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, 2015 |
|
|
[ ] |
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.) |
10
High Court, Little Falls, NJ |
(Address
of principal executive offices) |
(973)
557-8914 |
(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.
[
] Large accelerated filer
[
] Non-accelerated filer |
[
] Accelerated filer
[X]
Smaller reporting company |
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 January 28, 2016.
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
Our
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, 2015
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, |
|
2015 | |
2015 |
|
| (UNAUDITED) | | |
| | |
ASSETS |
| | | |
| | |
CURRENT ASSETS |
| | | |
| | |
Cash |
$ | 794,845 | | |
$ | 1,061,377 | |
Prepaid
expenses and other current assets |
| 145,748 | | |
| 119,236 | |
Common
stock of Amarantus Corporation |
| 158,750 | | |
| 300,000 | |
Total
current and total assets |
$ | 1,099,343 | | |
$ | 1,480,613 | |
|
| | | |
| | |
LIABILITIES AND STOCKHOLDERS'
DEFICIENCY |
| | | |
| | |
CURRENT LIABILITIES |
| | | |
| | |
Accounts
payable |
$ | 346,436 | | |
$ | 360,228 | |
Accrued
expenses |
| 1,340,938 | | |
| 1,286,386 | |
Dividends
payable |
| 339,887 | | |
| 322,042 | |
Bridge
financing |
| 175,000 | | |
| 175,000 | |
Loan
payable |
| 10,000 | | |
| 10,000 | |
Loans
payable - related parties |
| 110,500 | | |
| 95,000 | |
Total
current and total liabilities |
| 2,322,761 | | |
| 2,248,656 | |
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 |
| 157,911 | | |
| 157,914 | |
Additional
paid-in capital |
| 9,837,631 | | |
| 9,787,578 | |
Accumulated
deficit |
| (11,074,167 | ) | |
| (10,709,992 | ) |
Accumulated
other comprehensive loss |
| (141,250 | ) | |
| — | |
Less:
treasury stock; 4,428,360 shares at par |
| (4,428 | ) | |
| (4,428 | ) |
Total
stockholders' deficiency |
| (1,223,418 | ) | |
| (768,043 | ) |
Total
liabilities and stockholders' deficiency |
$ | 1,099,343 | | |
$ | 1,480,613 | |
See
Notes to Consolidated Financial Statements.
REGENICIN,
INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF INCOME
|
Three
Months | |
Three
Months |
|
Ended | |
Ended |
|
December
31, | |
December
31, |
|
2015 | |
2014 |
|
(UNAUDITED) | |
(UNAUDITED) |
Revenues |
$ | — | | |
$ | — | |
Operating
expenses |
| | | |
| | |
Research
and development |
| 738 | | |
| — | |
General
and administrative |
| 291,131 | | |
| 140,286 | |
Stock
based compensation - general and administrative |
| 67,895 | | |
| — | |
Reversal
of accounts payable - Lonza |
| — | | |
| (973,374 | ) |
Total
operating expenses |
| 359,764 | | |
| (833,088 | ) |
Income
(loss) from operations |
| (359,764 | ) | |
| 833,088 | |
Other
income (expenses) |
| | | |
| | |
Interest
expense, including amortization of debt discounts |
| (4,411 | ) | |
| (30,944 | ) |
Gain
on sale of assets |
| — | | |
| 4,104,431 | |
Loss
on derivative liabilities |
| — | | |
| (528,230 | ) |
Total
other income (expenses) |
| (4,411 | ) | |
| 3,545,257 | |
Income
(loss) before income tax |
| (364,175 | ) | |
| 4,378,345 | |
Income
tax expense |
| — | | |
| 1,965,700 | |
Net
income (loss) |
| (364,175 | ) | |
| 2,412,645 | |
Preferred
stock dividends |
| (17,845 | ) | |
| (17,845 | ) |
Net
income (loss) attributable to common stockholders |
$ | (382,020 | ) | |
$ | 2,394,800 | |
|
| | | |
| | |
Income
(loss) per share: |
| | | |
| | |
Basic |
$ | (0.00 | ) | |
$ | 0.02 | |
Diluted |
$ | (0.00 | ) | |
$ | 0.01 | |
|
| | | |
| | |
Weighted
average number of shares outstanding |
| | | |
| | |
Basic |
| 153,483,050 | | |
| 152,634,745 | |
Diluted |
| 153,483,050 | | |
| 168,999,745 | |
See
Notes to Consolidated Financial Statements.
REGENICIN,
INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
|
Three
Months | |
Three
Months |
|
Ended | |
Ended |
|
December
31, | |
December
31, |
|
2015 | |
2014 |
|
(UNAUDITED) | |
(UNAUDITED) |
Net
income (loss) |
$ | (364,175 | ) | |
$ | 2,412,645 | |
Other
Comprehensive loss: |
| | | |
| | |
Changes
in unrealized loss on available for sale securities, net of income taxes |
| (141,250 | ) | |
| (534,000 | ) |
Comprehensive
income (loss) |
$ | (505,425 | ) | |
$ | 1,878,645 | |
See
Notes to Consolidated Financial Statements.
REGENICIN,
INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
Three
Months | |
Three
Months |
|
Ended | |
Ended |
|
December
31, | |
December
31, |
|
2015 | |
2014 |
|
| (UNAUDITED) | | |
| (UNAUDITED) | |
CASH FLOWS FROM OPERATING
ACTIVITIES |
| | | |
| | |
Net
income |
$ | (364,175 | ) | |
$ | 2,412,645 | |
Adjustments
to reconcile net income to net cash used in operating activities: |
| | | |
| | |
Deferred
income taxes |
| — | | |
| 1,965,700 | |
Amortization
of debt discounts |
| — | | |
| 7,674 | |
Accrued
interest on notes and loans payable |
| 4,412 | | |
| 6,839 | |
Stock
based compensation - G&A |
| 67,895 | | |
| | |
(Gain)
loss on derivative liabilities |
| — | | |
| 528,230 | |
Gain
on sale of assets |
| — | | |
| (4,104,431 | ) |
Reversal
of accounts payable |
| — | | |
| (973,374 | ) |
Expenses
directly paid by Officer |
| 15,500 | | |
| — | |
Changes
in operating assets and liabilities |
| | | |
| | |
Prepaid
expenses and other current assets |
| (26,512 | ) | |
| (12,099 | ) |
Accounts
payable |
| (13,792 | ) | |
| (57,936 | ) |
Accrued
expenses |
| 50,140 | | |
| 13,577 | |
Net
cash used in operating activities |
| (266,532 | ) | |
| (213,175 | ) |
|
| | | |
| | |
CASH FLOWS FROM INVESTING
ACTIVITIES |
| | | |
| | |
Proceeds
from sale of assets |
| — | | |
| 650,000 | |
Purchase
of Intangible |
| — | | |
| (10,000 | ) |
Net
cash provided by financing activities |
| — | | |
| 640,000 | |
|
| | | |
| | |
CASH FLOWS FROM FINANCING
ACTIVITIES |
| | | |
| | |
Proceeds
from loans from related parties |
| — | | |
| 19,330 | |
Repayments
of loans from related party |
| — | | |
| (12,040 | ) |
Repayments
of notes payable - insurance financing |
| — | | |
| (26,839 | ) |
Repayments
of convertible promissory notes |
| — | | |
| (134,052 | ) |
Net
cash used in financing activities |
| — | | |
| (153,601 | ) |
|
| | | |
| | |
NET INCREASE (DECREASE)
IN CASH |
| (266,532 | ) | |
| 273,224 | |
CASH - BEGINNING
OF PERIOD |
| 1,061,377 | | |
| 492 | |
CASH - END OF
PERIOD |
$ | 794,845 | | |
$ | 273,716 | |
|
| | | |
| | |
Supplemental disclosures
of cash flow information: |
| | | |
| | |
Cash
paid for interest |
$ | — | | |
$ | 48,173 | |
Cash
paid for taxes |
$ | — | | |
$ | — | |
Non-cash activities: |
| | | |
| | |
Sale of assets |
| | | |
| | |
Common
Stock of Amarantus received |
$ | — | | |
$ | (3,000,000 | ) |
Amounts
receivable from Amarantus |
$ | — | | |
$ | (450,000 | ) |
Preferred
stock dividends |
$ | 17,845 | | |
$ | 17,845 | |
Shares
issued/to be issued in connection with conversion of debt and accrued interest |
$ | — | | |
$ | 11,091 | |
Derivative
liabilities reclassified to additional paid-in capital |
$ | — | | |
$ | 368,322 | |
Increase
in loans payable - related parties from Company expenses directly paid by officer |
$ | 15,500 | | |
$ | — | |
See
Notes to Consolidated Financial Statements.
REGENICIN,
INC. AND SUBSIDIARY
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
1 - THE COMPANY
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. (“Regenicin”). 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 original business was the development of a purification device. Such business was assigned to the Company’s
former management in July 2010.
The
Company adopted a new business plan and intended 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.
The
Company entered into a Know-How License and Stock Purchase Agreement (the “Know-How SPA”) with Lonza Walkersville,
Inc. (“Lonza Walkersville”) on July 21, 2010. Pursuant to the terms of the Know-How SPA, the Company paid Lonza Walkersville
$3,000,000 and, in exchange, the Company was to receive an exclusive license to use certain proprietary know-how and information
necessary to develop and seek approval by the U.S. Food and Drug Administration (“FDA”) for the commercial sale of
technology held by the Cutanogen Corporation (“Cutanogen”), a subsidiary of Lonza Walkersville. Additionally, pursuant
to the terms of the Know-How SPA, the Company was entitled to receive certain related assistance and support from Lonza Walkersville
upon payment of the $3,000,000. Under the Know-How SPA, once FDA approval was secured for the commercial sale of the technology,
the Company would be entitled to acquire Cutanogen, Lonza Walkersville’s subsidiary, for $2,000,000 in cash.
After
prolonged attempts to negotiate disputes with Lonza Walkersville failed, on September 30, 2013, the Company filed a lawsuit against
Lonza Walkersville, Lonza Group Ltd. and Lonza America, Inc. (“Lonza America”) in Fulton County Superior Court in
the State of Georgia.
On
November 7, 2014, the Company entered into an Asset Sale Agreement (the “Sale Agreement”) with Amarantus Bioscience
Holdings, Inc., (“Amarantus”). Under the Sale Agreement, the Company agreed to sell to Amarantus all of its rights
and claims in the litigation currently pending in the United States District Court for the District of New Jersey against Lonza
Walkersville and Lonza America, Inc. (the “Lonza Litigation”). This includes all of the Cutanogen intellectual property
rights and any Lonza manufacturing know-how technology. In addition, the Company agreed to sell the PermaDerm® trademark and
related intellectual property rights associated with it. The purchase price paid by Amarantus was: (i) $3,600,000 in cash, and
(ii) shares of common stock in Amarantus having a value of $3,000,000. See Note 4 for a further discussion.
The
Company intends to use the net proceeds of the transaction to fund development of cultured cell technology and to pursue approval
of the products through the FDA. The Company has been developing its own unique cultured skin substitute
since receiving Lonza’s termination notice.
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 three months ended December 31, 2015 are not necessarily indicative of the results
that may be expected for the year ending September 30, 2016. 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, 2015, 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 of approximately $11.0 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. The Company is using the proceeds
from the Asset Sale to fund operations. Once the funds are exhausted, 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:
The
Company measures fair value of its financial assets on a three-tier value hierarchy, which prioritizes the inputs, used in the
valuation methodologies in measuring fair value:
• Level
1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
• Level
2 - Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities in active markets; quoted
prices for identical or similar assets or liabilities in markets that are not active; inputs other than quoted prices that are
observable or inputs that can be corroborated by observable market data for substantially the full term of the assets or liabilities.
• Level
3 - Unobservable inputs which are supported by little or no market activity.
The
fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs
when measuring fair value.
The
carrying value of cash, prepaid expenses and other current assets, accounts payable, accrued expenses and all loans and notes
payable in the Company’s consolidated balance sheets approximated their values as of and December 31, 2015 and September
30, 2015 due to their short-term nature.
Common
stock of Amarantus represents equity investments in common stock that the Company classifies as available for sale. Such
investments are 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, are included in
net income. Unrealized gains and losses considered to be temporary are reported as other comprehensive income (loss) and are
included in stockholders equity. Other than temporary declines in the fair value of investment is included in Other income
(expense) on the statement of income.
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, 2015 is $158,750.
The unrealized loss for the three months ended December 31, 2015 and 2014 was $141,250 and $534,000 net of income taxes, respectively,
and was reported as a component of comprehensive loss. During the fiscal year ended September 30, 2015, the Company recognized
an other than temporary loss on the stock in the amount of $2.7 million which was recognized on the statement of net income.
Recent
Pronouncements:
Management
does not believe that any of the recently issued, but not yet effective, accounting standards if currently adopted would have
a material effect on the accompanying consolidated financial statements.
NOTE
3 - INCOME (LOSS) PER SHARE
Basic
income (loss) per share is computed by dividing the net income (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 table summarizes the
components of the income (loss) per common share calculation:
|
Three
Months Ended December 31, |
|
2015 | |
2014 |
Income
(Loss) Per Common Share - Basic: |
| |
|
Net
income (loss) available to common stockholders |
$ | (388,020 | ) | |
$ | 2,394,800 | |
Weighted-average
common shares outstanding |
| 153,483,050 | | |
| 152,634,745 | |
Basic
income (loss) per share |
$ | (0.00 | ) | |
$ | .02 | |
|
| | | |
| | |
Income
(Loss) Per Common Share - Diluted: |
| | | |
| | |
Net
income (loss) available to common stockholders |
$ | (388,020 | ) | |
$ | 2,394,800 | |
|
| | | |
| | |
Weighted-average
common shares outstanding |
| 153,483,050 | | |
| 152,634,745 | |
Convertible
preferred stock and debentures |
| - | | |
| 16,365,000 | |
Weighted-average
common shares outstanding and common share equivalents |
| 153,483,050 | | |
| 168,999,745 | |
|
| | | |
| | |
Diluted
income (loss) per share |
$ | (0.00 | ) | |
$ | 0.01 | |
The
following securities have been excluded from the calculation of net loss per share for the quarter ended December 31, 2015, as
their effect would be anti-dilutive:
Options |
|
|
13,542,688 |
|
Warrants |
|
|
799,167 |
|
Convertible preferred stock |
|
|
8,850,000 |
|
|
|
|
|
|
The
following securities have been excluded from the diluted per share calculation for the quarter ended December 31, 2014 because
the exercise price was greater than the average market price of the common shares:
Options |
5,542,688 |
Warrants |
3,561,667 |
NOTE
4 - SALE OF ASSET
On
November 7, 2014, the Company entered into a Sale Agreement with Amarantus, Clark Corporate Law Group LLP ("CCLG")
and Gordon & Rees, LLP (“Gordon & Rees”). Under the Sale Agreement, the Company had agreed to sell to
Amarantus all of its rights and claims in the Lonza Litigation. These include all of the Cutanogen intellectual property
rights and any Lonza manufacturing know-how technology. In addition, the Company had agreed to sell its PermaDerm®
trademark and related intellectual property rights associated with it. The purchase price to be paid by Amarantus was: i)
$3,500,000 in cash, and (ii) shares of common stock in Amarantus having a value of $3,000,000. A portion of the cash purchase
price was allocated to repay debt. On January 30, 2015, the agreement was amended whereby the cash portion of the purchase
price was increased by $100,000 to $3,600,000 and the final payment was extended to February 20, 2015. Since Amarantus did
not adhere to the original and amended agreements, the Company did not record the final installment of $2.5 million until it
was received on February 24, 2015.
The
payments to CCLG, satisfied in full the obligations owed to CCLG under its secured promissory note. The $3,000,000 in
Amarantus common stock was satisfied by the issuance of 37,500,000 shares of Amarantus common stock from Amarantus to the
Company. In addition to the sale price, Amarantus paid Gordon & Rees $450,000 upon entering the agreement. The payment to Gordon
& Rees was to satisfy in full all contingent litigation fees and costs owed to Gordon & Rees in connection with the
Lonza Litigation.
During
the three months ended December 31, 2014, the Company recorded a gain on the sale of assets of $4,104,431. In addition, as
a result of the Sale Agreement, the Company determined that it is no longer liable for accounts payable to Lonza in the
amount of $973,374. The liability was reversed and included in operating expenses as an item of income during the three months
ended December 31, 2014.
The
Company also 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.
NOTE
5 - INTANGIBLE ASSETS
As
discussed in Note 1, the Company paid $3,000,000 to Lonza in 2010 to purchase an exclusive know-how license and assistance in
gaining FDA approval. The $3,000,000 payment was recorded as an intangible asset. Due to ongoing disputes and pending any settlement
of the lawsuit, the Company subsequently determined that the value of the intangible asset and related intellectual property had
been fully impaired. As a result, the balance of the intangible asset was $-0- at September 30, 2014.
In
August 2010, the Company paid $7,500 and obtained the rights to the trademarks PermaDerm® and TempaDerm® from KJR-10 Corp.
As
discussed above in Note 4, the Company sold its intangible assets on November 7, 2014.
NOTE
6 - 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 December 31, 2015 and
September 30, 2015, the loan payable totaled $10,000.
Loans
Payable - Related Parties:
During
the year ended September 30, 2015, $95,000 of Company expenses were paid directly by Randall McCoy, the Company’s Chief
Executive Officer and were submitted for reimbursement. At both December 31, 2015 and September 30, 2015, the outstanding
balance was $95,000.
During
the quarter ended December 31, 2015, $15,500 of Company expenses were paid directly by John Weber, the Company’s Chief Financial
Officer and were submitted for reimbursement. At December 31, 2015 the outstanding balance was $15,500.
At
December 31, 2015 and September 30, 2015, loans payable - related parties totaled $110,500 and $95,000, respectively.
NOTE
7 – 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, which correlated to an effective rate of 31.23%.
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 described above. At both December 31, 2015 and September 30, 2015, the note balance was
$175,000.
NOTE 8
- INCOME TAXES
The
Company did not incur current tax expense for the three months ended December 31, 2015. The provision for income taxes of $1,965,700
for the three months ended December 31, 2014 represents deferred taxes.
At
December 31, 2015, the Company had available approximately $3.7 million of net operating loss carry forwards which expire in the
years 2029 through 2035. However, the use of the net operating loss carryforwards generated prior to September 30, 2011 totaling
$0.7 million is limited under Section 382 of the Internal Revenue Code. Section 382 of the Internal Revenue Code of 1986, as amended
(the Code), imposes an annual limitation on the amount of taxable income that may be offset by a corporation’s NOLs if the
corporation experiences an “ownership change” as defined in Section 382 of the Code.
Significant
components of the Company’s deferred tax assets at December 31, 2015 and September 30, 2015 are as follows:
|
December
31, 2015 |
|
September
30, 2015 |
Net operating
loss carry forwards |
$ |
1,489,225 |
|
|
$ |
2,574,628 |
|
Unrealized loss |
|
1,136,500 |
|
|
|
1,080,000 |
|
Stock based compensation |
|
40,476 |
|
|
|
227,201 |
|
Accrued expenses |
|
395,274 |
|
|
|
355,265 |
|
Total deferred tax assets |
|
3,061,475 |
|
|
|
4,237,094 |
|
Valuation allowance |
|
(3,061,475 |
) |
|
|
(4,237,094 |
) |
Net deferred tax assets |
$ |
- |
|
|
$ |
- |
|
Due
to the uncertainty of their realization, a valuation allowance has been established for all of the income tax benefit for
these deferred tax assets.
At
both December 31, 2015 and September 30, 2015, 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 December 31, 2015 and 2014, 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 2012 through 2015 tax years generally remain
subject to examination by federal tax authorities. The Company has not filed any of its state income tax returns since inception.
Due to recurring losses, management believes that once such returns are filed, the Company would incur state minimum tax liabilities
that were not deemed material to accrue.
NOTE
9 - STOCKHOLDERS’ DEFICIENCY
Preferred
Stock:
Series
A
Series
A Preferred pays a dividend of 8% per annum on the stated value and have a liquidation preference equal to the stated value of
the shares. Each share of Preferred Stock has an initial stated value of $1 and are convertible into shares of the Company’s
common stock at the rate of 10 for 1.
The
dividends are cumulative commencing on the issue date whether or not declared. Dividends amounted to $17,845 and $17,845 for the
three months December 31, 2015 and 2014, respectively. At December 31, 2015 and September 30, 2015, dividends payable total $339,887
and $322,042, respectively, and are included in dividends payable on the balance sheet.
At
both December 31, 2015 and September 30, 2015, 885,000 shares of Series A Preferred were outstanding.
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 December 31, 2015, no shares of Series
B Preferred are outstanding.
NOTE
10 - 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 expire on December 22, 2015. Effective as of the expiration date,
the Company extended the term of those options to December 31, 2018. 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 $67,895 in compensation expense. 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 208%, risk free rate of 1.31% and expected term of 3.03 years. Stock based
compensation amounted to $67,895 and $0 for the three months ended December 31, 2015 and 2014, respectively. Stock-based
compensation is included in general and administrative expenses.
NOTE
11 - 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 in Pennington, New Jersey, which is the materials and testing laboratory. An employee of the
Company is an owner of Materials Testing Laboratory.
No
rent is charged for either premise.
NOTE
12 - 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 affect 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
A
year and half after filing the lawsuit against Lonza Walkersville, Inc., and Lonza America, Inc. (the “Lonza Litigation”),
we began the new 2015 fiscal year in the process of consummating an agreement to sell certain assets, including the Lonza Litigation,
to Amarantus Bioscience Holdings, Inc. (the “Amarantus Agreement”). The Amarantus Agreement was finally consummated
at the end of February 2015, with their final payment to us and the transfer/dismissal of the Lonza Litigation. Managements' intentions
at the time were to utilize the proceeds of the Amarantus Agreement to develop the Company's own autologous Engineered Skin Substitute
(ESS). It was estimated that the proceeds from the sale of the Lonza Litigation, including the Amarantus stock received, would
fund the development of the new product up to the initiation of clinical trials, while at the same time reducing outstanding liabilities
and supporting the business operations of the Company. Unfortunately, due to a decline in the value of the Amarantus stock, management
has determined at this time that the proceeds will fall short of that goal and that further funding will most likely need to be
raised.
At
the start of 2015, we reached an agreement with an internationally recognized institution to provide analytical R&D services
for the proposed new product. This was a necessary step in the process of validating the science supporting our new approach.
We believe their research has thus far not only provided support for our new science, but has also brought us product improvements
in the form of the best starting materials, an extended shelf life, and potentially reducing the manufacturing time of the product.
Upon completion, we expect this research will be part of our application for FDA approval to start clinical trials, and will provide
the basis of the tech transfer to our chosen manufacturers.
NovaDerm™
was selected as the name for the proposed new product and documents were completed to register the name as a new Regenicin trademark.
We expect NovaDerm™ will be registered trademark during the first quarter of 2016. As reported, the tradename PermaDerm®
was transferred to Amarantus as part of that agreement.
We
submitted a "Request for Designation" to the FDA to determine which group within the agency would be assigned to evaluate
NovaDerm™. The FDA responded in a phone conversation with our CEO and staff that the product would be designated as a "Biologic".
NovaDerm™ would thus be the first and only autologous Engineered Skin Substitute classified as a Biologic for treatment
of burns greater than 30%, which not only serves as a point of product differentiation, but will also open up the opportunity
for NovaDerm™ to apply for Orphan Designation, with all available benefits.
The
most significant hurdle in the product development process to overcome, we believe, is the collagen substrate issue. Collagen
is used in many products, but it is the essential ingredient to fabricate scaffolds on which cells are grown. Type 1 Bovine Collagen
is harvested from corium, which is the lower part of the Dermis layer of the cow hide. The FDA regulations and guidance dictates
any animal part used in treatment of humans must be from a "Closed Herd". In our search for Closed Herd collagen, we
found that most of the suppliers' claiming to sell from a “Closed Herd" were not in fact compliant with the FDA regulations
and lacked the traceability required for animal materials used for drugs, devices, biologics or combination products. It was important
to our analysis of this issue that the FDA guidance documents clearly state that any product being requested for clinical trials
would be denied until the applicant supplied the traceability to demonstrate that all components derived from animals were obtained
from “Closed Herds”. We identified only one company that was able to satisfy the FDA's Closed Herd requirements. Negotiations
are ongoing regarding obtaining collagen supplies from this company, and as a result of the importance of this material to our
proposed new product, both Regenicin and members of management expect to enter into an arrangement to become part owners of this
vertical supply business.
There
are two separate manufacturing processes that must be performed to produce NovaDerm™. First, the collagen scaffold must
be fabricated to act as the platform on which to grow the skin cells. Secondly, the patient’s actual cells must be cultured
and organized to make the skin.
Both
are highly specialized manufacturing processes and must be performed under strict compliance with Current Good Manufacturing Practices
(cGMP) as set forth by regulations enforced by the US Food and Drug Administration (FDA), and produced
by a manufacturer registered with the FDA. After much discussion, we have identified two highly respected, recognized,
domestic cGMP manufacturers that can provide cultured skin substitute materials for clinical trials, and which we anticipate eventually
contracting with for the manufacture of NovaDerm™ when, and if, it is approved for commerce.
The
pre-IND (investigational new drug) package for the FDA is substantially complete and must await the final results from the analytical
R&D services report mentioned above. Once completed, we will request a Pre-IND meeting with the FDA. The Pre-IND meeting will
give us the opportunity to ask any questions we may have for the FDA as well as getting feedback from the FDA on the information
we provide about NovaDerm™. The meeting will also let us know if the FDA agrees with our plan of commercialization, or if
additional information will be needed for the IND. In order to save time we have already completed much of the IND that will request
permission to start clinical trials.
We
also expect to continue our discussions with the Biomedical Advanced Research and Development Agency (BARDA) related to a
grant application for NovaDerm™ product development.
Our
Business Moving Forward:
The
company goal is to be positioned to enter FDA clinical trials in the second half of 2016. Management believes this goal is obtainable
provided the following planned steps are completed on time as described below:
Calendar
Q1 2016
| 1. | Completion
of the laboratory portion of analytical research services. |
| 2. | Finalize
and execute the contract with a supplier of “Closed Herd” collagen. Pricing
and general terms still have to be determined. |
| 3. | Finalize
and execute a contract with a manufacturer of collagen scaffolds and the actual NovaDerm™
product. Pricing and general terms still have to be determined. |
| 4. | Selection
of a Clinical Research Organization and two clinical sites for the clinical trials |
| 5. | Assemble
a Data Safety Monitoring Board |
| 6. | Obtain
the final report of our analytical research company. |
Calendar
Q2 2016
| 1. | Arrange
a Tech Transfer of the manufacturing process |
| 2. | Apply
for Orphan Designation with the FDA |
| 3. | Submit
Documents to the an institutional review board (IRB) for approval of our biomedical research
plan |
| 4. | Run
First Engineering process to produce samples for a Mouse Study. |
| 5. | Request
FDA Pre-IND meeting. |
| 6. | Negotiate
and contract for mouse study |
| 8. | Obtain
Orphan Designation of NovaDerm™ as a Biologic for burns greater than 30% of the
total burn surface area. |
Calendar
Q3 2016
| 2. | Finalize
Clinical files and clinical site training. |
| 3. | Prepare
and file IRB final documentation |
Calendar
Q4 2016
Begin
Clinical Trials
Results
of Operations for the Three Months Ended December 31, 2015 and 2014
We
generated no revenues from September 6, 2007 (date of inception) to December 31, 2015. 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 $359,764 for the three months ended December 31, 2015, compared with operating expenses of $833,088
for the three months ended December 31, 2014. General and administrative expenses accounted for $291,131 of our operating expenses,
$67,895 resulted from stock based compensation and $738 was from research and development for the three months ended December 31,
2015. The major difference and shift in operating expenses from the three months ended December 31, 2014 was accounted for by
a reversal of our accounts payable in the amount of $973,374 related to the Lonza litigation. Otherwise, all operating expenses
during the three months ended December 31, 2014 were from General and Administrative expenses in the amount of $140,286.
Net
other income (expense) was ($4,411) for the three months ended December 31, 2015, as compared to net other income of
$3,545,257 for the three months ended December 31, 2014. Other income and expenses for the three months ended December 31,
2015 consisted of only interest expenses of $4,411. Other income and expenses for the same period ended 2014 consisted of a
loss on derivative liabilities of $528,230, an interest expense of $30,944, and a gain on sale of assets of
$4,104,431.
After
provision for preferred stock dividends of $17,845, we recorded net loss of $382,020 for the three months ended December
31, 2015. By comparison, we recorded net income attributable to common shareholders of $2,394,800 for the three months ended
December 31, 2014. Our net income for the quarter ended December 31, 2014 was primarily the result of gains recorded as a
result of our sale of intellectual property rights to Amarantus.
Liquidity
and Capital Resources
As
of December 31, 2015, we had cash of $794,845 and total current assets of $1,099,343. As of December 31, 2015, we had current
liabilities of $2,322,761. We therefore had negative working capital of ($1,223,418).
Operating
activities used $266,532 in cash for the three months ended December 31, 2015. The decrease in cash was primarily attributable
to funding the loss for the period.
Investing
activities and Financing activities provided no cash or cash expenditure during the quarter ended December 31, 2015. We note
that the value of the shares of Amarantus we obtained from the sale of assets transaction
have declined significantly in value since the consummation of the agreement.
We
have issued various promissory notes in prior years to meet our short term demands. 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 to be approximately $8 to $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 reduce operating costs and 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 offering to secure funding for operations. There can be no assurance that we will be successful
in raising additional funding. 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, 2014, 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, 2015. 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, 2015, 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, 2015, 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, 2016: (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, 2015 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
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 December 31, 2015, we issued 0 shares of common stock for the conversion of principal issued under our
bridge financing and accrued interest.
These
securities were issued pursuant to Section 4(2) of the Securities Act and/or Rule 506 promulgated thereunder. The holders represented
their intention to acquire the securities for investment only and not with a view towards distribution. The investors were given
adequate information about us to make an informed investment decision. We did not engage in any general solicitation or advertising.
We directed our transfer agent to issue the stock certificates with the appropriate restrictive legend affixed to the restricted
stock.
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
16, 2016 |
|
|
By: |
/s/
Randall McCoy |
|
Randall
McCoy |
Title: |
Chief
Executive Officer and Director |
CERTIFICATIONS
I, Randall McCoy, certify that;
1. |
|
I have reviewed this quarterly report on Form 10-Q for the quarter ended December 31, 2015 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 16, 2016
/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, 2015 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 16, 2016
/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, 2015 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 16, 2016 |
By: |
/s/ John J. Weber |
Name: |
John J. Weber |
Title: |
Principal Financial Officer and Director |
Date: |
February 16, 2016 |
This certification has been furnished solely pursuant to Section
906 of the Sarbanes-Oxley Act of 2002.
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v3.3.1.900
CONSOLIDATED BALANCE SHEET - USD ($)
|
Dec. 31, 2015 |
Sep. 30, 2015 |
CURRENT ASSETS |
|
|
Cash |
$ 794,845
|
$ 1,061,377
|
Prepaid expenses and other current assets |
145,748
|
119,236
|
Common stock of Amrantus Corporation |
158,750
|
300,000
|
Total current and total assets |
1,099,343
|
1,480,613
|
CURRENT LIABILITIES |
|
|
Accounts payable |
346,436
|
360,228
|
Accrued expenses |
1,340,938
|
1,286,386
|
Dividends payable |
339,887
|
322,042
|
Bridge financing |
175,000
|
175,000
|
Loan payable |
10,000
|
10,000
|
Loans payable - related parties |
110,500
|
95,000
|
Total current and total liabilities |
2,322,761
|
2,248,656
|
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 |
157,911
|
157,914
|
Additional paid-in capital |
9,837,631
|
9,787,578
|
Accumulated deficit |
(11,074,167)
|
$ (10,709,992)
|
Accumulated other comprehensive loss |
(141,250)
|
|
Less: treasury stock; 4,428,360 shares at par |
(4,428)
|
$ (4,428)
|
Total stockholders deficiency |
(1,223,418)
|
(768,043)
|
Total liabilities and stockholders deficiency |
1,099,343
|
1,480,613
|
Total stockholders equity (deficiency) |
820,786
|
(1,516,694)
|
Total liabilities and stockholders equity (deficiency) |
$ 3,079,959
|
$ 2,886,454
|
X |
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CONSOLIDATED BALANCE SHEET (Parenthetical) - $ / shares
|
Dec. 31, 2015 |
Sep. 30, 2015 |
Statement of Financial Position [Abstract] |
|
|
Series A Preferred Stock, Par Value |
$ 0.001
|
$ 0.001
|
Series A Preferred Stock, Shares Authorized |
5,500,000
|
5,500,000
|
Series A Preferred Stock, Issued and outstanding |
885,000
|
885,000
|
Common Stock, Par Value |
$ 0.001
|
$ 0.001
|
Common Stock, Shares Authorized |
200,000,000
|
200,000,000
|
Common Stock, Issued |
157,911,410
|
157,911,410
|
Common Stock, Outstanding |
153,483,050
|
153,483,050
|
Treasury Stock, Issued |
4,428,360
|
4,428,360
|
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v3.3.1.900
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)
|
3 Months Ended |
Dec. 31, 2015 |
Dec. 31, 2014 |
Income Statement [Abstract] |
|
|
Revenues |
|
|
Operating expenses |
|
|
Research and development |
$ 738
|
|
General and administrative |
291,131
|
$ 140,286
|
Stock based compensation - general and administrative |
$ 67,895
|
|
Reversal of accounts payable - Lonza |
|
$ (973,374)
|
Total operating expenses |
$ 359,764
|
(833,088)
|
Income (loss) from operations |
(359,764)
|
833,088
|
Other income (expenses) |
|
|
Interest expense, including amortization of debt discounts |
$ (4,411)
|
(30,944)
|
Gain on sale of assets |
|
4,104,431
|
Loss on derivative liabilities |
|
(528,230)
|
Total other income (expenses) |
$ (4,411)
|
3,545,257
|
Income (loss) before income tax |
$ (364,175)
|
4,378,345
|
Income tax expense |
|
1,965,700
|
Net income (loss) |
$ (364,175)
|
2,412,645
|
Preferred stock dividends |
(17,845)
|
(17,845)
|
Net income (loss) attributable to common stockholders |
$ (382,020)
|
$ 2,394,800
|
Income (loss) per share Basic |
$ (0.00)
|
$ 0.02
|
Income (loss) per share Diluted |
$ (0.00)
|
$ 0.01
|
Weighted average number of shares outstanding Basic |
153,483,050
|
152,634,745
|
Weighted average number of shares outstanding Diluted |
153,483,050
|
168,999,745
|
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v3.3.1.900
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($)
|
3 Months Ended |
Dec. 31, 2015 |
Dec. 31, 2014 |
Consolidated Statements Of Comprehensive Income Loss |
|
|
Net income (loss) |
$ (364,175)
|
$ 2,412,645
|
Other Comprehensive loss |
|
|
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(141,250)
|
(534,000)
|
Comprehensive income (loss) |
$ (505,425)
|
$ 1,878,645
|
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CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)
|
3 Months Ended |
Dec. 31, 2015 |
Dec. 31, 2014 |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
Net income |
$ (364,175)
|
$ 2,412,645
|
Adjustments to reconcile net income to net cash used in operating activities: |
|
|
Deferred income taxes |
|
1,965,700
|
Amortization of debt discounts |
|
7,674
|
Accrued interest on notes and loans payable |
$ 4,412
|
$ 6,839
|
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$ 67,895
|
|
(Gain) loss on derivative liabilities |
|
$ 528,230
|
Gain on sale of assets |
|
(4,104,431)
|
Reversal of accounts payable |
|
$ (973,374)
|
Expenses directly paid by Officer |
$ 15,500
|
|
Changes in operating assets and liabilities |
|
|
Prepaid expenses and other current assets |
(26,512)
|
$ (12,099)
|
Accounts payable |
(13,792)
|
(57,936)
|
Accrued expenses |
50,140
|
13,577
|
Net cash used in operating activities |
$ (266,532)
|
(213,175)
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
Proceeds from sale of assets |
|
650,000
|
Purchase of Intangible |
|
(10,000)
|
Net cash provided by investing activities |
|
640,000
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
Proceeds from loans from related parties |
|
19,330
|
Repayments of loans from related party |
|
(12,040)
|
Repayments of notes payable - insurance financing |
|
(26,839)
|
Repayments of convertible promissory notes |
|
(134,052)
|
Net cash used in financing activities |
|
(153,601)
|
NET INCREASE (DECREASE) IN CASH |
$ (266,532)
|
273,224
|
CASH - BEGINNING OF PERIOD |
1,061,377
|
492
|
CASH - END OF PERIOD |
$ 794,845
|
273,716
|
Supplemental disclosures of cash flow information: |
|
|
Cash paid for interest |
|
$ 48,173
|
Cash paid for taxes |
|
|
Non-cash activities: |
|
|
Sale of assets |
$ 6,600,000
|
|
Common Stock of Amarantus received |
|
$ (3,000,000)
|
Amounts receivable from Amarantus |
|
(450,000)
|
Preferred stock dividends |
$ 17,845
|
17,845
|
Shares issued/to be issued in connection with conversion of debt and accrued interest |
|
11,091
|
Derivative liabilities reclassified to additional paid-in capital |
|
$ 368,322
|
Increase in loans payable - related parties from Company expenses directly paid by officer |
$ 15,500
|
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v3.3.1.900
THE COMPANY
|
3 Months Ended |
Dec. 31, 2015 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
THE COMPANY |
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. (Regenicin). 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
Companys original business was the development of a purification device. Such business was assigned to the Companys
former management in July 2010.
The
Company adopted a new business plan and intended 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.
The
Company entered into a Know-How License and Stock Purchase Agreement (the Know-How SPA) with Lonza Walkersville,
Inc. (Lonza Walkersville) on July 21, 2010. Pursuant to the terms of the Know-How SPA, the Company paid Lonza Walkersville
$3,000,000 and, in exchange, the Company was to receive an exclusive license to use certain proprietary know-how and information
necessary to develop and seek approval by the U.S. Food and Drug Administration (FDA) for the commercial sale of
technology held by the Cutanogen Corporation (Cutanogen), a subsidiary of Lonza Walkersville. Additionally, pursuant
to the terms of the Know-How SPA, the Company was entitled to receive certain related assistance and support from Lonza Walkersville
upon payment of the $3,000,000. Under the Know-How SPA, once FDA approval was secured for the commercial sale of the technology,
the Company would be entitled to acquire Cutanogen, Lonza Walkersvilles subsidiary, for $2,000,000 in cash.
After
prolonged attempts to negotiate disputes with Lonza Walkersville failed, on September 30, 2013, the Company filed a lawsuit against
Lonza Walkersville, Lonza Group Ltd. and Lonza America, Inc. (Lonza America) in Fulton County Superior Court in
the State of Georgia.
On
November 7, 2014, the Company entered into an Asset Sale Agreement (the Sale Agreement) with Amarantus Bioscience
Holdings, Inc., (Amarantus). Under the Sale Agreement, the Company agreed to sell to Amarantus all of its rights
and claims in the litigation currently pending in the United States District Court for the District of New Jersey against Lonza
Walkersville and Lonza America, Inc. (the Lonza Litigation). This includes all of the Cutanogen intellectual property
rights and any Lonza manufacturing know-how technology. In addition, the Company agreed to sell the PermaDerm® trademark and
related intellectual property rights associated with it. The purchase price paid by Amarantus was: (i) $3,600,000 in cash, and
(ii) shares of common stock in Amarantus having a value of $3,000,000. See Note 4 for a further discussion.
The
Company intends to use the net proceeds of the transaction to fund development of cultured cell technology and to pursue
approval of the products through the FDA. The Company has been developing our its unique cultured skin substitute since receiving Lonzas termination notice.
|
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- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.3.1.900
BASIS OF PRESENTATION
|
3 Months Ended |
Dec. 31, 2015 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
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 three months ended December 31, 2015 are not necessarily indicative of the results
that may be expected for the year ending September 30, 2016. 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, 2015, 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 of approximately $11.0 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. The Company is using the proceeds
from the Asset Sale to fund operations. Once the funds are exhausted, 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:
The
Company measures fair value of its financial assets on a three-tier value hierarchy, which prioritizes the inputs, used in the
valuation methodologies in measuring fair value:
Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2 - Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities in active markets;
quoted prices for identical or similar assets or liabilities in markets that are not active; inputs other than quoted prices that
are observable or inputs that can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 - Unobservable inputs which are supported by little or no market activity.
The
fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs
when measuring fair value.
The
carrying value of cash, prepaid expenses and other current assets, accounts payable, accrued expenses and all loans and notes
payable in the Companys consolidated balance sheets approximated their values as of and December 31, 2015 and September
30, 2015 due to their short-term nature.
Common
stock of Amarantus represents equity investments in common stock that the Company classifies as available for sale. Such
investments are 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, are included in
net income. Unrealized gains and losses considered to be temporary are reported as other comprehensive income loss and are
included in stockholders equity. Other than temporary declines in the fair value of investment is included in Other income
(expense) on the statement of income.
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, 2015 is $158,750.
The unrealized loss for the three months ended December 31, 2015 and 2014 was $141,250 and $534,000 net of income taxes, respectively,
and was reported as a component of comprehensive loss. During the fiscal year ended September 30, 2015, the Company recognized
an other than temporary loss on the stock in the amount of $2.7 million which was recognized on the statement of net income.
Recent
Pronouncements:
Management
does not believe that any of the recently issued, but not yet effective, accounting standards if currently adopted would have
a material effect on the accompanying consolidated financial statements.
|
X |
- DefinitionThe entire disclosure for the basis of accounting, or basis of presentation, used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.3.1.900
INCOME (LOSS) PER SHARE
|
3 Months Ended |
Dec. 31, 2015 |
Notes to Financial Statements |
|
INCOME (LOSS) PER SHARE |
Basic
income (loss) per share is computed by dividing the net income (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 table summarizes the
components of the income (loss) per common share calculation:
|
Three
Months Ended December 31, |
|
2015 |
|
2014 |
Income (Loss) Per Common Share - Basic: |
|
|
|
Net
income (loss) available to common stockholders |
$ |
(388,020 |
) |
|
$ |
2,394,800 |
|
Weighted-average
common shares outstanding |
|
153,483,050 |
|
|
|
152,634,745 |
|
Basic
income (loss) per share |
$ |
(0.00 |
) |
|
$ |
.02 |
|
|
|
|
|
|
|
|
|
Income (Loss) Per Common
Share - Diluted: |
|
|
|
|
|
|
|
Net
income (loss) available to common stockholders |
$ |
(388,020 |
) |
|
$ |
2,394,800 |
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding |
|
153,483,050 |
|
|
|
152,634,745 |
|
Convertible
preferred stock and debentures |
|
--- |
|
|
|
16,365,000 |
|
Weighted-average
common shares outstanding and common share equivalents |
|
153,483,050 |
|
|
|
168,999,745 |
|
|
|
|
|
|
|
|
|
Diluted
income (loss) per share |
$ |
(0.00 |
) |
|
$ |
0.01 |
|
The
following securities have been excluded from the calculation of net loss per share for the quarter ended December 31, 2015, as
their effect would be anti-dilutive:
Options |
|
|
13,542,688 |
|
Warrants |
|
|
799,167 |
|
Convertible preferred stock |
|
|
8,850,000 |
|
The
following securities have been excluded from the diluted per share calculation for the quarter ended December 31, 2014 because
the exercise price was greater than the average market price of the common shares:
Options |
5,542,688 |
Warrants |
3,561,667 |
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v3.3.1.900
SALE OF ASSET
|
3 Months Ended |
Dec. 31, 2015 |
Notes to Financial Statements |
|
SALE OF ASSET |
On
November 7, 2014, the Company entered into a Sale Agreement with Amarantus, Clark Corporate Law Group LLP ("CCLG") and
Gordon & Rees, LLP (Gordon & Rees). Under the Sale Agreement, the Company had agreed to sell to Amarantus
all of its rights and claims in the Lonza Litigation. These include all of the Cutanogen intellectual property rights and any
Lonza manufacturing know-how technology. In addition, the Company had agreed to sell its PermaDerm® trademark and
related intellectual property rights associated with it. The purchase price to be paid by Amarantus was: (i) $3,500,000 in
cash, and (ii) shares of common stock in Amarantus having a value of $3,000,000. A portion of the cash purchase price was
allocated to repay debt. On January 30, 2015, the agreement was amended whereby the cash portion of the purchase price was
increased by $100,000 to $3,600,000 and the final payment was extended to February 20, 2015. Since Amarantus did not adhere
to the original and amended agreements, the Company did not record the final installment of $2.5 million until it was
received on February 24, 2015.
The
payments to CCLG, satisfied in full the obligations owed to CCLG under its secured promissory note. The $3,000,000
in Amarantus common stock was satisfied by the issuance of 37,500,000 shares of Amarantus common stock from Amarantus to
the Company. In addition to the sale price, Amarantus paid Gordon & Rees $450,000 upon entering the agreement. The payment to
Gordon & Rees was to satisfy in full all contingent litigation fees and costs owed to Gordon & Rees in connection
with the Lonza Litigation.
During
the three months ended December 31, 2014, the Company recorded a gain on the sale of assets of $4,104,431. In addition, as a
result of the Sale Agreement, the Company determined that it is no longer liable for accounts payable to Lonza in the amount
of $973,374. The liability was reversed and is included in operating expenses as an item of income during the three
months ended December 31, 2014.
The
Company also 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.
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v3.3.1.900
INTANGIBLE ASSETS
|
3 Months Ended |
Dec. 31, 2015 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
INTANGIBLES ASSETS |
As
discussed in Note 1, the Company paid $3,000,000 to Lonza in 2010 to purchase an exclusive know-how license and assistance in
gaining FDA approval. The $3,000,000 payment was recorded as an intangible asset. Due to ongoing disputes and pending any settlement
of the lawsuit, the Company subsequently determined that the value of the intangible asset and related intellectual property had
been fully impaired. As a result, the balance of the intangible asset was $-0- at September 30, 2014.
In
August 2010, the Company paid $7,500 and obtained the rights to the trademarks PermaDerm® and TempaDerm® from KJR-10 Corp.
As
discussed above in Note 4, the Company sold its intangible assets on November 7, 2014.
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v3.3.1.900
LOANS PAYABLE
|
3 Months Ended |
Dec. 31, 2015 |
Notes to Financial Statements |
|
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 December 31, 2015 and September 30, 2015, the loan payable
totaled $10,000.
Loans Payable - Related Parties:
During the year ended September 30,
2015, $95,000 of Company expenses were paid directly by Randall McCoy, the Companys Chief Executive Officer and were submitted
for reimbursement. At both December 31, 2015 and September 30, 2015, the outstanding balance was $95,000.
During the quarter ended December 31,
2015, $15,500 of Company expenses were paid directly by John Weber, the Companys Chief Financial Officer and were submitted
for reimbursement. At December 31, 2015 the outstanding balance was $15,500.
At December 31, 2015 and September 30,
2015, loans payable - related parties totaled $110,500 and $95,000, respectively.
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v3.3.1.900
BRIDGE FINANCING
|
3 Months Ended |
Dec. 31, 2015 |
Receivables [Abstract] |
|
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, which correlated to an effective rate of 31.23%. 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
described above. At both December 31, 2015 and September 30, 2015, the note balance was $175,000.
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v3.3.1.900
INCOME TAXES
|
3 Months Ended |
Dec. 31, 2015 |
Income Tax Disclosure [Abstract] |
|
INCOME TAXES |
The
Company did not incur current tax expense for the three months ended December 31, 2015. The provision for income taxes of $1,965,700
for the three months ended December 31, 2014 represents deferred taxes.
At
December 31, 2015, the Company had available approximately $3.7 million of net operating loss carry forwards which expire in the
years 2029 through 2035. However, the use of the net operating loss carryforwards generated prior to September 30, 2011 totaling
$0.7 million is limited under Section 382 of the Internal Revenue Code. Section 382 of the Internal Revenue Code of 1986, as amended
(the Code), imposes an annual limitation on the amount of taxable income that may be offset by a corporations NOLs if the
corporation experiences an ownership change as defined in Section 382 of the Code.
Significant
components of the Companys deferred tax assets at December 31, 2015 and September 30, 2015 are as follows:
|
December
31, 2015 |
|
September
30, 2015 |
Net operating
loss carry forwards |
$ |
1,489,225 |
|
|
$ |
2,574,628 |
|
Unrealized loss |
|
1,136,500 |
|
|
|
1,080,000 |
|
Stock based compensation |
|
40,476 |
|
|
|
227,201 |
|
Accrued expenses |
|
395,274 |
|
|
|
355,265 |
|
Total deferred tax assets |
|
3,061,475 |
|
|
|
4,237,094 |
|
Valuation allowance |
|
(3,061,475 |
) |
|
|
(4,237,094 |
) |
Net deferred tax assets |
$ |
- |
|
|
$ |
- |
|
Due
to the uncertainty of their realization, a valuation allowance has been established for all of the income tax benefit for these
deferred tax assets.
At
both December 31, 2015 and September 30, 2015, 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 December 31, 2015 and 2014, 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 2012 through 2015 tax years generally remain
subject to examination by federal tax authorities. The Company has not filed any of its state income tax returns since inception.
Due to recurring losses, management believes that once such returns are filed, the Company would incur state minimum tax liabilities
that were not deemed material to accrue.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.3.1.900
STOCKHOLDERS DEFICIENCY
|
3 Months Ended |
Dec. 31, 2015 |
Equity [Abstract] |
|
STOCKHOLDERS (DEFICIENCY) EQUITY |
Preferred
Stock:
Series
A
Series
A Preferred pays a dividend of 8% per annum on the stated value and have a liquidation preference equal to the stated value of
the shares. Each share of Preferred Stock has an initial stated value of $1 and are convertible into shares of the Companys
common stock at the rate of 10 for 1.
The
dividends are cumulative commencing on the issue date whether or not declared. Dividends amounted to $17,845 and $17,845 for the
three months December 31, 2015 and 2014, respectively. At December 31, 2015 and September 30, 2015, dividends payable total $339,887
and $322,042, respectively, and are included in dividends payable on the balance sheet.
At
both December 31, 2015 and September 30, 2015, 885,000 shares of Series A Preferred were outstanding.
Series
B
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 expire on December 22, 2015. Effective as of the expiration date, the Company extended the term of those options
to December 31, 2018. All other contractual terms of the options remained the same. The option exercise price was compared to the
fair market value of the Companys shares on the date when the extension was authorized by the Company, resulting in the
immediate recognition of $67,895 in compensation expense. 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 208%, risk free rate of 1.31% and
expected term of 3.03 years. Stock based compensation amounted to $67,895 and $0 for the three months ended December 31, 2015 and
2014, respectively. Stock-based compensation is included in general and administrative expenses.
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- DefinitionThe entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.
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v3.3.1.900
STOCK-BASED COMPENSATION
|
3 Months Ended |
Dec. 31, 2015 |
Accounting Policies [Abstract] |
|
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 expire on December 22, 2015. On February 4, 2016, the Company retroactively amended the stock option agreement again
to extend the expiration date to December 31, 2018. All other terms remained the same. The options were valued utilizing the Black-Scholes
option pricing model with the following assumptions: Exercise price: $0.035; expected volatility: 271%; risk-free rate: 1.31%;
expected term: 3.5 years. The grant date fair value was $0.02 and the options vest immediately. The expected life is the number
of years that the Company estimates, based upon history, that warrants will be outstanding prior to exercise or forfeiture. Expected
life is determined using the simplified method permitted by Staff Accounting Bulletin No. 107. The stock volatility
factor is based on the Nasdaq Biotechnology Index. The Company did not use the volatility rate for Companys common stock
as the Companys common stock had not been trading for the sufficient length of time to accurately compute its volatility
when these options were issued. Stock based compensation amounted to $73,895 and $0 for the three months ended December 31, 2015
and 2014, respectively. Stock-based compensation is included in general and administrative expenses.
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v3.3.1.900
RELATED PARTY TRANSACTIONS
|
3 Months Ended |
Dec. 31, 2015 |
Related Party Transactions [Abstract] |
|
RELATED PARTY TRANSACTIONS |
The
Companys 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 in Pennington, New Jersey, which is the materials and testing laboratory. An employee of the
Company is an owner of Materials Testing Laboratory.
No
rent is charged for either premise.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.3.1.900
INCOME (LOSS) PER SHARE (Tables)
|
3 Months Ended |
Dec. 31, 2015 |
Dec. 31, 2014 |
Income Loss Per Share Tables |
|
|
Schedule of Income Loss per Common Share |
|
Three
Months Ended December 31, |
|
2015 |
|
2014 |
Income (Loss) Per Common Share - Basic: |
|
|
|
Net
income (loss) available to common stockholders |
$ |
(388,020 |
) |
|
$ |
2,394,800 |
|
Weighted-average
common shares outstanding |
|
153,483,050 |
|
|
|
152,634,745 |
|
Basic
income (loss) per share |
$ |
(0.00 |
) |
|
$ |
.02 |
|
|
|
|
|
|
|
|
|
Income (Loss) Per Common
Share - Diluted: |
|
|
|
|
|
|
|
Net
income (loss) available to common stockholders |
$ |
(388,020 |
) |
|
$ |
2,394,800 |
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding |
|
153,483,050 |
|
|
|
152,634,745 |
|
Convertible
preferred stock and debentures |
|
--- |
|
|
|
16,365,000 |
|
Weighted-average
common shares outstanding and common share equivalents |
|
153,483,050 |
|
|
|
168,999,745 |
|
|
|
|
|
|
|
|
|
Diluted
income (loss) per share |
$ |
(0.00 |
) |
|
$ |
0.01 |
|
|
|
Schedule Of Income Loss per Common Share Exclusions |
Options |
|
|
13,542,688 |
|
Warrants |
|
|
799,167 |
|
Convertible preferred stock |
|
|
8,850,000 |
|
|
Options |
5,542,688 |
Warrants |
3,561,667 |
|
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v3.3.1.900
INCOME TAXES (Tables)
|
3 Months Ended |
Dec. 31, 2015 |
Income Tax Disclosure [Abstract] |
|
Deferred Tax Assets |
|
December
31, 2015 |
|
September
30, 2015 |
Net operating
loss carry forwards |
$ |
1,489,225 |
|
|
$ |
2,574,628 |
|
Unrealized loss |
|
1,136,500 |
|
|
|
1,080,000 |
|
Stock based compensation |
|
40,476 |
|
|
|
227,201 |
|
Accrued expenses |
|
395,274 |
|
|
|
355,265 |
|
Total deferred tax assets |
|
3,061,475 |
|
|
|
4,237,094 |
|
Valuation allowance |
|
(3,061,475 |
) |
|
|
(4,237,094 |
) |
Net deferred tax assets |
$ |
- |
|
|
$ |
- |
|
|
X |
- DefinitionTabular disclosure of the components of net deferred tax asset or liability recognized in an entity's statement of financial position, including the following: the total of all deferred tax liabilities, the total of all deferred tax assets, the total valuation allowance recognized for deferred tax assets.
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v3.3.1.900
THE COMPANY (Details Narrative) - USD ($)
|
3 Months Ended |
Dec. 31, 2015 |
Dec. 31, 2014 |
Date of Incorporation |
Sep. 06, 2007
|
|
Payment to Acquire Intangible Assets |
|
$ (10,000)
|
Purchase Price |
|
$ 650,000
|
Sale Agmt |
|
|
Date of Agreement |
|
Nov. 07, 2014
|
Purchase Price |
|
$ 3,500,000
|
Know How SPA |
|
|
Date of Agreement |
Jul. 21, 2010
|
|
Payment to Acquire Intangible Assets |
$ 3,000,000
|
|
Payment to Acquire Subsidiary |
$ 2,000,000
|
|
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v3.3.1.900
BASIS OF PRESENTATION (Details Narrative) - USD ($)
|
3 Months Ended |
|
Dec. 31, 2015 |
Dec. 31, 2014 |
Sep. 30, 2015 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
Common stock of Amarantus Corporation |
$ 158,750
|
|
$ 300,000
|
Change in unrealized gains on available-for-sale securities, net of |
(141,250)
|
$ (534,000)
|
|
Accumulated deficit |
$ (11,074,167)
|
|
$ (10,709,992)
|
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Schedule of Income Loss per Common Share (Details) - USD ($)
|
3 Months Ended |
Dec. 31, 2015 |
Dec. 31, 2014 |
Income (Loss) Per Common Share Basic |
|
|
Net income (loss) attributable to common stockholders |
$ (388,020)
|
$ 2,394,800
|
Weighted average number of shares outstanding |
153,483,050
|
152,634,745
|
Basic income (loss) per share |
$ (0.00)
|
$ 0.02
|
Income (Loss) Per Common Share Diluted |
|
|
Net income (loss) available to common shareholders |
$ (388,020)
|
$ 2,394,800
|
Weighted average number of shares outstanding |
153,483,050
|
152,634,745
|
Convertible preferred stock and debentures |
|
$ 16,365,000
|
Weighted average number of shares outstanding and common share equivalents |
153,483,050
|
168,999,745
|
Diluted income (loss) per share |
$ (0.00)
|
$ 0.01
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LOSS PER SHARE - Schedule Of Income Loss per Common Share Exclusions (Details) - shares
|
Dec. 31, 2015 |
Dec. 31, 2014 |
Exclusions - Calcs |
|
|
Options |
13,542,688
|
|
Warrants |
799,167
|
|
Convertible preferred stock |
8,850,000
|
|
Exclusions - Diluted Calcs |
|
|
Options |
|
5,542,688
|
Warrants |
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3,561,667
|
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v3.3.1.900
SALE OF ASSET (Details Narrative) - USD ($)
|
3 Months Ended |
Dec. 31, 2015 |
Dec. 31, 2014 |
Common Stock of Amarantus received |
|
$ (3,000,000)
|
Purchase Price |
|
650,000
|
Gain on sale of assets |
|
$ 4,104,431
|
Sale Agreement |
|
|
Date of Agreement |
|
Nov. 07, 2014
|
Common Stock of Amarantus received |
|
$ 3,000,000
|
Purchase Price |
|
$ 3,500,000
|
Common Stock of Amarantus received, shares |
|
37,500,000
|
Gain on sale of assets |
|
$ 4,104,431
|
Sale Agmt Amendment |
|
|
Date of Agreement |
Jan. 30, 2015
|
|
Purchase Price |
$ 3,600,000
|
|
Exclusive License Grant |
|
|
Purchase Price |
$ 10,000,000
|
|
Option, Term |
P5Y
|
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Royalty Fee |
5.00%
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v3.3.1.900
LOANS PAYABLE (Details Narrative) - USD ($)
|
Dec. 31, 2015 |
Sep. 30, 2015 |
Loan payable |
$ 10,000
|
$ 10,000
|
Loans payable - related parties |
110,500
|
95,000
|
Investor |
|
|
Loan payable |
10,000
|
10,000
|
Loan payable, balance |
10,000
|
10,000
|
Chief Executive Officer |
|
|
Loans payable - related parties |
95,000
|
|
Loan payable, balance |
95,000
|
$ 95,000
|
Chief Financial Officer |
|
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Loan payable, balance |
$ 15,500
|
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v3.3.1.900
INCOME TAXES - Deferred Tax Assets (Details) - USD ($)
|
Dec. 31, 2015 |
Sep. 30, 2015 |
Deferred tax asset attributable to: |
|
|
Net operating loss carryover |
$ 1,489,225
|
$ 2,574,628
|
Unrealized loss |
1,136,500
|
1,080,000
|
Stock based compensation |
40,476
|
227,201
|
Accrued expenses |
395,274
|
355,265
|
Total deferred tax assets |
3,061,475
|
4,237,094
|
Valuation allowance |
$ (3,061,475)
|
$ (4,237,094)
|
Net deferred tax asset |
|
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STOCKHOLDERS DEFICIENCY (Details Narrative) - USD ($)
|
3 Months Ended |
|
Dec. 31, 2015 |
Dec. 31, 2014 |
Sep. 30, 2015 |
Series A Preferred Stock, Shares Authorized |
5,500,000
|
|
5,500,000
|
Dividends payable |
$ 339,887
|
|
$ 322,042
|
Common stock, Issued |
157,911,410
|
|
157,911,410
|
Common stock, Value |
$ 157,911
|
|
$ 157,914
|
Common Stock, Par Value |
$ 0.001
|
|
$ 0.001
|
Series A Preferred Stock, Issued and outstanding |
885,000
|
|
885,000
|
Common Stock, Shares Authorized |
200,000,000
|
|
200,000,000
|
Stock based compensation - general and administrative |
$ 67,895
|
|
|
Series A |
|
|
|
Dividends |
17,845
|
$ 17,845
|
|
Dividends payable |
$ 339,887
|
|
$ 322,042
|
Series A Preferred Stock, Issued and outstanding |
885,000
|
|
885,000
|
Series B |
|
|
|
Series B Preferred Stock, Shares Authorized |
|
|
4,000,000
|
Series B Preferred Stock, Outstanding |
|
|
0
|
4 Board Members |
|
|
|
Date of Issuance |
Jan. 06, 2011
|
|
|
Common stock, Issued |
885,672
|
|
|
Common stock, Value |
$ 27,556
|
|
|
Common Stock, Par Value |
$ 0.62
|
|
|
Common Stock Option, Exercise Price |
$ 0.035
|
|
|
Stock based compensation - general and administrative |
$ 73,895
|
$ 0
|
|
Stock Option Agmt |
|
|
|
Date of Issuance |
Jan. 15, 2015
|
|
|
Common Stock Option, Issued |
|
|
10,000,000
|
Common Stock Option, Exercise Price |
|
|
$ 0.02
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v3.3.1.900
STOCK-BASED COMPENSATION (Details Narrative) - USD ($)
|
3 Months Ended |
|
Dec. 31, 2015 |
Dec. 31, 2014 |
Sep. 30, 2015 |
Common stock, Issued |
157,911,410
|
|
157,911,410
|
Common stock, Value |
$ 157,911
|
|
$ 157,914
|
Stock based compensation - general and administrative |
$ 67,895
|
|
|
4 Board Members |
|
|
|
Date of Issuance |
Jan. 06, 2011
|
|
|
Common stock, Issued |
885,672
|
|
|
Common stock, Value |
$ 27,556
|
|
|
Common Stock Option, Exercise Price |
$ 0.035
|
|
|
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$ 0.02
|
|
|
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Regenicin (CE) (USOTC:RGIN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Regenicin (CE) (USOTC:RGIN)
Historical Stock Chart
From Jul 2023 to Jul 2024