UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

 

[X] Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
   
  For the quarterly period ended June 30, 2019
   
[  ] Transition Report pursuant to 13 or 15(d) of the Securities Exchange Act of 1934
   
  For the transition period from                   to __________
   
  Commission File Number: 333-146834  

Regenicin, Inc.
(Exact name of registrant as specified in its charter)

 

Nevada 27-3083341

(State or other jurisdiction of incorporation or organization)

(IRS Employer Identification No.)

 

OTCBB RGIN COMMON
Principal US Market Symbol Class of Trading Security

 

10 High Court, Little Falls, NJ (973) 557-8914
(Address of principal executive offices) (Registrant’s telephone number)
_______________________________________________________________
(Former name, former address and former fiscal year, if changed since last report)

 

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 [X] No

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§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 [X] No

 

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

 

[ ] Large accelerated filer

[ ] Non-accelerated filer

[ ] Accelerated filer

[X] Smaller reporting company

[ ] Emerging growth company 

 

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

 

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

 

State the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 153,483,050  as of August 15, 2019.

 

     

 

  TABLE OF CONTENTS Page  
 
PART I – FINANCIAL INFORMATION
 
Item 1: Financial Statements 3
Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations 4
Item 3: Quantitative and Qualitative Disclosures About Market Risk 6
Item 4: Controls and Procedures 6
PART II – OTHER INFORMATION
Item 1: Legal Proceedings 7
Item 1A: Risk Factors 7
Item 2: Unregistered Sales of Equity Securities and Use of Proceeds 7
Item 3: Defaults Upon Senior Securities 7
Item 4: Mine Safety Disclosures 7
Item 5: Other Information 7
Item 6: Exhibits 7

 

  2  

 

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements

Our consolidated financial statements included in this Form 10-Q are as follows:

 

F-1 Consolidated Balance Sheets as of June 30, 2019 (unaudited) and September 30, 2018;
F-2 Consolidated Statements of Operations for the three and nine months ended June 30, 2019 and 2018 (unaudited);

F-3

Consolidated Statements of Stockholders’ Deficiency for the three and nine months ended June 30, 2019 and 2018 (unaudited);

F-4 Consolidated Statements of Cash Flows for the nine months ended June 30, 2019 and 2018 (unaudited); and
F-5 Notes to Consolidated Financial Statements.

 

These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and the SEC instructions to Form 10-Q. In the opinion of management, all adjustments considered necessary for a fair presentation have been included. Operating results for the interim period ended June 30, 2019 are not necessarily indicative of the results that can be expected for the full year.

 

  3  

REGENICIN, INC. AND SUBSIDIARY

CONSOLIDATED BALANCE SHEETS

 

  June 30,   September 30,
  2019   2018
    (UNAUDITED)          
ASSETS              
CURRENT ASSETS              
     Cash $ 1,707     $ 2,702  
     Prepaid expenses and other current assets   9,844       45,281  
     Common stock of Amarantus   4,850       8,450  
               Total current and total assets $ 16,401     $ 56,433  
               
LIABILITIES AND STOCKHOLDERS' DEFICIENCY              
CURRENT LIABILITIES              
     Accounts payable $ 127,689     $ 67,532  
     Accrued expenses - other   266,721       340,931  
     Accrued salaries - officers   2,723,751       2,288,001  
     Note payable - insurance financing   30,429       37,800  
     Bridge financing   175,000       175,000  
     Loan payable   10,000       10,000  
     Loans payable - officers   260,568       137,222  
               Total current and total liabilities   3,594,158       3,056,486  
               
STOCKHOLDERS' DEFICIENCY              
    Series A 10% Convertible Preferred stock, $0.001 par value, 5,500,000 shares authorized; 885,000 issued and outstanding   885       885  
     Common stock, $0.001 par value; 200,000,000 shares authorized; 157,911,410 issued and 153,483,050 outstanding   157,914       157,914  
     Additional paid-in capital   10,208,339       10,177,515  
     Accumulated deficit   (13,940,467 )     (13,332,889 )
     Accumulated other comprehensive income   —         950  
      Less: treasury stock; 4,428,360 shares at par   (4,428 )     (4,428 )
               Total stockholders' deficiency   (3,577,757 )     (3,000,053 )
               Total liabilities and stockholders' deficiency $ 16,401     $ 56,433  

 

See Notes to Consolidated Financial Statements.

  F- 1  

REGENICIN, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED) 

 

  Nine Months Ended   Nine Months Ended   Three Months Ended   Three Months Ended
  June 30,   June 30,   June 30,   June 30,
  2019   2018   2019   2018
               
Revenues $ —       $ —       $ —       $ —    
                               
Operating expenses                              
General and administrative   560,563       613,389       176,234       181,937  
Stock based compensation - general and administrative   30,824       —         —         —    
Total operating expenses   591,387       613,389       176,234       181,937  
                               
Loss from operations   (591,387 )     (613,389 )     (176,234 )     (181,937 )
                               
Other income (expenses)                              
Interest expense   (13,541 )     (14,371 )     (4,362 )     (4,451 )
Change in unrealized loss on securities   (3,600 )     —         (2,275 )     —    
Total other income (expenses)   (17,141 )     (14,371 )     (6,637 )     (4,451 )
                               
Net loss   (608,528 )     (627,760 )     (182,871 )     (186,388 )
                               
Preferred stock dividends   (52,954 )     (52,955 )     (17,651 )     (17,652 )
                               
Net loss attributable to common stockholders $ (661,482 )   $ (680,715 )   $ (200,522 )   $ (204,040 )
                               
Loss per share:                              
   Basic $ (0.00 )   $ (0.00 )   $ (0.00 )   $ (0.00 )
   Diluted $ (0.00 )   $ (0.00 )   $ (0.00 )   $ (0.00 )
Weighted average number of shares outstanding                              
   Basic   153,483,050       153,483,050       153,483,050       153,483,050  
   Diluted   153,483,050       153,483,050       153,483,050       153,483,050  

 

See Notes to Consolidated Financial Statements.

  F- 2  

REGENICIN, INC.

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' DEFICIENCY

(UNAUDITED) 

 

  Convertible Preferred Stock   Common Stock   Additional
Paid-in
  Accumulated   Accumulated
Other
Comprehensive
  Treasury    
  Shares   Amount   Shares   Amount   Capital   Deficit   Income   Stock (1)   Total
                                   
Balances at October 1, 2018   885,000     $ 885       157,911,410     $ 157,914     $ 10,177,515     $ (13,332,889 )   $ 950     $ (4,428 )   $ (3,000,053 )
                                                                       
Adoption of ASU 2016-01   —         —         —         —         —         950       (950 )     —         —    
                                                                       
Stock based compensation   —         —         —         —         30,824       —         —         —         30,824  
                                                                       
Net loss   —         —         —         —         —         (247,306 )     —         —         (247,306 )
                                                                       
Balances at December 31, 2018   885,000       885       157,911,410       157,914       10,208,339       (13,579,245 )     —         (4,428 )     (3,216,535 )
                                                                       
Net loss   —         —         —         —         —         (178,351 )     —         —         (178,351 )
                                                                       
Balances at March 31, 2019   885,000       885       157,911,410       157,914       10,208,339       (13,757,596 )     —         (4,428 )     (3,394,886 )
                                                                       
Net loss   —         —         —         —         —         (182,871 )     —         —         (182,871 )
                                                                       
Balances at June 30, 2019   885,000     $ 885       157,911,410     $ 157,914     $ 10,208,339     $ (13,940,467 )   $ —       $ (4,428 )   $ (3,577,757 )
                                                                       
Balances at October 1, 2017   885,000     $ 885       157,911,410     $ 157,914     $ 10,177,515     $ (12,773,831 )   $ 500     $ (4,428 )   $ (2,441,445 )
                                                                       
Other Comprehensive income   —         —         —         —         —         —         27,250       —         27,250  
                                                                       
Net loss   —         —         —         —         —         (208,106 )     —         —         (208,106 )
                                                                       
Balances at December 31, 2017   885,000       885       157,911,410       157,914       10,177,515       (12,981,937 )     27,750       (4,428 )     (2,622,301 )
                                                                       
Other Comprehensive loss   —         —         —         —         —         —         (21,125 )     —         (21,125 )
                                                                       
Net loss   —         —         —         —         —         (233,266 )     —         —         (233,266 )
                                                                       
Balances at March 31, 2018   885,000       885       157,911,410       157,914       10,177,515       (13,215,203 )     6,625       (4,428 )     (2,876,692 )
                                                                       
Other Comprehensive loss   —         —         —         —         —         —         (3,875 )     —         (3,875 )
                                                                       
Net loss   —         —         —         —         —         (186,388 )     —         —         (186,388 )
                                                                       
Balances at June 30, 2018   885,000     $ 885       157,911,410     $ 157,914     $ 10,177,515     $ (13,401,591 )   $ 2,750     $ (4,428 )   $ (3,066,955 )

(1) The number of shares in treasury stock at October 1, 2018 and 2017, March 31, 2019 and 2018, and June 30, 2019 and 2018 was 4,428,360.  

 

See Notes to Consolidated Financial Statements.

  F- 3  

REGENICIN, INC. AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

  Nine Months   Nine Months
  Ended   Ended
  June 30,   June 30,
  2019   2018
  (UNAUDITED)   (UNAUDITED)
       
CASH FLOWS FROM OPERATING ACTIVITIES              
     Net loss $ (608,528 )   $ (627,760 )
     Adjustments to reconcile net loss to net cash used in operating activities:              
         Unrealized loss on investment   3,600       —    
         Stock based compensation - general and administrative   30,824       —    
         Changes in operating assets and liabilities              
              Prepaid expenses and other current assets   35,437       50,750  
              Accounts payable   60,157     15,399  
              Accrued expenses  - other   (74,210 )     41,645  
              Accrued salaries - officers   435,750       435,750  
Net cash used in operating activities   (116,970 )     (84,216 )
               
CASH FLOWS FROM FINANCING ACTIVITIES              
         Repayments of notes payable - insurance financing   (7,371 )     (33,898 )
         Proceeds of loans from officers   132,075       104,108  
         Repayment of loans payable - officers   (8,729 )     (3,886 )
Net cash provided by financing activities   115,975       66,324  
               
NET DECREASE IN CASH   (995 )     (17,892 )
               
CASH - BEGINNING OF PERIOD   2,702       19,201  
               
CASH - END OF PERIOD $ 1,707     $ 1,309  
               
Supplemental disclosures of cash flow information:              
       Cash paid for interest $ 453     $ —    
       Cash paid for income taxes $ —         —    

 

See Notes to Consolidated Financial Statements.  

  F- 4  

REGENICIN, INC. AND SUBSIDIARY

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

NOTE 1 - THE COMPANY

 

Regenicin, Inc. (“Regenicin”), formerly known as Windstar, Inc., was incorporated in the state of Nevada on September 6, 2007. On July 19, 2010, the company amended its Articles of Incorporation to change the name of the company to Regenicin, Inc. In September 2013, Regenicin formed a new wholly owned subsidiary for the sole purpose of conducting research in the State of Georgia (together, the “Company”). The subsidiary has no activity since its formation due to the lack of funding. The Company’s business plan is to develop and commercialize a potentially lifesaving technology by the introduction of tissue-engineered skin substitutes to restore the qualities of healthy human skin for use in the treatment of burns, chronic wounds and a variety of plastic surgery procedures.

 

NOTE 2 - BASIS OF PRESENTATION

 

Interim Financial Statements:

 

The accompanying unaudited consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with Rule 8-03 of Regulation S-X. Accordingly, they do not include all of the information and note disclosures required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the nine months ended June 30, 2019 are not necessarily indicative of the results that may be expected for the year ending September 30, 2019. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and footnotes thereto included in the Company's Annual Report on Form 10-K for the year ended September 30, 2018, as filed with the Securities and Exchange Commission.

 

Going Concern:

 

The Company's consolidated financial statements have been prepared assuming that the Company will continue as a going concern which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has incurred cumulative losses and, as of June 30, 2019, has an accumulated deficit of approximately $13.9 million from inception, expects to incur further losses in the development of its business and has been dependent on funding operations through the issuance of convertible debt, private sale of equity securities, and the proceeds from the Asset Sale. These conditions raise substantial doubt about the Company's ability to continue as a going concern. Currently management plans to finance operations through the private or public placement of debt and/or equity securities. However, no assurance can be given at this time as to whether the Company will be able to obtain such financing. The consolidated financial statements do not include any adjustment 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.

 

  F- 5  

 

Financial Instruments and Fair Value Measurement:

 

As of October 1, 2018, the Company adopted ASU No. 2016-01, “Financial Instruments-Overall: Recognition and Measurement of Financial Assets and Financial Liabilities”. The new standard principally affects accounting standards for equity investments, financial liabilities where the fair value option has been elected, and the presentation and disclosure requirements for financial instruments. Upon the effective date of the new standards, all equity investments in unconsolidated entities, other than those accounted for using the equity method of accounting, will generally be measured at fair value through earnings. There no longer is an available-for-sale classification and therefore, no changes in fair value will be reported in other comprehensive income (loss) for equity securities with readily determinable fair values. As a result of the adoption, the Company recorded a cumulative effect adjustment of a $950 decrease to accumulated other comprehensive income, and a corresponding decrease to accumulated deficit, as of October 1, 2018.

 

Common stock of Amarantus is carried at fair value in the accompanying consolidated balance sheets. Fair value is determined under the guidelines of GAAP which defines fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements. Realized gains and losses, determined using the first-in, first-out (FIFO) method, and unrealized gains and losses are included in other income (expense) on the statement of operations.

 

The common stock of Amarantus is valued at the closing price reported on the active market on which the security is traded. This valuation methodology is considered to be using Level 1 inputs. The total value of Amarantus common stock at June 30, 2019 is $4,850. The change in unrealized loss for the nine and three months ended June 30, 2019 was $3,600 and $2,275, net of income taxes, respectively, and was reported as other income (expense). The change in unrealized gain (loss) for the nine and three months ended June 30, 2018 was $2,250 and $(3,875), net of income taxes, respectively, and was reported as a component of comprehensive income (loss).

 

Recently Issued Accounting Pronouncements:

 

Any recent pronouncements issued by the FASB or other authoritative standards groups with future effective dates are either not applicable or are not expected to be significant to the consolidated financial statements of the Company.

  

NOTE 3 - LOSS PER SHARE

 

Basic loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Diluted loss per share gives effect to dilutive convertible securities, options, warrants and other potential common stock outstanding during the period; only in periods in which such effect is dilutive.

 

The following securities have been excluded from the calculation of net loss per share for the three and nine months ended June 30, 2019 and 2018, as the exercise price was greater than the average market price of the common shares:

 

    2019   2018
  Warrants       —         390,000  
  Options       1,771,344       —    

 

The following weighted average securities have been excluded from the calculation even though the exercise price was less than the average market price of the common shares because the effect of including these potential shares was anti-dilutive due to the net loss incurred during the three and nine months ended June 30, 2019 and 2018:

 

  2019   2018
Options   4,051,465       9,270,817  
Convertible Preferred Stock   8,850,000       8,850,000  

 

The effects of options and warrants on diluted earnings per share are reflected through the use of the treasury stock method and the excluded shares that are “in the money” are disclosed above in that manner.

 

  F- 6  

 

NOTE 4 – LOANS PAYABLE

 

Loan Payable:

 

In February 2011, an investor advanced $10,000. The loan does not bear interest and is due on demand. At both June 30, 2019 and September 30, 2018, the loan payable totaled $10,000.

 

Loans Payable - Officer:

 

Loans payable - officer consists of the following: 

 

Through September 2018, John Weber, the Company’s Chief Financial Officer, made advances to the Company totaling $105,858. From October 2018 through June 2019 he advanced an additional $123,275. The loans do not bear interest and are due on demand.

 

Through September 2018, J. Roy Nelson, the Company’s Chief Science Officer, made net advances to the Company totaling $26,864. From October 2018 through June 2019 he made additional advances of $8,800 and was repaid $8,729 for a net increase of $71. The loans do not bear interest and are due on demand.

 

In September 2018, Randall McCoy, the Company’s Chief Executive Officer, made an advance to the Company of $4,500. The loan does not bear interest and is due on demand.

  

NOTE 5 - BRIDGE FINANCING

 

On December 21, 2011, the Company issued a $150,000 promissory note to an individual. The note bore interest so that the Company would repay $175,000 on the maturity date of June 21, 2012. Additional interest of 10% was charged on any late payments. The note was not paid at the maturity date and the Company is incurring additional interest as described above. At both June 30, 2019 and September 30, 2018, the note balance was $175,000. Interest expense was $13,089 for both the nine months ended June 30, 2019 and 2018. Interest expense was $4,363 for both the three months ended June 30, 2019 and 2018. Accrued interest on the note was $122,977 and $109,888 as of June 30, 2019 and September 30, 2018, respectively and is included in accrued expenses in the accompanying balance sheet.

 

NOTE 6 - INCOME TAXES

 

The Company recorded no income tax expense for the three and nine months ended June 30, 2019 and 2018 because the estimated annual effective tax rate was zero. As of June 30, 2019, the Company continues to provide a valuation allowance against its net deferred tax assets since the Company believes it is more likely than not that its deferred tax assets will not be realized.

 

In December 2017, the United States Government passed new tax legislation that, among other provisions, lowered the federal corporate tax rate from 35% to 21%. In addition to applying the new lower corporate tax rate to any taxable income the Company may have the legislation affects the way the Company can use and carryforward net operating losses and results in a revaluation of deferred tax assets and liabilities recorded on its balance sheet. Given that current deferred tax assets are offset by a full valuation allowance, these changes have no net impact on the balance sheet. However, if the Company becomes profitable, they will receive a reduced benefit from such deferred tax assets.

 

At both June 30, 2019 and September 30, 2018, the Company had no material unrecognized tax benefits and no adjustments to liabilities or operations were required. The Company does not expect that its unrecognized tax benefits will materially increase within the next twelve months. The Company recognizes interest and penalties related to uncertain tax positions in general and administrative expense. As of June 30, 2019, and September 30, 2018 the Company has not recorded any provisions for accrued interest and penalties related to uncertain tax positions.

 

The Company files its federal income tax returns under a statute of limitations. The tax years ended September 30, 2015 through September 30, 2018 generally remain subject to examination by federal tax authorities.

 

  F- 7  

 

NOTE 7 - STOCKHOLDERS’ DEFICIENCY

 

Preferred Stock:

 

Series A

 

At both June 30, 2019 and September 30, 2018, 885,000 shares of Series A Preferred Stock (“Series A Preferred”) were outstanding.

 

Series A Preferred pays a dividend of 8% per annum on the stated value and has a liquidation preference equal to the stated value of the shares ($885,000 liquidation preference as of June 30, 2019 and September 30, 2018 plus dividends in arrears as per below). Each share of Series A Preferred Stock has an initial stated value of $1 and is convertible into shares of the Company’s common stock at the rate of 10 for 1.

 

The Series A Preferred Stock was marketed through a private placement memorandum that included a reference to a ratchet provision which would have allowed the holders of the stock to claim a better conversion rate based on other stock transactions conducted by the Company during the three-year period following the original issuance of the shares. The Certificate of Designation does not contain a ratchet provision. Certain of the stock related transactions consummated by the Company during this time period may have triggered this ratchet provision, and thus created a claim by holders of the Series A Preferred Stock who purchased based on this representation for a greater conversion rate than initially provided. There have been no new developments related to the remaining Series A holders regarding this claim and the conversion rate of their Series A Preferred Stock. Changes to the preferred stock conversion ratio may result in modification or extinguishment accounting. That may result in a deemed preferred stock dividend which would reduce net income available to common stockholders in the calculation of earnings per share. Certain of the smaller Series A holders have already converted or provided notice of conversion of their shares. In respect of this claim, the Company and its outside counsel determined that it is not possible to offer an opinion regarding the outcome. An adverse outcome could materially increase the accumulated deficit.

 

The dividends are cumulative commencing on the issue date when and if declared by the Board of Directors. As of June 30, 2019, and September 30, 2018, dividends in arrears were $587,591 ($.66 per share) and $534,637 ($.60 per share), respectively.

 

Series B

 

On January 23, 2012, the Company designated a new class of preferred stock called Series B Convertible Preferred Stock (“Series B Preferred”). Four million shares have been authorized with a liquidation preference of $2.00 per share. Each share of Series B Preferred is convertible into ten shares of common stock. Holders of Series B Convertible Preferred Stock have a right to a dividend (pro-rata to each holder) based on a percentage of the gross revenue earned by the Company in the United States, if any, and the number of outstanding shares of Series B Convertible Preferred Stock, as follows: Year 1 - Total Dividend to all Series B holders = .03 x Gross Revenue in the U.S. Year 2 - Total Dividend to all Series B holders = .02 x Gross Revenue in the U.S. Year 3 - Total Dividend to all Series B holders = .01 x Gross Revenue in the U.S. At June 30, 2019, no shares of Series B Preferred are outstanding.

 

  F- 8  

 

NOTE 8 - STOCK-BASED COMPENSATION

 

The Company accounts for equity instruments issued in exchange for the receipt of goods or services from other than employees in accordance with FASB ASC 505, “Equity . Costs are measured at the estimated fair value of the consideration received or the estimated fair value of the equity instruments issued, whichever is more reliably measurable. The value of equity instruments issued for consideration other than employee services is determined on the earlier of a performance commitment or completion of performance by the provider of goods or services as defined by ASC 505.

 

On January 6, 2011, the Company approved the issuance of 885,672 options to each of the four members of the board of directors at an exercise price of $0.035, as amended, per share that were to expire, as extended, on December 31, 2018. Effective as of the expiration date, the Company extended the term of those options for two of the directors to December 31, 2023. All other contractual terms of the options remained the same. The option exercise price was compared to the fair market value of the Company’s shares on the date when the extension was authorized by the Company, resulting in the immediate recognition of $1,316 in compensation expense, which is included in the results of operations for the nine months ended June 30, 2019. There is no deferred compensation expense associated with this transaction, since all extended options had previously been fully vested. The extended options were valued utilizing the Black-Scholes option pricing model with the following assumptions: Exercise price of $0.035, expected volatility of 25.54%, risk free rate of 2.51% and expected term of 5 years.

 

On January 15, 2015, the Company approved the issuance of 10,000,000 options to one of its Officers at an exercise price of $0.02, per share that were set to expire on January 15, 2019. Effective December 31, 2018, the Company extended the term of those options to December 31, 2023. All other contractual terms of the options remained the same. The option exercise price was compared to the fair market value of the Company’s shares on the date when the extension was authorized by the Company, resulting in the immediate recognition of $29,508 in compensation expense, which is included in the results of operations for the nine months ended June 30, 2019. There is no deferred compensation expense associated with this transaction, since all extended options had previously been fully vested. The extended options were valued utilizing the Black-Scholes option pricing model with the following assumptions: Exercise price of $0.02, expected volatility of 25.54%, risk free rate of 2.51% and expected term of 5 years.

 

Stock-based compensation is included as a separate line item in operating expenses in the accompanying consolidated statement of operations.

 

NOTE 9 – LICENSE RIGHTS

 

On November 7, 2014, the Company entered into a Sale Agreement, as amended on January 30, 2015, as discussed in the Company’s Form 10-K for the year ended September 30, 2018, with Amarantus BioScience Holdings, Inc. (“Amarantus”). See Note 1. As part of the Sale Agreement, the Company granted to Amarantus an exclusive five (5) year option to license any engineered skin designed for the treatment of patients designated as severely burned by the FDA developed by the Company. Amarantus can exercise this option at a cost of $10,000,000 plus a royalty of 5% on gross revenues in excess of $150 million. As of June 30, 2019, the option has not been exercised.

 

NOTE 10 - RELATED PARTY TRANSACTIONS

 

The Company’s principal executive offices are located in Little Falls, New Jersey. The headquarters is located in the offices of McCoy Enterprises LLC, an entity controlled by Mr. McCoy. The office is attached to his residence but has its own entrances, restroom and kitchen facilities.

 

The Company also maintains an office at Carbon & Polymer Research Inc. ("CPR") in Pennington, New Jersey, which is the Company's materials and testing laboratory. An officer of the Company is an owner of CPR. No rent is charged for the premise.

 

On May 16, 2016, the Company entered into an agreement with CPR in which CPR will supply the collagen scaffolds used in the Company's production of the skin tissue. The contract contains a most favored customer clause guaranteeing the Company prices equal or lower than those charged to other customers. The Company has not yet made purchases from CPR.

 

See Note 4 for loans payable to related parties. 

 

NOTE 11 - SUBSEQUENT EVENTS

 

Management has evaluated subsequent events through the date of this filing.

 

  F- 9  

 

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

 

Forward-Looking Statements

 

Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements generally are identified by the words “believes,” “project,” “expects,” “anticipates,” “estimates,” “intends,” “strategy,” “plan,” “may,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. We intend such forward-looking statements to be covered by the safe-harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of complying with those safe-harbor provisions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our operations and future prospects on a consolidated basis include, but are not limited to: changes in economic conditions, legislative/regulatory changes, availability of capital, interest rates, competition, and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Further information concerning our business, including additional factors that could materially affect our financial results, is included herein and in our other filings with the SEC.

 

Overview  

 

Currently, we continue to work on several fronts to raise the required funding so that we will be able to complete the IND application and start our proposed Clinical Trials. As previously reported, our goal continues to be to raise funds via debt financing and licensing. We are also now considering a form of equity financing, and potentially government, state or private research grants. Additionally, we have begun evaluating registered burn centers that may be used as sites in our planned Clinical Trials once begun, as well as potential professionals that may act as part of our medical advisory boards within these trials.

 

As suggested in our Pre-IND meeting with the FDA, we have completed our test method development and validation to establish our incoming, in process and finished product release specifications. The next step: method development, testing, engineering runs and assembly of the IND will cost approximately $1.5 million. We have selected a well-regarded university to assist in the method development and validation requested by the FDA. The cost to complete Phase 1 of the Clinical Trials is expected to be approximately $2 million with an additional $3-3.5 million to complete the remainder of the Clinical Trial through Phase 3. We remain optimistic that we will obtain our proposed funding goals and secure FDA approval. NovaDerm having Orphan Status has several significant benefits, including: (a) waiver of the NDA/BLA IND application fee— an estimated $2.2 million value; and (b) a significant reduction in the number of patients required to gain approval.

 

While we have begun the preliminary planning for the Clinical Trials to the extent we are able, we have been working under considerable funding constraints and have thus not been able to proceed as far as management would have liked at this time. As previously reported we have chosen a CRO to assist in our IND submission and to conduct the Clinical Trials once approved and funded. We conducted preliminary discussions at one burn center in the Northeast which we will ultimately use to develop our clinical protocol development. Patient recruitment should be simpler than other clinical trials due to the small number of required patients, and the fixed number of available sites (the 127 registered burn centers). In addition, the clinical protocols are for the most part the same protocols that are currently being employed by physicians throughout the US. Therefore, physician training and IRB acceptance should be relatively straight-forward. The FDA has also offered assistance to the research protocol design because of our Orphan designation.

 

The initial trials are planned to begin with a total of ten subjects with an Initial Data Safety Monitoring Board review of safety on the first three patients once they have reached 6 months post treatment.

 

We are planning on producing our clinical trial cultured skin substitute materials in New Jersey. Management is considering locations across the US as additional manufacturing sites to meet the demand and geographical location needs of the burn centers, as needed. Finally, we intend to license manufacturing and distribution in various countries to avoid shipping live biologicals across international borders.

 

  4  

 

Results of Operations for the Three and Nine Months Ended June 30, 2019 and 2018

 

We generated no revenues from September 6, 2007 (date of inception) to June 30, 2019. We do not expect to generate revenues until we are able to obtain FDA approval of our product and thereafter successfully market and sell the product.

 

We incurred operating expenses of $176,234 and $591,387 for the three and nine months ended June 30, 2019, compared with operating expenses of $181,937 and $613,389 for the three and nine months ended June 30, 2018. General and administrative expenses accounted for substantially all of our operating expenses for the three and nine months ended June 30, 2019. General and administrative expenses accounted for all of our operating expenses for the three and nine months ended June 30, 2018.

 

Net other expense was $6,637 and $17,141 for the three and nine months ended June 30, 2019, as compared to net other expenses of $4,451 and $14,371 for the three and nine months ended June 30, 2018. Other income and expenses for the three and nine months ended June 30, 2019 consisted of interest expense and a change in unrealized loss on securities. Other income and expenses for the three and nine months ended June 30, 2018 consisted solely of interest expense.

 

After provision for preferred stock dividends of $17,651 and $52,954 for the three and nine months ended June 30, 2019, we recorded a net loss attributable to common stockholders of $200,522 and $661,482 for the three and nine months ended June 30, 2019, respectively. By comparison, we recorded a net loss attributable to common stockholders of $204,040 and $680,715 for the three and nine months ended June 30, 2018, respectively.

 

Liquidity and Capital Resources

 

As of June 30, 2019, we had cash of $1,707 and total current assets of $16,401. As of June 30, 2019, we had current liabilities of $3,594,158. We therefore had negative working capital of $3,577,757.

 

Operating activities used $116,970 in cash for the nine months ended June 30, 2019. The decrease in cash was primarily attributable to funding the loss for the period.

 

Investing activities provided no cash inflows or outflows during the reported period.

 

Cash flows from financing activities for the nine months ended June 30, 2019 includes net proceeds from loans from officers of $123,346, and repayments of notes payable of $7,371.

 

We have issued various promissory notes to meet our short term demands, the terms of which are provided in the notes to the consolidated financial statements accompanying this report. While this source of bridge financing has been helpful in the short term to meet our financial obligations, we will need additional financing to fund our operations, continue with the FDA approval process, and implement our business plan. Our long term financial needs are estimated at about $8-10 million.

 

Based upon our current financial condition, we do not have sufficient cash to operate our business at the current level for the next twelve months. We intend to fund operations through increased debt and/or equity financing arrangements, which may be insufficient to fund expenditures or other cash requirements. We plan to seek additional financing in a private equity or debt offering to secure funding for operations. Alternatively, we have been discussing the possibility of obtaining financing through a merger and/or other arrangements related to combining with other related companies or a going private transaction. There can be no assurance that we will be successful in raising additional funding or in entering into any of these sorts of arrangements. If we are not able to secure additional funding, the implementation of our business plan will be impaired. There can be no assurance that such additional financing will be available to us on acceptable terms or at all.

 

  5  

 

Off Balance Sheet Arrangements

 

As of June 30, 2019, there were no off-balance sheet arrangements.

 

Going Concern

 

Our consolidated financial statements have been prepared assuming that we will continue as a going concern which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. We have incurred operating losses from inception, expect to incur further losses in the development of our business, and have been dependent on funding operations through the issuance of convertible debt and private sale of equity securities. These conditions raise substantial doubt about our ability to continue as a going concern. Management’s plans include continuing to finance operations through the private or public placement of debt and/or equity securities and the reduction of expenditures. However, no assurance can be given at this time as to whether we will be able to achieve these objectives. The consolidated financial statements do not include any adjustment relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

A smaller reporting company is not required to provide the information required by this Item.

 

Item 4. Controls and Procedures

 

Disclosure Controls and Procedures

 

We carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of June 30, 2019. This evaluation was carried out under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of June 30, 2019, our disclosure controls and procedures were not effective due to the presence of material weaknesses in internal control over financial reporting.

 

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. Management has identified the following material weaknesses which have caused management to conclude that, as of June 30, 2019, our disclosure controls and procedures were not effective: (i) inadequate segregation of duties and effective risk assessment; and (ii) insufficient written policies and procedures for accounting and financial reporting with respect to the requirements and application of both US GAAP and SEC guidelines.

 

Remediation Plan to Address the Material Weaknesses in Internal Control over Financial Reporting

 

Our company plans to take steps to enhance and improve the design of our internal controls over financial reporting. During the period covered by this quarterly report on Form 10-Q, we have not been able to remediate the material weaknesses identified above. To remediate such weaknesses, we plan to implement the following changes during our fiscal year ending September 30, 2020 assuming we are able to obtain necessary funding: (i) appoint additional qualified personnel to address inadequate segregation of duties and ineffective risk management; and (ii) adopt sufficient written policies and procedures for accounting and financial reporting. The remediation efforts set out are largely dependent upon our securing additional financing to cover the costs of implementing the changes required. If we are unsuccessful in securing such funds, remediation efforts may be adversely affected in a material manner.

 

We are unable to remedy our controls related to the inadequate segregation of duties and ineffective risk management until we receive financing to hire additional employees. 

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting during the three months ended June 30, 2019 that have materially affected, or are reasonable likely to materially affect, our internal control over financial reporting.

 

  6  

   

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings  

 

We are not a party to any pending legal proceeding. We are not aware of any pending legal proceeding to which any of our officers, directors, or any beneficial holders of 5% or more of our voting securities are adverse to us or have a material interest adverse to us.

 

Item 1A. Risk Factors

 

A smaller reporting company is not required to provide the information required by this Item.

 

Item 2. Unregistered   Sales of Equity Securities and Use of Proceeds

 

The information set forth below relates to our issuances of securities without registration under the Securities Act of 1933 during the reporting period which were not previously included in a Quarterly Report on Form 10-Q or Current Report on Form 8-K.

 

For the three months ended June 30, 2019, we issued no shares of common stock.

 

Item 3. Defaults upon Senior Securities

 

None

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

None

 

Item 6. Exhibits

 

Exhibit Number Description of Exhibit
31.1 Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2 Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1 Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101** The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 formatted in Extensible Business Reporting Language (XBRL).
**Provided herewith  

 

  7  

 

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.

 

  Regenicin, Inc.
   
Date: August  19, 2019

 

By: /s/ Randall McCoy
  Randall McCoy
Title: Chief Executive Officer and Director

 

  8  
 

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