This annual report on Form 10-K and other reports filed by American CryoStem
Corporation (the "Company") from time to time with the U.S. Securities and
Exchange Commission (the "SEC") contain or may contain forward-looking
statements and information that are based upon beliefs of, and information
currently available to, the Company's management as well as estimates and
assumptions made by Company's management. Readers are cautioned not to place
undue reliance on these forward-looking statements, which are only predictions
and speak only as of the date hereof. When used in the filings, the words
"anticipate," "believe," "estimate," "expect," "future," "intend," "plan," or
the negative of these terms and similar expressions as they relate to the
Company or the Company's management identify forward-looking statements. Such
statements reflect the current view of the Company with respect to future events
and are subject to risks, uncertainties, assumptions, and other factors,
including the risks contained in the "Risk Factors" section of the this Annual
Report on Form 10-K., relating to the Company's industry, the Company's
operations and results of operations, and any businesses that the Company may
acquire. Should one or more of these risks or uncertainties materialize, or
should the underlying assumptions prove incorrect, actual results may differ
significantly from those anticipated, believed, estimated, expected, intended,
or planned.
Although the Company believes that the expectations reflected in the
forward-looking statements are reasonable, the Company cannot guarantee future
results, levels of activity, performance, or achievements. Except as required by
applicable law, including the securities laws of the United States, the Company
does not intend to update any of the forward-looking statements to conform these
statements to actual results.
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Our financial statements are prepared in accordance with accounting principles
generally accepted in the United States ("GAAP"). These accounting principles
require us to make certain estimates, judgments and assumptions. We believe that
the estimates, judgments and assumptions upon which we rely are reasonable based
upon information available to us at the time that these estimates, judgments and
assumptions are made. These estimates, judgments and assumptions can affect the
reported amounts of assets and liabilities as of the date of the financial
statements as well as the reported amounts of revenues and expenses during the
periods presented. Our financial statements would be affected to the extent
there are material differences between these estimates and actual results. In
many cases, the accounting treatment of a particular transaction is specifically
dictated by GAAP and does not require management's judgment in its application.
There are also areas in which management's judgment in selecting any available
alternative would not produce a materially different result. The following
discussion should be read in conjunction with our consolidated financial
statements and notes thereto appearing elsewhere in this report.
Background
We were 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 our common stock, par value $0.001 per
share, to ACS (the "Asset Purchase"). We filed a Current Report on Form 8-K with
the Securities and Exchange Commission on April 27, 2011 disclosing the Asset
Purchase and certain related matters including, but not limited to, the
appointment of our present officers and directors as well as the resignation by
the former chief executive officer and sole director. Our fiscal year ends
September 30 of each calendar year.
Overview
American CryoStem Corporation, which we refer to as "we," "us," "our" and "our
Company," is a developer, marketer and global licensor of patented adipose
tissue-based cellular technologies and related proprietary services with a focus
on processing, commercial bio-banking and application development for adipose
(fat) tissue and autologous adipose-derived regenerative cells (ADRCs). We
maintain a strategic portfolio of intellectual property and patent applications
that form our Adipose Tissue Processing Platform, which supports and promotes a
growing pipeline of biologic products and processes, services and international
licensing opportunities. Through our ACS Laboratories division, we operate an
FDA registered, human tissue processing, cryopreservation, and cell culture and
differentiation media development facility in Monmouth Junction, New Jersey.
Our growth strategy is centered on expanding our research and development
through scientific collaborations to fully capitalize on (1) scientific
breakthroughs that have been rapidly shaping the fast growing Regenerative and
Personalized Medicine industries; (2) to provide these growth industries with a
standardized cell processing platform and, (3) to enhance the delivery of
healthcare through cellular-based therapies and applications which address
disease treatment, wound and burn healing, joint repair and management, and
personalized health and beauty care.
Through our ACS Laboratories division, our Company operates its FDA registered,
human tissue processing, cryopreservation and cell culture and differentiation
media development facility in Monmouth Junction, New Jersey. On a mission to
fulfill the pressing need to set a global gold standard for end-to-end
collection, processing, tracking and storage, American CryoStem has spent nearly
years designing and constructing the necessary framework capable of replicating
its protocols in markets around the world.
American CryoStem continues to focus on expanding and securing additional
licensing arrangements with qualified partners around the world to institute and
operate its turnkey laboratories that are properly equipped for processing and
storing adipose tissue and ADSCs for use in Regenerative and Personalized
Medicine applications.
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 12 to 24 months. In order to finance further market
development with the associated expansion of operational capabilities for the
time period discussed above, we will need to raise additional working capital.
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.
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In order to move our Company through its next critical growth phase of
development and commercialization and to ensure we are in position to support
our research collaborations and market penetration strategies, Management
continues to seek new investment into the Company from existing and new
investors with particular emphasis on identifying the best deal structure to
attract and retain meaningful capital sponsorship from both the retail and
institutional investing communities, while limiting dilution to our current
shareholders. Management also focuses its efforts on increasing sales and
licensing revenue and reducing expenses.
Fiscal 2020 Operations
In Fiscal 2020, the Company's Total Revenue increased to $557,903 from $321,647
in Fiscal 2019, due to a discontinuation of the moratorium on billing of fees to
Baoxin. Accounts Receivable increased to $500,000 in Fiscal 2020 from $330,154
in Fiscal 2019 due to increased fees receivable from International Licensees. In
Fiscal 2020 Consulting Fees, Licensing Fees and Royalties increased to $523,333
from $269,757 in Fiscal 2019. Short term liabilities decreased to $1,049,634 in
Fiscal 2020 from $1,292,206 in Fiscal 2019 due to reduction of liabilities to
contractors, consultants and professionals. Long term debt decreased to $848,414
in 2020 from $1,239,716 in 2019; due to movement of convertible debt from long
term to current, payment of accrued salary and pay down of debt to the parent
company. Cost of Sales increased to $43,837 in Fiscal 2020 from $31,876 in
Fiscal 2019. Research and Development decreased to $19,176 in 2020 from $224,792
in 2019, since the company reduced its labor force and research and development
contractors in response to the COVID-19 pandemic. Laboratory Expense was reduced
to $74,093 in Fiscal 2020 from $156,512, due to reduction in activity, staffing
and facilities required. Stock Compensation increased to $417,542 in Fiscal 2020
from $125,403, primarily due to stock options granted. Bad Debt Expense
increased to $326,650 in Fiscal 2020 from $10,935 in Fiscal 2019. Management
increased its allowance for Bad Debt by $326,650. The majority of the increase
in Bad Debt Allowance was caused by Management's concern for its International
Partner, Baoxin's ability to pay caused by the COVID-19 Pandemic. General and
Administrative Expenses were reduced to $439,577 in Fiscal 2020 from $587,791 in
Fiscal 2019, since the company reduced payroll and consultants costs.
Going Concern
As of the date of this annual 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 proposed business.
We have suffered recurring losses from operations since our inception. In
addition, we have yet to generate an internal cash flow from our business
operations or successfully raised the financing required to expand 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. Our continued existence is dependent upon our ability to resolve our
liquidity problems and achieve 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
As of the fiscal year ended September 30, 2020, the Company had a cash balance
of $41,760 and accounts receivable of $500,000. Our sources of funds in 2020
were tissue processing and storage fees, international product sales, consulting
and licensing fees, and financing activities. In Fiscal 2020, we used $514,648
of net cash for Operations, and $12,731 for investment activities, including
Patent Development, and the purchase of computer equipment at the corporate
office. Additionally, the Company generated $545,339 from financing activities,
which included option exercises, issuance of convertible notes, issuance of
common stock and proceeds from the PPP Loan. The Company also paid down a
portion of its Finance Lease and debt to its parent company.
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The Company will continue to focus on its financing and investment activities
but 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.
There was no significant impact on the Company's operations as a result of
inflation for the fiscal year ended September 30, 2020.
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. See Note 1 and Note 3 of the
Financial Statements for additional information.
Basis of Presentation
Our financial statements are presented on the accrual basis of accounting in
accordance with generally accepted accounting principles in the United States of
America, whereby revenues are recognized in the period earned and expenses when
incurred.
Management's Use of Estimates
The preparation of financial statements in conformity with GAAP requires
management to make estimates and assumptions that affect the reported amounts of
assets and liabilities at the date of the financial statements and the reported
amounts of revenues and expenses during the reporting periods. Actual results
could differ from those estimates.
Long-Lived Assets
We review and evaluate our long-lived assets for impairment whenever events or
changes in circumstances indicate that their net book value may not be
recoverable. When such factors and circumstances exist, we compare the assets'
carrying amounts against the estimated undiscounted cash flows to be generated
by those assets over their estimated useful lives. If the carrying amounts are
greater than the undiscounted cash flows, the fair values of those assets are
estimated by discounting the projected cash flows. Any excess of the carrying
amounts over the fair values are recorded as impairments in that fiscal period.
Statement of Cash Flows
For purposes of the statement of cash flows, we consider all highly liquid
investments (i.e., investments which, when purchased, have original maturities
of three months or less) to be cash equivalents.
Fair Value of Financial Instruments
Our financial instruments consist of cash and cash equivalents. The fair value
of cash and cash equivalents approximates the recorded amounts because of the
liquidity and short-term nature of these items.
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Recent Accounting Pronouncements
In June 2016, the FASB issued ASU No. 2016-13 Financial Instruments-Credit
Losses. The new guidance provides better representation about expected credit
losses on financial instruments. This Update requires the use of a methodology
that reflects expected losses and requires consideration of a broader range of
reasonable and supportive information to inform credit loss estimates. This ASU
is effective for reporting periods beginning after December 15, 2022, with early
adoption permitted. The company is studying the impact of adopting the ASU in
fiscal year 2024, and what effect it could have. The Company believes the
accounting change would not have a material effect on the financial statements.
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). ASU 2016-02
which requires lessees to recognize lease assets and lease liabilities on the
balance sheet for all leases with terms longer than 12 months; and requires
expanded disclosures about leasing arrangements. ASU 2016-02 is effective for
fiscal years beginning after December 15, 2018 and interim periods in fiscal
years beginning after December 15, 2018, with early adoption permitted. ASU
2016-02 and additional ASUs are now codified as Accounting Standards
Codification Standard ("ASC") 842 - Leases ("ASC 842"). The Company adopted ASC
842 on October 1, 2019 and used the modified retrospective transition approach
and did not restate its comparative periods. As of the date of implementation on
October 1, 2019, the impact of the adoption of ASC 842 resulted in the
recognition of a Finance Lease Right-of-Use-Asset and an Operating Lease
Right-of-use-Asset and corresponding Lease Liability Obligations on the
Company's consolidated balance sheets. The Company elected to not recognize
lease assets and lease liabilities for leases with an initial term of 12 months
or less.
As the Right of use asset and the corresponding Lease Liability obligation were
the same upon adoption of ASC 842, there was no cumulative effect impact on the
Company's accumulated deficit. Since the Equipment Asset related to the Capital
Lease and the Finance Lease Asset established had different values, the Company
recorded a cumulative effect modification on October 31, 2019 by a reducing
equity (increasing the accumulated deficit) by $41,804.
In November 2018, the FASB issued ASU 2018-18, Clarifying the Interaction
between Topic 808 and Topic 606. This new ASU applies to companies that have
collaborative arrangements, or agreements that involve two parties that actively
participate in a joint operating activity. We believe our contract with Baoxin
falls under the collaborative arrangements guidance in (ASC 808). ASU 2018-18 is
effective for public companies for years beginning after December 15, 2019. The
Company plans to implement ASU 2018-18 in Fiscal 2021 and is currently assessing
the impact on its contracts.
Related Party Transactions.
At September 30, 2020, the Company was indebted to a company that is majority
owned by the Company's two chief executive officers for $99,125.
The advances are due on demand, are unsecured, and carry no interest rate.
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