UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the six month period ended March 31, 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
No o
Indicate
by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes
x No o
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller
reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer o |
Accelerated
filer o |
Non-accelerated
filer o (Do not check
if smaller reporting company) |
Smaller
reporting company x |
|
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)
Yes
o No x
As
of May 10, 2015, there were 32,913,150 shares of common stock outstanding.
TABLE
OF CONTENTS
PART
I – FINANCIAL INFORMATION
Item
1. Financial StatementS
American
CryoStem Corporation
Interim
Balance Sheets
As
of March 31, 2015 and September 30, 2014
| |
March 31, 2015 | | |
Sept 30, 2014 | |
ASSETS | |
| | | |
| | |
| |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 5,508 | | |
$ | 21,471 | |
Deferred Contract Expense | |
| 31,000 | | |
| 54,250 | |
Accounts Receivable | |
| 19,296 | | |
| 6,074 | |
Prepaid Expenses | |
| 250 | | |
| — | |
| |
| | | |
| | |
Total current assets | |
| 56,054 | | |
| 81,795 | |
| |
| | | |
| | |
Other Assets | |
| | | |
| | |
Other Deposit | |
| — | | |
| 550 | |
Investment in joint venture | |
| 1,000 | | |
| 1,000 | |
Security deposits | |
| 5,950 | | |
| 5,800 | |
Patents and Trademarks | |
| 221,751 | | |
| 200,767 | |
Equipment – net | |
| 230,561 | | |
| 250,182 | |
| |
| | | |
| | |
Total Assets | |
$ | 515,316 | | |
$ | 540,094 | |
| |
| | | |
| | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable & accrued expenses | |
$ | 803,711 | | |
$ | 698,105 | |
Bridge notes payable | |
| 596,000 | | |
| 596,000 | |
Convertible notes payable | |
| 159,500 | | |
| 173,000 | |
Deferred Revenue | |
| 17,568 | | |
| 17,768 | |
Capital Lease Payable | |
| — | | |
| 10,898 | |
| |
| | | |
| | |
Total current liabilities | |
| 1,576,779 | | |
| 1,495,771 | |
| |
| | | |
| | |
Long-Term Liabilities | |
| | | |
| | |
Convertible Notes payable | |
| 327,500 | | |
| 30,000 | |
Payable to Shareholder | |
| 132,947 | | |
| 134,947 | |
| |
| | | |
| | |
Total Long-Term Liabilities | |
| 460,447 | | |
| 164,947 | |
| |
| | | |
| | |
Shareholders’ equity: | |
| | | |
| | |
Common stock ($.001 par value, 32,915,500 shares issued and outstanding at March 31, 2015, and 32,890,864 shares issued and outstanding at September 30, 2014; 300,000,000 shares authorized) | |
| 32,916 | | |
| 32,286 | |
Additional paid in capital | |
| 7,018,502 | | |
| 5,990,623 | |
Accumulated deficit | |
| (8,573,328 | ) | |
| (6,075,393 | ) |
Total shareholders’ equity | |
| (1,521,910 | ) | |
| (52,484 | ) |
| |
| | | |
| | |
Total Liabilities & Shareholders’ Equity | |
$ | 515,316 | | |
$ | 569,032 | |
| |
| | | |
| | |
See
Notes to Financial Statements
American
CryoStem Corporation
Interim
Statements of Operations
For
the Three Months Ended March 31, 2015 and 2014
and
the Six Months Ended March 31, 2015 and 2014
| |
Three Months Ended | | |
Six Months Ended | |
| |
March 31, | | |
March 31, | |
| |
2015 | | |
2014 | | |
2015 | | |
2014 | |
| |
| | |
| | |
| | |
| |
Sales | |
$ | 58,511 | | |
$ | 4,480 | | |
$ | 94,555 | | |
$ | 10,619 | |
| |
| | | |
| | | |
| | | |
| | |
Operating Expenses: | |
| | | |
| | | |
| | | |
| | |
Professional Fees | |
| 22,107 | | |
| 146,890 | | |
| 32,452 | | |
| 214,801 | |
Research & Development | |
| 83,634 | | |
| 116,364 | | |
| 179,668 | | |
| 179,198 | |
Administration | |
| 100,047 | | |
| 210,315 | | |
| 247,984 | | |
| 392,318 | |
| |
| | | |
| | | |
| | | |
| | |
Total Operating Expenses | |
| 205,788 | | |
| 473,569 | | |
| 460,104 | | |
| 786,317 | |
| |
| | | |
| | | |
| | | |
| | |
Net Loss from Operations | |
| (147,277 | ) | |
| (469,089 | ) | |
| (365,549 | ) | |
| (775,698 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other Income (Expense) | |
| (20,382 | ) | |
| (8,396 | ) | |
| (44,237 | ) | |
| (14,410 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net Loss | |
$ | (167,659 | ) | |
$ | (477,485 | ) | |
$ | (409,786 | ) | |
$ | (790,108 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic & fully diluted net earnings (loss) per common share | |
$ | (.005 | ) | |
$ | (.015 | ) | |
$ | (.012 | ) | |
$ | (.024 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average of common shares outstanding: Basic & fully diluted | |
| 32,915,150 | | |
| 32,640,721 | | |
| 32,911,414 | | |
| 32,584,031 | |
See
Notes to Financial Statements
American
CryoStem Corporation
Interim
Statements of Cash Flows
For
the Six Months Ended March 31, 2015 and 2014
| |
2015 | | |
2014 | |
Operating Activities: | |
| | | |
| | |
Net loss | |
$ | (409,786 | ) | |
$ | (790,108 | ) |
Adjustments to reconcile net income items not requiring the use of cash: | |
| | | |
| | |
Depreciation & amortization expense | |
| 20,619 | | |
| 20,149 | |
Accrued Interest | |
| 44,237 | | |
| 13,048 | |
Changes in other operating assets and liabilities | |
| | | |
| | |
Accounts Receivable | |
| (13,222 | ) | |
| (2,017 | ) |
Deferred Contract Expense | |
| 23,250 | | |
| (54,500 | ) |
Prepaid Expenses | |
| (250 | ) | |
| (250 | ) |
Other Deposit | |
| 550 | | |
| — | |
Security Deposit | |
| (150 | ) | |
| | |
Accounts Payable and accrued expenses | |
| 61,369 | | |
| 185,133 | |
Contract Payable | |
| — | | |
| 45,000 | |
Deferred Revenue | |
| (200 | ) | |
| 1,100 | |
Net cash used by operations | |
| (273,583 | ) | |
| (582,445 | ) |
| |
| | | |
| | |
Investing activities: | |
| | | |
| | |
Purchase of equipment | |
| — | | |
| (8,149 | ) |
Investment of other assets | |
| (21,982 | ) | |
| (23,465 | ) |
Net cash used by investing activities | |
| (21,982 | ) | |
| (31,614 | ) |
| |
| | | |
| | |
Financing activities: | |
| | | |
| | |
Issuance of convertible notes | |
| 284,000 | | |
| 5,250 | |
Payment to Shareholder | |
| (2,000 | ) | |
| (2,000 | ) |
Issuance of notes payable | |
| — | | |
| 426,000 | |
Issuance of common stock | |
| 8,500 | | |
| 124,250 | |
Capital Lease | |
| (10,898 | ) | |
| (9,873 | ) |
| |
| | | |
| | |
Net cash provided by financing activities | |
| 279,602 | | |
| 543,627 | |
| |
| | | |
| | |
Net increase (decrease) in cash during the period | |
| (15,963 | ) | |
| (70,432 | ) |
| |
| | | |
| | |
Cash Balance, Beginning of Period | |
| 21,471 | | |
| 115,932 | |
| |
| | | |
| | |
Cash balance, End of Period | |
$ | 5,508 | | |
$ | 45,500 | |
| |
| | | |
| | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
Interest Paid | |
$ | 324 | | |
$ | 1,361 | |
Income Taxes Paid | |
$ | — | | |
$ | — | |
| |
| | | |
| | |
See
Notes to Financial Statements
American
CryoStem Corporation
Statement
of Changes in Shareholders’ Equity
For
the Six Months Ended March 31, 2015
Prices
& shares adjusted for stock splits
| |
| | |
| | |
Additional | | |
| | |
Total | |
| |
Common Stock | | |
Paid in | | |
Accumulated | | |
Shareholders’ | |
| |
Shares | | |
Par Value | | |
Capital | | |
Deficit | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| |
Balance at September 30, 2014 | |
| 32,890,864 | | |
$ | 32,892 | | |
$ | 7,010,026 | | |
$ | (8,163,542 | ) | |
$ | (1,120,624 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Exercises of Convertible Notes | |
| 24,286 | | |
| 24 | | |
| 8,476 | | |
| | | |
| 8,500 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Net Loss | |
| | | |
| | | |
| | | |
| (409,786 | ) | |
| (409,786 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at March 31, 2015 | |
| 32,915,150 | | |
$ | 32,916 | | |
$ | 7,018,502 | | |
$ | (8,573,328 | ) | |
$ | (1,521,910 | ) |
See
Notes to Financial Statements
American
CryoStem Corporation
Notes
to the Financial Statements
March
31, 2015
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 the name of the Company was changed to American CryoStem Corporation.
The
Company is in the business of collecting adipose tissue and processing and storing the adult stem cells extracted for future use.
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 current and future cellular treatments and therapies offered by existing and planned treatment centers
worldwide. Individualized collection and storage of adult stem cells provides personalized medical solutions by providing the
patient’s own preserved stem cells 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 intends to pursue additional licensing partners in the future.
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 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 reasonably assured.
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.
Equipment
- Equipment is stated at cost. Depreciation expense is computed using the straight-line method over the estimated useful
life of the assets, which is estimated as follows:
Office equipment |
5 years |
Lab equipment & Furniture |
7 years |
Lab software |
5 years |
Leasehold improvements |
15 years |
American
CryoStem Corporation
Notes
to the Financial Statements
March
31, 2015
NOTE
1. Organization of the Company and Significant Accounting Policies (continued)
Income
taxes - The Company accounts for income taxes in accordance with generally accepted accounting principles which require an
asset and liability approach to financial accounting and reporting for income taxes. Deferred income tax assets and liabilities
are computed annually for differences between financial statement and income tax bases of assets and liabilities that will result
in taxable income or deductible expenses in the future based on enacted tax laws and rates applicable to the periods in which
the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred
tax assets and liabilities to the amount expected to be realized. Income tax expense is the tax payable or refundable for the
period adjusted for the change during the period in deferred tax assets and liabilities.
The
Company follows the accounting requirements associated with uncertainty in income taxes using the provisions of Financial Accounting
Standards Board (FASB) ASC 740, Income Taxes. Using that guidance, tax positions initially need to be recognized in the
financial statements when it is more likely than not the positions will be sustained upon examination by the tax authorities.
It also provides guidance for derecognition, classification, interest and penalties, accounting in interim periods, disclosure
and transition. As of March 31, 2015, the Company has no uncertain tax positions that qualify for either recognition or disclosure
in the financial statements. All tax returns from fiscal years 2009 to 2012 are subject to IRS audit.
Recent
Accounting Pronouncements:
There
are no recently issued accounting pronouncements that have a material impact on the Company’s financial statements.
NOTE
2. Going Concern
The
accompanying financial statements have been presented in accordance with GAAP, 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 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 fundraising activities in fiscal 2015 until it generates sufficient revenue
to support its operations. The Company has entered into an advisory agreement to assist in raising additional capital from institutional
and strategic investors to fund the marketing and distribution of its products.
NOTE
3. Loss per Share
The
Company applies ASC 260, “Earnings per Share” to calculate loss per share. In accordance with ASC 260, basic
net loss per share has been computed based on the weighted average of common shares outstanding during the periods reported. The
effects of the options and notes convertible into shares of common stock are not included in the calculation of loss per share
since their inclusion would be anti-dilutive.
Net loss
per share is computed as follows:
| |
For the Three Months Ended | | |
For the Six Months Ended | |
| |
March 31, | | |
March 31, | |
| |
2015 | | |
2014 | | |
2015 | | |
2014 | |
Net Loss | |
$ | (167,659 | ) | |
$ | (477,485 | ) | |
$ | (409,786 | ) | |
$ | (790,108 | ) |
Weighted average shares outstanding | |
| 32,915,150 | | |
| 32,640,721 | | |
| 32,911,414 | | |
| 32,584,031 | |
Basic & fully diluted net earnings (loss) per common share | |
$ | (.005 | ) | |
$ | (.015 | ) | |
$ | (.012 | ) | |
$ | (0.024 | ) |
American
CryoStem Corporation
Notes
to the Financial Statements
March
31, 2015
NOTE
4. Equipment
Equipment
is comprised of the following:
| |
March 31, 2015 | | |
Sept 30, 2014 | |
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 | |
Less: Accumulated Depreciation | |
| (174,771 | ) | |
| (155,150 | ) |
Equipment - net | |
$ | 230,561 | | |
$ | 250,182 | |
NOTE
5. Patents
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 patent filings have been made:
|
· |
A
Business Method for Collection Cryogenic Storage and Distribution of a Biologic Sample Material PCT/US2011/39260 filed June
6, 2011 with 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 Lipospirates to Physician for Autologous Adipose
Transfer Procedures PCT/US13/44621 filed June 6, 2013 with a priority date of June 7, 2013. |
|
|
|
|
· |
Human
Albumin Serum for Cell Culture Medium for Clinical Growth of Human Adipose Stromal Cells. US Serial No. 62/098799 filed December
31, 2014 |
|
|
|
|
· |
Autologous
Serum for Transport of Isolated Stromal Vascular Fraction or Adipose Derived Stem Cells
61/810,970 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. |
American
CryoStem Corporation
Notes
to the Financial Statements
March
31, 2015
NOTE
6. Debt
As
of March 31, 2015, the Company had $487,000 of convertible notes outstanding. Of those convertible notes $159,500 had come due
on September 30, 2014. Of the $159,500, $17,500 have been extended to September 30, 2015. The Company is currently in negotiations
with the rest of these note holders 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 $327,500 come due at the end of fiscal year 2016 and are exercisable into common stock at $0.30 per share.
During
fiscal year 2014, the company issued “bridge notes” and received proceeds of $596,000. The notes are due in fiscal
year 2015 at 8% interest. Holders of the notes received options to purchase 596,000 shares of common stock at $0.05 per share.
The notes are unsecured.
The
following table describes the Company’s debt outstanding as of March 31, 2015:
Debt | |
Carrying Value | | |
Maturity | | |
Rate | |
Convertible notes | |
$ | 142,500 | | |
Demand | | |
| 8.00 | % |
Convertible notes | |
$ | 17,000 | | |
Fiscal 2015 | | |
| 8.00 | % |
Convertible notes | |
$ | 327,500 | | |
Fiscal 2015 | | |
| 8.00 | % |
Bridge Notes | |
$ | 596,000 | | |
Fiscal 2015 | | |
| 8.00 | % |
Due to shareholder | |
$ | 132,947 | | |
Demand | | |
| 0.00 | % |
NOTE
7. Common Stock Issuances
During
fiscal year 2014, option holders exercised 170,000 options and the Company issued 170,000 shares of common stock and received
proceeds of $24,500.
During
fiscal year 2014, holders of convertible notes converted $152,300 of convertible notes and the Company issued 435,143 shares of
common stock.
During
the six months ended March 31, 2015, holders of convertible notes converted $8,500 of convertible notes and the Company issued
24,286 shares of common stock.
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:
| |
2014 | | |
2013 | |
Dividend yield | |
| 0.00 | % | |
| 0.00 | % |
Risk free interest rate | |
| 0.25 | % | |
| 0.25 | % |
Volatility | |
| 48.39 | % | |
| 16.60 | % |
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.
American
CryoStem Corporation
Notes
to the Financial Statements
March
31, 2015
NOTE
8. Stock Options (continued) The following is a summary of common stock options outstanding at March 31, 2015:
| |
| | |
Wgtd Avg | | |
Wgtd Years | |
| |
Options | | |
Exercise Price | | |
to Maturity | |
| |
| | |
| | |
| |
Outstanding at September 30, 2014 | |
| 10,556,000 | | |
$ | 0.21 | | |
| 3.74 | |
| |
| | | |
| | | |
| | |
Issues | |
| 0 | | |
| | | |
| | |
Exercises | |
| 0 | | |
| | | |
| | |
Expires | |
| 0 | | |
| | | |
| | |
Outstanding at March 31, 2015 | |
| 10,556,000 | | |
$ | 0.21 | | |
| 3.24 | |
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,
prepaid expense, security deposit, accounts payable and accrued expenses, capital lease payable, payable to shareholder, and note
payable to shareholder in the balance sheet are estimated to approximate fair market value at March 31, 2015.
NOTE
10. Commitments & Contingencies
Operating
Leases – The Company leases laboratory facilities at the Burlington County College Science Incubator in Burlington,
New Jersey. The rent $3,300 per month.
The
Company leases office facilities in Eatontown, New Jersey. The rent is $2,650 per month.
NOTE
11. Reliance on Key Personnel
The
Company largely relies on the efforts of its Chief Operating Officer and its Chief Executive Officer and Chairman of its Board
of Directors. A withdrawal of the efforts of these individuals would have a material adverse effect on the Company’s ability
to continue as a going concern.
NOTE
12. Litigation
The
Company is not party to any litigation against it and is not aware of any litigation contemplated against it that would have a
materially adverse effect on the Company as of March 31, 2015 and the date of these financial statements.
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 the FDA’s current Good Manufacturing Procedures (“cGMP”) for human tissue
processing, cryro-storage and cell culture and differentiation media development is located in Mount Laurel, New Jersey at the
Burlington County College Science Incubator.
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 will help to accelerate
the transition from lab research to drug development and market launch.
Our
business strategy is centered on marketing our standardized platform as a complete adipose stem cell solution and expanding our
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.
Our
proprietary, patent pending clinical processing platform allows for the collection, preparation and cryo-preservation of adipose
tissue without manipulation, bio-generation or the addition of animal-derived products or other chemical materials which require
removal from the tissue sample upon retrieval or prior to use. Management believes this core process makes each tissue sample
suitable for use in cosmetic grafting procedures or for further processing to adult stem cells for other types of stem cell therapies.
Currently, we believe there are numerous therapeutic and orthopedic applications for adipose tissue and adult stem cell treatments
identified or in use globally. As of May 1, 2015, 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
(1583), adult stem cells (4820), adipose derived stem cells (137), mesenchymal stem cells (492), and stromal vascular fraction
(31).
On
February 10, 2015 the Company entered into an agreement to acquire the clients, physician network, all stored client samples and
the cryo storage equipment of BioLife Cell Bank (‘BioLife”) located in Dallas, Texas. BioLife Cell bank was one of
the first private cell banks in the United States to store adipose tissue and adipose derived stem cells. We have received the
samples and are currently undertaking a complete inventory and obtaining new storage agreements with the BioLife storage customers.
The agreement also calls for us to collect all current and future storage fee’s associated with the transferred samples.
The Company has begun the process of converting the BioLife clients to American CryoStem storage agreements, enrolling existing
BioLife physicians in the American CryoStem network and performing inventory and integration processes on the received samples.
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. Our products and services are the result of more than seven years of scientific development.
The Company also incorporates all of 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 requires
licensee’s of our tissue and cell processing technologies to purchase all the consumable products required in the collection,
processing 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® |
· |
Description:
Tissue Collection methodology designed for participating physicians to facilitate the collection and overnight shipping of
an individual’s adipose tissue to our FDA registered laboratory; |
|
|
· |
Sales
Channel: Manufacture and sale of our Cellect collection boxes to licensees for our ATGRAFT™ and ATCELL™
technologies. |
|
|
|
|
· |
ATGRAFT™ |
· |
Description:
Tissue processing at our Laboratory of a customer’s received adipose tissue and preparation for long term storage in
different configuration sizes allowing future retrieval for tissue grafting procedures or Regenerative Medicine applications |
|
|
· |
Sales
Channel: US Plastic and Cosmetic surgeons, licensing of the ATGRAFT™ processing technology to international
partners for utilizing our CELLECT™ collection boxes and ACSelerate mediums. |
|
|
|
|
· |
ATCELL™ |
· |
Description:
Clinical Processing separating the component parts of an individual’s adipose tissue, removing the adipocytes and red
blood cells, and creating the ATCELL™ autologous stem cell lines for storage, expansion, or differentiation |
|
|
· |
Sales
Channel Clinical and Research grade ATCELL™ (adipose Derived Stem Cells) lines for use with or sale to collaborative
partners in research and application development and optimization, cell morphology and characterization assays, and growth
analysis. |
|
|
|
|
· |
ACS
Laboratories™ |
· |
Laboratory
Division: 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® |
|
|
· |
ATGRAFT™ |
|
|
· |
ATCELL™ |
|
|
· |
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 the these technologies. The CELLECT® service
is included in our pending patent application U.S. Serial No. 13/702,304.
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 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 cGMP 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 AGTRAFT™ 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.
ATGRAFT™
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
ATGRAFT™ service creates patient retention and significant revenue opportunities for the participating physician
to promote additional procedures and generate additional fees from waste material collected during liposuction procedures. These
additional fees can be generated with significantly lower physician costs by eliminating the overhead associated with performing
a liposuction for each 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. The Company
can create 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. The Company charges the client fees ranging from $1,500 to $10,000 to process a
previously stored or newly collected ATGRAFT™ sample into the ATCELL™
product. Customer samples submitted for processing must utilize the CELLECT® collection system to
conform to our internal cGMP SOPs.
The
Company believes it will also 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™ SFM (fetal bovine serum (FBS) free media), 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 cGMP processed and cultured in our patented ACSelerate™
– SFM 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.
The Company’s research program makes donor demographics, processing, and testing data available to the clinical researcher.
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 provides opportunities for the Company’s ATCELL™
and ACSelerate™ products to become building blocks of final developed commercial
applications.
Additional
information on stem cell research can be found at www.clinicaltrials.gov and www.nih.gov (see adipose tissue, adipose
derived stem cells and mesenchymal stem cells)
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.
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 clinical grade and research grade, the complete line of ACSelerate™
products we manufacture is listed below. 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.
Currently,
we believe 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 to
support approved applications and treatments.
The
Company manufactures several versions of its ACSelerate™ cell culture media including:
| · | ACSelerate-SFM™
- our flagship clinical grade, cGMP manufactured animal serum free cell culture
media, which is ideally suited for the rapid expansion of adipose-derived cell samples
for direct use or further culturing into other cell types; |
| · | ACSelerate-LSM™
- our flagship research grade, cGMP manufactured 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-CR™-
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. |
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. 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 representing the most recent results of this ongoing optimization program. The new growth medium is designed to provide
enhanced cell growth allowing for reduced culture times and management believes that it can produce the new media with 60% less
materials costs. Internal growth studies have indicated a general increase in overall cell growth of up to 200% greater than other
cell culture medium.
ACS
Laboratories™ - Laboratory Product Sales, Contract Manufacturing and Professional Services –
ACS Laboratories is an unincorporated subsidiary of American CryoStem Corporation, responsible for the sale and licensing 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 cGMP 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 med 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 inquiries concerning the sale or licensing
of our SOPs, products and services in international jurisdictions to service 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 and the slow pace of approval
of cellular therapies and regenerative medicine applications in the US. To attempt to expand the Company’s sales, marketing
and branding opportunities globally, the Company has created an international licensing program.
Significant
to our international development activities is the proposed global expansion of the American CryoStem branded services and patented
products, as well as the proposed expansion of the Company’s services, technology and products as the core platform to implement
cellular therapies and regenerative medicine globally.
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”, 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.)
The
Company has designed the program to permit the licensing of the Company’s products and services to organizations that meet
the Company’s criteria. The Company believes that the proposed licensing program will allow for a variety of international
business relationship including franchising, partnering and joint venturing.
Our
licensing program is broken down into four operating modules corresponding to our CELLECTR, ATGRAFT™,
ATCELL™ and Contract Manufacturing services. Our proposed international development program offers the opportunity
to develop and establish a global footprint of American CryoStem’s laboratory services and patented products. The platform
allows the Company’s laboratory services, technology and products to become the core platform to implement cellular therapies
and regenerative medicine in licensed territories globally.
On
June 25, 2014, the Company entered into an agreement with Health Innovative Technology Corporation Limited, Hong Kong (“HIT”)
for the licensing of our ATGRAFT tissue storage product. Pursuant to the terms of the Agreement, American CryoStem has licensed
to HIT the exclusive rights to utilize the Company’s Standard Operating Procedures (SOP’s) to create and market the
Company’s ATGRAFT™ tissue storage service in Hong Kong. The financial terms call for annual minimum licensing payments
for a period of three years as well as additional royalty payments based on gross revenue. HIT will also purchase CRYO’s
ACSelerate™ storage media and other products necessary for clinical collection, processing and storage of Adipose Tissue.
Upon execution CRYO received the initial payment of the minimum annual licensing fee with the balance of first year licensing
payments due prior to full commercial launch of the ATGRAFT™ service in Hong Kong. HIT currently operates a cord blood,
cellular processing and banking platform and, offers comprehensive healthcare solutions to clients in Hong Kong.
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. 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
and Partnering Opportunities
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 patented products
designed for the wound healing market. Research and development has been ongoing since late 2012 and notable progress has been
achieved. In October of 2014, the early results of this initiative was the subject of local media coverage in Arizona showcasing
the groundwork laid by PGEN, DES and American CryoStem in providing assistance in what we believe is a quicker way to heal skin
injuries using a patient’s stem cells.
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 have 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™ product. Management believes the publication of the preliminary results
showed successful healing of full depth wounds on the backs of immune deficient mice. Following this publication the partnership
agreed to file grant applications to fund the additional research. The grant applications were prepared and filed in 2014.
Our
collaborative research has established that membrane scaffolds fabricated from human proteins can be cultivated with ATCELL cells
causing the scaffolds to rapidly, completely become covered by the cells. We believe 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. The next step in developing this remarkable result is preclinical
and clinical studies in humans.
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.
In
December of 2012, American CryoStem and Rutgers University executed a Collaboration and Research Agreement involving stem cell
differentiation molecules and molecular biological reagents under the direction and supervision of Dr. KiBum Lee, the PRINCIPAL
INVESTIGATOR (PI). Our collaborative efforts have advanced rapidly and new intellectual property resulted from this work. Based
on the collaborative efforts under the Collaboration and Research Agreement, our Company’s patent counsel prepared patent
applications based upon earlier developments which are now optioned to American CryoStem. In addition, American CryoStem’s
agreement with Rutgers University allows us the use of intellectual property and biomaterials developed by Dr. Lee and his team
in combination with our ATCELL™ and ACSelerate™ products for the development of new
cellular therapies and regenerative medicine applications. To support the new discoveries, Dr. Lee and our professionals
will develop, file and publish patent applications, research papers, government and private grant funding applications to support
future clinical studies as appropriate.
During
2013 and 2014 the Company and Dr. Lee’s team investigated various combinations of NanoScript and ATCELL™ focused
on the regeneration of neural, cartilage and muscle cells. This research led to filing a new patent jointly owned by Rutgers and
the Company entitled “Nanoparticle-Mediated Synthetic Transcription Factor from Enhanced Gene Expression and Cell Differentiation”
and the publication of papers and posters by Dr. Lee’s team. Dr. Lee’s team also received an initial seed grant to
Dr. Lee from Rutgers neural engineering group. The team is continuing its research, the creation of scientific papers and in 2014
filed for a new grant with the National Institute of Health.
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.
Institutional
Review Board Approval of Protocols
In
2013 we obtained 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 were, 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. 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 another Institutional Review Board; 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 Human 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
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.
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 and the first patient was treated by Dr. Lou Cona, Principal Investigator,
at the DaVinci on November 1, 2014. The IRB filing can be found on www.clinicaltrials.gov, (ClinicalTrials.gov Identifier
NCT02326935).
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 result 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 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 ATCELL™
and ATGRAFT™ prepared with our patent pending line of ACSelerate cell culture mediums. 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.
Our
Company has multiple patent applications for our products and methods to be used in the IRB studies, which include:
|
· |
ACSelerate-SF™
(animal serum free) adipose stromal cell culture and differentiation medium in clinical and research grades; |
|
· |
The CELLECT®
collection and tracking system for collecting tissue and cellular samples; |
|
· |
Adipose tissue,
stromal vascular fraction (SVF) and adipose-derived mesenchymal cell processing, expansion and differentiation; |
|
· |
Storage preparation
methods for adipose tissue, stromal vascular fraction (SVF) and adipose derived cellular samples; |
|
· |
Testing and quality
management methods, systems, data collection and maintenance; |
|
· |
Cryoprotectant
for the storage of adipose tissue samples; and |
|
· |
The ATGRAFT™
service for the collection, preparation, storage and retrieval of adipose tissue for cosmetic and plastic surgery biocompatible
fillers. |
Regulatory
Information
The
Company has spent years developing processing methodologies and laboratory facilities which are designed to be in compliance with
all current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) 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 Mount Laurel 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. We renew the
registrations as required. These state registrations required the submission of our SOPs for review by the respective State Health
Departments, and annual updates to maintain the registrations are required. Our New Jersey Medical Waste Generator registration
number is 036439.
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
SOPs, which we periodically review with our FDA consultants.
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 are and 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 help to ensure that every sample that is collected and processed is sterile (free
from adventitious agents), viable and capable of significant growth and expansion. While published studies generally report total
viable cells, our assessment testing also reports each sample’s growth capabilities.
Quality
Management
The
Company’s quality management program ensures that during processing and testing of each adipose tissue 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 cGMP/cGTP 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 seven pending patent applications, one joint patent filing with Rutgers University,
and 8 in-licensed patents which are detailed in the following charts:
American
CryoStem Patents:
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 |
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
Albumin Serum for Cell Culture Medium for Clinical Growth of Human Adipose Stromal Cells. |
New
formulation for an advanced animal product free medium formulation |
US
Serial No. 62/098799 filed December 31, 2014 |
Jointly
Owned and in licensed Patents;
PATENT
TITLE |
USE
OF PATENT |
APPLICATION
# |
Nanoparticle-Mediated
Synthetic Transcription Factor from Enhanced Gene Expression and Cell Differentiation |
Rutgers
collaboration and R&D |
Rutgers
Docket Number 20113-013
USPTO
Provisional Filing No. 61/947,898 |
Direct
Stamping-Assisted Graphene Oxide Patterned Substrates for Controlling Adipose Derived Adult Stem Cell Differentiation |
Rutgers
collaboration and R&D |
Rutgers
Docket Number 2014-024 |
Single
Vehicular Delivery of siRNA and Small Molecules to Control Stem Cell Differentiation |
Rutgers
collaboration and R&D |
Docket
Number 2014-034 |
Devices
and Methods to Guide Stem Cell Differentiation Using Graphene Nanofiber Hybrid Scaffold |
Rutgers
collaboration and R&D |
US
Provisional Filing No. 61/978,177 |
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-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. The combination of a traditional sales approach, supported by continuous internal and external marketing programs,
are/will be 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 2013. 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.
A
recent report published by Markets and Markets Research in July 2014 titled “Cell Culture Market by Equipment (Bioreactor,
Incubator, Centrifuge), by Reagent (Media, Sera, Growth Factors, Serum Free Media), by Application (Cancer Research, Gene Therapy,
Drug Development, Vaccine Production, Toxicity Testing) - Global Forecast to 2018” July 2014. (http://www.marketsandmarkets.com/Market-Reports/cell-culture-market-media-sera-reagents-559.html)
The
report states that “The global cell culture market was valued at $ 14,772 million in 2013 and is poised to grow at a
CAGR of 10.71% between 2013 and 2018, to reach $24,574 million in 2018. Rapid increase in biopharmaceutical production and increasing
healthcare expenditure will be the two most important growth drivers for this market in the forecast period from 2013 to 2018.
Biopharmaceutical production had the largest share of the cell culture market in 2013. According to IMS Health, biopharmaceutical
is expected to one of the fastest growing pharmaceutical segment between 2012 and 2017. The increasing demand for biopharmaceutical
products like vaccines and antibodies coupled with strong pipelines for biopharmaceuticals and increasing healthcare expenditure
will drive the demand for cell culture products.”
The
Report further states that “The global cell culture market comprises of cell culture equipment and cell culture media,
sera, and reagent markets. The cell culture equipment market consists of five equipment segments, namely, lab equipment, bio-safety
cabinets, consumables, storage equipment, and sterilization equipment. On the other hand, the cell culture media, sera, and reagents
market consists of six segments, namely, serum, media, lab reagents, contamination detection kits, cryoprotective agents, and
other reagents.
The
application segments included in this report are biopharmaceutical production, tissue culture and engineering, vaccine production,
drug screening and development, gene therapy, toxicity testing, cancer research, and other applications. The biopharmaceutical
application segment had the largest share of the cell culture market in 2013, owing to the large demand for cell culture sera,
media, and reagents for biopharmaceutical production.”
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
According
to BCC Research (January 2013), the market for Regenerative Medicine continues to grow worldwide. “It is expected to
accelerate at roughly 12% annually, from $3.8 billion in 2011 to $6.6 billion in 2016”. BCC Research states “the
American market for stem cell products was $1.3 billion in 2011. This sector is expected to rise at a CAGR of 11.5% and reach
nearly $2.3 billion by 2016. The European market for stem cell products was $872 million in 2011 and is expected to reach nearly
$1.5 billion by 2016, a CAGR of 10.9.”2
Medical
Tourism, Global Wellness Tourism
As
stated by the Global Wellness Institute; adding up all expenditures made by international/inbound and domestic, primary and secondary
wellness tourists, we estimate the wellness tourism industry to be $494 billion in 2013, a 12.7% increase over 2012. Wellness
tourism accounts for 14.6% of all tourism expenditures and is growing much faster than the 7.3% growth rate for overall tourism
expenditures from 2012-2013.
The
$494 billion in wellness tourism expenditures represent 586.5 million wellness trips taken in 2013, across 211 countries. Wellness
tourism accounts for about 6.2% of all domestic and international tourism trips taken in 2013.
http://www.globalwellnesssummit.com/images/stories/gsws2014/pdf/GWI_Global_Spa_and_Wellness_Economy_Monitor_Full_Report_Final.pdf
Cell
Culture Market
The
Company believes the reproducibility of scientific studies has become a substantial issue in life science research from drug discovery
and development through clinical trials as researchers throughout the world continue to use different protocols for processes
associated with sample preparation, cryopreservation and cold chain management. We believe the scientific community is becoming
more aware of factors that affect sample integrity and experiment variability. By standardizing handling, storage, and transportation
protocols we believe we can substantially improve the quality and reproducibility of preclinical and clinical data which we believe
will help to accelerate the transition from lab research to drug development and market launch.
1 http://www.trimarkpublications.com/regenerative-medicine-markets/
2http://www.bccresearch.com/market-research/biotechnology/stem-cells-global-markets-bio035d.html
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 2016.3
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
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.
3 http://www.researchandmarkets.com/research/mbmvbh/global
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.
Health
Information Technology Company, LTD
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.
BALS
Institute
On
April 23, 2013, we announced receipt of our first commercial international shipment of adipose tissue for processing and long
term cryostorage. The master sample was shipped to the Company by BALS (Biomedical and Life Sciences) Institute (BALS), a Hong
Kong-based regenerative medicine company and client of Personal Cell Sciences Corp. (PCS), the developer of U-Autologous skin
care products and formulations. In 2014 BALS and PCS mutually terminated their relationship.
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 Mount Laurel, New
Jersey at the Burlington County College Science Incubator located on the Burlington County College campus. 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 $5,508 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 $22,107 during the six months ended March 31, 2015 in professional fees (legal, accounting and consultants) and $ 83,634in
Research and Development.
Commitments
As
of the date of this quarterly report, the Company’s material capital commitments were (i) the continued funding of the expansion
of our marketing efforts and laboratory processing capabilities; and (ii) the current two-year lease for the laboratory spaces
at the Burlington County College Science Incubator, Laboratory 110 and 108, which was renewed for an additional three year period
on February1, 2014 and is subject to a monthly payment of $3,300.
The
Company has an operating lease for its main office facility located at 1 Meridian Road, Eatontown, New Jersey 07724. The lease
is for a term of three years with a monthly rent of $2,650. The total rent for office facilities for the three months ended March
31, 2015 was $7,950.
The
Company has unsecured liabilities without interest of $132,947 due to ACS Global, the majority shareholder of the Company, for
certain prepaid expenses made by ACS Global prior to the closing of the transaction. There is no due date associated with this
liability.
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 March 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 March 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
the six months ended March 31, 2015 the company issued $327,500 of its 8% convertible notes due 9/30/2016. The notes are convertible
into common shares of the Company at $0.30
There
are additional $159,500 of convertible notes, all of which are convertible at $0.35 per share, outstanding as of the date of this
report.
The
Company has outstanding $596,000 of 8% Notes. The Notes are due one year from their date of issuance. In addition each purchaser
of the Notes received an option to purchase one share of the Company’s common stock at $0.05 per share for each dollar of
principal. The Company issued options to purchase 596,000 common shares to the note holders. The options expire one year from
the date the note is repaid.
During
the six months ended March 31, 2015, holders of the convertible debt converted $8,500 of convertible debt and the Company issued
24,286 shares of common stock.
During
fiscal year 2014, holders of the convertible debt converted $152,300 of convertible debt and the Company issued 435,143 shares
of common stock.
During
fiscal year 2013, the Company issued 3,467,359 shares of common stock as a result of the convertible notes exercised.
During
fiscal year 2013, the Company issued 660,000 shares of common stock to consultants for services rendered valued at $236,000.
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
|
|
|
|
May
15, 2015 |
By: |
/s/
John Arnone |
|
|
John
Arnone, Chief Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
May
15, 2015 |
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:
May 15, 2015 |
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:
May 15, 2015 |
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 March 31, 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 March 31, 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 March 31, 2015 fairly presents, in all material
respects, the financial condition and results of operations of the Company. |
Dated: May
15, 2015 |
By: |
/s/
John Arnone |
|
|
|
John
Arnone |
|
|
|
Chief
Executive Officer
American
CryoStem Corporation |
|
Dated:
May 15, 2015 |
By: |
/s/
Anthony Dudzinski |
|
|
|
Anthony
Dudzinski |
|
|
|
Treasurer
American
CryoStem Corporation |
|
American Cryostem (CE) (USOTC:CRYO)
Historical Stock Chart
From Jun 2024 to Jul 2024
American Cryostem (CE) (USOTC:CRYO)
Historical Stock Chart
From Jul 2023 to Jul 2024