The accompanying unaudited condensed consolidated financial statements have been
prepared assuming the Company will continue as a going concern, which assumes
the realization of assets and satisfaction of liabilities and commitments in the
normal course of business. The Company experienced a net loss of $492,185 for
the nine months ended September 30, 2022, had a working capital deficit of
$868,332 and an accumulated deficit of $14,625,357 as of September 30, 2022.
These factors raise substantial doubt about the Company's ability to continue as
a going concern and to operate in the normal course of business. These unaudited
condensed consolidated financial statements do not include any adjustments
relating to the recoverability and classification of recorded asset amounts and
classification of liabilities that might result from this uncertainty.
In March 2020, the World Health Organization declared the novel COVID-19 virus
as a global pandemic. The COVID-19 outbreak in the United States negatively
impacted to the Company's ability to secure additional debt or equity funding to
support operations in 2020 and 2021. In 2021, the Company raised an aggregate of
$560,000 from the sale of 2,240,000 shares of common stock to support current
operations and extend research and development of its product line. No assurance
can be given that the Company will be successful in this effort. If the Company
is unable to raise additional funds in 2022, it will be forced to severely
curtail all operations and research and development activities.
8
NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING PRINCIPLES
Basis of Presentation and Principles of Consolidation
The accompanying condensed consolidated financial statements in this report have
been prepared by the Company without audit. In the opinion of management, all
adjustments necessary to present the financial position, results of operations
and cash flows for the stated periods have been made. Except as described below,
these adjustments consist only of normal and recurring adjustments. Certain
information and note disclosures normally included in the Company's consolidated
annual financial statements prepared in accordance with accounting principles
generally accepted in the United States of America ("U.S. GAAP") have been
condensed or omitted.
These unaudited condensed consolidated financial statements should be read in
conjunction with a reading of the Company's consolidated audited financial
statements and notes thereto for the year ended December 31, 2021, filed with
the Company's annual report on Form 10-K with the Securities and Exchange
Commission (the "SEC") on March 16, 2022. Interim results of operations for the
three and nine months ended September 30, 2022, and 2021, are not necessarily
indicative of future results for the full year. The unaudited condensed
consolidated financial statements of the Company include the consolidated
accounts of VLS and its wholly owned subsidiary VI. All intercompany accounts
and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP 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 date of the financial statements and the reported amount of revenues and
expenses during the reported period. Actual results could differ from those
estimates. Significant estimates included in the financial statements, include
useful the life of intangible assets, valuation allowance for deferred tax
assets and non-cash equity transactions and stock-based compensation.
Cash
The Company considers all highly liquid investments with an original term of
three months or less to be cash equivalents. The Company held no cash
equivalents as of September 30, 2022, and December 31, 2021. Cash balances may,
at certain times, exceed federally insured limits. If the amount of a deposit at
any time exceeds the federally insured amount at a bank, the uninsured portion
of the deposit could be lost, in whole or in part, if the bank were to fail.
Intangible Assets
Costs of intangible assets are accounted for through the capitalization of those
costs incurred in connection with developing or obtaining such assets.
Capitalized costs are included in intangible assets in the unaudited condensed
consolidated balance sheets. The Company's intangible assets consist of costs
incurred in connection with securing an Exclusive Patent License Agreement with
The General Hospital Corporation, d/b/a Massachusetts General Hospital ("MGH"),
as amended (the "License Agreement"). These costs are being amortized over the
term of the License Agreement which is based on the remaining patent life of the
related patents being licensed.
The Company reviews these intangible assets for possible impairment when events
or changes in circumstances indicate that the assets carrying amount may not be
recoverable. In evaluating the future benefit of its intangible assets,
management performs an analysis of the anticipated undiscounted future net cash
flows of the intangible assets over the remaining estimated useful life. An
impairment loss is recorded if the carrying value of the asset exceeds the
expected future cash flows.
9
Long-Lived Assets
The Company reviews long-lived assets at least annually or when events or
changes in circumstances reflect the fact that the recorded value may not be
recoverable for impairment and recognizes impairment losses on long-lived assets
used in operations when indicators of impairment are present and the
undiscounted cash flows estimated to be generated by those assets are less than
the assets' carrying values.
Equity Method Investment
The Company accounts for investments in which the Company owns more than 20% or
has the ability to exercise significant influence of the investee, using the
equity method in accordance with the Financial Accounting Standard Board's (the
"FASB") Accounting Standards Codification ("ASC") Topic 323, Investments-Equity
Method and Joint Ventures. Under the equity method, an investor initially
records an investment in the stock of an investee at cost and adjusts the
carrying amount of the investment to recognize the investor's share of the
earnings or losses of the investee after the date of acquisition.
The amount of the adjustment is included in the determination of net income by
the investor, and such amount reflects adjustments similar to those made in
preparing consolidated statements including adjustments to eliminate
intercompany gains and losses, and to amortize, if appropriate, any difference
between investor cost and underlying equity in net assets of the investee at the
date of investment. The investment of an investor is also adjusted to reflect
the investor's share of changes in the investee's capital. Dividends received
from an investee reduce the carrying amount of the investment. A series of
operating losses of an investee or other factors may indicate that a decrease in
value of the investment has occurred which is other than temporary, and which
should be recognized even though the decrease in value is in excess of what
would otherwise be recognized by application of the equity method.
In accordance with ASC 323-10-35-20 through 35-22, the investor ordinarily shall
discontinue applying the equity method if the investment (and net advances) is
reduced to zero and shall not provide for additional losses unless the investor
has guaranteed obligations of the investee or is otherwise committed to provide
further financial support for the investee. An investor shall, however, provide
for additional losses if the imminent return to profitable operations by an
investee appears to be assured. For example, a material, nonrecurring loss of an
isolated nature may reduce an investment below zero even though the underlying
profitable operating pattern of an investee is unimpaired. If the investee
subsequently reports net income, the investor shall resume applying the equity
method only after its share of that net income equals the share of net losses
not recognized during the period the equity method was suspended.
Equity and cost method investments are classified as investments. The Company
periodically evaluates its equity and cost method investments for impairment due
to declines considered to be other than temporary. If the Company determines
that a decline in fair value is other than temporary, then a charge to earnings
is recorded as an impairment loss in the accompanying consolidated statements of
operations.
The Company's equity method investment consisted of equity owned in Athens
Encapsulation Inc. ("AEI"), a Company controlled by former directors of the
Company which was given to the Company as part of an investment and
restructuring agreement entered into in May 2019. In January 2021, the Company
sold its' equity investment in AEI, back to AEI for $100,000, which is presented
as other income on the statement of operations for the nine months ended
September 30, 2021. As of September 30, 2022, the Company did not have any
remaining equity investment in AEI. During the three and nine months ended
September 30, 2021, the Company's proportionate share of net income was
insignificant.
10
Fair Value of Financial Instruments
ASC 825, "Disclosures about Fair Value of Financial Instruments," requires
disclosure of fair value information about financial instruments. ASC 820, "Fair
Value Measurements" defines fair value, establishes a framework for measuring
fair value in generally accepted accounting principles, and expands disclosures
about fair value measurements. Fair value estimates discussed herein are based
upon certain market assumptions and pertinent information available to
management as of September 30, 2022.
The carrying amounts of the Company's financial assets and liabilities, such as
cash, prepaid expenses, accounts payable and accrued liabilities, payables with
related parties, approximate their fair values because of the short maturity of
these instruments.
Revenue Recognition
Revenue recognition is accounted for under ASC Topic 606, "Revenue from
Contracts with Customers" ("ASC 606") and all the related amendments. The core
principle of ASC 606 requires that an entity recognize revenue to depict the
transfer of promised goods or services to customers in an amount that reflects
the consideration to which the company expects to be entitled in exchange for
those goods or services. ASC 606 defines a five-step process to achieve this
core principle and, in doing so, it is possible more judgment and estimates may
be required within the revenue recognition process than required under U.S. GAAP
including identifying performance obligations in the contract, estimating the
amount of variable consideration to include in the transaction price and
allocating the transaction price to each separate performance obligation.
The Company's contracts with customers are generally on a contract and work
order basis and represent obligations that are satisfied at a point in time, as
defined in the new guidance, generally upon delivery or has services are
provided. Accordingly, revenue for each sale is recognized when the Company has
completed its performance obligations. Any costs incurred before this point in
time, are recorded as assets to be expensed during the period the related
revenue is recognized. The Company did not generate any revenue for the three
and nine months ended September 30, 2022, and 2021.
Stock-Based Compensation
Stock-based compensation is accounted for based on the requirements of ASC 718 -
"Compensation -Stock Compensation," which requires recognition in the financial
statements of the cost of employee, director and non-employee services received
in exchange for an award of equity instruments over the period the employee,
director, or non-employee is required to perform the services in exchange for
the award (presumptively, the vesting period). The ASC also requires measurement
of the cost of employee, director, and non-employee services received in
exchange for an award based on the grant-date fair value of the award. The
Company has elected to recognize forfeitures as they occur as permitted under
the FASB's Accounting Standards Update ASU 2016-09 Improvements to Employee
Share-Based Payment.
Research and Development
Costs and expenses that can be clearly identified as research and development
are charged to expense as incurred. For the three and nine months ended
September 30, 2022, the Company incurred $3,097 and $13,097, respectively, in
research and development expenses with a related party. For the three and nine
months ended September 30, 2021, the Company incurred $0 and $7,243,
respectively, in research and development expenses to a related party.
11
Income Taxes
The Company accounts for income taxes in accordance with ASC 740-10, Income
Taxes. Deferred tax assets and liabilities are recognized to reflect the
estimated future tax effects, calculated at the tax rate expected to be in
effect at the time of realization. A valuation allowance related to a deferred
tax asset is recorded when it is more likely than not that some portion of the
deferred tax asset will not be realized. Deferred tax assets and liabilities are
adjusted for the effects of the changes in tax laws and rates of the date of
enactment.
ASC 740-10 prescribes a recognition threshold that a tax position is required to
meet before being recognized in the financial statements and provides guidance
on recognition, measurement, classification, interest and penalties, accounting
in interim periods, disclosure, and transition issues. Interest and penalties
are classified as a component of interest and other expenses. To date, the
Company has not been assessed, nor paid, any interest or penalties.
Uncertain tax positions are measured and recorded by establishing a threshold
for the financial statement recognition and measurement of a tax position taken
or expected to be taken in a tax return. Only tax positions meeting the
more-likely-than-not recognition threshold at the effective date may be
recognized or continue to be recognized.
Earnings (Loss) Per Share
The Company reports earnings (loss) per share in accordance with ASC 260,
"Earnings per Share." Basic earnings (loss) per share is computed by dividing
net income (loss) by the weighted-average number of shares of common stock
outstanding during each period. Diluted earnings per share is computed by
dividing net loss by the weighted-average number of shares of common stock,
common stock equivalents and other potentially dilutive securities outstanding
during the period using the treasury stock method and as-if converted method. As
of September 30, 2022, and 2021, the Company's dilutive securities are
convertible into 3,396,281 and 23,467,283 shares of common stock, respectively,
which are not included in the computation of dilutive loss per share because
their impact is antidilutive.
The following table represents the classes of dilutive securities as of
September 30, 2022, and 2021:
SCHEDULE OF ANTIDILUTIVE SECURITIES OF EARNINGS PER SHARE
September 30, 2022 September 30, 2021
Common stock to be issued 726,281 17,507,283
Stock options 2,670,000 -
Warrants to purchase common stock - 4,060,000
Anti-dilutive securities 3,396,281 23,467,283
Recent Accounting Pronouncements
Management does not believe that any recently issued, but not yet effective
accounting pronouncements, if adopted, would have a material effect on the
accompanying unaudited condensed consolidated financial statements for the three
and nine months ended September 30, 2022, and 2021.
12
NOTE 4 - INTANGIBLE ASSETS
The Company's intangible assets consist of costs incurred in connection with the
License Agreement with MGH (See Note 5). The consideration paid for the rights
included in the License Agreement was in the form of common stock shares which
resulted in MGH receiving approximately 20% of the total outstanding shares of
common stock of VI. The estimated fair value of the common stock as of the date
of the agreement is being amortized over the term of the License Agreement which
is based on the remaining patent life of the related patents being licensed
which is approximately 16years.
The Company's intangible assets consisted of the following at September 30,
2022, and December 31, 2021:
SCHEDULE OF INTANGIBLE ASSETS
September 30, 2022 December 31, 2021
Licensed patents $ 492,514 $ 492,514
Accumulated amortization (144,461 ) (120,994 )
Total $ 348,053 $ 371,520
The Company recognized $7,822 and $23,467 of amortization expense related to the
License Agreement with MGH for the three and nine months ended September 30,
2022, and 2021, respectively, which is included in general and administrative
expenses on the unaudited condensed consolidated statements of operations.
Future expected amortization of intangible assets is as follows:
SCHEDULE OF FUTURE AMORTIZATION OF INTANGIBLE ASSETS
Fiscal year ending December 31,
2022 (months remaining) $ 7,822
2023 31,299
2024 31,299
2025 31,299
2026 31,299
Thereafter 215,035
Total $ 348,053
NOTE 5 - RELATED PARTY TRANSACTIONS
Consulting Agreements
On November 5, 2021, the Company entered into a Consulting Agreement (the
"Poznansky Agreement") with Mark Poznansky, MD, a minority stockholder and
former Director. The Company engaged Dr. Poznansky to render consulting services
with respect to informing, guiding, and supervising the development of
antagonists to immune repellents or anti-fugetaxins for the treatment of cancer.
The initial term of the Poznansky Agreement was for six months (the "Initial
Term"), which was extended indefinitely, and the Company agreed to pay the
Consultant $2,000per month commencing November 5, 2021, with consideration for
an increase in the monthly fee following the completion for the Company's
successful up listing to the NASDAQ Stock Market. The Company incurred a total
of $6,000 and $18,000 in expenses for the three and nine months ended September
30, 2022, respectively, related to the Poznansky Agreement, which is included in
professional fees on the unaudited condensed consolidated statements of
operations. The Company did not incur any expenses related to the Poznansky
Agreement for the three and nine months ended September 30, 2021. As of
September 30, 2022, and December 31, 2021, $21,000 and $13,000, respectively, is
included in accounts payable, related parties, on the unaudited condensed
consolidated balance sheets, related to the Poznansky Agreement.
13
On January 1, 2022, the Company entered into a consulting agreement (the
"Toneguzzo Agreement") with Frances Toneguzzo, Ph.D., the Company's former CEO.
Pursuant to the one-year term of the Toneguzzo Agreement in exchange for
services in leading the research and development teams and laboratory work, the
consultant will receive $5,000 per month. The Company incurred a total of
$15,000 and $45,000 in expenses for the three and nine months ended September
30, 2022, respectively, related to the Toneguzzo Agreement, which is included in
professional fees on the unaudited condensed consolidated statements of
operations. The Company did not incur any expenses related to the Toneguzzo
Agreement for the three and nine months ended September 30, 2021. As of
September 30, 2022, and December 31, 2021, $25,000 and $-0-, respectively, is
included in accounts payable, related parties, on the unaudited condensed
consolidated balance sheets, related to the Toneguzzo Agreement.
MGH License Agreement
On May 8, 2013, VI and MGH, a principal stockholder (see Note 6), entered into
the License Agreement, pursuant to which MGH granted to the Company, in the
field of coating and transplanting cells, tissues and devices for therapeutic
purposes, on a worldwide basis: (i) an exclusive, royalty-bearing license under
its rights in Patent Rights (as defined in the License Agreement) to make, use,
sell, lease, import and transfer Products and Processes (each as defined in the
License Agreement); (ii) a non-exclusive, sub-licensable (solely in the License
Field and License Territory (each as defined in the License Agreement))
royalty-bearing license to Materials (as defined in the License Agreement) and
to make, have made, use, have used, Materials for only the purpose of creating
Products, the transfer of Products and to use, have used and transfer processes;
(iii) the right to grant sublicenses subject to and in accordance with the terms
of the License Agreement, and (iv) the nonexclusive right to use technological
information (as defined in the License Agreement) disclosed by MGH to the
Company under the License Agreement, all subject to and in accordance with the
License Agreement (the "License").
As amended by the Eighth Amendment to the License Agreement on March 14, 2022
("Effective Date"), which replaces the prior pre-sales due diligence
requirements in their entirety, the License Agreement requires that the Company
satisfy the following requirements prior to the first sale of Products ("MGH
License Milestones"), by certain dates.
Pre-Sales Diligence Requirement:
(x) The Company shall provide a detailed business plan and development plan
by June 1st, 2022. As of the date of this filing the Company has yet to
submit the business and development plan and is negotiating the
extension of this requirement with MGH.
(xi) The Company shall raise $2 million in financing by December 1st, 2022.
(xii) The Company shall raise an additional $8 million in financing by
December 1st, 2023.
(xiii) The Company shall initiate research regarding the role of CXCL12 in beta
cell function and differentiation by January 1st, 2023.
(xiv) The Company shall initiate diabetic non-human primate studies using
cadaveric islets encapsulated in the CXCL12 technology by March 1st,
2023.
(xv) The Company shall initiate research regarding other applications of the
CXCL12 platform by June 1st, 2023.
(xvi) The Company shall initiate a Phase I clinical trial of a Product or
Process by March 1st, 2024.
(xvii) The Company shall initiate a Phase II clinical trial of a Product or
Process within thirteen (13) years from Effective Date.
(xviii) The Company shall initiate Phase III clinical trial of a Product or
Process within sixteen (16) years from Effective Date.
14
Additionally, as amended by the Eighth Amendment to the License Agreement on
March 14, 2022, which replaces the prior post-sales due diligence requirements
in their entirety, the License Agreement requires that the Company satisfy the
following requirements post-sales of Products ("MGH License Milestones"), by
certain dates.
Post-Sales Diligence Requirements:
(i) The Company shall itself or through an Affiliate or Sublicensee make a
First Commercial Sale within the following countries and regions in the
License Territory within eighteen (18) years after the Effective Date of
this Agreement: US and Europe and China or Japan.
(ii) Following the First Commercial Sale in any country in the License
Territory, Company shall itself or through its Affiliates and/or
Sublicensees use commercially reasonable efforts to continue to make Sales
in such country without any elapsed time period of one (1) year or more in
which such Sales do not occur due to lack such efforts by Company.
In consideration of the update to the diligence milestones, the Company shall
pay the following Annual Minimum Royalty payments:
(i) Prior to the First Commercial Sale, the Company shall pay to MGH a
non-refundable annual license fee of ten thousand dollars ($10,000) by June
30, 2022, and on each subsequent anniversary of the Eighth Amendment
Effective Date thereafter. This agreed upon non-refundable license fee has
been included in accounts payable as of June 30, 2022 and expensed as
research and development expense upon execution of the Eight Amendment
during the six months ended June 30, 2022. The non-refundable annual
license fee was paid on July 1, 2022.
(ii) Following the First Commercial Sale, Company shall pay MGH a non-refundable
annual minimum royalty in the amount of one hundred thousand dollars United
States Dollars ($100,000) per year within sixty (60) days after each annual
anniversary of the Effective Date. The annual minimum royalty shall be
credited against royalties subsequently due on Net Sales made during the
same calendar year, if any, but shall not be credited against royalties due
on Net Sales made in any other year.
The License Agreement also requires VI to pay to MGH a 1% royalty rate on net
sales related to the first license sub-field, which is the treatment of Type 1
Diabetes ("T1D"). Future sub-fields shall carry a reasonable royalty rate,
consistent with industry standards, to be negotiated at the time the first such
royalty payment shall become due with respect to the applicable Products and
Processes (as defined in the License Agreement).
The License Agreement additionally requires VI to pay to MGH a $1.0 million
"success payment" within 60 days after the first achievement of total net sales
of Product or Process equal to or to exceed $100,000,000 in any calendar year
and $4,000,000 within 60 days after the first achievement of total net sales of
Product or Process equal or exceed $250,000,000 in any calendar year. The
Company is also required to reimburse MGH's expenses in connection with the
preparation, filing, prosecution and maintenance of all Patent Rights.
The License Agreement expires on the later of (i) the date on which all issued
patents and filed patent applications within the Patent Rights have expired
(November 2033) or have been abandoned, and (ii) one year after the last sale
for which a royalty is due under the License Agreement.
The License Agreement also grants MGH the right to terminate the License
Agreement if VI fails to make any payment due under the License Agreement or
defaults in the performance of any of its other obligations under the License
Agreement, subject to certain notice and rights to cure set forth therein. MGH
may also terminate the License Agreement immediately upon written notice to VI
if VI: (i) shall make an assignment for the benefit of creditors; or (ii) or
shall have a petition in bankruptcy filed for or against it that is not
dismissed within 60 days of filing. As of the date of this filing, this License
Agreement remains active and the Company has not received any termination notice
from MGH.
15
VI may terminate the License Agreement prior to its expiration by giving 90
days' advance written notice to MGH, and upon such termination shall, subject to
the terms of the License Agreement, immediately cease all use and sales of
Products and Processes.
The Company incurred costs to MGH of $3,097 and $13,097, respectively, for the
three and nine months ended September 30, 2022, respectively, which is
classified as research and development costs, related party, on the consolidated
statements of operations. The Company incurred costs to MGH of $0 and $7,243,
respectively, for the three and nine months ended September 30, 2021,
respectively. As of September 30, 2022, and December 31, 2021, $3,097 and
$3,860, respectively, is included in accounts payable, related parties, on the
consolidated balance sheets, for services that remain unpaid.
During the three and nine months ended September 30, 2022, and 2021, there have
not been any sales of Product or Process under this License Agreement.
Accounts Payable, related parties and Accrued Salaries, related party
The Company incurred director fees of $30,000 and $90,000 for the three and nine
months ended September 30, 2022, respectively, to Federico Pier, the Company's
Chief Executive Officer and Chairman of the Board, which are included in
personnel costs on the unaudited condensed consolidated statements of
operations. The Company incurred director fees of $22,500 and $67,500 for the
three and nine months ended September 30, 2021, respectively, to Mr. Pier. As of
September 30, 2022, and December 31, 2021, $115,000 and $60,000, respectively,
of these director fees are included in accounts payable, related parties, on the
unaudited condensed consolidated balance sheets.
The Company incurred consulting fees of $22,500 and $67,500 for the three and
nine months ended September 30, 2022, respectively, to Jeff Wright, the
Company's Chief Financial Officer, which are included in professional fees on
the unaudited condensed consolidated statements of operations. The Company
incurred consulting fees of $15,000 and $45,000 for the three and nine months
ended September 30, 2021, respectively, to Mr. Wright. As of September 30, 2022,
and December 31, 2021, $77,762 and $40,000, respectively, is included in
accounts payable, related parties, on the unaudited condensed consolidated
balance sheets.
In August 2020, Frances Tonneguzzo, the Company's Chief Executive Officer (the
"former CEO") tendered her resignation as CEO. For the three and nine months
ended September 30, 2022, and 2021, the Company did not incur any expenses to
the former CEO. As of September 30, 2022, and December 31, 2021, $115,312,
respectively, of unpaid salary to the former CEO is included in accrued
salaries, related party on the unaudited condensed consolidated balance sheets.
See Note 5 for a consulting agreement executed with the former CEO.
Sale of Equity Method Investment
In January 2021, the Company sold its' equity investment in AEI back to AEI for
$100,000, which is included in other income on the unaudited condensed
consolidated statements of operations for the nine months ended September 30,
2021 (see Note 3).
NOTE 6- COMMITMENTS AND CONTINGENCIES
Legal Matters
The Company is not aware of any material, existing or pending legal proceedings
against the Company, nor is it involved as a plaintiff in any material
proceeding or pending litigation. There are no proceedings in which any of our
directors, officers or affiliates, or any registered or beneficial shareholder,
is an adverse party or has a material interest adverse to our interest.
16
MGH License Agreement
As discussed in Note 5, the Company executed a License Agreement with MGH. Prior
to the first commercial sale, the License Agreement requires the Company to pay
MGH a non-refundable annual license fee of $10,000 by June 30, 2022, and on each
subsequent anniversary of the Effective Date thereafter. The first
non-refundable annual license fee was paid on July 1, 2022. Additionally,
following the first commercial sale, the License agreement requires the Company
to pay MGH a non-refundable annual minimum royalty in the amount of $100,000 per
year within sixty days after each annual anniversary of the Effective Date.
The License Agreement also requires VI to pay to MGH a 1% royalty rate on net
sales related to the first license sub-field, which is the treatment of T1D.
Future sub-fields shall carry a reasonable royalty rate, consistent with
industry standards, to be negotiated at the time the first such royalty payment
shall become due with respect to the applicable Products and Processes (as
defined in the License Agreement).
The License Agreement additionally requires VI to pay to MGH a $1.0 million
"success payment" within 60 days after the first achievement of total net sales
of Product or Process equal or exceeding $100,000,000 in any calendar year and
$4,000,000 within 60 days after the first achievement of total net sales of
Product or Process equal to or exceeding $250,000,000 in any calendar year. The
Company is also required to reimburse MGH's expenses in connection with the
preparation, filing, prosecution and maintenance of all Patent Rights. $3,097
and $0, respectively, of expense reimbursements were incurred to MGH during the
three and nine months ended September 30, 2022, and 2021. As of September 30,
2022, and December 31, 2021, $3,097 and $0, respectively, is included in
accounts payable, related parties, on the unaudited condensed consolidated
balance sheets.
Consulting Agreements
On January 12, 2022, the Company entered into a Consulting Agreement (the
"Consulting Agreement") with Donohoe Advisory Associates, LLC. (the
"Consultant"). The Company engaged the Consultant to provide assistance and
advice to the Company in support of the Company's efforts to obtain a listing on
a national securities exchange. The Company agreed to pay the Consultant a
retainer fee of $17,500, which is to be applied to the Company's monthly
invoices until such time as the retainer fee is exhausted or the engagement
under the agreement ends. The Company incurred $0 and $10,680 in expenses for
the three and nine months ended September 30, 2022, which are included in
professional fees on the unaudited condensed consolidated statements of
operations, and none of which is included in accounts payable on the unaudited
condensed consolidated balance sheet. As of September 30, 2022, the remaining
balance of the retainer paid to the Consultant was $6,820 and is included in
prepaid expenses on the unaudited condensed consolidated balance sheet. No
expenses were paid to the Consultant during the three and nine months ended
September 30, 2021. If the Company is successful in listing on an exchange, the
Company will be obligated to pay a "success fee" to the Consultant of either
$10,000 or that number of registered common shares equivalent to $10,000 divided
by the closing price of the Company's common stock on the last day of trading on
the OTC Market. The form of the success fee will be determined by the Company.
On March 7, 2022, the Company entered into a Consulting Agreement (the
"Consulting Agreement") with Alpha IR Group, LLC. (the "Consultant"). The
Company engaged the Consultant to provide consulting, investor relations, and
corporate and transaction communication related services. The initial term of
the Consulting Agreement is for three months (the "Initial Term") beginning
March 1, 2022, and the Company agreed to pay compensation equal to the sum of
$50,000 payable in cash or stock options for the three months of service. The
Company incurred $0 and $50,000 in expenses for the three and nine months ended
September 30, 2022, respectively, which are included in professional fees on the
unaudited condensed consolidated statements of operations. As of September 30,
2022, the balance owed to the Consultant was $50,000 which is included in
accounts payable on the unaudited condensed consolidated balance sheet. No
expenses were incurred with the Consultant during the three and nine months
ended September 30, 2021.
17
NOTE 7 - STOCKHOLDERS' EQUITY (DEFICIT)
Preferred Stock
The Company has 20,000,000 authorized shares of preferred stock, $0.001 par
value per share.
Series A Preferred Stock
On December 19, 2017, the Company amended its articles of incorporation by
filing a certificate of designation with the Secretary of State of Florida
therein designating a class of preferred stock as Series A Preferred Stock,
$0.001 par value per share, consisting of 3 million (3,000,000) shares. Each
holder of shares of Series A Preferred Stock shall be entitled to the number of
votes equal to the number of votes held by the number of shares of common stock
into which such share of Series A Preferred Stock could be converted, and except
as otherwise required by applicable law, shall have the voting rights and power
equal to the voting rights and powers of the common stock. The holders of the
Series A Preferred Stock shall vote together with the holders of the common
stock of the Company as a single class and as single voting group upon all
matters required to be submitted to a class or series vote pursuant to the
protective provisions of the Certificate of Designation or under applicable law.
In the event of liquidation, dissolution or winding up of the Company, either
voluntarily or involuntarily, the holders of Series A Preferred Stock shall be
entitled to receive, prior and in preference to any common stock holders,
distribution of any surplus funds equal to the greater of (i) the sum of $1.67
per share or (ii) such amount per share as would have been payable had all
shares been converted to common stock.
Each share of Series A Preferred Stock is convertible into shares of common
stock at a conversion Rate of 2:1 (the "Series A Conversion Rate"). The Series A
Conversion Rate shall be adjusted for stock splits, stock combinations, stock
dividends or similar recapitalizations.
Pursuant to the Articles of Incorporation, the shares of Series A Preferred
Stock automatically converted into 6,000,000 shares of common stock to be issued
on February 12, 2021, (the one-year anniversary of the initial filing by the
Company of the Form 10 filed with the SEC). The common stock shares for the
conversion of the Series A Preferred Stock were issued on January 13, 2022.
As of September 30, 2022, and December 31, 2021, there were -0- shares of Series
A Preferred Stock issued and outstanding.
Series B Preferred Stock
On December 19, 2017, the Company amended the articles of incorporation by
filing a certificate of designation with the Secretary of State of Florida
therein designating a class of preferred stock as Series B Preferred Stock,
$0.001 par value per share, consisting of 4.44million (4,440,000) shares (the
"Series B Preferred Stock Certificate of Designation").
Each holder of shares of Series B Preferred Stock shall be entitled to the
number of votes equal to the number of votes held by the number of shares of
common stock into which such share of Series B Preferred Stock could be
converted, and except as otherwise required by applicable law, shall have the
voting rights and power equal to the voting rights and powers of the common
stock. The holders of the Series B Preferred Stock shall vote together with the
holders of the common stock of the Company as a single class and as single
voting group upon all matters required to be submitted to a class or series vote
pursuant to the protective provisions of the Series B Preferred Stock
Certificate of Designation or under applicable law. In the event of liquidation,
dissolution or winding up of the Corporation, either voluntarily or
involuntarily, the holders of Series A Preferred Stock shall be entitled to
receive, prior and in preference to any common stock holders, distribution of
any surplus funds equal to the greater of : the sum of $0.83 per share or such
amount per share as would have been payable had all shares been converted to
common stock.
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The holder of Series B Preferred Stock may elect at any time to convert such
sharers into common stock of the Company. Each share of Series B Preferred Stock
is convertible into shares of common stock at a conversion rate of 1:1 (the
"Series B Conversion Rate"). The Series B Conversion Rate shall be adjusted for
stock splits, stock combinations, stock dividends or similar recapitalizations.
Pursuant to the Articles of Incorporation, the shares of Series B Preferred
Stock automatically converted into 4,440,000 shares of common stock to be issued
on February 12, 2021, the one-year anniversary of the initial filing by the
Company of the Form 10 filed by the Company with the SEC. The common stock
shares for the conversion of the Series B Preferred Stock were issued on January
13, 2022.
As of September 30, 2022, and December 31, 2021, there were -0- shares of Series
B Preferred Stock issued and outstanding.
Common Stock
The Company has 300,000,000 authorized shares of common stock, $0.001 par value
per share. As of September 30, 2022, and December 31, 2021, there were
31,188,460 and 19,747,283 shares, respectively, of common stock issued and
outstanding.
Common Stock Issuances
On February 11, 2021, the Company issued 24,000 shares to an investor. The
shares were previously included in common stock to be issued.
On February 12, 2021, the Company issued 6,000,000 shares of common stock to the
holders of Series A Preferred Stock, pursuant to the automatic conversion
feature of the Series A Certificate of Designation, whereby, the Series A shares
are to automatically convert on the one-year anniversary of the Company filing
its Registration Statement on Form 10. The Form 10 Registration Statement was
filed with the SEC on February 12, 2020. The common stock shares for the
conversion of the Series A Preferred Stock were issued on January 13, 2022.
On February 12, 2021, the Company issued 4,440,000 shares of common stock to the
holders of Series B Preferred Stock, pursuant to the automatic conversion
feature of the Series B Certificate of Designation, whereby, the Series B shares
are to automatically convert on the one-year anniversary of the Company filing
its Registration Statement on Form 10. The Form 10 Registration Statement was
filed with the SEC on February 12, 2020. The common stock shares for the
conversion of the Series B Preferred Stock were issued on January 13, 2022.
During the three and nine months ended September 30, 2022, the Company
determined that the former Series B Preferred Stockholders, subsequent to all
Series B Preferred Stock having previously been converted to shares of common
stock in 2021, were owed additional shares of common stock due to an adjustment
to the conversion price that occurred as a result of a down round trigger event
that occurred in 2019 when the Company sold shares of common stock and a warrant
in a private placement at a price of $0.25, which was below the original
conversion ratio of the Series B Preferred Stock. Management determined the
total additional shares owed to the Preferred B Stockholders to be 1,001,177as a
result of the down round trigger. The financial statement impact of this down
round trigger was not significant. The shares owed to the Series B Preferred
Stockholders due to the 2019 trigger event have been presented on the statement
of stockholders' equity retrospectively as common stock to be issued with no
impact on total stockholders' deficit. The Company issued the additional shares
to the Series B Preferred Stockholders on March 24, 2022.
In July 2022, the Company received proceeds totaling $50,000 and issued 100,000
shares of common stock pursuant to the exercise of warrants at $0.50 per share.
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Common Stock to be issued
As of September 30, 2022 and 2021, there were 726,281 and 12,607,281,
respectively, shares of common stock to be issued. The September 30, 2022,
amount relates to 597,281 shares to be issued pursuant to a Stock Issuance and
Release Agreement ("SRI Agreement") executed by the Company in February 2019 to
stockholders for no consideration who purchased shares in 2018 at $1.85, 30,000
shares of common stock to be issued to two initial shareholders of VI, and
100,000 shares to be issued pursuant to the exercise of warrants in July 2022.
The September 30, 2021 amount relates to 6,000,000 shares of common stock be
issued for the automatic conversion of the Series A Preferred Stock, 4,440,000
shares of common stock to be issued for the automatic conversion of the Series B
Preferred Stock, 1,540,000 shares of common stock to be issued pursuant to stock
subscription agreements, 597,281 shares to be issued pursuant to a Stock
Issuance and Release Agreement ("SRI Agreement") executed by the Company in
February 2019 to stockholders for no consideration who purchased shares in 2018
at $1.85, and 30,000 shares of common stock to be issued to two initial
shareholders of VI.
Stock Option-Based Compensation Plan
On August 10, 2022, the Board of Directors of the Company approved and adopted
the Vicapsys Life Sciences, Inc., 2022 Omnibus Equity Incentive Plan (the
"Plan"). The material terms of the 2022 Plan are set forth below:
? The Board or a committee established by the Board will administer the 2022
Plan.
? The total number of shares of common stock authorized for issuance under the
2022 Plan is 3,200,000 shares of Common Stock plus, to the extent the Company
issues new shares of Common Stock other than under the terms of the 2022 Plan
or other than certain Inducement Awards, 3.1% of the shares of Common Stock
issued by the Company in such issuance (or such lower amount as determined by
the Board). As of August 16, 2022, 3,200,000 shares of Common Stock represents
approximately 10.1% of our common stock outstanding.
? Eligible recipients of awards include an employee, director or independent
contractor of the Company who has been selected as an eligible participant by
the Administrator, subject to certain limitations relating to Section 409A of
the Internal Revenue Code of 1986, as amended (the "Code").
? No non-employee director may be granted awards under the 2022 plan during any
calendar year if such awards and cash fees paid for serving as a non-employee
director would exceed $150,000 in the non-employee director's initial year of
service, or $195,000 in any year thereafter.
? In no event shall the exercise price of an option issued pursuant to the 2022
Plan be less than one hundred percent (100%) of the Fair Market Value of a
share of Common Stock on the date of grant.
The purposes of the Plan are to (i) provide an additional incentive to selected
employees, directors, and independent contractors of the Company or its
Affiliates whose contributions are essential to the growth and success of the
Company, (ii) strengthen the commitment of such individuals to the Company and
its Affiliates, (iii) motivate those individuals to faithfully and diligently
perform their responsibilities and (iv) attract and retain competent and
dedicated individuals whose efforts will result in the long-term growth and
profitability of the Company. To accomplish these purposes, the Plan provides
that the Company may grant Options, Stock Appreciation Rights, Restricted Stock,
Restricted Stock Units, Other Stock-Based Awards or any combination of the
foregoing.
Stock Option Activity
On August 10, 2022, the Board of Directors authorized the Company to issue
options to purchase an aggregate of 770,000 shares of common stock to certain
consultants, and former directors. The stock options are exercisable at a price
of $0.50. The options granted are estimated to have fair market value per share
of $0.16. The stock options fully vest after six months from the grant date.
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We utilized the Black-Scholes valuation method to recognize compensation expense
over the vesting period. The expected life was determined using the simplified
method.
The simplified method provided in Securities and Exchange Commission release,
Staff Accounting Bulletin No. 110, averages an award's weighted average vesting
period and contractual term for "plain vanilla" share options. The expected
volatility was estimated by analyzing the historic volatility of similar public
biotech companies in an early stage of development. No dividend payouts were
assumed as we have not historically paid, and do not anticipate paying,
dividends in the foreseeable future. The risk-free rate of return reflects the
average interest rate offered for US treasury rates over the expected term of
the options.
The option price was set at the estimated fair value of the common stock on the
date of grant using an actual transactions approach. The actual transactions
method considers actual sales of the Company's equity prior to the valuation
date. The Company determined the price per share of the most recent private sale
of equity to be a more reliable indicator of the Company's fair value rather
than the quoted OTC prices, which reflected very low trading volume that
subjected the quote price to unusual fluctuations in the stock prices.
The significant assumptions used to estimate the fair value of the equity awards
granted were;
SCHEDULE OF STOCK OPTIONS VALUATION ASSUMPTIONS
Grant date August 10, 2022
Price of common stock of the Company's last capital raise $ 0.25
Expected term (years) 5.25
Risk-free interest rate 2.93 %
Volatility 95 %
Dividend yield None
The following table summarizes activities related to stock options of the
Company for the nine months ended September 30, 2022:
SCHEDULE OF STOCK OPTIONS ACTIVITY
Weighted- Weighted- Aggregate
Average Average Intrinsic
Exercise Remaining Value
Number of Price per Life (Per
Options Share (Years) Option)
Outstanding at December 31, 2021 1,900,000 $ 0.66 5.83 $ -
Granted 770,000 $ 0.50 9.86 $ -
Outstanding at September 30, 2022 2,670,000 $ 0.62 6.46 $ -
Exercisable at September 30, 2022 1,900,000 $ 0.66 5.08 $ -
As of September 30, 2022, there were 770,000shares of time-based, non-vested
stock options that fully vest in February 2023. As of September 30, 2022, there
was $82,789of total unrecognized stock-based compensation related to these
non-vested stock options. That expense is expected to be recognized on a
straight-line basis over a weighted average period of 0.33years.
The Company recorded stock compensation expense of $41,395 and $43,557 for the
three and nine months ended September 30, 2022, respectively. The Company
recorded stock compensation expense of $1,081 and $3,244 for the three and nine
months ended September 30, 2021, respectively.
Warrants
On July 14, 2022, the Board authorized and approved to extend the end date of
certain warrants issued with common stock purchases at various dates in 2019, by
and among the Company and certain investors, pursuant to which the investors had
the right to exercise the warrants until July 31, 2022.
21
Accounting Standards Codification ("ASC") ASC 718-20 Compensation-Stock
compensation, which provides for the guidance on the accounting for a
modification of the terms or conditions of an equity award, and requires a
modification to be treated as an exchange of the original issuance for a new
issuance, and any incremental value between the original award and the modified
award be recorded.
We utilized a Black-Scholes valuation method to determine any incremental value
due to the modification. The inputs used to value the warrant as of the
modification date are as follows:
SCHEDULE OF STOCK WARRANT VALUATION ASSUMPTIONS
? The price of the common stock the Company last raised capital: $0.25
? Exercise price of the warrant: $0.50
? Life of the warrant: 0.15 years
? Risk free return rate: 1.99%
? Annualized volatility rate of four comparative companies: 94%
The Company recognized $3,548 in incremental value for the fair market value of
the modified warrants over the fair market value of the original warrants. The
Company recognized the effect of the excess fair market value as a deemed
dividend which reduced the income available to common stockholders for the three
and nine months ended September 30, 2022.
The following table summarizes activities related to warrants of the Company for
the nine months ended September 30, 2022:
SCHEDULE OF WARRANTS ACTIVITY
Weighted-
Weighted- Average Aggregate
Average Remaining Intrinsic
Number of Exercise Price Life Value (Per
Warrants per Share (Years) Warrant)
Outstanding and exercisable at
December 31, 2021 4,060,000 $ 0.50 0.53 $ 1.50
Exercised 100,000 $ 0.50 - -
Expired 3,960,000 $ 0.51 - -
Outstanding and exercisable at
September 30, 2022 - $ - - $ -
The Company did not issue any warrants during the nine months ended September
30, 2022.
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Item 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations
The following discussion and analysis of our financial condition and results of
operations should be read in conjunction with the unaudited condensed
consolidated financial statements and the notes thereto appearing in Part I,
Item 1 of this Quarterly Report. Historical results and trends that might appear
in this Quarterly Report should not be interpreted as being indicative of future
operations.
Overview
Vicapsys Life Sciences, Inc. ("VLS") was incorporated in the State of Florida on
July 8, 1997 under the name All Product Distribution Corp. On August 19, 1998,
the Company changed its name to Phage Therapeutics International, Inc. On
November 13, 2007, the Company changed its name to SSGI, Inc. On December 22,
2017, pursuant to a Share Exchange Agreement (the "Exchange Agreement") by and
among VLS, Michael W. Yurkowsky, ViCapsys, Inc. ("VI") and the shareholders of
VI, a private company, VI became a wholly owned subsidiary of VLS. We refer to
VLS and VI together as the "Company".
The Company's strategy is to develop and commercialize, on a worldwide basis,
various intellectual property rights (patents, patent applications, know how,
etc.) relating to a series of encapsulated products that incorporate proprietary
derivatives of the chemokine CXCL12 for creating a zone of immuno protection
around cells, tissues, organs and devices for therapeutic purposes. The product
name VICAPSYN™ is the Company's proprietary product line that is applied to
transplantation therapies and related stem-cell applications in the
transplantation field.
COVID-19
The coronavirus outbreak ("COVID-19") adversely affected the Company's financial
condition and results of operations. The impact of the COVID-19 outbreak on
businesses and the economy in the United States is expected to continue to be
significant. The extent to which the COVID-19 outbreak will continue to impact
businesses and the economy is highly uncertain. Accordingly, the Company cannot
predict the extent to which its financial condition and results of operation
will be affected.
On January 30, 2020, the World Health Organization ("WHO") announced a global
health emergency caused by a new strain of the coronavirus and advised of the
risks to the international community as the virus spread globally. In March
2020, the WHO classified the COVID-19 outbreak as a pandemic based on the rapid
increase in exposure globally. The spread of COVID-19 coronavirus has caused
public health officials to recommend precautions to mitigate the spread of the
virus, especially as to travel and congregating in large numbers. In addition,
certain states and municipalities have enacted quarantining regulations which
severely limit the ability of people to move and travel.
In addition, the Company is uncertain of the full effect the pandemic will have
on it for the longer term since the scope and duration of the pandemic is
unknown, and evolving factors such as the level and timing of the distribution
of efficacious vaccines across the world and the extent of any resurgences of
the virus or emergence of new variants of the virus, such as the Delta variant
and the Omicron variant, will impact the stability of economic recovery and
growth. The Company may experience long-term disruptions to its operations
resulting from changes in government policy or guidance; quarantines of
employees, customers and suppliers in areas affected by the pandemic; and
closures of businesses or manufacturing facilities critical to its business.
Results of Operations - Three and Nine Months Ended September 30, 2022, and 2021
Revenues
The Company did not have any revenues for the three and nine months ended
September 30, 2022, and 2021.
23
Operating Expenses
We classify our operating expenses into four categories: personnel costs,
research and development expenses, professional fees, and general and
administrative expenses. The Company's total operating expenses for the three
and nine months ended September 30, 2022, were $145,081 and $492,185
respectively, compared to $111,181 and $233,013, for the three and nine months
ended September 30, 2021, respectively.
The $2,500 monthly increase in Director fees for our CEO commencing in January
2022, resulted in an increase in personnel costs to $30,470 and $91,754 for the
three and nine months ended September 30, 2022, respectively, from $23,072 and
$68,532 for the three and nine months ended September 30, 2021, respectively. We
incurred $3,097 and $13,097 in research and development expenses during the
three and nine months ended September 30, 2022, respectively, related to
expenses and a non-refundable royalty fee we agreed to pay upon execution of the
Eighth Amendment to the License Agreement with MGH which occurred in March 2022,
which is a slight increase from $-0- and $7,243 in research in development
expenses incurred during the three and nine months ended September 30, 2021,
respectively. Research and development expenses remained consistently low as the
Company continued ongoing financing efforts in the wake of the negative impact
of COVID-19, which continued to hinder the Company's ability to raise the
additional capital necessary to maintain regular operating activities. The
increase in general and administrative costs to $12,257 and $41,210 for the
three and nine months ended September 30, 2022, respectively, from $8,644 and
$26,410 for the three and nine months ended September 30, 2021, respectively,
was due to expenses incurred operating as a publicly traded entity. The increase
in professional fees to $99,257 and $346,124 for the three and nine months ended
September 30, 2022, respectively, from $79,465 and $130,828 for the three and
nine months ended September 30, 2021, respectively, was primarily attributable
to the legal, accounting, and consulting and investor relations costs incurred
in support of the Company's efforts to obtain a listing on a national securities
exchange.
Funding Requirements
We anticipate that substantial additional equity or debt financings or funding
from collaborative agreements or from foundations, government grants or other
sources, will be needed to complete preclinical and animal testing necessary to
file an Investigational New Drug Application with the U.S. Food and Drug
Administration, and that further funding beyond such amounts will be required to
commence trials and other activities necessary to begin the process of
development and regulatory approval of a product for the continued growth of the
Company. Additional capital will also be required for the clinical development
of the recently discovered anti-fibrotic applications and corporate partnerships
will be necessary to move Company products into advanced clinical development
and commercialization. We also anticipate our cash expenditures will increase as
we continue to operate as a publicly traded entity.
Liquidity and Capital Resources
At September 30, 2022, we had $26,210 of cash on hand and an accumulated deficit
of $14,625,358.
We do not believe that we have enough cash on hand to operate our business
during the next 12 months. We anticipate we will need to raise an additional $1
million through the issuance of debt or equity securities to sustain base
operations during the next 12 months, excluding development work. There can be
no assurance that we will be able to obtain additional funding on commercially
reasonable terms, or at all. To the extent that we raise additional capital
through the sale of equity or convertible debt securities, the ownership
interests of our common stockholders will be diluted, and the terms of these
securities may include liquidation or other preferences that adversely affect
the rights of our common stockholders. Debt financing, if available, may involve
agreements that include conversion discounts or covenants limiting or
restricting our ability to take specific actions, such as incurring debt, making
capital expenditures or declaring dividends.
If we raise additional funds through government or other third-party funding,
marketing and distribution arrangements or other collaborations, or strategic
alliances or licensing arrangements with third parties, we may have to
relinquish valuable rights to our future revenue streams, products or
therapeutic candidates or to grant licenses on terms that may not be favorable
to us.
24
To date, we have financed our operations through our sale of equity and debt
securities. Failure to generate revenue or to raise funds could cause us to go
out of business, which would result in the complete loss for investors in our
Company.
To date, we have generated no revenues, and no substantial revenues are
anticipated until we have implemented our full plan of operations. To implement
our strategy to grow and expand per our business plan, we intend to generate
working capital via a private placement of equity or debt securities, or to
secure a loan. If we are unsuccessful in raising capital or securing a loan, we
could be required to cease business operations and investors would lose all of
their investment.
In January 2021, the Company sold its equity investment in AEI, back to AEI for
$100,000, which is included in other income for the three and six months ended
March 31, 2021. During the year ended December 31, 2021, the Company entered
into Securities Purchase Agreements with select accredited investors in
connection with a private offering by the Company to raise a maximum of
$1,000,000 through the sale of common stock of the Company at $0.25 per share.
As of December 31, 2021, the Company had raised an aggregate amount of $560,000
from the sale of 2,240,000 shares of common stock. The Company did not raise any
additional capital during the three and nine month period ended September 30,
2022.
In July 2022, the Company received aggregate proceeds totaling of $50,000 and
issued 100,000 shares of common stock pursuant to the exercise of warrants at
$0.50 per share.
Additionally, we will have to meet all the financial disclosure and reporting
requirements associated with being a publicly reporting company. Our management
will have to spend additional time on policies and procedures to make sure our
Company is compliant with various regulatory requirements.
This additional corporate governance time required of management could limit the
amount of time management has to implement our business plan and may impede the
speed of our operations.
Working Capital Deficit
September 30, 2022 December 31, 2021
Current Assets $ 35,747 $ 222,793
Current Liabilities 904,079 715,964
Working Capital Deficit $ (868,332 ) $ (493,171 )
Cash Flows
Cash activity for the nine months ended September 30, 2022, and 2021 is
summarized as follows:
Nine Months Ended September 30,
2022 2021
Net cash used in operating activities $ (241,085 ) $ (320,720 )
Net cash provided by investing activities
- 100,000
Net cash provided by financing activities 50,000 385,000
Net increase (decrease) in cash $ (191,085 ) $ 164,280
As of September 30, 2022, the Company had $26,210 of cash on hand.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as defined in Regulation S-K
Item 303(a)(4) during the periods presented, investments in special-purpose
entities or undisclosed borrowings or debt. Additionally, we are not a party to
any derivative contracts or synthetic leases.
25
Board of Directors
On September 22, 2022, the Board of Directors (the "Board") accepted the
resignations of John Potts and Michael Yurkowsky as members of the Board,
effective immediately. The resignations were not because of a disagreement with
the Company on any matter relating to the Company's operations, policies or
practices.
Also on September 22, 2022, the Board appointed each of Charles "Charlie"
Farrahar, Dr. Colleen Delaney and Richard Rosenblum as members of the Board.
Contractual Obligations
MGH License Agreement
The Company has executed a License Agreement with MGH. Prior to the first
commercial sale, the License Agreement requires the Company to pay MGH a
non-refundable annual license fee of $10,000 by June 30, 2022, and on each
subsequent anniversary of the Effective Date thereafter. The first
non-refundable annual license fee was paid on July 1, 2022. Additionally,
following the first commercial sale, the License agreement requires the Company
to pay MGH a non-refundable annual minimum royalty in the amount of $100,000 per
year within sixty days after each annual anniversary of the Effective Date.
The License Agreement also requires VI to pay to MGH a 1% royalty rate on net
sales related to the first license sub-field, which is the treatment of T1D.
Future sub-fields shall carry a reasonable royalty rate, consistent with
industry standards, to be negotiated at the time the first such royalty payment
shall become due with respect to the applicable Products and Processes (as
defined in the License Agreement).
The License Agreement additionally requires VI to pay to MGH a $1.0 million
"success payment" within 60 days after the first achievement of total net sales
of Product or Process equal or exceeding $100,000,000 in any calendar year and
$4,000,000 within 60 days after the first achievement of total net sales of
Product or Process equal to or exceeding $250,000,000 in any calendar year. The
Company is also required to reimburse MGH's expenses in connection with the
preparation, filing, prosecution and maintenance of all Patent Rights.
Critical Accounting Policies and Estimates
Our discussion and analysis of financial condition and results of operations is
based upon our consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the United States of
America. The preparation of these consolidated financial statements and related
disclosures requires us to make estimates and judgments that affect the reported
amounts of assets, liabilities, expenses, and related disclosure of contingent
assets and liabilities. We evaluate, on an ongoing basis, our estimates and
judgments, including those related to the useful life of the assets. We base our
estimates on historical experience and assumptions that we believe to be
reasonable under the circumstances, the results of which form the basis for
making judgments about the carrying values of assets and liabilities that are
not readily apparent from other sources. Actual results may differ from these
estimates.
The methods, estimates and judgments we use in applying our most critical
accounting policies have a significant impact on the results that we report in
our consolidated financial statements. The Securities and Exchange Commission
(the "SEC"), considers an entity's most critical accounting policies to be those
policies that are both most important to the portrayal of a company's financial
condition and results of operations and those that require management's most
difficult, subjective or complex judgments, often as a result of the need to
make estimates about matters that are inherently uncertain at the time of
estimation.
We believe the following critical accounting policies, among others, require
significant judgments and estimates used in the preparation of our interim
condensed consolidated financial statements.
Our significant accounting policies are described in more detail in the notes to
our consolidated financial statements for the fiscal year ended December 31,
2021, included in the Company's Annual Report filed on Form 10-K with the SEC on
March 16, 2022.
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Recent Accounting Pronouncements
Management does not believe that any recently issued, but not yet effective
accounting pronouncements, if adopted, would have a material effect on the
accompanying unaudited condensed consolidated financial statements.
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