UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended SeptemberJune 30, 20222023

 

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

 

H-CYTE,INNOVEREN SCIENTIFIC, INC

(Exact name of registrant as specified in its charter)

 

Nevada 46-3312262
(State or other jurisdiction of (IRS Employer
incorporation or organization) Identification No.)

 

2202 N. West Shore BlvdBlvd.. Ste 200  
Tampa, Florida 33607
(Address of 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 class Ticker symbol(s) Name of each exchange on which registered
Common Stock, par value $0.001 per share HCYTIVRN OTC 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.

 

Yes ☐ No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files.)

 

Yes ☐ No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company 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 filerSmaller Reporting Company
 Emerging Growth Company

 

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

 

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

 

☐ Yes ☒ No

 

As of November 14, 202210, 2023, 477,610712,710 shares of the registrant’s common stock were outstanding.

 

 

 

 

H-CYTE,INNOVEREN SCIENTIFIC, INC AND SUBSIDIARIES

 

TABLE OF CONTENTS

 

  Page
PART I – FINANCIAL INFORMATION 
  
 Special Note Regarding Forward-looking Statements3
Item 1.Financial Statements4
 Consolidated Balance Sheets4
 Consolidated Statements of Operations5
 Consolidated Statements of Stockholders’ Equity (Deficit)Deficit6
 Consolidated Statements of Cash Flows7
 Notes to Consolidated Financial Statements8
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations2120
Item 3.Quantitative and Qualitative Disclosures About Market Risks2624
Item 4.Controls and Procedures2624
   
PART II – OTHER INFORMATION 
   
Item 1.Legal Proceedings2725
Item 1A.Risk Factors2725
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds2725
Item 3.Defaults Upon Senior Securities2725
Item 4.Mine Safety Disclosures2725
Item 5.Other Information2725
Item 6.Exhibits2725
   
SIGNATURES2826

 

2

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 the Company’s 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:

 

 the Company’s ability to market, commercialize, and achieve broader market acceptance for its products;
   
 the Company’s ability to successfully expand and achieve full productivity from its sales, clinical support, and marketing capabilities;
   
 the Company’s ability to successfully complete the development of, and obtain regulatory clearance or approval for its products; and
   
 the estimates regarding the sufficiency of the Company’s cash resources, the ability to obtain additional capital, or the 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 the Company believes that it has 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 the Company and its projections of the future, about which it cannot be certain. As a result of these factors, the Company cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Furthermore, if the 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 the Company, or any other person, that it will achieve its objectives and plans in any specified time frame, or at all. The Company does 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.

 

3

Item 1. Financial Statements

 

H-CYTE,INNOVEREN SCIENTIFIC, INC AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

       June 30, 2023  December 31, 2022 
 (Unaudited)    (Unaudited)   
 September 30, 2022  December 31, 2021  June 30, 2023  December 31, 2022 
Assets                
                
Current Assets                
Cash $36,723  $95,172  $12,611  $- 
Accounts receivable  -   13,500 
Patient financing receivable, current portion  32,111   43,900   14,012   29,464 
Other receivables  2,981   - 
Prepaid expenses  102,188   44,884   140,045   54,381 
Total Current Assets  174,003   197,456   166,668   83,845 
                
Property and equipment, net  22,018   38,374   17,148   20,394 
Patient financing receivable, net of current portion  26,126   67,163   5,894   14,436 
Other assets  18,412   18,412   18,412   18,682 
Total assets $240,559  $321,405  $208,122  $137,357 
                
Liabilities and Stockholders’ Deficit                
                
Current Liabilities                
Accounts payable $842,767  $585,291  $1,138,255  $971,492 
Accrued liabilities  1,223,237   164,680   1,575,710   1,418,368 
Other current liabilities  268,785   28,246   229,165   139,330 
Notes payable, current portion  79,455   69,455   122,472   104,468 
Convertible notes payable, related parties  1,969,174   1,969,174   3,325,000   3,325,000 
Convertible notes payable  1,783,416   1,355,826   421,095   430,095 
PPP Loan, current portion  -   66,275 
Deferred revenue  -   414,025 
Convertible notes payable carried at fair value, related parties  435,130   - 
Convertible notes payable carried at fair value  163,400   - 
Lease liability, current portion  87,828   94,805   12,774   63,291 
Anti-dilution share contingent consideration liability  501,531   501,531 
Interest payable, related parties  242,648   98,055   518,313   400,042 
Interest payable  195,725   75,048   182,154   123,276 
Total Current Liabilities  6,693,035   4,920,880   8,624,999   7,476,893 
                
Long-term Liabilities                
Royalty liability  1,697,000   -   1,697,000   1,697,000 
Lease liability, net of current portion  -   62,768 
Milestone payment contingent consideration liability  320,850   320,850 
Total Long-term Liabilities  1,697,000   62,768   2,017,850   2,017,850 
                
Total Liabilities  8,390,035   4,983,648   10,642,849   9,494,743 
                
Stockholders’ Equity (Deficit)                
Preferred Stock - $.001 par value: 1,000,000,000 shares authorized; Series A Preferred Stock - $.001 par value: 800,000,000 shares authorized, 438,776,170 and 501,887,534 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively.  438,773   501,887 
Common stock - $.001 par value: 500,000,000 shares authorized, 477,610 and 166,394 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively. 1  477   164,199 
Additional paid-in capital1  49,246,179   43,700,084 
Preferred Stock - $.001 par value: 1,000,000,000 shares authorized; Series A Preferred Stock - $.001 par value: 800,000,000 shares authorized, 438,776,170 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively.  438,773   438,773 
Common stock - $.001 par value: 500,000,000 shares authorized, 661,345 and 618,506 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively.  662   618 
Additional paid-in capital  49,723,571   49,531,216 
Accumulated deficit  (57,834,905)  (49,028,413)  (60,597,733)  (59,327,993)
Total Stockholders’ Deficit  (8,149,476)  (4,662,243)  (10,434,727)  (9,357,386)
                
Total Liabilities and Stockholders’ Deficit $240,559  $321,405  $208,122  $137,357 

1The number of outstanding shares of common stock have been adjusted for all periods presented to reflect a one-for-one thousand reverse stock split that became effective on June 13, 2022. The amounts in common stock and additional paid-in capital were adjusted as of the effective date of the one-for-one thousand reverse stock split. See Note 1 for additional information.

 

See accompanying notes to the consolidated financial statements

 

4

H-CYTE,INNOVEREN SCIENTIFIC, INC AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

             
  Three Months Ended September 30,  Nine Months Ended September 30, 
  2022  2021  2022  2021 
Revenues $-  $460,216  $453,460  $1,286,841 
Cost of Sales  -   (138,786)  (116,602)  (553,454)
Gross Profit  -   321,430   336,858   733,387 
                 
Operating Expenses                
Salaries and related costs  221,304   534,752   848,036   1,782,646 
Share based compensation  120,448   162,359   535,481   1,024,359 
Loss on disposal of property and equipment  -   -   9,610   92,804 
Acquired in process research and development  

1,245,948

   -   

1,245,948

   - 
Other general and administrative  268,076   851,593   1,172,738   2,470,135 
Total Operating Expenses  1,855,776   1,548,704   3,811,813   5,369,944 
                 
Operating Loss  (1,855,776)  (1,227,274)  (3,474,955)  (4,636,557)
                 
Other Income (Expense)                
Forgiveness of PPP loan  -   698,820   -   698,820 
Warrant expense  

(334,238

)  

-

   

(334,238

)  

-

 
Inducement expense  -  -   (3,024,872)  - 
Loss on extinguishment of convertible notes payable  -   -   (2,196,100)  - 
Interest income  1,756   -   506,795   - 
Interest expense  (91,186)  (50,516)  (278,665)  (110,446)
Other expense  -   (7,641)  (4,457)  (4,107)
Total Other Income (Expense)  (423,668)  640,663   (5,331,537)  584,267 
                 
Net Loss $(2,279,444) $(586,611) $(8,806,492) $(4,052,290)
                 
Net Loss attributable to common stockholders $(2,279,444) $(586,611) $(8,806,492) $(4,052,290)
                 
Loss per share - basic and diluted1  

(8.04

)  

-

   

(34.07

)  

(30.00

)
                 
Weighted average outstanding shares -basic and diluted  

283,579

   

142,408

   

258,483

   

140,074

 

 

  2023  2022  2023  2022 
  Three months ended June 30,  Six months ended June 30, 
  2023  2022  2023  2022 
Revenues $-  $73,900  $-  $453,460 
Cost of Sales  -   (30,097)  -   (116,602)
Gross Profit  -   43,803   -   336,858 
                 
Operating Expenses                
Salaries and related costs  161,719   279,513   326,976   626,732 
Share based compensation  33,299   188,954   74,527   415,033 
Loss on disposal of property and equipment  -   9,610   -   9,610 
Other general and administrative  213,814   394,751   428,013   904,662 
Total Operating Expenses  408,832   872,828   829,516   1,956,037 
                 
Operating Loss  (408,832)  (829,025)  (829,516)  (1,619,179)
                 
Other Income (Expense)                
Day one loss on convertible notes carried at fair value  (5,471)  -   (1,527,239)  - 
Gain on convertible notes carried at fair value  1,312,093   -   1,314,837   - 
Inducement expense  -   -   -   (3,024,872)
Loss on extinguishment of convertible notes payable  -   (2,196,100)  -   (2,196,100)
Interest income  1,495   501,670   1,495   505,040 
Interest expense  (98,647)  (111,758)  (248,860)  (187,480)
Other income (expense)  19,742   (52)  19,543  (4,457)
Total Other Expense  1,229,212   (1,806,240)  (440,224)  (4,907,869)
                
Net Income (Loss) $820,380  $(2,635,265) $(1,269,740) $(6,527,048)
                
Net Income (Loss) attributable to common stockholders $820,380  $(2,635,265) $(1,269,740) $(6,527,048)
                 
Income (loss) per share - basic $1.30  $(11.97) $(2.02) $(29.87)
Income (loss) per share – diluted $0.77  $(11.97) $(2.02) $(29.87)
                 
Weighted average outstanding shares – basic  631,167   220,180   625,911   218,531 
Weighted average outstanding shares – diluted  1,069,942   220,180   625,911   218,531 

1The number of outstanding shares of common stock have been adjusted for all periods presented to reflect a one-for-one thousand reverse stock split that became effective on June 13, 2022. The amounts in common stock and additional paid-in capital were adjusted as of the effective date of the one-for-one thousand reverse stock split. See Note 1 for additional information.

 

See accompanying notes to the consolidated financial statements

 

5

H-CYTE, INCINNOVEREN SCIENTIFIC AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

For the three months and ninesix months ended SeptemberJune 30, 20212023 and 2022

(Unaudited)

S Shares  Amount  Shares1  

Amount1

  

Capital1

  Deficit  Deficit 
Three months ended Preferred Series A Stock  Common Stock1  

Additional

Paid-in

  Accumulated  Stockholders’ 
September 30, 2021 and 2022 Shares  Amount  Shares  Amount  

Capital1

  Deficit  Deficit 
Balances - June 30, 2021  520,305,884  $520,305   144,963  $144,963  $43,377,999  $(47,694,785) $(3,651,518)
Conversion of Series A Preferred Stock to Common Stock  (4,431,530)  (4,431)  4,431   4,431   -   -   - 
Share based compensation  -   -   -   -   162,359   -   162,359 
Net loss  -   -   -   -   -   (586,611)  (586,611)
Balances - September 30, 2021  515,874,354  $515,874   149,394  $149,394  $43,540,358  $(48,281,396) $(4,075,770)

  Preferred Series A Stock  Common Stock1  

Additional

Paid-in

  Accumulated  Stockholders’ 
  Shares  Amount  Shares  Amount  Capital1  Deficit  Deficit 
Balances - June 30, 2022  494,579,119  $494,578   257,282  $257  $48,481,350  $(55,555,461) $(6,579,276)
Conversion of Series A Preferred Stock to Common Stock  (55,802,949)  (55,805)  55,805   55   

55,750

   -   - 
Issuance of Common Stock pursuant to securities purchase agreement  -   -   112,500   113   224,888   -   225,001 
Issuance of Common Stock pursuant to Jantibody acquisition  -   -   52,023   52   29,505  -   29,557 
Warrant expense  -   -   -   -   334,238   -   334,238 
Share based compensation  -   -   -   -   120,448   -   120,448 
Net loss  -   -   -   -   -   (2,279,444)  (2,279,444)
Balances - September 30, 2022  438,776,170  $438,773   477,610  $477  $49,246,179  $(57,834,905) $(8,149,476)

Nine months ended Preferred Series A Stock  Common Stock1  

Additional

Paid-in

  Accumulated  Stockholders’ 
September 30, 2021 and 2022 Shares  Amount  Shares  Amount  Capital1  Deficit  Deficit 
Balances - December 31, 2020  538,109,409  $538,109   127,159  $127,159  $42,515,999  $(44,229,106) $(1,047,839)
Conversion of Series A Preferred Stock to Common Stock  (22,235,055)  (22,235)  22,235   22,235   -   -   - 
Share based compensation  -   -   -   -   1,024,359   -   1,024,359 
Net Loss  -   -   -   -   -   (4,052,290)  (4,052,290)
Balances - September 30, 2021  515,874,354  $515,874   149,394  $149,394  $43,540,358  $(48,281,396) $(4,075,770)

  Preferred Series A Stock  Common Stock1  

Additional

Paid-in

  Accumulated  Stockholders’ 
  Shares  Amount  Shares  Amount  Capital1  Deficit  Deficit 
Balances - December 31, 2021  501,887,534  $501,887   166,394  $164,199  $43,700,084  $(49,028,413) $(4,662,243)
Beginning balance  501,887,534  $501,887   166,394  $164,199  $43,700,084  $(49,028,413) $(4,662,243)
Conversion of Series A Preferred Stock to Common Stock  (63,111,364)  (63,114)  63,114   7,364   55,750   -   - 
Adjustment for 1-for-1,000 reverse stock split 1  -   -   -   (254,831)  254,831   -   - 
Issuance of Common Stock pursuant to securities purchase agreement  -   -   112,500   113   224,888   -   225,001 

Issuance of Common Stock pursuant to

Jantibody acquisition
  -   -   52,023   52   29,505  -   29,557 
Inducement expense  -   -   -   -   3,024,872   -   3,024,872 
Warrant expense  

-

   

-

   

-

   

-

   

334,238

   

-

   

334,238

 
Conversion of warrants to Common Stock  -   -   83,579   83,580   1,086,530   -   1,170,110 
Share based compensation  -   -   -   -   535,481   -   535,481 
Net loss  -   -   -   -   -   (8,806,492)  (8,806,492)
Balances - September 30, 2022  438,776,170  $438,773   477,610  $477  $49,246,179  $(57,834,905) $(8,149,476)
Ending balance  438,776,170  $438,773   477,610  $477  $49,246,179  $(57,834,905) $(8,149,476)

 

                          
  Preferred Series A Stock  Common Stock  Additional
Paid-in
  Accumulated  Stockholders’ 
Three months ended June 30, 2022 and 2023 Shares  Amount  Shares  Amount  Capital1  Deficit  Deficit 
Balances - March 31, 2022  498,229,804  $498,229   253,631  $251,437  $48,037,565  $(52,920,196) $    (4,132,965)
Conversion of Series A Preferred Stock to Common Stock  (3,650,685)  (3,651)  3,651   3,651   -   -   - 
Adjustment for 1-for-1,000 reverse stock split1  -   -   -   (254,831)  254,831   -   - 
Share based compensation  -   -   -   -   188,954   -   188,954 
Net loss  -   -   -   -   -   (2,635,265)  (2,635,265)
Balances - June 30, 2022  494,579,119  $494,578   257,282  $257  $48,481,350  $(55,555,461) $(6,579,276)

  Preferred Series A Stock  Common Stock  Additional
Paid-in
  Accumulated  Stockholders’ 
  Shares  Amount  Shares  Amount  Capital1  Deficit  Deficit 
Balances - March 31, 2023  438,776,170  $438,773   628,121  $628  $49,650,254  $(61,418,113) $  (11,328,458)
Conversion of convertible notes payable to Common Stock  -   -   33,224   34   33,966   -   34,000 
Share based compensation  -   -   -   -   33,299   -   33,299 
Issuance of warrants pursuant to convertible notes payable  -   -   -   -   6,052   -   6,052 
Net income  -   -   -   -   -   820,380   820,380 
Balances - June 30, 2023  438,776,170  $438,773   661,345  $662  $49,723,571  $(60,597,733) $(10,434,727)

  Preferred Series A Stock  Common Stock  

Additional

Paid-in

  Accumulated  Stockholders’ 
Six months ended June 30, 2022 and 2023 Shares  Amount  Shares  Amount  Capital1  Deficit  Deficit 
Balances - December 31, 2021  501,887,534  $501,887   166,394  $164,199  $43,700,084  $(49,028,413) $    (4,662,243)
Conversion of Series A Preferred Stock to Common Stock  (7,308,415)  (7,309)  7,309   7,309   -   -   - 
Adjustment for 1-for-1,000 reverse stock split1  -   -   -   (254,831)  254,831   -   - 
Inducement expense  -   -   -   -   3,024,872   -   3,024,872 
Conversion of warrants to Common Stock  -   -   83,579   83,580   1,086,530   -   1,170,110 
Share based compensation  -   -   -   -   415,033   -   415,033 
Net Loss  -   -   -   -   -   (6,527,048)  (6,527,048)
Balances - June 30, 2022  494,579,119  $494,578   257,282  $257  $48,481,350  $(55,555,461) $(6,579,276)

  Preferred Series A Stock  Common Stock  Additional
Paid-in
  Accumulated  Stockholders’ 
  Shares  Amount  Shares  Amount  Capital1  Deficit  Deficit 
Balances - December 31, 2022  438,776,170  $438,773   618,506  $618  $49,531,216  $(59,327,993) $   (9,357,386)
Balance  438,776,170  $438,773   618,506  $618  $49,531,216  $(59,327,993) $   (9,357,386)
Share based compensation  -   -   -   -   74,527   -   74,527 
Issuance of warrants pursuant to convertible notes payable  -   -   -   -   73,872   -   73,872 
Conversion of convertible notes payable to Common Stock  -   -   42,839   44   43,956   -   44,000 
Net loss  -   -   -   -   -   (1,269,740)  (1,269,740)
Balances - June 30, 2023  438,776,170  $438,773   661,345  $662  $49,723,571  $(60,597,733) $(10,434,727)
Balance  438,776,170  $438,773   661,345  $662  $49,723,571  $(60,597,733) $(10,434,727)

1The number of outstanding shares of common stock have been adjusted for all periods presented to reflect a one-for-one thousand reverse stock split that became effective on June 13, 2022. The amounts in common stock and additional paid-in capital were adjusted as of the effective date of the one-for-one thousand reverse stock split. See Note 1 for additional information.

 

See accompanying notes to the consolidated financial statements

 

6

H-CYTE,INNOVEREN SCIENTIFIC, INC AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

Unaudited(Unaudited)

 

 2022  2021  2023  2022 
 Nine Months Ended September 30,  For the the six months ended June 30, 
 2022  2021  2023  2022 
Cash Flows from Operating Activities                
Net loss $(8,806,492) $(4,052,290) $(1,269,740) $(6,527,048)
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization  10,086   13,859   3,245   5,958 
Share based compensation expense  

74,527

   

415,033

 
Inducement expense  -   3,024,872 
Bad debt expense  

20,301

   

13,500

 
Day one loss on convertible notes carried at fair value  1,527,239   - 
Gain on convertible notes carried at fair value  (1,314,837)  - 
Amortization of debt premium  (499,100)  

-

   -   

(499,100

)
Inducement expense  3,024,872   - 
Share based compensation expense  535,481   1,024,359 
Loss on debt extinguishment  2,196,100   

-

   -   

2,196,100

 
Gain on extinguishment of debt - PPP Loan  

-

   (698,820)
Warrant expense  334,238   

-

 
Bad debt expense  59,820   

-

 
Expense of acquired IPR&D  

1,245,948

   - 
Loss on disposal of property and equipment  9,610   92,804   -   9,610 
Changes in operating assets and liabilities:                
Accounts receivable  (46,320)  (9,200)
Patient financing receivable, current portion  11,789   (35,080)  (420)  3,601
Other receivables  (2,981)  21,572 
Patient financing receivable, net of current portion  4,384   26,699
Prepaid expenses and other assets  (57,304)  (968)  (85,664)  (92,114)
Patient financing receivable, net of current portion  41,037   (61,547)
Interest payable  

58,878

   

80,090

 
Interest payable, related parties  

118,271

   

102,316

 
Other current liabilities  

39,318

   

42,140

 
Accounts payable  235,876   37,759   166,763   114,067 
Accrued liabilities  58,830   (89,296)  157,342   (28,719)
Other current liabilities  (24,739)  (13,482)
Deferred revenue  (414,025)  (224,118)  -   (414,025)
Interest payable, related parties  144,593   - 
Interest payable  120,677   6,333 
Net Cash Used in Operating Activities  (1,822,004)  (3,988,115)  (500,393)  (1,527,380)
                
Cash Flows from Investing Activities        
Purchase of property and equipment  -   (7,832)
Cash acquired in asset acquisition  469     
Net Cash Used in Investing Activities  

469

   (7,832)
        
Cash Flows from Financing Activities                
Payment on PPP Loan  -   

(66,275

)
Proceeds from warrants exercise related to inducement  -   1,170,110 
Proceeds from notes payable  67,500   

-

   18,004   15,000 
Proceeds from convertible notes payable, related parties  -   1,584,665 
Proceeds from convertible notes payable  437,500   1,091,080 
Proceeds from warrants exercised  1,170,110   - 
Proceeds from issuance of common stock  225,001   

-

 
Payment on debt obligations  (57,500)  

-

 
Proceeds from convertible note payable  150,000   372,500 
Payment on convertible note payable  (115,000)  - 
Payment on debt financing costs  (13,250)  

-

   -   

(13,250

)
Payment on PPP Loan  (66,275)  (13,230)
Proceeds from convertible notes payable carried at fair value, related parties  275,000   - 
Proceeds from convertible notes payable carried at fair value  185,000   - 
Net Cash Provided by Financing Activities  1,763,086   2,662,515   513,004   1,478,085 
                
Net Change in Cash  (58,449)  (1,333,432)  12,611   (49,295)
                
Cash - Beginning of period  95,172   1,640,645 
Cash – Beginning of period  -   95,172 
                
Cash - End of period $36,723  $307,213 
Cash – End of period $12,611  $45,877 
                
Supplementary Cash Flow Information                
Cash paid for interest $9,916  $3,367  $80,711  $4,077 
                
Non-cash investing and financing activities        
Non Cash Investing & Financing Activity        
Conversion of Series A Preferred Stock to Common Stock $

63,114

  

22,235

  $-  $7,309 
Issuance of warrants pursuant to inducement agreements $

2,993,872

  -

  $-  $2,993,872 
Issuance of warrants for services rendered $

31,000

 -

  $-  $31,000 
Issuance of warrants pursuant to securities purchase agreement $

334,238

   - 
Issuance of Common Stock pursuant to Jantibody acquisition $29,557   - 
Conversion of convertible notes payable to Common Stock $44,000  $- 
Issuance of warrants pursuant to convertible notes payable – related party $44,255  $- 
Issuance of warrants pursuant to convertible notes payable $29,617  $- 

 

See accompanying notes to the consolidated financial statements

 

7

H-CYTE,INNOVEREN SCIENTIFIC, INC

NOTES TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

Note 1 - Description of the Company

DESCRIPTION OF THE COMPANY

On July 5, 2023, Innoveren Scientific, Inc. (the “Company formerly known as H-CYTE, Inc.”) filed with the Secretary of State of the State of Nevada a Certificate of Amendment to Second Amended and Restated Article of Incorporation to change the corporate name from H-Cyte, Inc. to Innoveren Scientific, Inc. The name change and Company’s new symbol, IVRN, became effective with FINRA on July 10, 2023.

Innoveren Scientific, Inc (“the Company”) has shiftedevolved from focusing on treating chronic lung conditions after the closure of its focuslung treatment clinics due to COVID-19. The Company is currently focusing on acquiring and developing early-stage companies or their technologies in the areas of therapeutics, medical devices, and diagnostics. The goal is to develop these companies and incubate their technologies to meaningful clinical inflection points.

 

On June 3, 2022, the Company closed its clinic in Scottsdale, Arizona. The Company has now closed all of its clinical operations in the autologous infusion therapy business which delivered treatments for patients with chronic respiratory and pulmonary disorders. The Company will continue to pursue regulatoryFood and Drug Administration (“FDA”) approval of the device that was utilized in the treatment provided at the clinics. The Company also has a continued interest in the commercialization of the DenerveX device.device through a joint venture (see Note 11 – Subsequent Events). The Company has begun to transform itselfimplemented the transition into a biologics and therapeutic device incubator company to bring new technologies to market.

 

The consolidated results for H-CYTEInnoveren Scientific, Inc include the following wholly-owned subsidiaries: H-CYTE Management, LLC, Medovex Corp, Cognitive Health Institute, LLC, and Lung Institute Tampa, LLC and the results include Lung Institute Dallas, LLC (“LI Dallas”), Lung Institute Nashville, LLC (“LI Nashville”), Lung Institute Pittsburgh, LLC (“LI Pittsburgh”), and Lung Institute Scottsdale, LLC (“LI Scottsdale”), as Variable Interest Entities (“VIEs”). Additionally, H-CYTE Management, LLC was the operator and manager of the various Lung Health Institute (LHI) clinics: LI Dallas, LI Nashville, LI Pittsburgh, and LI Scottsdale. The LI Dallas and LI Pittsburgh clinics did not reopen in 2020 after the temporary closure of all LI clinics due to COVID-19. These two clinics will remain permanently closed. During the first quarter of 2022, the Company decided to closeclosed the LI Tampa and LI Nashville clinics. During the second quarter of 2022, the Company closed the LI Scottsdale clinic,clinic. All LHI clinics are closed as of June 30, 2023. The Company leases a shared office space for its corporate address as the final LHI clinic.Company’s employees continue to work remotely.

 

On June 10, 2022, the Company amended (the “Amendment”) its Articles of Incorporation to effectuate a one-for-one thousand reverse stock split (the “Reverse Split”) of its common stock. The Reverse Split was approved by FINRA on June 10, 2022 and effectuated on June 13, 2022. Pursuant to the Amendment, the Company also reduced the authorized shares of common stock to 500,000,000. As a result of the Reverse Split, as of SeptemberJune 30, 2022,2023, the Company has 477,610661,345 shares of common stock outstanding and 438,776,170 shares of Series A Preferred Stock outstanding. As a result of the Reverse Stock Split, the Series A Preferred Stock conversion ratio is now one thousand shares of Series A Preferred Stock converts into one share of common stock. Accordingly, the 438,776,170 outstanding shares of Series A Preferred Stock are now convertible into an aggregate of 438,776 shares of common stock.

 

On September 7, 2022, the Company acquired all of the membership interests, with common stock, of Jantibody LLC (“Jantibody”), a Nevada limited liability company. Jantibody is focused on the development of novel proprietary immunotherapies targeted towards ovarian cancer, pancreatic cancer, and mesothelioma (see Note 9).

Impact of COVID-19

The coronavirus outbreak (“COVID-19”) has adversely affected the Company’s financial condition and results of operations. The impact of the COVID-19 outbreak on businesses and the economy in the United States is expected to continue to be significant. The extent to which the COVID-19 outbreak will continue to impact businesses and the economy is highly uncertain. Accordingly, the Company cannot predict the extent to which its financial condition and results of operation will be affected.

 

On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency caused by a new strain of the coronavirus and advised of the risks to the international community as the virus spread globally. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic based on the rapid increase in exposure globally. The spread of COVID-19 coronavirus has caused public health officials to recommend precautions to mitigate the spread of the virus, especially as to travel and congregating in large numbers. In addition, certain states and municipalities have enacted quarantining regulations which severely limit the ability of people to move and travel.

In addition, the Company is uncertain of the full effect the pandemic will have on it for the longer term since the scope and duration of the pandemic is unknown, and evolving factors such as the level and timing of the distribution of efficacious vaccines across the world and the extent of any resurgences of the virus or emergence of new variants of the virus, such as the Delta variant and the Omicron variant, will impact the stability of economic recovery and growth. The Company may experience long-term disruptions to its operations resulting from changes in government policy or guidance; quarantines of employees, customers and suppliers in areas affected by the pandemic; and closures of businesses or manufacturing facilities critical to its business.

8

Autologous Infusion Therapy (“Infusion Division”)

The Company’s Infusion Division develops and implements innovative treatment options in autologous cellular therapy (PRP-PBMC) to treat chronic lung disorders. Committed to an individualized patient-centric approach, this division consistently provides oversight and management of the highest quality care to the LHI clinics located in Tampa, Nashville, and Scottsdale, while producing positive medical outcomes following the strictest CDC guidelines. During the first quarter ofDecember 22, 2022, the Company decided to closeacquired all the clinicsmembership interests, with common stock, in TampaScion Solutions, LLC (“Scion”). Scion is a life sciences company that has developed a new technology in regenerative medicine specifically for limb salvage. Their proprietary product SkinDisc (patent pending) is a combination of stem cells and Nashville. During the second quarter of 2022, the Company closed its clinic in Scottsdale. The Company has now closed all of its clinical operations in the autologous infusion therapy division which delivered treatments for patients with chronic respiratory and pulmonary disorders.several other molecular components that stimulate tissue regeneration (see Note 9).

Biotech Development (“Biotech Division”)

During the year ended December 31, 2021, the Company completed a review of the R&D status regarding the exclusive product supply and services agreements with Rion, LLC (“Rion”) to develop and distribute (post U.S. Food & Drug Administration, the “FDA”, approval) a biologic combining its PRP-PBMC (“PRP”) technology with Rion’s exosomes (“EV”) technology for the treatment of chronic obstructive pulmonary disease (“COPD”). The Company has determined a single entity biologic from an alternative commercial source will be a more viable solution. The Company has decided to move away from Rion’s PRP technology and is progressing towards alternate biologics and therapeutic devices to meet the needs of the business.

As of June 30, 2022, the Company has closed all of the LHI clinics and has moved away from the Infusion Division as part of its future plans. The Company has also decided that the Biotech Division will begin to transform into a medical biosciences incubator division focusing on bringing new biologics and therapeutic device technologies to market for various health conditions.

 

Note 2 – Basis of presentation

BASIS OF PRESENTATION

The accompanying interim consolidated financial statements have been prepared based upon U.S. Securities and Exchange Commission rules that permit reduced disclosure for interim periods. Therefore, they do not include all information and footnote disclosures necessary for a complete presentation of the Company’s financial position, results of operations and cash flows, in conformity with generally accepted accounting principles. The Company filed audited consolidated financial statements as of and for the fiscal years ended December 31, 20212022 and 2020,2021, which included all information and notes necessary for such complete presentation in conjunction with its 20212022 Annual Report on Form 10-K.

 

Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations.

 

8

The results of operations for the interim period ended SeptemberJune 30, 20222023, are not necessarily indicative of the results to be expected for any future period or the entire fiscal year. These interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2021,2022, which are contained in the Company’s 20212022 Annual Report on Form 10-K. For further discussion refer to Note 2 – “Basis ofOf Presentation And Summary of Significant Accounting Policies” to the consolidated financial statements and “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021.2022.

 

Note 3 - Liquidity, Going Concern and Management’s PlansSources of Liquidity

 

LIQUIDITY, GOING CONCERN AND MANAGEMENT’S PLANSSOURCES OF LIQUIDITY

The Company incurredgenerated net lossesincome (loss) of approximately $2,279,000820,000 and $8,806,000($1,270,000) for the three and ninesix months ended SeptemberJune 30, 2022.2023. The Company has historically incurred losses from operations and expects to continue to generate negative cash flows as it implements its plan around acquiring and developing early-stage companies or their technologies in the Biosciences Division.areas of therapeutics, medical devices, and diagnostics. The consolidated financial statements are prepared using accounting principles generally accepted in the United States (“U.S. GAAP”) as applicable to a going concern.

 

COVID-19 has adversely affected the Company’s financial condition and results of operations. The impact of the outbreak of COVID-19 on the economy in the U.S. and the rest of the world is expected to continue to be significant. The extent to which the COVID-19 outbreak will continue to impact the economy is highly uncertain and cannot be predicted. Accordingly, the Company cannot predict the extent to which its financial condition and results of operations will be affected.

The Company had cash on hand of approximately $37,00013,000 as of SeptemberJune 30, 2022,2023 and approximately $30,000150,000, as of November 14, 2022.9, 2023. The Company’s cash is insufficient to fund its operations over the next year and the Company is currently working to obtain additional debt or equity financing to help support short-term working capital needs.

 

There can be no assurance that the Company will be able to raise additional funds or that the terms and conditions of any future financings will be workable or acceptable to the Company or its shareholders. If the Company is unable to fund its operations from existing cash on hand, operating cash flows, additional borrowings, or raising equity capital, the Company may not continuebe forced to cease operations. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

9

In January 2022,On February 24, 2023, the Company offeredand certain warrant holdersinvestors entered into Securities Purchase Agreements (the “SPA”), whereby the opportunityCompany sold and issued to receivethe certain investors an additional warrant to purchaseaggregate of three hundred thousand dollars ($300,000) of the Company’s convertible promissory notes (the “Note” or “Notes”), which are convertible into the Company’s Common Stock, at $14.000.001 par value (“Common Stock”). In connection with the aforementioned Notes, the Company also issued to the investors a warrant to purchase (the “Purchase Warrant”) a certain number of shares of Common Stock, which are equal to 20% of the shares of Common Stock issuable upon conversion of the Note, based on a price of $2.00 per share, forshare. These warrants have a periodterm of five (5) years, from issuance for thewith an exercise price of each existing warrant originally issued in April 2020 prior to March 31, 2021. As of September 30, 2022,$2.00 per share. Unless the Company had eleven warrant holders exercise an aggregatechooses to terminate earlier, the offering and the sale of 83,579 warrants at $14.00the Notes shall terminate on the sooner of the sale of the maximum offering amount or April 30, 2023. However, the Company extended this offering to June 30, 2023, per share resulting in cash proceedsterms of approximately $1,170,000 to the Company.agreement.

 

The Notes have a maturity date of the earlier of (i) one year from issuance; or (ii) upon the closing of a qualified offering. Interest on the Note shall accrue on the unpaid principal balance of this Note at the rate of eight percent (8%) per annum, and will be calculated on an actual/365-day basis. In the event that the Company filedmoves forward with a Registration Statementqualified offering, as referenced in the SPA, the Holder may convert the unpaid and outstanding principal plus any accrued and unpaid interest into shares of the Company’s Common Stock at a conversion price equal to a 20% discount to the offering price.

Further, in connection with the SPA, the Company also issued Common Stock Purchase Warrants to certain investors, which are exercisable on Form S-1 registeringor prior to the resaleclose of business on the five (5) year anniversary of the initial issue date, to purchase up to a certain amount of shares of Common Stock, with 20% of the shares of common stockCommon Stock issuable upon exerciseconversion of the warrantsConvertible Promissory Note purchased by the Holder, pursuant to the SPA between the Holder and the Company, dated February 24, 2023. The Company issued inWarrants to purchase an aggregate of 30,000 shares of Common Stock. The exercise price per share of the April 2020 financing. The registration statement was declared effective on February 14, 2022.Common Stock under these Warrants is $2.00.

 

On June 9, 2022,February 28, 2023, the Company entered into a securities purchase agreement for a total of $272,500 with two accredited investors. The notes issued are convertible into common stock at a 35% discount to the lowest trading price in the 20-day period prior to conversion. The notes bear interest at 10% and are due one year from issuance. For the first six (6) months, the Company has the right to prepay the notes at a premium of between 25% and 35% depending on when it is repaid.

On June 9, 2022, the Company also issued a promissory note for $100,000 to another accredited investor. This note bears interest at 15% (no matter when repaid) and converts at a discount of 25% of the price of a public offering or a 25% discount to the volume-weighted average price (VWAP) of the five (5) days prior to conversion.

On August 9, 2022, the Company entered into a securities purchase agreement for a total of $65,000150,000 with an accredited investor. The note issued is convertible into common stock at a 35%65% discount to the lowest trading price in the 20-day period prior to conversion. The note bears interest at 10% and is due one year from issuance. For the first six (6) months, the Company has the right to prepay the notesnote at a premium of between 25% and 35%40% depending on when it is repaid.repaid.

9

On March 27, 2023, the Company and three related party investors entered into Securities Purchase Agreements (the “SPA”), whereby, the Company sold and issued to the certain investors, an aggregate of one hundred twenty five thousand dollars ($125,000) of the Company’s convertible promissory notes (the “Note” or “Notes”), which are convertible into the Company’s Common Stock, $0.001 par value (“Common Stock”). On April 12, 2023, the Company and an additional investor entered into the SPA, whereby, the Company sold and issued an aggregate of thirty five thousand dollars ($35,000) of the Company’s Notes. In connection with the aforementioned Notes, the Company also issued to the investors a warrant to purchase (the “Purchase Warrant”) a certain number of shares of Common Stock, which are equal to 20% of the shares of Common Stock issuable upon conversion of the Note, based on a price of $2.00 per share. These warrants have a term of five (5) years, with an exercise price of $2.00 per share. Unless the Company chooses to terminate earlier, the offering and the sale of the Notes shall terminate on the sooner of the sale of the maximum offering amount or April 30, 2023. However, the Company extended this offering to June 30, 2023, per terms of the agreement.

The March 27, 2023 Notes have a maturity date of the earlier of (i) one year from issuance; or (ii) upon the closing of a qualified offering. The April 12, 2023 Note has a maturity date 60 days from issuance. Interest on the Note shall accrue on the unpaid principal balance of this Note at the rate of eight percent (8%) per annum and will be calculated on an actual/365-day basis. The Company defaulted on this note as of June 12, 2023, which triggered an increase of interest from 8% to 12%. In the event that the Company moves forward with a qualified offering, as referenced in the SPA, the Holder may convert the unpaid and outstanding principal plus any accrued and unpaid Interest into shares of the Company’s Common Stock at a conversion price equal to a 20% discount to the offering price.

 

On September 29, 2022,Further, in connection with the SPA, the Company entered intoalso issued Common Stock Purchase Warrants to certain investors, which are exercisable on or prior to the close of business on the five (5) year anniversary of the initial issue date, to purchase up to a securities purchase agreement with two accredited investors for the salecertain amount of shares of Common Stock, and warrants (the “Purchase Agreement”). Pursuantwith 20% of the shares of Common Stock issuable upon conversion of the Convertible Promissory Note purchased by the Holder, pursuant to the Purchase Agreement,SPA between the Holder and the Company. The Company soldissued Warrants to purchase an aggregate of 112,500 shares of common stock and warrants to purchase 56,25012,500 shares of Common Stock exercisable at $2.50Stock. The exercise price per share for gross proceeds of $225,001. All of the shares describedCommon Stock under these Warrants is $2.00.

Note 4 – Fair Value of Financial Instruments

FAIR VALUE OF FINANCIAL INSTRUMENTS

The Company measures certain financial instruments and certain financial instruments with related parties at fair value on a recurring basis. The Company elected the fair value option of accounting for certain debt instruments. Under the fair value option, the financial instrument is initially measured at its issue date estimated fair value and subsequently remeasured at estimated fair value on a recurring basis each reporting period with the resulting fair value adjustment recognized as other income (expense) in this Current Reportthe consolidated statement of operations. As of June 30, 2023, the fair value of these instruments was as follows:

SCHEDULE OF FAIR VALUE INSTRUMENT

  Total  Level 1  Level 2  Level 3 
             
Assets: $-  $    -  $    -  $ - 
Liabilities:                
Convertible Notes at fair value $598,530  $-  $-  $598,530 

The following is a reconciliation of the beginning and ending balances for the Convertible Notes measured at fair value on Form 8-Ka recurring basis using significant unobservable inputs (Level 3) during the six months ended June 30, 2023:

SCHEDULE OF CONVERTIBLE NOTE MEASURED AT FAIR VALUE

     
Balance at December 31, 2022 $ 
Fair value of Convertible Notes issued  (1,913,367)
Gain on change in fair value of Convertible Notes  1,314,837 
Balance at June 30, 2023 $(598,530)

The estimated fair values reported utilize the Company’s common stock price along with certain Level 3 inputs, as discussed below, in the development of Monte Carlo simulation models. The estimated fair values are being offeredsubjective and issuedare affected by changes in inputs to accredited investorsthe valuation models /analyses, including the Company’s common stock price, the Company’s dividend yield, risk-free rates based on U.S. Treasury security yields, and certain other Level-3 inputs including, assumptions regarding the estimated volatility in reliance upon exemptions from the registration requirements under Section 4(a)(2) undervalue of the Securities ActCompany’s common stock price, the probability of 1933, as amended (“Securities Act”),a Qualified Offering, the estimated price of a Qualified Offering, and Rule 506 of Regulation D promulgated thereunder.credit-risk adjusted discount rates. Changes in these assumptions can materially affect the estimated fair values.

 

Note 4 –Related5 – Related Party Transactions

RELATED PARTY TRANSACTIONS

Officers and Board Members and Related Expenses

 

On January 12, 2021, Mr. Raymond Monteleone was appointed as Chairman of the Board, Audit Committee Chair, and Compensation Committee Chair. There are understandings between the Company and Mr. Monteleone for him to receive $5,000 per month to serve on the Board of Directors and an additional $2,500 per quarter to serve as Chairman of the Board, Audit Committee Chair, and Compensation Committee Chair. Effective January 1, 2022, Mr. Monteleone receives $7,500 per month to serve on the Board of Directors and an additional $2,500 per quarter to serve as Chairman of the Board, Audit Committee Chair, and Compensation Committee Chair. Effective July 1, 2022, due to lack of working capital, Mr. Monteleone receives $3,750 per month to serve on the Board of Directors and to serve as Chairman of the Board, Audit Committee Chair, and Compensation Committee Chair. For the three months and ninesix months ended SeptemberJune 30, 2022,2023 the Company expensed $13,75011,250 and $63,75022,500, respectively, for board of director fees to Mr. Monteleone. For the three months and ninesix months ended SeptemberJune 30, 2021,2022 the Company expensed $18,000 22,500and $53,00047,500, respectively, for board of director fees to Mr. Monteleone. Due to lack of financial resources, the Company has been unable to pay Mr. Monteleone for his services totaling $46,250, which is included in accounts payable as of June 30, 2023.

 

10

Mr. Michael Yurkowsky entered into an oral agreement with the Company on October 1, 2020, in which Mr. Yurkowsky will receive $4,167 per month to serve on the Board of Directors. For the three and nine months ended September 30, 2021, the Company expensed $13,000 and $38,000 respectively, for board of director fees to Michael Yurkowsky. On December 1, 2021, the Board of Directors of the Company appointed Michael Yurkowsky to serve as the Company’s Chief Executive Officer. Upon Mr. Yurkowsky’s appointment as CEO in December 2021, the Company terminated his payments for serving on the Board of Directors.

 

On January 12, 2021, Mr. William Horne stepped down as Chairman of the Board. Mr. Horne will remain a member of the Board. Effective March 1, 2021, the Company entered into an oral agreement with Mr. Horne in which Mr. Horne will receive $4,167 per month to serve on the Board of Directors. Mr. Horne agreed to continue to defer the $108,000in base salary deferred by him in 2018 until such time as there is a positive cash flow to meet the Company’s financial obligations and then the Company and Mr. Horne will work together in good faith to negotiate a payment plan for such deferred salary. Effective December 1, 2021, Mr. Horne will receive $5,000per month to serve on the Board of Directors. Effective July 1, 2022, due to lack of working capital, Mr. Horne receives $2,500per month to serve on the Board of Directors. For the three months and ninesix months ended SeptemberJune 30, 2022,2023, the Company expensed approximately $7,500and $42,50015,000, respectively, in compensation and board of director fees to Mr. Horne. For the three months and ninesix months ended SeptemberJune 30, 2021,2022 the Company expensed $13,00015,000 and $29,00035,000 , respectively, for board of director fees to Mr. Horne. Due to lack of financial resources, the Company has been unable to pay Mr. Horne for his services totaling $32,500, which is included in accounts payable as of June 30, 2023.

10

 

Mr. Richard Rosenblum entered into an oral agreement with the Company effective January 17, 2022, in which Mr. Rosenblum will receive $5,000per month to serve on the Board of Directors. Effective July 1, 2022, due to lack of working capital, Mr. Rosenblum receives $2,500per month to serve on the Board of Directors. For the three and ninesix months ended SeptemberJune 30, 2023 the Company expensed $7,500 and $15,000, for board of director fees to Mr. Rosenblum. For the three months and six months ended June 30, 2022 the Company expensed $7,500 15,000and $27,500, respectively, for board of director fees to Mr. Rosenblum. Due to lack of financial resources, the Company has been unable to pay Mr. Rosenblum for his services totaling $35,000, respectively.32,500, which is included in accounts payable as of June 30, 2023.

 

Mr. Matthew Anderer entered into an oral agreement with the Company effective January 17, 2022, in which Mr. Anderer will receive $5,000per month to serve on the Board of Directors. Effective July 1, 2022, due to lack of working capital, Mr. Anderer receives $2,500per month to serve on the Board of Directors. For the three month and six months ended June 30, 2023 the Company expensed $7,500 and $15,000, respectively, for board of director fees to Mr. Anderer. For the three months and ninesix months ended SeptemberJune 30, 2022 the Company expensed $7,500 15,000and $27,500, respectively, for board of director fees to Mr. Anderer. Due to lack of financial resources, the Company has been unable to pay Mr. Anderer for his services totaling $35,000, respectively.32,500, which is included in accounts payable as of June 30, 2023.

 

Debt and Other Obligations

 

Convertible Notes Payable

 

On April 1, 2021, the Company, entered into a Secured Convertible Note Purchase Agreement (the “April 2021 Note Purchase Agreement”) with five (5) related party investors (the “Holders”). Pursuant to the terms of the April 2021 Note Purchase Agreement, the Company sold promissory notes in the aggregate principal amount of $2,575,000 maturing on June 30,17, 2022 with an annual interest rate of 8%. The Notes are convertible into shares of Common Stock at a discount of 20% to the price paid for such New Securities in the next round of financing that meets the definition of Qualified Financing as defined in the April 2021 Note Purchase Agreement. The Notes are secured by the assets of the Company under a security agreement with the Holders. The lead investor of the April 2021 Note Purchase Agreement, FWHC Bridge, LLC, advanced $1,500,000 of the total amount to the Company. FWHC Bridge, LLC is an affiliated entity of FWHC, LLC, which is a principal stockholder and related party of the Company. An additional affiliate of FWHC, LLC provided an additional $25,000 as part of the April 2021 Note Purchase Agreement. The Company entered into an agreement with the noteholders to extend the maturity of the outstanding notes until July 31, 2024.

 

On October 14, 2021, the Company entered into the Second Closing Bring Down Agreement (the “October 2021 Note Purchase Agreement”) whereby the five (5) related party investors who had entered into the April 2021 Note Purchase Agreement purchased new notes in the Company in the aggregate principal amount of $750,000. The Notes are due and payable on June 17, 2022 and bear interest at an annual rate of 8%. The Notes are convertible into shares of Common Stock at a discount of 20% to the price paid for such New Securities in the next financing that meets the definition of a Qualified Financing as defined in the Note Purchase Agreement. The Notes are secured by all of the assets of the Company under a security agreement with the Holders. The lead investor of the October 2021 Note Purchase Agreement, FWHC Bridge, LLC, advanced $437,000 of the total amount to the Company. FWHC Bridge, LLC is an affiliated entity of FWHC, LLC, which is a principal stockholder and related party of the Company. An additional affiliate of FWHC, LLC provided an additional $7,000 as part of the October 2021 Note Purchase Agreement. Management is currently workingThe Company entered into an agreement with the noteholders on the extension ofto extend the maturity of the outstanding notes.notes until July 31, 2024.

11

 

On February 22, 2022, the Company entered into a Debt Conversion Agreement (the “Amendment Agreement”) which i) provided for an additional round of convertible debt financing (“Tranche 2 Notes”) of up to $500,000 and ii) amended the conversion price on the convertible notes issued April 1, 2021 and October 8, 2021 (“Tranche 1 Notes”) from 80% of the price paid in a Qualified Financing (proceeds of at least $15 million), to the lesser of (x) $0.002 and (y) the price paid in a Qualified Financing (proceeds of at least $10 million). The Amendment Agreement also provides the following Milestone Payments:

 

 1)$1,000,000 after filing a premarket notification pursuant to Section 510(k) of the Food, Drug and Cosmetic Act, of its intent to market its PRP cellular therapy
 2)Following the closing of a Qualified financing,Financing, 25% of all proceeds raised in excess of $10 million (not to exceed $1$1 million)

 

The Milestone Payments are not to exceed $2$2 million, and the Amendment Agreement also specifies that a Qualified Financing will not occur prior to the closing of the acquisition of Jantibody, LLC.

 

The Company evaluated the Amendment Agreement under ASC 470-50, “Debt - Modification and Extinguishment”, and concluded that probability of having to pay a Milestone payment was minimal and the change in the fair value of the conversion feature was not material. Since theThe Amendment did not cause a material change in cash flows so extinguishment accounting was not applicable.

 

On April 29, 2022, the Company entered into an Amended and Restated Note Conversion Agreement (the “Note Conversion Agreement”) with certain holders of its Tranche 1 Notes (i) providing for a conversion price equal to the lesser of (x) $0.002$0.002 per share (pre-split) and (y) the price per share paid by the investors in a Qualified Financing for such New Securities purchased for cash and not through conversion of Notes (as such terms are defined in the Note Conversion Agreement), in each case subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization, (ii) automatic conversion upon the occurrence of a Qualified Financing, and (iii) amendment of the maturity date from March 31, 2022 to June 17, 2022 (the “New Notes”). Upon the effectivenesseffective date of the Company’s 1,000-1 reverse split, the conversion price adjusted to the lesser of (a) the price in the Qualified Financing or (b) $2.00 per share. The New Notes also provided the investors with Royalty Payments equal to 15% of all net sales generated by the Company with respect to the sale of products or services associated with the 510(k) Notification related to the Company’s autologous cellular therapy (PRP-PBMC) to treat chronic lung disorder. The Royalty Payments are in lieu of the Milestone paymentsPayments but are perpetual and there is no limit to the aggregate amount of Royalty Payments that may be paid. It is the intent of the Company to pay the royalty payments even though the required conditions were not met. The Company entered into an agreement with the noteholders to extend the maturity of the outstanding notes until July 31, 2024.

 

Due to changes in key provisions of the Tranche 1 Notes, the Company analyzed the before and after cash flows between the (i) fair value of the New Notes and (ii) reacquisition price of the Tranche 1 Notes prior to the (A) change in the maturity date from March 31, 2022 to June 17, 2022, (B) change in the conversion price to the lesser of (x) $2.00 and (y) the price paid in a Qualified Financing, and (C) the fair value of the potential Royalty Payments, to determine whether these changes resulted in a modification or extinguishment of the Tranche 1 Notes.

 

11

The Company used a discounted cash flow method with Monte Carlo Simulation to value the Royalty Payments. Future Royalty Payments were estimated based on management’s best estimate of future cash flows under various scenarios which were discounted to present value using a risk-adjusted rate of 6570%.

 

Based on the before and after cash flows of each note, the change was considered significantly different. Consequently, the New Notes were accounted for as a debt extinguishment of the Tranche 1 Notes and a new debt issuance of the New Notes. The Company recorded a $2.2 million loss upon extinguishment of debt in the nine monthsyear ended September 30,December 31, 2022, which was comprised of the following:

SCHEDULE OF LOSS UPON EXTINGUISHMENT

     
Carrying value of Tranche 1 Notes $3,580,738 
Less: Fair value of New Notes  (4,079,838)
Less: Fair value of Royalty Payments  (1,697,000)
Loss on Extinguishment $(2,196,100)

 

The Note Conversion Agreement also provided for the consummation of a Tranche 2 Financing (the “Tranche 2 Notes”) subject to (i) the aggregate principal amount of indebtedness represented by the Tranche 2 Notes being capped at $500,000 and (ii) Tranche 2 Notes’ being an unsecured obligation of the Company and expressly subordinate in all respects to all indebtedness of the Company under the Notes and including language in which the holders of such Tranche 2 Notes acknowledge, confirm and agree to the foregoing subordination terms. Pursuant to the terms of the Note Conversion Agreement, the Investors have agreed not to sell any capital stock of the Company for a period of 12 months following the Qualified Financing. For the year ended December 31, 2022, approximately $499,000 of amortization of the debt premium is included in interest income. The Company entered into an agreement with the noteholders to extend the maturity of the outstanding notes until July 31, 2024.

On February 24, 2023, the Company and certain investors entered into Securities Purchase Agreements (the “SPA”), whereby the Company sold and issued to the certain investors an aggregate of three hundred thousand dollars ($300,000) of the Company’s convertible promissory notes (the “Note” or “Notes”), which are convertible into the Company’s Common Stock, $0.001 par value (“Common Stock”). In connection with the aforementioned Notes, the Company also issued to the investors a warrant to purchase (the “Purchase Warrant”) a certain number of shares of Common Stock, which are equal to 20% of the shares of Common Stock issuable upon conversion of the Note, based on a price of $2.00 per share. These warrants have a term of five (5) years, with an exercise price of $2.00 per share. Unless the Company chooses to terminate earlier, the offering and the sale of the Notes shall terminate on the sooner of the sale of the maximum offering amount or April 30, 2023. However, the Company extended this offering to June 30, 2023 per terms of the agreement.

The Notes have a maturity date of the earlier of (i) one year from issuance; or (ii) upon the closing of a qualified offering. Interest on the Note shall accrue on the unpaid principal balance of this Note at the rate of eight percent (8%) per annum, and will be calculated on an actual/365-day basis. In the event that the Company moves forward with a qualified offering, as referenced in the SPA, the Holder may convert the unpaid and outstanding principal plus any accrued and unpaid Interest into shares of the Company’s Common Stock at a conversion price equal to a 20% discount to the offering price.

Further, in connection with the February 2023 SPA, the Company also issued Common Stock Purchase Warrants to certain investors, which are exercisable on or prior to the close of business on the five (5) year anniversary of the initial issue date, to purchase up to a certain amount of shares of Common Stock, with 20% of the shares of Common Stock issuable upon conversion of the Convertible Promissory Note purchased by the Holder, pursuant to the SPA between the Holder and the Company, dated February 24, 2023. The Company issued Warrants to purchase an aggregate of 30,000 shares of Common Stock. The exercise price per share of the Common Stock under these Warrants is $2.00.

 

12

 

On June 9, 2022,March 27, 2023, the Company and three related party investors entered into a securities purchase agreement for a totalSecurities Purchase Agreements (the “SPA”), whereby, the Company sold and issued to the certain investors, an aggregate of $one hundred twenty five thousand dollars ($272,500125,000 with two accredited investors. The) of the Company’s convertible promissory notes issued(the “Note” or “Notes”), which are convertible into common stockthe Company’s Common Stock, $0.001 par value (“Common Stock”).

On April 12, 2023, the Company and an additional investor entered into the SPA, whereby the Company sold and issued thirty five thousand dollars ($35,000) of the Company’s Notes. In connection with the aforementioned Notes, the Company also issued to the investors a warrant to purchase (the “Purchase Warrant”) a certain number of shares of Common Stock, which are equal to 20% of the shares of Common Stock issuable upon conversion of the Note, based on a price of $2.00 per share. These warrants have a term of five (5) years, with an exercise price of $2.00 per share. Unless the Company chooses to terminate earlier, the offering and the sale of the Notes shall terminate on the sooner of the sale of the maximum offering amount or April 30, 2023. However, the Company extended this offering to June 30, 2023 per terms of the agreement.

The March 27, 2023, Notes have a maturity date of the earlier of (i) one year from issuance; or (ii) upon the closing of a qualified offering. The April 12, 2023, Note has a maturity date 60 days from issuance. Interest on the Note shall accrue on the unpaid principal balance of this Note at the rate of eight percent (8%) per annum, and will be calculated on an actual/365-day basis. The Company defaulted on this note as of June 12, 2023, which triggered an increase of interest from 8% to 12%. In the event that the Company moves forward with a qualified offering, as referenced in the SPA, the Holder may convert the unpaid and outstanding principal plus any accrued and unpaid Interest into shares of the Company’s Common Stock at a 35%conversion price equal to a 20% discount to the lowest tradingoffering price in the 20-day period prior to conversion. The notes bear interest at 10% and are due one year from issuance. For the first six months, the Company has the right to prepay the notes at a premium of between 25% and 35% depending on when it is repaid.

 

TheFurther, in connection with the March 2023 and April 2023 SPA, the Company also issued a promissory note for $100,000 Common Stock Purchase Warrants to another accredited investor. This note bears interest at 15% (no matter when repaid) and converts at a discount of 25% of the price of a public offeringcertain investors, which are exercisable on or a 25% discountprior to the VWAPclose of business on the five (5) days prioryear anniversary of the initial issue date, to purchase up to a certain amount of shares of Common Stock, with 20% of the shares of Common Stock issuable upon conversion of the Convertible Promissory Note purchased by the Holder, pursuant to the SPA between the Holder and the Company. The Company issued Warrants to purchase an aggregate of 12,500 shares of Common Stock. The exercise price per share of the Common Stock under these Warrants is $2.00.

 

The embedded featuresWe evaluated the February 2023, March 2023, and April 2023 SPA in accordance with ASC Topic 815, Derivatives and Hedging, and determined that they contained a variable share settlement feature tied to the Tranche 2 Notes were analyzed underprice of a future financing which functions as a redemption option. FASB ASC 815825-10-25 allows the Company to determineelect the fair value option for recording financial instruments when they are initially recognized or if they required bifurcation as derivative instruments. To be a derivative, onethere is an event that requires re-measurement of the criteriainstruments at fair value, such as a significant modification of the debt. The Company elected to initially and subsequently measure the Convertible Notes in their entirety at fair value, with changes in fair value recognized in earnings. Management believes the fair value option best reflects the underlying economics of these Convertible Notes.

Because these Convertible Notes are carried in their entirety at fair value, the value of the contingent conversion feature is embodied in that fair value. The Company estimates the embedded component mustfair value based on a probability weighted analysis which considers the present value of the cash flows using a credit risk adjusted rate enhanced by the conversion feature valued using a Monte Carlo model. This method was considered by management to be net-settleable. Whilethe most appropriate method of encompassing the credit risk and exercise behavior that a market participant would consider when valuing a hybrid financial instrument. Inputs used to value the Convertible Notes at inception included, (i) present value of future cash flows using a credit risk adjusted rate ranging from 19.0%-20.0%, (ii) remaining term of approximately one year, (iii) volatility ranging from 258%-261%, (iv) closing stock price on the valuation date, and (v) the conversion price based on the estimated price of a Qualified Offering, less a 20% discount, in accordance with the terms of the Note. A Qualified Offering is defined as an offering that results in the Company’s Common Stock was tradedbeing listed on an exchange ata National Exchange (NASDAQ or the time of the transaction, the underlying sharesNYSE/AMEX). Changes due to instrument-specific credit risk are not readily convertible into cash since there is insufficient daily trading volume for the holders to convert the Tranche 2 Notes into Common Stock without significantly affecting the share price. Accordingly, the embedded derivatives, including the embedded conversion feature, did not meet the definition of a derivative, and therefore, did not require bifurcation from the host instrument. Certain default put provisions, including a default put and default interest, were not considered to be clearly and closely related to the host instrument but the Company concluded that therecorded in Other Comprehensive Income with all other changes in value of these provisions was de minimus at inception. The Company will reconsider the value of these provisions each reporting period to determine if the value becomes material to the financial statements.being recorded in net income.

 

At inception, the fair value of the Convertible Notes using the fair value option was $1,878,948, and the fair value of the related Warrants issued was $67,820. Because the fair value of the hybrid instrument was in excess of the proceeds received of $425,000, the Company recorded a day one loss on convertible notes of $1,521,768. During the three months ending June 30, 2023, the Company issued an additional Convertible Note for $35,000. The Company chosefair value of related warrants to early adopt effective January 1, 2021, ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contractthe $35,000 convertible note issued on April 11, 2023 was approximately $6,000. On June 30, 2023, the debt instruments were revalued at approximately $598,000 resulting in Entity’s Own Equity. Thus, the April 2021 and October 2021 Note Purchase Agreements did not require considerationa gain of a beneficial conversion feature and were accounted for solely as debt on the balance sheets.approximately $1,315,000.

 

On August 9,Other Obligations

During the year ending December 31, 2022, Michael Yurkowsky, CEO, advanced the Company entered intoapproximately $40,000 as a securities purchase agreement for a totalnon-interest-bearing note with no established repayment terms. During the six months ended June 30, 2023, approximately $13,000 in additional advances were made. The balance owed is approximately $53,000 as of $65,000 with an accredited investor. The note issued is convertible into common stock at a 35% discount to the lowest trading price in the 20-day period prior to conversion. The note bears interest at 10% and is due one year from issuance. For the first six (6) months, the Company has the right to prepay the notes at a premium of between 25% and 35% depending on when it is repaid.June 30, 2023.

 

Note 56 - Equity Transactions

 EQUITY TRANSACTIONS

In January 2022, the Company offered certain warrant holders the opportunity to receive an additional warrant to purchase the Company’s Common Stock at $14.00 per share, for a period of five (5) years from issuance for the exercise by March 31, 2022 of each existing warrant originally issued in April 2020. As of September 30,December 31, 2022, the Company had eleven warrant holders exercise an aggregate of 83,579 warrants at $14.00 per share resulting in cash proceeds of approximately $1,170,000 to the Company.

 

On June 10, 2022, the Company amended (the “Amendment”) its Articles of Incorporation to effectuate a one-for-one thousand reverse stock split (the “Reverse Split”) of its common stock. The Reverse Split was approved by FINRA on June 10, 2022, and effectuated on June 13, 2022. Pursuant to the Amendment, the Company also reduced the authorized shares of common stock to 500,000,000. As a result of the Reverse Split, the Company hashad approximately 477,610618,506 shares of common stock outstanding and 438,776,170 shares of Series A Preferred Stock outstanding.outstanding as of December 31, 2022. As a result of the Reverse Stock Split, the Series A Preferred Stock is convertible at a ratio of one thousand shares of Series A Preferred Stock into one share of common stock. Accordingly, the 438,776,170 outstanding shares of Series A Preferred Stock are now convertible into an aggregate of 438,776 shares of common stock.

 

On September 29, 2022, the Company entered into a securities purchase agreement with two related party accredited investors for the sale of shares of Common Stock and warrants (the “Purchase Agreement”). Pursuant to the Purchase Agreement, the Company sold an aggregate of 112,500 shares of common stock and warrants to purchase 56,250 shares of Common Stock exercisable at $2.50 per share for gross proceeds of approximately $225,000.

On November 14, 2022, pursuant to the Purchase Agreement, the Company sold an aggregate of 15,000 shares of common stock and warrants to purchase 7,250 shares of Common Stock exercisable at $2.50 per share for gross proceeds of $30,000.

On March 17, 2023, the Company issued 9,615 shares of Common Stock to a convertible noteholder who, at the request of the noteholder, converted $10,000 of convertible notes into the Company’s Common Stock.

On May 23, 2023, the Company issued 17,351 shares of Common Stock to a convertible noteholder who, at the request of the noteholder, converted $14,000 of convertible notes into the Company’s Common Stock.

On June 8, 2023, the Company issued 15,873 shares of Common Stock to a convertible noteholder who, at the request of the noteholder, converted $20,000 of convertible notes into the Company’s Common Stock.

13

 

The following table summarizes the Company’s common and preferred stock outstanding by class. The number of common stock shares has been adjusted to reflect a one-for-one thousand reverse stock split that became effective on June 13, 2022.

 SCHEDULE OF COMMON AND PREFERRED STOCK OUTSTANDING

 September 30, 2022 December 31, 2021  June 30, 2023 December 31, 2022 
Common Stock  477,610   166,394   661,345   618,506 
Series A Preferred Stock  438,776,170   501,887,534   438,776,170   438,776,170 

 

Series A Preferred Stock

 

During the three and ninesix months ended SeptemberJune 30, 2022,2023, 55,802,949 noand 63,111,364 shares of Series A Preferred Stock were converted to 55,805 and 63,114 shares of Common Stock at the request of certain Series A Preferred Shareholders, respectively.Stock.

 

Voting Rights

 

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

 

Conversion

 

Series A Preferred Stock converts to common stock at a one-for-one thousand1:1,000 ratio immediately upon request of the Series A Holder.

 

Liquidation, Dissolution, or Winding Up

 

In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, the holders of shares of Series A Preferred Stock does not have preferential treatment over common stock shareholders ifthen outstanding shall be entitled to be paid out of the assets of the Company liquidatesavailable for distribution to its stockholders and, in the event of a Deemed Liquidation Event (as defined in the Second Amended and Restated Articles of Incorporation), the holders of shares of Series A Preferred Stock then outstanding shall be entitled to be paid out of the consideration payable to stockholders in such Deemed Liquidation Event or dissolves.out of the consideration received by the Company for such Deemed Liquidation Event (net of any retained liabilities associated with the assets sold or technology licensed, as determined in good faith by the Board of Directors of the Company), together with any other assets of the Company available for distribution to its stockholders, all to the extent permitted by Nevada law governing distributions to stockholders, as applicable, before any payment shall be made to the holders of Common Stock by reason of their ownership thereof, an amount per share equal to one (1) times the Series A Original Issue Price for such share of Series A Preferred Stock, plus any Series A Accruing Dividends accrued but unpaid thereon, whether or not declared. If upon any such liquidation, dissolution or winding up of the Company or Deemed Liquidation Event, the assets of the Company available for distribution to its stockholders shall be insufficient to pay the holders of shares of Series A Preferred Stock the full amount to which they shall be entitled under subsection 2.1 of the Second Amended and Restated Articles of Incorporation, the holders of shares of Series A Preferred Stock shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts which would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, after the payment in full of all Series A Liquidation Amounts (as defined in the Second Amended and Restated Articles of Incorporation) required to be paid to the holders of shares of Series A Preferred Stock the remaining assets of the Company available for distribution to its stockholders or, in the case of a Deemed Liquidation Event, the consideration not payable to the holders of shares of Series A Preferred Stock shall be distributed among the holders of the shares of Series A Preferred Stock and Common Stock, pro rata based on the number of shares held by each such holder, treating for this purpose all shares of Series A Preferred Stock as if they had been converted to Common Stock pursuant to the terms of the Second Amended and Restated Articles of Incorporation immediately prior to such liquidation, dissolution or winding up of the Company.

 

Share-Based Compensation Plan

 

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

14

 

Stock Option Activity

 

On April 1, 2021, the Board of Directors of the Company approved and granted to certain directors and officers of the Company an aggregate of 54,750 stock options of which4,750 were immediately vested on the date of grant. Each option granted has an exercise price of $70.00 per share and an expiration date of ten years from the date of grant. These options are not included in the Company’s current stock option plan as they were granted outside of the plan.

 

The Board of Directors decided not to renew the former CEO’s (Robert Greif) employment contract; therefore, the unvested shares were forfeited resulting in a reduction of share-based compensation of approximately $205,000 for the period ended September 30, 2021 that was recognized during the period ended June 30, 2021.

On June 10, 2022, the Company amended its Articles of Incorporation to effectuate a one-for-one thousand reverse stock split of its common stock. The Reverse Split was approved by FINRA on June 10, 2022 and effectuated on June 13, 2022.

 

At SeptemberAs of June 30, 2023, 29,385 options were outstanding and 23,697 were vested. As of June 30, 2022, 29,635 options were outstanding and 20,510 were vested. At September 30, 2021, 29,635 options were outstanding and 14,80219,364 were vested. For the three and six months ended June 30, 2023, the Company recognized an expense related to stock options of approximately $33,000 and $75,000, respectively, which is included in share-based compensation. For the three months and ninesix months ended SeptemberJune 30, 2022, the Company recognized approximately $61,00073,000 and $246,000 in stock-based compensation expense, respectively, which is included in share based compensation. For the three months and nine months ended September 30, 2021, the Company recognized approximately $162,000 and $1,024,000185,000 in stock-based compensation expense, respectively, which is included in share basedshare-based compensation. At SeptemberAs of June 30, 2022,2023, the Company has approximately $206,00081,000 of unrecognized compensation costs related to non-vested stock options, which is expected to thebe recognized over a weighted average period of approximately 2.17 1.54years.

 

Inputs used in the valuation models are as follows:

SCHEDULE OF ASSUMPTIONS USED TO CALCULATE FAIR VALUE OF STOCK OPTIONS

2021 Grants
Option value $54.00   to $56.00 
Risk Free Rate  0.90%  to  1.37%
Expected Dividend- yield  -   to  - 
Expected Volatility  173.99%  to  176.04%
Expected term (years)  5   to  7 

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The following is a summary of stock option activity for the ninesix months ended SeptemberJune 30, 20212022 and 2022:2023:

 SUMMARY OF STOCK OPTION ACTIVITY

  Shares  

Weighted

Average

Exercise

Price

  Weighted
Average Remaining
Term (Years)
 
Outstanding at December 31, 2020  410  $1,390.00   6.72 
Granted  54,750   70.00   9.50 
Expired/Cancelled  (25,525)  70.00    
Outstanding at September 30, 2021  29,635  $100.00   9.41 
             
Exercisable at September 30, 2021  14,802  $100.00   9.41 
             
Outstanding at December 31, 2021  29,635  $86.48   9.20 
Granted         
Outstanding at September 30, 2022  29,635  $86.48   8.46 
             
Exercisable at September 30, 2022  20,510  $93.81   8.44 

15
  Shares  

Weighted

Average

Exercise

Price

  

Weighted

Average
Remaining

Term
(Years)

 
Outstanding at December 31, 2021  29,635  $86.48   9.20 
Granted  -   -   - 
Exercised  -   -   - 
Outstanding at June 30, 2022  29,635  $86.48   8.71 
Exercisable at June 30, 2022  19,364  $95.22   8.69 
             
Outstanding at December 31, 2022  29,385  $83.81   8.22 
Granted  -   -   - 
Exercised  -   -   - 
Outstanding at June 30, 2023  29,385  $83.81   7.73 
Exercisable at June 30, 2023  23,697  $87.12   7.72 

 

The following is a summary of the Company’s non-vested shares for the ninesix months ended SeptemberJune 30, 2021 and 2022:2023:

 SUMMARY OF STOCK OPTION ACTIVITY NON-VESTED

  Shares  

Weighted

Average Grant

Date Fair Value

 
Non-vested at December 31, 2020  -  $- 
Granted  54,750   30.00 
Vested  (14,417)  50.00 
Forfeited  (25,500)  70.00 
Non-vested at September 30, 2021  14,833  $110.00 
         
Non-vested at December 31, 2021  14,250  $60.00 
Vested  (5,125)  54.56 
Non-vested at September 30, 2022  9,125  $55.61 
  Shares  

Weighted

Average Grant

Date Fair Value

 
Non-vested at December 31, 2022  7,979  $55.70 
Vested  (2,292)  55.44 
Non-vested at June 30, 2023  5,687  $55.80 

 

Net Loss Per Share

 

Basic 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 and if-converted methods, as applicable. Any potentially dilutive securities are antidilutive due to the Company’s net losses.

 

The Company excluded the following securities from the calculation of basic and diluted net loss per share as the effect would have been antidilutive:

 SCHEDULE OF ANTI-DILUTIVE SECURITIES OF BASIC AND DILUTED NET LOSS PER SHARE

 2022  2021  2023  2022 
 For the Nine Months Ended September 30,  For the Six Months Ended
June 30,
 
 2022  2021  2023  2022 
Warrants to purchase common stock (in the money)  56,250   385,033   -   384,694 
Series A Preferred Stock convertible to common stock  438,776   515,874   438,776   494,579 
Total  495,026   900,907   438,776   879,273 

 

Excluded from the above table are 384,788493,180 warrants and 29,385 stock options for the six months ended June 30, 2023 and 2,196 warrants and 29,635 stock options for the ninesix months ended SeptemberJune 30, 2022 and 22,608 warrants and 29,635 stock options for the nine months ended September 30, 2021 as they are out of the money (exercise price greater than the stock price). Inclusion of such would be anti-dilutive. As a result of the Reverse Stock Split, the Series A Preferred Stock is convertible at a ratio of one thousand shares of Series A Preferred Stock into one share of common stock.stock. Accordingly, the 438,776,170 outstanding shares of Series A Preferred Stock are convertible into an aggregate of438,776 shares of common stock at SeptemberJune 30, 2022.2023.

 

15

Note 67 – Commitments & Contingencies

 COMMITMENTS & CONTINGENCIES

CEO Compensation Agreement

 

On December 23, 2021, the Company entered into an employment agreement (the “Employment Agreement”) with Michael Yurkowsky, the Company’s Chief Executive Officer, to continue to serve as the Chief Executive Officer of the Company. Under the Employment Agreement, which commenced on December 1, 2021 (the “Effective Date”) and has a term of one year from the Effective Date (the “Employment Period”), Mr. Yurkowsky will receive a base salary of $180,000 per year. Upon the expiration of the Employment Period, Mr. Yurkowsky’s employment with the Company will be on an at-will basis.

 

In addition to his base salary, Mr. Yurkowsky may receive aan one-time cash bonus in gross amount equal to $100,000 if (i) the Company’s stock is listed and quoted on the NASDAQ Global Select Market, the NASDAQ Global Market, the NASDAQ Capital Market, or the New York Stock Exchange; or (ii) the Company secures and receives financing of at least $10,000,000.

 

As additional compensation, Mr. Yurkowsky shall receive shares of common stock of the Company representing 1% of the Company’s fully diluted equity as of the grant date if the Company achieves a market capitalization of at least $250 million for 60 consecutive days during the Employment Period (the “Equity Award”). If the Company achieves a market capitalization of at least $500million for 60 consecutive days during the Employment Period, the executive shall receive an additional Equity Award of 1%, such that he has in the aggregate received shares of common stock of the Company representing 2% of the Company’s fully diluted equity as of the date of grant. These market conditions were reflected in the grant date fair value of the award as required under ASC 718 Compensation-Stock Compensation.

 

The Equity Award was measured at fair value on its grant date using a Monte Carlo simulation model. The Monte Carlo simulation model includes assumptions for the expected term, volatility, and dividend yield, each of which are determined in reference to the Company’s historical results. The Company will recognize aggregate stock-basedshare-based compensation expense of approximately $328,000 related to the Equity Award on a straight-line basis over the derived service period determined by the Monte Carlo simulation model, which was 0.71 years. During the three and ninesix month period ending SeptemberJune 30, 2022, the Company recognized approximately $60,000114,000 and $290,000116,000, respectively, in compensation expense, respectively, related to the Equity Award. If the market capitalization targets are met sooner than the derived service period, the Company will adjust its stock-based compensation to reflect the cumulative expense associated with the vested Equity Award. The Company will recognize expense if the requisite service is provided, regardless of whether the market conditions are achieved.

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Consulting Agreements

 

The Company entered into a consulting agreement with Tanya Rhodes of Rhodes & Associates, Inc, effective June 15, 2020, to serve as the Chief Science Officer of the Company. The agreement has a minimum term of six months with an average fee of $21,000 per month plus expenses which increases 5% per month on January 1 of each calendar year unless an alternative retainer amount is negotiated and agreed upon by both parties. The Company extended the contract on January 1, 2021, resulting in monthly expenses of $22,500 plus expenses for services rendered. AsDue to lack of January 1, 2022,financial resources, the Company has been unable to pay Ms. Rhodes is continuing to receivefor her services totaling approximately $22,500187,000 and is engaged on a month-to-month basis., which has been accrued as part of accrued liabilities as June 30, 2023.

 

The Company entered into a consulting agreement with Alpha IR Group on March 1, 2022, to provide investor relations to the Company. The agreement is for twelve months with an average service fee of $9,750 per month.

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 legal 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.

 

The Company is involved in a lawsuit with Sinclair Broadcast Group, Inc. (“Sinclair”) which was filed on September 8, 2020, in the Circuit Court for the Thirteenth Judicial Circuit in and for Hillsborough County, Florida. Sinclair has filed suit allegingobtained a legal judgment for breach of contract for advertising services in the amount of approximately $75,000 plus interest and costs. The Company has retained legal counsel for its defense against the suit.guidance in this matter. The amount is recorded in accounts payable as of SeptemberJune 30, 2022.2023.

 

The Company is involved in a lawsuit with ITN Networks, LLC (“ITN”) which was filed on July 22, 2021, in the Circuit Court for the Thirteenth Judicial Circuit in and for Hillsborough County, Florida. ITN has filed suit allegingobtained a legal judgment for breach of contract for advertising services in the amount of approximately $75,00045,000 plus interest and costs. The Company has retained legal counsel for its defense against the suit.guidance in this matter. The amount is recorded in accounts payable as of SeptemberJune 30, 2022.2023.

 

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Note 78 – Debt

DEBT

Notes Payable

 

Notes payable were assumed in the Merger (for further discussion, see Note 1 - “Overview” to the consolidated financial statements in the Company’s 2020 Annual Report on Form 10-K) and are due in aggregate monthly installments of approximately $5,800 and carry an interest rate of 5%. Each note originally had a maturity date of August 1, 2019. The Company finalized an eighteen-month extension to March 1, 2021. The promissory notes have an aggregate outstanding balance of approximately $69,000 at June 30, 20222023 and December 31, 2021.2022. The Company has not made payments on these notes since February 10, 2020, due to COVID-19.the Company’s lack of working capital. On April 19, 2022, the Company entered into a promissory note modification agreement with the Lender extending the maturity date of the notes to April 1, 2024.2024. The modification agreement also reduces the interest rate from 5% to 3% and requires a monthly payment of $1,000 per month with a balloon payment at the end of the modified term.

 

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Paycheck Protection Program

On April 29, 2020,June 9, 2022, the Company entered into a securities purchase agreement for a total of $272,500 with two accredited investors. The notes issued are convertible into common stock at a promissory note65% discount to the lowest trading price in the principal amount20-day period prior to conversion. The notes bear interest at 10% and are due one year from issuance. For the first six months, the Company had the right to prepay the notes at a premium of $809,082 to the Bank of Tampa in connection with a loan in such amount made under the Paycheck Protection Program (“PPP Loan”). The PPP Loan bears an interest rate of 1% per annumbetween 25% and matures35% depending on April 29, 2022. The Company elected to use a 24-week Covered Period, per the SBA Paycheck Protection Program guidelines, which ended on October 14, 2020.when it is repaid.

 

The Company did applyalso issued a promissory note for loan forgiveness in an amount equal$100,000, on June 9, 2022, to another accredited investor. This note bears interest at 15% (no matter when repaid) and converts at a discount of 25% of the price of a public offering or a 25% discount to the sumVolume Average Weighted Price (“VWAP”) of the following costs incurred by the Company:five (5) days prior to conversion.

 

1) payroll costs;On August 8, 2022, the Company entered into a securities purchase agreement for a total of $65,000 with an accredited investor. The note issued is convertible into common stock at a 65% discount to the lowest trading price in the 20-day period prior to conversion. The note bears interest at 10% and is due one year from issuance. For the first six (6) months, the Company had the right to prepay the notes at a premium of between 25% and 40% depending on when it is repaid.

2) any payment of interest on covered mortgage obligations;

3) any paymentOn February 28, 2023, the Company entered into a securities purchase agreement for a total of $150,000 with an accredited investor. The note issued is convertible into common stock at a 65% discount to the lowest trading price in the 20-day period prior to conversion. The note bears interest at 10% and is due one year from issuance. For the first six months, the Company has the right to prepay the note at a premium of between 25% and 40% depending on when it is repaid.

The embedded features in the June 2022, August 2022, and February 2023 convertible notes were analyzed under ASC 815 to determine if they required bifurcation as derivative instruments. To be a derivative, one of the criteria is that the embedded component must be net-settleable. While the Company’s Common Stock was traded on an exchange at the time of the transaction, the underlying shares are not readily convertible into cash since there is insufficient daily trading volume for the holders to convert the convertible notes into Common Stock without significantly affecting the share price. Accordingly, the embedded derivatives, including the embedded conversion feature, did not meet the definition of a derivative, and therefore, did not require bifurcation from the host instrument. Certain default put provisions, including a default put and default interest, were not considered to be clearly and closely related to the host instrument but the Company concluded that the value of these provisions was de minimus at inception. The Company will reconsider the value of these provisions each reporting period to determine if the value becomes material to the financial statements.

Note 9 – Acquisitions

ACQUISITIONS

The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.

If an acquisition is determined to be a business combination as indicated in ASC 805, Business Combinations, the assets acquired, and liabilities assumed are recorded at their respective estimated fair values at the date of the acquisition. The Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired.

If an acquisition is determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, which requires the cost of the asset acquisition, including transaction costs, to be allocated to identifiable assets acquired and liabilities assumed based on a covered rent obligation;relative fair value basis. Assets acquired as part of an asset acquisition that are considered to be in-process research and development (IPR&D) are immediately expensed unless there is an alternative future use in other research and development projects. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values (excluding non-qualifying assets). If the cost of the asset acquisition is less than the fair value of the net assets acquired, no gain is recognized in earnings.

4) any covered utility

Contingent consideration payments in asset acquisitions are recognized when the contingency is resolved and the consideration is paid or becomes payable (unless the contingent consideration meets the definition of a derivative, in which case the amount becomes part of the basis in the asset acquired). Upon recognition of the contingent consideration payment, the amount is included in the cost of the acquired asset or group of assets.

On September 7, 2022, the Company acquired all of the membership interests, with Common Stock, of Jantibody LLC (“Jantibody”), a Nevada limited liability company. Jantibody is focused on the development of novel proprietary immunotherapies targeted towards ovarian cancer, pancreatic cancer, and mesothelioma. Prior to the acquisition, Michael Yurkowsky, CEO, had approximately 17.5% ownership interest in Jantibody.

Pursuant to the Jantibody Agreement, the Company issued the equity holders of Jantibody an aggregate of 52,023 shares of the Company’s common stock which represented 15% of the Company’s common stock on a fully diluted basis at the time of the transaction. In addition, for every share of the Company’s common stock issued as a result of the future conversion of the Company’s dilutive instruments, including Series A preferred stock, warrants, stock options, and convertible notes, the Jantibody members will receive 15% of the aggregate number of shares issued (the “Anti-Dilution” shares). The Anti-Dilution shares will be issued before the end of each fiscal quarter.

 

The Company had agreed to issue the Jantibody holders an additional 2.0% of the Company’s common stock then outstanding upon the enrollment of the first patient in a Phase I FDA trial and additional 3.0% of the Company’s then outstanding common stock on a fully diluted basis upon the enrollment of the first patient in a Phase [III] FDA trial. The Company determined the contingent consideration was not subject to derivative accounting and will be recognized when the contingency is resolved, and the consideration is paid or becomes payable as outlined in ASC 450, Contingencies.

The Company determined this transaction represented an asset acquisition as defined by ASC 805, Business Combinations, as substantially all of the value was in a single in-process research and development (“IPR&D”) group, which included the small molecule drug CXCR4 inhibitor, AMD3100, and/or checkpoint inhibitors (CPI) for anti-cancer immune modulation. As a result, the consideration transferred was allocated to the identifiable tangible and intangible assets acquired and liabilities assumed based on their relative fair values resulting in approximately $1,240,000 being assigned to the IPR&D asset and approximately $1,000,000 to assumed liabilities. The liabilities assumed were current accounts payable and as such were recorded a book value. The Company recently received notificationnotice from Jantibody that the Small Company was in default in its obligations to fund certain Jantibody activities and obligations and was terminating its agreement. The Company intends to engage in conversations with Jantibody with respect to restructuring the agreement.

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The purchase price of approximately $247,000 represented 52,023 shares of the Company’s common stock, 344,159 Anti-Dilution shares, and direct transaction costs of $21,600. The purchase price was allocated, on a relative fair value basis, to the acquired intellectual property, and the acquired net assets as follows:

SCHEDULE OF NET IDENTIFIABLE ASSETS ACQUIRED

     
Consideration:    
Common stock $29,557 
Common stock (anti-dilution shares, to be issued – included in other current liabilities)  195,532 
Direct transaction costs  21,600 
Total costs of the asset acquisition $246,689 
Assets acquired    
Cash $469 
Liabilities assumed – legal and administrative costs  (999,728)
Intangible assets: IPR&D  1,245,948 
Net identifiable assets acquired $246,689 

The IPR&D had not yet reached technological feasibility and had no alternative future use; thus, the purchased IPR&D asset and related costs were expensed immediately subsequent to the acquisition within the consolidated statements of operations.

On December 22, 2022, the Company acquired a 100% interest, with Common Stock, in Scion Solutions, LLC (“Scion”). Scion is a life sciences company that has developed a new technology in regenerative medicine specifically for limb salvage. Their proprietary product SkinDisc (patent pending) is a combination of stem cells and several other molecular components that stimulate tissue regeneration. Prior to the acquisition, Tanya Rhodes, CSO, had approximately 33.3% ownership interest in Scion.

Pursuant to the terms of the Scion Agreement, the Company issued the equity holders of Scion an aggregate of 123,153 shares of the Company’s common stock. In addition, for every share of the Company’s common stock issued within 18-months of the Effective Date of the transaction, as a result of the future conversion of the Company’s dilutive instruments, including Series A preferred stock, warrants, stock options, and convertible notes, the Scion members will receive 20% of the aggregate number of shares issued (the “Anti-Dilution” shares). The Anti-Dilution shares will be issued before the end of each fiscal quarter.

In addition, the former shareholders of Scion are eligible to receive Performance Payments consisting of the following:

SCHEDULE OF PERFORMANCE PAYMENTS

Performance Milestone Performance Payment 
Qualified Funding/Uplisting of Innoveren Scientific $45,000 
1-Year Anniversary of Uplisting of Innoveren Scientific $75,000 
2-Year Anniversary of Uplisting of Innoveren Scientific $120,000 
Initiation of SkinDisc Study $50,000 
Receipt of De Novo or any other approval/clearance that would allow SkinDisc to go to market $100,000 
Submission for specific and individual reimbursement codes relating to SkinDisc $25,000 
Receipt of specific and individual reimbursement codes relating to SkinDisc $50,000 
Completion of SkinDisc Study $50,000 
Launch of any additional SkinDisc product line extension (e.g., SkinDisc Lite)* $100,000 
Annual net sales from SkinDisc (including SkinDisc extensions) (2023 and each subsequent calendar year)*  Greater of (i) 4% of net revenues from SkinDisc (including SkinDisc line extensions) during such calendar year and (ii) $50,000 
Cumulative net sales from SkinDisc (including SkinDisc extensions) of $600,000 $200,000 
Cumulative net sales from SkinDisc (including SkinDisc extension) of $2,000,000 $150,000 
Cumulative net sales from SkinDisc (including SkinDisc extension) of $4,000,000 $300,000 
Net sales from SkinDisc (including SkinDisc extensions) of $6,000,000 during any single calendar year* $300,000 

Substantially all of the value acquired was concentrated in a single in-process research and development (“IPRD”) asset, which included license rights, clinical trial data, clinical trial development plans, research and development materials, formulations and intellectual property related to SkinDisc. There was no workforce, and no outputs were present. Accordingly, the acquired set of assets and activities did not meet the definition of a business as defined by ASC 805, Business Administration (“SBA”), dated August 17, 2021, notifying it that $689,974 in principal Combinations and $8,847 in interest was forgivenconsidered an asset acquisition. In an asset acquisition, the consideration transferred is allocated to identifiable tangible and intangible assets acquired and liabilities assumed based on their relative fair values. In the Scion acquisition, the only asset or liability acquired was IPR&D. As a result, the consideration transferred was recorded fully to the IPR&D asset.

In an asset acquisition, cash-settled contingent consideration is measured when probable and estimable, unless the contingent consideration falls under the guidelinesguidance of ASC 815. The Company determined the contingent consideration was not subject to ASC 815 and thus, the performance payments which were estimable and probable (i.e., more than 50% likely to occur) were recorded on the acquisition date. The fair value was estimated based on a probability weighting of the Paycheck Protection Program. Aspresent value of September 30, 2022,cash flows over the PPP loanexpected time period until payment, using a credit-risk adjusted interest rate. Each reporting period, the Company will determine if the performance payments are estimable and probable and will record them as a liability at that time.

18

The purchase price was paidallocated, as follows:

SCHEDULE OF NET IDENTIFIABLE ASSETS ACQUIRED AND LIABILITIES ASSUMED

     
Consideration:    
Common stock $54,070 
Anti-Dilution share liability  305,998 
Contingent Performance payment liability  417,850 
Direct transaction costs  14,338 
Total costs of the asset acquisition $792,256 

The common stock value was recorded as equity. The remaining consideration was recorded as IPR&D, since the SkinDisc technology was still in full.the research and development stage and had no alternative future use. The purchased IPR&D asset of $792,256 was expensed immediately subsequent to the acquisition within our consolidated statements of operations.

 

Note 8 -10- Common Stock Warrants

COMMON STOCK WARRANTS

A summary of the Company’s warrant issuance activity and related information for the ninesix months ended SeptemberJune 30, 20212023 and 2022 is as follows:

SCHEDULESUMMARY OF ISSUANCE OF WARRANTS

  Shares  Weighted
Average
Exercise Price
  Weighted
Average Remaining Contractual
Life
 
Outstanding and exercisable at December 31, 2020  413,424  $15.00   10.30 
Expired  (5,783)  33.00    
Outstanding and exercisable at September 30, 2021  407,641  58.00   8.42 
             
Outstanding and exercisable at December 31, 2021  406,301  $34.88   8.17 
Expired  (22,513) 373.85    
Exercised  (83,579)  14.00    
Granted  140,829   9.41   4.63 
Outstanding and exercisable at September 30, 2022  441,038  $12.52   6.84 

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  Shares  

Weighted

Average

Exercise Price

  

Weighted

Average Remaining

Contractual

Life

 
Outstanding at December 31, 2021  406,301  $34.88   8.17 
Expired  (20,411)  (372.12)  - 
Exercised  (83,579)  14.00   - 
Granted  84,579   14.00   4.64 
Outstanding and exercisable at June 30, 2022  386,890  $19.41   7.32 
             
Outstanding at December 31, 2022  447,967  $10.90   6.65 
Expired  (787)  (498.54)  - 
Granted  46,000   2.00   4.69 
Outstanding and exercisable at June 30, 2023  493,180  $9.30   5.93 

 

The fair value of all warrants issued are determined by using the Black-Scholes valuation technique. The inputs used in the Black-Scholes valuation technique to value each of the warrants as of their respective issue dates are as follows:

SCHEDULE OF ISSUANCE OF WARRANTS VALUATION TECHNIQUE

Event Description Date Number of Warrants  Innoveren Scientific Stock Price  Exercise Price of Warrant  Grant Date Fair Value  Life of Warrant Risk Free Rate of Return (%)  Annualized Volatility Rate (%) 
Granted for inducement agreement 1/19/2022  3,732  $63.25  $14.00  $62.00  5 years  1.62   187.79 
Granted for inducement agreement 1/20/2022  372  $64.50  $14.00  $64.00  5 years  1.62   187.85 
Granted for inducement agreement 1/20/2022  187  $64.50  $14.00  $64.00  5 years  1.62   187.85 
Granted for inducement agreement 1/24/2022  374  $48.00  $14.00  $47.00  5 years  1.53   188.01 
Granted for inducement agreement 1/25/2022  3,744  $49.10  $14.00  $48.00  5 years  1.56   188.00 
Granted for inducement agreement 2/02/2022  3,741  $44.55  $14.00  $44.00  5 years  1.60   188.25 
Granted for inducement agreement 2/04/2022  6,935  $44.38  $14.00  $43.00  5 years  1.78   188.33 
Granted for inducement agreement 2/04/2022  13,870  $44.38  $14.00  $43.00  5 years  1.78   188.33 
Granted for services provided 2/09/2022  1,000  $32.00  $14.00  $31.00  5 years  1.82   188.69 
Granted for inducement agreement 2/22/2022  41,609  $32.88  $14.00  $32.00  5 years  1.85   188.59 
Granted for inducement agreement 2/22/2022  693  $32.88  $14.00  $32.00  5 years  1.85   188.59 
Granted for inducement agreement 3/21/2022  8,322  $28.00  $14.00  $27.00  5 years  2.33   194.01 
Granted for securities purchase agreement 9/27/2022  56,250  $6.00  $2.50  $5.94  5 years  4.21   213.54 
Granted for securities purchase agreement 11/14/2022  7,500  $5.75  $2.50  $5.69  5 years  4.00   213.28 
Granted for convertible note agreement 2/21/2023  30,000  $1.60  $2.00  $1.57  5 years  4.16   211.43 
Granted for convertible note agreement 3/27/2023  10,000  $1.70  $2.00  $1.68  5 years  3.59   218.15 
Granted for convertible note agreement 3/28/2023  2,500  $1.60  $2.00  $1.58  5 years  3.63   218.17 
Granted for convertible note agreement 4/12/2023  3,500  $1.74  $2.00  $1.73  5 years  4.16   243.62 

Event Description Date  Number of Warrants  H-CYTE Stock Price  Exercise Price of Warrant  Grant Date Fair Value  Life of Warrant  Risk Free Rate of Return (%)  Annualized Volatility Rate (%) 
Granted for inducement agreement  1/19/2022   3,732  $63.25  $14.00  $62.00   5 years   1.62   187.79 
Granted for inducement agreement  1/20/2022   372  $64.50  $14.00  $64.00   5 years   1.62   187.85 
Granted for inducement agreement  1/20/2022   187  $64.50  $14.00  $64.00   5 years   1.62   187.85 
Granted for inducement agreement  1/24/2022   374  $48.00  $14.00  $47.00   5 years   1.53   188.01 
Granted for inducement agreement  1/25/2022   3,744  $49.10  $14.00  $48.00   5 years   1.56   188.00 
Granted for inducement agreement  2/02/2022   3,741  $44.55  $14.00  $44.00   5 years   1.60   188.25 
Granted for inducement agreement  2/04/2022   6,935  $44.38  $14.00  $43.00   5 years   1.78   188.33 
Granted for inducement agreement  2/04/2022   13,870  $44.38  $14.00  $43.00   5 years   1.78   188.33 
Granted for services provided  2/09/2022   1,000  $32.00  $14.00  $31.00   5 years   1.82   188.69 
Granted for inducement agreement  2/22/2022   41,609  $32.88  $14.00  $32.00   5 years   1.85   188.59 
Granted for inducement agreement  2/22/2022   693  $32.88  $14.00  $32.00   5 years   1.85   188.59 
Granted for inducement agreement  3/21/2022   8,322  $28.00  $14.00  $27.00   5 years   2.33   194.01 
Granted for securities purchase agreement  9/27/2022   56,250  $6.00  $2.50  $5.94   5 years   4.21   213.54 

The fair value of warrants issued during the three and ninesix months ended SeptemberJune 30, 20222023, totaled approximately $334,000 6,000and is included in warrant expense. The fair value of warrants issued as a result of the warrant inducement during the three and nine months ended September 30, 2022 totaled approximately $0 and $3,024,00074,000, respectively, and is included in inducement expense.respectively. 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 11 - Subsequent Events

SUBSEQUENT EVENTS

On July 10, 2023, the Company issued 21,530 shares of Common Stock to a convertible noteholder who, at the request of the noteholder, converted $6,000 of convertible notes into the Company’s Common Stock.

On July 20, 2023, the Company issued 29,834 shares of Common Stock to a convertible noteholder who, at the request of the noteholder, converted $8,700of convertible notes into the Company’s Common Stock.

On September 28, 2023, Medovex Corp., a Nevada corporation (“Seller”) and the wholly owned subsidiary of Innoveren Scientific, Inc. (the “Innoveren” collectively the “Company”) entered into a Membership Interest And LLCA Rights Redemption Agreement (the “Agreement”) with Medovex, LLC, a Delaware limited liability company (“Medovex”) and the members of Medovex. Pursuant to the Agreement, the Company agreed to transfer its (i) 400,000 Class B membership interests and 140,000 Class C membership interests (collectively, the “Membership Interests”) in Medovex; (ii) the Company’s rights pursuant to the Amended and Restated Limited Liability Company Agreement dated April 2, 2021, including the purchase option rights set out therein (“LLCA Rights” together with the Membership Interest as the “Transferred Rights”); and (iii) the intellectual property related to the Denervex device held by the Company to Medovex (the “IP”). As consideration for the Transferred Rights, the Company shall receive $720,996.72, plus the $92,500 deposit previously paid to the Company. The Company shall also receive $55,751 upon completion of the transfer of the IP from the Seller to Medovex. In addition, the Company shall be entitled to receive a 3% royalty on the sale of any products derived from the IP from the sixth anniversary of the transfer to the tenth anniversary. The transaction closed on September 28, 2023.

The Company recently received notice from Mass General Hospital (MGH) that the Company was in default in its obligations to fund certain Jantibody activities and obligations and was terminating the license agreement between Innoveren and The General Hopsital Corporation d/b/a MGH. The Company was sent an initial breach notice on February 24, 2023, following which Company met with MGH and negotiated a Second Amendment (MGH Agreement No. 2023-2413) effective April 24, 2023. MGH notified the Company of breach for a second time on September 11, 2023, indicating grounds for termination of the Agreement unless the breach was cured. To date, the breach has not been cured and MGH has not received payment. Consequently, the Agreement is hereby terminated effective immediately as of November 6, 2023.

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Note 9 – Acquisition

The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.

If an acquisition is determined to be a business combination as indicated in ASC 805, Business Combinations, the assets acquired, and liabilities assumed are recorded at their respective estimated fair values at the date of the acquisition. The Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired.

If an acquisition is determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, which requires the cost of the asset acquisition, including transaction costs, to be allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Assets acquired as part of an asset acquisition that are considered to be in-process research and development (IPR&D) are immediately expensed unless there is an alternative future use in other research and development projects. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values (excluding non-qualifying assets). If the cost of the asset acquisition is less than the fair value of the net assets acquired, no gain is recognized in earnings.

Contingent consideration payments in asset acquisitions are recognized when the contingency is resolved and the consideration is paid or becomes payable (unless the contingent consideration meets the definition of a derivative, in which case the amount becomes part of the basis in the asset acquired). Upon recognition of the contingent consideration payment, the amount is included in the cost of the acquired asset or group of assets.

Pursuant to the Jantibody Agreement, the Company issued the equity holders of Jantibody an aggregate of 52,023 shares of the Company’s common stock which represented 15% of the Company’s common stock on a fully diluted basis at the time of the transaction. In addition, for every share of the Company’s common stock issued as a result of the future conversion of the Company’s dilutive instruments, including Series A preferred stock, warrants, stock options, and convertible notes, the Jantibody members will receive 15% of the aggregate number of shares issued (the “Anti-Dilution” shares). The Anti-Dilution shares will be issued before the end of each fiscal quarter.

The Company has agreed to issue the Jantibody holders an additional 2.0% of the Company’s common stock then outstanding upon the enrollment of the first patient in a Phase I FDA trial and additional 3.0% of the Company’s then outstanding common stock on a fully diluted basis upon the enrollment of the first patient in a Phase [III] FDA trial. The Company determined the contingent consideration was not subject to derivative accounting and will be recognized when the contingency is resolved, and the consideration is paid or becomes payable as outlined in ASC 450, Contingencies.

The Company determined this transaction represented an asset acquisition as defined by ASC 805, Business Combinations, as substantially all of the value was in a single in-process research and development (“IPR&D”) group, which included the small molecule drug CXCR4 inhibitor, AMD3100, and/or checkpoint inhibitors (CPI) for anti-cancer immune modulation. As a result, the consideration transferred was allocated to the identifiable tangible and intangible assets acquired and liabilities assumed based on their relative fair values resulting in approximately $1,240,000 being assigned to the IPR&D asset and approximately $1,000,000 to assumed liabilities. The liabilities assumed were current accounts payable and as such were recorded a book value.

The purchase price of approximately $247,000 represented 52,023 shares of the Company’s common stock, 344,159 Anti-Dilution shares, and direct transaction costs of $21,600. The purchase price was allocated, on a relative fair value basis, to the acquired intellectual property, and the acquired net assets as follows:

SCHEDULE OF NET IDENTIFIABLE ASSETS ACQUIRED

Consideration:    
Common stock $29,557 
Common stock (anti-dilution shares, to be issued – included in other current liabilities)  195,532 
Direct transaction costs  21,600 
Total costs of the asset acquisition $246,689 
Assets acquired    
Cash $469 
Liabilities assumed – legal and administrative costs  (999,728)
Intangible assets: IPR&D  1,245,948 
Net identifiable assets acquired $246,689 

The IPR&D had not yet reached technological feasibility and had no alternative future use; thus, the purchased IPR&D asset and related costs were expensed immediately subsequent to the acquisition within the consolidated statements of operations.

Note 10 - Subsequent Events

Pursuant to the Purchase Agreement, the Company sold an aggregate of 15,000 shares of common stock and warrants to purchase 7,250 shares of Common Stock exercisable at $2.50 per share for gross proceeds of $30,000.

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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

 

H-CYTE,Innoveren Scientific, Inc (“the Company”) has shiftedevolved from focusing on treating chronic lung conditions after the closure of its focuslung treatment clinics due to COVID-19. The Company is currently focusing on acquiring and developing early-stage companies or their technologies in the areas of therapeutics, medical devices, and diagnostics. The goal is to develop these companies and incubate their technologies to meaningful clinical inflection points.

 

On June 3, 2022, the Company closed its clinic in Scottsdale, Arizona. The Company has now closed all of its clinical operations in the autologous infusion therapy business which delivered treatments for patients with chronic respiratory and pulmonary disorders. The Company will continue to pursue regulatoryFood and Drug Administration (“FDA”) approval of the device that was utilized in the treatment provided at the clinics. The Company also has a continued interest in the commercialization of the DenerveX device.device through a joint venture. The Company has begun to transform itselfimplemented the transition into a biologics and therapeutic device incubator company to bring new technologies to market.

 

The consolidated results for H-CYTEInnoveren Scientific include the following wholly-owned subsidiaries: H-CYTE Management, LLC, Medovex Corp, Cognitive Health Institute, LLC, and Lung Institute Tampa, LLC and the results include Lung Institute Dallas, LLC (“LI Dallas”), Lung Institute Nashville, LLC (“LI Nashville”), Lung Institute Pittsburgh, LLC (“LI Pittsburgh”), and Lung Institute Scottsdale, LLC (“LI Scottsdale”), as Variable Interest Entities (“VIEs”). Additionally, H-CYTE Management, LLC iswas the operator and manager of the various Lung Health Institute (LHI) clinics: LI Dallas, LI Nashville, LI Pittsburgh, and LI Scottsdale. The LI Dallas and LI Pittsburgh clinics did not reopen in 2020 after the temporary closure of all LI clinics due to COVID-19. These two clinics will remain permanently closed. During the first quarter of 2022, the Company decided to closeclosed the LI Tampa and LI Nashville clinics. During the second quarter of 2022, the Company closed the LI Scottsdale clinic, the finalclinic. All LHI clinic.clinics are closed as of June 30, 2023.

 

OnAs of June 10, 2022, the Company amended (the “Amendment”) its Articles of Incorporation to effectuate a one-for-one thousand reverse stock split (the “Reverse Split”) of its common stock. The Reverse Split was approved by FINRA on June 10, 2022 and effectuated on June 13, 2022. Pursuant to the Amendment, the Company also reduced the authorized shares of common stock to 500,000,000. As a result of the Reverse Split, as of September 30, 2022,2023, the Company has 477,610 shares of common stock outstanding and 438,776,170 shares of Series A Preferred Stock outstanding. As a result of the Reverse Stock Split, the Series A Preferred Stock conversion ratio is now one thousand shares of Series A Preferred Stock converts into one share of common stock. Accordingly, the 438,776,170 outstanding shares of Series A Preferred Stock are now convertible into an aggregate of 438,776 shares of common stock.

On September 7, 2022, the Company acquiredclosed all of the membership interestsLHI clinics and has moved away from the Infusion Division as part of Jantibody LLC (“Jantibody”), a Nevada limited liability company. Jantibody is focused on the development of novel proprietary immunotherapies targeted towards ovarian cancer, pancreatic cancer, and mesothelioma (see Note 9).

Impact of COVID-19

COVID-19 has adversely affected the Company’s financial condition and results of operations. The impact of the COVID-19 outbreak on businesses and the economy in the United States is expected to continue to be significant. The extent to which the COVID-19 outbreak will continue to impact businesses and the economy is highly uncertain. Accordingly, the Company cannot predict the extent to which its financial condition and results of operation will be affected.

On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency caused by a new strain of the coronavirus and advised of the risks to the international community as the virus spread globally. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic based on the rapid increase in exposure globally. The spread of COVID-19 coronavirus has caused public health officials to recommend precautions to mitigate the spread of the virus, especially as to travel and congregating in large numbers. In addition, certain states and municipalities have enacted quarantining regulations which severely limit the ability of people to move and travel.

In addition, the Company is uncertain of the full effect the pandemic will have on it for the longer term since the scope and duration of the pandemic is unknown, and evolving factors such as the level and timing of the distribution of efficacious vaccines across the world and the extent of any resurgences of the virus or emergence of new variants of the virus, such as the Delta variant and the Omicron variant, will impact the stability of economic recovery and growth.future plans. The Company may experience long-term disruptionshas transformed into a medical biosciences incubator focusing on bringing new biologics and therapeutic device technologies to its operations resulting from changes in government policy or guidance; quarantines of employees, customers and suppliers in areas affected by the pandemic; and closures of businesses or manufacturing facilities critical to its business.market for various health conditions.

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Critical Accounting Policies and Estimates

 

The Company’s discussion and analysis of its financial condition and results of operations are based on its consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues and expenses during the reporting periods.

 

The Company bases our estimates on historical experience and on various other factors that it believes 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.

 

Results of Operations - Three and ninesix months ended SeptemberJune 30, 20222023 and 20212022

 

Revenue, Cost of Sales and Gross Profit

 

The Company recorded no revenue for the three and six months ended June 30, 2023. The Company recorded revenue of approximately $0$74,000 and $453,000 for the three and ninesix months ended SeptemberJune 30, 2022, respectively. The Company recorded revenue of approximately $460,000 and $1,287,000 for

For the three and ninesix months ended SeptemberJune 30, 2021,2023 the Company did not generate a gross profit. For the three and six months ended June 30, 2022, the Company generated a gross profit totaling approximately $44,000 and $337,000, respectively. The Company has closed all of the LHI Clinics, as of September 30, 2022 which was the Company’s only current source of revenue. The Company has continued to transformtransformed itself into a biologics and therapeutic device incubator company to bring new technologies to market.

 

20

For the three and nine months ended September 30, 2022, the Company generated a gross profit totaling approximately $0 and $337,000, respectively. The Company generated gross profit of approximately $321,000 and $733,000 for the three and nine months ended September 30, 2021, respectively.

Operating Expenses

 

Salaries and Related Costs

 

For the three and ninesix months ended SeptemberJune 30, 2023 the Company incurred approximately $162,000 and $327,000 in salaries and related costs, respectively. For the three and six months ended June 30, 2022, the Company incurred approximately $221,000$280,000 and $848,000$627,000 in salaries and related costs, respectively. The Company incurred salaries and related costs of approximately $535,000 and $1,783,000 for the three and nine months ended September 30, 2021, respectively. The decrease in salaries and related costs for the three and six months ended June 30, 2023, as compared to the prior year, is due to the adjustments to the Company’s corporate structure by reducing expenses in marketing, sales, and operations due to decreased patient volume and closingas part of the LHI clinics.transition into a biologics and therapeutic incubator company to bring new technologies to market. As of SeptemberJune 30, 2022,2023, due to lack of financial resources, the Company has incurred $79,000$581,000 in unpaid salaries and wages.

 

Other General and Administrative

 

For the three and ninesix months ended SeptemberJune 30, 2022,2023 the Company incurred approximately, $290,000$214,000 and $1,194,000,$428,000, in other general and administrative costs, respectively. TheFor the three and six months ended June 30, 2022, the Company incurred approximately $395,000 and $905,000, in other general and administrative costs, of approximately $852,000 and $2,470,000 for the three and nine months ended September 30, 2021, respectively. The Company adjusted its corporate structure by reducing expenses in marketing, sales, and operations due to decreased patient volume and closingas part of the LHI clinics.transition into a biologics and therapeutic incubator company to bring new technologies to market.

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Other Income/Expense

For the three months and six months ended June 30, 2023, the Company generated other income (expense) of approximately $1,229,000 and ($440,000) primarily related to the convertible notes payable carried at fair value.

For the three and ninesix months ended SeptemberJune 30, 2022, the Company incurred2023 interest expense was approximately $3,024,000 in inducement expense related to the warrant inducement (see Note 8).$99,000 and $249,000, respectively. For the three and ninesix months ended SeptemberJune 30, 2022 the Company incurredinterest expense was approximately $334,000 in warrant expense related to the securities purchase agreements. $112,000 and $187,000 respectively.

For the three and ninesix months ended SeptemberJune 30, 2023 the Company did not incur inducement expense. For the three and six months ended June 30, 2022 the Company incurredinducement expense was approximately $0 and $2,196,000, respectively, related to the loss on extinguishment of convertible notes payable (see Note 4).

Appointment of New Board Members and Officers.

On January 17, 2022, Mr. Richard Rosenblum was appointed as a member of the Board.

On January 17, 2022, Mr. Matthew Anderer was appointed as a member of the Board.$3,025,000 respectively.

 

Funding Requirements

 

The Company has historically incurred losses from operations and expects to continue acquisitions and operations to generate negative cash flows as the Company implements its updated strategic business plan.plan to focus on acquiring and developing early-stage companies or their technologies in the areas of therapeutics, medical devices, and diagnostics. The Company will need to raise cash from debt and equity offerings to continue its operations. There can be no assurance that the Company will be successful in doing so.

 

Liquidity, Going Concern, and Sources of Liquidity

 

The Company incurred net lossesincome (loss) of approximately $2,279,000$820,000 and $8,806,000($1,270,000) for the three and ninesix months ended SeptemberJune 30, 2022,2023, respectively. The Company incurred net losses of approximately $587,000$2,635,000 and $4,052,000$6,527,000 for the three and ninesix months ended SeptemberJune 30, 2021.2022, respectively. The Company has historically incurred losses from operations and expects to continue to generate negative cash flows as it implements its plan around the Biosciences Division.transition into a biologics and therapeutic incubator company to bring new technologies to market. The consolidated financial statements are prepared using accounting principles generally accepted in the United States (“U.S. GAAP”) as applicable to a going concern.

 

COVID-19 has adversely affected the Company’s financial condition and results of operations. The impact of the outbreak of COVID-19 on the economy in the U.S. and the rest of the world is expected to continue to be significant. The extent to which the COVID-19 outbreak will continue to impact the economy is highly uncertain and cannot be predicted. Accordingly, the Company cannot predict the extent to which its financial condition and results of operations will be affected.

The Company had cash on hand of approximately $37,000$13,000 as of SeptemberJune 30, 20222023 and approximately $30,000$150,000 as of November 14, 2022.9, 2023. The Company’s cash is insufficient to fund its operations over the next year and the Company is currently working to obtain additional debt or equity financing to help support short-term working capital needs.

 

There can be no assurance that the Company will be able to raise additional funds or that the terms and conditions of any future financings will be workable or acceptable to the Company or its shareholders. If the Company is unable to fund its acquisitions and operations from existing cash on hand, operating cash flows, additional borrowings, or raising equity capital, the Company may not continuebe forced to discontinue operations. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

On February 24, 2023, the Company and certain investors entered into Securities Purchase Agreements (the “SPA”), whereby the Company sold and issued to the certain investors an aggregate of three hundred thousand dollars ($300,000) of the Company’s convertible promissory notes (the “Note” or “Notes”), which are convertible into the Company’s Common Stock, $0.001 par value (“Common Stock”). In connection with the aforementioned Notes, the Company also issued to the investors a warrant to purchase (the “Purchase Warrant”) a certain number of shares of Common Stock, which are equal to 20% of the shares of Common Stock issuable upon conversion of the Note, based on a price of $2.00 per share. These warrants have a term of five (5) years, with an exercise price of $2.00 per share. Unless the Company chooses to terminate earlier, the offering and the sale of the Notes shall terminate on the sooner of the sale of the maximum offering amount or April 30, 2023. However, the Company extended this offering to June 30, 2023.

2321

 

 

LiquidityThe Notes have a maturity date of the earlier of (i) one year from issuance; or (ii) upon the closing of a qualified offering. Interest on the Note shall accrue on the unpaid principal balance of this Note at the rate of eight percent (8%) per annum and Sourceswill be calculated on an actual/365-day basis. In the event that the Company moves forward with a qualified offering, as referenced in the SPA, the Holder may convert the unpaid and outstanding principal plus any accrued and unpaid Interest into shares of Liquiditythe Company’s Common Stock at a conversion price equal to a 20% discount to the offering price.

 

WithFurther, in connection with the February 2023 SPA, the Company historically having experienced losses,also issued Common Stock Purchase Warrants to certain investors, which are exercisable on or prior to the primary sourceclose of liquidity has been raising capital through debt and equity offerings, as described below.

Debt

Convertible Notes Payable

On April 1, 2021,business on the Company, entered into a Secured Convertible Note Purchase Agreement (the “April 2021 Note Purchase Agreement”) with five (5) investors (the “Holders”). Pursuant to the termsyear anniversary of the April 2021 Note Purchase Agreement, the Company sold promissory notes in the aggregate principalinitial issue date, to purchase up to a certain amount of $2,575,000 maturing on June 30, 2022 with an annual interest rate of 8%. The Notes are convertible into shares of Common Stock, at a discountwith 20% of 20% to the price paid for such New Securities in the next round of financing that meets the definition of Qualified Financing as defined in the April 2021 Note Purchase Agreement. The Notes are secured by the assets of the Company under a security agreement with the Holders. The lead investor of the April 2021 Note Purchase Agreement, FWHC Bridge, LLC, advanced $1,500,000 of the total amount to the Company. FWHC Bridge, LLC is an affiliated entity of FWHC, LLC, which is a principal stockholder and related party of the Company. An additional affiliate of FWHC, LLC provided an additional $25,000 as part of the April 2021 Note Purchase Agreement.

On October 14, 2021, the Company entered into the Second Closing Bring Down Agreement (the “October 2021 Note Purchase Agreement”) whereby the five (5) investors who had entered into the April 2021 Note Purchase Agreement purchased new notes in the Company in the aggregate principal amount of $750,000. The Notes are due and payable on June 30, 2022 and bear interest at an annual rate of 8%. The Notes are convertible into shares of Common Stock at a discountissuable upon conversion of 20%the Convertible Promissory Note purchased by the Holder, pursuant to the SPA between the Holder and the Company, dated February 24, 2023. The Company issued Warrants to purchase an aggregate of 30,000 shares of Common Stock. The exercise price paid for such New Securities in the next financing that meets the definition of a Qualified Financing as defined in the Note Purchase Agreement. The Notes are secured by allper share of the assets of the CompanyCommon Stock under a security agreement with the Holders. The lead investor of the October 2021 Note Purchase Agreement, FWHC Bridge, LLC, advanced $437,000 of the total amount to the Company. FWHC Bridge, LLCthis Warrant is an affiliated entity of FWHC, LLC, which is a principal stockholder and related party of the Company. An additional affiliate of FWHC, LLC provided an additional $7,000 as part of the October 2021 Note Purchase Agreement.$2.00.

 

On February 22, 2022, the Company entered into a Debt Conversion Agreement (the “Amendment Agreement”) which i) provided for an additional round of convertible debt financing (“Tranche 2 Notes”) of up to $500,000 and ii) amended the conversion price on the convertible notes issued April 1, 2021 and October 8, 2021 (Tranche 1 Notes”) from 80% of the price paid in a Qualified Financing (proceeds of at least $15 million), to the lesser of (x) $0.002 and (y) the price paid in a Qualified Financing (proceeds of at least $10 million). The Amendment Agreement also provides the following Milestone Payments:

3)$1,000,000 after filing a premarket notification pursuant to Section 510(k) of the Food, Drug and Cosmetic Act, of its intent to market its PRP cellular therapy
4)Following the closing of a Qualified financing, 25% of all proceeds raised in excess of $10 million (not to exceed $1 million)

The Milestone Payments are not to exceed $2 million, and the Amendment Agreement also specifies that a Qualified Financing will not occur prior to the closing of the acquisition of Jantibody, LLC.

The Company evaluated the Amendment Agreement under ASC 470-50, “Debt - Modification and Extinguishment”, and concluded that probability of having to pay a Milestone payment was minimal and the change in the fair value of the conversion feature was not material. Since the Amendment did not cause a material change in cash flows, extinguishment accounting was not applicable.

On April 29, 2022, the Company entered into an Amended and Restated Note Conversion Agreement (the “Note Conversion Agreement”) with certain holders of its Tranche 1 Notes (i) providing for a conversion price equal to the lesser of (x) $0.002 per share (pre-split) and (y) the price per share paid by the investors in a Qualified Financing for such New Securities purchased for cash and not through conversion of Notes (as such terms are defined in the Note Conversion Agreement), in each case subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization, (ii) automatic conversion upon the occurrence of a Qualified Financing, and (iii) amendment of the maturity date from March 31, 2022 to June 17, 2022 (the “New Notes”). Upon the effectiveness of the Company’s 1,000-1 reverse split, the conversion price adjusted to the lesser of (a) the price in the Qualified Financing or (b) $2.00 per share. The New Notes also provided the investors with Royalty Payments equal to 15% of all net sales generated by the Company with respect to the sale of products or services associated with the 510(k) Notification related to the Company’s autologous cellular therapy (PRP-PBMC) to treat chronic lung disorder. The Royalty Payments are in lieu of the Milestone payments but are perpetual and there is no limit to the aggregate amount of Royalty Payments that may be paid.

Due to changes in key provisions of the Tranche 1 Notes, the Company analyzed the before and after cash flows between the (i) fair value of the New Notes and (ii) reacquisition price of the Tranche 1 Notes prior to the (A) change in the maturity date from March 31, 2022 to June 17, 2022, (B) change in the conversion price to the lesser of (x) $2.00 and (y) the price paid in a Qualified Financing, and (C) the fair value of the potential Royalty Payments, to determine whether these changes resulted in a modification or extinguishment of the Tranche 1 Notes.

The Company used a discounted cash flow method with Monte Carlo Simulation to value the Royalty Payments. Future Royalty Payments were estimated based on management’s best estimate of future cash flows under various scenarios which were discounted to present value using a risk-adjusted rate of 65%.

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Based on the before and after cash flows of each note, the change was considered significantly different. Consequently, the New Notes were accounted for as a debt extinguishment of the Tranche 1 Notes and a new debt issuance of the New Notes. The Company recorded approximately a $2,200,000 loss upon extinguishment of debt in the nine months ended September 30, 2022, which was comprised of the following:

Carrying value of Tranche 1 Notes $3,580,738 
Less: Fair value of New Notes  (4,079,838)
Less: Fair value of Royalty Payments  (1,697,000)
Loss on Extinguishment $(2,196,100)

The Note Conversion Agreement also provided for the consummation of a Tranche 2 Financing (the “Tranche 2 Notes”) subject to (i) the aggregate principal amount of indebtedness represented by the Tranche 2 Notes being capped at $500,000 and (ii) Tranche 2 Notes’ being an unsecured obligation of the Company and expressly subordinate in all respects to all indebtedness of the Company under the Notes and including language in which the holders of such Tranche 2 Notes acknowledge, confirm and agree to the foregoing subordination terms. Pursuant to the terms of the Note Conversion Agreement, the Investors have agreed not to sell any capital stock of the Company for a period of 12 months following the Qualified Financing.

On June 9, 2022,28, 2023, the Company entered into a securities purchase agreement for a total of $272,500 with two accredited investors. The notes issued are convertible into common stock at a 35% discount to the lowest trading price in the 20-day period prior to conversion. The notes bear interest at 10% and are due one year from issuance. For the first six months, the Company has the right to prepay the notes at a premium of between 25% and 35% depending on when it is repaid.

The Company also issued a promissory note for $100,000 to another accredited investor. This note bears interest at 15% (no matter when repaid) and converts at a discount of 25% of the price of a public offering or a 25% discount to the VWAP of the five (5) days prior to conversion.

The embedded features in the Tranche 2 Notes were analyzed under ASC 815 to determine if they required bifurcation as derivative instruments. To be a derivative, one of the criteria is that the embedded component must be net-settleable. While the Company’s Common Stock was traded on an exchange at the time of the transaction, the underlying shares are not readily convertible into cash since there is insufficient daily trading volume for the holders to convert the Tranche 2 Notes into Common Stock without significantly affecting the share price. Accordingly, the embedded derivatives, including the embedded conversion feature, did not meet the definition of a derivative, and therefore, did not require bifurcation from the host instrument. Certain default put provisions, including a default put and default interest, were not considered to be clearly and closely related to the host instrument but the Company concluded that the value of these provisions was de minim us at inception. The Company will reconsider the value of these provisions each reporting period to determine if the value becomes material to the financial statements.

On August 9, 2022, the Company entered into a securities purchase agreement for a total of $65,000$150,000 with an accredited investor. The note issued is convertible into common stock at a 35%65% discount to the lowest trading price in the 20-day period prior to conversion. The note bears interest at 10% and is due one year from issuance. For the first six (6) months, the Company has the right to prepay the notesnote at a premium of between 25% and 35%40% depending on when it is repaid.

 

EquityOn March 27, 2023, the Company and three related party investors entered into Securities Purchase Agreements (the “SPA”), whereby, the Company sold and issued to the certain investors, an aggregate of one hundred twenty five thousand dollars ($125,000) of the Company’s convertible promissory notes (the “Note” or “Notes”), which are convertible into the Company’s Common Stock, $0.001 par value (“Common Stock”). On April 12, 2023, the Company and an additional investor entered into the SPA, whereby, the Company sold and issued an aggregate of thirty five thousand dollars ($35,000) of the Company’s Notes. In connection with the aforementioned Notes, the Company also issued to the investors warrants to purchase (the “Purchase Warrant”) a certain number of shares of Common Stock, which are equal to 20% of the shares of Common Stock issuable upon conversion of the Note, based on a price of $2.00 per share. These warrants have a term of five (5) years, with an exercise price of $2.00 per share. Unless the Company chooses to terminate earlier, the offering and the sale of the Notes shall terminate on the sooner of the sale of the maximum offering amount or April 30, 2023. However, the Company extended this offering to June 30, 2023.

 

The March 27, 2023 Notes have a maturity date of the earlier of (i) one year from issuance; or (ii) upon the closing of a qualified offering. The April 12, 2023 Note has a maturity date 60 days from issuance. Interest on the Note shall accrue on the unpaid principal balance of this Note at the rate of eight percent (8%) per annum, and will be calculated on an actual/365-day basis. The Company defaulted on this note as of June 12, 2023, which triggered an increase of interest from 8% to 12%. In January 2022,the event that the Company offered certain warrant holdersmoves forward with a qualified offering, as referenced in the opportunity to receive an additional warrant to purchaseSPA, the Holder may convert the unpaid and outstanding principal plus any accrued and unpaid Interest into shares of the Company’s Common Stock at $14.00 per share, for a period of five (5) years from issuance for the exercise of each existing warrant originally issued in April 2020 priorconversion price equal to March 31, 2021. As of September 30, 2022, the Company had eleven warrant holders exercise an aggregate of 83,579 warrants at $14.00 per share resulting in cash proceeds of $1,170,110a 20% discount to the Company.offering price.

 

TheFurther, in connection with the March 2023 and April 2023 SPA, the Company filed a Registration Statementalso issued Common Stock Purchase Warrants to certain investors, which are exercisable on Form S-1 registeringor prior to the resaleclose of business on the five (5) year anniversary of the shares of common stock issuable upon exercise of the warrants issued in the April 2020 financing. The registration statement was declared effective on February 14, 2022.

On September 29, 2022, H-CYTE, Inc. (the “Company”) entered intoinitial issue date, to purchase up to a securities purchase agreement with two accredited investors for the salecertain amount of shares of Common Stock, and warrants (the “Purchase Agreement”). Pursuant towith 20% of the Purchase Agreement, the Company sold an aggregate of 112,500 shares of common stock and warrants to purchase 56,250 shares of Common Stock exercisable at $2.50issuable upon conversion of the Convertible Promissory Note purchased by the Holder, pursuant to the SPA between the Holder and the Company. The Company issued Warrants to purchase an aggregate of 12,500 shares of Common Stock. The exercise price per share for gross proceeds of $225,001. All of the shares described inCommon Stock under this Current Report on Form 8-K are being offered and issued to accredited investors in reliance upon exemptions from the registration requirements under Section 4(a)(2) under the Securities Act of 1933, as amended (“Securities Act”), and Rule 506 of Regulation D promulgated thereunder.Warrant is $2.00.

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Cash activity for the ninesix months ended SeptemberJune 30, 20222023 and December 31, 20212022 is summarized as follows:

 

Working Capital Deficit

 

 As Of  As Of 
 September 30, 2022  December 31, 2021  June 30, 2023  December 31, 2022 
Current Assets $174,003   197,456  $166,668  $83,845 
Current Liabilities  6,693,035   4,920,880   8,624,999   7,476,893 
Working Capital Deficit $(6,519,032)  (4,723,424) $(8,458,331) $(7,393,048)

 

Cash Flows

 

Cash activity for the ninesix months ended SeptemberJune 30, 20222023 and 20212022 is summarized as follows:

 

 Nine Months Ended September 30,  Six months Ended June 30, 
 2022  2021  2023  2022 
Cash used in operating activities $(1,821,535)  (3,988,115) $(500,393) $(1,527,380)
Cash used in investing activities  -   (7,832)
Cash provided by financing activities  1,763,086   2,662,515   513,004   1,478,085 
Net increase (decrease) in cash $(58,449)  (1,333,432) $12,611  $(49,295)

 

As of SeptemberJune 30, 2022,2023, the Company had approximately $37,000$13,000 of cash on hand.

 

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Off-Balance Sheet Arrangements

 

The Company does 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.

 

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

 

We maintain disclosure controls and procedures designed to provide reasonable assurance that information required to be disclosed in reports filed under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the specified time periods and accumulated and communicated to our management, including our principal executive officer and principal accounting officer, as appropriate to allow timely decisions regarding disclosure.

 

The Company’s Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act) as of SeptemberJune 30, 2022.2023. 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.

 

Based on such evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that, as of SeptemberJune 30, 2022,2023, due to the lack of working capital, the Company’s disclosure controls and procedures were not as effective as desired because of the material weakness in our internal control over financial reporting due to lack of financial resources to hire personnel, as discussed below, and as a result, the Company engaged consultants, implemented a number of new entity and process level controls and installed a new accounting software system to help mitigate this material weakness.

 

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. In our assessment of the effectiveness of internal control over financial reporting as of SeptemberJune 30, 2022,2023, we determined that internal control deficiencies relating to a lack of segregation of duties and knowledge related to more complex accounting transactions still exist. Management believes these deficiencies mainly relate to the Company employing a limited number of accounting and finance personnel. The aggregation of these deficiencies is considered to be a material weakness in internal control over financial reporting.

 

In light of the conclusion that our disclosure controls and procedures were ineffective as of SeptemberJune 30, 2022,2023, we have applied additional procedures engaged consultants, and processes as necessary to ensure the reliability of our financial reporting in regard to this quarterly report. Accordingly, the Company believes, based on its knowledge, that: (i) this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which they were made, not misleading with respect to the period covered by this report; and (ii) the financial statements, and other financial information included in this quarterly report, fairly present in all material respects our financial condition, results of operations and cash flows as of and for the periods presented in this quarterly report.

 

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PART II – OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS.

 

The Company is involved in a lawsuit with Sinclair Broadcast Group, Inc. (“Sinclair”) which was filed on September 8, 2020, in the Circuit Court for the Thirteenth Judicial Circuit in and for Hillsborough County, Florida. Sinclair has filed suit allegingobtained a legal judgment for breach of contract for advertising services in the amount of approximately $75,000 plus interest and costs. The Company has retained legal counsel for its defense against the suit.guidance in this matter. The amount is recorded in accounts payable as of SeptemberJune 30, 2022.2023.

 

The Company is involved in a lawsuit with ITN Networks, LLC (“ITN”) which was filed on July 22, 2021, in the Circuit Court for the Thirteenth Judicial Circuit in and for Hillsborough County, Florida. ITN has filed suit allegingobtained a legal judgment for breach of contract for advertising services in the amount of approximately $75,000$45,000 plus interest and costs. The Company has retained legal counsel for its defense against the suit.guidance in this matter. The amount is recorded in accounts payable as of SeptemberJune 30, 2022.2023.

 

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.

 

None.

 

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.

 

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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, 20222023

 

 

H-CYTE,INNOVEREN SCIENTIFIC, INC

   
 By:/s/ Michael Yurkowsky
  Michael Yurkowsky
  

Chief Executive Officer

(Principal Executive Officer)

   
 By:/s/ Jeremy Daniel
  Jeremy Daniel
  

Chief Financial Officer

(Principal Financial Officer and

Principal Accounting Officer)

 

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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 Inline XBRL Instance Document **
101.SCH Inline XBRL Taxonomy Extension Schema Document **
101.CAL Inline XBRL Taxonomy Calculation Linkbase Document **
101.LAB Inline XBRL Taxonomy Labels Linkbase Document **
101.PRE Inline XBRL Taxonomy Presentation Linkbase Document **
101.DEF Inline XBRL Definition Linkbase Document **
104 Cover Page Interactive Data File (embedded within the Inline XBRL 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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