UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the six month period ended March 31, 2016
Commission file number: 000-54672
AMERICAN CRYOSTEM CORPORATION
(Name of registrant as specified in its charter)
| Nevada | 26-4574088 |
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
| 1 Meridian Road, Eatontown, NJ 07724 |
(Address of principal executive offices)(Zip Code)
|
(732) 747-1007
(Registrant’s telephone number, including area code)
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 o
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 o
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 o | Accelerated filer o |
| Non-accelerated filer o (Do not check if smaller reporting company) | 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 o No x
As of May 20, 2016, there were 36,564,272 shares of common stock outstanding.
TABLE OF CONTENTS
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PART I – FINANCIAL INFORMATION
| Item 1. | Financial StatementS |
American CryoStem Corporation
Interim Balance Sheets
As of March 31, 2016 and September 30, 2015
| March 31, 2016 | Sept 30, 2015 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | 20,462 | $ | 9,059 | ||||
| Accounts Receivable | 5,403 | 56,513 | ||||||
| Deferred Contract Expense | — | 7,750 | ||||||
| Total current assets | 25,865 | 73,322 | ||||||
| Property and Equipment (Net of Accumulated Depreciation) | 193,626 | 211,314 | ||||||
| Other Assets | 265,852 | 249,007 | ||||||
| Total Assets | $ | 485,343 | $ | 533,643 | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable & accrued expenses | $ | 684,582 | $ | 807,213 | ||||
| Bridge Notes Payable | 253,500 | 576,000 | ||||||
| Convertible Notes Payable | 550,159 | 557,000 | ||||||
| Deferred Revenues | 23,907 | 56,431 | ||||||
| Total current liabilities | 1,512,148 | 1,996,644 | ||||||
| Long-Term Liabilities | ||||||||
| Convertible Notes Payable | 500,000 | 50,000 | ||||||
| Payable to Shareholder | 126,947 | 118,347 | ||||||
| Total Long-Term Liabilities | 626,947 | 168,347 | ||||||
| Shareholders’ equity: | ||||||||
| Common stock ($.001 par value, 35,910,670 shares issued and outstanding at March 31, 2015, and 34,705,451 shares issued and outstanding at September 30, 2015; 300,000,000 shares authorized) | 35,912 | 34,707 | ||||||
| Additional paid in capital | 8,066,125 | 7,876,967 | ||||||
| Accumulated deficit | (9,755,789 | ) | (9,543,022 | ) | ||||
| Total shareholders’ equity | (1,653,752 | ) | (1,631,348 | ) | ||||
| Total Liabilities & Shareholders’ Equity | $ | 485,343 | $ | 533,643 | ||||
See Notes to Financial Statements
| 3 |
American CryoStem Corporation
Interim Statements of Operations
For the Three Months Ended March 31, 2016 and 2015
and the Six Months Ended March 31, 2016 and 2015
| Three Months Ended | Six Months Ended | |||||||||||||||
| March 31, | March 31, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Sales | $ | 140,440 | $ | 58,511 | $ | 279,554 | $ | 94,555 | ||||||||
| Cost of Sales | 69,805 | 148,421 | ||||||||||||||
| Gross Profit | 70,635 | 58,511 | 131,133 | 94,555 | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Professional Fees | 44,563 | 22,107 | 46,373 | 32,452 | ||||||||||||
| Laboratory Expense | 44,981 | 83,634 | 67,912 | 179,668 | ||||||||||||
| Administration | 147,768 | 100,047 | 232,942 | 247,984 | ||||||||||||
| Total Operating Expenses | 237,312 | 205,788 | 347,227 | 460,104 | ||||||||||||
| Net Loss from Operations | (166,677 | ) | (147,277 | ) | (216,094 | ) | (365,549 | ) | ||||||||
| Other Income (Expense) | 27,477 | (20,382 | ) | 3,327 | (44,237 | ) | ||||||||||
| Net Loss | $ | (139,200 | ) | $ | (167,659 | ) | $ | (212,767 | ) | $ | (409,786 | ) | ||||
| Basic & fully diluted net earnings (loss) per common share | $ | (.004 | ) | $ | (.005 | ) | $ | (.006 | ) | $ | (.012 | ) | ||||
| Weighted average of common shares outstanding: Basic & fully diluted | 35,351,888 | 32,915,150 | 35,051,711 | 32,911,414 | ||||||||||||
See Notes to Financial Statements
| 4 |
American CryoStem Corporation
Interim Statements of Cash Flows
For the Six Months Ended March 31, 2016 and 2015
| 2016 | 2015 | |||||||
| Operating Activities: | ||||||||
| Net loss | $ | (212,767 | ) | $ | (409,786 | ) | ||
| Adjustments to reconcile net income items not requiring the use of cash: | ||||||||
| Depreciation & amortization expense | 19,816 | 20,619 | ||||||
| Accrued Interest | 50,521 | 44,237 | ||||||
| Changes in other operating assets and liabilities | ||||||||
| Accounts Receivable | 51,110 | (13,222 | ) | |||||
| Deferred Contract Expense | 7,750 | 23,250 | ||||||
| Prepaid Expenses | (250 | ) | ||||||
| Other Deposits | (7,502 | ) | 550 | |||||
| Security Deposit | (7,150 | ) | (150 | ) | ||||
| Accounts Payable and accrued expenses | (173,152 | ) | 61,369 | |||||
| Deferred Revenue | (32,524 | ) | (200 | ) | ||||
| Net cash used by operations | (303,898 | ) | (273,583 | ) | ||||
| Investing activities: | ||||||||
| Purchase of equipment | (1,131 | ) | ||||||
| Investment of other assets | (3,190 | ) | (21,982 | ) | ||||
| Net cash used by investing activities | (4,321 | ) | (21,982 | ) | ||||
| Financing activities: | ||||||||
| Convertible Notes | 120,659 | 284,000 | ||||||
| Payable to Shareholder | 8,600 | (2,000 | ) | |||||
| Issuance of common stock | 190,363 | 8,500 | ||||||
| Capital Lease | — | (10,898 | ) | |||||
| Net cash provided by financing activities | 319,622 | 279,602 | ||||||
| Net increase (decrease) in cash during the period | 11,403 | (15,963 | ) | |||||
| Cash Balance, Beginning of Period | 9,059 | 21,471 | ||||||
| Cash balance, End of Period | $ | 20,462 | $ | 5,508 | ||||
| Supplemental disclosures of cash flow information: | ||||||||
| Interest Paid | $ | 1,438 | $ | 1,361 | ||||
| Income Taxes Paid | $ | 0 | $ | 0 | ||||
See Notes to Financial Statements
| 5 |
American CryoStem Corporation
Statement of Changes in Shareholders’ Equity
For the Six Months Ended March 31, 2016
Prices & shares adjusted for stock splits
| Common | Par | Paid in | Retained | Total | ||||||||||||||||
| Shares | Value | Capital | Deficit | Deficit | ||||||||||||||||
| Balance at September 30, 2015 | 34,705,451 | $ | 34,707 | $ | 7,876,967 | $ | (9,543,022 | ) | $ | (1,631,348 | ) | |||||||||
| Exercises of options | 462,500 | 463 | 41 | 504 | ||||||||||||||||
| Issuance of common shares | 257,500 | 257 | 51,243 | 51,500 | ||||||||||||||||
| Issuance of common shares for security deposit | 50,000 | 50 | 10,400 | 10,450 | ||||||||||||||||
| Issuance of common shares for services | 75,000 | 75 | 15,675 | 15,750 | ||||||||||||||||
| Issuance of common shares to pay interest | 360,219 | 360 | 111,799 | 112,159 | ||||||||||||||||
| Net loss | (212,767 | ) | (212,767 | ) | ||||||||||||||||
| Balance at March 31, 2016 | 35,910,670 | $ | 35,912 | $ | 8,066,125 | $ | (9,755,789 | ) | $ | (1,653,752 | ) | |||||||||
See Notes to Financial Statements
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American CryoStem Corporation
Notes to the Financial Statements
March 31, 2016
NOTE 1. Organization of the Company and Significant Accounting Policies
American CryoStem Corporation (the “Company”) is a publicly held corporation formed on March 13, 2009 in the state of Nevada as R&A Productions Inc. (R&A).
In April 2011, R&A purchased substantially all the assets and liabilities of American CryoStem Corporation (ACS), a company formed in 1987, for 21 million shares of common stock. ACS was deemed to be the accounting acquirer. At the date of the purchase, the former operations of R&A were discontinued and R & A’s name was changed to American CryoStem Corporation.
The Company is in the business of collecting adipose tissue, processing it to separate the adult stem cells, and preparing such stem cells for long-term storage. The process allows individuals to preserve their stem cells for future personal use in cellular therapy. The adipose derived stem cells are prepared and stored in their raw form without manipulation, bio-generation or the addition of biomarkers or other materials, making them suitable for use in cellular treatments and therapies offered by existing and planned treatment centers worldwide. Individualized collection and storage of adult stem cells provides personalized medicine solutions by making the patient’s own preserved stem cells available for future cellular therapies.
The Company has devoted a significant amount of its time and resources to develop its technologies and intellectual property. These efforts have resulted in the development of cell lines, cell culture medium and other laboratory products which the Company believes are suitable for licensing and distribution by third parties. Additionally the Company has initiated a licensing program to license its technologies to laboratories currently processing other types of biologic materials including cord blood and general blood banks. The Company closed its first licensing agreement in 2014, and closed an additional territory in fiscal 2015 and intends to pursue additional licensing partners in the future. Under the terms of the licensing agreements, Licensees purchase certain consumables from the Company including the Company’s CELLECT ® collection kits and ACSelerate ™ cellular mediums. The Company has also entered into its first private label arrangement in 2015, distributing its CELLECT ® kits and performing its ATGRAFT ™ and ATCELL ™ processing under a contract executed in Fiscal 2015.
Use of Estimates - The preparation of the financial statements in conformity with United States generally accepted accounting principles (“GAAP”) uniformly applied requires management to make reasonable estimates and assumptions that affect the reported amounts of the assets and liabilities and disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses at the date of the financial statements and for the period they include. Actual results may differ from these estimates.
Cash - For the purpose of calculating changes in cash flows, cash includes all cash balances and highly liquid short-term investments with an original maturity of three months or less.
Revenue Recognition - The Company recognizes tissue processing revenue from the processing of adipose tissue into usable stem cells once all the procedures have been performed and the client sample has been stored in the Company’ cryogenic storage tank. Storage revenues for stored client samples are recognized on an annual basis on the anniversary date of the storage. Royalties from the licensing of the Company’s assets are recognized when earned and collection of the royalty is reasonable assured. Revenue derived from the sales of collection kits and medium products to Licensees is recognized upon shipment of the products to the licensee.
Long Lived Assets - The Company reviews for the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition is less than its carrying amount.
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American CryoStem Corporation
Notes to the Financial Statements
March 31, 2016
NOTE 1. Organization of the Company and Significant Accounting Policies (continued)
Fixed Assets - Fixed Assets are stated at cost. Depreciation expense is computed using the straight-line method over the estimated useful life of the assets, which is estimated as follows:
| Office equipment | 5 years | ||
| Lab equipment & Furniture | 7 years | ||
| Lab software | 5 years | ||
| Leasehold improvements | 15 years |
Income taxes - The Company accounts for income taxes in accordance with generally accepted accounting principles which require an asset and liability approach to financial accounting and reporting for income taxes. Deferred income tax assets and liabilities are computed annually for differences between financial statement and income tax bases of assets and liabilities that will result in taxable income or deductible expenses in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets and liabilities to the amount expected to be realized. Income tax expense is the tax payable or refundable for the period adjusted for the change during the period in deferred tax assets and liabilities.
The Company follows the accounting requirements associated with uncertainty in income taxes using the provisions of Financial Accounting Standards Board (FASB) ASC 740, Income Taxes. Using that guidance, tax positions initially need to be recognized in the financial statements when it is more likely than not the positions will be sustained upon examination by the tax authorities. It also provides guidance for derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. As of March 31, 2014, the Company has no uncertain tax positions that qualify for either recognition or disclosure in the financial statements. All tax returns from fiscal years 2009 to 2012 are subject to IRS audit.
Recent Accounting Pronouncements:
There are no recently issued accounting pronouncements that have a material impact on the Company’s financial statements.
NOTE 2. Going Concern
The accompanying financial statements have been presented in accordance with generally accepted accounting principles in the United States, which assumes the continuity of the Company as a going concern. However, the Company has incurred significant losses since its inception and has no material revenues to date and continues to rely on financing, the issuance of debt and equity to raise capital to fund its business operations. Management’s plans with regard to this matter are as follows:
The Company plans to continue to fund its operations through capital fundraising activities in fiscal 2016 until it generates sufficient revenue to support its operations.
NOTE 3. Loss per Share
The Company applies ASC 260, “Earnings per Share” to calculate loss per share. In accordance with ASC 260, basic net loss per share has been computed based on the weighted average of common shares outstanding during the periods reported. The effects of the options and notes convertible into shares of common stock are not included in the calculation of loss per share since their inclusion would be anti-dilutive.
Net loss per share is computed as follows:
| For the Three Months Ended | For the Six Months Ended | |||||||||||||||
| March 31, | March 31, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Net Loss | $ | (139,200 | ) | $ | (167,659 | ) | $ | (212,767 | ) | $ | (409,786 | ) | ||||
| Weighted average shares outstanding | 35,351,888 | 32,915,150 | 35,051,711 | 32,911,414 | ||||||||||||
| Basic & fully diluted net earnings (loss) per common share | $ | (.004 | ) | $ | (.005 | ) | $ | (.006 | ) | $ | (0.012 | ) | ||||
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American CryoStem Corporation
Notes to the Financial Statements
March 31, 2016
NOTE 4. Fixed Assets
Fixed Assets owned by the Company are comprised of the following:
| March 31, 2016 | Sept 30, 2015 | |||||||
| Office Equipment | $ | 26,637 | $ | 26,637 | ||||
| Lab Furniture | 642 | 642 | ||||||
| Office Furniture | 999 | 999 | ||||||
| Lab Equipment | 253,707 | 254,054 | ||||||
| Lab Software | 123,000 | 123,000 | ||||||
| Less: Accumulated Depreciation | (211,359 | ) | (194,018 | ) | ||||
| Equipment - net | $ | 193,626 | $ | 211,314 | ||||
NOTE 5. Patents & Patents Filings
The patent and patents development are recorded at cost and are being amortized on a straight line basis over a period of seventeen years. The following is a description of the Company’s patent assets.
On August 2, 2011, the Company was awarded U.S. Patent No. US 7,989,205 B2, titled Cell Culture Media, Kits, and Methods of Use. The Patent is for cell culture media kits for the support of primary culture of normal non-hematopoietic cells of mesodermal origin suitable for both research and clinical applications. The Company filed and maintains a continuation (U.S. Serial No. 13/194,900) with additional claims pending.
The Company has filed the following additional patents to extend its intellectual property to encompass additional aspects of the Company’s platform processing technologies. To date the following additional patent filings have been made.
A business method for Collection, Cryogenic Storage and Distribution of a Biologic Sample Material US Serial No. 13/702,304 filed June 6, 2011with a priority date of June 6, 2010.
Systems and Methods for the Digestion of Adipose Tissue Samples Obtained from a Client for Cryopreservation U.S. Serial No. 13/646,647 filed October 5, 2012 with a priority date of October 6, 2011.
Compositions and Methods for Collecting, Washing, Cryopreserving, Recovering and Return of Lipoaspirates to Physician for Autologous Adipose Transfer Procedures PCT/US13/44621 filed June 6, 2013 with a priority date of June 7, 2013.
Stem Cell Based Therapeutic Devices and Methods U.S. Serial No. 14/196,616 filed March 4, 2014 with a priority dated of March 10, 2013.
Autologous Serum for Transport of Isolated Stromal Vascular Fraction or Adipose Derived Stem Cells US Serial No. 14,250,338 filed in 2014 with a priority date of April 11, 2013.
Cell Culture Media, Kits and Methods of Use, US Serial No. 13/1-94/900 continuation of US Serial No. 11/542,863.
Human Serum for Cell Culture Medium for Clinical Growth of Human Adipose Stromal Cells, PCT/US/68350 Filed December 31, 2015 with a priority date of December 31, 2014.
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American CryoStem Corporation
Notes to the Financial Statements
March 31, 2016
NOTE 6. Debt
As of March 31, 2016, the Company had $1,050,159 of convertible notes outstanding. Convertible notes of $159,500 came due on September 30, 2014. The Company is currently in negotiations with the holders of these notes to convert their notes or to extend their maturity dates. These notes are convertible into common stock at $0.35 per share. Convertible notes of $392,500 are due at the end of fiscal year 2016 and are exercisable into common stock at $0.30 per share. Convertible notes of $500,000 are due in fiscal year 2018 and are exercisable into common stock at $0.20 per share.
During fiscal year 2014, the company issued “bridge notes” which were due in fiscal year 2015. Bridge Notes of $253,500 are currently outstanding. The notes are currently in default and due on demand. Holders of the notes received options to purchase 576,000 shares of common stock at $0.05 per share.
The following table describes the Company’s debt outstanding at March 31, 2016:
| Debt | Carrying Value | Fair Value | Maturity | Rate | ||||||||||||||
| Convertible notes | $ | 157,659 | $ | 157,659 | Demand | 8.00 | % | In default | ||||||||||
| Convertible notes | $ | 392,500 | $ | 392,500 | Fiscal 2016 | 8.00 | % | |||||||||||
| Convertible notes | $ | 500,000 | $ | 500,000 | Fiscal 2018 | 8.00 | % | |||||||||||
| Bridge notes | $ | 253,500 | $ | 253,500 | Demand | 8.00 | % | In default | ||||||||||
| Due to shareholder | $ | 126,947 | $ | 126,947 | Demand | 0.00 | % | |||||||||||
NOTE 7. Common Stock Issuances
During fiscal year 2015, debenture holders converted $17,500 of convertible notes into 54,286 shares of common stock.
During fiscal year 2015, officers of the Company exercised 1,460,000 options at $0.01 and received 1,460,000 shares.
During fiscal year 2015, the Company issued 70,000 shares of common stock to pay $21,000 of the bridge loan discussed in Note 6. As part of this payment, the Company issued 4,542 shares to pay interest due on the bridge loan.
During fiscal year 2015, the Company issued 175,759 shares of common stock and received proceeds of $55,000.
During the six months ended March 31, 2016, the Company issued 257,500 shares of common stock and received proceeds of $51,500.
During the six months ended March 31, 2016, option holders exercised 462,500 options and received 462,500 shares of common stock.
During the six months ended March 31, 2016, the Company issued 50,000 shares of common stock to provide a security deposit of $10,450 for its new laboratory facility.
During the six months ended March 31, 2016, the Company issued 25,000 shares of common stock for professional services of $5,225.
During the six months ended March 31, 2016, the Company issued 360,219 shares of common stock to pay interest due on the convertible notes and bridge notes.
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American CryoStem Corporation
Notes to the Financial Statements
March 31, 2016
NOTE 8. Stock Options
The Company applies ASC 718, “Accounting for Stock-Based Compensation” to account for its option issues. Accordingly, all options granted are recorded at fair value using a generally accepted option pricing model at the date of the grant. For purposes of determining the option value at issuance, the fair value of each option granted is measured at the date of the grant by the option pricing model with the
following assumptions:
| 2015 | 2014 | |||||||
| Dividend yield | 0.00 | % | 0.00 | % | ||||
| Risk free interest rate | 0.25 | % | 0.25 | % | ||||
| Volatility | 26.37 | % | 48.39 | % | ||||
The fair values generated by option pricing model may not be indicative of the future values, if any, that may be received by the option holder.
The following is a summary of common stock options outstanding at March 31, 2016:
| Options | Wgtd Avg Exercise Price | Wgtd Years to Maturity | ||||||||||
| Outstanding at September 30, 2015 | 12,321,000 | $ | 0.21 | 3.41 | ||||||||
| Issues | 300,000 | |||||||||||
| Exercises | (462,500 | ) | ||||||||||
| Expires | (340,000 | ) | ||||||||||
| Outstanding at March 31, 2015 | 11,818,500 | $ | 0.22 | 3.18 | ||||||||
NOTE 9. Fair Values of Financial Instruments
Fair Value Measurements under generally accepted accounting principles clarifies the principle that fair value should be based on the assumptions market participants would use when pricing an asset or liability and establishes a fair value hierarchy that prioritizes the information used to develop those assumptions. Under the standard, fair value measurements are separately disclosed by level within the fair value hierarchy as follows.
Level 1 - Quoted prices in active markets for identical assets or liabilities.
Level 2 - Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 - Unobservable inputs to the valuation methodology that are significant to the measurement of fair value of assets or liabilities.
To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is disclosed and is determined based on the lowest level input that is significant to the fair value measurement.
Cash, accounts receivable, deferred expense, other deposit, security deposit, accounts payable and accrued expenses, capital lease payable, bridge notes payable, deferred revenue, payable to shareholder, and advances payable to shareholder in the balance sheet are estimated to approximate fair market value at March 31, 2016 and 2015 because of their short term nature.
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American CryoStem Corporation
Notes to the Financial Statements
March 31, 2016
NOTE 10. Commitments & Contingencies
Operating Leases - The Company leases approximately 1,628 square feet of laboratory facilities at 7 Deer Park Drive in South Brunswick, New Jersey. The term of the lease is from February 1, 2016 to January 31, 2019. The monthly rent and operating expenses are $5,225.
The Company leases office facilities on Meridian Road in Eatontown, New Jersey. The lease is on a “month to month” basis and rents for $2,650 per month.
The Company is not party to any litigation against it and is not aware of any litigation contemplated against it as of March 31, 2016.
NOTE 10. Concentrations of Credit
The Company largely relies on the efforts of its Chief Operating Officer and its Chief Executive Officer. A withdrawal of the efforts of these individuals would have a material adverse affect on the Company’s ability to continue as a going concern.
NOTE 13. Joint Venture
During fiscal year 2014, the Company invested $1,000 in a joint venture. The joint venture is called Autogenesis Corporation and was incorporated in the state of Florida. The Company and its two chief executives own 50% of Autogenesis. Autogenesis was formed for the purpose of developing a wound healing protocol. The Company has no further obligations to Autogenesis and the joint venture will be responsible for its own funding.
NOTE 14. Related Party Transactions
The other party to the joint venture discussed in Note 13 is controlled by a member of the Company’s scientific advisory board.
At March 31, 2016, the company was indebted to the Company’s majority shareholder for advances to the Company of $126,947. The advances are due on demand, are unsecured, and carry no interest rate.
At March 31, 2016, the company was indebted to an affiliated company. The Chief Executive Officer of American CryoStem Corporation is the majority shareholder of the affiliated company. Advances of $14,665 are due on demand, are unsecured, and carry no interest rate.
At March 31, 2016, the company was indebted to an affiliated company. The Chief Executive Officer of American CryoStem Corporation is the majority shareholder of the affiliated company. Advances of $4,485 are due on demand, are unsecured, and carry no interest rate.
NOTE 15. Subsequent Events
None.
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| ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND PLAN OF OPERATIONS |
Forward-looking Statements
We and our representatives may from time to time make written or oral statements that are “forward-looking,” including statements contained in this quarterly report and other filings with the Securities and Exchange Commission (the “SEC”), reports to our stockholders and news releases. All statements that express expectations, estimates, forecasts or projections are forward-looking statements. In addition, other written or oral statements which constitute forward-looking statements may be made by us or on our behalf. Words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” “project,” “forecast,” “may,” “should,” variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in or suggested by such forward-looking statements. We undertake no obligation to update or revise any of the forward-looking statements after the date of this quarterly report to conform forward-looking statements to actual results. Important factors on which such statements are based on assumptions concerning uncertainties, including but not limited to, uncertainties associated with the following:
| · | Inadequate capital and barriers to raising the additional capital or to obtaining the financing needed to implement our business plans; | |
| · | Our failure to earn revenues or profits; | |
| · | Inadequate capital to continue business; | |
| · | Volatility or decline of our stock price; | |
| · | Potential fluctuation in quarterly results; | |
| · | Rapid and significant changes in markets; | |
| · | Litigation with or legal claims and allegations by outside parties; and | |
| · | Insufficient revenues to cover operating costs. |
The following discussion should be read in conjunction with the financial statements and the notes thereto which are included in this quarterly report. This discussion contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ substantially from those anticipated in any forward-looking statements included in this discussion as a result of various factors.
Background
American CryoStem Corporation was incorporated in the state of Nevada on March 13, 2009. On April 20, 2011, we acquired, through our wholly owned subsidiary American CryoStem Acquisition Corporation, substantially all of the assets from, and assumed substantially all of the liabilities of, ACS Global, Inc. (“ACS”) in exchange for our issuance of 21,000,000 shares of Common Stock to ACS (the “Asset Purchase”). We filed a Current Report on Form 8-K with the Securities and Exchange Commission (SEC) on April 27, 2011 disclosing the Asset Purchase and certain related matters.
Overview
American CryoStem Corporation is a biotechnology pioneer in the field of Regenerative and Personalized Medicine and operates a state-of-the-art, FDA-registered, clinical laboratory dedicated to our standardized processing, bio-banking and development of cellular tools and applications using autologous adipose (fat) tissue and adipose derived stem cells (“ADSCs”). The Company has built a strong, strategic portfolio of intellectual property, patent applications, and proprietary operating processes that form its core standardized cellular platform which we believe supports and promotes a growing pipeline of biologic products and processes, clinical services and international licensing opportunities. Our FDA registered clinical laboratory which we believe to be in compliance with FDA regulations for human tissue processing, cryro-storage and cell culture and differentiation media development is located in Monmouth Junction, New Jersey.
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The Company believes the reproducibility of scientific studies has become a substantial issue in life science research from drug discovery and development through clinical trials as researchers throughout the world continue to use different protocols for processes associated with sample preparation, cryopreservation and cold chain management. We believe the scientific community is becoming more aware of factors that affect sample integrity and experimental variability. By standardizing handling, storage, and transportation protocols we can substantially improve the quality and reproducibility of preclinical and clinical data to help accelerate the transition from lab research to product development and market launch.
Our business strategy is centered on marketing our standardized platform products as a complete adipose stem cell solution and expanding our international footprint, research and development through scientific collaborations. We intend to generate revenue through the sale and licensing of our patented products, laboratory tools, and services to attempt to capitalize on: (1) ADSC technologies; (2) scientific breakthroughs incorporating ADSCs that have been developing in the fast growing Regenerative and Personalized Medicine industries; (3) providing these growth industries with a standardized ADSC cell processing platform; (4) enhancing the delivery of healthcare through cellular-based therapies and applications which address disease treatment, wound and burn healing, joint repair and personalized health and beauty care; and (5) building a global network of physicians and affiliated laboratory facilities for the delivery of our products and services internationally.
Our proprietary, patent pending clinical processing platform allows for the collection, preparation and cryo-preservation of adipose tissue without manipulation, bio-generation or the addition of animal-derived products or other chemical materials which require removal from the tissue sample upon retrieval or prior to use. Management believes this core process makes each tissue sample suitable for use in cosmetic grafting procedures or for further processing to adult stem cells for other types of stem cell therapies. Currently, we believe there are numerous therapeutic and orthopedic applications for adipose tissue and adult stem cell treatments identified or in use globally. As of May 1, 2016, a review of clinicaltrials.gov, operated by the US National Institutes of Health (NIH) indicates that there is a significant number of clinical trials registered or completed that are focused on adipose tissue (1877), adult stem cells (5346), adipose derived stem cells (165), mesenchymal stem cells (610), and stromal vascular fraction (53).
Products and Services
American CryoStem is focused on multiple high margin business lines capable of generating sustainable, recurring revenue streams from each of our developed products and services. The Company also incorporates its proprietary and patented or patent pending laboratory products, such as our ACSelerate™ cell culture media, into our processing product production and contract manufacturing services. Additionally, the Company may require licensees of our tissue and cell processing technologies to purchase all the consumable products required in the collection, processing, expansion and storage of tissue/stem cells as part of the licensing agreement.
To date, we have generated minimal revenue; however, subject to, among other factors, obtaining the requisite financing, management believes that we are well positioned to leverage our developed products and services as the basis for international distribution through licensees of our technologies and a host of Regenerative Medicine uses and future applications.
The following products and services are designed to become the basis of, or an integral part of, numerous planned licensing, revenue generating, and cellular therapy development activities: Our products and services are:
| · | CELLECT® | · | Patent Pending PCT/US2011-39260 Tissue Collection and transportation system designed for physicians to facilitate the collection and overnight shipping of an individual’s adipose tissue to our FDA registered laboratory; |
| · | The CELLECT® transportation system is used for all American CryoStem adipose tissue processing services (ATGRAFT™, ATCELL™, and contract manufacturing services). | ||
| · | Manufacture and sale of our CELLECT® collection system to licensees for our ATGRAFT™ and ATCELL™ technologies. | ||
| · | Proprietary transportation methodology utilizing our patent pending ACSelerate™-TR Transportation Medium for shipping adipose tissue at ambient temperature. |
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| · | ATGRAFT™ | · | Patent pending PCT/US13/44621 adipose tissue processing at our Laboratory and preparation for long term storage of cleaned, whole fat for fat transfer procedures and future reprocessing into cellular applications. |
| · | Multiple storage configuration sizes (4mL, 5mL, 50mL & 100mL) allow for maximum fat storage and transfer flexibility. | ||
| · | ATGRAFT™ is stored in a DMSO free cryoprotectant which requires no further processing by a physician upon retrieval of a patient’s sample. | ||
| · | Licensing of the ATGRAFT™ processing technology to international partners utilizing our CELLECT® collection boxes and ACSelerate™ mediums. | ||
| · | ATCELL™ | · | Patent pending #13/646,676 for the processing and isolation of cellular specific components of an individual’s adipose tissue to create adipose derived stem cell (ADSCs) lines for storage, expansion, or differentiation. |
| · | Proprietary processing methodologies of ATCELL™ have been confirmed to be 96%+ pure ADSCs by third party flow cytometry. IRB approved process as of June 2013. | ||
| · | Clinical and Research grade ATCELL™ lines for use with or sale to collaborative partners in research and application development and optimization, cell morphology and characterization assays, and growth analysis. | ||
| · | ACSELERATE™ | · | Patented #7,989,205 with a continuation filed. Cell media line for transporting, expanding, differentiating and storing human cells. Specially optimized for used with adipose tissue and adipose derived stem cells. |
| · | Superior growth and differentiation capabilities compared to industry competitors. | ||
| · | Used exclusively in all American CryoStem processing (ATGRAFT™, ATCELL™ and contract manufacturing). | ||
| · | Additional Patent filed on December 31, 2015 for ACSelerate – MAX PCT/US/68350 | ||
| · | ACS Laboratories™ | · | Manufacturing and sale of our patented ACSelerate™ cell culture media products. |
| · | Creation and sale of research grade ATCELL™ | ||
| · | Participation and support of all collaborative research projects | ||
| · | Contract manufacturing, including Autokine-CM® | ||
| · | Provide testing services for physicians performing in-office procedures and tissue processing | ||
| · | International Licensing | · | Standard Operating Procedures (SOPs) and all associated components and products |
| · | Consulting and Marketing Review and Assessment | ||
| · | CELLECT® (consumable) | ||
| · | ATGRAFT™ (consumable) | ||
| · | ATCELL™ (consumable) | ||
| · | Adipose tissue processing, cellular expansion and product manufacture |
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Our branded product and service offerings include:
CELLECT® Validated Collection, Transportation, and Storage System – An unbreakable “chain of custody” clinical solution for physicians to collect and deliver tissue samples utilizing proprietary and patent pending methods and materials. The CELLECT® service is monitored in real-time and assures the highest cell viability upon laboratory receipt. The CELLECT® system incorporates our ACSelerate–TR transport medium into all collection bags which supports the health of the tissue during transport. The CELLECT® kit is an integral part of our validated ATGRAFT™ and ATCELL™ technology to be used by all licensees of our technologies. The CELLECT® service is included in our pending patent application U.S. Serial No. 13/702,304.
American CryoStem is the first tissue bank to globally incorporate through its CELLECT® service the International Blood Banking identification and labeling and product identification coding system. The coding was developed in conjunction with the American Association of Blood Banks (AABB), the American Red Cross and the International Society of Blood Transfusion (ISBT). These groups formed the International Council for Commonality in Blood Banking Automation (ICCBBA) and developed the ISBT 128 Standard for machine readable labeling. This labeling system is an acceptable machine readable labeling standard, product description, and bar coding system for FDA Center for Biologics Evaluation and Research under 21 CFR 606.12(c) 13. American CryoStem conforms to this standard in its Monmouth Junction facility and all cellular and tissue products produced at the facility carry our W3750 ICCBBA facility identifier allowing any hospital, clinic, laboratory and regulator worldwide to identify the origin and obtain additional information of any sample produced at an American CryoStem facility. The Company will promote this standard in all laboratories that license or utilize our technology.
ATGRAFT™ Adipose Tissue Storage Service – A clinical fat storage solution allowing physicians to provide their patients with multiple tissue/stem cell storage options. The ATGRAFT™ service, through one liposuction procedure allows individuals the benefit of multiple cosmetic or regenerative procedures by using their own stored adipose tissue as a natural biocompatible filler or cellular therapy application without the trauma of further liposuctions. ATGRAFT™ procedures may include breast reconstruction, layered augmentation, buttocks enhancement or volume corrections of the hands, feet, face and neck areas that experience significant adipose tissue (fat) volume reduction as we age. ATGRAFT™ is processed and stored utilizing our standards so that any stored fat tissue sample may be retrieved in the future and re-processed to create ATCELL™, our clinical grade stem cell product for use in Regenerative Medicine applications. The ATGRAFT™ service is included in our pending patent application U.S. Serial No. 13/646,647.
The Company’s charges standardized fees for ATGRAFT™ tissue processing and initial storage ranges from $985 to $3,000, depending on the volume of tissue processed. The annual storage fee is $200 for up to 100ml of tissue. Storage of tissue over 100ml is billed an additional $1 per 1ml annually. These fees may be paid by the collecting/treating physician or the consumer. The Company earns additional fees ranging from $100 to $500 plus shipping costs, paid by the physician upon retrieval, for the thawing, packaging and shipment of the stored samples to the physician for immediate use upon receipt. Additionally, physicians may request that any stored package of ATGRAFT™ of 25ml or greater be reprocessed utilizing the Company’s ATCELL™ and Autokine-CM™ processing. The Company charges fees of $1,500 for the reprocessing of a 25ml stored ATGRAFT™ sample and may charge additional fee’s if additional expansion of the newly created ATCELL™ sample is also requested.
ATGRAFT™ Processing, Storage and Retrieval fees are determined by the storage configuration as follows:
| · | Small Sample package – for storages of 100ml of adipose tissue or less. |
| · | Medium Sample package – for storage of 100ml to 300ml of adipose tissue. |
| · | Large Storage package – for storage of over 300ml of adipose tissue. |
| · | Custom Package – storage configuration for pre planned procedures. |
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The Company believes, the ATGRAFT™ service may create patient retention, and significant revenue opportunities for the participating physician to promote additional procedures and generate additional fees from adipose tissue collected during liposuction procedures. These additional fees can be generated with significantly lower physician costs by eliminating the overhead associated with performing another liposuction for each scheduled fat transfer or therapy procedure. Physician cost savings may include: materials, supplies, equipment, and the expenses of utilizing a surgical center, hospital operating room or an in-office aseptic procedure room. The ATGRAFT™ service is designed to operate under the minimally manipulated regulations contained in both 21 CFR 1271.10 and PHS 361.
ATCELL™ Adipose Derived Stem Cells (ADSCs) – Clinically processed and characterized adipose derived stem cells (ADSCs) created using the Company’s proprietary Standard Operating Procedures (SOPs) and patented cell culture media. ATCELL™ is the Company’s trademarked name for its ADSC and differentiated cell products and processing methodology. The Company maintains multiple master and differentiated cell lines and labels them according to their characterization. (i.e. ATCELL™ (adipose derived stem cells) ATCELL-SVF™ (stromal vascular fraction), ATCELL – CH™ (differentiated chondrocytes), etc. Cell lines are custom created for patients desiring to store their cells for their own use in future Regenerative Medicine procedures. The Company charges its customers fees ranging from $1,500 to $10,000 to process a previously stored ATGRAFT™ sample or a minimum of $2,500 for newly collected client tissue samples to be processed to Stromal Vascular Fraction (SVF). Customer samples submitted for processing must utilize the CELLECT® collection system to conform to our internal SOPs.
The Company believes it will earn additional fees based upon the proposed storage configuration of the final ATCELL™ sample and for additional culturing in the ACSelerate™ cell culture and differentiation media. We believe cell culturing and differentiation can be performed upon receipt of the raw tissue sample or at any time on a previously processed and cryopreserved ATGRAFT™ or ATCELL™ sample. We believe ATCELL™ is ideally suited for expansion and differentiation into additional cell types utilizing the ACSelerate™ MAX (fetal bovine serum (FBS) free high yield media),SFM (standard serum free medium), LSM (low 0.05% FBS media) or differentiation media. The ATCELL™ products and services are incorporated into our pending patent filing US Serial No. 13/646,647.
The Company’s ATCELL™ cell lines are processed and cultured in our patented ACSelerate™ – MAX our high yield, animal product free cell culture media. All tissue, cells, and research materials that are made available for sale to research institutions are tested for sterility, disease, lifespan, and population doubling rate (PDL). Additionally, we believe these cells are suited for any type of cellular therapy or regenerative medicine research. Cell morphology is confirmed by (i) flow cytometry and (ii) differentiation analysis using ACSelerate™ differentiation media. Each ATCELL™ line can be further cultured and differentiated allowing the Company to provide genetically matched clinical grade cell types. We believe this research methodology may provide opportunities for the Company’s ATCELL™ and ACSelerate™ products to become the building blocks of final developed commercial applications.
The Company intends to support its application research, development and collaborative efforts by making ATCELL™ and ATGRAFT™ samples available for research and product development purposes through joint ventures, and university and commercial collaborations. These adipose tissue and cell line samples, we believe will be highly sought after by private researchers and universities for use in pre-clinical trial studies and in-vitro research due to our clinical processing methodology, donor sample data and the ability to create multiple cell types that have identical genetic profiles. We believe the clinical processing methods, data collection and testing of our ATCELL™ and the ability to make multiple cell types from the same donor line allows research teams to focus on application development and avoid bench to commercialization delays.
ACSelerate™ Cell Culture Media Products – Manufactured patented cell culture media products for growing human stromal cells (including all cells found in human skin, fat and other connective tissue). Certain ACSelerate™ cell culture media lines are available in animal serum free, which is suitable for human clinical and therapeutic uses; and a low serum version for application development and research purposes is also available. The patented ACSelerate™ cell culture media line was specifically developed to address increasing industry demand for animal serum-free cell culture products and for the acceleration of products from the laboratory to the patient.
On August 2, 2011, the Company was issued US patent number 7,989,205 for “Cell Culture Media, Kits and Methods of Use.” The granted claims include media variations for cellular differentiation of ADSCs into osteoblasts (bone), chondrocytes (cartilage), adipocytes (fat), neural cells, and smooth muscles cells in both HSA medium (clinical) grade and FBS (research) grade. This patent covers both non-GMP research grades and GMP clinical grades suitable for cell culture of adipose-derived stem cells intended for use in humans. Additionally, in 2014 the Company filed a continuation of this granted patent with additional claims and improvements, U.S. Serial No. 13/194,900. The Company has received notice from the USPTO of certain allowable claims within the continuation application and is aggressively pursuing the granting of these additional claims.
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We believe the most widely used cell culture medium today for growing and differentiating stem cell cultures for in vitro diagnostics and research contains 10% or more FBS. The use of FBS and other animal products in clinical cellular therapy application development and manufacture raises concerns and generates debates within the scientific and regulatory community relating to potential human/animal cross-contamination. These same concerns may also need to be addressed through additional expensive and expansive testing and documentation with the FDA during the application and approval process for new cellular therapies. FDA concerns are evidenced in their Guidance’s and Guidelines regarding cellular therapy involving human cells, tissues and products (HCT/Ps) published and maintained by the FDA such as: Guidance for Industry: Source Animal, Product, Preclinical and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans, FDA Final Guidance, April 2003. It is our belief that eliminating or greatly reducing FBS in cellular manufacturing, applications and products can eliminate or ease these scientific and regulatory concerns and may prove to be a winning strategy for cellular therapy application developers seeking FDA approval.
Currently, our media products are being utilized by our research partners engaged in developing novel new cellular applications and treatments. The Company supports these efforts by also making ATCELL™ samples available for research purposes and for internal product development through our research programs. We believe these cell lines are highly sought after by private researchers and universities for use in pre-clinical trial studies and in-vitro research. We also believe that the Company’s ability to provide clinical grade materials for these research and development collaborators, partners and other third parties extends the Company’s ability to become a primary source of clinical grade materials and services necessary to support approved applications and treatments.
The Company has created several versions of its ACSelerate™ cell culture media including:
| · | ACSelerate-MAX™ - our improved clinical grade, animal serum free cell culture media, is ideally suited for the rapid expansion of adipose-derived cell samples for direct use or further culturing into other cell types; |
| · | ACSelerate-SFM™ - our general purpose clinical grade, manufactured animal serum free cell culture media, which is ideally suited for the expansion of adipose-derived cell samples for direct use or further culturing into other cell types; |
| · | ACSelerate-LSM™ - our research grade, low FBS (0.05%) cell culture media, which is ideally suited for the rapid expansion of adipose-derived cell samples for research and cellular application development or further culturing into other research grade cell types; |
| · | ACSelerate-CY™ - for differentiation of ATCELL™ into chondrocytes (ATCELL-CY™), which are suitable for use in cartilage repair applications in knees and other joints for patients suffering from joint injury, osteoarthritis and other diseases that cause degeneration of joint cartilage; |
| · | ACSelerate-OB™ - for differentiation of ATCELL™ into osteoblasts (ATCELL-OB™) for the repair of bone injuries resulting from traumatic injury and musculoskeletal diseases; |
| · | ACSelerate-AD™ - for differentiation of ATCELL™ into adipocytes (ATCELL-AD™) for the repair of adipose tissue defects resulting from injury or surgical procedures and is designed for those patients without an appropriate amount of body fat for corrective tissue transfer procedures; |
| · | ACSelerate-MY™ - for differentiation of ATCELL™ into myocytes (ATCELL-MY™) for the repair of muscle tissue defects and loss as the result of traumatic injury, surgery or systemic disease; |
| · | ACSelerate-CP™ - a clinical grade, non-DMSO (Dimethyl Sulfoxide) cellular cryopreservation media designed to conform to certain FDA and PHS 361 exemptions available for marketing our ATGRAFT™ service. |
| · | ACSelerate- TR™ - A clinical grade sterile transportation medium designed to maintain the viability of the tissue, at ambient temperatures for up to 100 hours during the shipment of adipose tissue to our processing facility. |
The Company continues to optimize additional versions of ACSelerate™ media through further research and testing to develop versions for differentiation of ATCELL™ADSCs into neural, lung and other specific cell types that may be necessary for use in future clinical applications. Many of these applications are not currently approved by the US Food and Drug Administration. On December 31, 2014 the Company filed a new patent application for an advanced medium formulation titled Human Albumin Serum for Cell Culture Medium for Clinical Growth of Human Adipose Stromal Cells. (US Serial No. 62/098799) representing the most recent results of this ongoing optimization program. On December 31, 2015, the Company converted the provisional application to an international PCT filing (PCT/US/68350) under the title Human Serum for Cell Culture for Clinical Groth of Human Adipose Stromal Cells.
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ACS Laboratories™: Laboratory Product Sales, Contract Manufacturing and Professional Services – ACS Laboratories is a division of American CryoStem Corporation, responsible for the manufacturing and sale of all the Company’s patented and patent pending cellular, cell culture, processing and testing products to professional, institutional and commercial clients. The Company operates a separate website (acslaboratories.com) to distinguish the sale of commercial and research products from its consumer products and services, which are marketed on its main website (americancryostem.com). ACS Laboratories manufactures a full line of ACSelerate™ cell culture media and ATCELL™ products; and provides these products to our collaborative partners as further discussed below.
Contract Manufacturing, Autokine-CM® Anti-Aging, Autologous Skin Care Product Line – Under agreement with Personal Cell Sciences Corp. (PCS), we manufacture the key ingredient Autokine-CM® (autologous adipose derived stem cell conditioned medium) for PCS’ U-Autologous™ anti-aging topical formulation. Each product is genetically unique to the patient and custom blended, deriving its key ingredients from the individual client’s own stem cells. The Company provides its CELLECT® Tissue Collection service to collect the required tissue to manufacture the U-Autologous product and processes it under the same Standard Operating Procedures that it developed for the ATGRAFT™ and ATCELL™ cell processing services utilizing ACSelerate™ cell culture media. The Company receives collection, processing and long term storage fees and earns a royalty on all U-Autologous product sales. The utilization of the Company’s core services in its contract manufacturing relationships provides opportunities for the Company to promote ATGRAFT™ and ATCELL™ products.
Our Company’s contract manufacturing services can be extended to develop custom and/or white label products and services for both local and global cosmetic and regenerative medicine companies, physicians, wellness clinics and medical spas. The Company intends to expand its relationships and contract manufacturing regionally through its physician networks and globally through its International Licensing Program.
International Licensing Program – The Company believes that globally, many jurisdictions outside the US currently permit use of cellular therapies and regenerative medicine applications. The Company has received numerous international inquiries concerning the sale or licensing of our SOPs, products and services in the Regenerative Medicine and Medical Tourism Markets. The Company believes that the inquiries to date are a result of the global boom in Medical Tourism, Regenerative Medicine and the slow pace of approval of cellular therapies and regenerative medicine applications in the US. To address the Company’s sales, marketing and branding opportunities globally, the Company has created its international licensing program. To date we have licensed our technologies in Hong Kong and Shenzhen, China and, Tokyo, Japan.
The Company believes it can take advantage of the significant growth of the global cellular therapy market through its international licensing and marketing efforts. A recently published study by Transparency Market Research predicts that the Stem Cell market will grow at a CAGR of 24.2% upon its value of US $26.23 billion in 2013 and will reach an approximate value of US $119.52 billion by 2019. The report, titled “Stem Cells Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2012 - 2018”; which can be found at
(http://globenewswire.com/news-release/2014/12/22/693419/10113247/en/Global-Stem-Cells-Market-to-grow-at-a-CAGR-of-24-2-to-Push-US-119-52-billion-by-2019-Transparency-Market-Research
In June of 2015, The Company entered into an initial agreement with CellSource, LTD. (“CellSource”) located in Shibuya, Tokyo Japan for the licensing of our AGRAFT™ tissue processing and storage technology and the purchase of our CELLECT® collection products which include our ACSelerate-TR™ transport medium. The Company also assisted CellSource in upgrading its facility in Japan and provided training in the ATGRAFT™ processing and recordkeeping procedures. The Company believes CellSource will begin marketing the new services initially within its existing network of 5 clinics throughout Japan and begin purchasing its CELLECT™ and ACSelerate-CP™ cryoprotectant in the third quarter of 2015. Upon execution of this Agreement the Company received an upfront payment and will receive additional minimum annual payments, and consumable product sales revenue - in future years. The Agreement also provided CellSource with an opportunity to exercise a right of first refusal for the licensing and distribution of other products marketed by the Company.
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Product Development
Our strategic approach to product development is to design, develop and launch new products and services that utilize our existing products and services, i.e. the use of the CELLECT® collection materials in providing ATGRAFT™ tissue storage services. Management believes that this approach will provide the Company with opportunities to produce near term cash flow, strong recurring revenue streams, strong international licensing partners and complementary scientific data. We focus on developing products, services and applications that require tissue collection and processing as the initial requirement to produce cellular therapies and products. These products and services may include adipose tissue and stem cell sample processing and storage as a form of personal “bio-insurance”, adipose tissue (fat) storage for cosmetic fat engraftment procedures, and the creation and production of topical applications and ingredients used by other companies in the wound care and cosmetic industries as well as cellular applications and bio-materials development.
We intend to focus our efforts on expanding our product and services pipelines based upon our intellectual property portfolio, collaborative development relationships, product sales and distribution, and international licensing and partnering opportunities. Our current activities include supporting our university and industry collaborations by providing our products and services with the expectation that our products and services become the basis for new adipose tissue and stem cell based Regenerative Medicine and cellular therapy applications. We believe this strategy allows our proposed research partners and their application development teams to begin with clinically harvested and processed adipose tissue and ADSCs (ATCELL™), which may be a significant step toward accelerating the development and approval of new treatments.
Collaboration / Partnering Opportunities / Acquisitions
PeproTech, Inc.
On April 4, 2016 the Company entered into an Agreement with PeproTech, Inc of Rocky Hill, NJ. Under the Agreement PeproTech will manufacture, market and distribute the Company’s ACSelerate – Max cell growth medium. The Company and PeproTech are currently working together to scale up manufacturing and develop the marketing program. The Company believes that marketing will begin in the third quarter of 2016.
BioLife Customer and Physician Acquisition
In February 2015 the Company entered into a binding asset purchase agreement with BioLife Cell Bank Dallas, LLC and BioLife Cell Bank Management, LLC (collectively “BioLife”), to purchase all of BioLife’s current adipose tissue, stem cell storage clients samples, and physician network. The transaction was concluded in March of 2015. Transfer of the adipose tissue samples was completed on April 24, 2015 and the Company undertook a complete physical inventory of the transferred samples. The Company initiated annual storage fee billing to the acquired storage clients in June of 2015. Management believes that, with the acquisition of BioLife, the Company became one of the largest commercial adipose storage facility in the United States.
Protein Genomics and Formation of Autogenesis Corporation
In 2012, American CryoStem entered into a Memorandum of Understanding (MOU) outlining our initial collaborative efforts with Protein Genomics, Inc. (PGEN) to test and develop new products by combining certain components of our respective intellectual property and patented products. We have provided PGEN and its research partner, Development Engineering Sciences (DES), with Adipose Derived Stem Cells (ATCELL™) and our patented cell culture mediums (ACSelerate™) for testing with PGEN’s products designed for the wound healing market. Research and development has been ongoing since late 2012 and notable progress has been achieved.
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As a result of the success realized in the early stage of this research collaboration, in fiscal 2013 we entered into a formal joint venture with Protein Genomics through the incorporation of Autogenesis, Corp. as required by the 2012 MOU. Each company (CRYO and PGen) initially has an equal ownership interest. All products capable of being commercialized, as well as any new intellectual property, resulting from the ongoing scientific collaboration will be wholly-owned by Autogenesis. This is representative of how we believe additional research collaborations utilizing our Company’s technology may evolve in the future.
During 2013 and 2014, the collaborative efforts resulted in successful initial “proof of concept” combining PGEN’s unique biomaterial and the Company’s ATCELL™ and ACSelerate™ products. Management believes the publication of the preliminary results showed successful healing of full depth wounds on the backs of immune deficient mice.
Our collaborative research has established that membrane scaffolds fabricated from human proteins can be cultivated with ATCELL™ cells causing the scaffolds to be rapidly and completely covered by the cells. The cells then secrete their own extracellular matrix, creating a structure with layers of matrix, cells and scaffold. This living structure, when introduced into a mouse wound model, localizes the stem cells in the wound, protects the cells within the wound environment, promotes cell growth and causes a statistically significant increase in the rate of wound closure and healing compared to the standard of care. Further evaluation will measure the performance of these scaffolds in accelerating the rate of wound closure, healed scar thickness, growth of new blood vessels and production of key wound healing factors. Our objective is to show that these constructs can stimulate the growth of new tissue and promote wound closure and healing.
INTEGRA LifeSciences:
On June 4, 2015, the Company and Autogenesis, Corp. entered into Non-Disclosure and Material Transfer Agreements with Integra LifeSciences, under which the parties are exploring certain combinations of American CryoStem’s, ATCELL™ stem cells, Integra products and other biomaterials for the development of new products and services. Integra LifeSciences, a NYSE traded (INT) New Jersey based company, is a world leader in medical technology and wound healing. Integra offers innovative solutions, including leading regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies. (http://www.integralife.com/)
Under the terms of the Agreement the Company supplies Biomaterials to Integra and utilize its AGRFAFT™, CELLECT®, ATCELL™ and ACSelerate™ products for the development of new devices and biologic products. To date the Company has delivered biomaterials to Integra for use in the development of the new biomaterials and initiated the processing and testing of porcine (pig) adipose tissue for use in the initial animal studies. The Company is currently working with Integra to advance the product development combining our ATCELL™ and ACSelerate™ products with the new materials to form new biologic products to be used as wound coverings and bandages for the treatment of bed sores, leg ulcers, and non healing wounds that are common to the diabetic and other systemic disease.
Rutgers University
In May of 2012, American CryoStem entered into Material Transfer Agreements with three research scientists at Rutgers University allowing them to utilize the Company’s autologous Adipose-Derived Stem Cells (ATCELL™) and patented, serum free, GMP grade cell culture and differentiation mediums (ACSelerate™) for evaluation with the anticipation to implement additional agreements to research, develop and commercialize innovative new cellular therapies targeting incurable diseases, neurological disorders and the $5 billion global wound care market.
During the last quarter of 2015 the Company undertook a review of the collaborative efforts between the Company and Dr. Lee pending the expiration of the agreements in November of 2015. Management believes that potential commercialization of the licensed technologies would require a number of years of additional study and experimentation and requires substantial investment by the Company. In November of 2015 the Collaboration and Research Agreement and the Licensing Agreement were terminated.
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Cells on Ice:
In August of 2015 the company entered into an Agreement with Cells On Ice, Inc. (COI) located in Los Angeles, California to process and cryopreserve adipose tissue and adipose derived cellular samples for future use in Regenerative Medicine. COI is a network of physicians interested in the development and use of adipose tissue and adipose derived cellular samples in regenerative therapies and cellular medicine. The Company has agreed to distribute its CELLECT® collection boxes and provide its ATGRAFT™ and ATCELL™ processing services for the collection, processing and storage of tissue samples at its NJ facility. Under the agreement, COI will pay the Company for the processing and storage of each sample generated by COI network physicians. COI plans to seek regulatory approval for use of the stored samples in clinical studies and trials utilizing adipose tissue processed into Stromal Vascular Fraction (SVF) and ultimately expanded adipose derived mesenchymal adult stem cells. The Company is incorporating its existing Institutional Review Board (IRB) approved protocols into COI’s studies and may provide processing and other data to COI in support of their ongoing efforts to develop and obtain regulatory approval of its cellular therapies.
Additional Collaborations
The Company is in the early stages of developing collaborations with additional industry and university partners. These developing relationships in their earliest stages are covered by Confidential Disclosure Agreements and those that are more advanced also include Material Transfer Agreements under which the Company supplies either ATCELL™ or ACSelerate™ medium products for evaluation, testing, and the development of new cellular therapy applications.
To Date the Company has advanced to a Material Transfer Agreement with the University of Miami, University of Washington, UHV Technologies, and STEMCell Technologies and has provided both ATCELL™ and ACSelerate™ products to these entities under Agreement. No assurance can be given that these relationships will progress to full collaborative agreements or ultimately result in new technology for future commercialization. As of March 31, 2016 these relationships have yet to result in a material agreement.
Additionally in August of 2015 the Company entered into a Confidential Disclosure Agreement and a Material Transfer Agreement with Dr. Sazlay, a research scientist currently investigating unique cancer treatments at the University of Wurzburg in Germany and the University of California in San Diego. Following execution of the Agreement, the Company delivered a number of ATCELL-SVF™, ATCELL™ and ACSelerate™ samples to Dr. Sazlay for testing and determination of usefulness of our products for development of his novel treatments. Dr. Sazlay has reported positive results of this initial work and the Company and Dr. Sazlay are currently negotiating additional collaborative agreements for further development of the treatments.
Institutional Review Board Approval of Protocols
In an effort to make it easier for other physicians and researchers to study the safety of SVF and ADSCs, in 2013 we sought approval from the Institutional Review Board (IRB) of the International Cell Surgical Society (ICSS) of our protocols for the processing of SVF and culturing of mesenchymal stem cells from autologous adipose tissue. The two protocols, titled: Autologous Adipose Tissue-Derived Stromal Vascular Fraction (SVF) Containing Adult Stem Cells with Isolation of SVF, and Culturing of Adipose Derived Stem Cells (ADSCs) For Use in Institutional Review Board Studies, (the “IRB Studies”) provide appropriate processing, storage and testing methods necessary to move the clinical investigative process towards uniform treatments. The collection of processing and outcome data from IRB approved protocols is required by prevailing FDA regulations and guidance for approval of regenerative cellular therapies, including potency (cell count), contamination testing and cell viability.
The ICSS IRB thoroughly evaluated every step of our standardized processing protocols, which serve to isolate the SVF or ADSCs from a patient’s adipose tissue. The objective of the IRB is to assess these protocols to ensure the highest patient safety possible and to minimize the risks for those participating in innovative research and investigational studies. On June 30, 2013, the ICSS IRB approved the protocols until June 30, 2014. Additionally, the Company obtained approval for a new study, entitled “Comparative Viability Assessment of Human Adipose Tissue before and After Cryopreservation (ICSS -2013-010), the Study was approved on November 22, 2013 and is valid until November 22, 2014.
In June of 2014 the Company submitted its IRB Studies to the Institutional Review Board of the Institute of Regenerative Cellular Medicine (the “IRCM”) and on July 23, 2014 the ICEM IRB approved the following studies:
| · | Isolation of SVF: Autologous Adipose Derived Stromal Vascular Fraction Containing Adult Stem Cells (IRCM 2014-024) until July 23, 2015 |
| · | Comparative Viability Assessment of Humean Adipose Tissue Before and After Cryopreservation (IRCM 2014-025) until July 23, 2015 |
| · | Isolation of SCF and Culturing Adipose Derived Stem Cells for Use in Investigational Review Board Studies (IRCM 2014-023) until July 23, 2015 |
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The IRCM approved studies require annual renewal; the Company renewed the studies in July of 2015.
The Company is currently making its processing services available to physicians and clinical researchers utilizing the IRB-approved protocols for inclusion in their studies. By adopting these standardized and repeatable protocols utilizing our laboratory services, researchers are able to focus their resources on application development rather than creating, validating and managing a clinical laboratory for processing tissue and cellular samples. These studies above do not currently involve actual human clinical trials, but affords the IRB the opportunity to endorse our repeatable, standardized and validated processing methodologies for the isolation of SVF and for tissue culture expansion of ADSCs obtained from SVF as the basis for future human clinical study.
In 2014, the Company created and is the Sponsor of a new IRB study with The DaVinci Center, Dr. Louis Cona, Principal Investigator, in George Town, Grand Cayman Island entitled Impact and Safety of Cultured Expanded Autologous, Adipose-Derived Stem Cells deployed via Intravenous Injection for the Treatment of Multiple Sclerosis Protocol: CRYO-MS-ADSC-006. On July 23, 2014 the study was approved for 100 patients. On November 1, 2014 the first patient was treated at the Da Vinci Center utilizing the approved protocol. The IRB filing can be found on www.clinicaltrials.gov, (ClinicalTrials.gov Identifier NCT02326935). The Company renewed the IRB studies with The Institute of Regenerative Cellular Medicine in August of 2015 for another one year period.
Management intends to pursue additional collaborative and partnering opportunities as a strategic method to enhance awareness of and expand the distribution of our patented products, services, technologies and expertise in the IRB-approved clinical processing of adult adipose tissue and ADSCs for autologous (self) use. We believe that as the pace of clinical trials and cellular therapy results reporting increase and scientific and peer reviewed papers are published, new opportunities to market our existing products, services and Intellectual Property portfolio may also emerge.
Moreover, we further believe that the combination of our validated cellular processing capabilities and patented products give us an economical platform to develop and produce cellular therapy applications for injection or intravenous therapy, topical applications, burn and wound healing, joint repair, disease treatments and cosmeticeuticals. The clinical methods and products we have developed are designed to permit a variety of treatments for any patient with their own genetically matched raw materials utilizing our ATCELL™ and ATGRAFT™ products prepared with our patented line of ACSelerate™ cell culture mediums. We believe that autologous cellular therapies have shown promising results for safety and efficacy in a variety of applications in published early stage clinical trial results and application studies.
Regulatory Information
The Company believes that its processing methodologies and the testing laboratory facilities are designed to be in compliance with all current regulations as defined by the United States Public Health Service Act (“PHS” or the “PHS Act”) and the Food and Drug Administration (FDA) regulations as they relate to the operation of a tissue processing and storage facility.
The Company’s Monmouth Junction laboratory facility is registered with the FDA (FEI 3008307548) as a processing and storage facility for Human Cells, Tissues and Cellular and Tissue Based Products (HCT/Ps) since 2010. In 2013, we registered the facility with the State of New York (CP169TP136) and the State of California (CNC80948) the only states in the U.S. requiring registration. These state registrations required the submission of our operating procedures for review by the respective State Health Departments, and annual updates to maintain the registrations are required. In addition, we have discussed our operations with the State of New Jersey Health Department and Department of Environmental Protection (DEP) to ascertain any special regulations to which we may be subject. Based upon these discussions, and our use of a registered medical waste disposal company, we do not at this time have any special registrations or regulations for compliance with the State of New Jersey. Our New Jersey Medical Waste Generator registration number is 0364539.
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The Company is also subject to complying with a significant body of FDA and PHS regulation; the regulations governing our business are mainly contained within 21 CFR 1271.10, 800, 600, 200, 210 and 211. The forgoing regulations govern all aspects of the Company’s Standard Operating Procedures (SOPs), which we periodically review with our FDA advisors, Laboratory Director and Medical Laboratory Director.
Our Standard Operating Procedures (SOPs) are the key to properly operating our clinical tissue processing facility. To ensure delivery of the highest quality services, we incorporate these SOPs, which are designed to provide a basis for accreditation by the American Association of Blood Banks (AABB), the American Association of Tissue Banks (AATB) and the Foundation for the Accreditation of Cellular Therapy (FACT-JACIE). We have consistently endeavored to ensure that our processes, methodologies and procedures remain among the highest standards in the global tissue collection, processing and storage market. To this end, we have equipped ourselves with state-of-the-art quality processing and testing equipment, which we believe helps to ensure that every sample collected and processed is sterile (free from adventitious agents), viable and capable of significant cellular growth and expansion.
Quality Management
The Company’s quality management program ensures that during processing and testing of each adipose tissue, adipose derived stem cell or SVF sample, the appropriate quality management tests and processing methodologies are performed and the data is collected, recorded and reviewed by the laboratory management team.
Chain of Custody Control
Central to the individual sample testing is an unbroken chain of custody and tracking. Sample tracking begins with the creation of each collection box. All samples, processing, quality management, batch, and storage documents and records, are coded with this unique number. All records and testing samples are cross referenced and verified as required by the standard operating procedures.
Testing Design and Standard Operating Procedures(SOPs)
Testing methods are standardized and operate under a complete set of validated SOPs and Quality Management (QM) processes. All SOPs are designed to be in compliance with the US Food and Drug Administration’s regulations and guidance for aseptic processing. Strict QM is enforced to avoid and/or record any process deviations.
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Intellectual Property
From the Company’s formation, our strategy has been to invest time and capital in intellectual property protection. This strategy is intended to strengthen our Company’s foundation in any defensive or offensive legal challenge. In addition, we are developing our IP portfolio to ensure and enhance our business flexibility and allow us to gain favorable terms in potential future collaborative partnerships with third parties. Our intellectual property portfolio currently includes one issued U.S. patent (No. 7989205, Cell Culture Media Kits and Methods of Use); and seven pending patent applications which are detailed in the following chart:
| PATENT TITLE | USE OF PATENT | APPLICATION # |
| A Business Method for “Collection, Cryogenic Storage and Distribution of a Biological Sample Material” | Company Core Tissue Collection Processing and Storage Methodology | U.S. Serial No. 13/702,304 filed June 6, 2011, and claiming a priority date of June 7, 2010 from provisional application 61/352,217 |
| Systems and Methods for “The Digestion of Adipose Tissue Samples Obtained From a Client for Cryopreservation” | Adipose Tissue Digestion Laboratory Processing Methods | U.S. Serial No. 13/646,647 filed October 5, 2012, and claiming a priority date of October 6, 2011 from provisional application 61/544,103 |
| Compositions and Methods for “Collecting, Washing, Cyroprocessing, Recovering and Return of Lipoaspirate to Physicians for Autologous Adipose Transfer Procedures” | Company Adipose Tissue Storage Platform for Cosmetic Procedures | PCT/US13/44621 Filed June 6, 2013 and claiming a priority date of June 7, 2012 |
| Stem Cell-Based Therapeutic Devices and Methods | Combining ADRCs with Biomaterials for healing and tissue growth | U. S. Serial No. 14/196,616 filed March 4, 2014 and claiming a priority date from provisional application 61/773,112 filed March 5, 2013 |
| Autologous Serum for Transport of Isolated Stromal Vascular Fraction or Adipose Derived Stem Cells | Utilization of Autologous Blood Components for the Transport of Adipose Derived Cells to a Patient | U.S. Serial No. 14,250,338 and claiming a priority date from provisional application 61/810,970 filed April 11, 2013 |
| Cell Culture Media, Kits, and Methods of Use | Continuation of U.S. Serial No. 11/542,863, includes Optimized and improvements to Media Formulations | U.S. Serial No. 13/194,900 |
| Human Serum for Cell Culture Medium for Clinical Growth of Human Adipose Stromal Cells | International PCT filing of US Provisional Application Serial Number 62/098799 Filed December 31, 2014 | PCT/US/68350 Filed December 31, 2015 |
Additionally, the Company has in-licensed IP with the following collaborations and joint ventures;
| PATENT TITLE | USE OF PATENT | APPLICATION # |
| Cosmetic compositions including tropoelastin isomorphs | Protein Genomics and American CryoStem (Autogenesis) collaboration | USPTO #5,726,040 |
| Cosmetic compositions | Protein Genomics and American CryoStem (Autogenesis) collaboration | USPTO #6,451,326 |
| Recombinant hair treatment compositions | Protein Genomics and American CryoStem (Autogenesis) collaboration | USPTO #6,572,845 |
| Wound healing compositions and methods using tropoelastin and lysyl oxidase | Protein Genomics and American CryoStem (Autogenesis) collaboration | USPTO: #6,808,707 |
| Business methods, processes and systems for collection, cryogenic storage and distribution of cosmetic formulations from an obtained stem cell based biological | Personal Cell Sciences and American CryoStem collaboration | USPTO application #61/588,841 |
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Trademarks
In addition to patents, the Company has registered the following trademarks with the U.S. Patent and Trademark Office: American CryoStem®, CELLECT® and ATGRAFT™. We additional trademarks for our future products, slogans and themes to be used in our marketing initiatives, including, for example, ACSelerate – MAX SFM™ ACSelerate-SFM™, ACSelerate- LSM™ and ATCELL™.
The Company has also secured a number of online domain names relevant to its business, including www.americancryostem.com and www.acslaboratories.com.
Marketing and Distribution
The key objective of our marketing strategy is to position American CryoStem in the market as the “Gold Standard” for adipose tissue collection, cell processing and cryogenic storage, therapeutic applications, and research/commercial uses of adipose tissue within the current regulatory framework. The combination of a traditional sales approach supported by continuous internal and external marketing programs, are closely coordinated with the expansion of our laboratory processing capabilities. Our initial marketing efforts intend to disseminate current and future uses of adipose tissue and adult stem cells which support our business model, products and services. In 2016, we intend to continue to employ both print advertising and social media sales campaigns. In addition, we plan to continue to utilize key leaders, and early adopters in the medical community as a marketing resource to enhance awareness of our proprietary, patented products and services and to increase the number of surgeons who join our network, university and private collaboration and consumers who use our products and services.
We plan to continue direct marketing programs focused on reaching plastic and cosmetic surgeons to join the initial group of providers that offer our services to their patients. This marketing initiative has been implemented using a traditional sales approach common to the pharmaceutical and biotechnology industries. This fundamental sales approach at the core of our marketing activities is being strategically and tactically expanded using a combination of in-house sales personnel and outside independent channels.
Our plan, capital permitting, provides for a comprehensive integrated marketing approach using various traditional and new media, such as the Internet, social media/blogging, video, print, TV, radio and trade shows to reach targeted potential consumers and promote awareness of our Company and our branded products and services. The essence of this targeted strategy is to reach the end-users as quickly as possible and to accelerate the adoption curve of our products and services. We also plan to utilize outside marketing resources and trade groups to increase the number of surgeons willing to offer our products and services to their patients.
Market Size and Opportunities
By leveraging and capitalizing on our proprietary Adipose Tissue Processing Platform, our Company is working to address multiple high growth, multi-billion dollar market opportunities, including those prevailing within the Regenerative Medicine, Cosmeceuticals, Medical Tourism and Cell Culture Media markets. The Company regularly reviews independent market research to gauge the market dynamics of its intended domestic and international markets and to identify additional areas within these markets where the Company’s cell culture medium, laboratory products, and tissue and cellular processing services, can be marketed, sold and/or licensed.
Global Stem Cells Market
A recently released report from Transparency Market Research (TMR) forecasts that the global stem cells market will grow at a remarkable CAGR of 24.2% from 2012 to 2018. According to TMR, a market intelligence firm, the global stem cells market, which in 2013 stood at US$26.23 bn, is anticipated to reach US$119.52 bn by the end of the forecast period. The report, titled ’Stem Cells Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2012 - 2018’, http://www.transparencymarketresearch.com/pressrelease/stem-cells-market.htm
Another report by Transparency Market Research titled “Stem Cells Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2012 - 2018” states “The Global Stem Cells Market to grow at a CAGR of 24.2%, to Push US$119.52 billion by 2019. The report analyzes the highly fragmented stem cells market by the type of stem cells, processes in the stem cell market, applications of stem cells, and geography. Regenerative medicine is by far the dominant application of stem cells, including uses in neurology, cardiology, and oncology. According to process, the market is divided into the stem cell acquisition, stem cell production, stem cell cryopreservation, and stem cell expansion segments. Due to the expected increase in demand, stem cell acquisition will retain its position as the major segment of the stem cell market. Geographically, North America and Europe will remain well ahead of the competition.”
(http://globenewswire.com/news-release/2014/12/22/693419/10113247/en/Global-Stem-Cells-Market-to-grow-at-a-CAGR-of-24-2-to-Push-US-119-52-billion-by-2019-Transparency-Market-Research.html#sthash.4vzqG1wc.dpuf)
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Regenerative Medicine Market
According to a leading research firm focused on the biotechnology, healthcare and life sciences industries, TriMark Publications categorizes the Regenerative Medicine market into three main categories:
| · | Tissue Engineering; |
| · | Biomaterials; and |
| · | Biomolecules (scaffolds, growth factors and stem cell therapy). |
TriMark Publications.com cites in its “Regenerative Medicine Markets” report (March 2013) that the Regenerative Medicine market continues to witness significant advances in clinical efficacy, regulatory approval and product commercialization of cell based therapies which will catapult to over $35 billion by 2019. Affirmative results produced from the application of adult stem cells have resulted in greater government and private sector investment in research and development of new cell therapies. Investment made into the regenerative medicine market include firms that harvest, process, purify, expand, cryopreserve, store or administer stem cells”1 In a study from Market Research Reports, released “Global Regenerative Medicine Market (Technology, Applications, Geography) – Industry Analysis, Trends, Opportunities and Forecast, 2013-2020.” In it, the market analysis firm found the global regenerative medicine market will be worth some $67.6 billion by 2020 – a stark and notable increase from the $16.4 billion valuation it received in 2013. Between 2014 and 2020, the report expects the regenerative medicine market to grow at a compounded annual growth rate of 23.2 percent.
According to Allied Market Research, on the basis of geography, this market can be classified into North America, Europe, Asia-Pacific and LAMEA. Currently, North America dominates the global market due to heavy investment in development of regenerative products as well as more number of commercialized products. However, the growing focus on research and development in Japan and South Korea makes Asia-Pacific the fastest growing region at a CAGR of 30.9% during 2014-2020.
Medical Tourism, Global Wellness Tourism
As stated by the Global Wellness Institute; adding up all expenditures made by international/inbound and domestic, primary and secondary wellness tourists, we estimate the wellness tourism industry to be $494 billion in 2013, a 12.7% increase over 2012. Wellness tourism accounts for 14.6% of all tourism expenditures and is growing much faster than the 7.3% growth rate for overall tourism expenditures from 2012-2013. The $494 billion in wellness tourism expenditures represent 586.5 million wellness trips taken in 2013, across 211 countries. Wellness tourism accounts for about 6.2% of all domestic and international tourism trips taken in 2013.
http://www.globalwellnesssummit.com/images/stories/gsws2014/pdf/GWI_Global_Spa_and_Wellness_Economy_Monitor_Full_Report_Final.pdf
Cell Culture Market
The Company believes the reproducibility of scientific studies has become a substantial issue in life science research from drug discovery and development through clinical trials as researchers throughout the world continue to use different protocols for processes associated with sample preparation, cryopreservation and cold chain management. We believe the scientific community is becoming more aware of factors that affect sample integrity and experiment variability. By standardizing handling, storage, and transportation protocols we believe we can substantially improve the quality and reproducibility of preclinical and clinical data which we believe will help to accelerate the transition from lab research to drug development and market launch.
1 http://www.trimarkpublications.com/regenerative-medicine-markets/
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According to MarketsandMarkets, the global cell culture market was valued at an estimated $14,772 million in 2013. This market is expected to grow at a CAGR of 10.71% between 2013 and 2018, to reach $24,574 million in 2018. The cell culture media, sera, and reagents market consists of six segments, namely, contamination detection kits, cryoprotective agents, lab reagents, media, serum, and other reagents. Of these, the serum product segment had the largest share of the cell culture media, sera, and reagents market in 2013, whereas the media product segment is expected to grow at the highest CAGR between 2013 and 2018.
Cosmeceutical Market
Many industry experts agree that Cosmeceuticals has become one of the fastest growing segment of the Cosmetics and Personal Care industry. Cosmeceutical products have a big emphasis on scientifically advanced formulations and often contain active ingredients that can also be found in pharmaceutical products. This continued emergence of increasingly sophisticated active ingredients is said to be the main driving force behind the growth of this segment, which is rapidly evolving into significant category of the personal care industry.
In a report titled Global Cosmeceuticals Market Outlook 2016, published February 2013, RNCOS reports that the worldwide market is estimated to be valued at $30.5 billion and is likely to grow at a consistent CAGR of 7.7% during the period 2012 through 2016.2 In a separate report, Transparency Market Research, a U.S. - based market intelligence firm states that the global facial care market is expected to report an approximate value of $39.75 billion by 2019. The report, titled ‘Facial Care Market (By Product Type - Skin Whitening/ Lightening and Anti-Ageing, Facial Creams, Face Wash, Cleansing Wipes, Serums and Masks and Others (fade creams, pore strips and toners)- Asia-Pacific Industry Analysis, Size, Share, Growth, Trends and Forecast 2013 – 2019.
http://globenewswire.com/news-release/2014/10/17/674123/10103135/en/Global-Facial-Care-Market-to-be-Worth-39-75-Billion-by-the-year-2019-Transparency-Market-Research.html
Development of U.S. Markets
Cells on Ice
In August of 2015 the company entered into an Agreement with Cells On Ice, Inc. (COI) located in Los Angeles, California to process adipose tissue and adipose derived cellular samples for future use in Regenerative Medicine. COI is a network of physicians interested in the development and use of adipose tissue and adipose derived cellular samples in regenerative therapies and cellular medicine. The Company has agreed to distribute its CELLECT® collection boxes and provide its ATGRAFT™ and ATCELL™ processing services for the collection, processing and storage of tissue samples at its NJ facility. Under the agreement, COI will pay the Company for the processing and storage of each sample generated by COI network physicians. COI plans to seek regulatory approval for use of the stored samples in clinical studies and trials utilizing adipose tissue processed into Stromal Vascular Fraction (SVF) and ultimately expanded adipose derived mesenchymal adult stem cells. The Company is incorporating its existing Institutional Review Board (IRB) approved protocols into COI’s studies and providing processing and other data to COI in support of their ongoing efforts to develop and obtain regulatory approval of its cellular therapies.
Physician Network
The Company continues to develop relationships to leverage our products and services through existing cosmetic surgery and regenerative medicine practices while at the same time growing its current efforts to develop and expand its network of individual physicians and surgeons seeking to adopt the Company’s products and services. These efforts are currently focused on surgeons performing liposuction, tissue transfer or regenerative procedures involving the use of adipose tissue. The Company intends to expand its efforts to non-cosmetic medical professionals interested in Regenerative Medicine applications utilizing ADSCs to establish itself as a primary source of collection, processing and preparation of cellular therapies as they are developed and approved for patient use by the FDA.
2 http://www.researchandmarkets.com/research/mbmvbh/global
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Regenerative Medicine Institute
The Company recently announced that Dr. Vincent Giampapa, MD F.A.C.S has joined its Medical and Scientific Advisory Board. Dr. Giampapa is the founder /director of the Regenerative Medicine Institute located in Costa Rica, the Plastic Surgery Center International and The Giampapa Institute for Anti-Aging Medical Therapy located in Montclair, NJ. Dr. Giampapa’s research focuses on stem cell technologies and their clinical applications to improve the cellular aging process in order to enhance health span and quality of life. As a result of his research, Dr. Giampapa has been awarded medical and intellectual property patents with the United States Patent and Trademark Office for developments involving unique cell culture delivery techniques, new drug delivery systems, stem cell reprogramming, DNA repair, and telomerase maintenance. He is a co-founder of The Academy of Anti-Aging Medicine (A4M), comprised of over 26,000 members representing over 110 nations, the first president of the Board of Anti-Aging Medicine and the founder of healthycell®, an advanced cell health nutritional supplement and StemBank™, a blood derived stem cell extraction and storage company. Dr. Giampapa will have an active role assisting the Company with the development of its “From laboratory to clinic/physician’s office” services and applications platform.
Development of International Markets
International Licensing Program – Globally, many jurisdictions outside the US permit the use of adipose tissue, cellular therapies and regenerative medicine applications. The Company has received numerous inquiries concerning the sale or licensing of our products and services in these jurisdictions. The Company believes that the inquiries to date are a result of the global boom in Medical Tourism and the slow pace of approval of cellular therapies and regenerative medicine applications in the US. To address these inquiries and to expand the Company’s sales, marketing and branding opportunities the Company has designed and is offering an International Licensing Program.
The program is designed to permit the licensing of the company’s products and services to organizations that meet the Company’s financial and technical criteria. The licensing program allows for a variety of business relationship including franchising, partnering and joint venturing. Marketing efforts to date have been to clinics, physician and hospitals in foreign jurisdictions capable of rapidly building or committing the appropriate facilities and personnel to create the required laboratory facilities to operate the CELLECT®, ATGRAFT™ and ATCELL™ services in their local market. Strategically, the Company’s international licensees will maintain the branding of the Company’s services along the lines of the “Intel Inside” branding program.
Qualified Licensees can quickly take advantage of the rapidly expanding opportunity to collect, process, store and culture individual stem cell samples for their clients with the comfort and confidence that they are providing services that have been developed to US FDA standards. Core to the relationship is the developed proprietary and patent pending processing and laboratory operational methodologies contained in our Standard Operating Procedures (SOPs), Training, and Continuous Quality Management, Testing Program, and Laboratory Operations manuals.
Licensing programs may be initiated through a letter of intent (LOI) agreement between the Company and the prospective licensee. This LOI agreement is designed for due diligence and facility qualifications purposes. The Company may receive an initial fee under the agreement which is credited toward future royalty payments. Following evaluation of the prospective licensee the Company will enter into a final Agreement which outlines all upfront fees, minimum royalties and consumable purchase obligations of the Licensee. The Company’s first international licensing agreement was executed with Health Innovative Technology Company, LTD, a cord blood collection and storage company with operations in Hong Kong and Shenzhen China.
We have committed extensive resources to establishing and perfecting our international shipping methodologies and protocols, ensuring that our processes meet the highest possible standards of regulatory compliance for shipment of biologic materials. As a result, our FDA registered laboratory and cryostorage facilities in New Jersey are now able to send and receive viable tissue samples to and from clients globally.
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CellSource, LTD. – Tokyo, Japan
On June 2, 2015 the Company and Cell Source Ltd entered into an initial term sheet for licensing the ATGRAFT™ technology to Cell Source Ltd for Japan. The Agreement further calls for Cell Source Ltd to purchase consumables from us including the CELLECT® collection boxes and ACSelerate™ Cryopreservation Medium and provides Cell Source with a twenty four month limited Right of First Refusal for licensing additional technologies for the Japanese markets. According to Allied Market Research, World Regenerative Medicines Market currently, North America dominates the global Regenerative Medicine market due to heavy investment in development of regenerative products as well as more number of commercialized products. However, the growing focus on research and development in Japan and South Korea makes Asia-Pacific the fastest growing region at a CAGR of 30.9% during 2014-2020.
Health Information Technology Company, LTD – Hong Kong and Shenzhen, China
On June 30, 2014 the Company granted Health Information Technology Company, LTD (“HIT”) exclusive rights to utilize the Company’s Standard Operating Procedures (SOP’s) to market the Company’s ATGRAFT™ tissue storage service in Hong Kong. The Agreement calls for upfront fees, royalties and the purchase by HIT of certain consumables manufactured by the Company. The Company and HIT have reached further agreement to extend their relationship on a non exclusive basis to include HIT’s cord blood laboratory located in Shenzhen, Guangdong Province, one of China’s most successful Special Economic Zones. The HIT agreement includes, initial upfront fees and royalty payments for predetermined gross revenue volumes. HIT will also purchase CRYO ACSelerate™ storage media, CELLECT™ collection and transportation kit as well as other American CryoStem products necessary for clinical adipose tissue processing and storage at the Shenzhen cord blood collection facility. The final master licensing agreement is for a period of 5 years with renewal options and was executed between the parties on September 24, 2014.
Corporate Information
Our principal executive offices are located at 1 Meridian Road, Eatontown, New Jersey 07724 and our telephone number is (732) 747-1007. Our website is www.americancryostem.com. We also lease and operate a tissue processing laboratory in Monmouth Junction, New Jersey at 7 Deer Park Rd, Monmouth Junction, NJ 08852. Our laboratory website address is www.acslaboratories.com.
Available Information
We file electronically with the U.S. Securities and Exchange Commission (SEC) our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934. The public can obtain materials that we file with the SEC through the SEC’s website at http://www.sec.gov or at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. Information on the operation of the Public Reference Room is available by calling the SEC at 800-SEC-0330.
Going Concern
As of the date of this quarterly report, there is substantial doubt regarding our ability to continue as a going concern as we have not generated sufficient cash flow to fund our business.
We have suffered recurring losses from operations since our inception. In addition, we have yet to generate sufficient internal cash flow from our business operations or successfully raise the financing required to fully develop our business. As a result of these and other factors, our independent auditor has expressed substantial doubt about our ability to continue as a going concern. Our future success and viability, therefore, are dependent upon our ability to generate capital financing. The failure to generate sufficient revenues or raise additional capital may have a material and adverse effect upon us and our shareholders.
Our plans with regard to these matters encompass the following actions: (i) obtaining funding from new investors to alleviate our working capital deficiency, and (ii) implementing a plan to generate sales of our proposed products and services. Our continued existence is dependent upon our ability to resolve our liquidity problems and increase profitability in our current business operations. However, the outcome of management’s plans cannot be ascertained with any degree of certainty. Our financial statements do not include any adjustments that might result from the outcome of these risks and uncertainties.
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Liquidity and Capital Resources
We had a cash balance of $20,462 as of the date of this quarterly report. Our principal source of funds has been sales of our securities. Should we be unable to raise sufficient funds, we will be required to curtail our operating plans if not cease them entirely. We cannot assure you that we will generate the necessary funding to operate or develop our business. Please see “Cash Requirements” above for our existing plans with respect to raising the capital we believe will be required.
In the event that we are able to obtain the necessary financing to move forward with our business plan, we expect that our expenses will increase significantly as we attempt to grow our business. Accordingly, the above estimates for the financing required may not be accurate and must be considered in light these circumstances.
Cash Requirements
We will require additional capital to fund marketing, operational expansion, processing staff training, as well as for working capital. We are attempting to raise sufficient funds would enable us to satisfy our cash requirements for a period of the next twelve (12) to twenty-four (24) months. We have minimal long term debt and have been able to meet our past financial obligations.
In order to finance further market development with the associated expansion of operational capabilities for the time period discussed above we are planning additional fundraising through the sale of our equity and debt securities however we cannot assure you we can attract sufficient capital to enable us to fully fund our anticipated cash requirements during this period. In addition, we cannot assure you that the requisite financing, whether over the short or long term, will be raised within the necessary time frame or on terms acceptable to us, if at all. Should we be unable to raise sufficient funds we may be required to curtail our operating plans if not cease them entirely. As a result, we cannot assure you that we will be able to operate profitably on a consistent basis, or at all, in the future.
We expended $44,563 during the three months ended June 30, 2015 in professional fees (legal, accounting and consultants) and $44,981 in Laboratory expenses
Commitments
The Company leases approximately 1,628 square feet of laboratory facilities at 7 Deer Park Drive in Monmouth Junction, New Jersey. The term of the lease is from February 1, 2016 to January 31, 2019. The monthly rent and operating expenses are $5,225.
The Company’s main office facility is located at 1 Meridian Road, Eatontown, New Jersey 07724. The lease expired during fiscal 2015 and is currently on a month to month basis with monthly rent of $2,650. The total rent for office facilities for the three months ended December 31, 2015 was $7,950.
The Company has unsecured liabilities without interest of $126,947 due to ACS Global, the majority shareholder of the Company, for certain prepaid expenses made by ACS Global prior to the closing of the transaction. There is no due date associated with this liability.
At March 31, 2016, the Company was indebted to an affiliated company. The Chief Executive Officer of American CryoStem Corporation is the majority shareholder of the affiliated company. Advances of $14,665 are due on demand, are unsecured, and carry no interest rate.
At March 31, 2016, the Company was indebted to an affiliated company. The Chief Executive Officer of American CryoStem Corporation is the majority shareholder of the affiliated company. Advances of $4,485 are due on demand, are unsecured, and carry no interest rate.
We anticipate that any further capital commitments that may be incurred will be financed principally through the issuance of our securities. However, we cannot assure you that additional financing will be available to us on a timely basis, on acceptable terms, or at all.
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Off Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
Critical Accounting Policies
We prepare financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”), which requires us to make estimates and assumptions that affect the amounts reported in our combined and consolidated financial statements and related notes. We periodically evaluate these estimates and assumptions based on the most recently available information, our own historical experience and various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Since the use of estimates is an integral component of the financial reporting process, actual results could differ from those estimates. Some of our accounting policies require higher degrees of judgment than others in their application. We believe the following accounting policies involve the most significant judgments and estimates used in the preparation of our financial statements.
Basis of Presentation
Our financial statements are presented on the accrual basis of accounting in accordance with generally accepted accounting principles in the United State of America, whereby revenues are recognized in the period earned and expenses when incurred.
Management’s Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
Long-Lived Assets
We review and evaluate our long-lived assets for impairment whenever events or changes in circumstances indicate that their net book value may not be recoverable. When such factors and circumstances exist, we compare the assets’ carrying amounts against the estimated undiscounted cash flows to be generated by those assets over their estimated useful lives. If the carrying amounts are greater than the undiscounted cash flows, the fair values of those assets are estimated by discounting the projected cash flows. Any excess of the carrying amounts over the fair values are recorded as impairments in that fiscal period.
Statement of Cash Flows
For purposes of the statement of cash flows, we consider all highly liquid investments (i.e., investments which, when purchased, have original maturities of three months or less) to be cash equivalents.
Fair Value of Financial Instruments
Our financial instruments consist of cash and cash equivalents. The fair value of cash and cash equivalents approximates the recorded amounts because of the liquidity and short-term nature of these items.
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Recent Accounting Pronouncements
We have reviewed all recently issued, but not yet effective, accounting pronouncements and do not believe that any future adoption of such pronouncements will have a material impact on our financial condition or the results of our operations.
| ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. |
Not Applicable
| ITEM 4. | CONTROLS AND PROCEDURES |
Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and our Treasurer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As of December 31, 2015, our Chief Executive Officer and Treasurer evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act). Based on such evaluation, our Chief Executive Officer and Treasurer concluded that our disclosure controls and procedures were effective as of December 31, 2015.
Changes in Internal Control over Financial Reporting
Our management has evaluated whether any change in our internal control over financial reporting occurred during the last fiscal quarter. Based on that evaluation, management concluded that there has been no change in our internal control over financial reporting during the relevant period that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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| ITEM 1. | LEGAL PROCEEDINGS |
From time to time we may become party to litigation or other legal proceedings that we consider to be a part of the ordinary course of business. We are not currently involved in legal proceedings that we believe could reasonably be expected to have a material adverse effect on our business, prospects, financial condition or results of operations.
| ITEM 1A. | RISK FACTORS |
Not Applicable.
| ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
During fiscal year 2015, debenture holders converted $17,500 of convertible notes into 54,286 shares of common stock.
During fiscal year 2015, officers of the Company exercised 1,460,000 options at $0.01 and received 1,460,000 shares.
During fiscal year 2015, the Company issued 70,000 shares of common stock to pay $21,000 of the bridge loan discussed in Note 6. As part of this payment, the Company issued 4,542 shares to pay interest due on the bridge loan.
During fiscal year 2015, the Company issued 175,759 shares of common stock and received proceeds of $55,000.
During the six months ended March 31, 2016, the Company issued 257,500 shares of common stock and received proceeds of $51,500.
During the six months ended March 31, 2016, option holders exercised 462,500 options and received 462,500 shares of common stock.
During the six months ended March 31, 2016, the Company issued 50,000 shares of common stock to provide a security deposit of $10,450 for its new laboratory facility.
During the six months ended March 31, 2016, the Company issued 25,000 shares of common stock for professional services of $5,225.
During the six months ended March 31, 2016, the Company issued 360,219 shares of common stock to pay interest due on the convertible notes and bridge notes.
| ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
None
|
ITEM 4. |
Not Applicable
ITEM 5. |
None
| ITEM 6. | EXHIBITS |
(a) Exhibits furnished as Exhibits hereto:
| Exhibit No. | Description |
| 31.1 | Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
| 31.2 | Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
| 32.1 | Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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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.
|
AMERICAN CRYOSTEM CORPORATION | ||
| May 23, 2016 | By: | /s/ John Arnone |
| John Arnone, Chief Executive Officer | ||
(Principal Executive Officer) | ||
| May 23, 2016 | By: | /s/ Anthony Dudzinski |
| Anthony Dudzinski, Treasurer | ||
| (Principal Financial Officer) | ||
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