UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
| [X] | Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
| For the quarterly period ended March 31, 2012 | |
| [ ] | Transition Report pursuant to 13 or 15(d) of the Securities Exchange Act of 1934 |
| For the transition period from to __________ | |
Commission File Number: 333-146834
|
Regenicin,
Inc.
(Exact name of registrant as specified in its charter)
| Nevada | 27-3083341 |
| (State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
| 10 High Court, Little Falls, NJ |
| (Address of principal executive offices) |
| (646) 403 3581 |
| (Registrant’s telephone number) |
| _______________________________________________________________ |
| (Former name, former address and former fiscal year, if changed since last report) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days [ ] Yes [X] No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). [ ] Yes [X] No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.
| [ ] Large accelerated filer Accelerated filer | [ ] Non-accelerated filer |
| [X] Smaller reporting company |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). [ ] Yes [X] No
State the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 83,807,964 shares as of May 18, 2012.
| TABLE OF CONTENTS |
Page | |
| PART I – FINANCIAL INFORMATION | ||
| Item 1: | Financial Statements | 3 |
| Item 2: | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 4 |
| Item 3: | Quantitative and Qualitative Disclosures About Market Risk | 8 |
| Item 4: | Controls and Procedures | 8 |
| PART II – OTHER INFORMATION | ||
| Item 1: | Legal Proceedings | 9 |
| Item 1A: | Risk Factors | 10 |
| Item 2: | Unregistered Sales of Equity Securities and Use of Proceeds | 10 |
| Item 3: | Defaults Upon Senior Securities | 10 |
| Item 4: | Mine Safety Disclosures | 10 |
| Item 5: | Other Information | 10 |
| Item 6: | Exhibits | 10 |
| 2 |
PART I - FINANCIAL INFORMATION
Our financial statements included in this Form 10-Q are as follows:
These financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and the SEC instructions to Form 10-Q. In the opinion of management, all adjustments considered necessary for a fair presentation have been included. Operating results for the interim period ended March 31, 2012 are not necessarily indicative of the results that can be expected for the full year.
| 3 |
REGENICIN, INC.
(A Development Stage company)
| March 31, | September 30, | |||||||
| 2012 | 2011 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 36,243 | $ | 4,396 | ||||
| Prepaid expenses and other current assets | 33,468 | 73,630 | ||||||
| Total current assets | 69,711 | 78,026 | ||||||
| Intangible assets | 3,007,500 | 3,007,500 | ||||||
| Total assets | $ | 3,077,211 | $ | 3,085,526 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 1,468,153 | $ | 739,327 | ||||
| Accrued expenses | 962,033 | 658,251 | ||||||
| Note payable - insurance financing | 13,387 | 60,243 | ||||||
| Notes payable (net of discount of $25,205 and -0-) | 137,871 | — | ||||||
| Bridge financing (net of discount of $163,933 and -0-) | 187,770 | — | ||||||
| Loan payable | 10,000 | 10,000 | ||||||
| Due to related party | 48,000 | — | ||||||
| Total current liabilities | 2,827,214 | 1,467,821 | ||||||
| Total liabilities | 2,827,214 | 1,467,821 | ||||||
| STOCKHOLDERS' EQUITY | ||||||||
| Series A 10% Convertible Preferred stock, $0.001 par value, 5,500,000 shares authorized; 1,345,000 and 1,345,000 issued and outstanding | 1,345 | 1,345 | ||||||
| Common stock, $0.001 par value; 200,000,000 shares authorized; 88,236,324 issued; 83,807,964 outstanding | 88,237 | 88,237 | ||||||
| Common stock to be issued 3,027,683 and -0- shares | 151,384 | — | ||||||
| Additional paid-in capital | 6,925,486 | 6,573,794 | ||||||
| Deficit accumulated during development stage | (6,912,027 | ) | (5,041,243 | ) | ||||
| Less: treasury stock; 4,428,360 shares at par | (4,428 | ) | (4,428 | ) | ||||
| Total stockholders' equity | 249,997 | 1,617,705 | ||||||
| Total liabilities and stockholders' equity | $ | 3,077,211 | $ | 3,085,526 | ||||
See Notes to Financial Statements.
| F-1 |
REGENICIN, INC.
(A Development Stage company)
| September 6, 2007 | ||||||||||||||||||||
| Six Months | Six Months | (Inception Date) | Three Months | Three Months | ||||||||||||||||
| Ended | Ended | Through | Ended | Ended | ||||||||||||||||
| March 31, | March 31, | March 31, | March 31, | March 31, | ||||||||||||||||
| 2012 | 2011 | 2012 | 2012 | 2011 | ||||||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||||
| Revenues | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||
| Operating expenses | ||||||||||||||||||||
| Research and development | 869,859 | — | 1,388,761 | 449,377 | — | |||||||||||||||
| General and administrative | 760,985 | 1,503,855 | 3,771,708 | 371,930 | 847,094 | |||||||||||||||
| Stock based compensation - general and administrative | — | 855,991 | 1,248,637 | — | 743,491 | |||||||||||||||
| Total operating expenses | 1,630,844 | 2,359,846 | 6,409,106 | 821,307 | 1,590,585 | |||||||||||||||
| Loss from operations | (1,630,844 | ) | (2,359,846 | ) | (6,409,106 | ) | (821,307 | ) | (1,590,585 | ) | ||||||||||
| Other Expenses | ||||||||||||||||||||
| Interest expense, including amortization of beneficial conversion feature | (239,940 | ) | (4,053 | ) | (502,921 | ) | (234,471 | ) | (2,178 | ) | ||||||||||
| Total Other Expenses | (239,940 | ) | (4,053 | ) | (502,921 | ) | (234,471 | ) | (2,178 | ) | ||||||||||
| Net loss | (1,870,784 | ) | (2,363,899 | ) | (6,912,027 | ) | (1,055,778 | ) | (1,592,763 | ) | ||||||||||
| Preferred stock dividends | (54,187 | ) | — | (1,316,923 | ) | (26,826 | ) | — | ||||||||||||
| Net loss attibutable to common stockholders | $ | (1,924,971 | ) | $ | (2,363,899 | ) | $ | (8,228,950 | ) | $ | (1,082,604 | ) | $ | (1,592,763 | ) | |||||
| Basic and diluted loss per share: | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.01 | ) | $ | (0.02 | ) | ||||||||
| Weighted average number of shares outstanding | ||||||||||||||||||||
| Basic and diluted | 83,807,964 | 85,508,846 | 83,807,964 | 83,822,317 | ||||||||||||||||
See Notes to Financial Statements.
| F-2 |
REGENICIN, INC.
(A Development Stage company)
| September 6, 2007 | ||||||||||||
| Six Months | Six Months | (Inception Date) | ||||||||||
| Ended | Ended | Through | ||||||||||
| March 31, | March 31, | March 31, | ||||||||||
| 2012 | 2011 | 2012 | ||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | ||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||||
| Net loss | $ | (1,870,784 | ) | $ | (2,363,899 | ) | $ | (6,912,027 | ) | |||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
| Amortization of debt discount | 31,045 | — | 31,045 | |||||||||
| Accrued interest on notes and loans payable | 13,543 | — | 13,543 | |||||||||
| Amortization of beneficial conversion feature | 178,043 | — | 429,257 | |||||||||
| Warrants issued as part of debt conversion | 7,653 | — | 7,653 | |||||||||
| Stock based compensation | — | 855,991 | 1,248,637 | |||||||||
| Changes in operating assets and liabilities | ||||||||||||
| Prepaid expenses and other current assets | 40,162 | 25,970 | 26,775 | |||||||||
| Accounts payable | 728,826 | 506,723 | 1,468,153 | |||||||||
| Accrued expenses | 251,525 | 216,390 | 887,308 | |||||||||
| Net cash used in operating activities | (619,987 | ) | (758,825 | ) | (2,799,656 | ) | ||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||||
| Acquisition of intangible assets | — | — | (3,007,500 | ) | ||||||||
| Net cash used in investing activities | — | — | (3,007,500 | ) | ||||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||||
| Proceeds from the sale of common stock | — | 467,550 | 3,012,575 | |||||||||
| Proceeds from the sale of Series A convertible preferred stock | — | — | 1,180,000 | |||||||||
| Payments of expenses relating to the sale of common stock | — | (75,777 | ) | (444,910 | ) | |||||||
| Payment of expenses relating to the sale of convertible preferred stock | — | — | (9,600 | ) | ||||||||
| Repayments of notes payable - insurance financing | (46,856 | ) | — | (46,856 | ) | |||||||
| Proceeds from the issuance of notes payable | 660,690 | 115,000 | 1,675,690 | |||||||||
| Repayments of notes payable | (10,000 | ) | — | (245,000 | ) | |||||||
| Proceeds from advances from related party | 48,000 | 187,211 | 554,000 | |||||||||
| Proceeds from loans payable | — | 85,000 | 145,000 | |||||||||
| Proceeds from advances from officer | — | — | 22,500 | |||||||||
| Net cash provided by financing activities | 651,834 | 778,984 | 5,843,399 | |||||||||
| INCREASE IN CASH | 31,847 | 20,159 | 36,243 | |||||||||
| CASH - BEGINNING OF PERIOD | 4,396 | 4,564 | — | |||||||||
| CASH - END OF PERIOD | $ | 36,243 | $ | 24,723 | $ | 36,243 | ||||||
| Supplemental disclosures of cash flow information: | ||||||||||||
| Cash paid for interest | $ | 1,758 | $ | — | ||||||||
| Non-cash activities: | ||||||||||||
| Preferred stock dividends | $ | 54,187 | $ | — | ||||||||
| Shares to be issued upon conversion of debt and accrued interest | $ | 151,384 | $ | — | ||||||||
| Issuance of warrants upon conversion of debt | $ | 7,653 | $ | — | ||||||||
| Issuance of common stock for the conversion of amounts owed to related party | $ | — | $ | 506,000 | ||||||||
| Treasury stock | $ | — | $ | 4,428 | ||||||||
See Notes to Financial Statements.
| F-3 |
REGENICIN, INC.
NOTES TO THE FINANCIAL STATEMENTS
(A Development Stage Company)
(UNAUDITED)
NOTE 1 - THE COMPANY
Windstar, Inc. (the Company”) was incorporated in the state of Nevada on September 6, 2007 and is in the development stage. On July 19, 2010, the Company amended its Articles of Incorporation to change the name of the Company to Regenicin, Inc.
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 has adopted a new business plan and intends to help 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. To this end, we have entered into an agreement with Lonza Walkersville, Inc. (Lonza”) for the 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 a product known as PermaDerm.
PermaDerm is a tissue-engineered skin substitute prepared from autologous (patient’s own) skin cells. It is a combination of cultured epithelium with a collagen-fibroblast implant that produces a skin substitute that contains both epidermal and dermal components. This model has been shown in preclinical studies to generate a functional skin barrier and in clinical studies to promote closure and healing of burns. Clinically, the Company believes that self-to-self skin grafts for permanent skin tissue will not be rejected by the immune system of the patient, unlike with porcine or cadaver grafts in which rejection is an important possibility.
NOTE 2 - BASIS OF PRESENTATION
The accompanying unaudited financial statements of Regenicin, Inc. (the Company”) have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with Rule 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the six months ended March 31, 2012 are not necessarily indicative of the results that may be expected for the year ending September 30, 2012. These unaudited financial statements should be read in conjunction with the audited financial statements and footnotes thereto included in the Company's Annual Report on Form 10-K for the year ended September 30, 2011, as filed with the Securities and Exchange Commission.
Going Concern:
The Company’s 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 $6.9 million from inception, expects to incur further losses in the development of its business and has been dependent on funding operations through the issuance of convertible debt and private sale of equity securities. These conditions raise substantial doubt about the Company’s 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 the Company 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 the Company be unable to continue as a going concern.
| F-4 |
Development Stage Activities and Operations:
The Company is in the development stage and has had no revenues. 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.
Recent Pronouncements:
We do not believe that any of the recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on our accompanying financial statements.
NOTE 3 - LOSS PER SHARE
Basic loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Diluted loss per share 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 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 March 31, | ||||||||
| 2012 | 2011 | |||||||
| Options | 5,542,688 | 5,542,688 | ||||||
| Warrants | 1,269,842 | 2,300,067 | ||||||
| Convertible Preferred Stock | 14,277,000 | -0- | ||||||
| Convertible debentures | 3,804,914 | -0- | ||||||
NOTE 4 - INTANGIBLES ASSETS
In July 2010, the Company entered into an agreement with Lonza for the 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 a product known as PermaDerm.
The Company paid Lonza $3,000,000 for the exclusive know-how license and assistance to seek approval from the FDA for the commercial sale of PermaDerm in the U.S., and later for approval in foreign jurisdictions for commercial sale of PermaDerm throughout the world. In conjunction with Lonza, we intend to create and implement a strategy to conduct human clinical trials and to assemble and present the relevant information and data in order to obtain the necessary approvals for PermaDerm and possible related products.
In August 2010, the Company paid $7,500 and obtained the rights to the trademarks PermaDerm® and TempaDerm® from KJR-10 Corp.
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.
| F-5 |
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. We did not record any impairment charges in the six months ended March 31, 2012 and 2011.
NOTE 5 - NOTES PAYABLE
Insurance Financing Note:
In August 2011, the Company financed certain insurance premiums totaling $60,243. The note is payable over a nine-month term. The first payment due in September 2011 was made in October 2011. At March 31, 2012 and September 30, 2011, the note balance was $13,387 and $60,243, respectively.
Promissory Notes:
On October 12, 2011, the Company issued a $10,000 secured promissory note (“Note 1”) to NPNC Management LLC, a company whose principals also represent the Company as securities counsel. Note 1 bore interest at the rate of 5% per annum and was due on June 14, 2012. Note 1 was secured by the Company’s assets. At March 31, 2012, the Note 1 balance including interest was repaid in full.
On December 21, 2011, the Company issued a $150,000 promissory note (“Note 2”) to an individual. Note 2 bears interest so that the Company will repay $175,000 on the maturity date of June 21, 2012, which correlates to an effective rate of 31.23%. Additional interest of 10% will be charged on any late payments. At maturity, the Company will issue one million shares of common stock as additional consideration. For financial reporting purposes, the Company recorded a discount of $56,250 to reflect the value of these shares. The discount is being amortized over the term of Note 2. At March 31, 2012, the Note 2 balance was $138,174 net of a debt discount of $25,205.
On January 18, 2012, the Company issued a $165,400 convertible promissory note (“Note 3”) to an individual. Note 3 bears interest at the rate of 5% per annum and is due on June 18, 2012. Note 3 and accrued interest thereon is convertible into units at a conversion price of $2.00 per unit. A unit consists of one share of Series A Convertible Preferred Stock (“Series A Preferred”) and a warrant to purchase one-fourth (1/4), or 25% of one share of common stock. For financial reporting purposes, the Company recorded a discount of $6,686 to reflect the beneficial conversion feature. The discount is being amortized over the term of Note 2. At March 31, 2012, the Note 2 balance was $161,396 net of a debt discount of $4,004.
On January 27, 2012, the Company issued a $149,290 convertible promissory note (“Note 4”) to an individual. Note 4 bore interest at the rate of 8% per annum and was due on March 31, 2012. Note 4 and accrued interest thereon was convertible into shares of common stock at a rate of $.05 per share. In addition, at the date of conversion, the Company was to issue two-year warrants to purchase an additional 500,000 shares of common stock at $.10 per share. On March 31, 2012 Note 4 and the accrued interest became due but the 3,027,683 shares of common stock were not issued. As such, as of March 31, 2012, such shares were classified as common stock to be issued. In addition, at March 31, 2012, the warrants to purchase 500,000 shares were issued. For financial reporting purposes, the Company recorded a discount of $7,653 to reflect the value of the warrants and a discount of $149,290 to reflect the value of the beneficial conversion feature.
| F-6 |
In March 2012, the Company issued a series of convertible promissory notes (“Notes 5-9”) totaling $186,000 to four individuals. Notes 5-9 bear interest at the rate of 33% per annum and are due in August and September 2012. Notes 5-9 and accrued interest thereon are convertible into shares of common stock at the rate of $.05 per share and automatically convert on the maturity dates unless paid sooner by the Company. For financial reporting purposes, the Company recorded discounts of $186,000 to reflect the beneficial conversion features. The discounts are being amortized over the terms of Notes 5-9. At March 31, 2012, the Note 5-9 balances were $26,071, net of debt discounts of $159,929.
In April 2012, the Company issued a series of convertible promissory notes (“Notes 10-12”) totaling $55,000 to three individuals. Notes 10-12 bear interest at the rate of 33% per annum and are due in October 2012. Notes 10-12 and accrued interest thereon are convertible into shares of common stock at the rate of $.05 per share and automatically convert on the maturity dates unless paid sooner by the Company.
In April 2012, the Company issued a convertible promissory notes (“Note 13”) totaling $25,000 to an individual for services previous rendered. Note 13 bears interest at the rate of 33% per annum and is due in October 2012. Note 13 and accrued interest thereon is convertible into shares of common stock at the rate of $.05 per share and automatically converts on the maturity dates unless paid sooner by the Company.
NOTE 6 - LOANS PAYABLE
Loan Payable:
In February 2011, an investor advanced the Company $10,000. The loan does not bear interest and is due on demand. At March 31, 2012, the loan balance is $10,000.
Loan Payable - Related Party:
In October 2011, Craig Eagle, a director of the Company, advanced the Company $35,000. The loan does not bear interest and is due on demand. At March 31, 2012, the loan balance was $35,000.
In February 2012, John Weber, the Company’s Chief Financial Officer, advanced the Company $13,000. The loan does not bear interest and is due on demand. At March 31, 2012, the loan balance is $13,000. In April 2012 another $10,000 was advanced under the same terms.
NOTE 7 - STOCKHOLDERS’ EQUITY
Preferred Stock:
Series A
Series A Preferred pays a dividend of 8% per annum on the stated value and have a liquidation preference equal to the stated value of the shares. Each share of Preferred Stock has an initial stated value of $1 and is 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 $54,187 and $26,826 for the six and three months ended March 31, 2012, respectively. There were no dividends for both the six and three months ended March 31, 2011. At March 31, 2012 and September 30, 2011, dividends payable total $80,297 and $26,110, respectively, and are included in accrued expenses.
| F-7 |
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 March 31, 2012 and December 31, 2011, no shares of Series B Preferred are outstanding.
NOTE 8 - LEGAL PROCEEDINGS
On April 18, 2012, a settlement was reached in the case involving litigation between our Chief Executive Officer, Mr. Randall McCoy, and our former President, Mr. Joseph Connell in the United States District Court for the Southern District of New York.
As previously reported, on March 11, 2011, Mr. Connell filed a complaint in the Supreme Court of the State of New York (which was later removed to federal court) against Mr. Randall McCoy, our company, and the members of our board of directors. The company and members of the board were dismissed earlier from the proceedings and the chronology of the case is set forth in our previous filings.
As a final resolution, a Confidential Settlement Agreement and General Release (the Settlement Agreement”) was signed by and among Mr. McCoy, Mr. Connell, our company, and our board of directors. An amendment (the Amendment”) to the Settlement Agreement was signed on April 24, 2012. Pursuant to the Settlement Agreement and Amendment, in exchange for dismissal of the pending lawsuit with prejudice and a mutual release of all claims involving all parties concerned, Mr. McCoy agreed to issue to Mr. Connell 12,500,000 shares of his common stock in our company. On April 19, 2012, 10,000,000 of the shares were transferred to Mr. Connell, with the remaining shares assigned to his counsel in the case.
As a result of the Settlement Agreement and Amendment and the transfer of these shares, Mr. Connell is now a greater than 10% stockholder of the Company.
NOTE 9 - RELATED PARTY TRANSACTIONS
Our principal executive offices are located at in Little Falls, New Jersey. Our 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. No rent is charged.
We also maintain an office in Pennington New Jersey, which is our materials and testing laboratory. This office is owned by Materials Testing Laboratory, and the principal is an employee of our Company.
No rent is charged for either premise.
NOTE 10 - SUBSEQUENT EVENTS
Management has evaluated subsequent events through the date of this filing.
| F-8 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Statements
Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements generally are identified by the words “believes,” “project,” “expects,” “anticipates,” “estimates,” “intends,” “strategy,” “plan,” “may,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. We intend such forward-looking statements to be covered by the safe-harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of complying with those safe-harbor provisions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse affect on our operations and future prospects on a consolidated basis include, but are not limited to: changes in economic conditions, legislative/regulatory changes, availability of capital, interest rates, competition, and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Further information concerning our business, including additional factors that could materially affect our financial results, is included herein and in our other filings with the SEC.
Overview
We intend 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 certain clinical diagnoses. To this end, we have entered into an agreement to purchase stock of Cutanogen Corporation (“Cutanogen”) from Lonza Walkersville, Inc. (“Lonza”) and for the 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 several products. These products are aimed at the treatment of burns, chronic wounds and a variety of plastic and reconstructive surgical procedures. In the United States market alone, the company estimates the potential markets for severe burns and chronic skin wounds is in excess of $7 billion.
The first product, PermaDerm® is the only tissue-engineered skin prepared from autologous (patient’s own) skin cells. It is a combination of cultured epithelium with a collagen-fibroblast implant that produces a skin substitute that contains both epidermal and dermal components. This model has been shown in preclinical studies to generate a functional skin barrier and in clinical studies to promote closure and healing of burns. Clinically, we believe self-to-self skin grafts for permanent skin tissue are not rejected by the immune system of the patient, unlike with porcine or cadaver grafts in which immune system rejection is an important possibility. PermaDerm® was initially designated as an Orphan Device by the FDA for treatment of burns. We have applied to the FDA late last year for an Orphan designation as a biologic/drug for PermaDerm® If received, this would allow us to move forward to gain a Biological License Application Approval which would allow Regenicin to sell PermaDerm® in certain defined markets.
The second product is anticipated to be, TempaDerm®. TempaDerm® uses cells obtained from human donors to allow the development of banks of cryopreserved (frozen) cells and cultured skin substitute to provide a continuous supply of non-allogenic skin substitutes. This product has applications in the treatment of chronic skin wounds such as diabetic ulcers, decubitus ulcers and venous stasis ulcers. The U.S. markets are estimated to total more than $7 billion annually. This product is in the early development stage and does not have FDA approval.
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We believe the technology has many different uses beyond the burn indication. The other uses include chronic wounds, reconstructive surgery and the individual components of the PermaDerm® technology such as tendon wraps made of collagen or temporary coverings to protect the patients from infections while waiting for PermaDerm®. The collagen technology used for PermaDerm® is a wide-open field in wound healing and uses such as stem cell grafting substrates. It is important to know that all of these above are products by themselves regardless of whether PermaDerm® is approved for burns. We could pursue any or all of them independently if financing permitted. Even if PermaDerm® was not approved for burn treatments it could be approved for chronic wounds or reconstruction.
We will need to raise capital to fund benchmark payments agreed to under the Lonza agreement. Upon receipt of Orphan Product BLA Approval (Pediatric), we will initiate sales with manufacturing performed by Lonza. We hope to initiate clinical trials early 2012 with final submission to the FDA for approval for PermaDerm® anticipated by 2013.
Results of Operations for the Three and Six Months Ended March 31, 2012 and 2011
We have generated no revenues since the inception of the Company. We do not expect to generate revenues until we are able to obtain FDA approval of PermaDerm®, and thereafter acquire the license rights to sell products associated with that technology.
We incurred operating expenses of $821,307 for the three months ended March 31, 2012, compared with operating expenses of $1,590,585 for the three months ended March 31, 2011. We incurred operating expenses of $1,630,844 for the six months ended March 31, 2012, compared with operating expenses of $2,359,846 for the six months ended March 31, 2011. Our operating expenses increased dramatically in 2012 as a result of ramping up operations in connection with our tissue-engineered skin substitutes business and consisted mainly of the following in comparison to our expenses in 2011:
| Operating Expense | Three
Months Ended March 31, 2012 | Three
Months Ended March 31, 2011 | Six
Months Ended March 31, 2012 | Six
Months Ended March 31, 2011 | ||||||||||||
| Legal and Accounting | $ | 80,750 | $ | 288,240 | $ | 235,995 | $ | 388,438 | ||||||||
| Public Relations and Marketing Support | — | 42,125 | — | 202,942 | ||||||||||||
| Salaries, Wages and Payroll Taxes | 218,649 | 212,092 | 395,345 | 376,675 | ||||||||||||
| Consulting and Computer Support | 20,900 | 723,703 | 21,800 | 899,894 | ||||||||||||
| Office Expenses and Misc. | 7,678 | 8,775 | 17,177 | 22,275 | ||||||||||||
| Travel | 7,980 | 21,269 | 18,786 | 68,229 | ||||||||||||
| Insurance | 22,905 | 22,869 | 46,554 | 49,491 | ||||||||||||
| Website Expenses | 264 | — | 630 | — | ||||||||||||
| Research and Development | 449,377 | 183,687 | 869,859 | 183,687 | ||||||||||||
| Employee Benefits | 12,804 | 12,764 | 24,698 | 18,093 | ||||||||||||
| Registration Penalties | — | 75,061 | — | 150,122 | ||||||||||||
We incurred stock based compensation of $0 and $743,491 for the three months ended March 31, 2012 and 2011, respectively, from the issuance of common stock, warrants and options to our directors and third party consultants. We incurred stock based compensation of $0 and $855,991 for the six months ended March 31, 2012 and 2011, respectively, from the issuance of common stock, warrants and options to our directors and third party consultants. Such amounts are included above under consulting.
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We incurred other expenses of $234,471 for the three months ended March 31, 2012, as compared to $2,178 for the three months ended March 31, 2011. We incurred other expenses of $239,940 for the six months ended March 31, 2012, as compared to $4,053 for the six months ended March 31, 2011. Our other expenses for both periods consisted of interest expenses. Interest expense included $206,014 and $209,088 for the three and six months ended March 31, 2012, respectively, to reflect the amortization of debt discounts and beneficial conversion features of the various notes payable issued.
We incurred a net loss of $1,055,778 for the three months ended March 31, 2012, as compared with a net loss of $1,592,763 for the three months ended March 31, 2011. We incurred a net loss of $1,870,784 for the six months ended March 31, 2012, as compared with a net loss of $2,363,899 for the six months ended March 31, 2011. We incurred a net loss of $6,912,027 for the period from inception to March 31, 2012.
Liquidity and Capital Resources
As of March 31, 2012, we had cash of $36,243 and $4,396 as of September 30, 2011.
Operating activities used $619,987 in cash for the six months ended March 31, 2012. The decrease in cash was primarily attributable to funding the loss for the period.
Financing activities provided $651,834 for the six months ended March 31, 2012 and consisted of $660,690 in proceeds from notes payable and $48,000 in loans from a related party, offset by the repayment of the insurance premium financing of $46,856 and the repayment of other loans of $10,000.
During the current reporting period and thereafter, we received funds under the following notes and loans:
Based upon our current financial condition, we do not have sufficient cash to operate our business at the current level for the next twelve months. We intend to fund operations through increased sales and debt and/or equity financing arrangements, which may be insufficient to fund expenditures or other cash requirements. We plan to seek additional financing in a private equity offering to secure funding for operations. There can be no assurance that we will be successful in raising additional funding. If we are not able to secure additional funding, the implementation of our business plan will be impaired. There can be no assurance that such additional financing will be available to us on acceptable terms or at all.
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The primary short term objective of the Company is to gain FDA approval for both the pediatric and adult indications for the use of PermaDerm® . Understanding that these approvals are not contingent upon one another, but will be independent submissions, our most essential efforts and expenditures in the short term will be regulatory in nature. It should be noted that the regulatory expenditure related to adult indication will be substantially funded by the aforementioned government contract to Lonza, discussed above, 66% of clinical supplies, regulatory support and commercialization expenses are also covered by the government contract. The remaining expense, of the 33.3% to be absorbed by the company, is recognized as $130,000 per month in the Regulatory Expense category below. The regulatory expense related to pediatric indication is expected to be roughly $20,000 per month, due to the fact that over 100 patients have previously been treated with PermaDerm® , under a Humanitarian Use Device designation granted by the FDA. As a result, it is the opinion of management that not only will the expenditure be minimized but the time to approval will be greatly reduced. Commercial sales in the pediatric category are projected to begin within 12 month of funding.
| The Current Monthly Expenditures are as follows: | Total | Regulatory | Required | |||||||||
| Salaries | $ | 73,000 | $ | 8,000 | 65,000 | |||||||
| Fringe Benefits | 5,000 | 1,000 | 4,000 | |||||||||
| T&E | 10,000 | 5000 | 5,000 | |||||||||
| Subtotal | 88,000 | 14,000 | 74,000 | |||||||||
| clinical trials | 130,000 | 130,000 | ||||||||||
| Pediatric | 20,000 | 20,000 | ||||||||||
| Regulatory Expense subtotal | 150,000 | 150,000 | ||||||||||
| Professional Fees: | ||||||||||||
| Legal | 12,500 | 12,500 | ||||||||||
| Accounting & Audit | 6,500 | 6,500 | ||||||||||
| Subtotal | 19,000 | 19,000 | ||||||||||
| Public Relations | 12,000 | 12,000 | ||||||||||
| Insurance | 7,500 | 7,500 | ||||||||||
| Miscellaneous | 3,500 | 1,500 | 2,000 | |||||||||
| Total | $ | 280,000 | $ | 165,500 | $ | 114,500 | ||||||
As can be noted from the above schedule, management estimates the current total monthly expense at approximately $280,000. A further analysis of this total monthly amount indicates that the minimum regulatory expense required to meet the objectives, without delay, in the next 12 months is estimated at $165,500, with an additional minimum monthly expense to meet statutory requirements of $114,500. In summary, in order to continue operations meeting only the regulatory schedule and statutory requirements would cost approximately $280,000 per month.
We are hopeful that we will close on a new round of financing in the $2-$4 million range within the next 30 - 60 days. In addition, shareholder, directors, and officers have contributed capital in the past and it is expected that they will continue if required. Finally, creditors have also been willing to extend terms when necessary and employees have accepted delayed payment.
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For the first full year, after the approval of the Orphan indication, we are projecting revenue in the United States in excess of $10 million. Lead pricing from our manufacturer, Lonza, would yield gross contribution of approximately $4 million. This does not include any international licensing revenue opportunities, in which interest has been exhibited. It is also the opinion of management that since there are over 125 major burn centers in the U.S., marketing and selling expense will be minimal. It should also be noted, that Perma DermTM's grafting procedure is similar to the current method used with skin substitutes. As a result, the surgeon training will be minimal. In addition, due to the fact that Lonza, our contract manufacturer, will handle the patients' skin sample, manufacture the PermaDerm® and deliver the product directly to the surgeon, the company's distribution and manufacturing expense will be minimal. Finally, due to PermaDerm® being autologous, (made from the patient's own skin), rejection, infection, and time in the intensive unit can be greatly reduced.
Off Balance Sheet Arrangements
As of March 31, 2012, there were no off balance sheet arrangements.
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 of $6.9 million for the period September 6, 2007 (inception date) through March 31, 2012, 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.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
A smaller reporting company is not required to provide the information required by this Item.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
We carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of March 31, 2012. This evaluation was carried out under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of March 31, 2012, our disclosure controls and procedures were not effective due to the presence of material weaknesses in internal control over financial reporting.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. Management has identified the following material weaknesses which have caused management to conclude that, as of March 31, 2012, our disclosure controls and procedures were not effective: (i) inadequate segregation of duties and effective risk assessment; and (ii) insufficient written policies and procedures for accounting and financial reporting with respect to the requirements and application of both US GAAP and SEC guidelines.
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Remediation Plan to Address the Material Weaknesses in Internal Control over Financial Reporting
Our company plans to take steps to enhance and improve the design of our internal controls over financial reporting. During the period covered by this quarterly report on Form 10-Q, we have not been able to remediate the material weaknesses identified above. To remediate such weaknesses, we plan to implement the following changes during our fiscal year ending September 30, 2012: (i) appoint additional qualified personnel to address inadequate segregation of duties and ineffective risk management; and (ii) adopt sufficient written policies and procedures for accounting and financial reporting. The remediation efforts set out are largely dependent upon our securing additional financing to cover the costs of implementing the changes required. If we are unsuccessful in securing such funds, remediation efforts may be adversely affected in a material manner.
We are unable to remedy our controls related to the inadequate segregation of duties and ineffective risk management until we receive financing to hire additional employees. In January 2011, we hired an outsourced controller to improve the controls for accounting and financial reporting.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the three months ended March 31, 2012 that have materially affected, or are reasonable likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
Aside from what follows, we are not a party to any pending legal proceeding. We are not aware of any pending legal proceeding to which any of our officers, directors, or any beneficial holders of 5% or more of our voting securities are adverse to us or have a material interest adverse to us.
On February 28, 2011, our board of directors, Mr. Randall McCoy, and our company (collectively the “Plaintiffs”) filed an amended complaint in the Eighth Judicial District Court of Nevada (Case No. A-11-634976-C) against Joseph Connell, our former President. The Plaintiffs in the amended complaint are requesting declaratory relief from certain allegations Mr. Connell has made in relation to partnership claims with Mr. McCoy, board membership, and stock ownership in our company. Mr. Connell has requested that the case be removed to federal court in Nevada and has requested that our complaint be dismissed for lack of jurisdiction.
On March 11, 2011, Mr. Connell filed a complaint in the Supreme Court of the State of New York (Index No. 103007/11) against Mr. McCoy, Regenicin, Inc., Joseph Rubinfeld, John Weber and Craig Eagle. The complaint alleges, among other things, that Mr. Connell is entitled to 50% of Mr. McCoy’s stock in our company. The complaint requests an accounting from us and requests that we be enjoined from transferring title to Mr. McCoy’s shares.
On June 8, 2011, an agreement was reached (the “Agreement”) to dismiss the members of the Company’s board of directors (excluding Mr. McCoy) and the Company from the case currently pending in the United States District Court for the Southern District of New York. As part of this Agreement, the Company also agreed to dismiss its action originally brought against Mr. Connell in the United States District Court for the District of Nevada. Since then, the dispute continued involving only Mr. Connell and Mr. McCoy as parties in the action pending in the United States District Court for the Southern District of New York. As part of the Agreement, Mr. McCoy has agreed to lock-up 25,000,000 of his personal shares pending the outcome of the case.
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On November 17, 2011, there was a formal settlement conference before a
Magistrate Judge. On April 18, 2012, a settlement was reached. As a final resolution, a Confidential Settlement Agreement and
General Release (the “Settlement Agreement”) was signed by and among Mr. McCoy, Mr. Connell, our company, and our
board of directors. An amendment (the “Amendment”) to the Settlement Agreement was signed on April 24, 2012. Pursuant
to the Settlement Agreement and Amendment, in exchange for dismissal of the pending lawsuit with prejudice and a mutual release
of all claims involving all parties concerned, Mr. McCoy agreed to issue to Mr. Connell 12,500,000 shares of his common stock
in our company. On April 19, 2012, 10,000,000 of the shares were transferred to Mr. Connell, with the remaining shares assigned
to his counsel in the case.
As a result of the Settlement Agreement and Amendment and the transfer of these shares, Mr. Connell is now a greater than 10% shareholder of our company.
A smaller reporting company is not required to provide the information required by this Item.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None
Item 3. Defaults upon Senior Securities
None
Item 4. Mine Safety Disclosures
Not applicable.
None
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Regenicin, Inc. | |
| Date: | May 18, 2012 |
| By: | /s/ Randall McCoy |
| Randall McCoy | |
| Title: | Chief Executive Officer and Director |
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