10-K 1 mainbody.htm RGIN10K093015

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-K

 

[X] ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended September 30, 2015
[  ] TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
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) (I.R.S. Employer Identification No.)
10 High Court, Little Falls, NJ 07424
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number: 973 557 8914

 

 


Securities registered under Section 12(b) of the Exchange Act

 

Title of each class Name of each exchange on which registered
None not applicable

Securities registered under Section 12(g) of the Exchange Act:

 

Title of each class
None

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes [ ] No [X]

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes [X] No [ ]

 

Indicate by checkmark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [ ] No [X]

 

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 if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [X]

 

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

 

Large accelerated filer [ ] Accelerated filer [ ] Non-accelerated filer [ ] Smaller reporting company [X]

 

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

 

State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter: $2,419,389 as of March 31, 2015

 

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date: 153,483,050 as of January 11, 2016

 

   

 

TABLE OF CONTENTS

 

Page

PART I

 

Item 1. Business 3
Item 1A. Risk Factors 7
Item 1B. Unresolved Staff Comments 7
Item 2. Properties 7
Item 3. Legal Proceedings 7
Item 4. Mine Safety Disclosures 7

 

PART II

 

Item 5. Market for Registrant’s Common Equity and Related Stockholder Matters and Issuer Purchases of Equity Securities 8
Item 6. Selected Financial Data 11
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 11
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 13
Item 8. Financial Statements and Supplementary Data 14
Item 9. Changes In and Disagreements With Accountants on Accounting and Financial Disclosure 15
Item 9A. Controls and Procedures 15
Item 9B. Other Information 16

 

PART III

 

Item 10. Directors, Executive Officers and Corporate Governance 16
Item 11. Executive Compensation 18
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 21
Item 13. Certain Relationships and Related Transactions, and Director Independence 22
Item 14. Principal Accountant Fees and Services 22

 

PART IV

 

Item 15. Exhibits, Financial Statement Schedules 23

 

 

 2 

 

PART I

Item 1. Business

 

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 solely as a "Biologic". NovaDerm™ would thus be the first and only autologous cultured skin substitute designated solely 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. 

 3 

 

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
7.Revise IND as needed
8.Obtain Orphan Designation of NovaDerm™ as a Biologic for burns greater than 30% of the total burn surface area

 

Calendar Q3 2016

 

1.Submit IND
2.Finalize Clinical files and clinical site training
3.Prepare and file IRB final documentation

 

Calendar Q4 2016

 

Begin Clinical Trials

 4 

Our Proposed New Product:

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

Clinically speaking, a product designed to treat a life threatening condition must be available for the patient when needed. Our culture skin substitute is being developed to be ready to apply to the patient when the patient is ready for grafting, within the first month of the patient being admitted to the hospital. Patients with serious burn injuries may not be in a condition to be grafted on a predefined schedule made more than a month in advance. Therefore, in order to accommodate the patient’s needs, we are striving to ensure that our cultured skin substitute will be designed with an adequate shelf life and manufacturing schedule to ensure it is available whether the patient needs it the first month, or any day after, until the patient’s wound is completely covered and closed.

We intend to work with the FDA for the development of a cultured skin product. We are preparing documentation for Orphan Designation for the USA and European Union using our internal expertise. We will submit the request when we have qualified our cell therapy manufacturer. In order to obtain Orphan designation we will work with the Office of Orphan products to demonstrate that our cultured skin substitute is safe and the probable benefit of using our cultured skin substitute for burns outweighs the risks. There are less than 200,000 patients affected per year in the US with full thickness burns affecting greater than 30 percent of the Total Body Surface Area (TBSA). As noted above, we hope to obtain Orphan Designation for burns in the first half of 2016.

Having our cultured skin substitute approved as an Orphan Product would have significant benefits, including 7 years exclusivity with the FDA, 11 years exclusivity with the European Union generating revenue from sales of product used during the clinical trials and being able to utilize the data from patients from many different hospitals to gain Commercialization Approval. Orphan approval allows the product to be used to treat people a lot earlier than waiting for extensive clinical trials to gain Biological License Approval. The major difference between Orphan Product Approval and a full Biological License Approval is that the Orphan Product has additional FDA reporting requirements and additional procedural administration steps. Orphan Product patient’s data must be reported to the FDA annually. There is also a difference between Orphan Designation and Orphan Product Approval. Orphan Designation qualifies your product to get special assistance from the FDA such as grants, and additional guidance in designing your trials and what the FDA expects you to do to gain Orphan Approval. Orphan Approval is granted when you have demonstrated that your product is safe and has a probable benefit to a patient affected with the specific indication. Most importantly for us, Orphan Approval means we can provide our lifesaving product NovaDerm™ commercially to thousands of pediatric and adult burn victims.

We are assembling our Investigative New Drug (IND) Biologic application for our cultured skin substitute utilizing our internal expertise. This will allow us to move the product through the FDA pipeline with minimal expense. As we approach the clinical trials, we may need to obtain additional outside funding. We hope to receive the approval from the FDA to initiate clinical trials in 2015. We intend to apply for Biological License Approval in 2016.

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

 5 

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

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

Competition 

 

Several companies have developed or are developing products that propose to approach the markets described above. Other than Amarantus Biosciences, Inc., discussed above, this companies include:

 

- Smith & Nephew Wound Management

- Genzyme Biosurgery

- Integra Life Sciences Corporation

- LifeCell Corporation/Kinetic Concepts

- Organogenesis Inc

- Intercytex

- Genzyme

- Advanced Biohealing/ Shire

- Cy Ttera/ NovoCell/ViaCyte

- Biomimetic Therapeutics Inc.

-

RTI Biologics

 

Each of these companies has a proprietary approach to these markets, but none has yet penetrated the cell therapy markets fully and 4 companies, (Smith and Nephew, Genzyme, Organogenesis, Integra and Advanced Biohealing) have products that are FDA approved for use in burn patients. Conversely, our products are believed to be superior in design and function and, thus, provide significant advantages over the above competitors. The advantages of our cultured skin substitute include simultaneous delivery of Autologus epidermal keratinocytes and fibroblasts organized with a unique collagen base. Clinical skin replacements and grafts are in high demand for the treatment of skin injuries: they represent approximately 50% of tissue engineering and regenerative medicine market revenues. In 2009, the potential United States market for tissue-engineered skin replacements and substitutes totaled approximately $18.9 billion, based on a target patient population of approximately 5.0 million. By the year 2019, the total potential target population for the use of tissue-engineered skin replacements and substitutes is expected to increase to 6.4 million, resulting in a potential US market of approximately $24.3 billion. Tissue Engineering and Cell Transplantation: US Markets for Skin Replacements and Substitutes; Report #A426; Medtech Insight: Bridgeport, PA, USA, August 2010.

 

Government Regulation

 

The Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110-85) provides that Orphan Product applications for pediatric use only, or for use in both pediatric and adult patients, that are approved on or after September 27, 2007, are assigned an annual distribution number (ADN) and may be sold for profit (subject to the upper limit of the ADN). In addition, once a product receives an Orphan BLA, the developer of the product receives up to seven years market exclusivity for a specific indication following the product’s approval by the FDA.

 

Unrestricted sales of our cultured skin substitute will require full approval after data for safety and efficacy are collected from a multi-center study. Once the IND is submitted, we expect enrollment and treatment are expected to require one year evaluation on each patient. The final 9 months of the evaluation is expected to be only a monitoring period. After collection of data from the clinical trial and submission to FDA, six months is typically planned for FDA’s review and decision. Having an Orphan designation of which the indication is life threatening and there is an unmet need for catastrophic burns, the review time may be reduced significantly. Therefore, we believe Biological approval can be obtained in 2016 or 2017. A positive performance of the clinical study and a review from FDA in less than 6 months after pre approval inspection of the manufacturing facility by FDA would support a 2016-17 date for commercial sales. 

 6 

 

Intellectual Property

 

In August 2010, we paid $7,500 and obtained the rights to the trademarks PermaDerm® and TempaDerm® from KJR-10 Corp. In November of 2014, we sold the PermaDerm® trademark to Amarantus Biosciences as part of an Asset Purchase Agreement whereby they purchase all our rights to the Lonza lawsuit. Recently, we filed for the trademark for NovaDerm™.  We expect the NovaDerm™ trademark will be registered the first quarter of 2016.

  

Employees

 

As of September 30, 2015, we had 3 employees. 

 

Subsidiaries

 

On September 11, 2013 we completed formation documents with respect to the formation of a wholly - owned subsidiary created with the sole purpose of conducting research in the State of Georgia.

 

The subsidiary was given the name, Regenicin Research of Georgia, LLC, and was accepted by the Georgia Secretary of State on September 25, 2013, with an official certificate of formation being issued on September 26, 2013.

 

Item 1A. Risk Factors.

 

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

 

Item 1B. Unresolved Staff Comments.

 

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

 

Item 2. Properties

 

Our principal executive offices are located at 10 High Court, Little Falls, NJ 07424. Our headquarters is located in the offices of McCoy Enterprises LLC, an entity controlled by Randall McCoy, our Chief Executive Officer. The office is attached to his residence but has its own entrances, restroom and kitchen facilities. No rent is charged.

 

We also maintain an office at 3 Arvida Drive, Pennington NJ 08534, which is an FDA registered, cGMP compliant FDA audited facility. This office is owned by Materials Testing Laboratory, and the principal is an employee of our company. No rent is charged.

 

Item 3. Legal Proceedings

 

On September 30, 2013, we filed a lawsuit against Lonza Walkersville and others in Fulton County Superior Court in the State of Georgia.

 

On November 7, 2014, we entered into an Asset Purchase Agreement (“the Agreement”) with Amarantus Bioscience Holdings, Inc. (“Amarantus”) and others in which we agreed to sell to Amarantus all of our rights and claims in our litigation currently pending in the “Lonza Litigation”. This included all of our Cutanagen intellectual property rights and any Lonza manufacturing know-how technology. In addition, we agreed to transfer Amarantus our PermaDerm trademark and related intellectual property rights associated with it. The purchase price paid by Amarantus consisted of: (i) $3,500,000 in cash, and (ii) shares of common stock in Amarantus having a value of $3,000,000 at the time of the closing. A portion of the cash purchase price was allocated to our sole senior secured creditor.

 

The cash portion of the purchase price was paid to us over time and was fully consummated in February 2015.

 

In addition to the purchase price, Amarantus paid our attorneys in the Lonza Litigation, Gordon & Rees, $450,000 at closing. The payment to Gordon & Rees satisfied in full all obligations for litigation fees and costs owed to Gordon & Rees in connection with the Lonza Litigation.

 

In addition, we 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 Regenicin. Amarantus can exercise this option at a cost of $10,000,000 USD plus a royalty of 5% on gross revenues in excess of $150M USD.

 

Item 4. Mine Safety Disclosures

N/A

 

 7 

 

PART II

 

Item 5. Market for Registrant’s Common Equity and Related Stockholder Matters and Issuer Purchases of Equity Securities

 

Market Information

 

Our common stock is quoted under the symbol “RGIN” on the OTCBB operated by the Financial Industry Regulatory Authority, Inc. (“FINRA”) and the OTCQB operated by OTC Markets Group, Inc. Few market makers continue to participate in the OTCBB system because of high fees charged by FINRA. Consequently, market makers that once quoted our shares on the OTCBB system may no longer be posting a quotation for our shares. As of the date of this report, however, our shares are quoted by several market makers on the OTCQB. The criteria for listing on either the OTCBB or OTCQB are similar and include that we remain current in our SEC reporting.

Only a limited market exists for our securities. There is no assurance that a regular trading market will develop, or if developed, that it will be sustained. Therefore, a shareholder may be unable to resell his securities in our company.

The following table sets forth the range of high and low bid quotations for our common stock for each of the periods indicated as reported by the OTCQB. These quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not necessarily represent actual transactions. 

Fiscal Year Ending September 30, 2015
Quarter Ended High $ Low $
September 30, 2015 0.03 0.02
June 30, 2015 0.04 0.01
March 31, 2015 0.04 0.01
December 31, 2014 0.03 0.01
Fiscal Year Ending September 30, 2014
Quarter Ended High $ Low $
September 30, 2014 0.02 0.00
June 30, 2014 0.03 0.01
March 31, 2014 0.03 0.02
December 31, 2013 0.04 0.02

 

Penny Stock

 

The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a market price of less than $5.00, other than securities registered on certain national securities exchanges or quoted on the NASDAQ system, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock, to deliver a standardized risk disclosure document prepared by the SEC, that: (a) contains a description of the nature and level of risk in the market for penny stocks in both public offerings and secondary trading; (b) contains a description of the broker's or dealer's duties to the customer and of the rights and remedies available to the customer with respect to a violation of such duties or other requirements of the securities laws; (c) contains a brief, clear, narrative description of a dealer market, including bid and ask prices for penny stocks and the significance of the spread between the bid and ask price; (d) contains a toll-free telephone number for inquiries on disciplinary actions; (e) defines significant terms in the disclosure document or in the conduct of trading in penny stocks; and (f) contains such other information and is in such form, including language, type size and format, as the SEC shall require by rule or regulation.

 8 

 

The broker-dealer also must provide, prior to effecting any transaction in a penny stock, the customer with (a) bid and offer quotations for the penny stock; (b) the compensation of the broker-dealer and its salesperson in the transaction; (c) the number of shares to which such bid and ask prices apply, or other comparable information relating to the depth and liquidity of the market for such stock; and (d) a monthly account statement showing the market value of each penny stock held in the customer's account.

 

In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from those rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser's written acknowledgment of the receipt of a risk disclosure statement, a written agreement as to transactions involving penny stocks, and a signed and dated copy of a written suitability statement.

 

These disclosure requirements may have the effect of reducing the trading activity for our common stock. Therefore, stockholders may have difficulty selling our securities.

 

Holders of Our Common Stock

 

As of January 8, 2016, we had 153,483,051 shares of our common stock issued and outstanding, held by 111 shareholders of record, with others holding shares in street name.

 

Dividends

 

There are no restrictions in our articles of incorporation or bylaws that prevent us from declaring dividends. The Nevada Revised Statutes, however, do prohibit us from declaring dividends where after giving effect to the distribution of the dividend:

 

1.     We would not be able to pay our debts as they become due in the usual course of business, or;

2.     Our total assets would be less than the sum of our total liabilities plus the amount that would be needed to satisfy the rights of shareholders who have preferential rights superior to those receiving the distribution.

 

We have not declared any dividends and we do not plan to declare any dividends in the foreseeable future.

 

Recent Sales of Unregistered Securities

 

For the year ended September 30, 2014, we issued 2,600,000 shares of its common stock for the conversion of notes payable and accrued interest.

 

For the year ended September 30, 2014, we issued 14,840,392 shares of common stock for the conversion of principal and accreted interest owed.

 

For the year ended September 30, 2014, we issued 960,000 shares of common stock for the exercise of a warrant.

 

On December 24, 2013, we issued 1,038,751 shares of our common stock as a finder’s fee to an entity for introducing investors and/or lenders who provided funding to us in fiscal 2013. The shares were valued at $35,851.

 

For the year ended September 30, 2015, we issued 10,392,967 shares of its common stock for the conversion of notes payable and accrued interest.

 

For the year ended September 30, 2015, we issued 7,920,291 shares of common stock for the conversion of principal and accrued interest owed.

 

 9 

 

Shares and Warrants to be issued:

 

Various convertible promissory notes that automatically converted at their respective maturity dates into an aggregate of 10,367,094 shares of our common stock were not issued as of September 30, 2014. Accordingly, the shares were classified as common stock to be issued. These shares were all issued during the fiscal year ended September 30, 2015.

 

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.

 

Securities Authorized for Issuance under Equity Compensation Plans

 

The following table provides information about our compensation plans under which shares of common stock may be issued upon the exercise of options as of September 30, 2015.

 

Plan Category Number of securities to be
issued upon exercise of
outstanding option, warrants and rights
Weighted-average exercise price
of outstanding options,
warrants and rights
Number of securities remaining
available for future issuances under
equity compensation plans
Equity compensation plans approved by security holders 0 0 0
Equity compensation plans not approved by security holders 15,542,688 $ 0.08 0
Total 15,542,688 $ 0.08 0

 

On December 15, 2010, the board of directors approved the Regenicin, Inc. 2010 Incentive Plan (the “Plan”). The Plan provides for the granting of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock, stock units, performance shares and performance units to our employees, officers, directors and consultants, including incentive stock options, non-qualified stock options, restricted stock, and other benefits. The Plan provides for the issuance of up to 4,428,360 shares of our common stock.

 

On January 6, 2011, we approved the issuance of 885,672 options to each of the four members of the board of directors at an exercise price is $0.62 per share. The options vest over a three-year period and expired on December 22, 2015. On May 11, 2011, the terms of the options were amended to allow for immediate vesting. On December 10, 2013, we approved the amendment to those options to change the exercise price to $0.035 per share.

 

In November of 2010, we approved the issuance of 2,000,000 options to a consultant at an exercise price of $0.46 per share. The options vested immediately and expired in November 2015.

 

In addition, on January 15, 2015, the company entered into a stock option agreement with an officer of the company. The agreement grants the officer an option to purchase 10 million shares of common stock at $0.02 per share, and expires January 15, 2019.

 

Warrants Issued and Outstanding

 

In fiscal 2014, in connection with the issuance of convertible notes, we issued warrants to purchase 1,407,500 shares of common stock at a per share exercise prices ranging from $0.001 to $0.50. 

A summary of the warrants outstanding at September 30, 2015 is as follows

   Exercise  Expiration
Warrants  Price  Date
 50,000    Varies    2018 
 672,500   $0.15    2018 
 937,500   $0.25    2016 
 150,000   $0.50    2015 
 10,000   $0.75    2016 
 66,667   $1.50    2016 
 1,886,667           

 10 

Item 6. Selected Financial Data

 

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

 

Item 7. 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. 

 

Results of Operations for the Years Ended September 30, 2015 and 2014

 

We generated no revenues from September 6, 2007 (date of inception) to September 30, 2015. We do not expect to generate revenues until we are able to obtain FDA approval of cell therapy and biotechnology products and thereafter successfully market and sell those products.

  

We incurred operating expenses of $241,823 for the year ended September 30, 2015, compared with operating expenses of $725,895 for the year ended September 30, 2014. Our operating expenses decreased in 2015 from 2014, and are compared as follows:

 

Operating Expenses September 30, 2014  September 30, 2015
Research and Development $0   $38,401 
General and Administrative $698,339   $1,144,431 
Stock Based Compensation $27,556   $32,365 
Reversal of AP $0   $(973,374)

 

General and administrative expenses increased due to an increase in activity supporting our new product which is funded by the proceeds of the sale of intangibles to Amarantus. The reversal of the accounts payable of $973,374 relates to the Lonza settlement. 

 

We incurred net other income of $3,313,422 for the year ended September 30, 2015, as compared to other expenses of $37,017 for the year ended September 30, 2014. Our other income and expenses for 2015 consisted of interest expenses of $62,779, gain on sale of assets to Amarantus of $6,604,431, a loss on other than a temporary decline in fair value of Amarantus investment of $2,700,000, and a loss on derivative liabilities of $528,230.  Our other expenses for 2014 consisted of interest expenses of $232,379 and a gain on derivative liabilities of $269,396. 

 

We had a net gain before income tax of $3,071,599 for the year ended September 30, 2015, as compared with a net loss of $688,878 for the prior year. The primary reasons for our net gain before taxes in fiscal 2015 compared to fiscal 2014 was the sale of assets to Amarantus in the amount of $6,604,431 offset by the permanent decline in the value of the Amarantus stock.

 

For the year ended September 30, 2015, we recorded a provision for income tax in the amount of $2,829,000 as compared to our provision for income tax benefit in the same amount for the year ended September 30, 2014. Footnote I to our financial statements should be reviewed for further information. Finally, we accrued an expense for preferred stock dividends of $70,800 during the year ended September 30, 2015, the same amount as accrued for the year ended September 30, 2014.

 

Our net income attributable to common stockholders for the year ended September 30, 2015 was $171,799, compared to $2,069,322 for the year ended September 30, 2014.

 

 11 

 

Liquidity and Capital Resources

 

As of September 30, 2015, we had cash of $1,061,377, prepaid expenses and other current assets of $119,236, and common stock of Amarantus of $300,000, for total current assets of $1,480,613. Our total current liabilities as of September 30, 2015 were $2,248,656. We had a working capital deficit of $768,043 as of September 30, 2015.

 

Operating activities used a net $1,996,685 in cash for the year ended September 30, 2015. We generated $3,590,000 of cash from financing activities, primarily due to the proceeds from the sale of intangibles to Amaratus. Financing activities used $532,430 for the year ended September 30, 2015 and consisted of $275,000 in repayment of notes payable, the repayment of the insurance premium financings of $51,613 and repayments of loans from related party in the amount of $229,147. These were offset by $23,330 in advances from related parties.

 

We have issued various promissory notes over the course of the last several fiscal years in order to continue funding our operations. The terms of these promissory notes are detailed in Note G to the financial statements accompanying this Annual Report. While this financing has been helpful in the short term to meet our financial obligations and even with the proceeds from the Sale of Assets to Amarantus, we will need additional financing to fund our operations, continue with the FDA approval process, and implement our business plan over the long term.

For the near future, contrary to our earlier expectation, we believe that the net $3 million in cash received under the Asset Purchase Agreement with Amarantus, the potential of additional funding to be received from sales of the Amarantus common stock granted to us under the Agreement (depending on the market value of the Amarantus stock), and the anticipated reversal of our liability to Lonza, will still not be enough to enable us to fund our operations up to at least the initiation of the clinical trials on our cultured skin substitute. We will thus be seeking additional financing during the fiscal year end September 30, 2016.

Going Concern 

Our 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 cumulative losses to date, 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 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.

 

Critical Accounting Policies

 

In December 2001, the SEC requested that all registrants list their most “critical accounting polices” in the Management Discussion and Analysis. The SEC indicated that a “critical accounting policy” is one which is both important to the portrayal of a company’s financial condition and results, and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.

 

Development Stage Activities and Operations

 

The Company is in the development stage and has had no revenues other than the sale of its assets to Amarantus. A development stage company is defined as one in which all efforts are devoted substantially to establishing a new business and even if planned principal operations have commenced, revenues are insignificant.

 

Intangible Assets

 

Intangible assets, which include purchased licenses, patents and patent rights, are stated at cost and will be amortized using the straight-line method over their useful lives based upon the pattern in which the expected benefits will be realized, or on a straight-line basis, whichever is greater. Costs of internally developing intangibles (i.e. trademarks) are expensed as incurred and included in general and administrative expenses.

 

We review our intangible assets subject to amortization whenever events or changes in circumstances indicate that the carrying amount of such an asset may not be recoverable. Recoverability of these assets is measured by comparison of their carrying amount to the future undiscounted cash flows the assets are expected to generate. If such assets are considered impaired, the impairment to be recognized is equal to the amount by which the carrying value of the assets exceeds their fair value determined by either a quoted market price, if any, or a value determined by utilizing a discounted cash flow technique. In assessing recoverability, we must make assumptions regarding estimated future cash flows and discount factors. If these estimates or related assumptions change in the future, we may be required to record impairment charges.

 12 

 

Recently Issued Accounting Pronouncements

 

In May 2014, the FASB issued ASU 2014-09—Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”). ASU 2014-09 supersedes most of the existing guidance on revenue recognition in ASC Topic 605, Revenue Recognition. The core principle of the revenue model is that an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. In applying the revenue model to contracts within its scope, an entity will need to (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract and (v) recognize revenue when (or as) the entity satisfies a performance obligation. On July 9, 2015, the FASB extended the effective date of adoption of the standard to interim reporting periods within annual reporting periods beginning after December 15, 2017 (that is, beginning in the first interim period within the year of adoption). Early adoption of the standard is permitted for all entities for interim and annual periods beginning after December 15, 2016.

 

In June 2014, ASU 2014-15, “Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern” (“ASU No. 2014-15”) was issued. Before the issuance of ASU 2014-15, there was no guidance in U.S. GAAP about management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern or to provide related footnote disclosures. This guidance is expected to reduce the diversity in the timing and content of footnote disclosures. ASU 2014-15 requires management to assess an entity’s ability to continue as a going concern by incorporating and expanding upon certain principles that are currently in U.S. auditing standards as specified in the guidance. ASU 2014-15 becomes effective for the annual period ending at December 15, 2016 and for annual and interim periods thereafter. Early adoption is permitted. The Company is currently evaluating the effects of adopting ASU 2014-15 on its consolidated financial statements but the adoption is not expected to have a significant impact.

In February 2015, the FASB issued ASU 2015-02, Consolidation (Topic 810) (“ASU 2015-02”), to address financial reporting considerations for the evaluation as to the requirement to consolidate certain legal entities. ASU 2015-02 is effective for fiscal years and for interim periods within those fiscal years beginning after December 15, 2015. We are evaluating the impact of ASU 2015-02 and if early adoption is appropriate in future reporting periods.

In April 2015, the FASB issued ASU 2015-03, Interest—Imputation of Interest (Subtopic 835-30) (“ASU 2015-03”), as part of the initiative to reduce complexity in accounting standards. The update requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. ASU 2015-03 is effective for annual periods beginning after December 15, 2015 and for interim periods within those fiscal years.

In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes (“ASU 2015-17”), which requires entities to present deferred tax assets and deferred tax liabilities as noncurrent in a classified balance sheet. The ASU simplifies the current guidance in ASC Topic 740, Income Taxes, which requires entities to separately present deferred tax assets and liabilities as current and noncurrent in a classified balance sheet. ASU 2015-17 is effective for fiscal years beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted for all entities as of the beginning of an interim or annual reporting period. We do not expect the impact of ASU 2015-17 to be material to our consolidated financial statements. 

 

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

Management does not believe that any other recently issued, but not yet effective, accounting standard if currently adopted would have a material effect on the accompanying financial statements. 

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

 

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

 13 

 

Item 8. Financial Statements and Supplementary Data

 

Index to Financial Statements Required by Article 8 of Regulation S-X:

 

Audited Financial Statements:
F-1 Report of Independent Registered Public Accounting Firm
F-2 Consolidated Balance Sheets as of September 30, 2015 and 2014
F-3 Consolidated Statements of Operations for the years ended September 30, 2015 and September 30, 2014
F-4 Consolidated Statement of Stockholders’ (Deficiency) Equity for period from September 30, 2014 to September 30, 2015
F-5 Consolidated Statements of Cash Flows for the years ended September 30, 2015 and September 30, 2014
F-6 Notes to Consolidated Financial Statements
 14 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

 

To the Board of Directors and Stockholders of

Regenicin, Inc.

 

We have audited the accompanying consolidated balance sheets of Regenicin, Inc. and Subsidiary (the “Company”) as of September 30, 2015 and 2014 and the related consolidated statements of income, changes in stockholders’ deficiency and cash flows for the years then ended.  The consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit.    

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). These standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement.  The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of September 30, 2015 and 2014 and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.

 

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note B to the consolidated financial statements, the Company has incurred recurring losses, 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 and sales of its intangible assets.   This raises substantial doubt about the Company’s ability to continue as a going concern. Management’s plans concerning these matters are also described in Note B. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

 

 

/s/ ROTENBERG MERIL SOLOMON BERTIGER & GUTTILLA, P.C.

 

ROTENBERG MERIL SOLOMON BERTIGER & GUTTILLA, P.C.

Saddle Brook, New Jersey

January 13, 2016 

 F-1 

REGENICIN, INC. AND SUBSIDIARY

CONSOLIDATED BALANCE SHEETS

  September 30,  September 30,
  2015  2014
ASSETS         
CURRENT ASSETS         
     Cash $1,061,377   $492 
     Prepaid expenses and other current assets  119,236    49,462 
     Common stock of Amarantus Corporation  300,000    —   
     Deferred income taxes  —      2,829,000 
               Total current assets  1,480,613    2,878,954 
Intangible  assets  —      7,500 
               Total assets $1,480,613   $2,886,454 
          
LIABILITIES AND STOCKHOLDERS' DEFICIENCY         
CURRENT LIABILITIES         
     Accounts payable 360,228   1,393,605 
     Accrued expenses  1,286,386    1,740,090 
     Dividends payable  322,042    251,242 
     Note payable - insurance financing  —      51,613 
     Bridge financing  175,000    450,000 
     Convertible promissory notes (net of discount of $-0- and $7,675)  —      295,617 
     Loan payable  10,000    10,000 
     Loans payable - related parties  95,000    205,817 
     Derivative liabilities  —      5,164 
               Total current and total liabilities  2,248,656    4,403,148 
          
STOCKHOLDERS' EQUITY (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 and 139,598,152 issued, respectively;         
     153,483,050 and 135,169,792 outstanding, respectively  157,914    139,601 
     Common stock to be issued; 0 and 10,367,094 shares  —      402,040 
     Additional paid-in capital  9,787,578    8,897,799 
     Accumulated deficit  (10,709,992)   (10,952,591)
      Less: treasury stock; 4,428,360 shares at par  (4,428)   (4,428)
               Total stockholders' equity (deficiency)  (768,043)   (1,516,694)
               Total liabilities and stockholders' equity (deficiency) $1,480,613   $2,886,454 

 

See Notes to Consolidated Financial Statements.

 F-2 

RELGENICIN, INC. AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF INCOME

 

  Year  Year
  Ended  Ended
  September 30,  September 30,
  2015  2014
Revenues $—     $—   
          
Operating expenses         
Research and development  38,401    —   
General and administrative  1,144,431    698,339 
Stock based compensation - general and administrative  32,365    27,556 
Reversal of accounts payable - Lonza  (973,374)   —   
Total operating expenses  241,823    725,895 
Loss from operations  (241,823)   (725,895)
          
Other income (expenses)         
Interest expense, including amortization of debt discounts and beneficial conversion features  (62,779)   (232,379)
Gain on sale of assets  6,604,431    —   
Loss on other than a temporary decline in fair value of investment  (2,700,000)   —   
Gain (loss) on derivative liabilities  (528,230)   269,396 
Total other income (expenses)  3,313,422    37,017 
          
Income (loss) before income tax  3,071,599    (688,878)
Income tax expense (benefit)  2,829,000    (2,829,000)
Net income  242,599    2,140,122 
Preferred stock dividends  (70,800)   (70,800)
Net income attributable to common stockholders $171,799   $2,069,322 
          
Income (loss) per share:         
   Basic $0.00   $0.02 
   Diluted $0.00   $0.01 
          
Weighted average number of shares outstanding         
   Basic  153,262,851    132,966,528 
   Diluted (2014 restated)  162,114,351    156,025,784 

 

 See Notes to Consolidated Financial Statements.

 F-3 

REGENICIN, INC. AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' DEFICIENCY

              Common Stock  Additional         
  Convertible Preferred Stock  Common Stock  To  Paid-in  Accumulated  Treasury   
  Shares  Amount  Shares  Amount  Be Issued  Capital  Deficit  Stock  Total
Balances at October 1, 2013  885,000   $885    120,159,009   $120,160   $334,968   $8,501,390   $(13,092,713)  $(4,428)  $(4,139,738)
     Preferred stock dividends  —      —      —      —      —      (70,800)   —      —      (70,800)
     Shares issued in connection with conversion of debt and accrued interest  —      —      17,440,392    17,441    (41,613)   240,975    —      —      216,803 
     Shares issued for consulting expenses accrued in prior period  —      —      1,038,751    1,040    —      34,811    —      —      35,851 
     Shares issued for exercise of warrant  —      —      960,000    960    —      (320)   —      —      640 
     Shares to be issued in connection with conversion of debt and accrued interest  —      —      —      —      108,685    —      —      —      108,685 
Reversal of derivative liabilities to equity  —      —      —      —      —      84,070    —      —      84,070 
     Beneficial conversion features and warrant value on bridge financing  —      —      —      —      —      75,000    —      —      75,000 
     Stock compensation expense  —      —      —      —      —      27,556    —      —      27,556 
     Issuance of warrant to Cristoforo for Note #31A  —      —      —      —      —      5,117    —      —      5,117 
     Net income  —      —      —      —      —      —      2,140,122    —      2,140,122 
Balances at September 30, 2014  885,000    885    139,598,152    139,601    402,040    8,897,799    (10,952,591)   (4,428)   (1,516,694)
     Preferred stock dividends  —      —      —      —      —      (70,800)   —      —      (70,800)
     Shares issued in connection with conversion of debt and accrued interest  —      —      7,920,291    7,920    0    3,171    —      —      11,091 
Issuance of common stock  —      —      10,392,967    10,393    (402,040)   391,649    —      —      2 
Write off of derivative from payoff of host convertible debt  —      —      —      —      0    165,072    —      —      165,072 
Derivative liabilities  —      —      —      —      0    368,322    —      —      368,322 
Stock compensation expense  —      —      —      —      —      32,365    —      —      32,365 
Net income  —      —      —      —      0    —      242,599    —      242,599 
Balances at September 30,  2015  885,000   $885    157,911,410   $157,914   $—     $9,787,578   $(10,709,992)  $(4,428)  $(768,043)

 

See Notes to Consolidated Financial Statements.

 F-4 

REGENICIN, INC. AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF CASH FLOWS

  Year  Year
  Ended  Ended
  September 30,  September 30,
  2015  2014
CASH FLOWS FROM OPERATING ACTIVITIES         
     Net income $242,599   $2,140,122 
     Adjustments to reconcile net income to net cash used in operating activities:         
         Deferred income taxes  2,829,000    (2,829,000)
         Unrealized loss on investment  2,700,000    —   
         Amortization of debt discounts  7,675    155,576 
         Accrued interest on notes and loans payable  (2,704)   77,301 
         Amortization of beneficial conversion features  —      54,545 
         Original interest discount on convertible note payable  —      4,782 
         Stock based compensation - G&A  32,365    27,556 
        (Gain) loss on derivative liabilities  528,230    (269,393)
         Gain on sale of assets  (6,604,431)   —   
         Reversal of accounts payable  (973,374)   —   
         Other gain related to derivative liabilities  —      (63,095)
         Expenses paid directly by officer  95,000    —   
         Changes in operating assets and liabilities         
              Prepaid expenses and other current assets  (69,774)   68,486 
              Accounts payable  (380,251)   1,124 
              Accrued expenses  (401,020)   420,151 
Net cash used in operating activities  (1,996,685)   (211,845)
          
CASH FLOWS FROM INVESTING ACTIVITIES         
         Proceeds from sale of assets  3,600,000    —   
         Purchase of Intangible  (10,000)   —   
Net cash provided by financing activities  3,590,000    —   
          
CASH FLOWS FROM FINANCING ACTIVITIES         
         Proceeds from the issuance of notes payable  —      100,000 
         Repayments of notes payable  (275,000)   —   
         Proceeds from loans from related parties  23,330    143,507 
         Repayments of loans from related party  (229,147)   (2,090)
         Repayments of notes payable - insurance financing  (51,613)   (52,220)
         Proceeds from the sale of common stock  —      640 
Net cash (used in) provided by financing activities  (532,430)   189,837 
          
NET INCREASE (DECREASE) IN CASH  1,060,885    (22,008)
CASH - BEGINNING OF PERIOD  492    22,500 
CASH - END OF PERIOD $1,061,377   $492 
          
Supplemental disclosures of cash flow information:         
       Cash paid for interest $

107,830 

   $4,453 
       Cash paid for taxes $—     $—   
          
Non-cash activities:         
Sale of assets $6,600,000   $—   
Common Stock of Amarantus received  (3,000,000)   —   
Cash received $3,600,000   $—   
Preferred stock dividends $70,800   $70,800 
Shares issued/to be issued in connection with conversion of debt and accrued interest $11,091   $304,874 
Beneficial conversion feature and warrant value on bridge financing $—     $75,000 
Derivative liabilities reclassified to additional paid-in capital $533,394   $104,684 
Common stock issued for accrued expenses $—     $35,851 

 

See Notes to Consolidated Financial Statements.

 F-5 

REGENICIN, INC. AND SUBSIDIARY

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE A - 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 C 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 U.S. Food and Drug Administration. We have been developing our own unique cultured skin substitute since we received Lonza’s termination notice. 

 

NOTE B - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Principles of Consolidation:

 

The accompanying consolidated financial statements include the accounts of Regenicin and its wholly-owned subsidiary. All significant inter-company balances and transactions have been eliminated.

 

Reclassifications:

 

Dividends payable have been reclassified from accrued expenses in the 2014 balance sheet to conform to the 2015 presentation. 

 

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 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 intends on 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. 

 F-6 

 

Development Stage Activities and Operations:

 

In June 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-10, “Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation ” (“ASU 2014-10”). ASU 2014-10 eliminates the distinction of a development stage entity and certain related disclosure requirements, including the elimination of inception-to-date information on the statements of operations, cash flows and stockholders’ deficiency. The amendments in ASU 2014-10 will be effective prospectively for annual reporting periods beginning after December 15, 2014, and interim periods within those annual periods, however, early adoption is permitted. The Company evaluated and adopted ASU 2014-10 for the reporting period ended June 30, 2014. The Company’s consolidated financial statements will be impacted by the adoption of ASU 2014-10 primarily by the removal of inception-to-date information in the Company’s consolidated statements of operations, cash flows, and stockholders’ deficiency.

 

Intangible assets:

 

Intangible assets, which include purchased licenses, patents and patent rights, are stated at cost and amortized using the straight-line method over their useful lives based upon the pattern in which the expected benefits will be realized, or on a straight-line basis, whichever is greater (see Note D). Such amortization will begin once the Company has a saleable product. As discussed below in Note C, the Company sold its intangible assets on November 7, 2014. Costs of internally developing intangibles (i.e. trademarks) are expensed as incurred and included in general and administrative expenses.

 

The Company reviews intangible assets subject to amortization whenever events or changes in circumstances indicate that the carrying amount of such an asset may not be recoverable. Recoverability of these assets is measured by comparison of their carrying amount to the future undiscounted cash flows the assets are expected to generate. If such assets are considered impaired, the impairment to be recognized is equal to the amount by which the carrying value of the assets exceeds their fair value determined by either a quoted market price, if any, or a value determined by utilizing a discounted cash flow technique. In assessing recoverability, the Company must make assumptions regarding estimated future cash flows and discount factors. If these estimates or related assumptions change in the future, the Company may be required to record impairment charges.

 

Research and development: 

Research and development costs are charged to expense as incurred.

 

Income per share:

 

Basic income per share is computed by dividing the net income by the weighted average number of common shares outstanding during the period. Diluted loss per share give 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 per common share calculation:

 

  Year Ended
September 30,
  2015  2014
Income Per Common Share - Basic:     
Net income available to common stockholders $171,799   $2,069,322 
Weighted-average common shares outstanding  153,262,851    132,966,528 
Basic income per share $0.00   $0.02 
Income Per Common Share - Diluted:         
Net income $171,799   $2,069,322 
Weighted-average common shares outstanding  153,262,851    132,966,528 
Convertible preferred stock (2014 restated)  8,850,000    8,850,000 
Stock options  1,500    —   
Convertible debentures  ----    14,209,256 
Weighted-average common shares outstanding and common share equivalents (2014 restated)  162,114,351    156,025,784 
Diluted income per share $0.00   $.01 

 

 F-7 

The following securities have been excluded from the calculation of net loss per share, as their effect would be anti-dilutive:

 

   Shares of Common Stock
   Issuable upon Conversion/Exercise
   as of September 30,
   2015  2014
 Options    5,542,688    5,542,688 
 Warrants    3,611,167    3,611,167 

 

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 September 30, 2015 and 2014 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 equity. Other than temporary declines in the fair value of investment is included in Other Income (Loss) 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 common stock of Amarantus was restricted from sale for six months from acquisition pursuant to Security and Exchange Commission Rule 144. The restrictive period has lapsed. The total value of Amarantus common stock at September 30, 2015 is $300,000. The unrealized loss for the year ended September 30, 2015 was $2,700,000 and is considered to be an other than temporary decline in fair value. As such, the loss has been reported on the statement of income for the year ended September 30, 2015.

 

The Company issued notes payable that contained conversion features which were accounted for separately as derivative liabilities and measured at fair value on a recurring basis. Changes in fair value are charged to other income (expenses) as appropriate. The fair value of the derivative liabilities was determined based on Level 2 inputs utilizing observable quoted prices for similar instruments in active markets and observable quoted prices for identical or similar instruments in markets that are not very active. Derivative liabilities totaled $-0- and $5,164 as of September 30, 2015 and 2014, respectively. See Note G - Notes Payable - Convertible Promissory Notes for additional information.

 

Use of Estimates:

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period.  Such estimation includes the selection of assumptions underlying the calculation of the fair value of options. Actual results could differ from those estimates.

 F-8 

 

Stock-Based Compensation:

 

The Company accounts for stock-based compensation in accordance with FASB ASC 718, “Compensation - Stock Compensation.” Under the fair value recognition provision of the ASC, stock-based compensation cost is estimated at the grant date based on the fair value of the award. The Company estimates the fair value of stock options granted using the Black-Scholes-Merton option pricing model.

 

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 market 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.

 

Income Taxes:

 

The Company accounts for income taxes in accordance with accounting guidance FASB ASC 740, "Income Taxes," which requires that the Company recognize deferred tax liabilities and assets based on the differences between the financial statement carrying amounts and the tax bases of assets and liabilities, using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit (expense) results from the change in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all deferred tax assets will not be realized.

 

The Company has adopted the provisions of FASB ASC 740-10-05 "Accounting for Uncertainty in Income Taxes." The ASC clarifies the accounting for uncertainty in income taxes recognized in an enterprise's financial statements.  The ASC prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.  The ASC provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition.

 

Recently Issued Accounting Pronouncements:

 

In May 2014, the FASB issued ASU 2014-09—Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”). ASU 2014-09 supersedes most of the existing guidance on revenue recognition in ASC Topic 605, Revenue Recognition. The core principle of the revenue model is that an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. In applying the revenue model to contracts within its scope, an entity will need to (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract and (v) recognize revenue when (or as) the entity satisfies a performance obligation. On July 9, 2015, the FASB extended the effective date of adoption of the standard to interim reporting periods within annual reporting periods beginning after December 15, 2017 (that is, beginning in the first interim period within the year of adoption). Early adoption of the standard is permitted for all entities for interim and annual periods beginning after December 15, 2016.

In June 2014, ASU 2014-15, “Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern” (“ASU No. 2014-15”) was issued. Before the issuance of ASU 2014-15, there was no guidance in U.S. GAAP about management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern or to provide related footnote disclosures. This guidance is expected to reduce the diversity in the timing and content of footnote disclosures. ASU 2014-15 requires management to assess an entity’s ability to continue as a going concern by incorporating and expanding upon certain principles that are currently in U.S. auditing standards as specified in the guidance. ASU 2014-15 becomes effective for the annual period ending at December 15, 2016 and for annual and interim periods thereafter. Early adoption is permitted. The Company is currently evaluating the effects of adopting ASU 2014-15 on its consolidated financial statements but the adoption is not expected to have a significant impact.

In February 2015, the FASB issued ASU 2015-02, Consolidation (Topic 810) (“ASU 2015-02”), to address financial reporting considerations for the evaluation as to the requirement to consolidate certain legal entities. ASU 2015-02 is effective for fiscal years and for interim periods within those fiscal years beginning after December 15, 2015. We are evaluating the impact of ASU 2015-02 and if early adoption is appropriate in future reporting periods.

In April 2015, the FASB issued ASU 2015-03, Interest—Imputation of Interest (Subtopic 835-30) (“ASU 2015-03”), as part of the initiative to reduce complexity in accounting standards. The update requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. ASU 2015-03 is effective for annual periods beginning after December 15, 2015 and for interim periods within those fiscal years.

 F-9 

In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes (“ASU 2015-17”), which requires entities to present deferred tax assets and deferred tax liabilities as noncurrent in a classified balance sheet. The ASU simplifies the current guidance in ASC Topic 740, Income Taxes, which requires entities to separately present deferred tax assets and liabilities as current and noncurrent in a classified balance sheet. ASU 2015-17 is effective for fiscal years beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted for all entities as of the beginning of an interim or annual reporting period. We do not expect the impact of ASU 2015-17 to be material to our consolidated financial statements. 

 

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

 

NOTE C - 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 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 has agreed to sell its PermaDerm® trademark and related intellectual property rights associated with it. The purchase price to be paid by Amarantus was of: (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 is 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. The final payment of $2,500,000 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 at closing. 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 fiscal 2015, the Company recorded a gain on sale of assets in the amount of $6,604,431. 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 has been reversed and is included in operating expenses as an item of income.

 

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 D - INTANGIBLE ASSETS

 

As discussed in Note A, 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 C, the Company sold its intangible assets on November 7, 2014. At September 30, 2015 and 2014, intangible assets totaled $-0- and $7,500, respectively.

 

NOTE E - ACCRUED EXPENSES

 

Accrued expenses consisted of the following:

 

  September 30,
  2015  2014
Registration penalty $250,203   $250,203 
Salaries and payroll taxes  784,251    1,163,389 
Professional fees  194,590    216,472 
Interest  57,342    110,026 
  $1,286,386   $1,740,090 

 

 F-10 

NOTE F - 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 September 30, 2015 and 2014, the loan payable totaled $10,000.

 

Loans Payable - Related Parties:

 

In October 2011, Craig Eagle, a director of the Company, made advances to the Company. The loan bore interest at 5% and was due on demand. At September 30, 2014, the loan balance was $38,221 and was repaid in April 2015.

 

John Weber, the Company’s Chief Financial Officer, has made advances to the Company. The loan bore interest at 5% and was due on demand. At September 30, 2014, the loan balance was $122,100 and was repaid in April 2015.

 

Randall McCoy, the Company’s Chief Executive Officer, has made advances to the Company. The loan bears interest at 5% and is due on demand. During the year ended September 30, 2015, $95,000 of Company expenses paid directly by McCoy were submitted for reimbursement. These expenses had not been reimbursed to McCoy by a former underwriter. At September 30, 2015 and 2014, the loan balance was $95,000 and $8,500, respectively.

 

In March through September 2014, the Company received other advances from related parties totaling $35,696. The loans bore interest at 5% and were due on demand. At September 30, 2014 the loan balances were $36,996 and were repaid in April 2015. 

 

At September 30, 2015 and 2014, loans payable - related parties totaled $95,000 and $205,817, respectively.  

 

NOTE G - NOTES PAYABLE

 

Note Payable - Insurance Financing:

 

In September 2014, the Company renewed its policy and financed premiums totaling $51,613. The note required an initial down payment of $10,322 and was payable over a nine-month term. The note was paid in full in June 2015 in accordance with the original terms. The balance of the loan was $51,613 at September 30, 2014.

 

Bridge Financing:

 

On December 21, 2011, the Company issued a $150,000 promissory note (“Note 2”) to an individual. Note 2 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% will be charged on any late payments. Note 2 was not paid at the maturity date and the Company is incurring additional interest described above. At both September 30, 2015 and 2014, the Note 2 balance was $175,000.

 

In May 2013, the Company issued a convertible promissory note (“Note 29”) totaling $25,000 to an individual. Note 29 bore interest at the rate of 8% per annum and was due in November 2013. Note 29 and accrued interest thereon were convertible into shares of common stock at the rate of $0.05 per share and automatically converted on the maturity date unless paid sooner by the Company. The Company did not record a discount for the conversion feature as the conversion price was greater than the price of the common stock on the issuance date. At maturity, the principal and interest were scheduled to convert to 520,055 shares of common stock but the individual waived the conversion of the principal and accrued interest. At September 30, 2014 the Note 29 balance was $25,000. In February 2015 the note was repaid full.

 

In August 2013, the Company issued convertible promissory notes (“Note 35-36”) totaling $250,000 to two individuals. The notes bore interest at the rate of 8% per annum and were due in August 2014. The principal and accrued interest thereon were convertible into shares of common stock at the rate of $0.03 per share and automatically convert on the maturity dates unless paid sooner by the Company. The Company did not record discounts for the conversion features as the conversion prices were greater than the prices of the common stock on the issuance dates. At maturity, the principal and interest were scheduled to automatically convert into 4,500,000 shares of common stock but the individuals waived the conversion of the principal and accrued interest. At September 30, 2014, the balance of Notes 35-36 was $250,000. In February 2015 the notes were repaid full.

 

On December 31, 2013, the Company issued a convertible promissory note (“Note 37”) totaling $75,000 to an individual. The note bore interest at the rate of 8% per annum and was due in May 2014. The principal and accrued interest thereon were convertible into shares of common stock at the rate of $0.02 per share and automatically converted on the maturity date unless paid sooner by the Company. In addition, at the date of conversion, the Company was to issue a two-year warrant to purchase an additional 937,500 shares of common stock at $0.25 per share. The warrant has not been issued. For financial reporting purposes, the Company recorded discounts of $20,455 to reflect the value of the warrant and a discount of $54,545 to reflect the value of the beneficial conversion feature. The discount was amortized over the term of Note 37. At maturity, the principal and interest automatically converted and the Company subsequently issued 3,874,110 shares of common stock on March 31, 2015. 

 F-11 

 

Convertible Promissory Notes:

 

Lender 

 

In October 2012, the Company issued a promissory note to a financial institution (the “Lender”) to borrow up to a maximum of $225,000. The note bore interest so that the Company would repay a maximum of $250,000 at maturity, which correlated to an effective rate of 10.59%. From inception until February 2014, the Company received $175,000 including $25,000 during the year ended September 30, 2014. Material terms of the note include the following:

 

1. The Lender may make additional loans in such amounts and at such dates at its sole discretion.

2. The maturity date of each loan is one year after such loan is received.

3. The original interest discount is prorated to each loan received.

4. Principal and accrued interest is convertible into shares of the Company’s common stock at the lesser of $0.069 or 65%-70% (as defined) of the lowest trading price in the 25 trading days previous to the conversion.

5. Unless otherwise agreed to in writing by both parties, at no time can the Lender convert any amount of the principal and/or accrued interest owed into common stock that would result in the Lender owning more than 4.99% of the common stock outstanding.

6. There is a one-time interest payment of 10% of amounts borrowed that is due at the maturity date of each loan.

7. At all times during which the note is convertible, the Company shall reserve from its authorized and unissued common stock to provide for the issuance of common stock under the full conversion of the promissory note. The Company will at all times reserve at least 13,000,000 shares of its common stock for conversion.

8. The Company agreed to include on its next registration statement it files, all shares issuable upon conversion of balances due under the promissory note. Failure to do so would result in liquidating damages of 25% of the outstanding principal balance of the promissory note but not less than $25,000.

               

The balance of the notes was $9,592 at September 30, 2014. In October 2014, the remaining balance due on these notes of $9,592 plus accrued interest of $1,499 was converted into 7,920,291 shares of the Company’s common stock.

 

The conversion feature contained in the promissory note is considered to be an embedded derivative. The Company bifurcated the conversion feature and recorded a derivative liability on the consolidated balance sheet. The Company recorded the derivative liability equal to its estimated fair value. Such amount was also recorded as a discount to the convertible promissory note and is being amortized to interest expense using the effective interest method. For the years ended September 30, 2015 and 2014 amortization of the debt discount amounted to $7,675 and $64,675, respectively. At September 30, 2014 the unamortized discount was $7,675.

 

The Company is required to mark-to-market the derivative liability at the end of each reporting period. For the year ended September 30, 2014 the Company recorded a loss on the change in fair value of the conversion option of $76,149 and as of September 30, 2014 the fair value of the conversion option was $5,163.

 

CCLG 

 

In May 2013, the Company issued a convertible promissory note totaling $293,700 to “CCLG” in lieu of amounts payable. The note bears interest at the rate of 12% per annum and was originally due November 21, 2013. The maturity date of the note was extended to February 21, 2014 and extended again to August 31, 2014. The note is secured by all of the assets of the Company. The note and accrued interest are convertible into shares of common stock at a conversion rate of the lower of $0.04 per share or 80% of the average of the lowest three trading prices in the 20 trading days previous to the conversion but the number of shares that can be issued is limited as defined in the note agreement. In addition, the Company issued a five-year warrant to purchase an additional 50,000 shares of common stock at a per share exercise price of the lower of $0.04 per share or 80% of the average of the lowest three trading prices in the 20 trading days previous to the conversion. The note was not paid at the maturity date but no action was taken by CCLG. For the period from October 1, 2014 through February 2015, the Company repaid the total amount outstanding.

 

The conversion features contained in the promissory note and the warrant are considered to be embedded derivatives. The Company bifurcated the conversion features and recorded derivative liabilities on the consolidated balance sheet. The Company recorded the derivative liabilities equal to their estimated fair value of $153,300. Such amount was also recorded as a discount to the convertible promissory note and was amortized to interest expense using the effective interest method. For the year ended September 30, 2015 and 2014, amortization of the debt discount amounted to$-0- and $64,104, respectively. At September 30, 2014, the unamortized discount is $-0-.

 

The Company is required to mark-to-market the derivative liabilities at the end of each reporting period. For the year ended September 30, 2015 and 2014, the Company recorded a gain (loss) on the change in fair value of the conversion option of $(533,393) and $193,247, respectively, and as of September 30, 2015 and 2014, the fair value of the conversion option was $-0-.

 

At September 30, 2015 and 2014 the balance of the convertible notes was $-0- and $293,700, net of unamortized discounts of $-0- and $7,675, respectively.

 F-12 

 

NOTE H - RELATED PARTY TRANSACTIONS

 

Officers:

 

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. This office is owned by Materials Testing Laboratory, and the principal is an employee of the Company.

 

No rent is charged for either premise.

 

NOTE I - INCOME TAXES

 

The Company did not incur current tax expense for both the years ended September 30, 2015 and 2014. The provision for income taxes and income tax benefits for the years ended September 30, 2015 and 2014, respectively represents deferred taxes.

 

At September 30, 2015, the Company had available approximately $4.2 million of net operating loss carry forwards which expire in the years 2029 through 2034. 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 September 30, 2015 and 2014 are as follows:

 

  2015  2014
Net operating loss carry forwards $2,574,628   $2,850,535 
Unrealized loss  1,080,000    —   
Intangible assets  —      1,200,000 
Stock based compensation  227,201    355,265 
Accrued expenses  355,265    539,912 
Total deferred tax assets  4,237,094    4,945,712 
Valuation allowance  (4,237,094)   (2,116,712)
Net deferred tax assets $—     $2,829,000 

 

Due to the uncertainty of their realization, a valuation allowance has been established for all of the income tax benefit as of September 30, 2015 and a portion of the deferred income tax benefit as of September 30, 2014 for these deferred tax assets.

 

The following is a reconciliation of the Company’s income tax rate using the federal statutory rate to the actual income tax rate as of September 30, 2015 and 2014:

 

  2015  2014
Federal tax rate  34%   (34)%
Effect of state taxes  6%   (6)%
Adjustment of valuation allowance  92%    (412)%
Permanent differences  7%   3%
Net operating loss carry forward  (47)%   37%
Total  92 %   (412)%

 

At September 30, 2015 and 2014, 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 September 30, 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. 

 F-13 

 

NOTE J - STOCKHOLDERS’ DEFICIENCY

 

Preferred Stock:

 

Series A

 

Series A Preferred pays a dividend of 8% per annum on the stated value and has a liquidation preference equal to the stated value of the shares. Each share of Preferred Stock has an initial stated value of $1 and was 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 $70,800 and $70,800 for the years ended September 30, 2015 and 2014, respectively. At September 30, 2015 and 2014, dividends payable totaled $322,042 and $251,242, respectively.

 

At both September 30, 2015 and 2014, 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 September 30, 2015, no shares of Series B Preferred are outstanding.

 

Common Stock Issuances: 

 

2014 Transactions

 

1.The Company issued 2,600,000 shares of its common stock for the conversion of notes payable issued under the Bridge Financing and accrued interest.

2.The Company issued 14,840,392 shares of common stock for the conversion of principal and accreted interest owed to the Lender.

 

3.The Company issued 960,000 shares of common stock for the exercise of a warrant.

4.On December 24, 2013, the Company issued 1,038,751 shares of its common stock as a finder’s fee to an entity for introducing investors and/or lenders who provided funding to the Company in fiscal 2013. The shares were valued at $35,851. 

2015 Transactions

 

1.The Company issued 7,920,291 shares of its common stock for the conversion of principal and accreted interest owed to the Lender. $7,920 was credited to common stock and $3,171 to additional paid in capital.

 

2.The Company issued 10,392,967 shares of its common stock that had previously been classified as common stock to be issued upon conversion of principal and accrued interest owed to lenders. $10,393 was credited to common stock and $402,040 was credited to additional paid in capital.

 

 F-14 

2010 Incentive Plan:

 

On December 15, 2010, the board of directors approved the Regenicin, Inc. 2010 Incentive Plan (the “Plan”). The Plan provides for the granting of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock, stock units, performance shares and performance units to the Company’s employees, officers, directors and consultants, including incentive stock options, non-qualified stock options, restricted stock, and other benefits. The Plan provides for the issuance of up to 4,428,360 shares of the Company’s common stock.

 

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 $0.62 per share. The options originally vested over a three-year period and expire on December 22, 2015. On May 11, 2011, the terms of the options were amended to allow for immediate vesting. On December 10, 2013, the exercise price of the options was changed to $0.035 per share. As a result, the Company revalued the options as required under generally accepted accounting principles and recognized an expense of $27,556. The options were revalued utilizing the Black-Scholes option pricing model with the following assumptions: exercise price: $0.035 - $0.62; expected volatility: 20.71%; risk-free rate: 0.13% - 0.14%; expected term: 1 year.  

 

On January 15, 2015, the Company entered into a stock option agreement with an officer of the Company. The agreement grants the Officer an option to purchase 10 million shares of common stock at $0.02 per share. The agreement expires on January 15, 2019. The options were valued utilizing the Black-Scholes option pricing model with the following assumptions: exercise price: $0.02; expected volatility: 22.16%; risk-free rate: .75%; expected term: 3 years. The grant date fair value per share was $0.003 and the options vest immediately.

 

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 Company’s common stock as the Company’s 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 $32,365 and $27,556 for the year ended September 30, 2015 and 2014, respectively.

 

Option activity for 2014 and 2015 is summarized as follows:

 

      Weighted
     Average
   Options  Exercise Price
 Options outstanding, October 1, 2013    5,542,688   $0.19 
 Granted           
 Forfeited           
 Options outstanding, September 30, 2014    5,542,688   $0.19 
             
 Granted    10,000,000   $0.02 
 Forfeited           
 Options outstanding, September 30, 2015    15,542,688   $0.08 
             
 Aggregate intrinsic value   $0.00      

 

The aggregate intrinsic value was calculated based on the positive difference between the closing market price of the Company’s Common Stock and the exercise price of the underlying options.

  

The following table summarizes information regarding stock options outstanding at September 30, 2015:

 

      Weighted Average Remaining  Options Exercisable Weighted Average
Ranges of prices  Number
 Outstanding
  Contractual
 Life
  Exercise
 Price
  Number
 Exercisable
  Exercise
 Price
$0.020    10,000,000    4.29   $0.020    10,000,000   $0.020 
$0.035    3,542,688    .27   $0.035    3,542,688   $0.035 
$0.460    2,000,000    .14    0.460    2,000,000    0.460 
 $0.020-$0.46    15,542,688    2.84   $0.080    15,542,688   $0.080 

 

As of September 30, 2015, there was no unrecognized compensation cost related to non-vested options granted.

 F-15 

 

Warrants:

  

In fiscal 2014 in connection with the issuance of convertible notes the Company issued warrants to purchase 1,407,500 shares of common stock at a per share exercise prices ranging from $0.001 to $0.50.

 

These warrants were valued utilizing a Black-Scholes option pricing model with the following assumptions:   exercise price: $0.001 - $0.50; expected volatility: 20.88%; risk-free rate: 0.11% - 0.13%; expected term: .5 year - 1year.

 

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 Company’s common stock as the Company’s common stock had not been trading for the sufficient length of time to accurately compute its volatility when these options were issued.

 

A summary of the warrants outstanding at September 30, 2015 is as follows:

 

   Exercise  Expiration
Warrants  Price  Date
 50,000    Various    2018 
 —     $—      —   
 672,500   $0.15    2018 
 937,500   $0.25    2016 
 150,000   $0.50    2015 
 10,000   $0.75    2016 
 —     $—      —   
 66,667   $1.50    2016 
 1,886,667           

  

Registration Penalties:

 

On August 16, 2010, the Company sold 4,035,524 shares of common stock as part of a Securities Purchase Agreement with certain accredited investors (the “Purchasers”) pursuant to the closing of the Private Placement Offering (the “Offering”).

 

Pursuant to a Registration Rights Agreement that accompanied the Securities Purchase Agreement, the Company agreed to file an initial registration statement covering the resale of the common stock no later than 45 days from the closing of the Offering and to have such registration statement declared effective no later than 180 days from filing of the registration statement.  If the Company did not timely file the registration statement, cause it to be declared effective by the required date, or maintain the filing, then each Purchaser in the offering was entitled to liquidated damages equal to 1% of the aggregate purchase price paid by such Purchaser for the securities, and an additional 1% for each month that the Company did not file the registration statement, cause it to be declared effective, or fail to maintain the filing (subject to a maximum penalty of 10% of the aggregate purchase price).  The Offering closed on August 16, 2010.  The Company did not file an initial registration statement and accrued liquidating damages from October 1, 2010.  Registration penalties totaled $250,203 for the year ended September 30, 2011. The registration penalties have not been paid and are included in accrued expenses in the consolidated balance sheets as of September 30, 2014 and 2013. No actions have been taken by the investors to collect the penalty.

  

 F-16 

 

Item 9. Changes In and Disagreements with Accountants on Accounting and Financial Disclosure

 

No events occurred requiring disclosure under Item 304 of Regulation S-K during the fiscal year ending September 30, 2015.

 

Item 9A. Controls and Procedures

 

Disclosure Controls and Procedures

 

As required by Rule 13a-15 under the Securities Exchange Act of 1934, we have carried out an evaluation of the effectiveness of our disclosure controls and procedures as of the end of the period covered by this annual report, being September 30, 2015. This evaluation was carried out under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer.

 

Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed in our company’s reports filed under the Securities Exchange Act of 1934 is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure.

 

Based upon that evaluation, including our Chief Executive Officer and Chief Financial Officer, we have concluded that our disclosure controls and procedures were ineffective as of the end of the period covered by this annual report.

 

Management’s Report on Internal Control over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Securities Exchange Act of 1934). Management has assessed the effectiveness of our internal control over financial reporting as of September 30, 2015 based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. As a result of this assessment, management concluded that, as of September 30, 2015, our internal control over financial reporting was not effective. Our management identified the following material weaknesses in our internal control over financial reporting, which are indicative of many small companies with small staff: (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.

 

We plan to take steps to enhance and improve the design of our internal control over financial reporting. During the period covered by this annual report on Form 10-K, we have not been able to remediate the material weaknesses identified above. To remediate such weaknesses, we hope to implement the following changes during our fiscal year ending September 30, 2015: (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 in (i) and (ii) 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.

 

This annual report does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to an exemption for non-accelerated filers set forth in Section 989G of the Dodd-Frank Wall Street Reform and Consumer Protection Act.

 

Remediation of Material Weakness

 

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.

 15 

 

Limitations on the Effectiveness of Internal Controls

 

Our management, including our Chief Executive Officer and our Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting are or will be capable of preventing or detecting all errors or all fraud. Any control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements, due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns may occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of controls effectiveness to future periods are subject to risk.

 

Item 9B. Other Information

 

None 

 

PART III

 

Item 10. Directors, Executive Officers and Corporate Governance

 

The following table contains information with respect to our current executive officers and directors:

 

Name Age Principal Positions With Us
Randall McCoy 66 Chief Executive Officer and Director
John J. Weber 66 Chief Financial Officer and Director
Dr. J. Roy Nelson 68 Chief Science Officer
Joseph Rubinfeld 83 Director
Craig Eagle 48 Director

 

Randall McCoy has served as our Chief Executive Officer and director since July 2010. Prior to joining the Company, Mr. McCoy served as President of McCoy Enterprises LLC since its founding in May 2002. Mr. McCoy has more than 41 years of experience in the healthcare industry and has assisted both small and major pharmaceutical/device companies address FDA issues. He served as Laboratory Manager and Instructor at both George Washington University and Temple Medical School, and served as Program Manager at the Stanford Research Institute, Healthcare Division, of the David Sarnoff Research Center. Mr. McCoy has also helped over 225 foreign and domestic companies introduce their FDA regulated drug and medical device products into the US and world market. He currently holds over 30 US and international patents.

 

John J. Weber has served as our Interim Chief Financial Officer and Director since September 13, 2010. Mr. Weber served as the Executive Vice President of Fujifilm Medical Systems, USA from 2006 until 2009. While at Fujifilm he was responsible for overseeing all corporate activity with the exception of R&D. In previous positions at Fujifilm he served as Senior Vice President of Operations as well as Chief Financial Officer.

 

Mr. Weber brings 20 years of medical-related corporate, operational and financial management experience to the Company.

 

Dr. Joseph Rubinfeld began his career as a research scientist with several pharmaceutical and consumer product companies including Schering Plough and Colgate Palmolive. He served for 12 years at Bristol Myers, where in addition to developing Amoxicillin and Chephadroxil, he was instrumental in licensing their original anti-cancer line of products, including Mitomycin, Etoposide, and Bleomycin. After co-founding Amgen in 1980 and serving as its chief of operations, Dr. Rubinfeld has served as an advisor or Board member to a number of companies including AVI BioPharma and Quark Pharmaceuticals. In 1991 he co-founded Supergen, a drug development company based in Dublin, California, where he served as President and CEO until 2003 and as a member of the Board of Directors until 2005. During that time he oversaw the company’s initial public offering and its rise to a multi-billion dollar market capitalization. Management believes his wealth of experience in biotech and big pharma will be instrumental for Regenicin as it transitions to commercialization.

 16 

 

Dr. Craig Eagle was appointed to our board of directors on September 7, 2010. He currently serves as Vice President of Strategic Alliances and Partnerships for the Oncology business unit at Pfizer Inc. Dr. Eagle joined Pfizer Australia in 2001 as part of the medical group and has held various positions and over the years including his appointment in 2003 as the worldwide leader for development of Celecoxib in oncology to oversee the global research program. In 2007, he became head of the oncology therapeutic area medical group for Pfizer, including the United States oncology business.

 

We acknowledge Dr. Eagle’s wealth of experience in pharmaceutical product development as well as his extensive experience in forming strategic alliances and partnerships and believe he will provide us with critical guidance as we seek to maximize the commercialization potential of our products.

 

Dr. J. Roy Nelson Chief Science Officer owns and operates a FDA registered cGMP audited laboratory. The Material Testing Laboratory holds a Schedule I-V DEA drug license and with an electronic FDA submission portal. His laboratory provides material science supports for new medical devices and drug support for major pharmaceutical as well as smaller companies. In addition to numerous medical device and drug developmental projects, he has been on two FDA consent decree remediations writing SOPs and other FDA compliance documents. He has eight years experience working with various collagen products, such as sponges. Prior to 1988, Dr. Nelson was a senior material scientist at RCA/SRI in Princeton, NJ. He has more than twenty US patents. Dr. Nelson and Mr. McCoy have worked on numerous projects together since 1979 and share co-inventor positions on various patents.

 

Term of Office

 

Our directors are appointed for a one-year term to hold office until the next annual general meeting of our shareholders or until removed from office in accordance with our bylaws. Our officers are appointed by our board of directors and hold office until removed by the board.

 

Family Relationships

 

There are no family relationships between or among the directors, executive officers or persons nominated or chosen by us to become directors or executive officers.

 

Involvement in Certain Legal Proceedings

 

To the best of our knowledge, during the past ten years, none of the following occurred with respect to a present or former director, executive officer, or employee: (1) any bankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time; (2) any conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor offenses); (3) being subject to any order, judgment or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending or otherwise limiting his or her involvement in any type of business, securities or banking activities; and (4) being found by a court of competent jurisdiction (in a civil action), the SEC or the Commodities Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended or vacated.

 17 

 

Committees of the Board

 

Our company currently does not have nominating, compensation or audit committees or committees performing similar functions nor does our company have a written nominating, compensation or audit committee charter. Our directors believe that it is not necessary to have such committees, at this time, because the functions of such committees can be adequately performed by the board of directors.

  

Our company does not have any defined policy or procedural requirements for shareholders to submit recommendations or nominations for directors. The board of directors believes that, given the stage of our development, a specific nominating policy would be premature and of little assistance until our business operations develop to a more advanced level. Our company does not currently have any specific or minimum criteria for the election of nominees to the board of directors and we do not have any specific process or procedure for evaluating such nominees. The board of directors will assess all candidates, whether submitted by management or shareholders, and make recommendations for election or appointment.

 

A shareholder who wishes to communicate with our board of directors may do so by directing a written request addressed to our CEO and director, Randall McCoy, at the address appearing on the first page of this annual report.

 

Code of Ethics

 

We have adopted a Code of Ethics that applies our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. A copy of the Code of Ethics is attached to our Annual Report on Form 10-K for the year ended September 30, 2011 as Exhibit 14.1.

 

Item 11. Executive Compensation

 

Compensation Discussion and Analysis

 

Employment Agreement with Randall McCoy

 

On July 16, 2010, we entered into an employment agreement with Mr. Randall McCoy. The employment agreement has a three-year term that automatically extends in three-year increments unless notice of non-renewal is given by either party at least ninety (90) days prior to the expiration of the then current term.

 

The July 16, 2010, employment agreement provided for an initial annual base salary of $250,000. Under an addendum to the employment agreement, however, dated August 2, 2010, Mr. McCoy will earn an annual base salary of $125,000 until such time as we achieve a positive net income for the preceding calendar quarter as determined in accordance with GAAP and reported in our financial statements filed with the Securities and Exchange Commission under the Securities and Exchange Act of 1934, as amended. Immediately upon our attaining such positive net income, Mr. McCoy’s annual base salary will be increased to $250,000 as stated in the July 16, 2010 employment agreement.

 

The annual base salary will be reviewed each year by our board of directors (or compensation committee, if we then have one), but cannot be decreased from the amount in effect in the previous year. Pursuant to the employment agreement, Mr. McCoy is eligible for an annual bonus determined by our board of directors (or compensation committee, if any). The employment agreement also provides that Mr. McCoy is eligible to participate in our equity incentive plans and other employee benefit programs.

 

Mr. McCoy’s employment agreement imposes on him post-termination non-competition, non-solicitation and confidentiality obligations. Under the agreement, he agrees not to compete with our business in the United States, subject to certain limited exceptions, for a period of one year after termination of his employment. Mr. McCoy further agrees, for a period of one year after termination of his employment, to refrain from (i) soliciting, inducing, encouraging or attempting to induce or encourage any employee, contractor or consultant of the Company to terminate his or her employment or relationship with Company, or to breach any other obligation to Company; and (ii) soliciting, interfering with, disrupting, altering or attempting to disrupt or alter the relationship, contractual or otherwise, between the Company and any other person including, without limitation, any consultant, contractor, customer, potential customer, or supplier of the Company. He also agrees to maintain the confidentiality of all confidential or proprietary information of our company, and assign to us any inventions which pertain to or relate to our business or any of the work or businesses carried on by us that are discovered, conceived, reduced to practice, developed, made or produced by him during and as a result of his employment.

 18 

 

The employment agreement provides for payments and benefits upon termination of employment in addition to those previously accrued. If Mr. McCoy is terminated due to death, the salary payable to Mr. McCoy thereunder (in addition to items previously accrued, but excluding medical plan and other benefits) shall continue to be paid at the then current rate for three (3) months after the termination of employment in accordance with normal Company payroll practices. In addition, any bonuses actually earned prior to the termination (including, as reasonably determined by the Board of Directors or its Compensation Committee, a pro-rated amount of any annual bonus for the portion of the fiscal year during which termination takes place) shall be paid to Mr. McCoy.

 

In the event of the termination of Mr. McCoy’s employment due to disability, the salary payable thereunder (inclusive of paid medical plan then in effect and available, if any) shall continue to be paid at the then current rate for three (3) months after the termination of employment in accordance with normal Company payroll practices; provided, however, that the Company may deduct from such payments the amount of any and all disability insurance benefits paid during such three-month period with respect to Mr. McCoy that were paid for by the Company during any period for which payment was made by the Company during the term of the and prior to the termination. In addition, any bonuses actually earned prior to the termination (including, as reasonably determined by the Board of Directors or its Compensation Committee, a pro-rated amount of any annual bonus for the portion of the fiscal year during which termination takes place) which shall be paid to Mr. McCoy.

 

The table below summarizes all compensation awarded to, earned by, or paid to our officers for all services rendered in all capacities to us for our fiscal years ended September 30, 2015 and 2014.

 

SUMMARY COMPENSATION TABLE   
Name and
principal position
Year Salary ($)

Bonus

($)

 

Stock

Awards

($)

Option

Awards

($)

Non-Equity

Incentive Plan

Compensation

($)

Nonqualified

Deferred

Compensation

Earnings ($)

All Other

Compensation

($)

Total

($)

Randall McCoy

Chief Executive Officer, Principal Executive Officer and Director

2015

2014

$218,750(1)

$125,000(2)

0

0

0

0

0

0

 0

0

0

0

0

0

$218,750
$125,000

John J. Weber

Interim Chief Financial Officer, and Director

2015

2014

$125,000(5)

$31,250

0

0

0

0

0

0

0

0

0

0

0

0

$125,000

$31,250

Chris Hadsall
Chief Operating Officer

2015

2014

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Dr. J. Roy Nelson Chief Science Officer

2015

2014

$150,000(3)

$125,000(4)

0

0

0

0

0

0

0

0

0

0

0

0

$150,000

$125,000

 

(1) Of the $125,000 in salary to Mr. McCoy, $97,083 remains unpaid as accrued compensation. On January 1, 2015, Mr. McCoy’s annual salary was increased to $250,000 based on the terms of his employment agreement.
(2) Of the $125,000 in salary to Mr. McCoy, $125,000 remains unpaid as accrued compensation.
(3) Of the $150,000 in salary to Mr. Nelson, $87,500 remains unpaid as accrued compensation.
(4) Of the $150,000 in salary to Mr. Nelson, $150,000 remains unpaid as accrued compensation.
  (5) Of the $125,000 in salary to Mr. Weber, $109,375 remains unpaid as accrued compensation.  

 19 

 

Outstanding Equity Awards at Fiscal Year-End

 

The table below summarizes all unexercised options, stock that has not vested, and equity incentive plan awards for each named executive officer as of September 30, 2015.

 

OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END
OPTION AWARDS STOCK AWARDS
Name

Number of Securities Underlying Unexercised Options

(#) Exercisable

Number of Securities Underlying Unexercised Options

(#) Unexercisable

Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options

(#)

Option Exercise Price ($) (1) Option Expiration Date

Number of Shares or Units of Stock That Have Not Vested

(#)

Market Value of Shares or Units of Stock That Have Not Vested ($) Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested (#)

Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested

(#)

Randall McCoy 885,672 —   —   $ 0.035 12/22/15 —   —   —   —  
John J. Weber 885,672 —   —   $ 0.035 12/22/15 —   —   —   —  
John J. Weber     10,000,000       —           —        $ 0.02     01/15/2019     —         —         —         —            

  (1) On December 10, 2013 the Board amended the option price to $0.035 from $0.62, and agreed to extend these options. Formal extension was left open until the next board meeting.

 

Director Compensation

 

The table below summarizes all compensation of our directors during the fiscal year ended September 30, 2015.

 

DIRECTOR COMPENSATION
Name

Fees Earned or

Paid in

Cash

($)

 

 

Stock Awards

($)

 

 

Option Awards

($)

Non-Equity

Incentive

Plan

Compensation

($)

Non-Qualified

Deferred

Compensation

Earnings

($)

 

All

Other

Compensation

($)

 

 

 

Total

($)

Dr. Joseph Rubinfeld —   —   —   —   —   —   —  
Dr. Craig Eagle —   —   —   —   —   —   —  

 

 20 

 

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 

The following table sets forth, as of January 8, 2016, certain information as to shares of our common stock owned by (i) each person known by us to beneficially own more than 5% of our outstanding common stock, (ii) each of our directors, and (iii) all of our executive officers and directors as a group.

 

Unless otherwise indicated below, to our knowledge, all persons listed below have sole voting and investment power with respect to their shares of Common Stock, except to the extent authority is shared by spouses under applicable law. Unless otherwise indicated below, each entity or person listed below maintains an address of 10 High Court, Little Falls, NJ 07424.

 

The number of shares beneficially owned by each stockholder is determined under rules promulgated by the SEC. The information is not necessarily indicative of beneficial ownership for any other purpose. Under these rules, beneficial ownership includes any shares as to which the individual or entity has sole or shared voting or investment power and any shares as to which the individual or entity has the right to acquire beneficial ownership within 60 days through the exercise of any stock option, warrant or other right. The inclusion in the following table of those shares, however, does not constitute an admission that the named stockholder is a direct or indirect beneficial owner.

 

Beneficial owner Number of shares beneficially owned (1) Percentage Owned(2)
Officers and Directors
Randall McCoy 21,207,313 (3) 13.74 %
John J. Weber 10,935,672 (4) 6.65 %
Joseph Rubinfeld 1,935,672 (5) 1.25 %
Craig Eagle 935,672 (6) *
Officers and Directors collectively 35,014,329 22.68 %
5 Percent Shareholders

Christopher Brown

100 N Tryon St. #4700

Charlotte, NC 28200

10,000,000 6.52

 * Less than 1%

 

(1) Unless otherwise indicated, each person or entity named in the table has sole voting power and investment power (or shares that power with that person’s spouse) with respect to all shares of common stock listed as owned by that person or entity.

(2) A total of 8,850,000 shares of the Company’s common stock and Series A Convertible Preferred Stock, on an as converted basis, are considered to be outstanding pursuant to Rule 13d-3(d)(1) under the Securities Exchange Act of 1934.

(3) Includes 20,321,641 shares of common stock held in his name and options to purchase 885,672 shares of common stock. These options expired but are expected to be renewed in 2016.

(4) Includes 50,000 shares of common stock held in his name and options to purchase 10,885,672 shares of common stock. 885,672 of these options are expired but are expected to be renewed in 2016.

(5) Includes 1,050,000 shares of common stock held in his name and options to purchase 885,672 shares of common stock. These options expired but are expected to be renewed in 2016.

(6) Includes 50,000 shares of common stock held in his name and options to purchase 885,672 shares of common stock. These options expired but are expected to be renewed in 2016.

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Item 13. Certain Relationships and Related Transactions, and Director Independence 

 

Other than the transactions described below and under the heading “Executive Compensation” (or with respect to which such information is omitted in accordance with SEC regulations), since October 1, 2012 there have not been, and there is not currently proposed, any transaction or series of similar transactions to which we were or will be a participant in which the amount involved exceeded or will exceed $120,000, and in which any director, executive officer, holder of 5% or more of any class of our capital stock or any member of the immediate family of any of the foregoing persons had or will have a direct or indirect material interest:

 

1.Our 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.

2.We also maintain an office in Pennington, New Jersey, which is the materials and testing laboratory. This office is owned by Materials Testing Laboratory, and the principal is an employee.

3.We have an employment agreement with our CEO, Randall McCoy, as discussed above.

 

4.In October 2011 and again in May 2014, Craig Eagle, one of our directors, made advances to us. The loans do not bear interest and are due on demand. At September 30, 2015 and 2014, the loan balance was $ 0 and $38,221, respectively.

 

5.Randall McCoy, our Chief Executive Officer, made advances to us. The loans do not bear interest and are due on demand. At September 30, 2015 and 2014, the loan balance was $95,000 and $8,500, respectively.

 

6.John Weber, our Chief Financial Officer, has made advances to us. The loans do not bear interest and are due on demand. At September 30, 2015 and 2014, the loan balance was $0 and $122,100, respectively.

  

Director Independence

 

We are not a “listed issuer” within the meaning of Item 407 of Regulation S-K and there are no applicable listing standards for determining the independence of our directors. Applying the definition of independence set forth in Rule 4200(a)(15) of The Nasdaq Stock Market, Inc., we believe that Joseph Rubinfeld and Craig Eagle are independent directors. 

 

Item 14. Principal Accountant Fees and Services

 

We do not have an audit committee. Our Board of Directors pre-approves all services, including both audit and non-audit services, provided by our independent accountants. For audit services, each year the independent auditor provides our Board of Directors with an engagement letter outlining the scope of the audit services proposed to be performed during the year, which must be formally accepted by the Board of Directors before the audit commences. The independent auditor also submits an audit services fee proposal, which also must be approved by the Board of Directors before the audit commences.

 

Aggregate fees for professional services rendered for the Company by Rotenberg Meril Solomon Bertiger & Guttilla, P.C., our independent registered public accounting firm, for the years ended September 30, 2015 and 2014 are set forth below:

 

Financial Statements for the Year Ended September 30 Audit Fees Audit Related Fees Tax Fees Other Fees
2015  $ 88,500 $ 0 $ 0 $ 0
2014 $ 99,046 $ 0   $ 0 $ 0

 

Audit Fees were for professional services rendered for the audits of our financial statements, quarterly review of the financial statements included in Quarterly Reports on Form 10-Q, consents, and other assistance required to complete the year-end audit of the financial statements.

 

Audit-Related Fees were for assurance and related services reasonably related to the performance of the audit or review of financial statements and not reported under the caption Audit Fees. 

 

Tax Fees were for professional services related to tax compliance, tax authority audit support and tax planning.

 

All Other Fees include any other fees charged that are not otherwise specified.

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PART IV

 

Item 15. Exhibits, Financial Statements Schedules

 

(a) Financial Statements and Schedules

 

The following financial statements and schedules listed below are included in this Form 10-K.

 

Financial Statements (See Item 8)

 

(b) Exhibits

 

Exhibit Number Description
3.1 Articles of Incorporation, as amended (1)
3.2 Bylaws, as amended (1)
10.4 Know-How License and Stock Purchase Agreement (2)
10.5 Form of Stock Option Agreement(3)
10.6 Employment Agreement for Randall McCoy(5)
10.7 Asset Purchase Agreement(7)
14.1 Code of Ethics (6)
31.1 Certification of Chief Executive Officer pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2 Certification of Chief Financial Officer pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a), 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

 

 (1)Incorporated by reference to the Registration Statement on Form SB-2 filed on October 25, 2006; also incorporated by reference to the Current Report on Form 8-K filed on October 29, 2010.
 (2)Incorporated by reference to the Current Report on Form 8-K/A filed on April 27, 2011. 
 (3)Incorporated by reference to the Annual Report on Form 10-K filed on January 13, 2011.
 (4)Incorporated by reference to the Current Report on Form 8-K filed on October 5, 2010.
 (5)Incorporated by reference to the Current Report on Form 8-K filed on July 22, 2010.
 (6)Incorporated by reference to the Current Report on Form 8-K filed on May 17, 2011.
(7)Incorporated by reference to the Current Report on Form 8-K filed November 17, 2014.

 

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SIGNATURES

 

In accordance with Section 13 or 15(d) of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Regenicin, Inc.

 

By:  /s/ Randall McCoy

Randall McCoy

President, Chief Executive Officer, Principal Executive Officer,

and Director

 

January 13, 2016

 

In accordance with Section 13 or 15(d) of the Exchange Act, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:

 

By:  /s/ Randall McCoy

Randall McCoy

President, Chief Executive Officer, Principal Executive Officer,

and Director

 

January 13, 2016

 

By: /s/ John J. Weber

John J. Weber

Interim Chief Financial Officer, Principal Financial and Accounting Officer, and Director

 

January 13, 2016

 

By: /s/ Dr. Joseph Rubinfeld

Dr. Joseph Rubinfeld

Director

 

January 13, 2016

  

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