other representatives have been notified that the Company is temporarily suspending the manufacture and sale of the DenerveX product while the Company sources alternative manufacturing and distributor options as well as considers other product monetizing strategies, including strategic partnerships. The H-CYTE operations will continue to incur losses until the plan for the DenerveX System monetization is determined and executed.

The Company’s independent registered public accounting firm has included an explanatory paragraph with respect to our ability to continue as a going concern in its report on the Company’s consolidated financial statements for the year ended December 31, 2018. The presence of the going concern explanatory paragraph suggests that the Company may not have sufficient liquidity or minimum cash levels to operate the business. Since inception, the Company has incurred losses and anticipates that the Company will continue to incur losses until itits products can sell a sufficientgenerate enough volume of the DenerveX System with margins sufficientrevenue to offset its operating expenses.

To date, the Company’s primary source of funds has been from the issuance The Company, through September 2019, raised $7,100,000 (excluding $200,000 of debt and equity.conversions) year to date.

 

The Company pursued raising additional funds from the sale of equity securities. On June 7, 2019 the Board of Directors approved a new private placements securities offering up to $8,500,000 of common stock at a price of $0.50 per share, and a three-year warrant to purchase such number of shares of common stock equal to fifty percent (50%) of the number of shares of common stock issuable as part of this offering (the “Warrants”), at an exercise price of $1.00 per share. The Company raised $100,000 from these new private placement securities since June 30, 2019. The aforementioned security offering has been terminated.

On October 26, 2019, the Board of Directors approved a new private placement securities offering up to $9,750,000 of Series D Preferred Stock (“Series D Preferred”). The terms of this offering are up to $9,750,000 to be raised at $.41 per share with 100% warrant coverage at $.75 per share for a term of ten years. The Series D Preferred will require additional cashcarry an annual 8% cumulative dividend payable upon a liquidation or redemption. For any other dividends, the Series D Preferred will participate with common stock on an as-converted basis.

On July 25 and July 26, 2019, the Company issued two promissory notes (the “Notes”) in 2018the aggregate principal amount of $900,000 to Horne Management, LLC, and controlled by Mr. William E. Horne, the Chief Executive Officer of the Company. The Notes bear an interest rate of 5.5% per annum and are due on demand. The Company has received the funds represented by the Notes. On September 26, 2019, the Company issued a promissory note to Horne Management, LLC, for $350,000. The Terms of the Note are:

12% interest rate with a maturity date of March 26, 2020.
If the Company is unable to pay the loan as of March 26, 2020, the interest rate increases to 15%.
If the Company does not pay back the principal and interest by November 26, 2019, the Company shall issue to Lender a three-year warrant to purchase 400,000 shares of the Company’s common stock at a purchase price of $0.75 per share.

The Company has certain convertible promissory notes in the aggregate principal amount of approximately $650,000 that originally matured in August and September 2019. The convertible notes are secured by all of the assets of the Company. The Company negotiated an extension with two of the three noteholders through the expected closing of the Series D Preferred .There were certain fees and penalties that were negotiated along with these extensions in the aggregate amount of approximately $80,000. The Company also reached an extension with the third noteholder which extended the maturity date of the loan for one year, until September 30, 2020, plus interest and penalties. The penalties associated with the extension of this loan were approximately $125,000 as outlined in the terms of the original agreement. The total liability on these notes including principal, accrued interest, and penalties is currently exploring other fundraising options. No assurancesapproximately $904,000.

There can be provided regardingno assurances that the success of such efforts. Furthermore,Company will be able to obtain additional financing on commercially reasonable terms, if at all. If the Company is unable to raise sufficient financing in 2018, it could be required to undertake initiatives to conserve its capital resources, including delaying or suspending the launch of its product outside the United States and seeking FDA approval to sell its product in the United States. Delaying or suspending these initiativescurtail operations, there would raisebe substantial doubt about the Company’s ability to continue as a going concern.

A condition Cash as of September 30, 2019 was approximately $368,000. The present level of cash and the fourth quarter raise to closing the Asset Purchase Agreement as described in Note 16 is a net raise of $3,000,000 from the sale of new securities. At the time of filing, this condition had not been met. If no additional funds are raised, the Asset Purchase Agreementdate may not close. If that occurs, the Company will havebe sufficient to curtail operations, as it has no viable alternatives to this agreement. Curtailing operation would raise substantial doubt aboutsatisfy the Company’s ability to continuecurrent operating requirements, as a going concern.such, the additional raising of funds is required.

 

The unaudited consolidated financial statements do not include any adjustments to the carrying value of amounts of its assets or liabilities that might be necessary should the Company be unable to continue as a going concern.

 

Note 1615 - Subsequent Events

 

On October 3, 2018, the Board approved the issuance of shares of common stock in lieu of cash payments due to certain directors and officers of the Company. This issuance was conditioned upon the Company signing a definitive agreement with Regenerative Medical Solutions,Horne Management, LLC (“RMS”). That agreement was signedloaned H-CYTE $150,000 on October 15, 2018, and a total of 1,168,956 shares were subsequently issued as follows: All non-employee directors were issued 35,578 shares each,28, 2019, for a total of 320,202 shares being issued. Executives were issued a total of 524,945 shares in lieu of cash due for 2017 bonus awards and 323,810 shares were issued to Jarrett Gorlin, former Chief Executive Officer, as severance in lieu of six months of cash salary.working capital purposes. The 2017 bonus awards were not previously accrued as management determined it was not probable they would be paid. The board’s approval to issue shares to settle the 2017 bonus awards changed management’s probability assessment and the Company recorded the fair value of the shares issued ($210,000) as a liability at September 30, 2018.

On October 9, 2018, the Company entered into an employment agreement with William E. Horne pursuant to which Mr. Horne will serve as the Company’s President and Chief Executive Officer. The employment agreement is for a term of five years subject to additional one year renewals. The employment agreement provides for an annual base salary of $650,000 provided that if he is receiving his full salary from Laser Spine Institute, his annual base salary shall be reduced to $500,000. Mr. Horne is also eligible to participate in any discretionary or incentive bonus program approved by the Company’s Compensation Committee. Mr. Horne shall also be entitled to receive incentive stock options and restricted stock awards equal to 7% of the Company’s issued and outstanding common stock, as of the closing date of the consummation of the Asset Purchase Agreement (“APA”), as discussed below, between the Company and RMS. In the event that the APA is not consummated, the employment agreement shall terminate. Mr. Jarrett Gorlin resigned as President and Chief Executive Officer upon the effectiveness of the employment agreement.

On October 15, 2018, Directors Jarrett Gorlin, James R. Lawson, Randal R. Betz, John C. Thomas, Jr., James R. Andrews, Clyde A. Hennies, Jon Mogford, Scott Haufe and Jesse W. Crowne, this being all Board members except for Larry W. Papasan, tendered their resignations to Mr. Papasan, Co-Chairman of the Board. Mr. Papasan then invited newly appointed President and Chief Executive Officer, William E. Horne, to join the Board as Chairman. Mr. Horne accepted, and Mr. Papasan tendered his resignation to Mr. Horne, leaving Mr. Horne as the sole director of the Company.

On October 18, 2018, the Company entered into an APA with RMS, Lung Institute LLC, RMS Lung Institute Management LLC, Cognitive Health Institute Tampa, LLC, RMS Shareholder, LLC and RMS Acquisition Corp. (“Buyer”) (collectively, the “Parties”). Pursuant to the terms of the APA, buyer shall purchase all of the assets of RMS, Cognitive Health Institute Tampa, LLC, Lung Institute LLC and RMS Lung Institute Management LLC (collectively the “Sellers”). As consideration, Buyer shall (i) deliver to Sellers (a) 583,333 shares of common stock of the Company (“Common Stock”), (b) 33,632 shares of Series C Preferred Stock of the Company (“Series C Preferred Stock”), where each share of Series C Preferred Stock will convert into 1,000 shares of Common Stock and shall combine to represent the right to convert into and acquire an aggregate of fifty-five percent (55%) of the outstanding common stock of the Company and (c) “Additional Exchange Shares”loan are as defined in the APA; and (ii) assume certain liabilities as provided in the APA. As further consideration, the Company shall pay RMS the sum of $350,000. The close of the APA is subject to certain closing conditions as set forth in the APA.

follows:

 

ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.12% interest rate with a maturity date of April 28, 2020.
If the Company does not pay back the principal and interest by December 28, 2019, the Company shall issue to Lender a three-year warrant to purchase 171,429 shares of the Company’s common stock at a purchase price of $0.75 per share.
If the Company is unable to pay the loan as of April 28, 2020, the interest rate increases to 15%.

 

On November 13, 2019 the Company issued a promissory note (the “Note”) with a principal amount of $235,000 to Horne Management, LLC. The Note bears an interest rate of 12% per annum and is due on demand. The terms of the note are:

12% interest rate with a maturity date of May 13, 2020.
If the Company does not pay back the principal and interest by January 13, 2020, the Company shall issue to Lender a three-year warrant to purchase 268,571 shares of the Company’s common stock at a purchase price of $0.75 per share.
If the Company is unable to pay the loan as of April 28, 2020, the interest rate increases to 15%.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the consolidated financial statements and the notes thereto appearing in Part I, Item 1 of this Quarterly Report. Historical results and trends that might appear in this Quarterly Report should not be interpreted as being indicative of future operations.

 

Overview

 

MedoveX was incorporated in NevadaOn July 11, 2019, Medovex Corp. (“MedoveX”) changed its named to H-CYTE, Inc. (“H-CYTE” or the “Company”) by filing a Certificate of Amendment (the “Amendment”) to the Company’s Amended and Restated Certificate of Incorporation (the “Certificate of Incorporation”) with the Secretary of the State of Nevada. The name change and the Company’s new symbol, HCYT, became effective with FINRA on July 30, 201315, 2019.

On October 18, 2018, H-CYTE (formerly named MedoveX) entered into an Asset Purchase Agreement with Regenerative Medicine Solutions, LLC, RMS Shareholder, LLC (“Shareholder”), Lung Institute LLC (“LI”), RMS Lung Institute Management LLC (“RMS LI Management”) and Cognitive Health Institute Tampa, LLC (“CHIT”), (collectively “RMS”). On January 8, 2019, the Asset Purchase Agreement was amended, and the Company acquired certain assets and assumed certain liabilities of RMS as SpineZ Corp. MedoveXreported in the 8-K/A filed in March of 2019. Based on the terms of the Asset Purchase Agreement and its amendment, the former RMS members had voting control of the combined company as of the closing of the RMS acquisition. For accounting purposes, the acquisition transaction has been treated as a reverse acquisition whereby the Company is deemed to have been acquired by RMS and the historical financial statements prior to the acquisition date of January 8, 2019 now reflect the historical financial statements of RMS.

The Company’s RMS division is a healthcare medical biosciences company that develops and implements advance innovative treatment options in regenerative medicine to treat an array of debilitating medical conditions. In addition, the company is the parent companyoperator and manager of Debride, which was incorporated under the lawsvarious Lung Health Institute clinics. Committed to an individualized patient-centric approach, RMS consistently provides oversight and management of the highest quality care while producing positive outcomes. RMS offices are located in Tampa, Florida. The Lung Health Institute located in Tampa, Florida is a wholly owned subsidiary of RMS. RMS also provides oversight and management to the Lung Health Institutes located in Nashville, TN, Scottsdale AZ, Pittsburgh, PA, and Dallas, TX.

On June 21, 2019, H-CYTE entered into an agreement with Rion LLC (“Rion”) to develop a disruptive cytotherapy technology for chronic obstructive pulmonary disease (“COPD”), the fourth leading cause of death in the U.S. This agreement provides for a 10-year exclusive and extendable supply agreement with Rion to enable H-CYTE to develop proprietary biologics. This will be managed through a new Rion division of H-CYTE. Rion has established a novel technology to harness the healing power of the body. Rion’s novel exosome technology, based on October 1, 2012. science developed at Mayo Clinic, provides an off-the-shelf platform to enhance healing in soft tissue, musculoskeletal, cardiovascular and neurological organ systems.

With this agreement, Rion will serve as the product supplier and will co-develop a proprietary cellular platform with H-CYTE for the treatment of COPD. H-CYTE will control the commercial development and facilitate clinical trial investigation. After conducting joint research and development of these biologics, H-CYTE intends to pursue submission of an investigational new drug (IND) application for review ty the U.S. Food and Drug Administration (“FDA”) for treatment of COPD.

The Company is also in the business of designing and marketing proprietary medical devices for commercial use in the United States and Europe. The Company received CE marking in June 2017 for the DenerveX System, and it is now commercially available throughout the European Union and several other countries that accept CE marking. The Company’s first sale of the DenerveX System occurred in July 2017. The Company is currently seekingplans to seek approval for the DenerveX System from the FDA in the US.United States. The Company is presently reevaluating its approaches to revenue generation including the continuing use of distribution channels, source of manufacturing, and evaluating joint venture opportunities.

 

In April, the Company determined that their contract manufacturer was not able to meet the quality and quantity requirements for producing the DenerveX

The DenerveX® System consists product. As a result, the manufacture of the DenerveX Kitproduct has been temporarily suspended while the Company sources alternative manufacturing options. Additionally, in the Company’s review and evaluation of its current distribution channels, the Company has determined that many of these channels were not cost effective. As a result of the above evaluations, certain European distributor agreements were terminated, and all other representatives have been notified that the Company is temporarily suspending the manufacture and sale of the DenerveX Power Pro-40 generator. We believe that the DenerveX System can be developed in the future to encompass a number of medical applications in addition to the current application for facet joint syndrome, including pain relief.

The Company acquired the DenerveX patent on January 31, 2013 from Scott Haufe, M.D. (“Dr. Haufe”), a director ofproduct while the Company in exchange for 750,108 shares of common stock in the Companysources alternative manufacturing and a 1% royalty on all sales of anydistributor options as well as considers other product sold based on the patent.monetizing strategies, including joint venture opportunities.

 

In September 2013, we entered into a Co-Development Agreement with James Andrews, M.D. (“Dr. Andrews”), a director ofJuly 2019, the Company whereby Dr. Andrews committedsigned a new engineering feasibility proposal that will confirm a new sterilization process will be a slightly less expensive option and expand the shelf life of DenerveX from six months to further evaluatea minimum of one year and potentially up to three years. The longer shelf life will help the DenerveX Systemdistributors reach more end-users as many hospital systems and medical practitioners will not purchase medical products with less than a one-year shelf life. The Company still considers the United States to be a target market and it remains the Company’s goal to seek to make modifications and improvements to such technology. In exchange for such services, theFDA approval. The Company agreed to pay Dr. Andrews a royalty equal to two (2%) percent of the DenerveX net sales during the five (5) year term of the Co-Development Agreement. Upon the termination of the term of the Co-Development Agreement, which has a minimum term of five (5) years, the royalty payable to Dr. Andrews shall be reduced to one (1%) percent of DenerveX net sales after such termination of products covered by any U.S. patent on which Dr. Andrews is listed as a co-inventor; if any such patents are obtained. Such one (1%) percent royalty shall continue during the effectiveness of such patent. Pursuant to the Co-Development Agreement, Dr. Andrews agreed to assign any modifications or improvements to the DenerveX to the Company subject to the royalty rights described above.

We are marketing the product as a disposable, single-use kit which includes all components of the DenerveX device product. In addition to the DenerveX device itself, we have developed a dedicated Electro Surgical Generator, the DenerveX Pro-40, to power the DenerveX device.

The generator is provided to customers agreeing to purchase the DenerveX device and cannot be used for any other purpose.

We accepted a proposal from Devicix, a Minneapolis, Minnesota third party design and development firm, in November 2013, to develop a prototype device. This proposal included a 5-phase development plan, culminating in the production ready prototypeanticipates that could be used for validation purposes. We have recently completed the final stages of the build and test phase of the device, culminating in receiving CE marking to market the product in Europe. The DenerveX Kit and Pro-40 generator is now in commercial production. We anticipate very minimal, if any, additional build and test related expenses, which consists of product design verification activities, in the future as we launch the DenerveX System in Europe. Through September 30, 2018, we have incurred approximately $1,947,000 in fees to Devicix.

In November 2014, we selected Nortech Systems Inc. (“Nortech”), a Minneapolis, Minnesota based FDA registered contract manufacturer, to produce test DenerveX devices from the prototype supplied by Devicix for use in final development and non-clinical testing. The agreement with Nortech includes agreed upon per unit prices for delivery of the devices. Actual work on development of the final units began in November 2014. Through September 30, 2018, we have incurred approximately $997,000 in fees to Nortech. We are now in commercial production, however, the Company may still incur non-recurring expenses related to the DenerveX Kit under the agreement.

Also in November 2014, we engaged Bovie Medical Corporation (“Bovie”), a Delaware Corporation, to develop the Electro Surgical Generator and provide post production support services. Per our agreement with Bovie, we are invoiced based on deliverables produced by Bovie, which was originally supposed to amount to $295,000 upon completion of all the deliverables. Through September 30, 2018, we have incurred approximately $422,000 in fees to Bovie for production services. The original $295,000 agreement was a base number along the pathway of development. Additional requirements were incurred as the research and development process progressed and as a result certain prices increased and additional costs were incurred to further customize the DenerveX System. Development of the generator is now complete andit will do so once it is currentlyback in commercial production.

The Company has completed the final stages of the developmentproduction and verification of the DenerveX Device and the DenerveX Pro-40 power generator as a system.

Regulatory Approval

The Company received CE markinggenerating revenue through sales in June 2017 for the DenerveX System. It is now being sold throughout the European Union and countries that accept CE Mark.

In March 2018, the Company received INVIMA registration approval in Columbia for the Denervex System which allows the company to now market the product in Columbia.

The Company is currently seeking marketing clearance from the FDA for commercialization of the DenerveX System in the US.

Aside from the European Union, we may seek regulatory approval for commercialization of the DenerveX System from Peru, Argentina, Mexico, Turkey, Israel, New Zealand, AustraliaEurope and other approved countries. The documentation required to accompany the CE Mark to obtain regulatory approval in the aforementioned countries may include copies of the ISO 13485 certification, the SGS certificate of approval and a statement of Good Manufacturing Practices (“GMP”).

Critical Accounting Policies and Estimates

 

Our discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which we have prepared in accordance with United States generally accepted accounting principles. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues and expenses during the reporting periods. On an ongoinga continual basis, we evaluate our estimates and judgments, including those described in greater detail below.

 

We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

Our significant accounting policies are described in more detail in the notes to our consolidated financial statements for the fiscal year ended December 31, 2017,2018, included in the Company’s Annual Report on Form 10K.10-K as well as in the notes to our unaudited consolidated financial statements for the nine months ended September 30, 2019 included in this Quarterly Report on Form 10-Q. The December 31, 2018 financial information included in the Company’s Annual Report on Form 10-K reflect the historical financial information of the H-CYTE (formerly MedoveX) business and do not include the RMS financial information. With the reverse merger accounting, historical financial information for periods prior to the Merger on January 8, 2019 presented in the comparative consolidated financial statements and footnotes included in the 2019 Quarterly Reports on Form 10-Q will only reflect the historical financial information related to RMS.

 

Factors Which May Influence Future Results of Operations - Three and Nine Months Ended September 30, 2019 and 2018

 

The following is a description of factors that may influence our future results of operations, and that we believe are important to an understanding of our business and results of operations.

Revenue;Revenue, Cost of RevenueSales and Gross Profit

 

The Company’s first saleCompany recorded gross revenue for the three and nine months ended September 30, 2019 of the DenerveX System occurred in July 2017. Weapproximately $2,742,000 and $6,498,000, respectively. The Company recorded gross revenue for the three and nine months ended September 30, 2018 of approximately $209,000$1,537,000 and $605,000,$6,881,000 respectively.

The Company sells the DenerveX System through a combination of direct sales and independent distributors in international markets. The Company recognizes revenue at the time product is shipped to customers from the third-party distribution warehouse in Berlin, Germany. We believe this action satisfies the performance obligation as outlined in new revenue recognition standards.

The DenerveX Device is manufactured by Nortech in Minneapolis, MN and subsequently shipped to the third-party warehouse in packages of five units per one package. Our independent distributors then order the DenerveX Devices as single units at specified prices as outlined in their distribution agreements. The international distribution agreements also specify the pricing for which the independent distributor is to sell the DenerveX Device to their end-user customers.

The Pro-40 Generator is manufactured in Bulgaria and shipped to the third-party warehouse as single units. The generators are typically provided for use to customers at no cost, however, demo units can be purchased by customers for which the Company recordsdecrease in revenue for the nine months ended September 30, 2019 is mainly attributable to a decrease in the number of treatments provided by the biomedical services business (RMS). The revenue for the nine months ended September 30, 2019 is derived predominantly from RMS and cost of sales and removes the demo units from inventory.

Our independent distribution customers place initial purchase ordersrevenue for minimum stocking quantities of both the DenerveX Devices and Pro-40 Generators as agreed upon per their signed international distribution agreements. Subsequent stocking orders are required to be placed initially at specified dates and quantities based upon projected end-user sales volumes. Stocking orders thereafter are required to be placed quarterly based off actual end-user sales volumes.nine months ended September 30, 2018 is exclusively RMS.

 

For the three and nine month period endingmonths ended September 30, 2018,2019 the Company incurred approximately $550,000 and $1,539,000, in cost of sales, as a percentage of revenue was approximately 70% resulting in a gross profit margin of approximately 29%.

Operating Expenses

We classify our operating expenses into four categories: research and development, sales and marketing, general and administrative, and depreciation.

Research and Development Expenses

Research and development costs and expenses consist primarily of fees paid to external service providers, laboratory supplies, costs for facilities and equipment, and other costs for regulatory, patent, and research and development activities.respectively. For the three and nine months ended September 30, 2018 the Company incurred approximately $46,000$504,000 and $202,000, respectively,$1,979,000, in researchcosts of sales, respectively. The cost of sales for the three and development expenses. nine months ended September 30, 2019 is derived predominantly from RMS and the cost of sales for the three and nine months ended September 30, 2018 is exclusively from the RMS business.

The Company’s cost of sales is comprised of two main components: medical supplies and personnel costs for the biomedical services business, RMS. Medical supplies are predominantly variable costs and based on the number of treatments provided; personnel expenses are also variable as these are hourly positions. The number of treatments currently being provided can be handled adequately with the Company’s present level of personnel. The Company possesses the opportunity to increase the number of treatments performed without increasing personnel costs as it can leverage the current personnel’s availability until the Company’s treatment volume reaches critical mass. However, upon an increase in treatment volume beyond that capacity, the Company will need to hire additional personnel.

The increase in cost of sales for the three months ending September 30, 2019 as compared to the prior year is attributable to more treatments being completed. The decrease in cost of sales for the nine months ending September 30, 2019 as compared to the prior year is attributable to reduced costs for medical supply purchases from cost control initiatives as well as reduced variable costs associated with reduced revenue volume and the ability to perform treatments using fewer staff members.

For the three and nine months ended September 30, 2017,2019 the Company generated a gross profit totaling approximately $2,192,000 (80%) and $4,959,000 (76%), respectively. For the three and nine months ended September 30, 2018, the Company generated a gross profit totaling $1,033,000 (67%) and $4,902,000 (71%), respectively. The increase in gross margin for the three months ending September 30, 2019 as compared to the prior year is attributable to increased revenue and less than proportional cost of sales increases from cost controls for medical supply purchases and the ability to perform treatments using fewer staff members. The increase in gross margin for the nine months ended September 30, 2019, is due to reduced cost of sales from cost controls for medical supply purchases and the ability to perform treatments using fewer staff members, net of revenue decline.

26

Operating Expenses

Salaries and Related Costs

For the three and nine months ended September 30, 2019, the Company incurred approximately, $70,000$1,914,000 and $462,000, respectively,$7,079,000 in researchsalaries and development expenses. Research and development expenses are recorded in operating expenses in the period in which they are incurred.

General and Administrative Expenses

related costs, respectively. For the three and nine months ended September 30, 2018, the Company incurred approximately $620,000$895,000 and $1,510,000, respectively,$3,073,000, in personnel costs. salaries and related costs, respectively. Included in salaries and related costs for the three and nine months ended September 30, 2019 was approximately $1,690,000 in compensation expense related to the 4,225,634 shares of common stock valued at $.40 per share issued to Mr. William E. Horne on April 25, 2019. These shares were fully-vested upon the issuance of a restricted stock award, pursuant to his employment agreement with the Company, which stated that this award would be fully vested if it was not issued within fifteen days of the Merger. The restricted stock award was not issued within that time frame and was fully vested when issued. The Company recognized approximately $1,690,000 of compensation expense in the quarter ended June 30, 2019. The remaining increase in salaries and related costs is primarily attributable to the three and nine months ended September 30, 2018 reflecting only the expenses of the RMS business and 2019 reflecting the consolidated costs for RMS and H-CYTE. Excluding the stock compensation expense of approximately $1,690,000, the Company anticipates that salaries and related costs will continue at a comparable or reduced level in the future. Salary-related expenses are currently under review in order to determine cost-saving measures to assist the Company in its pursuit of becoming a leading biomedical services company and the Company may or may not reduce these expenses going forward.

Other General and Administrative

For the three and nine months ended September 30, 2017,2019, the Company incurred approximately, $477,000$2,026,000 and $1,394,000, respectively,$5,310,000 in personnel costs. The increase is primarily attributable to recognizing $210,000 2017 bonus awards inother general and administrative costs, respectively. For the three and nine months ended September 30, 2018, that were previously not considered probable by the Company.Company incurred approximately $809,000 and $2,483,000, in other general and administrative costs, respectively. The increase is attributable to the three and nine months ended September 30, 2018 reflecting only the expenses of the RMS business and 2019 reflecting the consolidated business costs for RMS and H-CYTE.

 

Professional fees were approximately $497,000Of the total other general and $1,302,000, respectively,administrative costs, for the three and nine months ended September 30, 2018. Professional2019, professional fees were approximately $381,000$523,000 and $1,182,000, respectively, for$1,379,000, respectively. For the three and nine months ended September 30, 2017.2018, professional fees were approximately $183,000 and $318,000, respectively. Professional fees consist primarily of accounting, legal, patent and public company compliance costs as well as regulatory costs incurred to maintain CE Mark in Europe. The Company has incurred additional accounting, consulting and legal fees due to the cost of being a public company and costs related to the reverse acquisition accounting in 2019 and 2018.

 

General and administrative related travel expenses were approximately $3,900 and $14,000, respectively, forThe Company anticipates that the three and nine months ended September 30, 2018. General and administrative related travel expenses were approximately $17,000 and $68,000, respectively, for the three and nine months ended September 30, 2017.

We anticipate that ourother general and administrative expenses will continue at a comparable rate in the future to support clinical trials, commercialization of our product candidate and include the continued costs of operating as a public company.

 

Sales and Marketing ExpensesAdvertising

 

For the three and nine months ended September 30, 2018,2019, the Company incurredhad approximately $215,000$1,468,000 and $666,000,$4,188,000 respectively, in salesadvertising costs, as compared to $279,000 and marketing expenses. For the three and nine months ended September 30, 2017, the Company incurred approximately $217,000 and $450,000, respectively, in sales and marketing expenses. Sales and marketing expenses consist primarily of travel related expenses and fees paid to vendors for tradeshows and consultants in correlation with the launch and commercialization of the DenerveX System in Europe. We expect these expenses will continue to increase as we launch the product in new markets and expand penetration in existing markets.

Depreciation and Amortization

Depreciation and amortization expense are recorded in the period in which they are incurred. The Company recognized approximately $6,700 and $21,000, respectively, in depreciation and amortization expense$1,436,000 for the three and nine months ended September 30, 2018. The increases were attributable to increased marketing efforts to promote the Company’s healthcare medical biosciences business. We expect these expenses will continue at a comparable rate as we expand penetration in existing markets.

Depreciation and Amortization

For the three and nine months ended September 30, 2019, the Company recognized approximately $7,000$212,000 and $20,000,$632,000 respectively, in depreciation and amortization expenseexpense. Of that, the Company recognized approximately $184,000 and $552,000 for the three and nine months ended September 30, 2017.

Results of Continued Operations

Three and Nine Months Ended September 30, 2018 Compared2019, respectively, in amortization expense related to the Three and Nine Months Ended September 30, 2017.

The Company recorded gross revenue fortechnology intangibles that arose as a result of the reverse merger by RMS of H-CYTE. For the three and nine months ended September 30, 2018, of approximately $209,000 and $605,000, respectively.

The Company incurred net losses of approximately $3,722,000 and $4,842,000 for the nine months ended September 30, 2018 and 2017, respectively.

Total operating expenses increased approximately $36,000, or 2.6%, to approximately $1,422,000 for the three months ended September 30, 2018, as compared to approximately $1,386,000 for the three months ended September 30, 2017.

Total operating expenses decreased approximately $661,000, or 15%, to approximately $3,806,000 for the nine months ended September 30, 2018, as compared to approximately $4,467,000 for the nine months ended September 30, 2017.

The overall decrease in operating expenses is the result of intentional spending cut-backs in order to preserve working capital due to low cash balances. Additionally, research and development and regulatory expenses are lower as we completed the final stages of the development and verification of the DenerveX System and have received CE Mark certification. Sales & Marketing expenses increased as we entered commercial production of the DenerveX System and launched our product in Europe. We continued to incur similar costs associated with being a public entity.

Results of Discontinued Operations

We did not incur any operating losses related to the disposition of Streamline for the three and nine months ended September 30, 2018. Our discontinued operations generated net losses of approximately $0 and $1,000, respectively for the three and nine months ended September 30, 2017.

Regenerative Medicine Solutions Asset Purchase Agreement

On October 18, 2018, the Company entered into an Asset Purchase Agreement ( the “APA”) with Regenerative Medicine Solutions, LLC (“RMS”), Lung Institute LLC, RMS Lung Institute Management LLC, Cognitive Health Institute Tampa, LLC, RMS Shareholder, LLCrecognized approximately $28,000 and RMS Acquisition Corp. (“Buyer”) (collectively, the “Parties”). Pursuant to the terms of the APA, the Company shall purchase all of the assets of Regenerative Medicine Solutions LLC, Cognitive Health Institute Tampa, LLC, Lung Institute LLC and RMS Lung Institute Management LLC (collectively the “Sellers”). As consideration, the Company shall (i) deliver to Sellers (a) 583,333 shares of common stock of the Company, (b) 33,632,290 shares of Series C Preferred Stock of the Company, where each share of Series C Preferred Stock will convert into 1,000 shares of Common Stock and shall combine to represent the right to convert into and acquire an aggregate of fifty-five percent (55%) of the outstanding common stock of the Company and (c) “Additional Exchange Shares” as defined$80,000 respectively, in the APA; and (ii) assume certain liabilities as provided in the APA. As further consideration, the Company shall pay RMS the sum of $350,000. The close of the APA is subject to certain closing conditions as set forth in the APA.

depreciation expense.

Departure of Directors and Certain Officers, Election of Directors.Directors, Appointment of Certain Officer; Compensatory Agreement of CertainNew Board Members and Officers.

 

On October 3, 2018,January 8, 2019, in connection with the APA, the Board approved the issuance of shares of common stock in lieu of cash payments due to certain directors and officersDirectors of the Company. This issuance was conditioned uponCompany (“the Board”) appointed Michael Yurkowsky and Raymond Monteleone as additional members of the Board.

Mr. Michael Yurkowsky is to receive $5,000 per Board meeting. Besides this arrangement, there are no arrangements or understandings between the Company signing a definitive agreement with Regenerative Medicine Solutions LLC. That agreement was signed on October 15, 2018, and a total of 1,090,412 shares were subsequently issued as follows: All non-employee directors were issued 35,578 shares each, for a total of 320,202 shares being issued. Executives were issued a total of 524,945 shares in lieu of cash due for 2017 bonus awardsMr. Yurkowsky and 323,810 shares were issued to Jarrett Gorlin, former Chief Executive Officer, as severance in lieu of six months of cash salary. The 2017 bonus awards were not previously accrued as management determined it was not probable they would be paid. The board’s approval to issue shares in lieu of cash, changed management’s probability assessment and the Company recorded the fair value of the shares issued $209,978 as a liability at September 30, 2018.

On October 9, 2018, the Company entered into an employment agreement with William E. Horneany other person or persons pursuant to which Mr. Horne will serveYurkowsky was appointed as a member of the Company’s PresidentBoard and Chief Executive Officer. The employment agreementthere is for a termno family relationship between Mr. Yurkowsky and any other director or executive officer of five years subject to additional one year renewals. The employment agreement provides for an annual base salary of $650,000 provided that if he is receiving his full salary from Laser Spine Institute, his annual base salary shall be reduced to $500,000. Mr. Horne is also eligible to participate inthe Company or any discretionaryperson nominated or incentive bonus program approvedchosen by the Company’s Compensation Committee. Company to become a director or executive officer.

Mr. Horne shall also be entitledRaymond Monteleone is to receive incentive stock options$5,000 per Board meeting. Besides this arrangement and restricted stock awards equal to 7% of the Company’s issued and outstanding common stock, as of the closing date of the consummation of the Asset Purchase Agreement (“APA”)consulting agreement (see Note 8), there are no arrangements or understandings between the Company and Regenerative Medical Solutions, Inc. In the event that the APA is not consummated, the employment agreement shall terminate. Mr. Jarrett Gorlin resignedMonteleone and any other person or persons pursuant to which Mr. Monteleone was appointed as President and Chief Executive Officer upon the effectivenessa member of the employment agreement,Board and 323,810 shares were issuedthere is no family relationship between Mr. Monteleone and any other director or executive officer of the Company or any person nominated or chosen by the Company to Jarrett Gorlin as severance in lieu of six months of cash salary.become a director or executive officer.

 

On OctoberFebruary 4, 2019, the Board accepted the resignation of Mr. Charles Farrahar as the Chief Financial Officer, effective immediately. Mr. Farrahar resigned as the Chief Financial Officer for personal reasons and not as a result of any disputes or disagreements between Mr. Farrahar and the Company on any matter relating to the Company’s operations, policies, accounting policies, or practices.

On February 4, 2019, the Board of the Company appointed Mr. Jeremy Daniel as the Chief Financial Officer of the Company. There are no arrangements or understandings between the Company and Mr. Daniel.

On February 15, 2018, Directors Jarrett Gorlin, James R. Lawson, Randal R. Betz, John C. Thomas, Jr., James R. Andrews, Clyde A. Hennies, Jon Mogford, Scott Haufe2019, Dennis Moon resigned from his position as the Executive Vice President of the Company, effective immediately. Mr. Moon resigned from his position at the Company for personal reasons, not as a result of or caused by any disagreements between Mr. Moon and Jesse W. Crowne, this being allthe Company on any matter relating to the Company’s operations, policies, or practices.

On June 7, 2019, the Board members exceptappointed Briley Cienkosz as Chief Marketing Officer, Gary Mancini as Chief Relationship Officer, and Ann Miller as Chief Operating Officer of the Company. There are no arrangements or understandings between the Company and these new officers. There are no family relationships between the new officers and any other director or executive officer of the Company, or any person nominated or chosen by the Company to become a director or executive officer.

On July 29, 2019, the Board appointed Dr. Andre Terzic to the Board. Dr. Andre Terzic, 57, has served as a director at the Center for Larry W. Papasan, tendered their resignations to Mr. Papasan, Co-ChairmanRegenerative Medicine of Mayo Clinic in Rochester, Minnesota for the last five years. Dr. Andre Terzic is the Chair of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee of Food and Drug Administration, the President of the American Society for Clinical Pharmacology & Therapeutics, and one of the co-founders of Rion. Rion is a Minnesota Bio-tech Company focused on cutting-edge regenerative technologies. Dr. Terzic received his M.D. at University of Belgrade in Paris, France in 1985 and his Ph.D. from the Department of Pharmacology of University of Illinois in 1991.

On July 30, 2019, the Board appointed Dr. Atta Behfar as a member of the Board. Mr. Papasan then invited newly appointed President and Chief Executive Officer, William E. Horne, to joinDr. Atta Behfar, 42, has worked as a cardiologist at the Board as Chairman. Mr. Horne accepted, and Mr. Papasan tendered his resignation to Mr. Horne, leaving Mr. Horne asDepartment of Cardiovascular Medicine of Mayo Clinic for the sole directorlast five years. Dr. Atta Behfar is a Director of the Company.Van Cleve Cardiac Regenerative Medicine program at Mayo Clinic and one of the founders of Rion. Dr. Behfar received a Bachelor of Science degree in Biochemistry from Marquette University in 1998 and a M.D. and Ph.D. from Mayo Clinic College of Medicine, Mayo Graduate School in 2006.

 

Funding Requirements

 

We anticipate our cash expenditures will remain relatively consistentincrease as we continue to operate as a publicly traded entity, and as we move forward with increased sales and marketing initiatives for the recent commercializationBiomedical products and services and investing in the Rion division and as we incur losses associated with temporarily suspending the manufacture and sale of the DenerveX System onto clinical trial studies. We expect future cash flow expendituresproduct. In addition, the Company is pursuing the acquisition of new technologies to increase ifexpand the FDA requires a de novo regulatory path, insteadbusiness lines and with the intent of a 510(k) approval.increasing profitability.

 

To the extent our availableThe present level of cash is insufficient to satisfy our long-termcurrent operating requirements, we will need to seekrequirements. The Company is seeking additional sources of funds from the sale of equity or debt securities or through a credit facility, or we will need to modify our current business plan.facility. There can be no assurances that we will be able to obtain additional financing on commercially reasonable terms, if at all.

 

The Company is pursuing raising additional funds from the sale of additional equity or convertible debtsecurities. On June 7, 2019 the Board approved a new private placements securities would likely result in dilutionoffering up to our current stockholders.$8,500,000 of common stock at a price of $0.50 per share, and a three-year warrant to purchase such number of shares of common stock equal to fifty percent (50%) of the number of shares of common stock issuable as part of this Agreement (the “Warrants”), at an exercise price of $1.00 per share. The Company raised $100,000 from these new private placement securities since June 30, 2019. This offering was terminated on August 30, 2019.

The Company expects to close on $6,000,000 of the Series D Preferred offering replacing the $8,500,000 offering adopted by the Board on June 7, 2019, with an offering for up to $9,750,000. Such closing is expected to be completed by the end of November 2019.

 

Going Concern

 

OurThe Company incurred net losses of approximately $11,615,000 and $2,295,000 for the nine months ended September 30, 2019 and 2018, respectively.

The RMS products and services division will incur losses until sufficient revenue volume and geographical coverage is attained utilizing the infusion of capital resources to expand marketing and sales initiatives. The H-CYTE operations will continue to incur losses until the plan for the DenerveX System commercialization is determined and executed.

The Company’s independent registered public accounting firm has included an explanatory paragraph with respect to ourthe Company’s ability to continue as a going concern in its report on ourthe Company’s consolidated financial statements for the yearsyear ended December 31, 2017 and 2016.2018. The presence of the going concern explanatory paragraph suggests that wethe Company may not have sufficient liquidity or minimum cash levels to operate the business. Since ourits inception, we havethe Company has incurred losses and anticipateanticipates that wethe Company will continue to incur losses until ourits products can generate enough revenue to offset ourits operating expenses. A conditionThe Company, through September 2019, had raised $7,100,000 (excluding $200,000 of debt conversions) year to closingdate in additional cash to sustain the Asset Purchase AgreementCompany. Cash as described in Note 16of September 30, 2019 was approximately $368,000. The present level of cash is insufficient to the Financial Statements- Subsequent Eventssatisfy our current operating requirements.

The Company is a net raise of $3,000,000pursuing raising additional funds from the sale of newequity securities. AtIn the timethird quarter of filing, this condition had not been met. If2019, the Company raised $100,000 by selling 200,000 shares of commons stock at $0.50 per share. The Company also issued the investors 100,000 warrants with an exercise price of $1.00 per share. The Company expects to close on $6,000,000 of the Series D Preferred offering replacing the $8,500,000 offering adopted by the Board on June 7, 2019, with an offering for up to $9,750,000. Such closing is expected to be completed by the end of November 2019.

There can be no additional funds are raised, the Asset Purchase Agreement may not close. Ifassurances that occurs, the Company will havebe able to curtail operations, as it has no viable alternatives to this agreement.obtain additional financing on commercially reasonable terms, if at all. If we arethe Company is required to curtail operations, there would be substantial doubt about the Company’s ability to continue as a going concern.

 

Liquidity and Capital Resources

 

Since ourits inception, we havethe Company has incurred losses and anticipateanticipates that we will continue to incur losses infor the foreseeable future.

While we expect our research and development costs for the DenerveX System to dissipate, we also anticipate increased expenditures for clinical trials to obtain FDA approval of the DenerveX System as well as expenses related to the commercial launch of the DenerveX system. We will need additional cash to fully fund these activities.

 

Sources of Liquidity

 

Equity

 

In August and September 2018,On January 8, 2019, the Company entered into a securities purchase agreement (the “SPA”) with select accredited investors, wherebyfour purchasers (the “Purchasers”) pursuant to which the four Purchasers invested in the Company an aggregate amount of $2,000,000, with $1,800,000 in cash and $200,000 by cancellation of debt as explained below, in exchange for forty (40) units (the “Units”), each consisting of a convertible note (the “Convertible Note”) with the principal amount of $50,000 and a warrant (the “Warrant”) to purchase common stock (the “common stock”) of the Company. Pursuant to this SPA, the Company initially offered upa minimum of $1,000,000 and a maximum of $6,000,000, and subsequently increased to $1,000,000 in unitsa maximum of $8,000,000 (the “Maximum Amount”) of Units at a purchase price of $50,000 per unit. Unit until the earlier of i) the closing of the subscription of the Maximum Amount and ii) March 31, 2019 (the “Termination Date”), subject to the Company’s earlier termination at its discretion. The SPA includes the customary representations and warranties from the Company and purchasers. Steve Gorlin, the Company’s former Chairman of the Board, converted a $200,000 promissory note owed to him by the Company in exchange for four (4) Units on the same terms as all other Purchasers.

Each Convertible Note offered by the Company as part of the Unit consistsbears an interest rate of (i)12% per annum, has a 12% senior secured convertible note, initiallyprincipal amount of $50,000, shall mature in one year from the original issue date on January 8, 2019, and will be convertible into shares of the Company’s common stock par value $0.001 per share, at a conversion price equalof $0.40 subject to adjustment stated in the Convertible Note. Pursuant to the lesser of $0.40 or ninety percent (90%)terms of the per share purchase priceConvertible Note, each holder of anythe Convertible Notes shall not own more than 4.99% of the number of shares of common stock oroutstanding immediately after giving effect to the issuance of common stock equivalents issued inissuable upon exercise of such Convertible Note. Upon default, the next private placementpenalty interest rate of equity and/or debt securities completed bythe Convertible Note shall rise to 18% per annum. In addition, pursuant to the SPA, the Company following this offering, and (ii) a three-year warrantoffers, as part of the unit, warrants to purchase suchthe common stock at a price of $0.75 per share (the “Exercise Price”), subject to adjustments stated therein.

The holder of each Warrant may purchase the number of shares of the Company’s common stock equal to one hundred percent (100%) of the number of shares of common stock issuable upon conversion of each Convertible Note while the notes.Warrant is exercisable. The Warrants are exercisable athave a price equalterm of three years and shall be exercised in cash or on a cashless basis as described in the Warrant. All of such notes have been converted into an aggregate of 18,000,000 shares of common stock.

Steve Gorlin, the Company’s former Chairman of the Board, converted a $200,000 promissory note owed to him by the Company pursuant to the lessor of $0.75 or 90%same terms of the per share purchase priceSPA entered into by other investors to consummate the acquisition in January 8, 2019. The promissory note was converted into an aggregate of any500,000 shares of common stock, oreliminating the Company’s debt obligation.

Debt

On July 25 and July 26, 2019, the Company issued two promissory notes (the “Notes”) in the aggregate principal amount of $900,000 to Horne Management, LLC, and controlled by Mr. William E. Horne, the Chief Executive Officer (“CEO”) of the Company. The Notes bear an interest rate of 5.5% per annum and are due on demand. The Company has received the funds represented by the Notes. On September 26, 2019, the Company issued a promissory note to Horne Management, LLC, for $350,000. The Terms of the Note are:

12% interest rate with a maturity date of April 28, 2020.
If the Company does not pay back the principal and interest by December 28, 2019, the Company shall issue to Lender a three-year warrant to purchase 171,428 shares of the Company’s common stock at a purchase price of $0.75 per share.
If the Company is unable to pay the loan as of April 28, 2020, the interest rate increases to 15%.

On October 28, 2019 the Company issued a promissory note (the “Note”) with a principal amount of $150,000 to Horne Management, LLC and controlled by Mr. William E. Horne, the CEO of the Company. The Note bears an interest rate of 12% per annum and is due on demand. The terms of the note are:

12% interest rate with a maturity date of April 28, 2019
If the Company does not pay back the principal and interest by December 28, 2019, the Company shall issue to Lender a three-year warrant to purchase 171,429 shares of the Company’s common stock at a purchase price of $0.75 per share.
If the Company is unable to pay the loan as of April 28, 2020, the interest rate increases to 15%.

On November 13, 2019 the Company issued a promissory note (the “Note”) with a principal amount of $235,000 to Horne Management, LLC and controlled by Mr. William E. Horne, the CEO of the Company. The Note bears an interest rate of 12% per annum and is due on demand. The terms of the note are:

12% interest rate with a maturity date of May 13, 2020.
If the Company does not pay back the principal and interest by January 13, 2020, the Company shall issue to Lender a three-year warrant to purchase 268,571 shares of the Company’s common stock at a purchase price of $0.75 per share.
If the Company is unable to pay the loan as of April 28, 2020, the interest rate increases to 15%.

The $750,000 convertible notes payable assumed in the Merger, had a fair value of approximately $598,000 on the acquisition date. Subsequently, on February 6, 2019, $100,000 of the outstanding Convertible Notes was converted into an aggregate of 250,000 shares of common stock, equivalents issued in the next private placement of debt or equity securities completed by the following the issuanceeliminating $100,000 of the warrants.Company’s debt obligation. The debt was converted into shares at $0.40 per share, which was the conversion price per the securities purchase agreement. The $650,000 remaining principal balance of these convertible notes mature in August and September 2019. The convertible notes are secured by all of the assets of the Company.

 

InDuring the offering,third quarter, the Company sold an aggregatenegotiated extensions of 15 units and issued to investors an aggregatefor two of $750,000 in principal amount ofthese convertible notes until the closing of the Series D Preferred. The third note was extended to September 2020. The total liability covered by these notes is $775,000. The extensions required certain interest adjustments and 1,875,000 warrantstransaction fees.

The Company has certain promissory notes with outstanding balances of approximately $95,000 at September 30, 2019. The notes had a maturity date of August 1, 2019, but the Company successfully reached an agreement on August 12, 2019 for an eighteen-month extension on the notes.

In connection with the APA, on January 8, 2019, Steve Gorlin, the Company’s former Chairman of the Board, converted a $200,000 promissory note owed to purchase common stock, resulting in total gross proceeds of $750,000him by the Company pursuant to the Company.same terms of the security purchase agreement entered into by other investors to consummate the acquisition in January 8, 2019. The convertible notes sold in the offering are initially convertiblepromissory note was converted into an aggregate of 1,875,000500,000 shares of common stock.

Debt

On August 21, 2018, the Company paid back the remaining $100,000 principal plus unpaid accrued interest in the amount of $2,944, to Steve Gorlin,stock, eliminating the Company’s promissory note debt obligation.

 

The Company issued to investors an aggregate of $750,000 in 12% senior secured convertible notes in August and September 2018. The notes are secured by all of the assets of the Company.

 

 

Working Capital (Deficit) Surplus

 September 30, 2018  December 31, 2017 
Current Assets $644,000  $1,138,000 
Current Liabilities  2,059,000   475,000 
Working Capital (Deficit) Surplus $(1,415,000) $663,000 

24

Cash Flows

Cash activity for the nine months ended September 30, 20182019 and 2017the twelve months ended December 31, 2018 is summarized as follows:

 

  Nine Months Ended September 30, 
  2018  2017 
Cash used in operating activities $(2,116,000) $(2,655,000)
Cash provided by (used in) investing activities  150,000   (10,000)
Cash provided by financing activities  1,949,000   2,521,000 
Net decrease in cash and cash equivalents $(17,000) $(144,000)

Working Capital Deficit

  As Of 
  September 30, 2019  December 31, 2018 
Current Assets $764,000  $150,000 
Current Liabilities  7,268,000   2,193,000 
Working Capital Deficit $6,504,000  $2,043,000 

Cash Flows

Cash activity for the nine months ended September 30, 2019 and 2018 is summarized as follows:

  Nine Months Ended September 30, 
  2019  2018 
Cash used in operating activities $(7,906,764) $(2,378,418)
Cash used in investing activities  (389,577)  (207,895)
Cash provided by financing activities  8,594,590   2,412,800 
Net increase (decrease) in cash $298,249  $(173,513)

 

As of September 30, 2018,2019, the Company had approximately $228,000$368,000 of cash on hand.

 

Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements as defined in Regulation S-K Item 303(a)(4) during the periods presented, investments in special-purpose entities or undisclosed borrowings or debt. Additionally, we are not a party to any derivative contracts or synthetic leases.

 

Contractual Obligations and Commercial Commitments

 

The Company has long term contractualContractual Debt Obligations

Contractual debt obligations relate to financing arrangements for D&O and general liability insurance premiums that were financed at various points throughout 2018 and the first quarter of 2019, and two promissory notes issued to the Bank of North Dakota New Venture Capital Program and North Dakota Development Fund. BothConvertible Notes from the Bank of North Dakota New Venture Capital Program and North Dakota Development were assumed in conjunctionthe Merger.

These insurance financing arrangements require aggregate monthly payments of approximately $18,000, reflect interest rates ranging from 7% to 12.8% and are to be paid in full by April 2020 and had balances of approximately $114,000 September 30, 2019 and $31,000 at December 31, 2018. Interest expense related to these insurance financing arrangements was approximately $2,200 and $5,200 for the three and nine months ended September 30, 2019, respectively, and was $0 for the three and nine months ended September 30, 2018 respectively.

Payments on both promissory notes assumed are due in aggregate monthly installments of approximately $5,700 and carry an interest rate of 5%. Both notes had a maturity date of August 1, 2019 and the Company was successful in reaching an agreement resulting in the extension on the notes until March 1, 2020 with no change in the consummationinterest rate and no penalties were incurred. The promissory notes had outstanding balances of approximately $103,000 at date of the Streamline acquisition on March 25, 2015Merger and require combined monthly principal and interest payments of $5,661 into the third quarter ofapproximately $95,000 at September 30, 2019.

 

The Convertible Notes represent a securities purchase agreement with select accredited investors, which were assumed in the Merger. The debt consisted of $750,000 of Units at a purchase price of $50,000 per Unit. Each Unit consists of (i) a 12% senior secured convertible note, initially convertible into shares of the Company’s common stock, par value $0.001 per share, at a conversion price equal to the lesser of $0.40 or ninety percent (90%) of the per share purchase price of any shares of common stock or common stock equivalents issued in future private placements of equity and/or debt securities completed by the Company rents commercial office spacefollowing this offering, and (ii) a three-year warrant to purchase such number of shares of the Company’s common stock equal to one hundred percent (100%) of the number of shares of common stock issuable upon conversion of the notes at $0.40. The warrants were initially exercisable at a price equal to the lesser of $0.75 or ninety percent (90%) of the per share purchase price of any shares of common stock or common stock equivalents issued in Alpharetta, GA. Base annual rentfuture private placements of the debt and/or equity securities completed by the Company following the issuance of warrants.

The $750,000 Convertible Notes payable assumed in the acquisition transaction with RMS had a fair value of approximately $598,000 on the acquisition date. Subsequently, on February 6, 2019, $100,000 of the outstanding Convertible Notes was converted into an aggregate of 250,000 shares of common stock, eliminating $100,000 of the Company’s debt obligation. The debt was converted into shares at $0.40 per share, which was the conversion price per the securities purchase agreement. The $650,000 remaining principal balance of these convertible notes mature in August and September 2019. The Convertible Notes are secured by all the assets of the Company. The Company successfully negotiated an extension to the maturity date; for two of the three notes ($350,000) until the initial closing of the Series D Preferred and for the third note ($300,000) until September 30, 2020.

On February 6, 2019, $100,000 of the Company’s $750,000 outstanding Convertible Notes was converted into an aggregate of 277,778 shares of common stock, eliminating $100,000 of the Company’s debt obligation. The debt was converted into shares at $0.36 per share, which was the conversion price per the securities purchase agreement subsequent to the trigger of the down round feature.

On July 25, 2019 and July 26, 2019, H-CYTE, Inc. (the “Company”) issued two promissory notes (the “Notes”) in the principal amount (the “Principal Amount”) of $900,000 to Horne Management, LLC controlled by Mr. William E. Horne, the Chief Executive Officer of the Company. The Notes bear an interest rate of 5.5% per annum and are due on demand. The Company has received the funds represented by the Notes.

In addition, awaiting the funding of the capital raise to be closed in the early part of the fourth quarter, the Chief Executive Officer loaned H-CYTE $350,000 on September 26, 2019, for working capital purposes. The terms of the loan as follows:

12% interest rate with a maturity date of March 26, 2020.
If the Company is unable to pay the loan as of March 26, 2020, the interest rate increases to 15%.
If the Company does not pay back the principal and interest by November 26, 2019, the Company shall issue to Lender a three-year warrant to purchase 400,000 shares of the Company’s common stock at a purchase price of $0.75 per share.

On October 28, 2019 the Company issued a promissory note (the “Note”) with a principal amount of $150,000 to Horne Management, LLC and controlled by Mr. William E. Horne, the CEO of the Company. The Note bears an interest rate of 12% per annum and is currently set at $3,095due on demand. The terms of the note are:

12% interest rate with a maturity date of April 28, 2019
If the Company does not pay back the principal and interest by December 28, 2019, the Company shall issue to Lender a three-year warrant to purchase 171,429 shares of the Company’s common stock at a purchase price of $0.75 per share.
If the Company is unable to pay the loan as of April 28, 2020, the interest rate increases to 15%.

On November 13, 2019 the Company issued a promissory note (the “Note”) with a principal amount of $235,000 to Horne Management, LLC and controlled by Mr. William E. Horne, the CEO of the Company. The Note bears an interest rate of 12% per monthannum and is due on demand. The terms of the lease term ends December 31,note are:

12% interest rate with a maturity date of May 13, 2020.
If the Company does not pay back the principal and interest by January 13, 2020, the Company shall issue to Lender a three-year warrant to purchase 268,571 shares of the Company’s common stock at a purchase price of $0.75 per share.
If the Company is unable to pay the loan as of April 28, 2020, the interest rate increases to 15%.

Commitments

Biotechnology Agreement

 

The Company also currently reimbursesentered into a 10-year exclusive and extendable supply agreement with Rion that will enhance its CEO, Jarrett Gorlin,existing cytotherapy product line, developing a disruptive technology for chronic obstructive pulmonary disease (“COPD”), the fourth leading cause of death in the U.S. Rion has established a novel technology to harness the healing power of the body. Rion’s novel exosome technology, based on science developed at Mayo Clinic, provides an off-the-shelf platform to enhance healing in soft tissue, musculoskeletal, cardiovascular and neurological organ systems.

With this agreement, Rion will serve as the product supplier and will co-develop a proprietary cellular platform with H-CYTE for the treatment of COPD. H-CYTE will control the commercial development and facilitate clinical trial investigation. After conducting joint research and development of these biologics, H-CYTE intends to pursue submission of an investigational new drug (IND) application for review by the U.S. Food and Drug Administration (“FDA”) for treatment of COPD.

Sublease Agreement

The Company entered into a sub-lease agreement for the lease in Alpharetta, Georgia. The period of executive office space atthe lease is from July 1, 2019 to December 31, 2020 and sublessee shall pay to sublessor a costminimum rent, of $2,147$2,000 per month, which it believes is at fair market value.month.

Consulting Agreements

 

The Company has reached a consultingnew agreement with Jesse Crowne, a former Director and Co-Chairman of the Board of the Company, to provide business development consulting services for a fee of $13,333$5,000 per month. The Company incurred expense of $10,000 and $49,999, for the three and nine months ended September 30, 2019 related to this consulting agreement. Since this agreement was assumed January 8, 2019 as part of the reverse merger transaction, there were no historical costs related to this prior to January 8, 2019.

 

The Company entered into a consulting agreement with LilyCon Investments, LLC effective February 1, 2019 for services related to evaluation and negotiation of future acquisitions, joint ventures, and site evaluations/lease considerations. The duration of the is for a period of twelve months in the amount of $12,500 per month with a $15,000 signing bonus which was paid in full during the quarter ending March 31, 2019. The agreement also provides LilyCon Investments with $35,000 in stock (calculated using an annual Variable Weighted Average Price from February 2019 through January 2020) to be granted on the one-year anniversary of this agreement, if the agreement has not been terminated prior to that date. Either party may terminate this agreement with or without cause upon 30 days written notice. For the three and nine months ended September 30, 2019, the Company has expensed a total of $37,500 and $115,000 in compensation to LilyCon Investments, respectively.

The Company entered into an oral consulting agreementsarrangement with St. Louis Family Office, LLC, controlled by Jimmy St. Louis, former CEO of RMS, in January 2019 in the amount of $10,000 per month plus benefits reimbursement for advisory services. The Company terminated this agreement effective June 30, 2019. For the three sales, marketing, and distribution consultantsnine months ended September 30, 2019, the Company has expensed $0 and $71,000 in Europe whoconsulting fees to St. Louis Family Office, respectively.

The Company entered into a consulting agreement with Strategos Public Affairs, LLC (Strategos) on February 15, 2019 for a period of twelve months, unless otherwise terminated by giving thirty days prior written notice. Strategos will provide information to key policymakers in the legislature and executive branches of government on the benefits of the cellular therapies offered by the Lung Health Institute, advocate for legislation that supports policies beneficial to patient access and oppose any legislation that negatively impacts the Company’s ability to expand treatment opportunities, and position the Company and its related entities as the expert for information and testimony. For the three and nine months ended September 30, 2019, the Company has expensed $22,500 and $48,500, respectively.

The Company entered into a consulting agreement with Goldin Solutions for media engagement and related efforts. The agreement was effective August 4, 2019 for a minimum period of six months including both proactive public relations and crisis management services, for aggregate compensation amounting to approximately €21,000 (approximately $25,000) per month. The consulting agreements, while subject to modifications, commenced at separate dateswith a $33,000 monthly fee payable each month with a first month discount of $12,000. For the three and will also terminate at separate dates through April 2019.nine months ended September 30, 2019, the Company has expensed $54,000 and $54,000, respectively.

Distribution center and logistic services agreement

 

The Company has a consulting agreement with a sales, marketing, and distribution consultant in Latin America who provides consulting services for a monthly compensation of $7,000.

The Company has anon-exclusive distribution center agreement with a logistics service provider in Berlin, Germany pursuant to which they shall manage and coordinate the DenerveX System products which the Company exportsexported to the EU through June 2019. The Company pays a fixed monthly fee of €6,900€4,500 (approximately $7,900)$5,000) for all accounting, customs declarations and office support, and a variable monthly fee ranging from €1,900 to €6,900 (approximately $2,300 to $8,300), based off volume of shipments, for logistics, warehousing and customer support services.

 

Total expenses incurred for the distribution center and logistics agreement were approximately $10,080 and $40,080, respectively, for the three and nine months ended September 30, 2019. Since this agreement was assumed January 8, 2019 as part of the reverse merger transaction, there were no historical costs related to this prior to January 8, 2019. The Company issuedreported a higher expense amount related to investorsthis agreement in the second quarter of 2019, but it was deemed an aggregateimmaterial amount.

Patent Assignment and Contribution Agreements

The terms of $750,000a Contribution and Royalty Agreement dated January 31, 2013 with Dr. Scott Haufe, M.D was assumed in 12% senior secured convertible notesthe Merger as of January 8, 2019. This agreement provides for the Company to pay Dr. Haufe royalties equal to 1% of revenues earned from sales of any and all products derived from the use of the DenerveX technology. Royalties are payable to Dr. Haufe within 30 days after the close of each calendar quarter based on actual cash collected from sales of applicable products. The royalty period expires on September 6, 2030.

The Company incurred approximately $0 and $1,100 respectively, in Augustroyalty expense under the Contribution and Royalty agreement for the three months and nine months ended September 2018. The notes are secured by30, 2019, all of the assetswhich was included in accounts payable at September 30, 2019. Since this agreement was assumed January 8, 2019 as part of the Company.Merger, there were no historical costs related to this prior to January 8, 2019.

Guarantee

The Company has guaranteed payments based upon the terms found in the management services agreements to two affiliated physicians related to LI Nashville, LI Scottsdale, LI Pittsburgh, and LI Dallas. For the three and nine months ending September 30, 2019, payments totaling approximately $42,000 and $105,000 respectively were made to these affiliates.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

Not applicable to smaller reporting companies.

 

ITEM 4. CONTROLS AND PROCEDURES.

 

Evaluation of Disclosure Controls and Procedures

OurThe Company maintains “disclosure controls and procedures” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to ensure that information required to be disclosed by us in reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the Company’s management, assessedincluding its Chief Executive Officer, Chief Financial Officer, and Board of Directors, as appropriate, to allow timely decisions regarding required disclosures.

In designing and evaluating the Company’s disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired objectives, and the Company necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures.

The Company’s management, including its Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our internal control over financial reportingthe design and operation of the Company’s disclosure controls and procedures as of September 30, 2018. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) inInternal Control-Integrated Framework. Based on our assessment, management2019 and concluded that while there was sufficient segregation of routine duties, the Company lacked thehas a material weakness in disclosure controls and procedures as of September 30, 2019.

The Company has an ineffective control environment due to a lack of internal resources with expertise to retain experts who could assist in the preparation and calculation ofdetermine entries and disclosures related to some of the Company’s more complex equity transactions. Management believes this lack of expert advice amountsinternal expertise has been somewhat mitigated by continuing to aretain consultants with this expertise in the quarter ended September 30, 2019. This material weakness in our financial reportingthe Company’s disclosure controls and our disclosure controls.procedures will be further remediated in 2019.

 

Changes in Internal Control Over Financial Reporting

 

During the quarternine months ended September 30, 2018,2019, there were no changes in ourthe Company’s internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) that have materially affected, or that are reasonably likely to materially affect, ourthe Company’s internal control over financial reporting.

 

PART II – OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS.

 

We areThe Company is not a party to any pending legal proceeding, nor is ourthe Company’s property the subject of a pending legal proceeding. None of ourthe Company’s directors, officers or affiliates are involved in a proceeding adverse to our business or has a material interest adverse to ourthe Company’s business.

 

ITEM 1A. RISK FACTORS.

 

We are a smaller reporting company as defined by 17 CFR 229.10(f)(1). Thus, we are not required to provide information under this item.

 

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

 

None.During the three months ended September 30, 2019, the Company received proceeds of $100,000 and issued 200,000 of common stock at a price of $0.50 per share, and a three-year warrant to purchase 100,000 shares of common stock at an exercise price of $1.00 per share.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES.

 

Not applicable.

 

ITEM 5. OTHER INFORMATION.

 

Not applicable.

 

ITEM 6. EXHIBITS.

 

The exhibits listed in the accompanying Exhibit Index are filed, furnished or incorporated by reference as part of this Quarterly Report on Form 10-Q.

 

35

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.

 

Date: November 14, 20182019

 

 MEDOVEX CORPH-CYTE, INC
   
 By:/s/ William E. Horne
  William E. Horne
  

Chief Executive Officer

(Principal Executive Officer)

   
 By:/s/ Charles FarraharJeremy Daniel
  Charles FarraharJeremy Daniel
  

Chief Financial Officer

(Principal Financial Officer and

Principal Accounting Officer)

EXHIBIT INDEX

 

31.1 Section 302 Certification of Principal Executive Officer*
31.2 Section 302 Certification of Principal Financial Officer*
32.1 Section 906 Certification of Principal Executive Officer and Principal Financial Officer***
101.INS XBRL Instance Document **
101.SCH XBRL Taxonomy Extension Schema Document **
101.CAL XBRL Taxonomy Calculation Linkbase Document **
101.LAB XBRL Taxonomy Labels Linkbase Document **
101.PRE XBRL Taxonomy Presentation Linkbase Document **
101.DEF XBRL Definition Linkbase Document **

 

*Filed herewith.
  
**Pursuant to Rule 406T of Regulation S-T adopted by the SEC, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Section 11 or 12 of the Securities Act of 1933, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, and otherwise are not subject to liability under these sections.
  
***

This certification is being furnished solely to accompany this Quarterly Report pursuant to 18 U.S.C. Section 1350, and it is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

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