SEC Info - Regenicin, Inc. - ‘10-Q’ for 6/30/22

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		Alternative Formats (Word, et al.) Consolidated Balance Sheets as of June 30, 2022 (unreviewed) and September 30, 2021 (unaudited) Consolidated Statements of Cash Flows for the three and nine months ended June 30, 2022 and 2021 (unreviewed); and Consolidated Statements of Operations for the three and nine months ended June 30, 2022 and 2021 (unreviewed) Consolidated Statements of Stockholders' Deficiency for the nine months ended June 30, 2022 and 2021 (unreviewed) Controls and Procedures Defaults Upon Senior Securities Exhibits Financial Statements Legal Proceedings Management's Discussion and Analysis of Financial Condition and Results of Operations Mine Safety Disclosures Notes to Consolidated Financial Statements Other Information Quantitative and Qualitative Disclosures About Market Risk Risk Factors Table of Contents Unregistered Sales of Equity Securities and Use of Proceeds
1	1st Page – Filing Submission
"	Table of Contents
"	Financial Statements
"	Consolidated Balance Sheets as of June 30, 2022 (unreviewed) and September 30, 2021 (unaudited)
"	Consolidated Statements of Operations for the three and nine months ended June 30, 2022 and 2021 (unreviewed)
"	Consolidated Statements of Stockholders' Deficiency for the nine months ended June 30, 2022 and 2021 (unreviewed)
"	Consolidated Statements of Cash Flows for the three and nine months ended June 30, 2022 and 2021 (unreviewed); and
"	Notes to Consolidated Financial Statements
"	Management's Discussion and Analysis of Financial Condition and Results of Operations
"	Quantitative and Qualitative Disclosures About Market Risk
"	Controls and Procedures
"	Legal Proceedings
"	Risk Factors
"	Unregistered Sales of Equity Securities and Use of Proceeds
"	Defaults Upon Senior Securities
"	Mine Safety Disclosures
"	Other Information
"	Exhibits

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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 ☒ i 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 ☒ i No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.

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

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

State the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: i 153,483,050 as of July 26, 2022.

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

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

The consolidated financial statements as of and for the three months ended June 30, 2022 and 2021 have not been reviewed by our independent registered public accounting firm. The consolidated balance sheet as September 30, 2021 has not been audited by our independent registered public accounting firm.

These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and the SEC instructions to Form 10-Q. In the opinion of management, all adjustments considered necessary for a fair presentation have been included. Operating results for the interim period ended June 30, 2022 are not necessarily indicative of the results that can be expected for the full year.

(1) The number of shares in treasury stock for all periods presented was 4,428,360.

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

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

The company’s major objective for 2022 remains to secure the required funding to finalize some additional requirements of the IND application and begin the clinical trials.

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

As previously reported, our goal in obtaining this funding has been to minimize shareholders' dilution as much as possible. Consequently, we are continuing to pursue financing through the issuance of a debt instrument and international licensing agreements.

We continue to work with a number of potential investors and continue to pursue the necessary funding based on our stated objectives. It has taken longer to raise the funds than originally estimated; however, we remain confident that our goal is achievable. In the interim, the officers and related parties intend to continue to fund the Company’s essential operating costs.

We have continued the planning for the clinical trials to the extent we are able, considering funding constraints. As previously reported we have chosen a CRO to assist in our IND submission and conducting the trials. We have identified and received quotes from potential NovaDerm contract manufacturers. Clinical site selection and patient recruitment should be somewhat simpler than other clinical trials, as we are limited in site selection to the 127 burn centers qualified to treat pediatric and adult full thickness catastrophic burns. In addition, the surgical protocol will be similar to the split thickness allografting procedures currently in use at those facilities. NovaDerm® should thus require minimal physician training.

The initial trials are planned to begin with a total of ten subjects with an Initial Data Safety Monitoring Board (DSMB) review of safety on the first three subjects once they have reached 6 months follow-up. We do not intend to interrupt our trial waiting for the DSMB report.

Our management is considering various possibilities and approaches to obtaining clinical trial materials and manufacturing. While no final decision has been made, management’s approach is to set up the trials so as to allow for a seamless transition into commercial production upon approval.

We have access to a clean room facility for growing NovaDerm here in New Jersey in addition to instate and out of state FDA registered contract manufacturers. Our selection for the clinical trial material manufacturer must have the ability to produce marketable material when NovaDerm is approved for sale by the FDA.

Results of Operations for the Three and Nine Months Ended June 30, 2022 and 2021

We generated no revenues from September 6, 2007 (date of inception) to June 30, 2022. 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 $152,721 and $454,766 for the three and nine months ended June 30, 2022, compared with operating expenses of $155,559 and $532,113 for the three and nine months ended June 30, 2021.. The decrease was the result of a decrease in insurance expense and stock-based compensation.

Other expenses was $10,372 and $29,101 for the three and nine months ended June 30, 2022, as compared to other expenses of $9,786 and $26,414 for the three and nine months ended June 30, 2021. Other income (expenses) consisted of interest expense and an unrealized loss on securities. The increase in interest expense related primarily to interest charged on a convertible note issued to John Weber, the Company’s chief financial officer, on March 31, 2020.

Operating activities used $27,216 in cash for the nine months ended June 30, 2022. The decrease in cash was primarily attributable to funding the loss for the period.

Cash flows from financing activities for the nine months ended June 30, 2022 represents proceeds from loans from officers of $27,000.

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

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.

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

We carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of June 30, 2022. This evaluation was carried out under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of June 30, 2022, our disclosure controls and procedures were not effective due primarily to the lack of segregation of duties, resulting in the presence of material weaknesses in internal control over financial reporting.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. Management has identified the following material weaknesses which have caused management to conclude that, as of June 30, 2022, 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 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, 2022 assuming we are able to obtain necessary funding: (i) appoint additional qualified personnel to address inadequate segregation of duties and ineffective risk management; and (ii) adopt sufficient written policies and procedures for accounting and financial reporting. The remediation efforts set out are largely dependent upon our securing additional financing to cover the costs of implementing the changes required. If we are unsuccessful in securing such funds, remediation efforts may be adversely affected in a material manner.

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

There were no changes in our internal control over financial reporting during the three months ended June 30, 2022 that have materially affected, or are reasonable likely to materially affect, our internal control over financial reporting.

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.

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

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.

i ☒	Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
	For the quarterly period ended i June 30, 2022

i ☐	Transition Report pursuant to 13 or 15(d) of the Securities Exchange Act of 1934
	For the transition period from to __________

	Commission File Number: i 333-146834

i Nevada	i 27-3083341
(State or other jurisdiction of incorporation or organization)	(IRS Employer Identification No.)

OTCBB	RGIN	i COMMON
Principal US Market	Symbol	Class of Trading Security

Large accelerated filer	☐	i Non-accelerated Filer	☐
Non-accelerated filer	☐	Smaller reporting company	i ☒
		Emerging growth company	i ☐

	TABLE OF CONTENTS	Page

PART I – FINANCIAL INFORMATION

Item 1:	Financial Statements	3
Item 2:	Management’s Discussion and Analysis of Financial Condition and Results of Operations	4
Item 3:	Quantitative and Qualitative Disclosures About Market Risk	7
Item 4:	Controls and Procedures	7
PART II – OTHER INFORMATION
Item 1:	Legal Proceedings	8
Item 1A:	Risk Factors	8
Item 2:	Unregistered Sales of Equity Securities and Use of Proceeds	8
Item 3:	Defaults Upon Senior Securities	8
Item 4:	Mine Safety Disclosures	8
Item 5:	Other Information	8
Item 6:	Exhibits	8

Regenicin, Inc. – ‘10-Q’ for 6/30/22

On: Friday, 8/12/22, at 2:44pm ET · For: 6/30/22 · Accession #: 1662252-22-28 · File #: 333-146834

Previous ‘10-Q’: ‘10-Q’ on 5/23/22 for 3/31/22 · Next: ‘10-Q’ on 2/13/23 for 12/31/22 · Latest: ‘10-Q’ on 5/15/23 for 3/31/23

Quarterly Report — Form 10-Q

Filing Table of Contents

‘10-Q’ — Quarterly Report

Document Table of Contents

This is an HTML Document rendered as filed. [ Alternative Formats ]

Dates Referenced Herein and Documents Incorporated by Reference

F-1	Consolidated Balance Sheets as of June 30, 2022 (unreviewed) and September 30, 2021 (unaudited);
F-2	Consolidated Statements of Operations for the three and nine months ended June 30, 2022 and 2021 (unreviewed);
F-3	Consolidated Statements of Stockholders’ Deficiency for the nine months ended June 30, 2022 and 2021 (unreviewed);
F-4	Consolidated Statements of Cash Flows for the three and nine months ended June 30, 2022 and 2021 (unreviewed); and
F-5	Notes to Consolidated Financial Statements.

	June 30, 2022			September 30, 2021
		(Unreviewed)			(Unaudited)
ASSETS
CURRENT ASSETS
Cash	$	i 1,643		$	i 1,859
Common stock of Amarantus		i 600			i 2,750
Total current and total assets	$	i 2,243		$	i 4,609
LIABILITIES AND STOCKHOLDERS' DEFICIENCY
CURRENT LIABILITIES
Accounts payable	$	i 85,000		$	i 93,674
Accrued expenses - other (related party of $ i 60,575 and $ i 46,713)		i 262,319			i 234,894
Accrued salaries - officers		i 4,466,751			i 4,031,001
Promissory note payable		i 175,000			i 175,000
Convertible promissory note - officer		i 335,683			i 335,683
Loan payable		i 10,000			i 10,000
Loans payable - officer		i 109,235			i 82,235
Total current liabilities		i 5,443,988			i 4,962,487
STOCKHOLDERS' DEFICIENCY
Series A 8% Convertible Preferred stock, $ i i 0.001 / par value, i i 5,500,000 / shares authorized; i i 885,000 / issued and outstanding		i 885			i 885
Common stock, $ i i 0.001 / par value; i i 200,000,000 / shares authorized; i i 157,911,410 / issued and i i 153,483,050 / outstanding		i 157,914			i 157,914
Additional paid-in capital		i 10,208,339			i 10,208,339
Accumulated deficit		( i 15,804,455	)		( i 15,320,588	)
Less: treasury stock; i i 4,428,360 / shares at par		( i 4,428	)		( i 4,428	)
Total stockholders' deficiency		( i 5,441,745	)		( i 4,957,878	)
Total liabilities and stockholders' deficiency	$	i 2,243		$	i 4,609

	Nine Months Ended June 30,			Nine Months Ended June 30,
	2022			2021

CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	( i 483,867	)	$	( i 558,527	)
Adjustments to reconcile net loss to net cash used in operating activities:
Unrealized loss on investment		i 2,150			i 900
Accrued interest on loans and notes payable		i 26,952			i 25,514
Changes in operating assets and liabilities
Accounts payable		( i 8,676	)		i 5,016
Accrued expenses - other		i 475			i 69,187
Accrued salaries - officers		i 435,750			i 435,749
Net cash used in operating activities		( i 27,216	)		( i 22,161	)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds of loans from officers		i 27,000			i 23,600
Net cash provided by financing activities		i 27,000			i 23,600
NET DECREASE IN CASH		( i 216	)		i 1,439
CASH - BEGINNING OF PERIOD		i 1,859			i 1,366
CASH - END OF PERIOD	$	i 1,643		$	i 2,805
Supplemental disclosures of cash flow information:
Cash paid for interest	$	—		$	—
Cash paid for taxes	$	—		$	—

	2022		2021
Options		i 11,771,344		i 11,771,344
Convertible Preferred Stock		i 8,850,000		i 8,850,000
Convertible Promissory Note		i 27,078,816		i 11,615,329
		i 46,700,160		i 32,236,673

Exhibit Number	Description of Exhibit
31.1	Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2	Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1	Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101**	The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 formatted in Extensible Business Reporting Language (XBRL).
**Provided herewith

	Regenicin, Inc.

Date:	August 12, 2022

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

By:	/s/ John J. Weber
	John J. Weber
Title:	Chief Financial Officer and Director (Principal Financial Officer)

This ‘10-Q’ Filing	Date	Other Filings

	9/30/22
Filed on:	8/12/22
	7/26/22
For Period end:	6/30/22
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