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 three month period ended December 31, 2015
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 Noo
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 Noo
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 February 9, 2016, there were 35,518,985 shares of common stock outstanding.
TABLE
OF CONTENTS
PART
I – FINANCIAL INFORMATION
Item
1. Financial StatementS
American
CryoStem Corporation
Balance
Sheets
December
31, 2015 and September 30, 2014
| |
December 31, 2015 | | |
December 31, 2014 | |
ASSETS | |
| | | |
| | |
| |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 3,851 | | |
$ | 9,059 | |
Deferred Contract Expense | |
| — | | |
| 7,750 | |
Accounts receivable | |
| 8,613 | | |
| 56,513 | |
| |
| | | |
| | |
Total current assets | |
| 12,464 | | |
| 73,322 | |
| |
| | | |
| | |
Property and Equipment (Net of Accumulated Depreciation) | |
| 201,770 | | |
| 211,314 | |
| |
| | | |
| | |
Other assets | |
| 262,758 | | |
| 249,007 | |
| |
| | | |
| | |
Total assets | |
$ | 476,992 | | |
$ | 533,643 | |
| |
| | | |
| | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable & accrued expenses | |
$ | 811,883 | | |
$ | 807,213 | |
Bridge notes payable | |
| 576,000 | | |
| 576,000 | |
Convertible notes payable | |
| 557,000 | | |
| 557,000 | |
Deferred revenues | |
| 38,489 | | |
| 56,431 | |
Total current liabilities | |
| 1,983,372 | | |
| 1,996,644 | |
| |
| | | |
| | |
Convertible notes payable | |
| 50,000 | | |
| 50,000 | |
Payable to shareholder | |
| 126,947 | | |
| 118,347 | |
Total Long-Term Liabilities | |
| 176,947 | | |
| 168,347 | |
| |
| | | |
| | |
Shareholders’ equity: | |
| | | |
| | |
Common stock- $.001 par value, authorized 300,000,000 shares
authorized, issued and outstanding, 32,915,500 shares at December 31, 2014 and 34,815,451 at December 31, 2015 | |
| 34,817 | | |
| 34,707 | |
Additional paid in capital | |
| 7,897,357 | | |
| 7,876,967 | |
Accumulated deficit | |
| (9,615,501 | ) | |
| (9,543,022 | ) |
Total shareholders’ deficit | |
| (1,683,327 | ) | |
| (1,631,348 | ) |
| |
| | | |
| | |
Total Liabilities & Shareholders’ Deficit | |
$ | 476,992 | | |
$ | 533,643 | |
See the notes to the financial statements.
American
CryoStem Corporation
Statements
of Operations
For
the Three Months Ended December 31, 2015 and 2014
| |
December 31, 2015 | | |
December 31, 2014 | |
| |
| | |
| |
Revenues | |
$ | 139,114 | | |
$ | 36,044 | |
Cost of sales | |
| 77,728 | | |
| | |
| |
| | | |
| | |
Gross Profit | |
| 61,386 | | |
| 36,044 | |
| |
| | | |
| | |
Operating Expenses | |
| | | |
| | |
Professional fees | |
| 1,810 | | |
| 10,290 | |
Laboratory Expense | |
| 22,931 | | |
| 95,894 | |
Administration | |
| 84,974 | | |
| 147,937 | |
Total general & administrative expenses | |
| 109,715 | | |
| 254,121 | |
| |
| | | |
| | |
Net loss from operations | |
| (48,329 | ) | |
| (218,077 | ) |
| |
| | | |
| | |
Other income (expenses): | |
| | | |
| | |
Interest Income | |
| 36 | | |
| | |
Interest expense | |
| (24,186 | ) | |
| (23,855 | ) |
Net loss | |
$ | (72,479 | ) | |
$ | (241,932 | ) |
| |
| | | |
| | |
Basic & fully diluted net loss per common share: | |
| | | |
| | |
Net loss | |
$ | (0.0021 | ) | |
$ | (0.0074 | ) |
| |
| | | |
| | |
Weighted average of common shares outstanding: | |
| | | |
| | |
Basic & fully diluted | |
| 34,757,429 | | |
| 32,907,759 | |
See
the notes to the financial statements.
American
CryoStem Corporation
Statements
of Cash Flows
For the
Three Months Ended December 31, 2015 and 2014
| |
| | |
| |
| |
December 31, 2015 | | |
December 31, 2014 | |
Operating Activities: | |
| | | |
| | |
Net loss | |
| | | |
| | |
Adjustments to reconcile net loss items not requiring the use of cash: | |
$ | (72,479 | ) | |
$ | (241,932 | ) |
Depreciation & amortization expense | |
| 10,043 | | |
| 10,341 | |
Interest expense | |
| 24,186 | | |
| 23,855 | |
Changes in other operating assets and liabilities : | |
| | | |
| | |
Accounts receivable | |
| 47,900 | | |
| 376 | |
Deferred charge | |
| 7,750 | | |
| 11,625 | |
Security Deposits | |
| — | | |
| (150 | ) |
Other Deposit | |
| (7,500 | ) | |
| 550 | |
Deferred revenue | |
| (17,942 | ) | |
| 25,000 | |
Accounts payable and accrued expenses | |
| (19,516 | ) | |
| 25,251 | |
Net cash used by operations | |
| (27,558 | ) | |
| (145,084 | ) |
| |
| | | |
| | |
Investing activities: | |
| | | |
| | |
Patents development | |
| (6,750 | ) | |
| (6,835 | ) |
Net cash used by investing activities | |
| (6,750 | ) | |
| (6,835 | ) |
| |
| | | |
| | |
Financing activities: | |
| | | |
| | |
Payment of capital lease | |
| — | | |
| (5,381 | ) |
Payable to shareholder | |
| 8,600 | | |
| (2,000 | ) |
Issuance of convertible notes | |
| — | | |
| 166,500 | |
Issuance of common shares | |
| 20,500 | | |
| 8,500 | |
Options exercised | |
| — | | |
| — | |
Net cash provided by financing activities | |
| 29,100 | | |
| 167,619 | |
| |
| | | |
| | |
Net increase (decrease) in cash | |
| (5,208 | ) | |
| 15,700 | |
| |
| | | |
| | |
Cash balance Beginning of Period | |
| 9,059 | | |
| 21,471 | |
| |
| | | |
| | |
Cash balance at End of Period | |
$ | 3,851 | | |
$ | 37,171 | |
| |
| | | |
| | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
Interest paid during the fiscal year | |
$ | — | | |
$ | — | |
Income taxes paid during the fiscal year | |
$ | — | | |
$ | — | |
See
the notes to the financial statements.
American
CryoStem Corporation
Statement
of Changes in Shareholders’ Equity
For
the Three Months Ended December 31, 2015
| |
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 | |
| 10,000 | | |
| 10 | | |
| 490 | | |
| | | |
| 500 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common shares | |
| 100,000 | | |
| 100 | | |
| 19,900 | | |
| | | |
| 20,000 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| | | |
| | | |
| | | |
| (72,479 | ) | |
| (72,479 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at December 31, 2015 | |
| 34,815,451 | | |
$ | 34,817 | | |
$ | 7,897,357 | | |
$ | (9,615,501 | ) | |
$ | (1,683,327 | ) |
See the notes to the financial statements.
American
CryoStem Corporation
Notes
to the Financial Statements
December
31, 2015 and 2014
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 2015and 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.
American
CryoStem Corporation
Notes
to the Financial Statements
December
31, 2015 and 2014
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 |
|
|
|
|
|
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 December 31, 2015 and December 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 2011 to 2015 are subject to IRS audit.
Recently
Issued 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
and fully diluted net loss per share has been computed based on the weighted average of common shares outstanding during the years.
The dilutive effects of the convertible notes and the options outstanding 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:
| |
Dec 31, 2015 | | |
Dec 31, 2014 | |
Net Loss | |
$ | (72,479 | ) | |
| (241,932 | ) |
Weighted average shares outstanding | |
| 34,757,429 | | |
| 32,907,759 | |
Basic & fully diluted net earnings (loss) per common share | |
$ | (0.0021 | ) | |
$ | (0.0074 | ) |
American
CryoStem Corporation
Notes
to the Financial Statements
December
31, 2015 and 2014
NOTE
4. Fixed Assets
Fixed
Assets owned by the Company are comprised of the following:
| |
December 31, 2015 | | |
September 30, 2015 | |
Office Equipment | |
$ | 26,637 | | |
$ | 26,637 | |
Lab Furniture | |
| 642 | | |
| 642 | |
Office Furniture | |
| 999 | | |
| 999 | |
Lab Equipment | |
| 254,054 | | |
| 254,054 | |
Lab Software | |
| 123,000 | | |
| 123,000 | |
| |
| 405,332 | | |
| 405,332 | |
Less: Accumulated Depreciation | |
| (203,562 | ) | |
| (194,018 | ) |
| |
| | | |
| | |
Net Property and Equipment | |
$ | 201,770 | | |
$ | 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 Therapuetic 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
American
CryoStem Corporation
Notes
to the Financial Statements
December
31, 2015 and 2014
Note
6. Debt
As
of December 31, 2015, the Company had $607,000 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 $447,500 are due at the end of fiscal
years 2016 and 2017 and are exercisable into common stock at $0.30 per share.
During
fiscal year 2014, the company issued “bridge notes” and received proceeds of $576,000, which were due in fiscal year
2015. 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 notes are unsecured.
The
following table describes the Company’s debt outstanding at December 31, 2015:
Debt | |
Carrying Value | | |
Fair Value | | |
Maturity | | |
Rate | | |
|
| |
| | |
| | |
| | |
| | |
|
Convertible notes | |
$ | 159,500 | | |
$ | 159,500 | | |
| Demand | | |
| 8.00 | % | |
In default |
| |
| | | |
| | | |
| | | |
| | | |
|
Convertible notes | |
$ | 397,500 | | |
$ | 397,500 | | |
| Fiscal 2016 | | |
| 8.00 | % | |
|
| |
| | | |
| | | |
| | | |
| | | |
|
Convertible notes | |
$ | 50,000 | | |
$ | 53,000 | | |
| Fiscal 2017 | | |
| 8.00 | % | |
|
| |
| | | |
| | | |
| | | |
| | | |
|
Bridge notes | |
$ | 576,000 | | |
$ | 576,000 | | |
| Demand | | |
| 8.00 | % | |
In default |
| |
| | | |
| | | |
| | | |
| | | |
|
Due to shareholders | |
$ | 118,347 | | |
$ | 118,347 | | |
| 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 three months ended December 31, 2015, option holders exercised 10,000 options at $0.05 and received 10,000 shares of common
stock.
During
the three months ended December 31, 2015, the Company issued 100,000 shares of common stock and received proceeds of $20,000.
American
CryoStem Corporation
Notes
to the Financial Statements
December
31, 2015 and 2014
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 December 31, 2015:
| |
| | |
Wgtd Avg | | |
Wgtd Years | |
| |
Options | | |
Exercise Price | | |
to Maturity | |
Outstanding at September 30, 2015 | |
| 12,321,000 | | |
$ | 0.21 | | |
| 3.41 | |
| |
| | | |
| | | |
| | |
Issues | |
| 0 | | |
| | | |
| | |
Exercises | |
| (10,000 | ) | |
| | | |
| | |
Expires | |
| (100,000 | ) | |
| | | |
| | |
Outstanding at December 31, 2015 | |
| 12,221,000 | | |
$ | 0.21 | | |
| 3.19 | |
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 December 31, 2015 and 2014 because of their short term nature.
American
CryoStem Corporation
Notes
to the Financial Statements
December
31, 2015 and 2014
Note
10. Commitments & Contingencies
Operating
Leases - The Company leased laboratory facilities at the Burlington County College Science Incubator in Burlington, New Jersey.
The monthly lease payment was $3,300. Burlington County College terminated the lease as of January 15, 2016. The Company
fulfilled its lease obligation to the college.
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 December 31,
2015.
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
December 31, 2015, 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
December 31, 2015, 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 $15,860 are due on demand, are unsecured, and carry no interest
rate.
At
December 31, 2015, 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 $1,245 are due on demand, are unsecured, and carry no interest
rate.
Note
15. Subsequent Events
The lease
with Burlington County College has been terminated as of January 15, 2016. The Company has fulfilled its lease obligation to the
college.
The
Company has executed a new lease for laboratory facilities in Princeton, New Jersey and has moved into the new facilities.
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.
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 January 1, 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
(1799), adult stem cells (5221), adipose derived stem cells (159), mesenchymal stem cells (588), and stromal vascular fraction
(43).
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 serves 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; |
|
|
• |
CELLECT®
transportation system is used for all American CryoStem adipose tissue processing services ATGRAFT™,
ATCELL™, 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. |
|
|
|
|
• |
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 |
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 Mount Laurel 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. |
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.
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.
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 (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 TCCS 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.
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
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.
Additionally
the Company acquired the physician customer list of approximately 60 cosmetic and plastic surgeons, and began marketing its services
to all previous physician users of the BioLife services.
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.
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, its licensed biomaterials and 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 will supply Tropoelastin to Integra and utilize its AGRFAFT™, CELLECT®,
ATCELL™ and ACSelerate™ products for the development of new devices and biologic
products for use with the co-developed biomaterials. To date the Company has delivered tropoelastin 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 schedule additional work necessary to advance the product development
which includes additional porcine tissue processing, and combining our ATCELL™ and ACSelerate™
products with the new materials.
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.
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 under the COI brand 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 September 30, 2015 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 |
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 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.
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
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
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.
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 five 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 |
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 plan to obtain additional registered
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 2015, 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 began to offer our services to their patients in 2014. 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)
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:
| · | 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
1
http://www.trimarkpublications.com/regenerative-medicine-markets/
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.
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 under the COI brand 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.
2
http://www.researchandmarkets.com/research/mbmvbh/global
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.
The
Stern Center
During
our first fiscal quarter ended December 31, 2012, we announced the initiation of adult stem cell and adipose tissue collection
at the Stern Center for Aesthetic Surgery in Bellevue Washington. Dr. Frederick Stern, a member of the Company’s Scientific
and Medical Advisory Board, founded the Stem Center in 1997. The Stern Center offers state-of-the-art laser and cosmetic surgical
techniques to patients throughout the western U.S., and is one of the premier laser-assisted liposuction centers in the Pacific
Northwest.
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, 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 Compay will enter
into a final Agreement which outlines all upfront fees, minimum royalties and consumable purchase obligations of the Licnesee.
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 Shenzen 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.
CellSource,
LTD. – Tokyo, Japan
In
the second quarter of 2015 the Company entered into negotiations with CellSource, LLC in Tokyo, Japan for the licensing of its
ATGRAFT™ products and services and on June 2, 2015 the Company and Cell Source entered into an initial term sheet
Licensing the ATGRAFT™ technology to Cell Source for Japan. The Agreement further calls for Cell Source to purchase
our CELLECT® collection boxes and ACSelerate™ Cryopreservation Medium and provides Cell
Source with a 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. 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.
Liquidity
and Capital Resources
We
had a cash balance of $3,851 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 $1,810 during the three months ended June 30, 2015 in professional fees (legal, accounting and consultants) and $22,931
in Laboratory expenses
Commitments
The
Company’s main office facility 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 $118.347 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.
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.
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.
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.
PART
II - OTHER INFORMATION
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.
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.. 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 three months ended December 31, 2015, option holders exercised 10,000 options at $0.05 and received 10,000 shares of common
stock.
During
the three months ended December 31, 2015, the Company issued 100,000 shares of common stock and received proceeds of $20,000.
ITEM
3. |
DEFAULTS
UPON SENIOR SECURITIES |
|
|
None
ITEM 4. | MINE
SAFETY DISCLOSURES |
| |
Not
Applicable
None
(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 |
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
|
|
|
|
February
22, 2016 |
By: |
/s/
John Arnone |
|
|
John
Arnone, Chief Executive Officer |
|
|
(Principal
Executive Officer)
|
|
|
|
February
22, 2016 |
By: |
/s/
Anthony Dudzinski |
|
|
Anthony
Dudzinski, Treasurer |
|
|
(Principal
Financial Officer) |
EXHIBIT
31.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT
TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO SECTION 302 OF
THE
SARBANES-OXLEY ACT OF 2002
I,
John Arnone, certify that:
1. |
I
have reviewed this Form 10-Q of American CryoStem Corporation; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect
to the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
present in this report; |
|
|
4. |
Along
with the Principal Accounting Officer, I am responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13-a-15(f) and 15d-15(f)) for the registrant and have: |
|
|
|
|
a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to
us by others within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based
on such evaluation; and |
|
|
|
|
d) |
Disclosed
in this report any change in the registrant’s internal control over financing reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
and |
|
|
|
5. |
I
have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s
auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
|
|
|
a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial
information; and |
|
|
|
|
b) |
Any
fraud, whether or not material, that involved management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Dated:
February 22, 2016 |
By: |
/s/
John Arnone |
|
|
|
John
Arnone |
|
|
|
Principal
Executive Officer
American
CryoStem Corporation |
|
EXHIBIT
31.2
CERTIFICATION
OF PRINCIPAL ACCOUNTING OFFICER
PURSUANT
TO18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO SECTION 302 OF
THE
SARBANES-OXLEY ACT OF 2002
I,
Anthony Dudzinski, certify that:
1. |
I
have reviewed this Form 10-Q of American CryoStem Corporation; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect
to the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
present in this report; |
|
|
4. |
Along
with the Principal Executive Officer, I am responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13-a-15(f) and 15d-15(f)) for the registrant and have: |
|
|
|
|
a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to
us by others within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based
on such evaluation; and |
|
|
|
|
d) |
Disclosed
in this report any change in the registrant’s internal control over financing reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
and |
|
|
|
5. |
I
have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s
auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
|
|
|
a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial
information; and |
|
|
|
|
b) |
Any
fraud, whether or not material, that involved management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Dated:
February 22, 2016 |
By: |
/s/
Anthony Dudzinski |
|
|
|
Anthony
Dudzinski |
|
|
|
Principal
Accounting Officer
American
CryoStem Corporation |
|
EXHIBIT
32.1
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO SECTION 906 OF
THE
SARBANES-OXLEY ACT OF 2002
In
connection with this Quarterly Report of American CryoStem Corporation (the “Company”), on Form 10-Q for the
quarter ended June 30, 2015, as filed with the U.S. Securities and Exchange Commission on the date hereof, I, John
Arnone, Chief Executive Officer of the registrant and Anthony Dudzinski, Treasurer of the registrant, certify to the best of
my knowledge, pursuant to 18 U.S.C. Sec. 1350, as adopted pursuant to Sec. 906 of the Sarbanes-Oxley Act of 2002,
that:
| (1) | Such
Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 fully complies with
the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| (2) | The
information contained in such Quarterly Report on Form 10-Q for the quarter ended June
30, 2015 fairly presents, in all material respects, the financial condition and results
of operations of the Company. |
|
|
|
|
Dated: February
22, 2016 |
By: |
/s/
John Arnone |
|
|
|
John
Arnone |
|
|
|
Chief
Executive Officer
American
CryoStem Corporation |
|
|
|
|
|
Dated:
February 22, 2016 |
By: |
/s/
Anthony Dudzinski |
|
|
|
Anthony
Dudzinski |
|
|
|
Treasurer
American
CryoStem Corporation |
|
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v3.3.1.900
Balance Sheets - USD ($)
|
Dec. 31, 2015 |
Dec. 31, 2014 |
Current assets: |
|
|
Cash |
$ 3,851
|
$ 9,059
|
Deferred Contract Expense |
|
7,750
|
Accounts receivable |
$ 8,613
|
56,513
|
Total current assets |
12,464
|
73,322
|
Property and Equipment (Net of Accumulated Depreciation) |
201,770
|
211,314
|
Other Assets |
262,758
|
249,007
|
Total Assets |
476,992
|
533,643
|
Current liabilities: |
|
|
Accounts payable & accrued expenses |
811,883
|
807,213
|
Bridge notes payable |
576,000
|
576,000
|
Convertible notes payable |
557,000
|
557,000
|
Deferred revenues |
38,489
|
56,431
|
Total current liabilities |
1,983,372
|
1,996,644
|
Convertible notes payable |
50,000
|
50,000
|
Payable to Shareholder |
126,947
|
118,347
|
Total Long-Term Liabilities |
176,947
|
168,347
|
Shareholders' equity: |
|
|
Common stock- $.001 par value, authorized 300,000,000 shares authorized, issued and outstanding, 32,915,500 shares at December 31, 2014 and 34,815,451 at December 31, 2015 |
34,817
|
34,707
|
Additional paid in capital |
7,897,357
|
7,876,967
|
Accumulated deficit |
(9,615,501)
|
(9,543,022)
|
Total shareholders' deficit |
(1,683,327)
|
(1,631,348)
|
Total Liabilities & Shareholders' Deficit |
$ 476,992
|
$ 533,643
|
X |
- DefinitionSum of the carrying values as of the balance sheet date of obligations incurred through that date and due within one year (or the operating cycle, if longer), including liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received, taxes, interest, rent and utilities, accrued salaries and bonuses, payroll taxes and fringe benefits.
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v3.3.1.900
Balance Sheets (Parenthetical) - $ / shares
|
Dec. 31, 2015 |
Dec. 31, 2014 |
Assets [Abstract] |
|
|
Common Stock, Par Value |
$ 0.001
|
$ 0.001
|
Common stock, authorized |
300,000,000
|
300,000,000
|
Common Stock, shares issued |
34,815,451
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32,915,500
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34,815,451
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32,915,500
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v3.3.1.900
Statements of Operations - USD ($)
|
3 Months Ended |
Dec. 31, 2015 |
Dec. 31, 2014 |
Revenues [Abstract] |
|
|
Revenues |
$ 139,114
|
$ 36,044
|
Cost of sales |
77,728
|
|
Gross Profit |
61,386
|
36,044
|
Operating Expenses: |
|
|
Professional Fees |
1,810
|
10,290
|
Laboratory Expense |
22,931
|
95,894
|
Administration |
84,974
|
147,937
|
Total general & administrative expenses |
109,715
|
254,121
|
Net Loss from Operations |
(48,329)
|
(218,077)
|
Other income (expenses): |
|
|
Interest Income |
36
|
|
Interest expense |
(24,186)
|
(23,855)
|
Net Loss |
$ (72,479)
|
$ (241,932)
|
Basic & fully diluted net loss per common share: |
|
|
Net loss |
$ (0.0021)
|
$ (0.0074)
|
Weighted average of common shares outstanding: |
|
|
Basic & fully diluted |
34,757,429
|
32,907,759
|
X |
- DefinitionThe aggregate cost of goods produced and sold and services rendered during the reporting period.
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v3.3.1.900
Statements of Cash Flows - USD ($)
|
3 Months Ended |
Dec. 31, 2015 |
Dec. 31, 2014 |
Operating Activities: |
|
|
Net loss |
$ (72,479)
|
$ (241,932)
|
Adjustments to reconcile net loss items not requiring the use of cash: |
|
|
Depreciation & amortization expense |
10,043
|
10,341
|
Interest expense |
24,186
|
23,855
|
Changes in other operating assets and liabilities : |
|
|
Accounts Receivable |
47,900
|
376
|
Deferred charge |
$ 7,750
|
11,625
|
Security Deposits |
|
(150)
|
Other deposit |
$ (7,500)
|
550
|
Deferred Revenue |
(17,942)
|
25,000
|
Accounts Payable and accrued expenses |
(19,516)
|
25,251
|
Net cash used by operations |
(27,558)
|
(145,084)
|
Investing activities: |
|
|
Patents development |
(6,750)
|
(6,835)
|
Net cash used by investing activities |
$ (6,750)
|
(6,835)
|
Financing activities: |
|
|
Payment of capital lease |
|
(5,381)
|
Payable to shareholder |
$ 8,600
|
(2,000)
|
Issuance of convertible notes |
|
166,500
|
Issuance of common shares |
$ 20,500
|
$ 8,500
|
Options exercised |
|
|
Net cash provided by financing activities |
$ 29,100
|
$ 167,619
|
Net increase (decrease) in cash |
(5,208)
|
15,700
|
Cash balance Beginning of Period |
9,059
|
21,471
|
Cash balance at End of Period |
$ 3,851
|
$ 37,171
|
Supplemental disclosures of cash flow information: |
|
|
Interest paid during the fiscal year |
|
|
Income taxes paid during the fiscal year |
|
|
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v3.3.1.900
Statement of Changes in Shareholders' Equity - 3 months ended Dec. 31, 2015 - USD ($)
|
Common Shares Par Value |
Paid in Capital |
Retained Deficit |
Total |
Beginning Balance, Shares at Sep. 30, 2015 |
34,705,451
|
|
|
|
Beginning Balance, Amount at Sep. 30, 2015 |
$ 34,707
|
$ 7,876,967
|
$ (9,543,022)
|
|
Exercises of options, Shares |
10,000
|
|
|
10,000
|
Exercises of options, Amount |
$ 10
|
490
|
|
$ 500
|
Issuance of common shares, Shares |
100,000
|
|
|
100,000
|
Issuance of common shares, Amount |
$ 100
|
$ 19,900
|
|
$ 20,000
|
Net loss |
|
|
$ (72,479)
|
$ (72,479)
|
Ending Balance, Shares at Dec. 31, 2015 |
34,815,451
|
|
|
34,815,451
|
Ending Balance, Amount at Dec. 31, 2015 |
$ 34,817
|
$ 7,897,357
|
$ (9,615,501)
|
$ (1,683,327)
|
X |
- DefinitionNumber of shares of common stock outstanding. Common stock represent the ownership interest in a corporation.
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v3.3.1.900
1. Organization of the Company and Significant Accounting Policies
|
3 Months Ended |
Dec. 31, 2015 |
Organization of the Company and Significant Accounting Policies |
|
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 & As 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 patients
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 2015and 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 Companys 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 Companys 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.
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 |
|
|
|
|
|
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 December 31, 2015 and December 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 2011 to 2015 are subject to IRS audit.
Recently
Issued Accounting Pronouncements- There are no recently issued accounting pronouncements that have a material impact on the
Companys financial statements.
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- DefinitionThe entire disclosure for the business description and accounting policies concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Accounting policies describe all significant accounting policies of the reporting entity.
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v3.3.1.900
2. Going Concern
|
3 Months Ended |
Dec. 31, 2015 |
Going Concern |
|
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. Managements 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.
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- DefinitionThe entire disclosure when substantial doubt is raised about the ability to continue as a going concern. Includes, but is not limited to, principal conditions or events that raised substantial doubt about the ability to continue as a going concern, management's evaluation of the significance of those conditions or events in relation to the ability to meet its obligations, and management's plans that alleviated or are intended to mitigate the conditions or events that raise substantial doubt about the ability to continue as a going concern.
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v3.3.1.900
3. Loss per Share
|
3 Months Ended |
Dec. 31, 2015 |
Loss per Share |
|
Loss per Share |
The
Company applies ASC 260, Earnings per Share to calculate loss per share. In accordance with ASC
260, basic and fully diluted net loss per share has been computed based on the weighted average of common shares outstanding during
the years. The dilutive effects of the convertible notes and the options outstanding 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:
|
|
Dec 31, 2015 |
|
|
Dec 31, 2014 |
|
Net Loss |
|
$ |
(72,479 |
) |
|
|
(241,932 |
) |
Weighted average shares outstanding |
|
|
34,757,429 |
|
|
|
32,907,759 |
|
Basic & fully diluted net earnings (loss) per common share |
|
$ |
(0.0021 |
) |
|
$ |
(0.0074 |
) |
|
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v3.3.1.900
4. Fixed Assets
|
3 Months Ended |
Dec. 31, 2015 |
Property, Plant and Equipment [Abstract] |
|
Fixed Assets |
Fixed
Assets owned by the Company are comprised of the following:
|
|
December 31, 2015 |
|
|
September 30, 2015 |
|
Office Equipment |
|
$ |
26,637 |
|
|
$ |
26,637 |
|
Lab Furniture |
|
|
642 |
|
|
|
642 |
|
Office Furniture |
|
|
999 |
|
|
|
999 |
|
Lab Equipment |
|
|
254,054 |
|
|
|
254,054 |
|
Lab Software |
|
|
123,000 |
|
|
|
123,000 |
|
|
|
|
405,332 |
|
|
|
405,332 |
|
Less: Accumulated Depreciation |
|
|
(203,562 |
) |
|
|
(194,018 |
) |
|
|
|
|
|
|
|
|
|
Net Property and Equipment |
|
$ |
201,770 |
|
|
$ |
211,314 |
|
|
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v3.3.1.900
5. Patents & Patents Filings
|
3 Months Ended |
Dec. 31, 2015 |
Patents |
|
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 Companys 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 Companys 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 Therapuetic
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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v3.3.1.900
6. Debt
|
3 Months Ended |
Dec. 31, 2015 |
Debt: |
|
Debt |
As
of December 31, 2015, the Company had $607,000 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 $447,500 are due at the end of fiscal
years 2016 and 2017 and are exercisable into common stock at $0.30 per share.
During
fiscal year 2014, the company issued bridge notes and received proceeds of $576,000, which were due in fiscal year
2015. 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 notes are unsecured.
The
following table describes the Companys debt outstanding at December 31, 2015:
Debt |
|
Carrying Value |
|
|
Fair Value |
|
|
Maturity |
|
|
Rate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
|
$ |
159,500 |
|
|
$ |
159,500 |
|
|
|
Demand |
|
|
|
8.00 |
% |
|
In default |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
|
$ |
397,500 |
|
|
$ |
397,500 |
|
|
|
Fiscal 2016 |
|
|
|
8.00 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
|
$ |
50,000 |
|
|
$ |
53,000 |
|
|
|
Fiscal 2017 |
|
|
|
8.00 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bridge notes |
|
$ |
576,000 |
|
|
$ |
576,000 |
|
|
|
Demand |
|
|
|
8.00 |
% |
|
In default |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Due to shareholders |
|
$ |
118,347 |
|
|
$ |
118,347 |
|
|
|
Demand |
|
|
|
0.00 |
% |
|
|
|
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v3.3.1.900
7. Common Stock Issuances
|
3 Months Ended |
Dec. 31, 2015 |
Common Stock Issuances |
|
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
three months ended December 31, 2015, option holders exercised 10,000 options at $0.05 and received 10,000 shares of common stock.
During
the three months ended December 31, 2015, the Company issued 100,000 shares of common stock and received proceeds of $20,000.
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v3.3.1.900
8. Stock Options
|
3 Months Ended |
Dec. 31, 2015 |
Stock Options |
|
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 December 31, 2015:
|
|
|
|
|
Wgtd Avg |
|
|
Wgtd Years |
|
|
|
Options |
|
|
Exercise Price |
|
|
to Maturity |
|
Outstanding at September 30, 2015 |
|
|
12,321,000 |
|
|
$ |
0.21 |
|
|
|
3.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issues |
|
|
0 |
|
|
|
|
|
|
|
|
|
Exercises |
|
|
(10,000 |
) |
|
|
|
|
|
|
|
|
Expires |
|
|
(100,000 |
) |
|
|
|
|
|
|
|
|
Outstanding at December 31, 2015 |
|
|
12,221,000 |
|
|
$ |
0.21 |
|
|
|
3.19 |
|
|
X |
- DefinitionThe entire disclosure for compensation-related costs for equity-based compensation, which may include disclosure of policies, compensation plan details, allocation of equity compensation, incentive distributions, equity-based arrangements to obtain goods and services, deferred compensation arrangements, employee stock ownership plan details and employee stock purchase plan details.
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v3.3.1.900
9. Fair Values of Financial Instruments
|
3 Months Ended |
Dec. 31, 2015 |
Fair Values of Financial Instruments |
|
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 December 31, 2015 and 2014 because of their short term nature.
|
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- DefinitionThe entire disclosure for financial instruments. This disclosure includes, but is not limited to, fair value measurements of short and long term marketable securities, international currencies forward contracts, and auction rate securities. Financial instruments may include hedging and non-hedging currency exchange instruments, derivatives, securitizations and securities available for sale at fair value. Also included are investment results, realized and unrealized gains and losses as well as impairments and risk management disclosures.
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v3.3.1.900
10. Commitments & Contingencies
|
3 Months Ended |
Dec. 31, 2015 |
Commitment and Contingencies: |
|
Commitments & Contingencies |
Operating
Leases - The Company leased laboratory facilities at the Burlington County College Science Incubator in Burlington, New
Jersey. The monthly lease payment was $3,300. Burlington County College terminated the lease as of January 15, 2016. The Company
fulfilled its lease obligation to the college.
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 December 31,
2015.
|
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.3.1.900
11. Concentrations of Credit
|
3 Months Ended |
Dec. 31, 2015 |
Concentrations Of Credit |
|
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 Companys ability to continue as a going concern.
|
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v3.3.1.900
12. Joint Venture
|
3 Months Ended |
Dec. 31, 2015 |
Joint Venture |
|
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.
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v3.3.1.900
13. Related Party Transactions
|
3 Months Ended |
Dec. 31, 2015 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
The other party to the joint venture
discussed in Note 13 is controlled by a member of the Companys scientific advisory board.
At December 31, 2015,
the company was indebted to the Companys majority shareholder for advances to the Company of $126,947. The advances are
due on demand, are unsecured, and carry no interest rate.
At December 31, 2015,
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 $15,860 are due on demand, are unsecured, and carry no interest rate.
At December 31, 2015, 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 $1,245 are due on demand, are unsecured, and carry no interest rate.
|
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- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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14. Subsequent Events
|
3 Months Ended |
Dec. 31, 2015 |
Subsequent Events [Abstract] |
|
Subsequent Events |
The lease with Burlington County College
has been terminated as of January 15, 2016. The Company has fulfilled its lease obligation to the college.
The Company has executed
a new lease for laboratory facilities in Princeton, New Jersey and has moved into the new facilities.
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v3.3.1.900
1. Organization of the Company and Significant Accounting Policies (Policies)
|
3 Months Ended |
Dec. 31, 2015 |
Significant Accounting Policies |
|
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 Companys
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.
|
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 |
|
|
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 December 31, 2015 and December 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 2011 to 2015 are subject to IRS audit.
|
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There are no recently issued accounting pronouncements that have a material impact on the Companys financial statements.
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4. Fixed Assets (Tables)
|
3 Months Ended |
Dec. 31, 2015 |
Property, Plant and Equipment [Abstract] |
|
Schedule of summary of property and equipment |
|
|
December 31, 2015 |
|
|
September 30, 2015 |
|
Office Equipment |
|
$ |
26,637 |
|
|
$ |
26,637 |
|
Lab Furniture |
|
|
642 |
|
|
|
642 |
|
Office Furniture |
|
|
999 |
|
|
|
999 |
|
Lab Equipment |
|
|
254,054 |
|
|
|
254,054 |
|
Lab Software |
|
|
123,000 |
|
|
|
123,000 |
|
|
|
|
405,332 |
|
|
|
405,332 |
|
Less: Accumulated Depreciation |
|
|
(203,562 |
) |
|
|
(194,018 |
) |
|
|
|
|
|
|
|
|
|
Net Property and Equipment |
|
$ |
201,770 |
|
|
$ |
211,314 |
|
|
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v3.3.1.900
6. Debt (Tables)
|
3 Months Ended |
Dec. 31, 2015 |
Schedule of Debt Outstanding |
|
Schedule of Debt Outstanding |
Debt |
|
Carrying Value |
|
|
Fair Value |
|
|
Maturity |
|
|
Rate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
|
$ |
159,500 |
|
|
$ |
159,500 |
|
|
|
Demand |
|
|
|
8.00 |
% |
|
In default |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
|
$ |
397,500 |
|
|
$ |
397,500 |
|
|
|
Fiscal 2016 |
|
|
|
8.00 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes |
|
$ |
50,000 |
|
|
$ |
53,000 |
|
|
|
Fiscal 2017 |
|
|
|
8.00 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bridge notes |
|
$ |
576,000 |
|
|
$ |
576,000 |
|
|
|
Demand |
|
|
|
8.00 |
% |
|
In default |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Due to shareholders |
|
$ |
118,347 |
|
|
$ |
118,347 |
|
|
|
Demand |
|
|
|
0.00 |
% |
|
|
|
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v3.3.1.900
4. Fixed Assets - Summary of property and equipment (Details) - USD ($)
|
Dec. 31, 2015 |
Sep. 30, 2015 |
Property, Plant and Equipment [Abstract] |
|
|
Office Equipment |
$ 26,637
|
$ 26,637
|
Lab Furniture |
642
|
642
|
Office Furniture |
999
|
999
|
Lab Equipment |
254,054
|
254,054
|
Lab Software |
123,000
|
123,000
|
Property and Equipment |
405,332
|
405,332
|
Less: Accumulated Depreciation |
(203,562)
|
(194,018)
|
Net Property and Equipment |
$ 201,770
|
$ 211,314
|
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6. Debt - Summary of debt outstanding (Details)
|
3 Months Ended |
Dec. 31, 2015
USD ($)
|
Convertible Notes |
|
Debt Instrument [Line Items] |
|
Carrying Value |
$ 159,500
|
Fair Value |
$ 159,500
|
Maturity |
Demand
|
Rate |
8.00%
|
Convertible Notes |
|
Debt Instrument [Line Items] |
|
Carrying Value |
$ 397,500
|
Fair Value |
$ 397,500
|
Maturity |
Fiscal 2016
|
Rate |
8.00%
|
Convertible Notes |
|
Debt Instrument [Line Items] |
|
Carrying Value |
$ 50,000
|
Fair Value |
$ 53,000
|
Maturity |
Fiscal 2017
|
Rate |
8.00%
|
Bridge Notes |
|
Debt Instrument [Line Items] |
|
Carrying Value |
$ 576,000
|
Fair Value |
$ 576,000
|
Maturity |
Demand
|
Rate |
8.00%
|
Due To Shareholder |
|
Debt Instrument [Line Items] |
|
Carrying Value |
$ 118,347
|
Fair Value |
$ 118,347
|
Maturity |
Demand
|
Rate |
0.00%
|
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v3.3.1.900
7. Common Stock Issuances (Detail Textuals) - USD ($)
|
3 Months Ended |
12 Months Ended |
Dec. 31, 2015 |
Sep. 30, 2015 |
Stockholders' Equity Note [Abstract] |
|
|
Number of common stock issued (in shares) |
100,000
|
175,759
|
Proceeds from issuance of common stock |
$ 20,000
|
$ 55,000
|
Convertible note exercise amount |
|
$ 17,500
|
Convertible note exercise amount (in shares) |
|
54,286
|
Options exercised |
10,000
|
1,460,000
|
Option exercise price |
$ 0.05
|
$ 0.01
|
Bridge note amount |
|
$ 21,000
|
Shares issued to pay bridge loan |
|
70,000
|
Shares issued to pay bridge loan interest |
|
4,542
|
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- DefinitionRepresents debt instrument exercise amount.
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v3.3.1.900
8. Stock Options - Summary of Common Stock Options Outstanding (Details) - $ / shares
|
3 Months Ended |
12 Months Ended |
Dec. 31, 2015 |
Sep. 30, 2015 |
Exercises |
10,000
|
1,460,000
|
Options |
|
|
Outstanding |
12,321,000
|
|
Issues |
0
|
|
Exercises |
(10,000)
|
|
Expires |
(100,000)
|
|
Outstanding |
12,221,000
|
12,321,000
|
Weighted average exercise price, outstanding beginning |
$ 0.21
|
|
Weighted average exercise price, outstanding ending |
$ 0.21
|
$ 0.21
|
Weighted years to maturity outstanding beginning |
3 years 4 months 28 days
|
|
Weighted years to maturity outstanding |
3 years 2 months 9 days
|
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