SIGYN
THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
See
accompanying notes to unaudited condensed consolidated financial statements.
SIGYN
THERAPEUTICS, INC.
UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
See
accompanying notes to unaudited condensed consolidated financial statements.
SIGYN
THERAPEUTICS, INC.
UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF SHAREHOLDERS’ EQUITY (DEFICIT)
See
accompanying notes to unaudited condensed consolidated financial statements.
SIGYN
THERAPEUTICS, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
See
accompanying notes to unaudited condensed consolidated financial statements.
SIGYN THERAPEUTICS, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
NOTE
1 – ORGANIZATION AND PRINCIPAL ACTIVITIES
Corporate
History and Background
Sigyn
Therapeutics, Inc. (“Sigyn” or the “Company”) was incorporated on October 29, 2019 in the State of Delaware.
We are a development-stage therapeutic technology company that is headquartered in San Diego, California USA. Our primary focus is directed
toward a significant unmet need in global health: the treatment of acute life-threatening inflammatory conditions that are precipitated
by Cytokine Storm Syndrome (“The Cytokine Storm” or “Cytokine Release Syndrome”) and not addressed with approved
drug therapies. Cytokine Storm Syndrome is a dysregulated immune response that can be induced by a wide range of infectious and non-infectious
conditions. A hallmark of the Cytokine Storm is an over-production of inflammatory cytokines, which can destroy tissue, trigger multiple-organ
failure and cause death.
On
October 19, 2020, Reign Resources Corporation, a Delaware corporation (the “Registrant”) completed a Share Exchange Agreement
(the “Agreement”) with our organization (Sigyn Therapeutics) that resulted in the registrant acquiring 100% of our issued
and outstanding shares of common stock in exchange for 75% of the fully paid and nonassessable shares of the Registrant’s common
stock outstanding (the “Acquisition”). In conjunction with the transaction, the Registrant changed its name to Sigyn Therapeutics,
Inc. pursuant to an amendment to its articles of incorporation that was filed with the State of Delaware. Subsequently, the Registrant’s
trading symbol was changed to SIGY. The Acquisition was treated by the Company as a reverse merger in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”). For accounting purposes, Sigyn is considered to have acquired
the Registrant as the accounting acquirer because: (i) Sigyn stockholders own 75% of the combined company, on an as-converted basis,
immediately following the Closing Date, (ii) Sigyn directors hold a majority of board seats in the combined company and (iii) Sigyn management
held all key positions in the management of the combined company. Accordingly, Sigyn’s historical results of operations will replace
the registrant’s historical results of operations for all periods prior to the Acquisition and, for all periods following the Acquisition,
the results of operations of the combined company will be included in the Company’s financial statements. The
Acquisition was treated as a “tax-free exchange” under Section 368 of the Internal Revenue Code of 1986 and resulted in the
Sigyn corporate entity (established on October 29, 2019) to become a wholly owned subsidiary of the Registrant. Among the conditions
for closing the acquisition, the Registrant extinguished all previously reported liabilities, its preferred class of shares, and all
stock purchase options. As a result, the reported liabilities totaling $3,429,516 were converted into a total of 7,907,351 common shares.
Additionally, assets held on the books of Reign Resources Corporation, such as Gem inventory, was
kept in the Company and therefore recorded as assets on the Share Exchange date. The Registrant’s Board of Directors appointed
James A. Joyce and Craig P. Roberts to serve as members of the Registrant’s Board of Directors upon closing of the Acquisition.
As
of November 12, 2021, we have a total 37,295,803 shares issued and outstanding, of which 11,655,083 shares are held by non-affiliate
shareholders.
About
Sigyn Therapy
Sigyn
Therapy is a novel blood purification technology designed to mitigate cytokine storm syndrome through the broad-spectrum depletion of
inflammatory targets from the bloodstream. Sigyn Therapy’s mechanism of action allows for it to be implemented on the established
infrastructure of dialysis and CRRT machines that are already located in hospitals and clinics worldwide. Cytokine Storm Syndrome is
a hallmark of sepsis, which is the most common cause of in-hospital deaths and claims more lives each year than all forms of cancer combined.
Virus induced cytokine storm (VICS) is associated with high mortality and is a leading cause of SARS-CoV-2 (COVID-19) deaths. Other therapeutic
opportunities include but are not limited to bacteria induced cytokine storm (BICS), acute respiratory distress syndrome (ARDS) and acute
forms of liver failure such as Hepatic Encephalopathy, which is associated with elevated levels of toxins and inflammatory cytokines
in the bloodstream.
Recent
Developments
Since
December 1, 2020, we have reported the results from a series of in vitro blood purification studies that have demonstrated the
expansive capabilities of Sigyn Therapy to address pathogen sources of inflammation, deadly toxins and relevant inflammatory mediators.
Among
the therapeutic targets validated were viral pathogens (including COVID-19), bacterial endotoxin, relevant inflammatory cytokines (Interleukin-1
beta, Interleukin-6 and Tumor Necrosis Factor alpha) and hepatic toxins (ammonia, bilirubin, and bile acid). We also completed a study
that modeled our ability to capture CytoVesicles that transport inflammatory cargos throughout the bloodstream.
Contributing
to these expansive capabilities is a formulation of adsorbent components that are incorporated within Sigyn Therapy. Our adsorbent formulation
provides more than 170,000 square meters of surface area on which to adsorb and remove bloodstream targets. This equates to more than
40 acres of surface adsorption area in each adult version of Sigyn Therapy. To date, we have demonstrated that Sigyn Therapy can addresses
inflammatory targets as well as pathogen sources of inflammation whose molecular size can exceed 100 nanometers in size.
On
July 29, 2020, we disclosed the completion of our first-in-mammal pilot study that demonstrated the safe administration of Sigyn Therapy
during six-hour treatment exposures. In coming months, we plan to continue our collection of animal safety data, which will be included
in an Investigational Device Exemption (IDE) that we are drafting for submission to The United States Food and Drug Administration (FDA)
to support the potential initiation of human clinical studies. However, there is no assurance that FDA will permit the initiation of
our proposed human studies in the United States.
Since January 1, 2020, we have raised a total
of $2,840,010 through the sale of Common Shares of $1,865,000 and convertible promissory debentures of $975, 010 in transactions exempt
from registration under section 4(a)(2) of the Securities Act.
NOTE
2 – BASIS OF PRESENTATION
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (“GAAP”) and include all adjustments necessary for the fair presentation of the
Company’s financial position and results of operations for the periods presented.
The
Company currently operates in one business segment. The Company is not organized by market and is managed and operated as one business.
A single management team reports to the chief operating decision maker, the Chief Executive Officer, who comprehensively manages the
entire business. The Company does not currently operate any separate lines of businesses or separate business entities.
Going
Concern
The
accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern,
which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. The
Company had an accumulated deficit of $3,039,000 at September 30, 2021, had working capital of $287,000 at September 30, 2021 and $76,000
at December 31, 2020, respectively, had a net loss of $666,000 and $1,777,000 for the three and nine months ended September 30, 2021,
and net cash used in operating activities of $1,221,000 for the nine months ended September 30, 2021, with no revenue earned since inception,
and a lack of operational history. These matters raise substantial doubt about the Company’s ability to continue as a going concern.
While
the Company is attempting to expand its research and development activities, the Company’s cash position may not be significant
enough to support the Company’s daily operations. Management intends to raise additional funds by way of a private offering or
an asset sale transaction. Management believes that the actions presently being taken to further implement its business plan and generate
revenues provide the opportunity for the Company to continue as a going concern. While management believes in the viability of its strategy
to generate revenues and in its ability to raise additional funds or transact an asset sale, there can be no assurances to that effect
or on terms acceptable to the Company. The ability of the Company to continue as a going concern is dependent upon the Company’s
ability to further implement its business plan and generate revenues.
The
unaudited condensed consolidated financial statements do not include any adjustments that might be necessary if the Company is unable
to continue as a going concern.
NOTE
3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
This
summary of significant accounting policies of the Company is presented to assist in understanding the Company’s unaudited condensed
consolidated financial statements. The unaudited condensed consolidated financial statements and notes are representations of the Company’s
management, which is responsible for their integrity and objectivity. These accounting policies conform to GAAP and have been consistently
applied in the preparation of the unaudited condensed consolidated financial statements.
Use
of Estimates
The
preparation of these unaudited condensed consolidated financial statements in accordance with accounting principles generally accepted
in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosures of contingent assets and liabilities at the dates of the unaudited condensed consolidated financial statements
and the reported amounts of net sales and expenses during the reported periods. Actual results may differ from those estimates and such
differences may be material to the unaudited condensed consolidated financial statements. The more significant estimates and assumptions
by management include among others: realizability of inventory, common stock valuation, and the recoverability of intangibles. The current
economic environment has increased the degree of uncertainty inherent in these estimates and assumptions.
Cash
The
Company’s cash is held in bank accounts in the United States and is insured by the Federal Deposit Insurance Corporation (FDIC)
up to $250,000 for all single accounts owned by
the same person at the same bank. The Company
has not experienced any cash losses.
Income
Taxes
Income
taxes are accounted for under an asset and liability approach. This process involves calculating the temporary and permanent differences
between the carrying amounts of the assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
The temporary differences result in deferred tax assets and liabilities, which would be recorded on the Balance Sheets in accordance
with ASC 740, which established financial accounting and reporting standards for the effect of income taxes. The likelihood that its
deferred tax assets will be recovered from future taxable income must be assessed and, to the extent that recovery is not likely, a valuation
allowance is established. Changes in the valuation allowance in a period are recorded through the income tax provision in the consolidated
Statements of Operations.
ASC
740-10-30 was adopted from the date of its inception. ASC 740-10 clarifies the accounting for uncertainty in income taxes recognized
in an entity’s consolidated financial statements and prescribes a recognition threshold and measurement attributes for financial
statement disclosure of tax positions taken or expected to be taken on a tax return. Under ASC 740-10, the impact of an uncertain income
tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit
by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being
sustained. Additionally, ASC 740-10 provides guidance on derecognition, classification, interest and penalties, accounting in interim
periods, disclosure and transition. As a result of the adoption of ASC 740-10 and currently, the Company does not have a liability for
unrecognized income tax benefits.
Advertising
and Marketing Costs
Advertising
expenses are recorded as general and administrative expenses when they are incurred. The Company had no advertising expenses for the
three and nine months ended September 30, 2021, respectively, and had $400 and $505 for the three and nine months ended September 30,
2020, respectively.
Inventories
In
conjunction with the October 19, 2020 Share Exchange Agreement, the Company kept the gem inventory of Reign Resources Corporation. Inventories
are stated at the lower of cost or market (net realizable value) on a lot basis each quarter. A lot is determined by the cut, clarity,
size, and weight of the sapphires. Inventory consists of sapphire jewels that meet rigorous grading criteria and are of cuts and sizes
most commonly used in the jewelry industry. As of September 30, 2021 and December 31, 2020, the Company carried primarily loose sapphire
jewels, jewelry for sale on our website, and jewelry held as samples. Samples are used to show potential customers what the jewelry would
look like. Promotional items given to customers that are not expected to be returned will be removed from inventory and expensed. There
have been no promotional items given to customers as of September 30, 2021. The Company performs its own in-house assessment based on
gem guide and the current market price for metals to value its inventory on an annual basis or if circumstances dictate sooner to determine
if the estimated fair value is greater or less than cost. In addition, the inventory is reviewed each quarter by the Company against
industry prices from gem-guide and if there is a potential impairment, the Company would appraise the inventory. The estimated fair value
is subject to significant change due to changes in popularity of cut, perceived grade of the clarity of the sapphires, the number, type
and size of inclusions, the availability of other similar quality and size sapphires, and other factors. As a result, the internal assessed
value of the sapphires could be significantly lower from the current estimated fair value. Loose sapphire jewels do not degrade in quality
over time. The estimated fair value per management’s internal assessment is greater than the cost, therefore, there is no indicator
of impairment as of September 30, 2021.
Property
and Equipment
Property
and equipment are carried at cost and are depreciated on a straight-line basis over the estimated useful lives of the assets, generally
five years. The cost of repairs and maintenance is expensed as incurred; major replacements and improvements are capitalized. When assets
are retired or disposed of, the cost and accumulated depreciation are removed from the accounts, and any resulting gains or losses are
included in income in the year of disposition.
Intangible
Assets
Intangible
assets consist primarily of website development costs. Our intangible assets are being amortized on a straight-line basis over a period
of three years.
Assignment
of Patent
On
January 8, 2020, James Joyce, the Company’s CEO and Craig Roberts, the Company’s CTO, assigned to the Company the rights
to patent 62/881,740 pertaining to the devices, systems and methods for the broad-spectrum reduction of pro-inflammatory cytokines in
blood in exchange for founder’s shares.
Impairment
of Long-lived Assets
We
periodically evaluate whether the carrying value of property, equipment and intangible assets has been impaired when circumstances indicate
the carrying value of those assets may not be recoverable. The carrying amount is not recoverable if it exceeds the sum of the undiscounted
cash flows expected to result from the use and eventual disposition of the asset. If the carrying value is not recoverable, the impairment
loss is measured as the excess of the asset’s carrying value over its fair value.
Our
impairment analysis requires management to apply judgment in estimating future cash flows as well as asset fair values, including forecasting
useful lives of the assets, assessing the probability of different outcomes, and selecting the discount rate that reflects the risk inherent
in future cash flows. If the carrying value is not recoverable, we assess the fair value of long-lived assets using commonly accepted
techniques, and may use more than one method, including, but not limited to, recent third-party comparable sales and discounted cash
flow models. If actual results are not consistent with our assumptions and estimates, or our assumptions and estimates change due to
new information, we may be exposed to an impairment charge in the future. As of September 30, 2021 and December 31, 2020, the Company
had not experienced impairment losses on its long-lived assets.
Fair
Value of Financial Instruments
The
provisions of accounting guidance, FASB Topic ASC 825 requires all entities to disclose the fair value of financial instruments, both
assets and liabilities recognized and not recognized on the balance sheet, for which it is practicable to estimate fair value, and defines
fair value of a financial instrument as the amount at which the instrument could be exchanged in a current transaction between willing
parties. As of September 30, 2021 and December 31, 2020, the fair value of cash, accounts payable, accrued expenses, and notes payable
approximated carrying value due to the short maturity of the instruments, quoted market prices or interest rates which fluctuate with
market rates.
Fair
Value Measurements
Fair
value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal
or most advantageous market for the asset or liability, in an orderly transaction between market participants on the measurement date.
Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.
The fair value hierarchy is based on three levels of inputs, of which the first two are considered observable and the last unobservable,
as follows:
|
●
|
Level
1 – Quoted prices in active markets for identical assets or liabilities.
|
|
|
|
|
●
|
Level
2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets
or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable
market data for substantially the full term of the assets or liabilities.
|
|
|
|
|
●
|
Level
3 – Unobservable inputs that are supported by little or no market activity and that are significant to the measurement of the
fair value of the assets or liabilities
|
The
carrying value of financial assets and liabilities recorded at fair value are measured on a recurring or nonrecurring basis. Financial
assets and liabilities measured on a non-recurring basis are those that are adjusted to fair value when a significant event occurs. There
were no financial assets or liabilities carried and measured on a nonrecurring basis during the reporting periods. Financial assets and
liabilities measured on a recurring basis are those that are adjusted to fair value each time a financial statement is prepared. There
have been no transfers between levels.
Basic
and diluted earnings per share
Basic
net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period,
without consideration for common stock equivalents. Diluted earnings (loss) per share are computed on the basis of the weighted average
number of common shares (including common stock subject to redemption) plus dilutive potential common shares outstanding for the reporting
period. In periods where losses are reported, the weighted-average number of common stock outstanding excludes common stock equivalents,
because their inclusion would be anti-dilutive.
There
were no potential dilutive securities outstanding for the three and nine months ended September 30, 2021 and 2020.
Stock
Based Compensation
In
accordance with ASC No. 718, Compensation – Stock Compensation (“ASC 718”), we measure the compensation costs
of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over
the period during which employees are required to provide services. Share-based compensation arrangements include stock options, restricted
share plans, performance-based awards, share appreciation rights and employee share purchase plans. As such, compensation cost is measured
on the date of grant at their fair value. Such compensation amounts, if any, are amortized over the respective vesting periods of the
option grant. We apply this statement prospectively.
Non-Employee
Stock Based Compensation
In
accordance with ASC 505, Equity Based Payments to Non-Employees, issuances of the Company’s common stock or warrants for
acquiring goods or services are measured at the fair value of the consideration received or the fair value of the equity instruments
issued, whichever is more reliably measurable. The measurement date for the fair value of the equity instruments issued to consultants
or vendors is determined at the earlier of (i) the date at which a commitment for performance to earn the equity instruments is reached
(a “performance commitment” which would include a penalty considered to be of a magnitude that is a sufficiently large disincentive
for nonperformance) or (ii) the date at which performance is complete. Although situations may arise in which counter performance may
be required over a period of time, the equity award granted to the party performing the service is fully vested and non-forfeitable on
the date of the agreement. As a result, in this situation in which vesting periods do not exist as the instruments fully vested on the
date of agreement, the Company determines such date to be the measurement date and will record the estimated fair market value of the
instruments granted as a prepaid expense and amortize such amount to general and administrative expense in the accompanying statement
of operations over the contract period. When it is appropriate for the Company to recognize the cost of a transaction during financial
reporting periods prior to the measurement date, for purposes of recognition of costs during those periods, the equity instrument is
measured at the then-current fair values at each of those interim financial reporting dates.
Concentrations,
Risks, and Uncertainties
Business
Risk
Substantial
business risks and uncertainties are inherent to an entity, including the potential risk of business failure.
The
Company is headquartered and operates in the United States. To date, the Company has generated no revenues from operations. There can
be no assurance that the Company will be able to raise additional capital and failure to do so would have a material adverse effect on
the Company’s financial position, results of operations and cash flows. Also, the success of the Company’s operations is
subject to numerous contingencies, some of which are beyond management’s control. Currently, these contingencies include general
economic conditions, price of components, competition, and governmental and political conditions.
Interest
rate risk
Financial
assets and liabilities do not have material interest rate risk.
Credit
risk
The
Company is exposed to credit risk from its cash in banks. The credit risk on cash in banks is limited because the counterparties are
recognized financial institutions.
Seasonality
The
business is not subject to substantial seasonal fluctuations.
Major
Suppliers
Sigyn
Therapy is comprised of components that are supplied by various industry vendors. Additionally, the Company is reliant on third-party
organizations to conduct clinical development studies that are necessary to advance Sigyn Therapy toward the marketplace.
Should
the relationship with an industry vendor or third-party clinical development organization be interrupted or discontinued, it is believed
that alternate component suppliers and third-party clinical development organizations could be identified to support the continued advancement
of Sigyn Therapy.
Recent
Accounting Pronouncements
In
August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurements (Topic 820): Disclosure Framework—Changes to the Disclosure
Requirements for Fair Value Measurement. This standard removes, modifies, and adds certain disclosure requirements for fair value
measurements. This pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December
15, 2019, with early adoption permitted. The Company adopted ASU No. 2018-13 in the first quarter of fiscal 2020, coinciding with the
standard’s effective date, and had an immaterial impact from this standard.
In
August 2018, the FASB issued ASU No. 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40):
Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. This standard
aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements
for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use
software license). The Company’s accounting for the service element of a hosting arrangement that is a service contract is not
affected by the proposed amendments and will continue to be expensed as incurred in accordance with existing guidance. This standard
does not expand on existing disclosure requirements except to require a description of the nature of hosting arrangements that are service
contracts. This standard is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15,
2019. Early adoption is permitted, including adoption in any interim period for which financial statements have not been issued. Entities
can choose to adopt the new guidance prospectively or retrospectively. The Company adopted the updated disclosure requirements of ASU
No. 2018-15 prospectively in the first quarter of fiscal 2020, coinciding with the standard’s effective date, and had an immaterial
impact from this standard.
In
December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes. This standard simplifies the accounting
for income taxes by removing certain exceptions to the general principles in ASC 740, Income Taxes, while also clarifying and
amending existing guidance, including interim-period accounting for enacted changes in tax law. This standard is effective for fiscal
years, and for interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company
adopted ASU No. 2019-12 in the first quarter of fiscal 2021, coinciding with the standard’s effective date, and had an immaterial
impact from this standard.
Other
recently issued accounting updates are not expected to have a material impact on the Company’s unaudited condensed consolidated
financial statements.
NOTE
4 – PROPERTY AND EQUIPMENT
Property
and equipment consisted of the following as of:
SCHEDULE OF PROPERTY AND EQUIPMENT
|
|
Estimated Life
|
|
September 30, 2021
|
|
|
December 31, 2020
|
|
|
|
|
|
|
|
|
|
|
Office equipment
|
|
5 years
|
|
$
|
22,279
|
|
|
$
|
2,074
|
|
Accumulated depreciation
|
|
|
|
|
(1,625
|
)
|
|
|
(346
|
)
|
|
|
|
|
$
|
20,654
|
|
|
$
|
1,728
|
|
Depreciation
expense was $432 and $1,279 and $0 and $0 for the three and nine months ended September 30, 2021 and 2020, respectively, and is classified
in general and administrative expenses in the condensed consolidated Statements of Operations.
NOTE
5 – INTANGIBLE ASSETS
Intangible
assets consisted of the following as of:
SCHEDULE OF INTANGIBLE ASSETS
|
|
Estimated life
|
|
September 30, 2021
|
|
|
December 31, 2020
|
|
Trademarks
|
|
3 years
|
|
$
|
22,061
|
|
|
$
|
22,061
|
|
Website
|
|
3 years
|
|
|
10,799
|
|
|
|
10,799
|
|
Accumulated amortization
|
|
|
|
|
(26,260
|
)
|
|
|
(10,955
|
)
|
|
|
|
|
$
|
6,600
|
|
|
$
|
21,905
|
|
As
of September 30, 2021, estimated future amortization expenses related to intangible assets were as follows:
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE RELATED TO INTANGIBLE ASSETS
|
|
Intangible Assets
|
|
2021 (remaining 3 months)
|
|
$
|
900
|
|
2022
|
|
|
3,600
|
|
2023
|
|
|
2,100
|
|
Total
|
|
$
|
6,600
|
|
The
Company had amortization expense of $900 and $15,305 and $360 and $600 for the three and nine months ended September 30, 2021 and 2020,
respectively.
On
January 8, 2020, James Joyce, the Company’s CEO and Craig Roberts, the Company’s CTO, assigned to the Company the rights
to patent 62/881,740 pertaining to the devices, systems and methods for the broad-spectrum reduction of pro-inflammatory cytokines in
blood in exchange for founder’s shares.
NOTE
6 – CONVERTIBLE PROMISSORY DEBENTURES
Convertible
notes payable consisted of the following:
SCHEDULE OF CONVERTIBLE NOTES PAYABLE
|
|
September 30, 2021
|
|
|
December 31, 2020
|
|
|
|
|
|
|
|
|
February 10, 2021 ($110,000) –
0% interest per annum outstanding principal and interest due February 10, 2022
|
|
$
|
110,000
|
|
|
$
|
-
|
|
January 28, 2020 ($385,000) – 8% interest
per annum outstanding principal and interest due October 20, 2021
|
|
|
385,000
|
|
|
|
385,000
|
|
June 23, 2020 ($55,000) – 0% interest per
annum outstanding principal and interest due October 20, 2021
|
|
|
55,000
|
|
|
|
50,000
|
|
September 17, 2020 ($181,500)
– 0% interest per annum outstanding principal and interest due October 20, 2021
|
|
|
181,500
|
|
|
|
181,500
|
|
|
|
|
|
|
|
|
|
|
Total convertible notes payable
|
|
|
731,500
|
|
|
|
616,500
|
|
Original issue discount
|
|
|
(4,984
|
)
|
|
|
(19,667
|
)
|
Debt discount
|
|
|
(41,773
|
)
|
|
|
(78,165
|
)
|
|
|
|
|
|
|
|
|
|
Total convertible notes payable
|
|
$
|
684,743
|
|
|
$
|
518,668
|
|
Principal
payments on convertible promissory debentures are due as follows:
SCHEDULE OF PRINCIPAL PAYMENTS DUE ON CONVERTIBLE PROMISSORY DEBENTURES
Year ending December 31,
|
|
|
|
2021 (remaining 3 months)
|
|
$
|
609,827
|
|
2022
|
|
|
74,916
|
|
Total
|
|
$
|
684,743
|
|
Current
Noteholders
Osher
– $110,000
On
February 10, 2021, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due February 11, 2022 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 157,143 shares of the Company’s Common
Stock at an exercise price of $1.20 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.70 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
On
October 25, 2021, Osher elected to convert the aggregate principal amount of the Note, $110,000, into 157,143 common shares (see Note
12).
Osher
– $385,000
On
January 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $385,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
due January 26, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants to purchase up
to an aggregate of 80,209 shares of the Company’s Common Stock at an exercise price of $7.00 per share. The aggregate cash subscription
amount received by the Company from Osher for the issuance of the note and warrants was $350,005 which was issued at a $34,995 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.094 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follow on October 20, 2020:
|
●
|
The
parties amended the Warrants dated January 28, 2020, for the number of warrant shares from 80,209 warrant shares to 4,113,083 warrant
shares at an exercise price of $0.14 per share.
|
|
●
|
The
parties amended the Note to provide for interest at 8% per annum.
|
|
●
|
The
parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.
|
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows (see Note 12):
|
●
|
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
|
|
●
|
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
|
|
●
|
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share.
|
On
October 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $385,000, into 42,857 common shares
(see Note 12).
Osher
– $50,000 (as amended on October 20, 2020 to $55,000)
On
June 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $50,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
(the “Note”) due June 23, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants
(“Warrants”) to purchase up to an aggregate of 10,000 shares of the Company’s Common Stock at an exercise price of
$30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants
was $50,005 which was issued at a $0 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,
as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follow on October 20, 2020:
|
●
|
The
parties amended the Note for the aggregate principal amount from $50,000 to $55,000.
The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $50,005
which was issued at an amended $4,995
original issue discount from the face value
of the Note.
|
|
●
|
The
parties amended the Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020
warrant shares at an exercise price of $0.59
per share.
|
|
●
|
The
parties amended the Note for the maturity date from June 23, 2021 to October
20, 2021.
|
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows (see Note 12):
|
●
|
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
|
|
●
|
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
|
|
●
|
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share.
|
Osher
– $181,500
On
September 17, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $181,500 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
(the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase
Warrants (“Warrants’) to purchase up to an aggregate of 8,250 shares of the Company’s Common Stock at an exercise price
of $30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants
was $165,000 which was issued at a $16,500 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,
as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follow on October 20, 2020:
|
●
|
The
parties amended the Warrants dated September 17, 2020, for the number of warrant shares from 8,250 warrant shares to 465,366
warrant shares at an exercise price of $0.59
per share.
|
|
●
|
The
parties amended the Note for the maturity date from September 30, 2021 to October
20, 2021.
|
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows (see Note 12):
|
●
|
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
|
|
●
|
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
|
|
●
|
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share.
|
Previous
Noteholders
Previous
Noteholder – $50,000 (as amended on October 20, 2020 to $55,000)
On
June 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $50,000 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due June 23, 2021, based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 10,000
shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $50,000 which was issued at a $0 original issue
discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
|
●
|
The
parties amended the Note for the aggregate principal amount from $50,000 to $55,000. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $50,000 which was issued at an amended
$5,000 original issue discount from the face value of the Note.
|
|
●
|
The
parties amended the Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.
|
On
December 2, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $55,000, into 141,020 common
shares.
Previous
Noteholder - $25,000 (as amended on October 20, 2020 to $27,500)
On
August 18, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $25,000 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due August 18, 2021, based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 5,000
shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $25,000 which was issued at a $0 original issue
discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
|
●
|
The
parties amended the Note for the aggregate principal amount from $25,000 to $27,500. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $25,000 which was issued at an amended
$2,500 original issue discount from the face value of the Note.
|
|
●
|
The
parties amended the Warrants dated August 18, 2020, for the number of warrant shares from 5,000 warrant shares to 70,510 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from August 18, 2021 to October 20, 2021.
|
On
October 28, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $27,500, into 70,510 common
shares.
On
February 19, 2021, the previous noteholder exercised the warrants pursuant to the cashless exercise provision of the warrant agreement
into 57,147
common shares. The common shares have not
been issued as of November 10, 2021.
Previous
Noteholder – $93,500
On
September 18, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $93,500 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by
the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of
4,250 shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $85,000 which was issued at a $8,500 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
|
●
|
The
parties amended the Warrants dated September 18, 2020, for the number of warrant shares from 4,250 warrant shares to 239,734 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.
|
On
December 2, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $93,500, into 239,734 common
shares.
Previous
Noteholder - $165,000
On
September 21, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $165,000 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by
the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of
7,500 shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $150,000 which was issued at a $15,000 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follow on October 20, 2020:
|
●
|
The
parties amended the number of shares from the Warrants dated September 21, 2020, for the number of warrant shares from 7,500 warrant
shares to 423,060 warrant shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.
|
On
November 5, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $165,000, into 423,060 common
shares.
Previous
Noteholder – $27,500 (as amended on October 20, 2020 to $22,000)
On
September 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $27,500 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due August 28, 2021, based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 1,000
shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $20,000 which was issued at a $7,500 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
|
●
|
The
parties amended the Note for the aggregate principal amount from $27,500 to $22,000. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $20,000 which was issued at an amended
$2,000 original issue discount from the face value of the Note.
|
|
●
|
The
parties amended the Warrants dated September 28, 2020, for the number of warrant shares from 1,000 warrant shares to 56,408 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from August 18, 2021 to October 20, 2021.
|
On
October 27, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $22,000, into 56,408 common
shares.
Previous
Noteholder – $33,000
On
September 29, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $33,000 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due August 18, 2021, based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 1,500
shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $30,000 which was issued at a $3,000 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
|
●
|
The
parties amended the Warrants dated September 29, 2020, for the number of warrant shares from 1,500 warrant shares to 84,612 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from August 18, 2021 to October 20, 2021.
|
On
October 26, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $33,000, into 84,612 common
shares.
Previous
Noteholder – $110,000
On
February 10, 2021, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to a previous noteholder of (i) $110,000 aggregate principal amount of Note due February 11, 2022 based on $1.00
for each $0.90909 paid by the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase
up to an aggregate of 157,143 shares of the Company’s Common Stock at an exercise price of $1.20 per share. The aggregate cash
subscription amount received by the Company from the previous noteholder for the issuance of the Note and Warrants was $100,000 which
was issued at a $10,000 original issue discount from the face value of the Note. The conversion
price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.70 per share, subject to
adjustment as provided therein, such as stock splits and stock dividends.
On
May 10, 2021, the previous noteholder elected to convert the aggregate principal amount of a $110,000 convertible note issued on February
10, 2021 into 157,143 shares of the Company’s common stock.
Previous
Noteholder – $55,000
On
May 4, 2021, the Company repaid the aggregate principal amount of a $55,000 convertible debenture that was entered into on April 7, 2021
with a previous noteholder. The note was a 10% Original Issue Discount Senior Convertible Debenture (the “Note”) which included
a five-year Common Stock Purchase Warrant (“Warrants’) to purchase up to an aggregate of 71,429 shares of the Company’s
Common Stock at an exercise price of $1.20 per share. The aggregate cash subscription amount received by the Company from the previous
noteholder for the issuance of the Note and Warrants was $50,000 which was issued at a $5,000 original issue discount from the face value
of the Note.
NOTE
7 – STOCKHOLDERS’ Equity
The
Company issued 500,000
restricted common shares to founder’s,
valued at $50
(based on the par value on the date of grant)
in exchange for patient rights. The issuance was an isolated transaction not involving a public offering pursuant to Section 4(2)
of the Securities Act of 1933.
The
Company has authorized 1,000,000,000 shares of par value $0.0001 common stock, of which 500,000 shares are outstanding at December 31,
2020.
On
January 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock price
of the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuance
was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.
On
February 19, 2021, a previous noteholder exercised warrants pursuant to the cashless exercise provision of the warrant agreement into
57,147
common shares. The common shares have not
been issued as of November 10, 2021 (see Note 6).
On
April 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock price
of the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuance
was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.
In
April 2021, the Company initiated a private placement of up to $1.5
million of the Company’s restricted common shares. The
offering allowed for qualified investors to purchase one share of the Company’s common stock $1.25.
For each share purchased, the qualified investors received a five-year warrant to purchase one share of common stock at $1.75 per
share. On May 10, 2021, the Company closed the offering to investors and subsequently disclosed that it had entered into
securities purchase agreements with accredited investors that resulted in the issuance of 1,172,000
shares of common stock and warrants to purchase an aggregate of 1,172,000
shares of the Company’s common stock for total proceeds totaling $1,465,000.
No commissions were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended,
in a transaction exempt from registration.
On
May 10, 2021, Brio Capital elected to convert the aggregate principal amount of a $110,000 convertible note issued on February 10, 2021
into 157,143 shares of the Company’s common stock (see Note 6).
On
July 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $47,000 (based on the stock price
of the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuance
was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.
During
the nine months ended September 30, 2021, the Company issued 1,313,000
shares common shares to third parties for services
and cash and 157,143
common shares to third parties in conjunction
with the conversion of convertible promissory debentures (see Note 6).
NOTE
8 – OPERATING LEASES
The
Company adopted ASC 842 as of December 31, 2019. The Company has an operating lease for the Company’s
corporate office and accounts for this lease in accordance with ASC 842. Adoption of the standard resulted in the initial recognition
of operating lease ROU asset of $290,827 and operating lease liability of $290,827 as of
June 15, 2021.
On
May 27, 2021, the Company entered into a sixty-three month lease for its corporate office at $5,955 per month commencing June 15, 2021
maturing September 30, 2026.
Operating
lease right-of-use (“ROU”) assets and liabilities are recognized at commencement date based on the present value of lease
payments over the lease term. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent
our obligation to make lease payments arising from the lease. Generally, the implicit rate of interest in arrangements is not readily
determinable and the Company utilizes its incremental borrowing rate in determining the present value of lease payments. The Company’s
incremental borrowing rate is a hypothetical rate based on its understanding of what its credit rating would be. The operating lease
ROU asset includes any lease payments made and excludes lease incentives. Our variable lease payments primarily consist of maintenance
and other operating expenses from our real estate leases. Variable lease payments are excluded from the ROU assets and lease liabilities
and are recognized in the period in which the obligation for those payments is incurred. Our lease terms may include options to extend
or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense for minimum lease payments is recognized
on a straight-line basis over the lease term.
We
have lease agreements with lease and non-lease components. We have elected to account for these lease and non-lease components as a single
lease component. We are also electing not to apply the recognition requirements to short-term leases of twelve months or less and instead
will recognize lease payments as expense on a straight-line basis over the lease term.
The
components of lease expense and supplemental cash flow information related to leases for the period are as follows:
In accordance with ASC 842, the components of lease expense were as follows:
SCHEDULE OF OPERATING LEASE COST AND SUPPLEMENTAL CASH FLOW INFORMATION
|
|
Nine Months ended
September 30,
|
|
|
Three Months ended
September 30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Operating lease expense
|
|
$
|
24,094
|
|
|
$
|
-
|
|
|
$
|
18,070
|
|
|
$
|
-
|
|
Short term lease cost
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Total lease expense
|
|
$
|
24,094
|
|
|
$
|
-
|
|
|
$
|
18,070
|
|
|
$
|
-
|
|
In accordance with ASC 842, other information related to leases was as follows:
Nine Months ended September 30,
|
|
|
2021
|
|
|
|
2020
|
|
Operating cash flows from operating leases
|
|
$
|
9,131
|
|
|
$
|
-
|
|
Cash paid for amounts included in the measurement of lease liabilities
|
|
$
|
9,131
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
Weighted-average remaining lease term—operating leases
|
|
|
4.92 years
|
|
|
|
-
|
|
Weighted-average discount rate—operating leases
|
|
|
10
|
%
|
|
|
-
|
|
In accordance with ASC 842, maturities of operating lease liabilities as of September 30, 2021 were as follows:
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES
Year ending:
|
|
Operating Lease
|
|
2021 (remaining three months)
|
|
$
|
11,911
|
|
2022
|
|
|
72,714
|
|
2023
|
|
|
74,895
|
|
2024
|
|
|
77,142
|
|
2025
|
|
|
79,456
|
|
Thereafter
|
|
|
54,225
|
|
Total undiscounted cash flows
|
|
$
|
370,342
|
|
|
|
|
|
|
Reconciliation of lease liabilities:
|
|
|
|
|
Weighted-average remaining lease terms
|
|
|
4.92 years
|
|
Weighted-average discount rate
|
|
|
10
|
%
|
Present values
|
|
$
|
291,331
|
|
|
|
|
|
|
Lease liabilities—current
|
|
|
38,524
|
|
Lease liabilities—long-term
|
|
|
252,807
|
|
Lease liabilities—total
|
|
$
|
291,331
|
|
|
|
|
|
|
Difference between undiscounted and discounted cash flows
|
|
$
|
79,011
|
|
Operating
lease cost was $18,070 and $24,094, and $0 and $0 for the three and nine months ended September 30, 2021 and 2020, respectively.
NOTE
9 – RELATED PARTY TRANSACTIONS
Other
than as set forth below, and as disclosed in Notes 5, 7, and 11, there have not been any transaction entered into or been a participant
in which a related person had or will have a direct or indirect material interest.
Employment
Agreements
Mr.
Joyce receives an annual base salary of $455,000, plus bonus compensation not to exceed 50% of salary. Mr. Joyce’s employment also
provides for medical insurance, disability benefits and one year of severance pay if his employment is terminated without cause or due
to a change in control. Additionally, the Company has agreed to maintain a beneficial ownership target of 9% for Mr. Joyce. Mr. Joyce’s
compensation was approved by the Reign Resources Corporation Board of Directors on October 6, 2020 and was among conditions of the Share
Exchange Agreement that was completed with Sigyn Therapeutics on October 19, 2020. The Company incurred compensation expense of $112,500
and $337,500, and $91,800 and $195,260, and employee benefits of 10,104 and $19,000, and $5,106 and $15,318 for the three and nine months
ended September 30, 2021 and 2020, respectively.
Sigyn
had no employment agreement with its Chief Technology Officer (“CTO”) but Sigyn still incurred compensation on behalf of
the CTO. The Company incurred compensation expense of $60,000 and $180,000, and $65,000 and $133,016, and employee benefits of $3,261
and $12,157, and $5,106 and $15,318, for the three and nine months ended September 30, 2021 and 2020, respectively.
Bonus
On
July 21, 2021, as a result of achieving certain milestones, the Board of Directors agreed to pay each of the Company’s CEO and
CTO a performance bonus equal to 5% of their annual salary totaling $34,750.
NOTE
10 – EARNINGS PER SHARE
FASB
ASC Topic 260, Earnings Per Share, requires a reconciliation of the numerator and denominator of the basic and diluted earnings
(loss) per share (EPS) computations.
Basic
and diluted earnings (loss) per share are the same since net losses for all periods presented and including the additional potential
common shares would have an anti-dilutive effect.
The
following table sets forth the computation of basic and diluted net income per share:
SCHEDULE OF COMPUTATION OF BASIC AND DILUTED NET INCOME PER SHARE
|
|
Nine Months Ended
September 30,
|
|
|
Three Months Ended
September 30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to the common stockholders
|
|
$
|
(1,777,447
|
)
|
|
$
|
(807,568
|
)
|
|
$
|
(665,904
|
)
|
|
$
|
(295,990
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average outstanding shares of common stock
|
|
|
36,138,191
|
|
|
|
500,000
|
|
|
|
36,721,651
|
|
|
|
500,000
|
|
Dilutive effect of options and warrants
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Diluted weighted average common stock and common stock equivalents
|
|
|
36,138,191
|
|
|
|
500,000
|
|
|
|
36,721,651
|
|
|
|
500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.05
|
)
|
|
$
|
(1.62
|
)
|
|
$
|
(0.02
|
)
|
|
$
|
(0.59
|
)
|
NOTE
11 – COMMITMENTS AND CONTINGENCIES
Legal
From
time to time, various lawsuits and legal proceedings may arise in the ordinary course of business. However, litigation is subject to
inherent uncertainties and an adverse result in these or other matters may arise from time to time that may harm our business. We are
currently not aware of any legal proceedings or claims that it believes will have a material adverse effect on its business, financial
condition or operating results.
Media
Advertising Agreement
On
May 13, 2021, the Company mutually terminated the Media Relations Agreement (“Media Agreement”) with a third party for marketing
and to promote brand awareness that was entered into on February 10, 2021. The Company agreed to pay $25,000 due in cash at the execution
of the Media Agreement. No shares were issued in conjunction with the Media Agreement.
NOTE
12 – SUBSEQUENT EVENTS
Convertible
Promissory Debenture
On
October 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $385,000, into 42,857 common shares.
On
October 25, 2021, Osher elected to convert the aggregate principal amount of the Note, $110,000, into 157,143 common shares.
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows:
|
●
|
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
|
|
●
|
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
|
|
●
|
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share.
|
Common
Stock
On
November 3, 2021, the Company entered into a three-month Advertising and Marketing Consulting Agreement (“Agreement”) with
a third party. The Company agreed to pay $20,000 per month and issue 15,000 shares of the Company’s common stock on the 60th
day of the term of the Agreement. This issuance will be pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended,
in a transaction exempt from registration.
On
October 20, 2021, the entered into a securities purchase agreement with an accredited investor that resulted in the issuance of 320,000
shares of common stock and warrants to purchase an aggregate of 320,000 shares of the Company’s common stock for total proceeds
totaling $400,000. The offering allowed for qualified investors to purchase one share of the Company’s common stock at $1.25. For
each share purchased, the investor received a five-year warrant to purchase one share of common stock at $1.25 per share. No commissions
were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction
exempt from registration.
On
October 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $37,600 (based on the stock price
of the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuance
was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Special
Note Regarding Forward Looking Statements.
This
quarterly report on Form 10-Q of Sigyn Therapeutics, Inc. for the period ended September 30, 2021 contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended, which are intended to be covered by the safe harbors created thereby. To the extent that such statements are not recitations
of historical fact, such statements constitute forward looking statements which, by definition, involve risks and uncertainties. In particular,
statements under the Sections; Description of Business, Management’s Discussion and Analysis of Financial Condition and Results
of Operations contain forward looking statements. Where in any forward-looking statements, the Company expresses an expectation or belief
as to future results or events, such expectation or belief is expressed in good faith and believed to have a reasonable basis, but there
can be no assurance that the statement of expectation or belief will result or be achieved or accomplished.
The
following are factors that could cause actual results or events to differ materially from those anticipated and include but are not limited
to: general economic, financial and business conditions; changes in and compliance with governmental regulations; changes in tax laws;
and the cost and effects of legal proceedings.
You
should not rely on forward looking statements in this quarterly report. This quarterly report contains forward looking statements that
involve risks and uncertainties. We use words such as “anticipates,” “believes,” “plans,” “expects,”
“future,” “intends,” and similar expressions to identify these forward-looking statements. Prospective investors
should not place undue reliance on these forward-looking statements, which apply only as of the date of this quarterly report. Our actual
results could differ materially from those anticipated in these forward-looking statements.
Recent
Developments
Common
Stock
On
November 3, 2021, the Company entered into a three-month Advertising and Marketing Consulting Agreement (“Agreement”) with
a third party. The Company agreed to pay $20,000 per month and issue 15,000 shares of the Company’s common stock on the 60th
day of the term of the Agreement. This issuance will be pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended,
in a transaction exempt from registration.
On
October 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $385,000, into 42,857 common shares.
On
October 25, 2021, Osher elected to convert the aggregate principal amount of the Note, $110,000, into 157,143 common shares.
On
October 20, 2021, the entered into a securities purchase agreement with an accredited investor that resulted in the issuance of 320,000
shares of common stock and warrants to purchase an aggregate of 320,000 shares of the Company’s common stock for total proceeds
totaling $400,000. The offering allowed for qualified investors to purchase one share of the Company’s common stock at $1.25. For
each share purchased, the investor received a five-year warrant to purchase one share of common stock at $1.25 per share. No commissions
were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction
exempt from registration.
On
October 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $37,600 (based on the stock price
of the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuance
was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.
On
July 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $47,000 (based on the stock price
of the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuance
was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.
On
May 10, 2021, Brio Capital elected to convert the aggregate principal amount of a $110,000 convertible note issued on February 10, 2021
into 157,143 shares of the Company’s common stock.
In
April 2021, the Company initiated an offering of up to $1.5 million of the Company’s restricted common shares. The offering allowed
for qualified investors to purchase one share of the Company’s common stock $1.25. For each share purchased, the investor received
a five-year warrant to purchase one share of common stock at $1.75 per share. On May 10, 2021, the Company closed the offering to investors
and subsequently disclosed that it had entered into securities purchase agreements with accredited investors that resulted in the issuance
of 1,172,000 shares of common stock and warrants to purchase an aggregate of 1,172,000 shares of the Company’s common stock for
total proceeds totaling $1,465,000. No commissions were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the Securities
Act of 1933, as amended, in a transaction exempt from registration.
On
April 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock price
of the Company’s common stock on the date of issuance) to a third party, for marketing and to promote brand awareness. This issuance
was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.
On
February 19, 2021, a previous noteholder exercised warrants pursuant to the cashless exercise provision of the warrant agreement into
57,147 common shares. The common shares have not been issued as of November 10, 2021.
On
January 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock price
of the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuance
was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.
During
the nine months ended September 30, 2021 and 2020, the Company issued 1,313,000 shares common shares to third parties for services and
cash, 157,143 common shares to third parties in conjunction with the conversion of convertible promissory debentures, and 57,147 common
shares to a third party with the exercise of warrants.
Convertible
Notes Payable
Current
Noteholders
Osher
– $110,000
On
February 10, 2021, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due February 11, 2022 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 157,143 shares of the Company’s Common
Stock at an exercise price of $1.20 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.70 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
On
October 25, 2021, Osher elected to convert the aggregate principal amount of the Note, $110,000, into 157,143 common shares.
Osher
– $457,380
On
January 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $385,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
due January 26, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants to purchase up
to an aggregate of 80,209 shares of the Company’s Common Stock at an exercise price of $7.00 per share. The aggregate cash subscription
amount received by the Company from Osher for the issuance of the note and warrants was $350,005 which was issued at a $34,995 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.094 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follow on October 20, 2020:
|
●
|
The
parties amended the Warrants dated January 28, 2020, for the number of warrant shares from 80,209 warrant shares to 4,113,083 warrant
shares at an exercise price of $0.14 per share.
|
|
●
|
The
parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.
|
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows:
|
●
|
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
|
|
●
|
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
|
|
●
|
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share.
|
On
October 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $385,000, into 42,857 common shares.
Osher
– $60,500
On
June 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $50,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
(the “Note”) due June 23, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants
(“Warrants”) to purchase up to an aggregate of 10,000 shares of the Company’s Common Stock at an exercise price of
$30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants
was $50,005 which was issued at a $0 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,
as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follow on October 20, 2020:
|
●
|
The
parties amended the Note for the aggregate principal amount from $50,000 to $55,000. The aggregate cash subscription amount received
by the Company from Osher for the issuance of the Note and Warrants was $50,005 which was issued at an amended $4,995 original issue
discount from the face value of the Note.
|
|
●
|
The
parties amended the Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.
|
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows:
|
●
|
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
|
|
●
|
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
|
|
●
|
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share.
|
Osher
– $199,650
On
September 17, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $181,500 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
(the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase
Warrants (“Warrants’) to purchase up to an aggregate of 8,250 shares of the Company’s Common Stock at an exercise price
of $30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants
was $165,000 which was issued at a $16,500 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,
as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follow on October 20, 2020:
|
●
|
The
parties amended the Warrants dated September 17, 2020, for the number of warrant shares from 8,250 warrant shares to 465,366 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.
|
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows:
|
●
|
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
|
|
●
|
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
|
|
●
|
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share.
|
Previous
Noteholders
Previous
Noteholder – $50,000 (as amended on October 20, 2020 to $55,000)
On
June 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $50,000 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due June 23, 2021, based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 10,000
shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $50,000 which was issued at a $0 original issue
discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
|
●
|
The
parties amended the Note for the aggregate principal amount from $50,000 to $55,000. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $50,000 which was issued at an amended
$5,000 original issue discount from the face value of the Note.
|
|
●
|
The
parties amended the Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.
|
On
December 2, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $55,000, into 141,020 common
shares.
Previous
Noteholder - $25,000 (as amended on October 20, 2020 to $27,500)
On
August 18, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $25,000 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due August 18, 2021, based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 5,000
shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $25,000 which was issued at a $0 original issue
discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
|
●
|
The
parties amended the Note for the aggregate principal amount from $25,000 to $27,500. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $25,000 which was issued at an amended
$2,500 original issue discount from the face value of the Note.
|
|
●
|
The
parties amended the Warrants dated August 18, 2020, for the number of warrant shares from 5,000 warrant shares to 70,510 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from August 18, 2021 to October 20, 2021.
|
On
October 28, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $27,500, into 70,510 common
shares.
Previous
Noteholder – $93,500
On
September 18, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $93,500 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by
the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of
4,250 shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $85,000 which was issued at a $8,500 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
|
●
|
The
parties amended the Warrants dated September 18, 2020, for the number of warrant shares from 4,250 warrant shares to 239,734 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.
|
On
December 2, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $93,500, into 239,734 common
shares.
Previous
Noteholder - $165,000
On
September 21, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $165,000 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by
the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of
7,500 shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $150,000 which was issued at a $15,000 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follow on October 20, 2020:
|
●
|
The
parties amended the number of shares from the Warrants dated September 21, 2020, for the number of warrant shares from 7,500 warrant
shares to 423,060 warrant shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.
|
On
November 5, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $165,000, into 423,060 common
shares.
Previous
Noteholder – $27,500 (as amended on October 20, 2020 to $22,000)
On
September 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $27,500 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due August 28, 2021, based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 1,000
shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $20,000 which was issued at a $7,500 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
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The
parties amended the Note for the aggregate principal amount from $27,500 to $22,000. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $20,000 which was issued at an amended
$2,000 original issue discount from the face value of the Note.
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The
parties amended the Warrants dated September 28, 2020, for the number of warrant shares from 1,000 warrant shares to 56,408 warrant
shares at an exercise price of $0.59 per share.
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The
parties amended the Note for the maturity date from August 18, 2021 to October 20, 2021.
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On
October 27, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $22,000, into 56,408 common
shares.
On
February 19, 2021, the previous noteholder exercised the warrants pursuant to the cashless exercise provision of the warrant agreement
into 57,147 common shares. The common shares have not been issued as of November 10, 2021.
Previous
Noteholder – $33,000
On
September 29, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $33,000 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due August 18, 2021, based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 1,500
shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $30,000 which was issued at a $3,000 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
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●
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The
parties amended the Warrants dated September 29, 2020, for the number of warrant shares from 1,500 warrant shares to 84,612 warrant
shares at an exercise price of $0.59 per share.
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The
parties amended the Note for the maturity date from August 18, 2021 to October 20, 2021.
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On
October 26, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $33,000, into 84,612 common
shares.
Previous
Noteholder – $110,000
On
February 10, 2021, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to a previous noteholder of (i) $110,000 aggregate principal amount of Note due February 11, 2022 based on $1.00
for each $0.90909 paid by the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase
up to an aggregate of 157,143 shares of the Company’s Common Stock at an exercise price of $1.20 per share. The aggregate cash
subscription amount received by the Company from the previous noteholder for the issuance of the Note and Warrants was $100,000 which
was issued at a $10,000 original issue discount from the face value of the Note. The conversion
price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.70 per share, subject to
adjustment as provided therein, such as stock splits and stock dividends.
On
May 10, 2021, the previous noteholder elected to convert the aggregate principal amount of a $110,000 convertible note issued on February
10, 2021 into 157,143 shares of the Company’s common stock.
Previous
Noteholder – $55,000
On
May 4, 2021, the Company repaid the aggregate principal amount of a $55,000 convertible debenture that was entered into on April 7, 2021
with a previous noteholder. The note was a 10% Original Issue Discount Senior Convertible Debenture (the “Note”) which included
a five-year Common Stock Purchase Warrant (“Warrants’) to purchase up to an aggregate of 71,429 shares of the Company’s
Common Stock at an exercise price of $1.20 per share. The aggregate cash subscription amount received by the Company from the previous
noteholder for the issuance of the Note and Warrants was $50,000 which was issued at a $5,000 original issue discount from the face value
of the Note.
Media
Advertising Agreement
On
May 13, 2021, the Company mutually terminated the Media Relations Agreement (“Media Agreement”) with a third party for marketing
and to promote brand awareness that was entered into on February 10, 2021. The Company agreed to pay $25,000 due in cash at the execution
of the Media Agreement. No shares were issued in conjunction with the Media Agreement.
Bonus
On
July 21, 2021, as a result of achieving certain milestones, the Board of Directors agreed to pay each of the Company’s CEO and
CTO a performance bonus equal to 5% of their annual salary totaling $34,750.
Limited
Operating History; Need for Additional Capital
There
is limited historical financial information about us on which to base an evaluation of our performance. We cannot guarantee we will be
successful in our business operations. Our business is subject to risks inherent in the establishment of a new business enterprise, including
limited capital resources, and possible cost overruns due to increases in the cost of services. To become profitable and competitive,
we must receive additional capital. We have no assurance that future financing will materialize. If that financing is not available,
we may be unable to continue operations.
Description
of Business, Principal Products, Services
Business
Overview
Sigyn
Therapeutics, Inc. (“Sigyn” or the “Company”) was established on October 29, 2019 in the State of Delaware. We
are a development-stage therapeutic technology company that is headquartered in San Diego, California USA. Our primary focus is directed
toward a significant unmet need in global health: the treatment of acute life-threatening inflammatory conditions that are precipitated
by Cytokine Storm Syndrome (“The Cytokine Storm” or “Cytokine Release Syndrome”) and not addressed with approved
drug therapies. Cytokine Storm Syndrome is a dysregulated immune response that can be induced by a wide range of infectious and non-infectious
conditions. A hallmark of the Cytokine Storm is an over-production of inflammatory cytokines, which can destroy tissue, trigger multiple-organ
failure and cause death.
On
October 19, 2020, Reign Resources Corporation, a Delaware corporation (the “Registrant”) completed a Share Exchange Agreement
(the “Agreement”) with our organization (Sigyn Therapeutics) that resulted in the registrant acquiring 100% of our issued
and outstanding shares of common stock in exchange for 75% of the fully paid and nonassessable shares of the Registrant’s common
stock outstanding (the “Acquisition”). In conjunction with the transaction, the Registrant changed its name to Sigyn Therapeutics,
Inc. pursuant to an amendment to its articles of incorporation that was filed with the State of Delaware. Subsequently, the Registrant’s
trading symbol was changed to SIGY. The Acquisition was treated as a “tax-free exchange”
under Section 368 of the Internal Revenue Code of 1986 and resulted in the Sigyn corporate entity (established on October 29,
2019) to become a wholly owned subsidiary of the Registrant. Among the conditions for closing the acquisition, the Registrant extinguished
all previously reported liabilities, its preferred class of shares, and all stock purchase options. As a result, the reported liabilities
totaling $3,429,516 converted into a total of 7,907,351 common shares. Additionally, assets held
on the books of Reign Resources Corporation, such as Gem inventory, was kept in the Company and therefore recorded as assets on the Share
Exchange date. The Registrant’s Board of Directors appointed James A. Joyce and Craig P. Roberts to serve as members of
the Registrant’s Board of Directors upon closing of the Acquisition.
As
of November 10, 2021, we have a total 37,295,803 shares issued and outstanding, of which 11,135,803 shares are held by non-affiliate
shareholders.
About
Sigyn Therapy
Sigyn
Therapy is a novel blood purification technology designed to mitigate cytokine storm syndrome through the broad-spectrum depletion of
inflammatory targets from the bloodstream. Sigyn Therapy’s mechanism of action allows for it to be implemented on the established
infrastructure of dialysis and CRRT machines that are already located in hospitals and clinics worldwide. Cytokine Storm Syndrome is
a hallmark of sepsis, which is the most common cause of in-hospital deaths and claims more lives each year than all forms of cancer combined.
Virus induced cytokine storm (VICS) is associated with high mortality and is a leading cause of SARS-CoV-2 (COVID-19) deaths. Other therapeutic
opportunities include but are not limited to bacteria induced cytokine storm (BICS), acute respiratory distress syndrome (ARDS) and acute
forms of liver failure such as Hepatic Encephalopathy, which is associated with elevated levels of toxins and inflammatory cytokines
in the bloodstream.
Recent
Clinical Disclosures
Since
December 1, 2020, we have reported the results from a series of in vitro blood purification studies that have demonstrated the
expansive capabilities of Sigyn Therapy to address pathogen sources of inflammation, deadly toxins and relevant inflammatory mediators.
Among
the therapeutic targets validated were viral pathogens (including COVID-19), bacterial endotoxin, relevant inflammatory cytokines (Interleukin-1
beta, Interleukin-6 and Tumor Necrosis Factor alpha) and hepatic toxins (ammonia, bilirubin, and bile acid). We also completed a study
that modeled our ability to capture CytoVesicles that transport inflammatory cargos throughout the bloodstream.
Contributing
to these expansive capabilities is a formulation of adsorbent components that are incorporated within Sigyn Therapy. Our adsorbent formulation
provides more than 170,000 square meters of surface area on which to adsorb and remove bloodstream targets. This equates to more than
40 acres of surface adsorption area in each adult version of Sigyn Therapy. To date, we have demonstrated that Sigyn Therapy can addresses
inflammatory targets as well as pathogen sources of inflammation whose molecular size can exceed 100 nanometers in size.
On
July 29, 2020, we disclosed the completion of our first-in-mammal pilot study that demonstrated the safe administration of Sigyn Therapy
during six-hour treatment exposures. In coming months, we plan to continue our collection of animal safety data, which will be included
in an Investigational Device Exemption (IDE) that we are drafting for submission to The United States Food and Drug Administration (FDA)
to support the potential initiation of human clinical studies. However, there is no assurance that FDA will permit the initiation of
our proposed human studies in the United States.
Sigyn
Therapy Mechanism of Action
Sigyn
Therapy is a novel blood purification technology whose broad-spectrum mechanism of action establishes a basis to treat an expansive pipeline
of candidate indications. Incorporated within Sigyn Therapy is a “cocktail” of adsorbent components that have been formulated
to optimize the depletion of inflammatory cytokines, toxins, CytoVesicles, endotoxin and potentially other pathogenic factors that are
known to induce Cytokine Storm Syndrome.
In
the medical field, the term “cocktail” is a reference to the simultaneous administration of multiple drugs (a drug cocktail)
with differing mechanisms of actions. While drug cocktails have begun to emerge as potential mechanisms to treat cancer, they are proven
life-saving countermeasures to treat HIV/AIDS and Hepatitis-C virus infection. However, dosing of multi-drug agent cocktails is limited
by toxicity and adverse events that can result from deleterious drug interactions. Sigyn Therapy is not constrained by such limitations
as our active components are not introduced into the body. As a result, we are able to incorporate a substantial dose of multiple adsorbents,
each with differing mechanisms and capabilities to optimize Sigyn Therapy’s ability to calm the cytokine storm that underlies life-threatening
inflammatory conditions.
Beyond
our advantageous dosing strategy, the components of our adsorbent cocktail have surface characteristics and structures that permit Sigyn
Therapy to bind or adsorb inflammatory targets that exceed 100 nanometers in diameter. Whereas the two most broadly deployed devices
to treat acute life-threatening inflammatory conditions are limited to addressing either a single molecular target (endotoxin) or a broad-spectrum
of inflammatory cytokines below 5 nanometers in diameter.
Beyond
these mechanistic advantages, Sigyn Therapy is a single-use, “blood-in-blood-out device” that can be deployed on the established
infrastructure of dialysis and CRRT machines that are already located in hospitals and clinics worldwide. Sigyn Therapy isolates inflammatory
targets from the bloodstream to optimize their interaction with our cocktail of adsorbent components. We believe this mechanism to be
a further competitive advantage as our adsorbent components are restricted from contacting or activating blood cells.
From
a technical perspective, Sigyn Therapy converges the plasma separation function of hollow-fiber plasmapheresis devices with the expansive
capacity of adsorbent components housed in the extra-lumen space (outside the fiber walls, yet inside the outer shell of the cartridge)
to optimize the elimination of inflammatory targets in a low-shear force environment without interacting with blood cells. As blood flows
into our device, the plasma components along with inflammatory targets move through the porous walls (≈200 nm) of the hollow-fibers
(2500+ fibers) due to the blood side pressure. Because the hollow fiber bundle creates a resistance to the flow of blood, a pressure
drop is created along the length of the device such that the blood-side pressure is higher at the blood inlet and lower at the blood
outlet. This causes plasma to flow away from the blood and into the extra-lumen space (home of our adsorbent components) along the proximal
third of the fiber bundle. In the distal third of the fiber bundle, the pressure gradient is reversed, which causes the plasma to flow
backward through the fiber walls where it is recombined with cellular components without the inflammatory initiators, cytokines or toxins
that have been bound or captured by the cocktail of adsorbent components housed in the extra-lumen space. Based on blood flow rates of
200ml/min, a patient’s entire blood volume can pass through Sigyn Therapy approximately 10 times during a four-hour treatment period.
Market
Overview
Cytokine
Storm Syndrome is a hallmark of sepsis, which is the most common cause of in-hospital deaths and claims more lives each year than all
forms of cancer combined. Virus induced cytokine storm (VICS) is associated with high mortality and is a leading cause of SARS-CoV-2
(COVID-19) deaths. Other therapeutic opportunities include but are not limited to bacteria induced cytokine storm (BICS), acute respiratory
distress syndrome (ARDS) and acute forms of liver failure such as Hepatic Encephalopathy, which is associated with elevated levels of
toxins and inflammatory cytokines in the bloodstream. The annual market opportunity for a therapeutic strategy to prevent or mitigate
the Cytokine Storm has been reported to exceed $20 billion.
In
April 2020, the FDA published the following statement, which supports the regulatory advancement of anti-cytokine blood purification
technologies: “Based on the totality of scientific evidence available, the removal of pro-inflammatory cytokines may ameliorate
the cytokine storm due to the overabundance of pro-inflammatory cytokines and, in turn, provide clinical benefit.”
The
Cytokine Storm Precipitates Sepsis
Sepsis
is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. In January of 2020, a report
entitled; “Global, Regional, and National Sepsis Incidence and Mortality, 1990-2017: Analysis for the Global Burden of Disease
Study,” was published in the Journal Lancet. The publication reported 48.9 million cases of sepsis and 11 million deaths in
2017. In that same year, an estimated 20.3 million sepsis cases and 2.9 million deaths were among children younger than 5-years old.
The report referenced that sepsis kills more people around the world than all forms of cancer combined. In the United States, sepsis
was reported to be the most common cause of in-hospital deaths with annual costs exceeding $24 billion.
To
date, more than 100 human studies have been conducted to evaluate the safety and benefit of candidate drugs to treat sepsis. With one
brief exception (Xigris, Eli Lilly), none of these studies resulted in a market approved therapy. As the treatment of sepsis remains
elusive for therapeutic drug agents, an increased understanding of the complex mechanisms that underlie sepsis support the potential
of therapeutic strategies that modulate a broad-spectrum of inflammatory factors.
As
a result, an increased focus has been directed toward extracorporeal blood purification, with an emphasis on devices that improve immune
homeostasis through the depletion of circulating inflammatory mediators. Given the pivotal role of endotoxin and cytokine production
in sepsis, it is anticipated that the simultaneous depletion of these inflammatory factors may establish the basis for an efficacious
strategy. We also believe that inflammatory cytokine cargos transported by CytoVesicles represent a novel, yet important therapeutic
target.
Virus
Induced Cytokine Storm (VICS)
Virus
Induced Cytokine Storm (VICS) is associated with high mortality rates and is defined by an excess production of inflammatory cytokines
in response to a virulent viral infection. As the vast majority of human viruses are not addressed with a corresponding drug or vaccine,
there is an urgent and ongoing need for therapies that mitigate the Cytokine Storm that can be initiated by a broad-spectrum of viral
pathogens. At present, VICS is a leading cause of COVID-19 deaths and often precipitates other life-threatening conditions including
acute respiratory distress syndrome (ARDS) and sepsis, which are highly prevalent in hospitalized COVID-19 patients.
In
March of 2020, Yale University researchers reported that elevated levels of pro-inflammatory cytokines correlated with the severity of
COVID-19 infection and increased mortality rates. Inversely, the researchers reported that declining levels of these same cytokines are
associated with patient recovery. In April of 2020, the FDA established pro-inflammatory cytokine reduction as a clinical endpoint to
ameliorate the cytokine storm induced by a viral infection.
Beyond
COVID-19, virus induced Cytokine Storms are associated with many of the 250,000 to 500,000 global deaths that result from severe influenza
infections each year. In some years, the death toll resulting from influenza rises to pandemic proportions. In modern history, the best-known
example is the H1N1 Spanish Flu of 1918 which caused the deaths of more than 50 million individuals. Other deadly influenza outbreaks
included the 1957 H2N2 Asian influenza, the 1968 H3N2 Hong Kong influenza, and the 2009 H1N1 pandemic influenza. Between 1997 and 2014,
several epizootic avian influenza viruses (e.g., H5N1, H7N9, and H10N8) crossed the species barrier to cause increased human death tolls.
In
recent years, virus induced Cytokine Storm was associated with high mortality resulting from the 2003 SARS virus outbreak and the 2014-15
Ebola virus outbreak. VICS is also reported to play a role in mosquito-borne viral infections, including severe Dengue infections, which
result in approximately 40,000 deaths each year.
We
believe that Sigyn Therapy can serve as a first-line countermeasure to mitigate Cytokine Storm Syndrome resulting from emerging viral
outbreaks that are increasingly being fueled by a confluence of global warming, urban crowding and intercontinental travel. As it is
improbable for post-exposure drugs and vaccines to be developed, proven effective, manufactured and delivered at the outset of a pandemic,
we believe there will be an ongoing demand for therapies to address virus induced Cytokine Storm Syndrome. Additionally, we believe that
Sigyn Therapy aligns with U.S. Government initiatives that support the development of broad-spectrum medical countermeasures that mitigate
the impact of emerging pandemic threats, yet also have viability in established disease indications.
Bacteria
Induced Cytokine Storm (BICS)
Gram-negative
bacteria infections are a significant global health issue due to their resistance to antibiotic therapy. In severe infections, bacteria
shed endotoxins into the circulatory system, which are potent drivers of Cytokine Storm Syndrome. According to the Centers for Disease
Control and Prevention (CDC), over two million infections are caused by antibiotic-resistant bacteria each year in the United States,
resulting in approximately 23,000 deaths. From a national biodefense perspective, four species of bacteria have been classified as “Category
A” biological threats as they pose a high risk to national security and public health. These include Bacillus anthracis (anthrax),
Clostridium botulinum toxin (botulism), Yersinia pestis (plague) and Francisella tularensis (tularemia). The extracorporeal elimination
of circulating endotoxin has previously been demonstrated to help rebalance the innate immune system, decrease levels of inflammatory
mediators and improve vascular function and hemodynamics.
Acute
Respiratory Distress Syndrome (ARDS) Treatment Opportunity
Acute
respiratory distress syndrome (ARDS) is a form of respiratory failure characterized by the rapid onset of widespread inflammation in
the lungs. ARDS is often associated with multiple organ failure and is known to be precipitated by a variety of clinical disorders, including
Cytokine Storm Syndrome. Globally, ARDS is associated with approximately 3 million deaths each year and has a mortality rate of 30-50%.
Hepatic
Encephalopathy (HE)
Hepatic
Encephalopathy (HE) is a life-threatening complication of liver cirrhosis that results in 25,000-40,000 U.S. hospital admissions each
year. The three-year survival rate following the first episode of HE is approximately 15%. HE severity has been correlated with highly
elevated serum concentrations of pro-inflammatory cytokines and toxins. At present, we have not conducted studies that validate the ability
of Sigyn Therapy to deplete HE related toxins from blood or blood plasma.
Bridge-To-Liver
Transplant
There
is a significant need for a medical device that can reduce the circulating presence of inflammatory cytokines and toxins in patients
with liver failure. Based on these requirements, Sigyn Therapy is a candidate strategy to stabilize or extend the life of a patient prior
to the identification of a matched liver for transplantation. Otherwise known as a bridge-to-liver transplant. In 2017, 8,082 U.S. patients
received a liver transplant and 13,885 patients were on the waiting list for a liver transplant. The average cost associated with a liver
transplant is $577,100 USD. As with Hepatic Encephalopathy, we have not conducted studies that validate the ability of Sigyn Therapy
to deplete deleterious toxins associated with liver failure.
Other
Potential Opportunities
Cytokine
Storm Syndrome may also result from trauma, severe burns, acute pancreatitis, adverse drug reactions, cancer immunotherapies, cancer
cachexia, acute kidney injury (AKI) and severe pneumonia.
Competition
Our
primary focus is directed toward treating acute life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome
and not addressed with approved drug therapies. As a result of COVID-19, single-mechanism drugs to inhibit specific cytokine targets
are being clinically evaluated in COVID-19 infected individuals. The candidate targets for these drug agents include IL-1, IL-6 and TNF-a,
which are simultaneously addressed by Sigyn Therapy based on recent in vitro study outcomes.
Emerging
and historic evidence reveals the considerable challenge to temper the Cytokine Storm through the inhibition of a single cytokine target.
In April of 2020, an article in the Journal Nature reported 14 different inflammatory cytokines to be highly elevated in bloodstream
of COVID-19 patients. In May of 2020, Stanford researchers reported that elevated levels of inflammatory cytokines in COVID-19 patients
are consistent with those observed in critically ill (non-COVID-19) sepsis and ARDS patients, which are conditions for which anti-cytokine
drugs have previously been unable to demonstrate benefit in clinical studies. Specific to sepsis, more than 70 human studies have been
conducted to evaluate the safety and benefit of candidate drugs. With one brief exception (Xigris, Eli Lilly), none of these studies
resulted in a market approved therapy.
In
the absence of safe and effective drugs to address Cytokine Storm related conditions, we anticipate that the market for therapeutic blood
purification technologies to address Cytokine Storm Syndrome will be extremely competitive.
The
most broadly deployed blood purification technologies to address life-threatening inflammatory conditions are the Toraymyxn device from
Toray Industries and the CytoSorb device from CytoSorbents Corporation. While not yet market cleared in the United States, these industry-pioneering
technologies are approved for use in more than 40 countries, have been administered to hundreds of thousands of patients, are the subject
of hundreds of peer-reviewed publications and are being evaluated to treat severe COVID-19 infections. However, the mechanism of action
of each of these technologies differs substantially.
The
Toraymyxin device houses an immobilized antibiotic agent that has a high specificity to bind circulating endotoxin, which is a potent
activator of cytokine storm syndrome induced by gram-negative bacterial infections. However, Toraymyxin does not address inflammatory
cytokines or CytoVesicles. Conversely, the CytoSorb device incorporates an adsorbent bead that depletes inflammatory cytokines from the
bloodstream but does not address endotoxin or CytoVesicles.
We
believe that Sigyn Therapy’s ability to address inflammatory cytokines, endotoxin and CytoVesicles provides us with a significant
competitive advantage that we plan to demonstrate in human clinical studies. However, there is no assurance that we will advance human
clinical studies that demonstrate safety and efficacy of our technology.
Marketing
and Sales
At
present, we do not market or sell any therapeutic products. We plan to establish relationships with organizations that have established
distribution channels into markets that might be served by Sigyn Therapy should it receive market clearance from FDA or other foreign
regulatory agencies.
Intellectual
Property
We
own the intellectual property rights to pending royalty-free patents that have been assigned to us by our co-founders, James A. Joyce
and Craig P. Roberts. We have also received a “Notice of Allowance” from the United States Patent and Trademark Office (USPTO)
related to the use of Sigyn Therapeutics, Sigyn Therapy and the protection of our corporate logo. We plan to continually expand our intellectual
property portfolio and protect trade secrets that are not the subject of patent submissions. However, there is no assurance that the
claims of current pending and future patent applications will result in issued patents.
At
present, we own the rights to the following patents pending.
DEVICES,
SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - U.S. Application No.: 62/881,740; Filing
Date: 2019-08-01 - Inventors: Joyce & Roberts
DEVICES,
SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - International Patent Application No.: PCT/US2020/044223;
Filing Date: 2020-07-30 - Inventors: Joyce & Roberts
DEVICES,
SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - U.S. Patent Application No.: 16/943,436;
Filing Date: 2020-07-30 - Inventors: Joyce & Roberts
EXTRA-LUMEN ADSORPTION OF VIRAL PATHOGENS FROM BLOOD
U.S. Patent Application No.: 63/177,520; Filing Date: 2021-04-21
Inventors: Joyce & Roberts
Government
Regulation
In
the United States, Sigyn Therapy is subject to regulation by the FDA and other healthcare agencies. Should we seek to commercialize Sigyn
Therapy outside the United States, we expect to face comparable international regulatory oversight. Based on published guidance by FDA,
we anticipate Sigyn Therapy to be a Class III medical device whose regulatory jurisdiction will be the Center for Devices and Radiological
Health (CDRH), the FDA branch that oversees the market approval of medical devices. As a Class III device, we are subject to a Pre-Market
Approval (PMA) submission pathway with CDRH. The approval of PMA application to support market clearance of Sigyn Therapy will require
extensive data, which includes but is not limited to technical documents, preclinical studies, human clinical trials, the establishment
of Good Manufacturing Practice (GMA) standards and labeling that fulfills FDA’s requirement to demonstrate reasonable evidence
of safety and effectiveness of a medical device product. There is no assurance that Sigyn Therapy will be demonstrated to be a safe and
effective product to treat any life-threatening inflammatory condition precipitated by Cytokine Storm Syndrome.
Additionally,
we must comply with applicable laws and regulations that govern the development, testing, manufacturing, labeling, marketing, storage,
distribution, advertising and promotion, and post-marketing surveillance reporting for medical devices. Failure to comply with these
applicable requirements may subject a device and/or its manufacturer to a variety of administrative sanctions, such as issuance of warning
letters, import detentions, civil monetary penalties and/or judicial sanctions, such as product seizures, injunctions and criminal prosecution.
Our failure to comply with any of these laws and regulations could have a material adverse effect on our operations.
Manufacturing
and Procurement
We
are advancing a manufacturing relationship with an FDA registered Contract Manufacturing Organization (CMO) to establish GMP compliant
manufacturing to support human clinical studies and potential commercialization should we receive clearance to market Sigyn Therapy.
We plan to establish manufacturing procedure specifications that define each stage of our manufacturing, inspection and testing processes
and the control parameters or acceptance criteria that apply to each activity that result in the production of our technology.
We
have also established relationships with industry vendors that provide components necessary to manufacture our device. Should the relationship
with an industry vendor be interrupted or discontinued, we believe that alternate component suppliers can be identified to support the
continued manufacturing of our product. However, delays related to interrupted or discontinued vendor relationships could adversely impact
our business.
Research
and Product Development
We
have sourced our research and product development activities, which include the performance of in vitro validation studies, pre-GMP
product assembly and manufacturing through an organization with extensive experience in advancing extracorporeal blood purification technologies.
At present, we do not plan to build and staff our own research and product development facility.
Environmental
Laws and Regulations
At
present, our operations are not subject to any environmental laws or regulations.
Employees
We
have 4 full-time employees and no part-time employees as of the date of this filing. We have an employer contribution for healthcare,
but we do not provide pension, annuity, insurance, profit sharing, or similar benefit plans; however, we may adopt such plans in the
future. To conserve cash and resources, we utilize consultants on an as-needed basis to provide various functions. Additionally, we also
contract with clinical and research organizations to support the advancement of Sigyn Therapy.
Overview
of Presentation
The
following Management’s Discussion and Analysis (“MD&A”) or Plan of Operations includes the following sections:
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General
and administrative expenses consist primarily of personnel costs and professional fees required to support our operations and growth.
Depending
on the extent of our future growth, we may experience significant strain on our management, personnel, and information systems. We will
need to implement and improve operational, financial, and management information systems. In addition, we are implementing new information
systems that will provide better record-keeping, customer service and billing. However, there can be no assurance that our management
resources or information systems will be sufficient to manage any future growth in our business, and the failure to do so could have
a material adverse effect on our business, results of operations and financial condition.
Results
of Operations
Three
Months Ended September 30, 2021 Compared to Three Months Ended September 30, 2020
The
following discussion represents a comparison of our results of operations for the three months ended September 30, 2021 and 2020. The
results of operations for the periods shown in our audited unaudited condensed consolidated financial statements are not necessarily
indicative of operating results for the entire period. In the opinion of management, the audited condensed consolidated financial statements
recognize all adjustments of a normal recurring nature considered necessary to fairly state our financial position, results of operations
and cash flows for the periods presented.
|
|
Three Months Ended September 30,
|
|
|
|
2021
|
|
|
2020
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$
|
-
|
|
|
$
|
-
|
|
Cost of sales
|
|
|
-
|
|
|
|
-
|
|
Gross Profit
|
|
|
-
|
|
|
|
-
|
|
Operating expenses
|
|
|
573,363
|
|
|
|
202,977
|
|
Other expense
|
|
|
92,541
|
|
|
|
93,013
|
|
Net loss before income taxes and discontinued operations
|
|
$
|
(665,904
|
)
|
|
$
|
(295,990
|
)
|
Net
Revenues
For
the three months ended September 30, 2021 and 2020, we had no revenues.
Cost
of Sales
For
the three months ended September 30, 2021 and 2020, we had no cost of sales because we had no revenues.
Operating
expenses
Operating
expenses increased by $370,386, or 182.5%, to $573,363 for three months ended September 30, 2021 from $202,977 for the three months ended
September 30, 2020 primarily due to increases in consulting fees of $81,823, compensation costs of $146,088, research and development
costs of $49,659, depreciation and amortization costs of $732, investor relations costs of $69,309, operating lease costs of $23,957,
and general and administration costs of $5,256, offset partially by decreases in professional fees of $6,038 and marketing expenses of
$400, as a result of adding administrative infrastructure for our anticipated business development.
For
the three months ended September 30, 2021, we had research and development costs of $49,659, and general and administrative expenses
of $523,704 primarily due to professional fees of $24,301, compensation costs of $315,165, operating lease costs of $24,412, depreciation
and amortization costs of $1,332, investor relations costs of $69,309, consulting fees of $81,823, and general and administration costs
of $7,362, as a result of adding administrative infrastructure for our anticipated business development.
For
the three months ended September 30, 2020, we had marketing expenses of $400 and general and administrative expenses of $202,577 primarily
due to compensation costs of $169,077, professional fees of $30,339, amortization costs of $600, rent of $455, travel costs of $438,
and general and administration costs of $1,668, as a result of adding administrative infrastructure for our anticipated business development.
Other
(Income) Expense
Other
expense for the three months ended September 30, 2021 totaled $92,541 primarily due to interest expense of $29,095, interest expense
of $49,749 in conjunction with accretion of debt discount and interest expense of $13,697 in conjunction with accretion of original issuance
discount, compared to other expense of $93,013 for the three months ended September 30, 2020 primarily due to interest expense of $82,915
in conjunction with accretion of debt discount and interest expense of $10,098 in conjunction with accretion of original issuance discount.
Net
loss before income taxes
Net
loss before income taxes and discontinued operations for the three months ended September 30, 2021 totaled $665,904 primarily due to
(increases/decreases) in compensation costs, professional fees, marketing costs, investor relations costs, consulting fees, and general
and administration costs compared to a loss of $295,990 for the three months ended September 30, 2020 primarily due to (increases/decreases)
in compensation costs and general and administration costs.
Assets
and Liabilities
Assets
were $1,440,823 as of September 30, 2021. Assets consisted primarily of cash of $502,976, inventories of $586,047, other current assets
of $27,509, property and equipment of $20,654, intangible assets of $6,600, operating lease right-of-use assets of $276,326, and other
assets of $20,711. Liabilities were $1,082,591 as of September 30, 2021. Liabilities consisted primarily accounts payable of $32,874,
accrued payroll and payroll taxes of $44,434, convertible notes of $684,743, net of $46,757 of unamortized debt discount and debt issuance
costs, operating lease liabilities of $291,331, and other current liabilities of $29,209.
Nine
Months Ended September 30, 2021 Compared to Nine Months Ended September 30, 2020
The
following discussion represents a comparison of our results of operations for the nine months ended September 30, 2021 and 2020. The
results of operations for the periods shown in our audited condensed consolidated financial statements are not necessarily indicative
of operating results for the entire period. In the opinion of management, the audited condensed consolidated financial statements recognize
all adjustments of a normal recurring nature considered necessary to fairly state our financial position, results of operations and cash
flows for the periods presented.
|
|
Nine Months Ended September 30,
|
|
|
|
2021
|
|
|
2020
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$
|
-
|
|
|
$
|
-
|
|
Cost of sales
|
|
|
-
|
|
|
|
-
|
|
Gross Profit
|
|
|
-
|
|
|
|
-
|
|
Operating expenses
|
|
|
1,417,278
|
|
|
|
571,867
|
|
Other expense
|
|
|
360,169
|
|
|
|
235,701
|
|
Net loss before income taxes and discontinued operations
|
|
$
|
(1,777,447
|
)
|
|
$
|
(807,568
|
)
|
Net
Revenues
For
the nine months ended September 30, 2021 and 2020, we had no revenues.
Cost
of Sales
For
the nine months ended September 30, 2021 and 2020, we had no cost of sales because we had no revenues.
Operating
expenses
Operating
expenses increased by $845,411, or 147.8%, to $1,417,278 for nine months ended September 30, 2021 from $571,867 for the nine months ended
September 30, 2020 primarily due to increases in professional fees of $58,867, compensation costs of $342,242, consulting fees of $17,818,
research and development costs of $89,281, depreciation and amortization costs of $15,986, investor relations costs of $286,351, operating
lease costs of $27,626, and general and administration costs of $8,351, offset primarily by a decrease in travel costs of $606 and marketing
expenses of $505, as a result of adding administrative infrastructure for our anticipated business development.
For
the nine months ended September 30, 2021, we had research and development costs of $91,259, and general and administrative expenses of
$1,326,019 primarily due to professional fees of $98,277, compensation costs of $725,343, operating lease costs of $28,685, depreciation
and amortization costs of $16,586, investor relations costs of $286,351, consulting fees of $157,818, and general and administration
costs of $12,723, as a result of adding administrative infrastructure for our anticipated business development.
For
the nine months ended September 30, 2020, we had marketing expenses of $505, research and development costs of $1,978, and general and
administrative expenses of $569,384 primarily due to professional fees of $39,410, compensation costs of $383,101, rent of $1,059, consulting
fees of $140,000, amortization costs of $600, and general and administration costs of $5,214, as a result of adding administrative infrastructure
for our anticipated business development.
Other
Expense
Other
expense for the nine months ended September 30, 2021 totaled $360,169 primarily due to interest expense of $29,095, interest expense
of $286,391 in conjunction with accretion of debt discount and interest expense of $44,683 in conjunction with accretion of original
issuance discount, compared to other expense of $235,701 for the nine months ended September 30, 2020 primarily due to interest expense
of $210,836 in conjunction with accretion of debt discount and interest expense of $24,865 in conjunction with accretion of original
issuance discount.
Net
loss before income taxes
Net
loss before income taxes and discontinued operations for the nine months ended September 30, 2021 totaled $1,777,447 primarily due to
(increases/decreases) in compensation costs, professional fees, marketing costs, investor relations costs, consulting fees, and general
and administration costs compared to a loss of $807,568 for the nine months ended September 30, 2021 primarily due to (increases/decreases)
in compensation costs, professional fees, marketing costs, consulting fees, and general and administration costs.
Liquidity
and Capital Resources
General
– Overall, we had an increase in cash flows for the nine months ended September 30, 2021 of $418,574 resulting from cash
used in operating activities of $1,221,221 and cash used in investing activities of $20,205, offset partially by cash provided by financing
activities of $1,660,000.
The
following is a summary of our cash flows provided by (used in) operating, investing, and financing activities during the periods indicated:
|
|
Nine Months Ended September 30,
|
|
|
|
2021
|
|
|
2020
|
|
|
|
|
|
|
|
|
Net cash provided by (used in):
|
|
|
|
|
|
|
|
|
Operating activities
|
|
$
|
(1,221,221
|
)
|
|
$
|
(549,056
|
)
|
Investing activities
|
|
|
(220,205
|
)
|
|
|
(10,799
|
)
|
Financing activities
|
|
|
1,660,000
|
|
|
|
925,000
|
|
|
|
$
|
418,574
|
|
|
$
|
365,145
|
|
Nine
Months Ended September 30, 2021 Compared to Nine Months Ended September 30, 2020
Cash
Flows from Operating Activities – For the nine months ended September 30, 2021, net cash used in operations was $1,221,221
compared to net cash used in operations of $549,056 for the nine months ended September 30, 2020. Net cash used in operations was primarily
due to a net loss of $1,777,447 for nine months ended September 30, 2021 and the changes in operating assets and liabilities of $2,932,
primarily due to the increase in accounts payable of $16,869 and other current liabilities of $43,692, offset primarily by other current
assets of $27,509, other assets of $20,711, and accrued payroll and payroll taxes of $15,273. In addition, net cash used in operating
activities includes adjustments to reconcile net profit from depreciation expense of $1,279, amortization expense of $15,305, stock issued
for services of $211,500, accretion of original issuance costs of $44,683, and accretion of debt discount of $286,391.
For
the nine months ended September 30, 2020, net cash used in operating activities was $549,056. Net cash used in operations was primarily
due to a net loss of $807,568, and the changes in operating assets and liabilities of $22,201, primarily due to the net changes in accounts
payable of $180 and accrued payroll and payroll taxes of $22,021. In addition, net cash provided by operating activities was offset primarily
by adjustments to reconcile net profit from the accretion of the debt discount of $210,836, accretion of original issuance costs of $24,875,
and amortization expense of $600.
Cash
Flows from Investing Activities – For the nine months ended September 30, 2021, net cash used in investing was $20,205
due to the purchase of property and equipment compared to cash flows from investing activities of $10,799 for the nine months ended September
30, 2020 due to the purchase of website development costs.
Cash
Flows from Financing Activities – For the nine months ended September 30, 2021 and 2020, net cash provided by financing
was $1,660,000 due to common stock issued for cash of $1,465,000, proceeds from short term convertible notes of $250,000, and repayment
of short-term convertible notes of $55,000 compared to cash flows from financing activities of $925,000 for the nine months ended September
30, 2020 due to the proceeds from short term convertible notes.
Financing
– We expect that our current working capital position, together with our expected future cash flows from operations will
be insufficient to fund our operations in the ordinary course of business, anticipated capital expenditures, debt payment requirements
and other contractual obligations for at least the next twelve months. However, this belief is based upon many assumptions and is subject
to numerous risks, and there can be no assurance that we will not require additional funding in the future.
We
have no present agreements or commitments with respect to any material acquisitions of other businesses, products, product rights or
technologies or any other material capital expenditures. However, we will continue to evaluate acquisitions of and/or investments in
products, technologies, capital equipment or improvements or companies that complement our business and may make such acquisitions and/or
investments in the future. Accordingly, we may need to obtain additional sources of capital in the future to finance any such acquisitions
and/or investments. We may not be able to obtain such financing on commercially reasonable terms, if at all. Due to the ongoing global
economic crisis, we believe it may be difficult to obtain additional financing if needed. Even if we are able to obtain additional financing,
it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our shareholders,
in the case of equity financing.
Common
Stock
The
Company issued 500,000 restricted common shares to founders, valued at $50 (based on the par value on the date of grant) in exchange
for patent rights. The issuance was an isolated transaction not involving a public offering pursuant to Section 4(2) of the Securities
Act of 1933.
The
Company has authorized 1,000,000,000 shares of par value $0.0001 common stock, of which 500,000 shares are outstanding at December 31,
2020.
On
November 3, 2021, the Company entered into a three-month Advertising and Marketing Consulting Agreement (“Agreement”) with
a third party. The Company agreed to pay $20,000 per month and issue 15,000 shares of the Company’s common stock on the 60th
day of the term of the Agreement. This issuance will be pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended,
in a transaction exempt from registration.
On
October 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $385,000, into 42,857 common shares.
On
October 25, 2021, Osher elected to convert the aggregate principal amount of the Note, $110,000, into 157,143 common shares.
On
October 20, 2021, the entered into a securities purchase agreement with an accredited investor that resulted in the issuance of 320,000
shares of common stock and warrants to purchase an aggregate of 320,000 shares of the Company’s common stock for total proceeds
totaling $400,000. The offering allowed for qualified investors to purchase one share of the Company’s common stock at $1.25. For
each share purchased, the investor received a five-year warrant to purchase one share of common stock at $1.25 per share. No commissions
were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction
exempt from registration.
On
October 14, 2021, the Company issued a total of 47,000 shares of its common stock valued at $37,600 (based on the stock price of the
Company’s common stock on the date of issuance) to a third party, for communications to the financial industry.
On
July 14, 2021, the Company issued a total of 47,000 shares of its common stock valued at $47,000 (based on the stock price of the Company’s
common stock on the date of issuance) to a third party, for communications to the financial industry.
On
May 10, 2021, Brio Capital elected to convert the aggregate principal amount of a $110,000 convertible note issued on February 10, 2021
into 157,143 shares of the Company’s common stock.
In
April 2021, the Company initiated an offering of up to $1.5 million of the Company’s restricted common shares. The offering allowed
for qualified investors to purchase one share of the Company’s common stock $1.25. For each share purchased, the investor received
a five-year warrant to purchase one share of common stock at $1.75 per share. On May 10, 2021, the Company closed the offering to investors
and subsequently disclosed that it had entered into securities purchase agreements with accredited investors that resulted in the issuance
of 1,172,000 shares of common stock and warrants to purchase an aggregate of 1,172,000 shares of the Company’s common stock for
total proceeds totaling $1,465,000. No commissions were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the Securities
Act of 1933, as amended, in a transaction exempt from registration.
On
April 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock price
of the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuance
was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.
On
February 19, 2021, a previous noteholder exercised the warrants pursuant to the cashless exercise provision of the warrant agreement
into 57,147 common shares. The common shares have not been issued as of November 10, 2021.
On
January 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock price
of the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuance
was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.
During
the nine months ended September 30, 2021 and 2020, the Company issued 1,266,000 shares common shares to third parties for services and
cash, 157,143 common shares to third parties in conjunction with the conversion of convertible promissory debentures, and 57,147 common
shares to a third party with the exercise of warrants.
Convertible
Promissory Debentures
Current
Noteholders
Osher
– $110,000
On
February 10, 2021, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due February 11, 2022 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 157,143 shares of the Company’s Common
Stock at an exercise price of $1.20 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.70 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
On
October 25, 2021, Osher elected to convert the aggregate principal amount of the Note, $110,000, into 157,143 common shares.
Osher
– $457,380
On
January 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $385,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
due January 26, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants to purchase up
to an aggregate of 80,209 shares of the Company’s Common Stock at an exercise price of $7.00 per share. The aggregate cash subscription
amount received by the Company from Osher for the issuance of the note and warrants was $350,005 which was issued at a $34,995 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.094 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follow on October 20, 2020:
|
●
|
The
parties amended the Warrants dated January 28, 2020, for the number of warrant shares from 80,209 warrant shares to 4,113,083 warrant
shares at an exercise price of $0.14 per share.
|
|
●
|
The
parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.
|
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows:
|
●
|
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
|
|
●
|
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
|
|
●
|
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share.
|
On
October 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $385,000, into 42,857 common shares.
Osher
– $60,500
On
June 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $50,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
(the “Note”) due June 23, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants
(“Warrants”) to purchase up to an aggregate of 10,000 shares of the Company’s Common Stock at an exercise price of
$30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants
was $50,005 which was issued at a $0 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,
as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follow on October 20, 2020:
|
●
|
The
parties amended the Note for the aggregate principal amount from $50,000 to $55,000. The aggregate cash subscription amount received
by the Company from Osher for the issuance of the Note and Warrants was $50,005 which was issued at an amended $4,995 original issue
discount from the face value of the Note.
|
|
●
|
The
parties amended the Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.
|
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows:
|
●
|
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
|
|
●
|
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
|
|
●
|
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share.
|
Osher
– $199,650
On
September 17, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $181,500 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
(the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase
Warrants (“Warrants’) to purchase up to an aggregate of 8,250 shares of the Company’s Common Stock at an exercise price
of $30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants
was $165,000 which was issued at a $16,500 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,
as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follow on October 20, 2020:
|
●
|
The
parties amended the Warrants dated September 17, 2020, for the number of warrant shares from 8,250 warrant shares to 465,366 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.
|
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows:
|
●
|
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
|
|
●
|
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
|
|
●
|
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share.
|
Previous
Noteholders
Previous
Noteholder – $50,000 (as amended on October 20, 2020 to $55,000)
On
June 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $50,000 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due June 23, 2021, based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 10,000
shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $50,000 which was issued at a $0 original issue
discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
|
●
|
The
parties amended the Note for the aggregate principal amount from $50,000 to $55,000. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $50,000 which was issued at an amended
$5,000 original issue discount from the face value of the Note.
|
|
●
|
The
parties amended the Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020 warrant
shares at an exercise price of $0.59 per share.
|
|
●
|
The
parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.
|
On
December 2, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $55,000, into 141,020 common
shares.
Previous
Noteholder - $25,000 (as amended on October 20, 2020 to $27,500)
On
August 18, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $25,000 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due August 18, 2021, based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 5,000
shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $25,000 which was issued at a $0 original issue
discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
|
●
|
The
parties amended the Note for the aggregate principal amount from $25,000 to $27,500. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $25,000 which was issued at an amended
$2,500 original issue discount from the face value of the Note.
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The
parties amended the Warrants dated August 18, 2020, for the number of warrant shares from 5,000 warrant shares to 70,510 warrant
shares at an exercise price of $0.59 per share.
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The
parties amended the Note for the maturity date from August 18, 2021 to October 20, 2021.
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On
October 28, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $27,500, into 70,510 common
shares.
Previous
Noteholder – $93,500
On
September 18, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $93,500 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by
the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of
4,250 shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $85,000 which was issued at a $8,500 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
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The
parties amended the Warrants dated September 18, 2020, for the number of warrant shares from 4,250 warrant shares to 239,734 warrant
shares at an exercise price of $0.59 per share.
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The
parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.
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On
December 2, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $93,500, into 239,734 common
shares.
Previous
Noteholder - $165,000
On
September 21, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $165,000 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by
the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of
7,500 shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $150,000 which was issued at a $15,000 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follow on October 20, 2020:
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The
parties amended the number of shares from the Warrants dated September 21, 2020, for the number of warrant shares from 7,500 warrant
shares to 423,060 warrant shares at an exercise price of $0.59 per share.
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The
parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.
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On
November 5, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $165,000, into 423,060 common
shares.
Previous
Noteholder – $27,500 (as amended on October 20, 2020 to $22,000)
On
September 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $27,500 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due August 28, 2021, based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 1,000
shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $20,000 which was issued at a $7,500 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
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The
parties amended the Note for the aggregate principal amount from $27,500 to $22,000. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $20,000 which was issued at an amended
$2,000 original issue discount from the face value of the Note.
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The
parties amended the Warrants dated September 28, 2020, for the number of warrant shares from 1,000 warrant shares to 56,408 warrant
shares at an exercise price of $0.59 per share.
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The
parties amended the Note for the maturity date from August 18, 2021 to October 20, 2021.
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On
October 27, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $22,000, into 56,408 common
shares.
On
February 19, 2021, the previous noteholder exercised the warrants pursuant to the cashless exercise provision of the warrant agreement
into 57,147 common shares. The common shares have not been issued as of November 10, 2021.
Previous
Noteholder – $33,000
On
September 29, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to a previous noteholder of (i) $33,000 aggregate principal amount of Original
Issue Discount Senior Convertible Debenture (the “Note”) due August 18, 2021, based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 1,500
shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount received
by the Company from the previous noteholder for the issuance of the Note and Warrants was $30,000 which was issued at a $3,000 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:
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The
parties amended the Warrants dated September 29, 2020, for the number of warrant shares from 1,500 warrant shares to 84,612 warrant
shares at an exercise price of $0.59 per share.
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The
parties amended the Note for the maturity date from August 18, 2021 to October 20, 2021.
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On
October 26, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $33,000, into 84,612 common
shares.
Previous
Noteholder – $110,000
On
February 10, 2021, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to a previous noteholder of (i) $110,000 aggregate principal amount of Note due February 11, 2022 based on $1.00
for each $0.90909 paid by the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase
up to an aggregate of 157,143 shares of the Company’s Common Stock at an exercise price of $1.20 per share. The aggregate cash
subscription amount received by the Company from the previous noteholder for the issuance of the Note and Warrants was $100,000 which
was issued at a $10,000 original issue discount from the face value of the Note. The conversion
price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.70 per share, subject to
adjustment as provided therein, such as stock splits and stock dividends.
On
May 10, 2021, the previous noteholder elected to convert the aggregate principal amount of a $110,000 convertible note issued on February
10, 2021 into 157,143 shares of the Company’s common stock.
Previous
Noteholder – $55,000
On
May 4, 2021, the Company repaid the aggregate principal amount of a $55,000 convertible debenture that was entered into on April 7, 2021
with a previous noteholder. The note was a 10% Original Issue Discount Senior Convertible Debenture (the “Note”) which included
a five-year Common Stock Purchase Warrant (“Warrants’) to purchase up to an aggregate of 71,429 shares of the Company’s
Common Stock at an exercise price of $1.20 per share. The aggregate cash subscription amount received by the Company from the previous
noteholder for the issuance of the Note and Warrants was $50,000 which was issued at a $5,000 original issue discount from the face value
of the Note.
Employment
Agreements
Mr.
Joyce receives an annual base salary of $455,000, plus bonus compensation not to exceed 50% of salary. Mr. Joyce’s employment also
provides for medical insurance, disability benefits and one year of severance pay if his employment is terminated without cause or due
to a change in control. Additionally, the Company has agreed to maintain a beneficial ownership target of 9% for Mr. Joyce. Mr. Joyce’s
compensation was approved by the Reign Resources Corporation Board of Directors on October 6, 2020 and was among conditions of the Share
Exchange Agreement that was completed with Sigyn Therapeutics on October 19, 2020. The Company incurred compensation expense of $112,500
and $337,500, and $91,800 and $195,260, and employee benefits of 10,104 and $19,000, and $5,106 and $15,318 for the three and nine months
ended September 30, 2021 and 2020, respectively.
Sigyn
had no employment agreement with its CTO but Sigyn still incurred compensation on behalf of the CTO. The Company incurred compensation
expense of $60,000 and $180,000, and $65,000 and $133,016, and employee benefits of $3,261 and $12,157, and $5,106 and $15,318, for the
three and nine months ended September 30, 2021 and 2020, respectively.
Media
Advertising Agreement
On
May 13, 2021, the Company mutually terminated the Media Relations Agreement (“Media Agreement”) with a third party for marketing
and to promote brand awareness that was entered into on February 10, 2021. The Company agreed to pay $25,000 due in cash at the execution
of the Media Agreement. No shares were issued in conjunction with the Media Agreement.
Bonus
On
July 21, 2021, as a result of achieving certain milestones, the Board of Directors agreed to pay each of the Company’s CEO and
CTO a performance bonus equal to 5% of their annual salary totaling $34,750.
Capital
Expenditures
Other
Capital Expenditures
We
expect to purchase approximately $30,000 of equipment in connection with the expansion of our business during the next twelve months.
Fiscal
year end
Our
fiscal year end is December 31.
Going
Concern
The
accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern,
which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. The
Company had an accumulated deficit of approximately $3,039,000 at September 30, 2021, had working capital of approximately $287,000 at
September 30, 2021 and $76,000 at December 31, 2020, respectively, had a net loss of approximately $666,000 and $1,777,000 for the three
and nine months ended September 30, 2021, and net cash used in operating activities of approximately $1,221,000 for the nine months ended
September 30, 2021, with no revenue earned since inception, and a lack of operational history. These matters raise substantial doubt
about the Company’s ability to continue as a going concern.
While
the Company is attempting to expand its research and development activities, the Company’s cash position may not be significant
enough to support the Company’s daily operations. Management intends to raise additional funds by way of a private offering or
an asset sale transaction. Management believes that the actions presently being taken to further implement its business plan and generate
revenues provide the opportunity for the Company to continue as a going concern. While management believes in the viability of its strategy
to generate revenues and in its ability to raise additional funds or transact an asset sale, there can be no assurances to that effect
or on terms acceptable to the Company. The ability of the Company to continue as a going concern is dependent upon the Company’s
ability to further implement its business plan and generate revenues.
The
unaudited condensed consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue
as a going concern.
Critical
Accounting Policies
Refer
to Note 3 in the accompanying notes to the unaudited condensed consolidated financial statements for critical accounting policies.
Recent
Accounting Pronouncements
Refer
to Note 3 in the accompanying notes to the unaudited condensed consolidated financial statements.
Off-Balance
Sheet Arrangements
As
of September 30, 2021, we have not entered into any transaction, agreement or other contractual arrangement with an entity unconsolidated
under which it has:
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a
retained or contingent interest in assets transferred to the unconsolidated entity or similar arrangement that serves as credit;
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liquidity
or market risk support to such entity for such assets;
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an
obligation, including a contingent obligation, under a contract that would be accounted for as a derivative instrument; or
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an
obligation, including a contingent obligation, arising out of a variable interest in an unconsolidated entity that is held by, and
material to us, where such entity provides financing, liquidity, market risk or credit risk support to or engages in leasing, hedging,
or research and development services with us.
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Inflation
We
do not believe that inflation has had a material effect on our results of operations.