NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Note
1. Organization, Nature and Continuance of Operations
Organization
RenovaCare,
Inc., together with its wholly owned subsidiary, focuses on the acquisition, research, development and, if warranted, commercialization
of autologous (using a patient's own cells) cellular therapies that can be used for medical and aesthetic applications.
On
July 12, 2013, the Company, through its wholly owned subsidiary, RenovaCare Sciences Corp., completed the acquisition of its flagship
technologies (collectively, the “
CellMist
TM
System
”) along with associated United States patent
applications and two foreign patent applications, the first of which was filed on August 23, 2007 (DE 10 2007 040 252.1) and the
second of which was filed on April 27, 2011 (DE 10 2011 100 450.9), both of which have been granted. One of the US patent applications
was granted on November 29, 2016 (Patent No. US 9,505,000) and the other patent application was granted on April 4, 2017 (Patent
No. US 9,610,430).
The
CellMist
TM
System is comprised of (a) a treatment methodology for cell isolation for the regeneration of human skin
cells (the “
CellMist
TM
Solution
”) and (b) a solution sprayer device (the “
SkinGun
TM
”)
for delivering the cells to the treatment area. The Company has filed additional patent applications related to the CellMist
TM
Solution and SkinGun
TM
technologies.
Nature
and Continuance of Operations
The
Company does not have any commercialized products. The Company's activities have consisted principally of performing research
and development activities and raising capital. These development activities are subject to significant risks and uncertainties,
including possible failure of preclinical testing. The Company has not generated any revenue since inception and has sustained
recurring losses and negative cash flows from operations since inception. The Company expects to incur losses as it continues
development of its products and technologies and expects that it will need to raise additional capital through the sale of its
securities to accomplish its business plan and failing to secure such additional funding before achieving sustainable revenue
and profit from operations poses a significant risk. The Company's ability to fund the development of its cellular therapies will
depend on the amount and timing of cash receipts from future financing activities. There can be no assurance as to the availability
or terms upon which such financing and capital might be available.
As
of December 31, 2018, the Company had $15,397,524 of cash on hand. On January 26, 2018, the Company entered into the first amendment
to the convertible promissory note dated September 9, 2016 and the Company entered into the first amendment to the convertible
promissory note dated February 23, 2017 both with KCC pursuant to which both notes were amended (with a combined principal balance
of $1,095,000) to extend the maturity date to December 31, 2019. On February 13, 2018, the Company received $110,000 upon the
exercise of 100,000 Series D Warrants. On November 26, 2018, the Company completed a private placement, whereby the Company received
proceeds of $14,407,500 from the sale of common stock and warrants and settled the principal balance of $1,095,000 of the convertible
promissory notes. The Company believes that, as a result of the financings, it currently has sufficient cash to meet its funding
requirements over the next twelve months following the issuance of this Annual Report on Form 10-K. However, the Company has experienced and continues to experience negative cash flows from operations, as well as an ongoing requirement for substantial additional capital investment. The Company expects that it may need to raise additional capital to accomplish its business plan over the next several years. If additional funding is required, the Company expects to seek to obtain that funding through private equity or convertible debt. There can be no assurance as to the availability or terms upon which such financing and capital might be available.
The
accompanying consolidated financial statements have been prepared in conformity with generally accepted accounting principles
in the United States of America (“US GAAP”), which contemplates continuation of the Company as a going concern, which
is dependent upon the Company’s ability to establish itself as a profitable business.
Note
2. Significant Accounting Policies
Principles
of Consolidation
These
consolidated financial statements have been prepared in accordance with US GAAP and include the accounts of the Company and its
wholly owned subsidiary, RenovaCare Sciences. All significant intercompany transactions and balances have been eliminated. RenovaCare
Sciences was incorporated under the laws of the State of Nevada on June 12, 2013.
New
Accounting Standards
Any
reference in these notes to applicable accounting guidance is meant to refer to the authoritative non-governmental US GAAP as
found in the Financial Accounting Standards Board's Accounting Standards Codification.
In
July 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)
No. 2017-11,
Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and
Hedging (Topic 815).
The amendments in Part I of this Update change the classification analysis of certain equity-linked
financial instruments (or embedded features) with down round features. When determining whether certain financial instruments
should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when
assessing whether the instrument is indexed to an entity’s own stock. The amendments also clarify existing disclosure requirements
for equity-classified instruments. As a result, a freestanding equity-linked financial instrument (or embedded conversion option)
no longer would be accounted for as a derivative liability at fair value as a result of the existence of a down round feature.
For freestanding equity classified financial instruments, the amendments require entities that present earnings per share (EPS)
in accordance with Topic 260 to recognize the effect of the down round feature when it is triggered. That effect is treated as
a dividend and as a reduction of income available to common shareholders in basic EPS. Convertible instruments with embedded conversion
options that have down round features are now subject to the specialized guidance for contingent beneficial conversion features
(in Subtopic 470-20, Debt—Debt with Conversion and Other Options), including related EPS guidance (in Topic 260). The amendments
in Part II of this Update recharacterize the indefinite deferral of certain provisions of Topic 480 that now are presented as
pending content in the Codification, to a scope exception. Those amendments do not have an accounting effect. For public business
entities, the amendments in Part I of this Update are effective for fiscal years, and interim periods within those fiscal years,
beginning after December 15, 2018. Early adoption is permitted for all entities, including adoption in an interim period.
If an entity early adopts the amendments in an interim period, any adjustments should be reflected as of the beginning of the
fiscal year that includes that interim period. Management has assessed that there is no impact upon the adoption of ASU 2017-11
to the Company’s consolidated financial statements.
In
May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718), Scope of Modification Accounting. The
amendments in this Update provide guidance about which changes to the terms or conditions of a share-based payment award require
an entity to apply modification accounting in Topic 718. The amendments in this Update are effective for all entities for annual
periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted,
including adoption in any interim period, for public business entities for reporting periods for which financial statements have
not yet been issued. Management has assessed that there is no impact upon the adoption of ASU 2017-09 to the Company’s consolidated
financial statements.
In
February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)”, which supersedes ASC Topic 840, Leases, and
creates a new topic, ASC Topic 842, Leases. ASU 2016-02 requires lessees to recognize a lease liability and a lease asset for
all leases, including operating leases, with a term greater than 12 months on its balance sheet. ASU 2016-02 also expands the
required quantitative and qualitative disclosures surrounding leases. ASU 2016-02 is effective for the Company beginning January
1, 2019. Early adoption is permitted. The Company has determined that the adoption of ASU 2016-02 will currently have no impact
on its consolidated financial statements.
In
November 2015, the FASB issued ASU No. 2015-17, “Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes” (“ASU
2015-17”). The standard requires that deferred tax assets and liabilities be classified as noncurrent on the balance sheet
rather than being separated into current and noncurrent. The Company adopted the guidance under ASU 2015-17 with no material impact
on its consolidated financial statements.
In
May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers (Topic 606)”, to clarify the principles
used to recognize revenue for all entities. In March 2016, the FASB issued ASU 2016-08 to further clarify the implementation guidance
on principal versus agent considerations. The guidance is effective for annual and interim periods beginning after December 15,
2017, and early adoption is permitted. The Company has determined that the adoption of ASU 2014-09 will currently have no impact
on its consolidated financial statements.
The
Company reviews new accounting standards as issued. Although some of these accounting standards issued or effective after the
end of the Company’s previous fiscal year may be applicable, the Company has not identified any standards that the Company
believes merit further discussion other than as discussed above. The Company believes that none of the new standards will have
a significant impact on the financial statements.
Accounting
Estimates
The
preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting
period. Actual results, as determined by future events, may differ from these estimates. Management utilizes various other estimates, including but not limited to, determining the estimated lives of long-lived assets, determining the potential impairment of intangibles, the fair value of warrants issued, the fair value of stock options and other legal claims and contingencies.
Cash
and Cash Equivalents
The
Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents.
Cash and cash equivalents may at times exceed federally insured limits.
Fair
Value Measurement
The
Company measures fair value as the price that would be received to sell an asset or paid to transfer a liability (an exit price)
in an orderly transaction between market participants at the reporting date. The Company utilizes a three-tier hierarchy which
prioritizes the inputs used in the valuation methodologies in measuring fair value:
Level
1. Valuations based on quoted prices in active markets for identical assets or liabilities that an entity has the ability to access.
The Company has no assets or liabilities valued with Level 1 inputs.
Level
2. Valuations based on quoted prices for similar assets or liabilities, quoted prices for identical assets or liabilities in markets
that are not active, or other inputs that are observable or can be corroborated by observable data for substantially the full
term of the assets or liabilities. The Company has no assets or liabilities valued with Level 2 inputs.
Level
3. Valuations based on inputs that are supported by little or no market activity and that are significant to the fair value of
the assets or liabilities. The Company has no assets or liabilities valued with Level 3 inputs.
Fair
Value of Financial Instruments
The
carrying value of cash and cash equivalents, accounts payable, and contract payable, approximate their fair value because of the
short-term nature of these instruments and their liquidity. It is not practical to determine the fair value of the Company’s
notes payable and accrued interest due to the complex terms. Management is of the opinion that the Company is not exposed to significant
interest or credit risks arising from these financial instruments.
Research
and Development Costs
The
Company intends to outsource its research and development efforts and expense related costs as incurred, including the cost of
manufacturing product for testing, licensing fees and costs associated with planning and conducting clinical trials. The value
ascribed to patents and other intellectual property acquired will be capitalized as it relates to particular research and development
projects that may have alternative future uses.
Equipment
Equipment
is carried at cost, less accumulated depreciation and amortization. Major improvements are capitalized, while repair and maintenance
are expensed when incurred. Renewals and betterments that materially extend the life of the assets are capitalized. When assets
are retired or otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts, and any resulting
gain or loss is reflected in income for the period.
Depreciation
is computed on a straight-line basis over estimated useful lives of the related assets. The estimated useful lives of depreciable
assets are:
|
Estimated
Useful
Lives
|
|
|
Office equipment
|
3-5
years
|
Furniture &
equipment
|
5
- 7 years
|
Intangible
Assets
The
Company’s intangible asset consists primarily of the CellMist
TM
System technology that the Company acquired during
2013 and is recorded at cost. At the time of acquisition, the technology had not reached technological feasibility. The amount
capitalized is accounted for as an indefinite-lived intangible asset, subject to impairment testing until completion or abandonment.
Upon successful completion, a determination will be made as to the then useful life of the intangible asset, generally determined
by the period in which substantially all of the cash flows are expected to be generated, and begin amortization. The Company tests
the intangible asset for impairment at least annually or more frequently if impairment indicators exist after performing a qualitative
analysis. Management has multiple criteria that it considers when performing the qualitative analysis. The results of this review
are then weighed and prioritized. If the totality of the relevant events and circumstances indicate that the intangible asset
is not impaired, additional impairment tests are not necessary.
The
Company assessed the following qualitative factors that could affect any change in the fair value of the intangible asset: analysis
of the technology's current phase, additional testing necessary to bring the technology to market, development of competing products,
changes in projections caused by delays, changes in regulations, changes in the market for the technology and changes in cost
projections to bring the technology to market. Based on a qualitative assessment, management concluded that a positive assertion
can be made from the qualitative assessment that it is more likely than not that the intangible asset related to the CellMist
TM
System is not impaired.
Stock
Options
The
Company measures all stock-based compensation awards using a fair value method on the date of grant and recognizes such expense
in its consolidated financial statements over the requisite service period. The Company uses the Black-Scholes pricing model to
determine the fair value of stock-based compensation awards on the date of grant. The Black-Scholes pricing model requires management
to make assumptions regarding option lives, expected volatility, and risk free interest rates. Forfeitures are recognized as they
occur. The Company’s policy is to issue new shares upon exercise of options.
Financial Instruments, Convertible Instruments,
Warrants and Derivatives
The Company reviews its convertible instruments
for the existence of embedded conversion features that may require bifurcation. If certain criteria are met, the bifurcated derivative
financial instrument is required to be recorded at fair value. The Company also reviews and re-assesses, at each reporting date,
any common stock purchase warrants and other freestanding derivative financial instruments and classifies them on the consolidated
balance sheet as equity, assets or liabilities based upon the nature of the instruments.
Income
Taxes
The
Company accounts for income taxes using the asset and liability method. Under the asset and liability method, deferred tax assets
and liabilities are recognized for the future tax consequences attributed to differences between the financial statement carrying
amounts of existing assets and liabilities and their respective tax bases and tax credits and loss carry-forwards. Deferred tax
assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary
differences and carry-forwards are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a
change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established
when necessary to reduce deferred tax assets to amounts expected to be realized. The Company reports a liability for unrecognized
tax benefits resulting from uncertain income tax positions, if any, taken or expected to be taken in an income tax return. Estimated
interest and penalties are recorded as a component of interest expense or other expense, respectively.
Earnings
(Loss) Per Share
The
Company presents both basic and diluted earnings per share ("EPS") amounts. Basic EPS is calculated by dividing net
income (loss) by the weighted average number of common shares outstanding during the period presented. Diluted EPS amounts are
based upon the weighted average number of common and common equivalent shares outstanding during the period presented. The Company
has not included the effects of warrants, stock options and convertible debt on net loss per share because to do so would be antidilutive.
Following
is the computation of basic and diluted net loss per share for the years ended December 31, 2018 and 2017:
|
|
Years
Ended
December
31,
|
|
|
2018
|
|
2017
|
Basic and Diluted EPS
Computation
|
|
|
|
|
|
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
Loss available
to common stockholders
|
|
$
|
(2,120,841
|
)
|
|
$
|
(3,689,338
|
)
|
Denominator:
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding
|
|
|
77,748,437
|
|
|
|
74,386,340
|
|
Basic and diluted EPS
|
|
$
|
(0.03
|
)
|
|
$
|
(0.05
|
)
|
|
|
|
|
|
|
|
|
|
The shares listed below
were not included in the computation of diluted losses per share because to do so would have been antidilutive for the periods
presented:
|
|
|
|
|
|
|
|
|
Stock options
|
|
|
317,500
|
|
|
|
545,000
|
|
Warrants
|
|
|
13,346,912
|
|
|
|
3,609,158
|
|
Convertible debt
|
|
|
—
|
|
|
|
619,266
|
|
Total shares not included
in the computation of diluted losses per share
|
|
|
13,664,412
|
|
|
|
4,773,424
|
|
Related
Party Transactions
A
related party is generally defined as (i) any person who holds 10% or more of the Company's securities and their immediate families;
(ii) the Company's management; (iii) someone who directly or indirectly controls, is controlled by or is under common control
with the Company; or (iv) anyone who can significantly influence the financial and operating decisions of the Company. A transaction
is considered to be a related party transaction when there is a transfer of resources or obligations between related parties.
See “Note 9. Related Party Transactions” for further discussion.
Note
3. Assets – Intellectual Property
On
July 12, 2013, the Company, together with its wholly owned subsidiary, RenovaCare Sciences, entered into an asset purchase agreement
(“APA”) with Dr. Jörg Gerlach, MD, PhD, pursuant to which RenovaCare Sciences purchased all of Dr. Gerlach’s
rights, title and interest in the CellMist
TM
System. Acquisition related costs amounted to $52,852 and were capitalized
together with the cash payment upon the closing of the transaction in July 2013 of $100,002. Intangible assets amounted to $152,854
at December 31, 2018 and 2017.
Note
4. Contract Payable
On
June 9, 2014, the Company, together with its wholly owned subsidiary, RenovaCare Sciences, entered into an amended asset purchase
agreement (the “Amended APA”) with Dr. Jörg Gerlach, MD, PhD, pursuant to which RenovaCare Sciences purchased
all of Dr. Gerlach's rights, title and interest in the CellMist™ System. The Amended APA provided for cash payments of $300,000
as partial consideration for the purchase which are payable as follows: (a) $100,000 on December 31, 2014; (b) $50,000 on December
31, 2015; (c) $50,000 on December 31, 2017; and (d) $100,000 on December 31, 2017. At December 31, 2017, $100,000 of the amount
payable to Dr. Gerlach was recorded as current liabilities in the accompanying consolidated balance sheet and was paid on January
24, 2018.
See
also “Note 9. Related Party Transactions.”
Note
5. Debt
As
of December 31, 2018 and 2017, the Company had the following outstanding debt balances:
|
|
Issue
Date
|
|
Maturity
Date
|
|
Principal
|
|
Debt
Discount
|
|
Balance
|
|
Interest
Payable
|
As
of December 31, 2018:
|
|
|
|
|
|
|
|
|
|
|
|
|
February
2017 Note as amended
|
|
2/23/2017
|
|
11/26/2018
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
51,225
|
|
September
2016 Note as amended
|
|
9/9/2016
|
|
11/26/2018
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
116,272
|
|
|
|
|
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
167,497
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
of December 31, 2017:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February
2017 Note as amended
|
|
2/23/2017
|
|
12/31/2019
|
|
$
|
395,000
|
|
|
$
|
(58,438
|
)
|
|
$
|
336,562
|
|
|
$
|
24,074
|
|
September
2016 Note as amended
|
|
9/9/2016
|
|
12/31/2019
|
|
|
700,000
|
|
|
|
—
|
|
|
|
700,000
|
|
|
|
66,604
|
|
|
|
|
|
|
|
$
|
1,095,000
|
|
|
$
|
(58,438
|
)
|
|
$
|
1,036,562
|
|
|
$
|
90,678
|
|
February
2017 Convertible Promissory Notes
Between
February 23, 2017 and March 9, 2017, the Company entered into three separate loan agreements containing identical terms (the
“
February 2017 Loan Agreements
”) with Joseph Sierchio (“
Sierchio
”), an investor (the
“
Investor
”), Paul Barbiero, a related party, and Kalen Capital Corporation (“
KCC
”); KCC
is wholly owned by Mr. Harmel S. Rayat, the Company's majority shareholder (collectively, the “
Holders
”).
Pursuant to the terms of the February 2017 Loan Agreements, Sierchio and the Investor each agreed to loan the Company $25,000
($50,000 total) and KCC agreed to loan the Company $395,000 at an annual interest rate of 7% per year, compounded quarterly.
Each loan was evidenced by a convertible promissory note (collectively, the “
February 2017 Notes
”). The
February 2017 Notes, including any interest due thereon, may not be prepaid without the consent of the Holders. The February
2017 Notes were initially due on February 23, 2018, and, beginning on the one month anniversary, can be converted, at the
Holders’ sole discretion, into shares of the Company’s common stock at conversion rate equal to the lesser of:
(i) $3.45, the closing price of the Company’s common stock on the day prior to the issuance of the February 2017 Notes
or (ii) a 20% discount to the average closing price of the Company’s common stock for the five days prior to the date
on which the Holder(s) elect to convert the February 2017 Note(s), subject to a floor price of $2.76.
Per
the February 2017 Loan Agreement, the Company issued Sierchio, the Investor and KCC a Series F Stock Purchase Warrant (the “
Series
F Warrant
”) to purchase up to 7,246 shares, 7,246 shares and 114,493 shares, respectively, of the Company’s common
stock at an exercise price per share equal to the lesser of: (i) $3.45, the closing price of the Company’s common stock
on the day prior to issuance of the Series F Warrant; or (ii) a 20% discount to the average closing price of the Company’s
common stock for the five days prior to the date on which the Holder elects to exercise their Series F Warrant. The Series F Warrant
is exercisable for a period of five years from the date of issuance and may be exercised on a cashless basis.
The
Company calculated the debt discount related to the February 2017 Notes and Series F Warrants by first allocating the respective
fair value of the February 2017 Notes and Series F Warrants based upon their relative fair values to the total February 2017 Notes
proceeds. The fair value of the Series F Warrant issued with the February 2017 Notes was calculated using the Black-Scholes option
pricing model and the following assumptions: exercise price - $3.45 per share as to $420,000 of February 2017 Note principal and
$2.90 per share as to $25,000 of February 2017 Note principal; market price of common stock - $3.53 as to $420,000 of February
2017 Note principal and $3.80 per share as to $25,000 of February 2017 Note principal; estimated volatility – 110.0% as
to $420,000 of February 2017 Note principal and 116.0% as to $25,000 of February 2017 Note principal; risk free interest rate
– 2.13% as to $420,000 of February 2017 Note principal and 1.87% as to $25,000 of February 2017 Note principal; expected
dividend rate - 0% and expected life - 5.0 years. The resulting fair value of $211,073 was allocated to the Series F Warrant.
The intrinsic value of the beneficial conversion feature amounted to $232,213. The resulting $443,286 discount to the February
2017 Notes is being accreted over their 1.25 year term.
The
February 2017 Loan Agreements provide the Holders with registration rights for all of the shares issuable upon conversion of the
February 2017 Notes, including exercise of the Series F Warrants, beginning on the first anniversary of the February 2017 Loan
Agreements.
On
July 27, 2017, the Company repaid the Investor in full, including $25,000 of note principal and $676 of accrued interest.
On
October 19, 2017, the Company repaid Sierchio in full, including $25,000 of note principal and $1,149 of accrued interest.
On
January 29, 2018, KCC and the Company entered into an Amendment No. 1 to the February 2017 Note whereby the maturity date of the
KCC February Note was extended from February 23, 2018 to December 31, 2019. On November 26, 2018, KCC and the Company entered
into an Amendment No. 2 to the February 2017 Note whereby the principal amount was settled by the issuance of 296,667 units of
the Company’s equity securities (the “
Units
”) at a price of $1.50 per Unit. Each Unit consists of: (i)
one (1) share of common stock; and (ii) one (1) Series I Stock Purchase Warrant to purchase one (1) share of common stock at a
price of $2.00 per share for a period of seven (7) years commencing on the date the Warrants are first issued. (the “
Series
I Warrants
”).
The
Series I Warrants do not have a cashless exercise provision. KCC does not have any registration rights with respect
to the shares comprising a part of the Units or issuable upon exercise of the Series I Warrants.
During
the year ended December 31, 2018, the Company recognized $27,151 of interest expense and $58,438 of accretion related to the debt
discount.
September
9, 2016 Convertible Promissory Note
On
September 9, 2016, the Company entered into a loan agreement (the “
Loan Agreement
”) with KCC. Pursuant to the
terms of the Loan Agreement, KCC agreed to loan the Company up to $900,000 at an annual interest rate of 7% per year, compounded
quarterly. KCC provided the Company with an initial loan in the amount of $700,000, which was evidenced by a convertible promissory
note (the “
Note
”); the remaining $200,000 needed to be loaned prior to December 31, 2018. The Note, including
any interest due thereon, may be prepaid at any time without penalty. The Note matured on December 31, 2017, but was extended
to December 31, 2019 pursuant to the Amendment No. 1, dated as of January 29, 2018, to the Note. Beginning on September 9, 2017,
the Note became convertible, at KCC’s sole discretion, into shares of our common stock at conversion rate equal to the lesser
of: (i) $1.54, the closing price of our common stock on the day prior to the issuance of the Note or (ii) a 20% discount to the
average closing price of our common stock for the five days prior to the date on which KCC elects to convert the Note, subject
to a floor price of $1.23 per share. On November 26, 2018, KCC and the Company entered into an Amendment No. 2 to the February
2017 Note whereby the principal amount was settled by the issuance of 463,333 units of the Company’s equity securities (the
“
Units
”) at a price of $1.50 per Unit. The Unit price represents a discount of $0.03 from the closing price
on November 23, 2018 and a $0.05 discount to the 20-day lookback of the closing price of the Company's common stock as quoted
on the OTC Markets Pink Sheets for the 20 trading days prior to the Closing Date. Each Unit consists of: (i) one (1) share of
common stock; and (ii) one (1) Series I Stock Purchase Warrant to purchase one (1) share of common stock at a price of $2.00 per
share for a period of seven (7) years commencing on the date the Warrants are first issued. (the “
Series I Warrants
”).
The
Series I Warrants do not have a cashless exercise provision. KCC does not have any registration rights with respect
to the shares comprising a part of the Units or issuable upon exercise of the Series I Warrants.
Per
the Loan Agreement, the Company issued KCC a Series E Stock Purchase Warrant (the “
Series E Warrant
”) to purchase
up to 584,416 shares of the Company’s common stock at a purchase price of the lesser of: (i) $1.54, the closing price of
the Company’s common stock on the day prior to issuance of the Series E Warrant; or (ii) a 20% discount to the average closing
price of the Company’s common stock for the five days prior to the date on which KCC elects to exercise the Series E Warrant.
The Series E Warrant is exercisable for a period of five years from the date of issuance and may be exercised on a cashless basis.
The
Company calculated the debt discount related to the Note and Series E Warrant by first allocating the respective fair value of
the Note and Series E Warrant based upon their relative fair values to the total Note proceeds. The fair value of the Series E
Warrant issued with the Note was calculated using the Black-Scholes option pricing model and the following assumptions: exercise
price - $1.25 per share; market price of common stock - $1.54 per share; estimated volatility – 92.3%; risk free interest
rate - 1.23%; expected dividend rate - 0% and expected life - 5.0 years. The resulting fair value of $340,735 was allocated to
the Series E Warrant. The intrinsic value of the beneficial conversion feature amounted to $359,265. The resulting $700,000 discount
to the Note is being accreted over their 1.25 year term.
During
the years ended December 31, 2018 and 2017, the Company recognized $49,680 and $51,385, respectively, of interest expense and
$0 and $534,519, respectively, of accretion related to the debt discount.
Note
6. Common Stock and Warrants
Common
Stock
At
December 31, 2018, the Company had 500,000,000 authorized shares of common stock with a par value of $0.00001 per share, 87,175,522
shares of common stock outstanding and 19,440,765 shares reserved for issuance under the Company’s 2013 Long-Term Incentive
Plan (the “2013 Plan”) as adopted and approved by the Company’s Board of Directors (the “Board”)
on June 20, 2013 that provides for the grant of stock options to employees, directors, officers and consultants. See “Note
7. Stock Options” for further discussion.
During
the year ended December 31, 2018, the Company had the following common stock related transactions:
|
•
|
On
February 3, 2018, Thomas Bold, the Company’s President, CEO and Interim Chief Financial Officer exercised options to
purchase up to 60,000 shares, on a cashless basis, resulting in the issuance of 44,083 shares of common stock.
|
|
|
|
|
•
|
On
February 11, 2018, a consultant exercised options to purchase up to 40,000 shares, on a cashless basis, resulting in the issuance
of 17,480 shares of common stock.
|
|
|
|
|
•
|
On
February 12, 2018, Dr. Gerlach exercised a Series A Warrant to purchase up to 480,000 shares, on a cashless basis, resulting
in the issuance of 457,480 shares of common stock.
|
|
|
|
|
•
|
On
February 13, 2018, the Company issued 100,000 shares of common stock, upon the exercise of a Series D Warrant at an exercise
price of $1.10 per share resulting in $110,000 of proceeds to the Company.
|
|
|
|
|
•
|
On
February 22, 2018, Kenneth Kirkland, a member of the Company’s board of directors, exercised options to purchase up
to 50,000 shares, on a cashless basis, resulting in the issuance of 41,033 shares of common stock.
|
|
•
|
On
February 22, 2018, Joseph Sierchio, a member of the Company’s board of directors 1)
exercised options to purchase up to 37,500 shares, on a cashless basis, resulting in the issuance
of 22,711 shares of common stock; 2) exercised a Series F Warrant to purchase up to 7,246
shares, on a cashless basis, resulting in the issuance of 4,899 shares of common stock; and
3) exercised a Series H Warrant to purchase up to 10,000 shares, on a cashless basis, resulting
in the issuance of 7,418 shares of common stock.
On
November 26, 2018, the Company entered into Subscription Agreements (each, a “
Subscription Agreement
”)
with KCC, a private corporation owning in excess of 10% of the Company's issued and outstanding common stock, for the
purchase and sale of 10,335,000 units of the Company's equity securities (the “
Units
”) at a price
of $1.50 per Unit, pursuant to a private placement offering conducted by the Company (the “
Offering
”)
for (i) aggregate cash proceeds of $14,407,500 and (ii) conversion of $1,095,000 principal amount of outstanding loan
indebtedness. The Each Unit consists of: (i) one (1) share of common stock; and (ii) one (1) Series I Stock Purchase Warrant
to purchase one (1) share of common stock at a price of $2.00 per share for a period of seven (7) years commencing on
the date the Warrants are first issued. (the “
Series I Warrants
”). The Series I Warrants do not have
a cashless exercise provision. KCC does not have any registration rights with respect to the shares comprising
a part of the Units or issuable upon exercise of the Series I Warrants. A deemed dividend of $180,000 was incurred
with respect to the difference between the floor price of the conversion feature of $395,000 of outstanding loan indebtedness.
This amount is a reclassification within equity only.
|
During
the year ended December 31, 2017, the Company had the following common stock related transactions:
|
•
|
On
October 16, 2017, the Company completed a self-directed offering of 920,000 shares of the Company common stock at a price of $2.50
per share for $2,300,000 in aggregate proceeds (the “
October 2017 Private Placement
”). Additionally, each purchaser,
in a concurrent private placement, received one stock purchase warrant for each share of stock purchased for no additional consideration
(the "
Series H Warrant
"). Each Series H Warrant is exercisable at a price of $2.75 per share for a period of
five years. The warrants may be exercised on a cashless basis. The relative fair value of the common stock was estimated to be
$1,309,458. The relative fair value of the Series H Warrants was estimated to be $990,542 as determined based on the relative
fair value allocation of the proceeds received. The Series H Warrants were valued using the Black-Scholes option pricing model
using the following variables: market price of common stock - $3.10 per share; exercise price of $2.75; estimated volatility –
98.25%; 5-year risk free interest rate – 1.95%; expected dividend rate - 0% and expected life - 5 years.
|
|
•
|
On
July 21, 2017, the Company completed a self-directed offering of 460,250 units of the Company's equity securities (the "Units")
at a price of $2.44 per unit for $1,122,610 in aggregate proceeds (the “
July 2017 Private Placement
”).
Each unit consists of (a) one share of common stock and one Series G Stock Purchase Warrant (the “
Series G Warrants
”)
allowing the holder to purchase one share of the Company’s common stock at a price of $2.68 per share for a period of
five years. The warrants may be exercised on a cashless basis. The relative fair value of the common stock was estimated to
be $634,782. The relative fair value of the Series G Warrants was estimated to be $487,828 as determined based on the relative
fair value allocation of the proceeds received. The Series G Warrants were valued using the Black-Scholes option pricing model
using the following variables: market price of common stock - $2.92 per share; estimated volatility – 102.23%; 5-year
risk free interest rate – 1.81%; expected dividend rate - 0% and expected life - 5 years.
|
|
|
|
|
•
|
On
June 28, 2017, KCC exercised 114,493 Series F Warrants for $3.01 per share resulting in the issuance of 114,493 shares of
common stock and proceeds of $344,624.
|
|
•
|
March
1, 2017, KCC exercised 1,326,087 Series B Warrants and 3,500,000 Series C Warrants, on a cashless basis, resulting in the
issuance of 4,273,831 shares of common stock.
|
|
|
|
|
•
|
On
February 17, 2017, Thomas Bold, the Company’s former President exercised options
to purchase up to 40,000 shares, on a cashless basis, resulting in the issuance of 34,296
shares of common stock. Mr. Bold resigned as President and Director on March 30, 2019.
|
|
|
|
|
•
|
On
February 10, 2017, Joseph Sierchio, a former member of the Company’s board of directors,
exercised options to purchase up to 70,000 shares, on a cashless basis, resulting in
the issuance of 38,642 shares of common stock.
|
|
•
|
On
February 2, 2017, Kenneth Kirkland, a member of the Company’s board of directors,
exercised options to purchase up to 40,000 shares, on a cashless basis, resulting in
the issuance of 29,642 shares of common stock.
|
|
|
|
|
•
|
On
January 10, 2017, Dr. Gerlach exercised a Series A Warrant to purchase up to 240,000
shares, on a cashless basis, resulting in the issuance of 204,571 shares of common stock.
|
Warrants
The
following table summarizes information about warrants outstanding at December 31, 2018 and 2017:
|
Shares
of Common Stock Issuable from Warrants Outstanding as of
|
|
Weighted
|
|
|
Description
|
|
December
31,
|
|
December
31,
|
|
Average
Exercise Price
|
|
Expiration
|
2018
|
|
2017
|
Series
A
|
|
240,000
|
|
720,000
|
|
$ 0.35
|
|
July
12, 2019
|
Series
D
|
|
810,000
|
|
910,000
|
|
$ 1.10
|
|
June
5, 2020
|
Series
E
|
|
584,416
|
|
584,416
|
|
$ 1.54
|
|
September
8, 2021
|
Series
F
|
|
7,246
|
|
14,492
|
|
$
3.45
|
|
February
23, 2022 & March 9, 2022
|
Series
G
|
|
460,250
|
|
460,250
|
|
$ 2.68
|
|
July
21, 2022
|
Series
H
|
|
910,000
|
|
920,000
|
|
$ 2.75
|
|
October
16, 2022
|
Series
I
|
|
10,335,000
|
|
-
|
|
$ 2.00
|
|
November
26, 2025
|
Total
|
|
13,346,912
|
|
3,609,158
|
|
|
|
|
As
consideration for the CellMist
TM
System and services performed in connection therewith, the Company issued to Dr. Gerlach
a Series A Stock Purchase Warrant entitling him to purchase 1,200,000 shares of the Company’s common stock at an exercise
price of $0.35 per share. Pursuant to the terms of the Amended APA, the Series A Warrant will vest in five equal installments
of 240,000 shares on each of July 12, 2014, July 12, 2015, July 12, 2016, July 12, 2017 and July 12, 2018. On August 5, 2015,
Dr. Gerlach exercised a Series A Warrant to purchase up to 240,000 shares on a cashless basis and the Company issued him 196,812
shares of common stock. On January 10, 2017, Dr. Gerlach exercised a Series A Warrant to purchase up to 240,000 shares on a cashless
basis and the Company issued him 204,571 shares of common stock. On February 3, 2018, Dr. Gerlach exercised a Series A Warrant
to purchase up to 480,000 shares on a cashless basis and the Company issued him 457,480 shares of common stock.
A
Series B Warrant with an exercise price of $0.46 to purchase 3,500,000 shares of common stock was issued on November 29, 2013
to KCC in connection with the November 29, 2013 financing. On February 2, 2016, KCC exercised a portion of its Series B Warrant
for 2,173,913 shares of the Company’s common stock resulting in proceeds of $1,000,000. On March 1, 2017, KCC exercised,
in full, on a cashless basis, the remaining 1,326,087 Series B Warrants resulting in the issuance of 1,181,194 shares of common
stock.
A
Series C Warrant with an exercise price of $0.49, to purchase 3,500,000 shares of common stock was issued on November 29, 2013
to KCC in connection with a financing. On March 1, 2017, KCC exercised, in full, on a cashless basis, the 3,500,000 Series C Warrants
resulting in the issuance of 3,092,637 shares of common stock.
Series
D Warrants with an exercise price of $1.10 to purchase 1,010,000 shares of common stock were issued on June 5, 2015 in connection
with the sale of units pursuant to a private placement. On December 6, 2016, 100,000 Series D Warrants were exercised resulting
in the Company receiving $110,000 of proceeds. On February 13, 2018, an additional 100,000 Series D Warrants were exercised resulting
in the Company receiving $110,000 of proceeds
A
Series E Warrant to purchase 584,416 shares of common stock was issued on September 9, 2016 in connection with the Loan Agreement.
See “Note 5. Debt” for further discussion.
Three
Series F Warrants to purchase 128,985 shares of common stock were issued between February 22, 2017 and March 9, 2017 in connection
with the February 2017 Loan Agreements. On June 28, 2017, KCC exercised 114,493 Series F Warrants for $3.01 per share resulting
in the issuance of 114,493 shares of common stock and proceeds of $344,624. See “Note 5. Debt” for further discussion.
On February 22, 2018, Joe Sierchio exercised a Series F Warrant to purchase up to 7,246 shares on a cashless basis and the Company
issued him 4,899 shares of common stock.
The
Series G Warrants to purchase 460,250 shares of common stock were issued on July 21, 2017 in connection with the sale of units
pursuant to the July 2017 Private Placement.
S
ee above for further discussion.
The
Series H Warrants to purchase 920,000 shares of common stock were issued on October 16, 2017 in connection with the sale of units
pursuant to the October 2017 Private Placement.
S
ee “Note 6. Common Stock and Warrants” for further discussion.
On February 22, 2018, Joe Sierchio exercised a Series F Warrant to purchase up to 10,000 shares on a cashless basis and the Company
issued him 7,418 shares of common stock.
Note
7. Stock Options
On
June 20, 2013, the Company’s Board adopted the 2013 Long-Term Incentive Plan and on November 15, 2013, a stockholder owning
a majority of the Company’s issued and outstanding stock approved adoption to the 2013 Plan. Pursuant to the terms of the
2013 Plan, an aggregate of 20,000,000 shares of the Company’s common stock are reserved for issuance to the Company’s
officers, directors, employees and consultants in order to attract and hire key technical personnel and management. Options granted
to employees under the 2013 Plan, including directors and officers who are employees, may be incentive stock options or non-qualified
stock options; options granted to others under the 2013 Plan are limited to non-qualified stock options. As of December 31, 2018,
there were 19,440,765 shares available for grant.
The
2013 Plan is administered by the Board or a committee designated by the Board. Subject to the provisions of the 2013 Plan, the
Board has the authority to determine the officers, employees and consultants to whom options will be granted, the number of shares
covered by each option, vesting rights and the terms and conditions of each option that is granted to them; however, no person
may be granted in any of the Company's fiscal year, options to purchase more than 2,000,000 shares under the 2013 Plan, and the
aggregate fair market value (determined at the time the option is granted) of the shares with respect to which incentive stock
options are exercisable for the first time by an optionee during any calendar year cannot exceed $100,000. Options granted pursuant
to the 2013 Plan are exercisable no later than ten years after the date of grant.
The
exercise price per share of common stock for options granted under the 2013 Plan will be the fair market value of the Company's
common stock on the date of grant, using the closing price of the Company's common stock on the last trading day prior to the
date of grant, except for incentive stock options granted to a holder of ten percent or more of the Company's common stock, for
whom the exercise price per share will not be less than 110% of the fair market value. No option can be granted under the 2013
Plan after June 20, 2023. The Company adopted ASU 2017-09 (Compensation – Stock Compensation (Topic 718)) effective January
1, 2017 with no effect on retained deficit or other components of equity as of the beginning of the period.
Stock
Option Activity
The
following table summarizes stock option activity for the period ended December 31, 2018 :
|
|
Number
of Options
|
|
Weighted
Average Exercise Price ($)
|
|
Weighted
Average Remaining Contractual Term
|
|
Aggregate
Intrinsic Value ($)
|
Outstanding at December 31,
2016
|
|
|
385,000
|
|
|
|
1.42
|
|
|
|
|
|
|
|
|
|
Grants
|
|
|
310,000
|
|
|
|
4.20
|
|
|
|
|
|
|
|
|
|
Exercises
|
|
|
(150,000
|
)
|
|
|
1.12
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2017
|
|
|
545,000
|
|
|
|
3.09
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(40,000
|
)
|
|
|
4.20
|
|
|
|
|
|
|
|
|
|
Exercises
|
|
|
(187,500
|
)
|
|
|
1.12
|
|
|
|
|
|
|
|
|
|
Outstanding at
December 31, 2018
|
|
|
317,500
|
|
|
|
3.41
|
|
|
|
7.68
years
|
|
|
|
70,000
|
|
Exercisable at December 31, 2018
|
|
|
307,500
|
|
|
|
3.49
|
|
|
|
7.76
years
|
|
|
|
60,000
|
|
Available for grant
at December 31, 2018
|
|
|
19,440,765
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
fair value of each stock option is estimated at the date of grant using the Black-Scholes option pricing model. There were 310,000
stock options granted during the year ended December 31, 2017 with a weighted-average grant date fair value of $3.38. During the
year ended December 31, 2017, there were 150,000 options exercised on a cashless basis resulting in the issuance of 102,582 shares
of common stock, with an aggregate intrinsic value of $397,100. Non-employee options are remeasured each reporting period and
adjusted to reflect the remeasurement. Final remeasurement was done during the year ended December 31, 2018 when the options fully
vested. Assumptions regarding volatility, expected term, dividend yield and risk-free interest rate are required for the Black-Scholes
model. The volatility assumption is based on the Company's historical experience. The risk-free interest rate is based on a U.S.
treasury note with maturity similar to the option award's expected life. The expected life represents the average period of time
that options granted are expected to be outstanding. The assumptions for volatility, expected life, dividend yield and risk-free
interest rate for options granted are presented in the table below:
|
|
Years
Ended December 31,
|
|
|
2018
|
|
2017
|
Risk-free
interest rate
|
|
|
2.97
|
%
|
|
|
1.93%
- 2.39
|
%
|
Expected life in
years
|
|
|
9.0
|
|
|
|
5.5
– 10.0
|
|
Weighted Avg. Expected
Volatility
|
|
|
108
|
%
|
|
|
98%
- 106
|
%
|
Expected dividend
yield
|
|
|
0
|
|
|
|
0
|
|
The
share-based compensation cost resulting from stock option grants, including those previously granted and vesting over time is
expensed ratably over the respective vesting periods. During the years December 31, 2018 and 2017, the Company recognized $170,517
and $904,004, respectively, in share-based compensation. As of December 31, 2018, the Company had $416 unrecognized compensation
cost related to unvested stock options. Stock-based compensation has been included in the consolidated statement of operations
as follows:
|
|
Years
Ended December 31,
|
|
|
2018
|
|
2017
|
Research
and development
|
|
$
|
27,967
|
|
|
$
|
100,630
|
|
General
and administrative
|
|
|
142,550
|
|
|
|
803,374
|
|
Total
|
|
$
|
170,517
|
|
|
$
|
904,004
|
|
The
following table summarizes information about stock options outstanding and exercisable at December 31, 2018:
|
|
Stock
Options Outstanding
|
|
Stock
Options Exercisable
|
Range
of Exercise Prices
|
|
Number
of Shares Subject to Outstanding Options
|
|
Weighted
Average Contractual Life (years)
|
|
Weighted
Average Exercise Price
|
|
Number
of Shares Subject To Options Exercise
|
|
Weighted
Average Remaining Contractual Life (Years)
|
|
Weighted
Average Exercise Price
|
|
1.05
|
|
|
|
55,000
|
|
|
|
5.25
|
|
|
|
1.05
|
|
|
|
45,000
|
|
|
|
5.25
|
|
|
|
1.05
|
|
|
1.25
|
|
|
|
7,500
|
|
|
|
6.46
|
|
|
|
1.25
|
|
|
|
7,500
|
|
|
|
6.46
|
|
|
|
1.25
|
|
|
1.34
|
|
|
|
7,500
|
|
|
|
6.50
|
|
|
|
1.34
|
|
|
|
7,500
|
|
|
|
6.50
|
|
|
|
1.34
|
|
|
1.70
|
|
|
|
7,500
|
|
|
|
6.79
|
|
|
|
1.70
|
|
|
|
7,500
|
|
|
|
6.79
|
|
|
|
1.70
|
|
|
2.28
|
|
|
|
7,500
|
|
|
|
7.55
|
|
|
|
2.28
|
|
|
|
7,500
|
|
|
|
7.55
|
|
|
|
2.28
|
|
|
4.20
|
|
|
|
232,500
|
|
|
|
8.36
|
|
|
|
4.20
|
|
|
|
232,500
|
|
|
|
8.36
|
|
|
|
4.20
|
|
|
Total
|
|
|
|
317,500
|
|
|
|
7.68
|
|
|
$
|
3.41
|
|
|
|
307,500
|
|
|
|
7.68
|
|
|
$
|
3.49
|
|
Note
8. Commitments
Effective
March 1, 2015, the Company entered into a lease agreement (the “Lease”) in the Pittsburgh Life Sciences Greenhouse
at a monthly rate of $750. The Lease was renewed effective March 1, 2016 at a monthly rate of $800 through August 30, 2018. Rent
expense for the years ended December 31, 2018 and 2017 was $6,400 and $9,600, respectively.
In
connection with the Company’s anticipated regulatory filings, the Company has engaged StemCell Systems GmbH (“StemCell
Systems”) to provide it with prototypes and related documents under various agreements. Pursuant to these engagements the
Company incurred expenses of $80,229 and $219,806 in during the years ended December 31, 2018 and 2017, respectively. Dr. Gerlach,
from whom the Company purchased the CellMist
TM
System technologies, is a principal of StemCell Systems.
On
August 1, 2017, the Company and the University of Pittsburgh entered into a Corporate Research Agreement whereby the University
of Pittsburgh will perform academic research related to the Company’s technologies in exchange for $171,595 with $42,899
due on August 1, 2017; $42,899 due on November 1, 2017; $42,899 due on February 1, 2018 and $42,898 due on May 31, 2018. As of
December 31, 2018, the Company has paid the amounts in full.
See
also “Note 9. Related Party Transactions.”
Note
9. Related Party Transactions
As
compensation for their service on the Board, Dr. Kirkland and Mr. Sierchio receive an annual retainer of $6,000, payable in equal
quarterly installments in arrears. Additionally, on March 15, 2016, the Company granted to each of Dr. Kirkland and Mr. Sierchio
an incentive stock option to purchase up to 50,000 shares of the Company’s common stock at an exercise price of $1.91 per
share; and on May 11, 2017, the Company granted to each of Dr. Kirkland and Mr. Sierchio an incentive stock option to purchase
up to 75,000 shares of the Company’s common stock at an exercise price of $4.20 per share. The 50,000 options became fully
vested upon grant and the 75,000 options vested 50% on the date of grant and 50% one year hence. The options may be exercised
on a “cashless basis” using the formula contained therein. Compensation expense of $86,325 and $394,725 with
respect to these options was recorded during the years ended December 31, 2018 and 2017 respectively.
Effective
July 1, 2018, Joseph Sierchio resigned his position as a Company director. The law firm of Satterlee Stephens LLP (“Satterlee”),
of which Joseph Sierchio is a partner, provides counsel to the Company. Mr. Sierchio will continue to be the Company’s primary
attorney. During the years ended December 31, 2018 and 2017, the Company recognized $577,718 and $277,933 of fees for legal services
billed by Satterlee. At December 31, 2018 and 2017, accounts payable to Satterlee amounted to $171,828 and $30,000, respectively.
In
connection with the Company’s anticipated FDA and other regulatory filings, the Company engaged StemCell Systems to provide
it with prototypes and related documents. Pursuant to this engagement the Company incurred expenses of $80,229 and $219,806 during
the years ended December 31, 2018 and 2017, respectively. Dr. Gerlach, from whom the Company purchased the CellMist
TM
System technologies, is a principal of StemCell Systems. Thomas Bold is a business consultant and economic advisor to StemCell
Systems.
Dr.
Gerlach is entitled to payments for consulting services. During the years ended December 31, 2018 and 2017, the Company recognized
expenses related to Dr. Gerlach services of $7,020 and $38,540, respectively. Accounts payable to Dr. Gerlach amounted to $0 and
$17,640 at December 31, 2018 and 2017, respectively.
On
August 1, 2013, the Company entered into a consulting agreement, as amended on May 1, 2016, with Jatinder Bhogal, an individual
owning in excess of 5% of our issued and outstanding shares of common stock, to provide consulting services to the Company through
his wholly owned company, Vector Asset Management, Inc. (“VAM”). Pursuant to the consulting agreement Vector assisted
the Company with identifying subject matter experts in the medical device and biotechnology industries and assisted the Company
with its ongoing research, development and eventual commercialization of its Regeneration Technology. Pursuant to the amendment
the monthly consulting fee was increased to $6,800 from $5,000. On June 22, 2018, the Company and VAM entered into an Executive
Consulting Agreement (“ECA”) whereby Mr. Bhogal will serve as the Company’s Chief Operating Officer. The ECA
supersedes the prior consulting agreement. Pursuant to the ECA, VAM will receive compensation of $120,000 per year. During the
year ended December 31, 2018 and 2017, the Company recognized expenses of $103,467 and $81,600, respectively for consulting services
provided by VAM.
On
September 9, 2016, the Company entered into the Loan Agreement with KCC whereby KCC loaned the Company $700,000 at an interest
rate of 7%. The Note was amended on January 29, 2018 to extend the maturity date to December 31, 2019. Per the Loan Agreement,
the Company issued KCC a Series E Warrant to purchase up to 584,416 shares of the Company’s common stock. See “Note
5. Debt” for further discussion.
On
January 10, 2017, Dr. Gerlach exercised a Series A Warrant to purchase up to 240,000 shares, on a cashless basis, resulting in
the issuance of 204,571 shares of common stock.
On
February 2, 2017, Kenneth Kirkland, a member of the Company’s board of directors, exercised options to purchase up to 40,000
shares, on a cashless basis, resulting in the issuance of 29,642 shares of common stock.
On
February 10, 2017, Joseph Sierchio, a former member of the Company’s board of directors, exercised options to purchase up
to 70,000 shares, on a cashless basis, resulting in the issuance of 38,642 shares of common stock.
On
February 17, 2017, Thomas Bold, the Company’s former President exercised options to purchase up to 40,000 shares, on a cashless
basis, resulting in the issuance of 34,296 shares of common stock.
On
February 23, 2017, the Company entered into two of the February 2017 Loan Agreements with Sierchio and KCC pursuant to which Sierchio
loaned the Company $25,000 and KCC loaned $395,000 at an interest rate of 7%. On October 19, 2017, the Company repaid the Sierchio
in full, including $25,000 of note principal and $1,149 of accrued interest. The remaining note with KCC was amended on January
29, 2018 to extend the maturity date to December 31, 2019. Per the February 2017 Loan Agreement, the Company issued Sierchio,
and KCC a Series F Warrant to purchase up to 7,246 shares and 114,493 shares, respectively, of the Company’s common stock.
See “Note 5, Debt” for further discussion.
March
1, 2017, KCC exercised 1,326,087 Series B Warrants and 3,092,637 Series C Warrants, on a cashless basis, resulting in the issuance
of 4,273,831 shares of common stock.
On
June 28, 2017, KCC exercised 114,493 Series F Warrants for $3.01 per share resulting in the issuance of 114,493 shares of common
stock and proceeds of $344,624.
On
July 21, 2017, the Company entered into the July 2017 Private Placement with KCC for the sale of 410,000 units at a price of $2.44
per unit for $1,000,400 in aggregate proceeds. Each unit consisted of one share of common stock and one Series G Warrant to purchase
one (1) share of common stock at an exercise price of $2.68 per share through July 21, 2022. The warrants may be exercised on
a cashless basis. See “Note 6. Common Stock and Warrants” for further discussion.
On
August 1, 2017, the Company and the University of Pittsburgh entered into a Corporate Research Agreement whereby the University
of Pittsburgh will perform academic research related to the Company’s technologies in exchange for $171,595. Dr. Gerlach,
from whom the Company purchased the CellMist
TM
System technologies, is a professor at the University.
On
October 16, 2017, the Company entered into the October 2017 Private Placement with Joseph Sierchio for the sale of 10,000 shares
of common stock at a price of $2.50 per share for $25,000 in aggregate proceeds. Additionally, Mr. Sierchio, in a concurrent private
placement, received one Series H Warrant for each share of stock purchased for no additional consideration. Each Series H Warrant
has an exercise price of $2.75 per share through October 16, 2022. The warrants may be exercised on a cashless basis. See “Note
6. Common Stock and Warrants” for further discussion.
On
February 12, 2018, Dr. Gerlach exercised a Series A Warrant to purchase up to 480,000 shares, on a cashless basis, resulting in
the issuance of 457,480 shares of common stock.
On
February 22, 2018, Kenneth Kirkland, a member of the Company’s board of directors, exercised options to purchase up to 50,000
shares, on a cashless basis, resulting in the issuance of 41,033 shares of common stock.
On
February 22, 2018, Mr. Sierchio, a member of the Company’s board of directors until his resignation effective July 1, 2018,
1) exercised options to purchase up to 37,500 shares, on a cashless basis, resulting in the issuance of 22,711 shares of common
stock; 2) exercised a Series F Warrant to purchase up to 7,246 shares, on a cashless basis, resulting in the issuance of 4,899
shares of common stock; and 3) exercised a Series H Warrant to purchase up to 10,000 shares, on a cashless basis, resulting in
the issuance of 7,418 shares of common stock.
On
February 3, 2018, Thomas Bold, the Company’s former President, exercised options to purchase up to 60,000 shares, on a cashless
basis, resulting in the issuance of 44,086 shares of common stock.
On
August 1, 2017, the Company and the University of Pittsburgh entered into a Corporate Research Agreement whereby the University
of Pittsburgh will perform academic research related to the Company’s technologies in exchange for $171,595. During the
years ended December 31, 2018 and 2017, the Company paid the University of Pittsburgh $nil and $171,595, respectively, pursuant
to the Corporate Research Agreement. Dr. Gerlach, from whom the Company purchased the CellMist
TM
System technologies,
is a professor at the University.
During
the year ended December 31, 2018, the Company was offered executive office space located at 9375 E. Shea Blvd., Suite 107-A, Scottsdale,
AZ 85260 for consideration of $1 per year. The executive office space is owned indirectly by Harmel S. Rayat, the Company’s
majority shareholder and Chairman and CEO.
Note
10. Income Taxes
Income
taxes are accounted for using an asset and liability approach that requires the recognition of deferred tax assets and liabilities
for the expected future tax consequences of events that have been recognized in the Company's financial statements or tax returns.
A valuation allowance is established to reduce deferred tax assets if all, or some portion, of such assets will more than likely
not be realized.
On
December 22, 2017, the President of the United States signed into law H.R. 1, “An Act to Provide for Reconciliation Pursuant
to Titles II and V of the Concurrent Resolution on the Budget for Fiscal Year 2018” (the “Tax Cuts and Jobs Act”).
ASC Topic 740, Accounting for Income Taxes, requires companies to recognize the effect of tax law changes in the period of enactment.
The Tax Cuts and Jobs Act made significant changes to existing U.S. tax law, including, but not limited to, a permanent reduction
to the U.S. federal corporate income tax rate from 35% to 21%, imposition of a one-time tax on deferred foreign income (“Repatriation
Transition Tax”), adoption of a participation exemption system with respect to the taxation of future dividends received
from foreign corporations, and repeal of the corporate alternative minimum tax system. Other significant changes in the Tax Cuts
and Jobs Act include taxing payments made to foreign related parties that are deemed to be excessive, imposing a minimum tax on
certain foreign earnings, requiring (beginning after December 31, 2021) the capitalization and subsequent amortization of certain
research and development related expenses, and placing additional limits on the use of net operating losses and the deductibility
of certain executive compensation. The reduction of the Company’s deferred tax assets resulting from the Tax Cuts and Jobs
Act’s reduction in the U.S. federal corporate income tax rate from 35% to 21% amounted to $1,831,000 during 2017 with an
offsetting decrease to the valuation allowance with no effect on the Statement of Operations. There has been no change to the amount determined in 2017.
There
is no current or deferred tax expense for 2018 and 2017, due to the Company’s loss position. Realization of the future tax
benefits related to the deferred tax assets is dependent on many factors, including the Company’s ability to generate taxable
income within the net operating loss carryforward period. Management has considered these factors in reaching its conclusion as
to the valuation allowance for financial reporting purposes and has recorded a full valuation allowance against the deferred tax
asset. The income tax effect of temporary differences comprising the deferred tax assets and deferred tax liabilities is a result
of the following at December 31:
|
|
2018
|
|
2017
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Net operating
loss and contribution carryforwards
|
|
$
|
3,068,000
|
|
|
$
|
2,480,000
|
|
Intangible asset
|
|
|
85,000
|
|
|
|
85,000
|
|
Capital loss carryforward
|
|
|
—
|
|
|
|
146,000
|
|
Stock-based
compensation
|
|
|
208,000
|
|
|
|
247,000
|
|
|
|
|
3,361,000
|
|
|
|
2,958,000
|
|
Valuation
allowance
|
|
|
(3,361,000
|
)
|
|
|
(2,958,000
|
)
|
Net
deferred tax assets
|
|
$
|
—
|
|
|
$
|
—
|
|
The
2018 increase in the valuation allowance was $403,000 compared to a decrease of $792,000 in 2017.
The
Company has available net operating loss and contribution carryforwards of approximately $14,612,000 for tax purposes to offset
future taxable income which $11,592,000 incurred prior to 2018 expire commencing 2019 through to the year 2037 while $3,020,000
incurred in 2018 do not expire. The capital loss carryforward expired during 2018. Pursuant to the Tax Reform Act of 1986, annual
utilization of the Company’s net operating loss and contribution carryforwards may be limited if a cumulative change in
ownership of more than 50% is deemed to occur within any three-year period. The tax years 2015 through 2018 remain open to examination
by federal agencies and other jurisdictions in which it operates.
A
reconciliation between the statutory federal income tax rate and the effective rate of income tax expense for the years ended
December 31 follows:
|
|
2018
|
|
2017
|
Statutory
federal income tax rate
|
|
|
21
|
%
|
|
|
34
|
%
|
Permanent differences
and other
|
|
|
(2
|
%)
|
|
|
(5
|
%)
|
Deferred tax impact
from tax rate change
|
|
|
0
|
%
|
|
|
(50
|
%)
|
Valuation
allowance
|
|
|
(19
|
%)
|
|
|
21
|
%
|
|
|
|
0
|
%
|
|
|
0
|
%
|
Note
11. Subsequent Events
Management
has reviewed material events subsequent of the period ended December 31, 2018 and prior to the filing of financial statements
in accordance with FASB ASC 855 “Subsequent Events”.