Form 10-Q Regenicin, Inc. For: Dec 31


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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 December 31, 2020
   
[  ] 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, a smaller reporting
company, or an emerging growth company.

 

[
] 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
of December 31, 2020.

 

NOTICE:
THIS 10Q FILING DOES NOT CONTAIN FINANCIAL OR OTHER INFORMATION WHICH HAS BEEN AUDITED OR REVIEWED BY OUR INDEPENDENT PUBLIC
ACCOUNTING FIRM FOR REASONS SPECIFIED HEREIN. WE INTEND TO SUPPLEMENT THIS FILING, AT A CURRENTLY UNKNOWN LATER DATE, WITH SUCH
REVIEWED AND AUDITED FINANCIAL INFORMATION, IF AND WHEN SUCH REVIEW AND AUDIT CAN BE OBTAINED.

 

 

 

PART
I – FINANCIAL INFORMATION

 

Item
1. Financial Statements

 

The
consolidated financial statements as of and for the three months ended December 31, 2020 have not been reviewed by our independent
registered public accounting firm. The consolidated balance sheet as of September 30, 2020 has not been audited by our independent
registered public accounting firm.

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

 

 

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 December 31, 2020
are not necessarily indicative of the results that can be expected for the full year.

 

REGENICIN,
INC. AND SUBSIDIARY

CONSOLIDATED
BALANCE SHEETS

 

  December
31,
  September
30,
  2020   2020
  nreviewed   Unaudited
ASSETS      
CURRENT ASSETS      
     Cash $ 1,373     $ 1,366  
     Common
stock of Amarantus
  2,000       2,775  
               Total
current and total assets
$ 3,373     $ 4,141  
LIABILITIES AND STOCKHOLDERS’
DEFICIENCY
             
CURRENT LIABILITIES              
     Accounts
payable
$ 83,034     $ 88,659  
     Accrued
expenses – other (related party of $33,426 and $29,552)
  182,723       174,438  
     Accrued
salaries – officers
  3,595,252       3,450,002  
     Promissory
note payable
  175,000       175,000  
     Convertible
promissory note – officer
  335,683       335,683  
     Loan
payable
  10,000       10,000  
     Loans
payable – officer
  68,835       57,635  
               Total
current and total liabilities
  4,450,527       4,291,417  
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       10,208,339  
     Accumulated
deficit
  (14,809,864 )     (14,649,986 )
      Less:
treasury stock; 4,428,360 shares at par
  (4,428 )     (4,428 )
               Total
stockholders’ deficiency
  (4,447,154 )     (4,287,276 )
               Total
liabilities and stockholders’ deficiency
$ 3,373     $ 4,141  

 

See
Notes to Consolidated Financial Statements.

REGENICIN,
INC. AND SUBSIDIARY

CONSOLIDATED
STATEMENTS OF OPERATIONS

(UNREVIEWED)

 

  Three
Months Ended
December 31,
2020
  Three
Months Ended
December 31,
2019
   
       
Revenues $ —       $ —    
               
Operating expenses              
General
and administrative
  150,818       192,350  
Total
operating expenses
  150,818       192,350  
Operating loss before
other operating income
  (150,818 )     (192,350 )
Loss
from operations
  (150,818 )     (192,350 )
Other income (expenses)              
Interest
expense (related party of $3,874
and $0)
  (8,285 )     (4,411 )
Change
in unrealized loss on securities
  (775 )     (1,225 )
Total
other income (expenses)
  (9,060 )     (5,636 )
Net loss   (159,878 )     (197,986 )
Preferred
stock dividends
  (17,845 )     (17,845 )
Net
loss attributable to common stockholders
$ (177,723 )   $ (215,831 )
Loss per share:              
   Basic $ (0.00 )   $ (0.00 )
   Diluted $ (0.00 )   $ (0.00 )
Weighted average number of shares outstanding              
   Basic   153,483,050       153,483,050  
   Diluted   153,483,050       153,483,050  

 

See
Notes to Consolidated Financial Statements. 

REGENICIN,
INC.

CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIENCY

(UNREVIEWED) 

 

  Convertible
Preferred Stock
  Common
Stock
  Additional
Paid-in
  Accumulated   Accumulated
Other
Comprehensive
  Treasury    
  Shares   Amount   Shares   Amount   Capital   Deficit   Income   Stock   Total
                                   
Balances at October 1, 2020   885,000     $ 885       157,911,410     $ 157,914     $ 10,208,339     $ (14,649,986 )           $ (4,428 )     (4,287,276 )
Net
loss
                                          (159,878 )                     (159,878 )
Balances at December
31,  2020
  885,000     $ 885       157,911,410     $ 157,914     $ 10,208,339     $ (14,809,864 )   $ —       $ (4,428 )   $ (4,447,154 )
Balances at October 1, 2019   885,000     $ 885       157,911,410     $ 157,914     $ 10,208,339     $ (14,090,395 )   $ 950     $ (4,428 )     (3,726,735 )
Net
loss
                                          (197,986 )                     (197,986 )
Balances at December
31,  2019
  885,000     $ 885       157,911,410     $ 157,914     $ 10,208,339     $ (14,288,381 )   $ 950     $ (4,428 )   $ (3,924,721 )

 

See
Notes to Consolidated Financial Statements. 

REGENICIN,
INC. AND SUBSIDIARY

CONSOLIDATED
STATEMENTS OF CASH FLOWS

(UNREVIEWED) 

 

Three
Months Ended
December 31,
2020
  Three
Months Ended
December 31,
2019
 
CASH FLOWS FROM OPERATING
ACTIVITIES
             
     Net
loss
$ (159,878 )   $ (197,986 )
     Adjustments
to reconcile net loss to net cash used in operating activities:
             
         Unrealized
loss on investment
  775       1,225  
         Accrued
interest on loans and notes payable
  8,285       —    
         Changes
in operating assets and liabilities
             
              Accounts
payable
  (5,625 )     (73,641 )
              Accrued
expenses  – other
  —         44,411  
              Accrued
salaries – officers
  145,250       145,250  
Net
cash used in operating activities
  (11,193 )     (80,741 )
CASH FLOWS FROM FINANCING
ACTIVITIES
             
         Proceeds
of loans from officers
  11,200       82,250  
Net
cash provided by financing activities
  11,200       82,250  
NET INCREASE IN CASH   7       1,509  
CASH – BEGINNING
OF PERIOD
  1,366       815  
CASH – END OF
PERIOD
$ 1,373     $ 2,324  
Supplemental disclosures
of cash flow information:
             
       Cash
paid for interest
$ —       $ —    
       Cash
paid for taxes
$ —       $ —    

 

See
Notes to Consolidated Financial Statements.

REGENICIN,
INC. AND SUBSIDIARY

NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

(UNREVIEWED)

 

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 (“U.S. GAAP”) 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 only of those of a recurring nature) considered necessary
for a fair presentation have been included. Operating results for the three months ended December 31, 2020 are not necessarily
indicative of the results that may be expected for the year ending September 30, 2021. These unaudited consolidated financial
statements should be read in conjunction with the unaudited consolidated financial statements and footnotes thereto included in
the Company’s Annual Report on Form 10-K for the year ended September 30, 2020, as filed with the Securities and Exchange Commission.
The consolidated balance sheet as of September 30, 2020 contained herein has been derived from the unaudited consolidated financial
statements as of September 30, 2020, but does not include all disclosures required by U.S. GAAP.

 

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
recurring losses and as of December 31, 2020, has an accumulated deficit of approximately $14.8 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 and private sale of equity securities. 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. 

 

 

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 BioScience Holdings, Inc. (“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 December 31, 2020 is $2,000.
The change in unrealized loss for the three months ended December 31, 2020 and 2019 was $775 and $1,225, net of income taxes,
respectively, and was reported as other income (expense). 

 

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 weighted average securities have been excluded from the calculation of net loss per share for the three months ended
December 31, 2020 and 2019 as the exercise price was greater than the average market price of the common shares:

 

    2020   2019
Options       —         1,568,022  

 

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 losses incurred during the three months ended December 31, 2020 and 2019:

 

  2020   2019
Options   11,771,344       —    
Convertible
Preferred Stock
  8,850,000       8,850,000  
Convertible
Promissory Note
  22,084,408       —    
    42,705,752       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.

 

 

NOTE
4 – LOANS PAYABLE

 

Convertible
Promissory Note – Officer:

Through
September 30, 2019, John Weber, the Company’s Chief Financial Officer, advanced the Company a total of $238,133. From October
2019 through December 31, 2020, he advanced an additional $97,550 for a total of $335,683. On December 31, 2020, these advances were
converted into a convertible promissory note. Interest on the note is computed at 5% per annum and accrues from the time of the
advances until the maturity date. The maturity date was September 30, 2020, at which time all the accrued interest and principal
became due. The note has been extended to March 31, 2021. For the three months ended December 31, 2020 interest totaling $3,874
was incurred. As of December 31, 2020, a total of $33,426 of interest was incurred and accrued. The note is convertible at the
option of Mr. Weber into shares of the Company’s common stock at the prevailing market rate on the date of conversion

 

Loan
Payable:

 

In
February 2011, an investor advanced $10,000. The loan does not bear interest and is due on demand. At both December 31, 2020 and
September 30, 2020, the loan payable totaled $10,000.

 

Loans
Payable – Officer:

 

Through December 31, 2020, John Weber, the Company’s Chief Financial Officer, advanced to the Company $37,100.
The loan does not bear interest and is due on demand

 

Through
September 30, 2020, J. Roy Nelson, the Company’s Chief Science Officer, made net advances to the Company totaling $26,935.
The loans do not bear interest and are due on demand.

 

In
September 2018, Randall McCoy, the Company’s Chief Executive Officer, advanced to the Company $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 December 31, 2020
and September 30, 2020, the note balance was $175,000. Interest expense was $4,411 for both quarters ended December 31, 2020 and
2019. Accrued interest on the note was $144,938 and $149,938 as of December 31, 2020 and September 30, 2020, respectively, and
is included in Accrued expenses – other in the accompanying consolidated balance sheets. 

 

NOTE
6 – INCOME TAXES

 

The
Company recorded no income tax expense for the three months ended December 31, 2020 and 2019 because the estimated annual effective
tax rate was zero. As of December 31, 2020, 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.

 

 

NOTE
7 – STOCKHOLDERS’ DEFICIENCY

 

Preferred
Stock:

 

Series
A

 

At
both December 31, 2019 and September 30, 2019, 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 December 31, 2019 and September 30, 2019 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 December 31, 2020,
and September 30, 2020, dividends in arrears were $694,275 ($.78 per share) and $676,430 ($.76 per share), respectively.

 

Series
B

 

Four
million shares of Series B Convertible Preferred Stock (“Series B Preferred”) 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 Preferred 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 Preferred, 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 December 31, 2020, no shares
of Series B Preferred are outstanding.

 

 

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.

 

NOTE
9 – 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 either premises.

 

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
10 – SUBSEQUENT EVENTS

 

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

 

  

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

  

During
the quarter ended, December 31, 2019, the Company continued to position its product, NovaDerm®, to enter clinical
trials to gain FDA product approval. Having secured Orphan Drug Designation as a biologic for NovaDerm®, we complied
with the FDA annual reporting requirements. In addition, as part of an asset purchase agreement, we granted Amarantus Bioscience
Holdings, Inc., a right of first refusal for the purchase of any engineered skin technology designed for treatment of severe burns
in humans that we developed. This right of first refusal expired during this quarter on November 7, 2019. 

 

Recently,
the risk of introducing pathogens when using materials from animals to produce drugs, devices, and biologics has increased awareness
of the safety issues. NovaDerm® and future Regenicin products use animal sourced materials like collagen to
produce the life-saving products. We have worked with our collagen supplier and the FDA to ensure we are meeting the expectations
for traceability and purity of the FDA for NovaDerm® production.  We have arranged for sufficient Bovine
Closed Herd corium to produce sufficient collagen scaffolds to meet our needs for the clinical trials, ensuring compliance with
FDA requirements. 

 

Our
major objective for 2021 is to secure the required funding to finalize some additional requirements of the IND application and
begin the clinical trials. As previously reported, our goal in obtaining the required funding has been to minimize shareholders’
dilution as much as possible. Consequently, we are primarily pursuing financing through the issuance of debt instruments, international
licensing agreements and governmental grants. We have completed all the administrative requirements to allow us to apply for grants.
Regenicin is now registered with System For Award Management (“SAM”) which is required to do business with the US
Government.  We must have our IND submitted before we can request financial assistance from The US FDA Office of Orphan Products
Clinical Trials Grant. We intend to take full advantage of working with OOPD to develop our clinical protocol according to suggestions
from the FDA during our Pre-IND meeting.

 

The
Orphan Drug Act created the Orphan Product Grants Program, which is administered by OOPD, to stimulate the development of promising
products for rare diseases and conditions. Orphan product grants are a proven method of fostering and encouraging the development
of new safe and effective medical products for rare diseases and conditions. These grants support new and continuing extramural
research projects that test the safety and efficacy of promising new drugs, biologics, devices, and medical foods through human
clinical trials in very vulnerable populations often with life-threatening conditions.

 

 

As
a registered member of SAM we will be investigating numerous government programs to seek developmental funding needed to complete
our IND.

 

We
estimated that the completion of the IND and the clinical trials would take approximately 12-18 months and cost in the range of
$6.9 million once initial funding is in place. It is estimated that the cost to finalize the IND will be approximately 1.9 million,
and the cost to complete Phase 1/2 of the clinical trial will be approximately 5.0 million. In addition to the completion of the
IND, the only other significant gating item to entering the clinical trials is funding for this process.

 

Two
board positions remain open anticipating requests of Board representation from potential investors.

 

Importantly,
we are filing this quarterly report without our auditor’s review of our financial information or this report. Our reason
for doing this is simply that we cannot afford at this time to pay our auditor for past due services or prior filings or to pay
the costs necessary for this current filing. Instead, we have provided herein information as typically presented in our 10Q quarterly
report, including financial information, which has not been reviewed or audited by any independent outside source.

 

We
intend, if and when able, to file an amendment to this 10Q and previously filed 10K with such audited and reviewed information.
We are unaware at this time when, if ever, we will obtain the necessary funding for this amended filing, but we will continue
to provide such information to investors as and when we are able through either this SEC EDGAR filing process and/or through postings
on our website as things change.

 

We
are continuing to work with potential investors in order to pursue the necessary funding based on our stated objectives. It has
taken longer to raise the funds than originally estimated; however, we remain confident that our goal is achievable. In the interim,
the officers and related parties intend to continue to fund our essential operating costs as they have in the past, as disclosed
in the accompanying financial statement.

 

In
preparation of the IND application, we will continue, subject to funding, to develop the testing suggested by the FDA during the
Pre-IND meeting. Our scaffold supplier continues to introduce the FDA suggested testing on collagen processing which addresses
Bovine Closed Herd requirements for the tighter safety and traceability of the collagen scaffolds used to produce NovaDerm®.
Our scaffold supplier is close to entering a contract for ASTM-F2212 testing of Type I collagen. We continue discussions and evaluation
of possible clinical trial sites for NovaDerm®. Our discussions have confirmed that patient recruitment and enrollment
should be faster and less complicated than other clinical trials because of our Orphan Designation. In addition, the surgical
protocol will be similar to the grafting procedures currently in use at those limited burn center facilities, NovaDerm
® should
thus require minimal physician training and documentation to complete the clinical trial.

 

Subject
to funding, the initial trials are planned to begin with a total of ten subjects and an Initial Data Safety Monitoring Board,
(DSMB), review of safety on the first three subjects once they have reached 6 months follow-up. We do not intend to interrupt
our trial waiting for the DSMB report. Our management’s approach is to set up the trials so as to allow for a seamless transition
into commercial production upon approval. 

 

Our
first cultured skin substitute product candidate, NovaDerm®, is a multi-layered tissue-engineered living skin prepared
by utilizing autologous (patient’s own) skin cells. It is a graftable cultured epithelium skin substitute containing both
epidermal and dermal components with a collagen base. Clinically, we expect our Cultured Skin substitute self-to-self skin graft
product will perform the same as split thickness allograft skin. Our Autologous cultured skin substitute should not be rejected
by the immune system of the patient, unlike porcine or cadaver cellular grafts. Immune system rejection is a serious concern in
Xeno-transplant procedures which have a cellular component. The use of our cultured skin substitute should not require any specialized
physician training because it is applied the same as in a standard split thickness allograft procedure.

 

NovaDerm® does
not require the large harvest areas that are required when performing split thickness allograft procedures. NovaDerm® is
designed to need only a small area of harvest material to cover the wound. Where split thickness allograft skin can be stretched
2 to 4 times, NovaDerm® can expand the coverage 100 to 400 times, greatly reducing scarring from harvesting. There are
limits to how much burned area can be covered with the current split thickness allograft procedure. When a patient has more than
50% of their body with full thickness burns there is not enough harvest area available to cover the area so the same area harvested
must be allowed to grow back the replacement skin before it can be harvested the second or third time, allowing to wound area
to open with high risk of infection and even mortality.

 

Clinically
speaking, a product designed to treat a life-threatening condition must be available for the patient when needed. Our Culture
skin substitute is being developed to be ready to apply to the patient when the patient is ready for grafting, within the first
month of the patient being admitted to the hospital. Patients with serious burn injuries may not be in a condition to be grafted
on a predefined schedule made more than a month in advance. Therefore, in order to accommodate the patient’s needs, we are
striving to ensure that our cultured skin substitute will have an adequate shelf life and manufacturing schedule to ensure it
is available whether the patient needs it the first month, or any day after, until the patient’s wound is completely covered
and closed. We intend to provide the patient enough NovaDerm® to meet the patients’ needs in a single lot of material
with adequate shelf life to be available when the patient is ready. With our extended shelf life and enough material in the first
shipment the physician may perform a second grafting 5 or ten days post grafting period 1.

 

 

Our
second product is anticipated to be TempaDerm®. TempaDerm® uses cells obtained from human donors to develop banks
of cryo-preserved (frozen) cells and cultured skin substitute to provide a continuous supply of non-allogenic skin substitutes
to treat much smaller wound areas on patients, such as ulcers. This product is expected to have applications in the treatment
of chronic skin wounds such as diabetic ulcers, decubitus ulcers and venous stasis ulcers. This product is also expected to be
similar to our burn indication product, except for the indications, and it will not depend totally on autologous cells. In fact,
it may be possible to use the excess cultured skin that was originally produced for use on the patient that donated the cells
used to grow the skin. Hopefully, TempaDerm® will be able to take this original cultured skin and use it on someone other
than the original donor. As currently planned, TempaDerm® has the possibility of using banked cells, or even frozen cultured
skin substitutes, to carry inventory to satisfy unknown needs or large volumes to meet the demands created in large scale disasters.
Because of our focus to date on NovaDerm®, we have taken only limited steps toward the development of TempaDerm®. We may
also decellularize TempaDerm® or NovaDerm® to make collagen wound coverings containing
all the natural growth promoters found in skin.

 

We
believe this technology has many different uses beyond the burn indication. The other uses may include chronic wounds, reconstructive
surgery, other complex organs and tissues. Some of the individual components of our planned cultured skin substitute technology
is expected to be developed for devices, such as tendon wraps made of collagen or collagen temporary coverings of large area wounds
to protect the patients from infections while waiting for the permanent skin substitute. The collagen technology used for cultured
skin substitutes, as designed, is expected to be used for many different applications in wound healing and stem cell technology
and even drug delivery systems.

 

We
could pursue any or all of the indications simultaneously if financing permitted, but for now we will seek approval for burns
first as an Orphan Biologic Product to establish significant safety data and then Biological License Approval. 

 

Results
of Operations for the Three Months Ended December 31, 2020 and 2019

 

We
generated no revenues from September 6, 2007 (date of inception) to December 31, 2020. 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 $150,818 for the three months ended December 31, 2020, compared with operating expenses of $192,350
for the three months ended December 31, 2019. General and Administrative expenses accounted for all of our operating expenses
for the three months ended December 31, 2020. The major difference and shift in operating expenses from the three months ended
December 31, 2020 was accounted for by lower General and Administrative expenses.

 

Net
other expense was $9,060 for the three months ended December 31, 2020, as compared to net other expense of $5,636 for the three
months ended December 31, 2019. Other expenses for the three months ended December 31, 2020 consisted of interest expense of $8,285
and an unrealized loss on securities of $775. Other income and expense for the same period ended 2019 consisted of interest expense
of $4,411, and an unrealized loss on securities of $1,225.

 

After
provision for preferred stock dividends of $17,845, we recorded net loss of $177,723 for the three months ended December 31, 2020.
By comparison, we recorded net loss of $215,831 for the three months ended December 31, 2019. Our net loss for the quarter ended
December 31, 2020 was primarily the result of General and Administrative expenses of $150,818.

 

 

Liquidity
and Capital Resources

 

As
of December 31, 2020, we had cash of $1,373 and total current assets of $3,373. As of December 31, 2020, we had current liabilities
of $4,450,527. We therefore had working capital deficit of $4,447,154.

 

Operating
activities used $11,193 in cash for the three months ended December 31, 2020. This use of cash was primarily attributable to funding
the loss for the period.

 

There
were no investing activities during the reported period.

 

Cash
flows from financing activities for the three months ended December 31, 2020 represent net proceeds from a loan from John Weber,
the Company’s Chief Financial Officer of $11,200.

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 going private transactions. 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. 

Off
Balance Sheet Arrangements

 

As
of December 31, 2020, 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 December 31, 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 December 31, 2020, 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 December 31, 2020, 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

 

We
plan 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, 2021 assuming we are able
to obtain necessary funding or alternative financing: (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 December 31, 2020 that have materially
affected, or are reasonable likely to materially affect, our internal control over financial reporting.

 

 

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

 

None

 

Item
3. Defaults upon Senior Securities

 

None

 

Item
4. Mine Safety Disclosures

 

Not
applicable.

 

Item
5. Other Information

 

None

 

Item
6. Exhibits

 

 

 

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:
February
22, 2021
   
By: /s/
Randall McCoy
  Randall
McCoy
Title: Chief
Executive Officer and Director
  (Principal
Executive Officer)
   
Date: February
22, 2021
   
By: /s/
John J. Weber
  John
J. Weber
Title: Chief
Financial Officer and Director
  (Principal
Financial Officer)

 

CERTIFICATIONS

 

I, Randall McCoy, certify that;

 

1. I
have reviewed this quarterly report on Form 10-Q for the quarter ended December 31, 2020 of Regenicin, Inc (the
“registrant”);

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Date: February 22, 2021

 

 

/s/ Randall McCoy

By: Randall McCoy

Title: Chief Executive Officer

CERTIFICATIONS

 

I, John J. Weber, certify that;

 

1. I
have reviewed this quarterly report on Form 10-Q for the quarter ended December 31, 2020 of Regenicin, Inc (the
“registrant”);

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Date: February 22, 2021

 

 

/s/ John J. Weber

By: John J. Weber

Title: Chief Financial Officer

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

 

In connection with the quarterly Report
of Regenicin, Inc (the “Company”) on Form 10-Q for the quarter ended December 31, 2020 filed with the Securities
and Exchange Commission (the “Report”), I, Randall McCoy, Chief Executive Officer of the Company, and, I John
J. Weber, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

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

 

2. The information contained in the Report fairly presents, in all material
respects, the consolidated financial condition of the Company as of the dates presented and the consolidated result of operations
of the Company for the periods presented.

 

By: /s/ Randall McCoy
Name: Randall McCoy
Title: Principal Executive Officer and Director
Date: February 22, 2021


By: /s/ John J. Weber
Name: John J. Weber
Title: Principal Financial Officer and Director
Date: February 22, 2021

This certification has been furnished solely pursuant to Section
906 of the Sarbanes-Oxley Act of 2002.