Item 9A. Controls and Procedures
ITEM
9A. CONTROLS AND PROCEDURES.
Disclosure
Controls and Procedures
Based
on an evaluation as of the date of the end of the period covered by this report, the Company’s Chief Executive Officer and
Interim Chief Financial Officer conducted an evaluation of the effectiveness of the design and operation of the Company’s
disclosure controls and procedures, as required by Exchange Act Rule 13a-15. Based on that evaluation, the Company’s Chief
Executive Officer and Interim Chief Financial Officer concluded that, because of the disclosed material weaknesses in the Company’s
internal control over financial reporting, the Company’s disclosure controls and procedures were ineffective as of the end
of the period covered by this report to ensure that information required to be disclosed by the Company in the reports that the
Company files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified
by the SEC’s rules and forms.
Disclosure
controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed
in the Company’s reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported, within
the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation,
controls and procedures designed to ensure that information required to be disclosed in the Company’s reports filed under
the Exchange Act is accumulated and communicated to management, including the Company’s Chief Executive Officer and the
Company’s Interim Chief Financial Officer, to allow timely decisions regarding required disclosure.
Management’s
Annual Report on Internal Control Over Financial Reporting
Management
is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Exchange Act
Rule 13a-15(f). Management conducted an evaluation of the effectiveness of the internal control over financial reporting as of
December 31, 2020, using the criteria established in Internal Control – Integrated Framework (2013 framework)
issued by the Committee of Sponsoring Organizations of the Treadway Commission (“ COSO ”). Because of its
inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of
any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes
in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
A
material weakness is a control deficiency, or combination of control deficiencies, that results in more than a remote likelihood
that a material misstatement of the annual or interim financial statements will not be prevented or detected. As a result of management’s
assessment, management has determined that there are material weaknesses due to the lack of segregation of duties and, due to
the limited resources based on the size of the Company. Due to the material weaknesses management concluded that as of December
31, 2020, the Company’s internal control over financial reporting was ineffective. In order to address and resolve the weaknesses,
the Company will endeavor to locate and appoint additional qualified personnel to the board of directors and pertinent officer
positions as the Company’s financial means allow. To date, the Company’s limited financial resources have not allowed
the Company to hire the additional personnel necessary to address the material weaknesses.
Management’s
Annual Report on Internal Control Over Financial Reporting
This
annual report does not include an attestation report of the Company’s registered public accounting firm regarding internal
control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public
accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the Company to provide only
management’s report in this annual report.
34
Changes
in Internal Control Over Financial Reporting
There
have been no changes in the Company’s internal control over financial reporting that occurred during the Company’s
last fiscal quarter (the Company’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
The
term “internal control over financial reporting” is defined as a process designed by, or under the supervision of,
the registrant’s principal executive and principal financial officers, or persons performing similar functions, and effected
by the registrant’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted
accounting principles and includes those policies and procedures that:
(a)
Pertain
to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of
the assets of the registrant;
(b)
Provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance
with generally accepted accounting principles, and that receipts and expenditures of the registrant are being made only in
accordance with authorizations of management and directors of the registrant; and
(c)
Provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the registrant’s
assets that could have a material effect on the financial statements.
ITEM
9B. OTHER INFORMATION.
None.
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
The
Company’s current directors and executive officers are as follows:
NAME
AGE
POSITION
Michael
K. Korenko
74
President,
Chief Executive Officer, and Director
Michael
Pollack
54
Interim
Chief Financial Officer
Carlton
M. Cadwell
76
Chairman
of the Board and Secretary
Term
of Office
All
the Company’s directors hold office until the next annual meeting of the stockholders or until their successors is elected
and qualified. The Company’s executive officers are appointed by the Company’s board of directors and hold office
until their resignation, removal, death or retirement.
Background
and Business Experience
The
business experience during the past five years of each of the Company’s directors and executive officers is as follows:
Dr.
Michael K. Korenko , President and Chief Executive Officer of the Company since December 2016, and a member of the
Board of Directors since August 2017, joined the Company as an Advisor to the Board of the Company during 2009 and served as
member of the Board from May 2009 to March 2010. Dr. Korenko has also served on the Hanford Advisory Board since 2009. Dr.
Korenko served as Business Development Manager for Curtiss-Wright from 2006 to 2009, as Chief Operating Officer for
Curtiss-Wright from 2000 to 2005 and was Executive Vice President of Closure for Safe Sites of Colorado at Rocky Flats from
1994 to 2000. Dr. Korenko served as Vice President of Westinghouse from 1987 to 1994 and was responsible for the 300 and 400
areas, including the Fast Flux Testing Facility (“ FFTF ”) and all engineering, safety analysis, and
projects for the Hanford site.
35
Dr.
Korenko is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research
and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award
for Performance Manager of the Year. Dr. Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University,
and was selected as a White House Fellow for the Department of Defense, reporting to Secretary Cap Weinberger.
Dr.
Korenko brings to the Board over seven years’ experience working with and advising various small businesses, including companies
involved in turnarounds. Dr. Korenko has also been involved as an advisor to the Company since 2009 in the development of medical
isotopes.
Carlton
M. Cadwell , Chairman of the Board and Secretary since December 2016, joined the Company as a director in 2006.
Dr. Cadwell brings over 30 years of experience in business management, strategic planning, and implementation. He co-founded Cadwell
Laboratories, Inc. in 1979 and has served as its President since its inception. Cadwell Laboratories, Inc. is a major international
provider of neurodiagnostic medical devices. After receiving his bachelor’s degree from the University of Oregon in 1966
and a doctoral degree from the University of Washington in 1970, he began his career serving in the United States Army as a dentist
for three years. From 1973 to 1980, Dr. Cadwell practiced dentistry in private practice and since has started several businesses.
Mr.
Cadwell brings to the Board over ten years of service on the Board and over forty-five years of experience as a successful entrepreneur,
as well as medical expertise.
Michael
Pollack CPA, the Interim Chief Financial Officer, joined the Company as interim Chief Financial Officer in December 2018.
Mr. Pollack has been a partner in a certified public accounting firm for the past fifteen years and specializes in accounting
and auditing for small public companies. Mr. Pollack has approximately 30 years of experience in public accounting and consulting
to over 100 publicly traded and 250 private companies. Mr. Pollack has also held CFO and Controller positions in an array of industries.
Mr. Pollack graduated from the University of Maryland with a Bachelor of Arts in Economics. Mr. Pollack is a member of the American
Institute of Certified Public Accountants, as well as licensed to practice in New Jersey, and New York.
Identification
of Significant Consultants
David
J. Swanberg, M.S., P.E. Mr. Swanberg has over 30 years’ experience in radiochemical processing, medical isotope
production, nuclear waste management, materials science, regulatory affairs, and project management. Mr. Swanberg has worked in
diverse organizations ranging from small start-up businesses to corporations with multi-billion dollar annual revenues. From 2005
to 2008, he served as Executive Vice President of Operations and as a member of the Board of Directors for IsoRay Medical Inc.
from 2005 to 2008 managing day-to-day operations, R&D, and New Product Development. Mr. Swanberg was a co-founder of IsoRay
and led the initial Cs-131 brachytherapy seed product development, FDA 510(k) submission/clearance, and NRC Sealed Source review
and registration. Mr. Swanberg led the radiation dosimetry evaluations to meet American Association of Physicists in Medicine
guidelines and is a current member of the AAPM. Mr. Swanberg and participated in several capital financing rounds totaling over
$30.0 million. Mr. Swanberg also served as Assistant General Manager of IsoRay LLC from 2000 to 2003, and in additionally in key
management roles as IsoRay transitioned from IsoRay LLC to IsoRay Medical, Inc. Mr. Swanberg holds a BA in Chemistry from Bethel
University (MN) and an MS in Chemical Engineering from Montana State University. Mr. Swanberg has numerous technical publications
and holds several patents.
Medical
and Veterinarian Advisory Boards
Dr.
Barry D. Pressman MD, FACR - Chairman Medical Advisory Board. Dr. Pressman is Professor and Chairman of the S. Mark Taper
Foundation Imaging Centre and Department, and Chief of the Section of Neuroradiology and Head and Neck Radiology at Cedars-Sinai
Medical Center , located in Los Angeles, California.
Dr.
Pressman is a past President of The American College of Radiology, the Western Neuroradiological Society, as well as past President
of the California Radiological Society. Currently he is a member of the American Society of Neuroradiology and the American Society
of Pediatric Neuroradiology.
36
Dr.
Pressman earned his medical degree Cum Laude from Harvard Medical School after graduating Summa Cum Laude from Dartmouth College.
After a surgical internship at Harvard’s Peter Bent Brigham Hospital in Boston, he completed a diagnostic radiology residency
at Columbia-Presbyterian Medical Center in New York and a Neuroradiology fellowship at George Washington University Hospital.
During this period, he wrote many original papers for Computer Tomography (CT).
Dr.
Albert S. DeNittis MD, MS, FCPP - Medical Advisory Board. Dr. Albert S. DeNittis is currently is the Chief of Radiation
Oncology at Lankenau Medical Center and Clinical Professor at Lankenau Institute for Medical Research in Wynnewood, Pennsylvania
and the Director of Radiation Oncology at Brodesseur Cancer Center in New Jersey. He is also the Principal Investigator and in
charge of a grant awarded by the NIH for its National Cancer Oncology Research Program (NCORP) at Main Line Health. Dr. DeNittis’
practice experience includes image-guided radiosurgery, stereotactic body radiation therapy (SBRT), intensity modulated radiation
therapy (IMRT), image guided radiation therapy (IGRT), high-dose rate (HDR) brachytherapy, cranial and extracranial stereotactic
radiosurgery, respiratory gating, and Cyberknife.
Dr.
DeNittis has served on numerous regional, national and government committees related to key issues in Dr. DeNittis earned a BA
and a MS at Rutgers University and a MD from the Robert Wood Johnson Medical School at the University of Medicine and Dentistry
of New Jersey. He completed postdoctoral training internships and residency at the Department of Radiation Oncology at the Hospital
of the University of Pennsylvania. Dr. DeNittis is board certified by the American Board of Radiology and Licensed in New Jersey
and Pennsylvania.
Dr.
Alice Villalobos, DVM, FNAP - Chair of the Veterinary Medicine Advisory Board. Dr. Alice Villalobos is a well-known pioneer
in the field of cancer care for companion animals and a founding member of the Veterinary Cancer Society. A 1972 graduate of UC
Davis, she completed Dr. Gordon Theilen’s first mock residency program in oncology and has served the profession by consulting,
writing and lecturing in the rapidly growing field of veterinary oncology and end of life care.
Dr.
Alice Villalobos is President Emeritus of the Society for Veterinary Medical Ethics, Past President of the American Association
of Human Animal Bond Veterinarians and Chair of the Veterinary Academy for the National Academies of Practice. She operated Coast
Pet Clinic/Animal Cancer Center for 25 years, which is now VCA Coast Animal Hospital. She is the author of numerous articles,
papers, and including her classic veterinarian textbook, Canine and Feline Geriatric Oncology: Honoring the Human-Animal Bond.
She has lectured worldwide on oncology, quality of life, the human-animal bond and end of life care and bioethics. She founded
Pawspice, an end of life care program that embraces kinder, gentler palliative cancer medicine and integrative care for pets with
cancer and terminal illness (www.Pawspice.com). Dr. Alice is Director of Animal Oncology Consultation Service in Woodland Hill,
California and Pawspice at VCA Coast Animal Hospital in Hermosa Beach, California. Dr. Alice was elected 2016 Hermosa Beach Woman
of the Year.
Dr.
Villalobos’ role with the Company is to support the commercialization of the Company’s yttrium-90 brachytherapy products
for use in companion animals.
Dr.
Richard Weller, DVM, DACVIM (Internal Medicine; Oncology) DipMS - Veterinary Medicine Advisory Board Member . Prior to
his retirement in 2014, Dr. Weller was a Senior Program Manager in the Radiation Biology Group of the Biological Sciences Division
at Pacific Northwest National Laboratory (PNNL), where he was involved in the development of RadioGel. A 1973 graduate of Washington
State University. Dr. Weller has extensive experience in designing and executing clinical studies, treatment planning, mechanisms
of carcinogenesis, radiation biology, targeted delivery systems for chemotherapeutic and radio-therapeutic agents, bio-markers
of disease, and comparative oncology; as well as over 30 years of experience developing and using animal models, including the
use of spontaneous tumors in companion animals, for bio-medical applications.
Dr.
Weller is board-certified by the American College of Veterinary Internal Medicine in Internal Medicine (1980) and Oncology
(1987), Past Chairperson of the Organizing Committee for the Specialty of Veterinary Medical Oncology, Past Chairperson of
the Board of Regents of the American College of Veterinary Internal Medicine, Past President of the Board of Regents of the
American College of Veterinary Internal Medicine, Past President of the Specialty of Oncology, and a Charter Member of the
Veterinary Cancer Society which he served as Treasurer for 16 years. He is an Honorary Professor of the Institute of
Veterinary Medicine in Kyiv, Ukraine. Dr. Weller has lectured and trained veterinarians worldwide and has authored or
co-authored over 250 articles, technical reports, book chapters, and presentations in his fields of expertise.
37
Section
16(a) Beneficial Ownership Reporting Compliance
Section
16(a) of the Securities Exchange Act of 1934 requires the Company’s executive officers, directors and persons who own more
than 10% of the Company’s common stock to file with the SEC initial reports of beneficial ownership on Form 3, changes in
beneficial ownership on Form 4, and an annual statement of beneficial ownership on Form 5. Such executive officers, directors
and greater than 10% stockholders are required by SEC rules to furnish the Company with copies of all such forms that they have
filed.
Based
solely on its review of such forms filed with the SEC and received by the Company and representations from certain reporting persons,
the Company believes that all reports required to be filed by each of each of its executive officers, directors and 10% stockholders
were filed during the year ended December 31, 2020 and that such reports were timely.
Code
of Ethics
The
Company’s Board of Directors has not adopted a code of ethics that applies to the principal executive officer, principal
financial officer, principal accounting officer or controller, or persons performing similar functions, because of the Company’s
limited number of executive officers and employees that would be covered by such a code and the Company’s limited financial
resources. The Company anticipates that it will adopt a code of ethics after it increases the number of executive officers and
employees and obtain additional financial resources.
Audit
Committee and Audit Committee Financial Expert
As
of the date of this report, the Company has not established an audit committee, and therefore, the Company’s full board
of directors performs the functions that customarily would be undertaken by an audit committee. The Company’s board of directors
during 2020 was comprised of two directors, one of whom the Company had determined satisfied the general independence standards
of the NASDAQ listing requirements.
The
Company’s Board of Directors has determined that none of its current members qualifies as an “audit committee financial
expert,” as defined by the rules of the SEC. In the future, the Company intends to establish board committees and to appoint
such persons to those committees as are necessary to meet the corporate governance requirements imposed by a national securities
exchange, although it is not required to comply with such requirements until the Company elects to seek listing on a national
securities exchange.
Board of Directors; Attendance at
Meetings
The Board held two
meetings and acted by unanimous written consent two times during the year ended December 31, 2020. Each director attended
both Board meetings during the year ended December 31, 2020. We have no formal policy with respect to the attendance
of Board members at annual meetings of shareholders, but encourage all incumbent directors and director nominees to attend each
annual meeting of shareholders.
ITEM
11. EXECUTIVE COMPENSATION.
Summary
Compensation Table
The
following table sets forth the compensation paid to the Company’s Chief Executive Officer and those executive officers that
earned in excess of $100,000 during the year ended December 31, 2020 (collectively, the “ Named Executive Officers ”):
Name and Principal Position (1)
Year
Salary ($)
Bonus ($)
Stock
Awards ($)
Option
Awards
($) (2)
Total ($)
Dr. Michael K. Korenko
2020
$ 120,086 (3)
$ 98,165
$ -
$ -
$ 218,251
CEO, President and Director
2019
$ 120,000
$ -
$ -
$ 585,144
$ 705,144
38
(1)
Michael
Pollack began serving as the Company’s Interim Chief Financial Officer in December 2018 and was paid no compensation
in 2018 or 2019. Accordingly, he has not been included in this table.
(2)
The
amounts in this column represent the grant date fair value of stock option awards, computed in accordance with FASB ASC Topic
718.
(3)
Of
the $120,000 due Mr. Korenko for 2019, $100,000 is accrued for as of December 31, 2019, and as of December 31, 2020, the Company
has $69,914 in accrued compensation to Mr. Korenko.
Narrative
Disclosure to Summary Compensation Table
Dr.
Michael K. Korenko. On October 24, 2018, Mr. Korenko entered into an employment agreement with the Company (the “ Old
Employment Agreement ”), which was scheduled to terminate on December 31, 2019. On June 4, 2019, Mr. Korenko and the
Company entered into a new employment agreement, effective June 11, 2019, which shall terminate on December 31, 2020 and December
31 of subsequent years (the “ Termination Date ”) if the agreement is extended pursuant to its terms. Under the
terms of his employment agreement, the Company may terminate Dr. Korenko’s employment either with or without cause prior
to the Termination Date, but in the event of a termination without cause, Dr. Korenko shall be entitled to receive monthly payments
of his base salary for a period of six months thereafter, all of Dr. Korenko’s outstanding options, if any, shall vest,
and Dr. Korenko shall be entitled to receive all past due compensation within three weeks of the date of termination. The employment
agreement automatically renewed for another year through December 31, 2021.
The
Company shall pay to Dr. Korenko an annual base compensation of $180,000, which is payable in equal monthly intervals. Of the
$180,000 in annual base salary, $60,000 of annual pay shall be deferred and accrued until the Company’s cash balance exceeds
$1,000,000, which occurred in December 2020. Dr. Korenko’s employment agreement provides that he shall receive a
stock option grant issued under the Company’s 2015 Omnibus Securities and Incentive Plan in an amount equal to 21 million
options ten days after the Company’s 1-for-8 reverse split, which was consummated in late June 2019. The options shall have
a seven year term, shall be exercisable at a price of $0.024 per share, and shall vest as follows: 50% shall vest in equal amounts
at the end of each quarter for the two quarters after grant date, 25% shall vest upon the Company filing for a patent, and the
remaining 25% shall vest upon the first commercial sale of IsoPet. In December 2020, Mr. Korenko exercised 2,500,000 of these
options for $60,000.
Pursuant
to Dr. Korenko’s Old Employment Agreement, the Company agreed to issue to Dr. Korenko 3,500,000 shares of common stock and
warrants to purchase 1,762,321 shares of common stock in satisfaction of his past due and accrued compensation. In addition, in
consideration for Dr. Korenko’s past performance, the Company agreed to compensate Dr. Korenko with a cash bonus in the
amount of $200,000, which will be deferred until the cash balance exceeds $2,000,000. The Company also granted Dr. Korenko a stock
option grant of 8,120,152 options under the 2015 Omnibus Securities and Incentive Plan on October 24, 2018. The options vested
immediately upon issuance, have a term of seven years, and are exercisable at a price of $0.112 per share.
The
Company paid bonuses to certain employees based on their performance, the Company’s need to retain such employees, and funds
available. All bonus payments were approved by the Company’s Board of Directors.
39
Outstanding
Equity Awards at Fiscal Year-End Table
The
following table sets forth all outstanding equity awards held by the Company’s Named Executive Officers as of the end of
last fiscal year.
Option Awards
Name
Number of Securities Underlying Unexercised Options(#) Exercisable
Number of Securities Underlying Unexercised Options (#) Unexercisable
Option
Exercise
Price ($)
Option
Exercise Date
Michael Korenko (1)
8,120,152
-
$ 0.112
10/24/25
Michael Korenko (2)
18,500,000
-
$ 0.024
7/7/26
(1)
Issued
pursuant to employment contract dated October 24, 2018
(2)
Issued
pursuant to employment contract dated July 7, 2019
Compensation
of Directors
During
the year ended December 31, 2020, the Company’s non-employee directors were not paid any compensation.
The
following table sets forth, for each of the Company’s non-employee directors who served during 2020, the aggregate number
of stock awards and the aggregate number of stock option awards that were outstanding as of December 31, 2020:
Outstanding
Outstanding
Stock
Stock
Name
Awards (#)
Options (#)
Carlton M. Cadwell
-
-
During
June 2016, the Company granted to Mr. Cadwell options to purchase 12,500 shares of common stock at an exercise price of $8.00
per share, which options expired June 21, 2019. These options had a grant date fair value of $34,771, which amounts were calculated
in accordance with ASC Topic 718.
Additionally,
the Company granted warrants to purchase 6,425,503 shares of Company common stock to Carlton Cadwell in 2018 as a result of the
Path Forward Agreements and conversion of his advances to the Company. These warrants expired in October 2020.
There
are no employment contracts or compensatory plans or arrangements with respect to any director that would result in payments by
the Company to such person because of his or her resignation as a director or any change in control of the Company.
Compensation
Committee Interlocks and Insider Participation
None
of our officers currently serves, or has served during the last completed fiscal year, on the compensation committee or board
of directors of any other entity that has one or more officers serving as a member of our board of directors.
40
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
Beneficial
Ownership of the Company’s Common Stock
The
following table sets forth, as of March 18, 2021, the number of shares of common stock beneficially owned by the following
persons: (i) all persons the Company knows to be beneficial owners of at least 5% of the Company’s common stock, (ii) the
Company’s current directors, (iii) the Company’s current executive officers, and (iv) all current directors and executive
officers as a group.
As
of March 18, 2021, there were 297,346,254 shares of common stock outstanding and up to 90,093,648 shares issuable
upon exercise of common stock equivalents, assuming exercise and conversion occurred as of that date, for a total of 387,439,902
shares.
Name and Address of Beneficial Owner (1)
Amount and
Nature
of Beneficial
Ownership (2)
Percent of Class
Cadwell Family Irrevocable Trust
26,912
*%
Carlton M. Cadwell (3)
14,113,442
3.6 %
Michael K. Korenko (4)
34,140,222
8.8 %
Michael Pollack
16,000
*
All Current Directors and Executive Officers as a group (3 individuals)
48,296,576
12.4 %
*Less
than 1%
(1)
The
address of each of the beneficial owners above is c/o Vivos Inc, 719 Jadwin Avenue, Richland, WA 99336, except that the address
of the Cadwell Family Irrevocable Trust (the “ Cadwell Trust ”) is 909 North Kellogg Street, Kennewick, WA
99336.
(2)
In
determining beneficial ownership of the Company’s common stock as of a given date, the number of shares shown includes
shares of common stock which may be acquired upon exercise of the common stock equivalents within 60 days of that date. In
determining the percent of common stock owned by a person or entity on March 18, 2021, (a) the numerator is the number
of shares of the class beneficially owned by such person or entity, including shares which may be acquired within 60 days
on exercise of the common stock equivalents, and (b) the denominator is the sum of (i) the total shares of common stock outstanding
on March 18, 2021, and (ii) the total number of shares that the beneficial owner may acquire upon conversion of the
common stock equivalents. Subject to community property laws where applicable, the Company believes that each beneficial owner
has sole power to vote and dispose of its shares, except that under the terms of the Cadwell Trust, Dr. Cadwell does not have
or share voting or investment power over the shares beneficially owned by the Cadwell Trust.
(3)
Includes
1,136,137 shares issuable upon conversion of Series A Preferred; and 4,816,275 shares issuable upon conversion of Series C
Preferred.
(4)
Includes
125,000 shares issuable upon conversion of Series A Preferred; 825,000 of vested Restricted Stock Units; 26,620,152 shares
issuable upon the exercise of stock options exercisable within 60 days of March 18, 2021; and 225,000 shares issuable
upon the exercise of warrants that may be exercised within 60 days of March 18, 2021.
41
Beneficial
Ownership of the Company’s Series A Convertible Preferred Stock
As
of March 18, 2021, there were 2,171,007 shares of Series A Preferred issued and outstanding, convertible into 2,713,759
shares of the Company’s common stock.
The
following table sets forth, as of March 18, 2021, the number of shares of Series A Preferred beneficially owned by the
following persons: (i) all persons the Company known to be beneficial owners of at least 5% of the Company’s Series A Preferred,
(ii) the Company’s current directors, (iii) the Company’s current executive officers, and (iv) all current directors
and executive officers as a group.
Name and Address of Beneficial Owner (1)
Amount and
Nature
of Beneficial
Ownership (2)
Percent of Class
Cadwell Family Irrevocable Trust
148,309
6.8 %
Carlton M. Cadwell
908,910
41.9 %
Michael K. Korenko
100,000
4.6 %
All Current Directors and Executive Officers as a group (2 individuals) (3)
1,157,219
53.3 %
Major Shareholder(s):
Firstfire Global Opportunities Fund
113,724
5.2 %
L. Bruce Jolliff
197,979
9.1 %
Stoel Rives
133,333
6.1 %
(1)
The
address of each of the beneficial owners above is c/o Vivos Inc, 719 Jadwin Avenue, Richland, WA 99336, except that the address
of (i) the Cadwell Family Irrevocable Trust (the “ Cadwell Trust ” ) is 909 North Kellogg Street, Kennewick,
WA 99336; (ii) Firstfire Global Opportunities Fund LLC is 1040 First Avenue, Suite 190, New York, NY 10022; (iii) L. Bruce
Jolliff is 206 N 41st St. Unit 1, Yakima, WA 98901; and (iv) Stoel Rives is One Union Square, 600 University Street, Suite
3600, Seattle, WA 98101.
(2)
Subject
to community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose
of its shares, except that Dr. Cadwell under the terms of the Cadwell Trust does not have or share voting or investment power
over the Series A Convertible Preferred beneficially owned by the Cadwell Trust.
(3)
Michael
Pollack, the Company’s Interim Chief Financial Officer, does not hold any Company Series A Convertible Preferred, and
has therefore been omitted from this table.
42
Beneficial
Ownership of the Company’s Series B Convertible Preferred Stock
As
of March 18, 2021, there were 436,653 shares of Series B Preferred issued and outstanding, convertible into 5,458,163 shares
of the Company’s common stock.
The
following table sets forth, as of March 18, 2021, the number of shares of Series B Preferred beneficially owned by the
following persons: (i) all persons the Company known to be beneficial owners of at least 5% of the Company’s Series B Preferred,
(ii) the Company’s current directors, (iii) the Company’s current executive officers, and (iv) all current directors
and executive officers as a group.
Name and Address of Beneficial Owner (1)
Amount and
Nature
of Beneficial
Ownership (2)
Percent of Class
All Current Directors and Executive Officers as a group (3
individuals)
-
*%
Major Shareholder(s):
Jason Adelman (3)
436,290
99 %
*Less
than 1%
(1)
None
of the Company’s directors and executive officers hold any shares of the Company’s Series B Convertible Preferred,
and they have therefore been omitted from this table. The address of each of the beneficial owners are as follows: (i) Jason
Adelman is 40 East 66th St., New York, NY 10065; and (ii) Cipher 06, LLC, c/o Ellis Lake Capital, 444 Madison Avenue, 40 th
Floor, New York, NY 10022.
(2)
Subject
to community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose
of its shares.
(3)
Includes
200,000 shares of Series B Preferred held by JTA Resources LLC.
Beneficial
Ownership of the Company’s Series C Convertible Preferred Stock
As
of March 18, 2021, there were 385,302 shares of Series C Preferred issued and outstanding, convertible into 4,816,275 shares
of the Company’s common stock.
The
following table sets forth, as of March 18, 2021, the number of shares of Series C Preferred beneficially owned by the
following persons: (i) all persons the Company known to be beneficial owners of at least 5% of the Company’s Series C Preferred,
(ii) the Company’s current directors, (iii) the Company’s current executive officers, and (iv) all current directors
and executive officers as a group.
Name and Address of Beneficial Owner (1)
Amount and
Nature
of Beneficial
Ownership (2)
Percent of
Class
Carlton M. Cadwell
385,302
100 %
All
Current Directors and Executive Officers as a group (3 individuals) (3)
385,302
100
%
43
(1)
The
address of each of the beneficial owners above is c/o Vivos Inc, 719 Jadwin Avenue, Richland, WA 99336.,
(2)
Subject
to community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose
of its shares, except that Dr. Cadwell under the terms of the Cadwell Trust does not have or share voting or investment power
over the Series C Preferred beneficially owned by the Cadwell Trust.
(3)
Neither
Michael Korenko, the Company’s Chief Executive Officer, nor Michael Pollack, the Company’s Interim Chief Financial
Officer, hold any shares of the Company’s Series C Preferred, and they have therefore been omitted from this table.
Changes
in Control
The
Company does not know of any arrangements, including any pledges of the Company’s securities that may result in a change
in control of the Company.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
Indebtedness
from Related Parties
On
January 24, 2019, the Company entered into a note payable with a trust related to Mr. Cadwell in the amount of $60,000. The note
is for a one-year period maturing January 24, 2020 and bears interest at an annual rate of 8.0%. This note is currently in default.
44
On
March 27, 2019 the Company entered into a note payable with a trust related to Mr. Cadwell in the amount of $48,000. The note
is for a one-year period maturing March 27, 2020 and bears interest at an annual rate of 8.0%. This note is currently in default.
On
April 29, 2019, the Company entered into a note payable with a trust related to Mr. Cadwell in the amount of $29,000. The note
is for a one-year period maturing April 29, 2020 and bears interest at an annual rate of 8.0%.
On
May 20, 2019 and May 23, 2019, Mr. Korenko advanced $20,000 collectively to the Company. Mr. Korenko is not charging interest
on these amounts advanced and they are short-term advances, due on demand. Of this amount $5,000 was repaid and the balance of
$15,000 was converted into a convertible note payable at an annual interest rate of 8% due January 15, 2020. This note was converted
in April 2020.
On
July 5, 2019, the Company entered into a note payable with a trust related to Mr. Cadwell in the amount of $50,000. The note is
for a one-year period maturing July 5, 2020 and bears interest at an annual rate of 8.0%.
On
November 25, 2019, the Company entered into a note payable with a trust related to Mr. Cadwell in the amount of $50,000. The note
is for a one-year period maturing November 25, 2020 and bears interest at an annual rate of 8.0%.
The
Company borrowed $107,000 in the year ended December 31, 2020 from its CEO and repaid these amounts in full.
Independent
Directors
The
Company’s common stock is traded on the OTCQB Marketplace, which does not impose any independence requirements on the Board
of Directors or the board committees of the companies whose stock is traded on that market. The Company has decided to adopt the
independence standards of the Nasdaq listing rules in determining whether the Company’s directors are independent. Generally,
under those rules a director does not qualify as an independent director if the director or a member of the director’s immediate
family has had in the past three years certain relationships or affiliations with the Company, the Company’s auditors, or
other companies that do business with the Company. The Company’s Board of Directors has determined that Mr. Cadwell is qualified
as an independent director under those Nasdaq rules, and accordingly, would have been qualified under those rules to serve on
a compensation committee or a nominating committee, if the Company had established such committees of the Company’s Board
of Directors. Dr. Korenko is not an independent director due to his employment by the Company as an executive officer.
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
Audit
Fees
The
aggregate fees incurred by the Company’s principal accountant for the audit of the Company’s annual financial statements,
review of financial statements included in the quarterly reports and other fees that are normally provided by the accountant in
connection with statutory and regulatory filings or engagements for the years ended December 31, 2020 and 2019 were $61,500 and
$61,500, respectively, all of which was paid to Fruci & Associates II, PLLC.
Audit
Related Fees
The
aggregate fees billed for professional services that are reasonably related to the performance of the audit or review of the Company’s
financial statements but are not reported “Audit Fees” for the years ended December 31, 2020 and 2019 in the amounts
of $7,250 and $7,250, respectively. All services performed by the Company’s Registered Public Accounting Firm, Fruci &
Associates II, PLLC have been pre-approved by the Company’s Board of Directors.
45
Tax
Fees
The
aggregate fees billed for professional services rendered by principal accountant for tax compliance, tax advice and tax planning
during the years ended December 31, 2020 and 2019 were $2,750 and $2,750, respectively, all of which was paid to Fruci & Associates
II, PLLC.
All
Other Fees
Other
fees billed for products or services provided by the Company’s principal accountant during the years ended December 31,
2020 and 2019 There were no fees incurred to Fruci & Associates II, PLLC related to all other fees.
PART
IV
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
(a)
Documents filed as part of this Report.
1.
Financial
Statements . The Vivos Inc. Balance Sheets as of December 31, 2020 and 2019, the Statements of Operations for the
years ended December 31, 2020 and 2019, the Statements of Changes in Stockholders’ Deficit for the years ended December
31, 2020 and 2019, and the Statements of Cash Flows for the years ended December 31, 2020 and 2019, together with the notes
thereto and the reports of Fruci & Associates II, PLLC as required by Item 8 are included in this 2020 Annual Report on
Form 10-K as set forth in Item 8 above.
2.
Financial
Statement Schedules . All financial statement schedules have been omitted since they are either not required or
not applicable, or because the information required is included in the financial statements or the notes thereto.
3.
Exhibits .
The following exhibits are either filed as a part hereof or are incorporated by reference. Exhibit numbers correspond to the
numbering system in Item 601 of Regulation S-K.
Exhibit
Number
Description
3.1
Certificate of Incorporation of Savage Mountain Sports Corporation, dated January 11, 2000 (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497) filed on November 12, 2008).
3.2
By-Laws (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497) filed on November 12, 2008).
3.3
Certificate of Amendment of Certificate of Incorporation changing the name of the Company to Advanced Medical Isotope Corporation, dated May 23, 2006 (incorporated by reference to Exhibit 3.5 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497) filed on November 12, 2008).
3.4
Certificate of Amendment of Certificate of Incorporation increasing authorized capital dated September 26, 2006 (incorporated by reference to Exhibit 3.6 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497) filed on November 12, 2008).
3.5
Certificate of Amendment to the Certificate of Incorporation increasing authorized common stock and authorizing preferred stock, dated May 18, 2011 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on May 18, 2011).
3.6
Certificate of Amendment to the Certificate of Incorporation authorizing a series of Preferred Stock to be named “Series A Convertible Preferred Stock”, consisting of 2,500,000 shares, which series shall have specific designations, powers, preferences and relative and other special rights, qualifications, limitations and restrictions as outlined in the Certificate of Designations, filed June 30, 2015 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on July 7, 2015).
46
3.7
Certificate of Amendment to the Certificate of Incorporation increasing the authorized series of “Series A Convertible Preferred Stock” to 5,000,000 shares, filed March 31, 2016 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on April 7, 2016).
3.8
Certificate of Amendment to the Certificate of Incorporation authorizing a series of Preferred Stock to be named “Series B Convertible Preferred Stock”, consisting of 5,000,000 shares, which series shall have specific designations, powers, preferences and relative and other special rights, qualifications, limitations and restrictions as outlined in the Certificate of Designations, filed October 10, 2018 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on October 17, 2018).
4.1
Form of Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on October 17, 2018).
10.1
Agreement and Plan of Reorganization, dated as of December 15, 1998, by and among HHH Entertainment, Inc. and Earth Sports Products, Inc. (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497) filed on November 12, 2008).
10.2
Agreement and Plan of Merger of HHH Entertainment, Inc. and Savage Mountain Sports Corporation, dated as of January 6, 2000 (incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497), filed on November 12, 2008).
10.3
Agreement and Plan of Acquisition by and between Neu-Hope Technologies, Inc., UTEK Corporation and Advanced Medical Isotope Corporation, dated September 22, 2006 (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497), filed on November 12, 2008).
10.4
Agreement and Plan of Acquisition by and between Isonics Corporation and Advanced Medical Isotope Corporation dated June 13, 2007 (incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497), filed on November 12, 2008).
10.5
Form of Non-Statutory Stock Option Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 15, 2012).
10.6
Promissory Note dated December 16, 2008 between Advanced Medical Isotope Corporation and Carlton M. Cadwell (incorporated by reference to Exhibit 10.11 to the Company’s Annual Report on Form 10-K filed on March 3, 2012).
10.7
2015 Omnibus Securities and Incentive Plan (incorporated by reference to Exhibit 10.12 to the Company’s Annual Report on Form 10-K, filed May 25, 2016).
10.8
Washington State University Sub-Award Agreement for the period December 15, 2017 through January 31, 2018.(incorporated by reference to Exhibit 10.13 to the Company’s Annual report on Form 10-K, filed April 2, 2018).
10.9
The Curators of the University of Missouri Sponsored Research Contract for the period November 1, 2017 through October 31, 2018. (incorporated by reference to Exhibit 10.14 to the Company’s Annual report on Form 10-K, filed April 2, 2018).
10.10
Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 17, 2018).
10.11
Employment Agreement by and between Vivos Inc. and Michael Korenko, dated June 4, 2019 (incorporated by reference to Exhibit 6.18 to the Company’s Offering Statement on Form 1-A filed on July 29, 2019).
23
Consent
of Independent Registered Public Accounting Firm
31.1*
Certification of Chief Executive Officer pursuant to Sec. 302 of the Sarbanes-Oxley Act of 2002 (4)
31.2*
Certification of Chief Financial Officer pursuant to Sec. 302 of the Sarbanes-Oxley Act of 2002 (4)
32.1*
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 (4)
101.INS*
XBRL
Instance Document
101.SCH*
XBRL
Taxonomy Extension Schema
101.CAL*
XBRL
Taxonomy Extension Calculation Linkbase
101.DEF*
XBRL
Taxonomy Extension Definition Linkbase
101.LAB*
XBRL
Taxonomy Extension Label Linkbase
101.PRE*
XBRL
Taxonomy Extension Presentation Linkbase
*
Filed herewith.
47
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report
to be signed on its behalf by the undersigned, thereunto duly authorized.
VIVOS
INC.
Date:
March 24, 2021
By:
/s/
Michael K. Korenko
Name:
Michael
K. Korenko
Title:
Chief
Executive Officer
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf
of the Registrant and in the capacities and on the dates indicated.
Date:
March 24, 2021
By:
/s/
Michael K. Korenko
Name:
Michael
K. Korenko
Title:
Chief
Executive Officer
(Principal
Executive Officer)
Date:
March 24, 2021
By:
/s/
Michael Pollack
Name:
Michael
Pollack
Title:
Interim
Chief Financial Officer
(Principal
Financial and Accounting Officer)
Date:
March 24, 2021
By:
/s/
Carlton M. Cadwell
Name:
Carlton
M. Cadwell
Title:
Secretary
and Chairman of the Board
48
Vivos
Inc.
Index
to Financial Statements
Pages
Report of Independent Registered Public Accounting Firm
F-1
Financial
Statements:
Balance Sheets as of December 31, 2020 and 2019
F-2
Statements of Operations for the years ended December 31, 2020 and 2019
F-3
Statement of Changes in Stockholders’ Deficit for the years ended December 31, 2020 and 2019
F-4
Statements of Cash Flow for the years ended December 31, 2020 and 2019
F-5
Notes to Financial Statements
F-6
49
Report
of Independent Registered Public Accounting Firm
To
the Board of Directors and Shareholders of Vivos, Inc.
Opinion
on the Financial Statements
We
have audited the accompanying balance sheets of Vivos, Inc. (“the Company”) as of December 31, 2020 and 2019, and
the related statements of operations, changes in stockholders’ equity (deficit), and cash flows for each of the years in
the two-year period ended December 31, 2020, and the related notes (collectively referred to as the financial statements). In
our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December
31, 2020 and 2019, and the results of its operations and its cash flows for each of the years in the two-year period ended December
31, 2020, in conformity with accounting principles generally accepted in the United States of America.
Going
Concern
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed
in Note 1 to the financial statements, the Company has suffered recurring losses, has utilized significant cash in operations,
and its cash position is not sufficient to support operations. These factors raise substantial doubt about the Company’s
ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The
financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on
the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company
Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance
with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the
PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit
to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error
or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial
reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but
not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to
error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
We believe that our audits provide a reasonable basis for our opinion.
Critical
Audit Matters
The
critical audit matters communicated below are matters arising from the current period audit of the financial statements that were
communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material
to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of
critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by
communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or
disclosures to which they relate.
Recognition
of common stock warrant transactions
Description
of the Critical Audit Matter
As
discussed in Note 8 to the financial statements, the Company issued a number of common stock warrants during the period alongside
various agreements. The Company’s initial recognition of outstanding warrants and the evaluation of common shares issued
in exchange for stock warrants involved complexity and judgement in applying the relevant accounting standards when auditing management’s
conclusions on the classification and recognition of warrants on issuance and on exercise.
How
the Critical Audit Matter Was Addressed in the Audit
Our
principal audit procedures to evaluate management’s calculation of common shares issued for exchange of stock warrants included
the following:
● We
evaluated the appropriateness and consistency of management’s methods and assumptions
used in the identification, recognition, measurement, and disclosure of considerations
of the underlying warrants, including the classification with respect to the terms and
in considering applicable generally accepted accounting standards.
● We
read the applicable agreements and compared the key terms to management’s analysis
of the transaction.
● We
read, evaluated, and tested the reasonableness of management’s calculation utilized
in the determination of common shares issued in exchange for stock warrants.
● We
evaluated whether management had appropriately considered new information that could
significantly change the measurement or disclosure of common shares issued in exchange
for stock warrants, and evaluated the disclosures related to the financial statement
impacts of the transactions.
We
have served as the Company’s auditor since 2016.
Spokane,
Washington
March
24, 2021
F- 1
VIVOS
INC
BALANCE
SHEETS
DECEMBER
31, 2020 AND 2019
DECEMBER 31,
DECEMBER 31,
2020
2019
ASSETS
Current Assets:
Cash
$ 903,704
$ 20,381
Prepaid expenses
33,835
23,492
Total Current Assets
937,539
43,873
TOTAL ASSETS
$ 937,539
$ 43,873
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
LIABILITIES
Current Liabilities:
Accounts payable and accrued expenses
$ 361,880
$ 511,817
Related party accounts payable
32,110
32,110
Accrued interest payable
100,954
93,249
Payroll liabilities payable
66,143
100,000
Convertible notes payable, related party, net
-
14,500
Convertible notes payable, net
107,418
434,886
Promissory notes payable, net of discount
-
100,000
Related party promissory note
237,000
237,000
Total Current Liabilities
905,505
1,523,562
Total Liabilities
905,505
1,523,562
Commitments and contingencies
-
-
STOCKHOLDERS’ EQUITY (DEFICIT)
Preferred stock, par value, $0.001, 20,000,000 shares authorized, Series A Convertible Preferred,
5,000,000 shares authorized, 2,171,007 and 2,552,642 shares issued and outstanding, respectively
2,171
2,553
Additional paid in capital - Series A Convertible preferred stock
8,857,358
8,870,626
Series B Convertible Preferred, 5,000,000 shares authorized, 436,653 and 1,113,245 shares issued and outstanding, respectively
436
1,113
Additional paid in capital - Series B Convertible preferred stock
385,235
665,195
Series C Convertible Preferred, 5,000,000 shares authorized, 385,302 and 821,292 shares issued and outstanding, respectively
385
821
Additional paid in capital - Series C Convertible preferred stock
500,507
674,457
Common stock, par value, $0.001, 950,000,000 shares authorized, 292,278,591 and 184,845,821 issued and outstanding, respectively
292,279
184,846
Additional paid in capital - common stock
64,551,764
61,721,809
Accumulated deficit
(74,558,101 )
(73,601,109 )
Total Stockholders’ Equity (Deficit)
32,034
(1,479,689 )
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
$ 937,539
$ 43,873
The
accompanying notes are an integral part of these financial statements.
F- 2
VIVOS
INC
STATEMENTS
OF OPERATIONS
FOR
THE YEARS ENDED DECEMBER 31, 2020 AND 2019
2020
2019
Revenues, net
$ 7,000
$ 9,500
Cost of Goods Sold
(5,608 )
(6,028 )
Gross profit
1,392
3,472
OPERATING EXPENSES
Professional fees
243,942
462,952
Stock based compensation
2,176
608,588
Payroll expenses
234,094
120,000
Research and development
84,668
67,584
General and administrative expenses
109,033
74,327
Total Operating Expenses
673,913
1,333,451
OPERATING LOSS
(672,521 )
(1,329,979 )
NON-OPERATING INCOME (EXPENSE)
Interest expense
(287,471 )
(261,374 )
Other income - SBA
3,000
-
Loss on debt extinguishment
-
(18,744 )
Total Non-Operating Income (Expenses)
(284,471 )
(280,118 )
NET LOSS BEFORE PROVISION FOR INCOME TAXES
(956,992 )
(1,610,097 )
Provision for income taxes
-
-
NET LOSS
$ (956,992 )
$ (1,610,097 )
Net loss per share - basic and diluted
$ (0.00 )
$ (0.01 )
Weighted average common shares outstanding - basic
222,804,039
175,195,600
The
accompanying notes are an integral part of these financial statements.
F- 3
VIVOS
INC
STATEMENT
OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
FOR
THE YEARS ENDED DECEMBER 31, 2020 AND 2019
Additional
Additional
Additional
Series
A Preferred
Paid-In
Capital
-
Series
B Preferred
Paid-In
Capital
-
Series
C Preferred
Paid-In
Capital
-
Common
Stock
Additional Paid-In
Shares
Amount
Series
A Preferred
Shares
Amount
Series
B Preferred
Shares
Amount
Series
C Preferred
Shares
Amount
Capital -
Common
Accumulated
Deficit
Total
Balance - December 31, 2018
2,552,642
$ 2,553
$ 8,870,626
3,305,755
$ 3,306
$ 1,876,768
-
$ -
$ -
163,445,736
$ 163,446
$ 60,132,139
$ (71,991,012 )
$ (942,174 )
Stock issued for:
Cash
-
-
-
100,000
100
49,900
-
-
-
1,250,000
1,250
48,750
-
100,000
Accounts payable
-
-
-
-
-
-
-
-
-
1,062,500
1,063
42,837
-
43,900
Services
-
-
-
-
-
-
-
-
-
312,500
312
12,188
-
12,500
Adjustment for fractional shares in reverse split
-
-
-
-
-
-
-
-
-
(140 )
-
-
-
-
Conversion of restricted stock units into common stock
-
-
-
-
-
-
-
-
-
385,000
385
(385 )
-
-
Conversion of preferred stock into common stock
-
-
-
(1,471,218 )
(1,472 )
(587,016 )
-
-
-
18,390,225
18,390
570,098
-
-
Conversion of Series B Preferred into Series C Preferred
-
-
-
(821,292 )
(821 )
(674,457 )
821,292
821
674,457
-
-
-
-
-
Warrants issued with notes payable (discount)
-
-
-
-
-
-
-
-
-
-
-
151,049
-
151,049
Warrants issued in settlement of litgation
-
-
-
-
-
-
-
-
-
-
-
18,500
-
18,500
Warrants issued for extension of notes payable
-
-
-
-
-
-
-
-
-
-
-
25,656
-
25,656
Options issued for settlement of accounts payable
-
-
-
-
-
-
-
-
-
-
-
48,641
-
48,641
Options and warrants issued for services
-
-
-
-
-
-
-
-
-
-
-
612,379
-
612,379
BCF recognized on convertible notes
-
-
-
-
-
-
-
-
-
-
-
59,957
-
59,957
Net loss for the year
-
-
-
-
-
-
-
-
-
-
-
-
(1,610,097 )
(1,610,097 )
Balance - December 31, 2019
2,552,642
2,553
8,870,626
1,113,245
1,113
665,195
821,292
821
674,457
184,845,821
184,846
61,721,809
(73,601,109 )
(1,479,689 )
Stock issued for:
Cash
-
-
-
-
-
-
-
-
-
60,617,778
60,618
1,576,062
-
1,636,680
Note conversions/settlements
-
-
-
-
-
-
-
-
-
25,964,594
25,965
675,079
-
701,044
Warrant exercises
-
-
-
-
-
-
-
-
-
8,193,185
8,193
51,807
-
60,000
Redemption of preferred stock in convertible note agreement
-
-
-
(100,000 )
(100 )
(49,900 )
-
-
-
-
-
-
-
(50,000 )
Redemption of preferred stock for cash
(381,635 )
(382 )
(13,268 )
-
-
-
-
-
-
-
-
-
-
(13,650 )
Conversion of preferred stock into common stock
-
-
-
(576,592 )
(577 )
(230,060 )
(435,990 )
(436 )
(173,950 )
12,657,275
12,657
392,366
-
-
Warrants issued with notes payable (discount)
-
-
-
-
-
-
-
-
-
-
-
28,482
-
28,482
Warrants purchased for cash
-
-
-
-
-
-
-
-
-
-
-
26,100
-
26,100
Options and warrants issued for services
-
-
-
-
-
-
-
-
-
-
-
80,059
-
80,059
Share adjustment
-
-
-
-
-
-
-
-
-
(62 )
-
-
-
-
Net loss for the year
-
-
-
-
-
-
-
-
-
-
-
-
(956,992 )
(956,992 )
Balance - December 31, 2020
2,171,007
$ 2,171
$ 8,857,358
436,653
$ 436
$ 385,235
385,302
$ 385
$ 500,507
292,278,591
$ 292,279
$ 64,551,764
$ (74,558,101 )
$ 32,034
The
accompanying notes are an integral part of these financial statements.
F- 4
VIVOS
INC
STATEMENTS
OF CASH FLOWS
FOR
THE YEARS ENDED DECEMBER 31, 2020 AND 2019
2020
2019
CASH FLOW FROM OPERTING ACTIVIITES
Net loss
$ (956,992 )
$ (1,610,097 )
Adjustments to reconcile net loss to net cash used in operating activities
Amortization of convertible debt discount
53,527
134,034
Amortization of BCF discount
6,187
55,740
Common stock issued for services
-
12,500
Stock options and warrants for services
2,176
612,379
Forgiveness of debt
-
(34,106 )
Warrants issued for interest expense
77,883
25,656
Exchange premium in conversion of notes
98,508
-
Changes in assets and liabilities
Prepaid expenses and other assets
(10,343 )
(12,500 )
Accounts payable and accrued expenses
(149,937 )
(136,371 )
Accounts payable and accrued expenses from related party
-
(6,500 )
Payroll liabilities
(33,857 )
88,549
Accrued interest
37,041
33,603
Total adjustments
81,185
772,984
Net cash used in operating activities
(875,807 )
(837,113 )
CASH FLOWS FROM FINANCING ACTIVITES
Proceeds from related party notes payable
-
237,000
Redemption of preferred stock
(63,650 )
-
Proceeds from sale of preferred stock
-
50,000
Proceeds from sale of common stock
-
50,000
Proceeds from sale of common stock and warrants
1,662,780
-
Proceeds from the exercise of stock options
60,000
-
Proceeds from convertible debt
150,000
500,000
Proceeds from promissory notes - related party, net of repayments
-
15,000
Payment of notes payable
(50,000 )
-
Net cash provided by financing activities
1,759,130
852,000
NET INCREASE IN CASH
883,323
14,887
CASH - BEGINNING OF YEAR
20,381
5,494
CASH - END OF YEAR
$ 903,704
$ 20,381
CASH PAID DURING THE PERIOD FOR:
Interest expense
$ 13,442
$ 4,000
Income taxes
$ -
$ -
SUPPLEMENTAL INFORMATION - NON-CASH INVESTING AND FINANCING ACTIVITIES:
Cashless exercise of warrants
$ 5,693
$ -
Conversion of preferred stock into common stock
$ 405,023
$ 588,487
Conversion of convertible preferred B into convertible preferred C
$ -
$ 675,278
Recognition of debt discount at inception of notes payable
$ 28,482
$ 151,048
Conversion of notes payable and accrued interest into common stock
$ 701,044
$ -
Recognition of BCF discount at inception of notes payable
$ -
$ 59,957
Common stock issued in settlement of accounts payable
$ -
$ 43,900
Stock options issued in settlement of accounts payable
$ -
$ 48,643
Reclassification of notes payable and accrued interest into common stock
$ -
$ 15,000
Warrants issued for settlement of litigation
$ -
$ 18,500
The
accompanying notes are an integral part of these financial statements.
F- 5
Vivos
Inc.
Notes
to Financial Statements
For
the Years Ended December 31, 2020 and 2019
NOTE
1: ORGANIZATION & BASIS OF PRESENTATION
Business
Overview
Vivos
Inc. (the “ Company ”) was incorporated under the laws of Delaware on December 23, 1994 as Savage Mountain Sports
Corporation (“ SMSC ”). On September 6, 2006, the Company changed its name to Advanced Medical Isotope Corporation,
and on December 28, 2017, the Company began operating as Vivos Inc. The Company has authorized capital of 950,000,000 shares of
common stock, $0.001 par value per share, and 20,000,000 shares of preferred stock, $0.001 par value per share.
Our
principal place of business is located at 719 Jadwin Avenue, Richland, WA 99352. Our telephone number is (509) 736-4000. Our corporate
website address is http://www.radiogel.com. Our common stock is currently quoted on the OTC Pink Marketplace under the symbol
“RDGL.”
The
Company is a radiation oncology medical device company engaged in the development of its yttrium-90 based brachytherapy device,
RadioGel™, for the treatment of non-resectable tumors. A prominent team of radiochemists, scientists and engineers, collaborating
with strategic partners, including national laboratories, universities and private corporations, lead the Company’s development
efforts. The Company’s overall vision is to globally empower physicians, medical researchers and patients by providing them
with new isotope technologies that offer safe and effective treatments for cancer.
In
January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel TM should be classified
as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company
believes that the device classification obtained from the Food and Drug Administration (“ FDA ”) Center for Veterinary
Medicine is not limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers,
including all or most solid tumors in animals. We expect the result of such classification and label review will be that no additional
regulatory approvals are necessary for the use of IsoPet ® for the treatment of solid tumors in animals. The FDA
does not have premarket authority over devices with a veterinary classification, and the manufacturers are responsible for assuring
that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.
Based
on the FDA’s recommendation, RadioGel TM will be marketed as “IsoPet ® ” for use by veterinarians
to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet ® ”
name. IsoPet ® and RadioGel TM are used synonymously throughout this document. The only distinction between
IsoPet ® and RadioGel TM is the FDA’s recommendation that we use “IsoPet®” for veterinarian
usage, and reserve “RadioGel TM” for human therapy. Based on these developments, the Company has shifted
its primary focus to the development and marketing of Isopet® for animal therapy, through the Company’s IsoPet®
Solutions division.
IsoPet
Solutions
The
Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement
of university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of the
technology in private clinics. The Company has worked with three different university veterinarian hospitals on IsoPet® testing
and therapy. Washington State University treated five cats for feline sarcoma and served to develop the procedures which are incorporated
in our label. They concluded that the product was safe and effective in killing cancer cells. Colorado State University demonstrated
the CT and PET-CT imaging of IsoPet®. A contract was signed with University of Missouri to treat canine sarcomas and equine
sarcoids starting in November 2017.
F- 6
The
dogs were treated for canine soft tissue sarcoma. Response evaluation criteria in solid tumors (“ RECIST ”) is
a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress)
during treatment. The criteria were published by an international collaboration including the European Organisation for Research
and Treatment of Cancer (“EORTC”), National Cancer Institute of the United States, and the National Cancer
Institute of Canada Clinical Trials Group.
The
testing at the University of Missouri met its objective to demonstrate the safety of IsoPet®. Using its advanced CT and PET
equipment it was able to demonstrate that the dose calculations were accurate and that the injections perfused into the cell interstices
and did not stay concentrated in a bolus. This results in a more homogeneous dose distribution. There was insignificant spread
of Y-90 outside the points of injection demonstrating the effectiveness of the particles and the gel to localize the radiation
with no spreading to the blood or other organs nor to urine or fecal material. This confirms that IsoPet® is safe for same
day therapy.
The
effectiveness of IsoPet® for life extension was not the prime objective, but it resulted in valuable insights. Of the cases
one is still cancer-free but the others eventually recurred since there was not a strong focus on treating the margins. The University
of Missouri has agreed to become a regional center to administer IsoPet® therapy and will incorporate the improvements suggested
by the testing program.
The
Company anticipates that future profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet®)
and related services, and from licensing to private medical and veterinary clinics in the U.S. and internationally. The Company
intends to report the results from the IsoPet® Solutions division as a separate operating segment in accordance with GAAP.
Commencing
in July 2019, the Company recognized its first commercial sale of IsoPet®. A veterinarian from Alaska brought his cat with
a re-occurrent spindle cell sarcoma tumor on his face. The cat had previously received external beam therapy, but now the tumor
was growing rapidly. He was given a high dose of 400Gy with heavy therapy at the margins. This sale met the revenue recognition
requirements under ASC 606 as the performance obligation was satisfied. The Company completed sales for an additional four animals
that received the IsoPet® during 2019.
Our
plan is to incorporate the data assembled from our work with Isopet® in animal therapy to support the Company’s efforts
in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell
RadioGel™ as a Class II medical device. RadioGel™ is an injectable particle-gel for brachytherapy radiation treatment
of cancerous tumors in people and animals. RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature
and then gels when reaching body temperature after injection into a tumor. In the gel are small, less than two microns, yttrium-90
phosphate particles (“ Y-90 ”). Once injected, these inert particles are locked in place inside the tumor by
the gel, delivering a very high local radiation dose. The radiation is beta, consisting of high-speed electrons. These electrons
only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the surrounding tissue.
Optimally, patients can go home immediately following treatment without the risk of radiation exposure to family members. Since
Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its original value after ten days.
Recently,
the Company modified its Indication for Use from skin cancel to cancerous tissue or solid tumors pathologically associated with
locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic
lymph nodes or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require
post-surgical remnant ablation (for example, after prior incomplete radioiodine therapy). Papillary thyroid carcinoma belongs
to the general class of head and neck tumors for which tumors are accessible by intraoperative direct needle injection. The Company’s
Medical Advisory Board felt that demonstrating efficacy in clinical trials was much easier with this new indication.
The
Company’s lead brachytherapy products, including RadioGel™, incorporate patented technology developed for
Battelle Memorial Institute (“ Battelle ”) at Pacific Northwest National Laboratory, a leading research
institute for government and commercial customers. Battelle has granted the Company an exclusive license to patents covering
the manufacturing, processing and applications of RadioGel™ (the “ Battelle License ”). This exclusive
license is to terminate upon the expiration of the last patent included in this agreement (March 2022). Other intellectual
property protection includes proprietary production processes and trademark protection in 17 countries. The Company plans to
continue efforts to develop new refinements on the production process, and the product and application hardware, as a basis
for future patents.
The
Company received the Patent Cooperation Treaty (“PCT”) International Search Report on our patent application
(No.1811.191). Seven of our claims were immediately ruled as having novelty, inventive step and industrial applicability. This
gives us the basis to extend for many years the patent protection for our proprietary Yttrium-90 phosphate particles utilized
in Isopet® and Radiogel™. As part of the normal review process, we have also submitted the technical justification for
seven additional claims. We are in the process of filing patent claims in Canada, UK (Great Britain, Scotland, Wales and Ireland),
Japan, Germany, Italy, France, Australia, Brazil, China, India, North Countries (Sweden, Norway, Finland, and Denmark).
F- 7
Going
Concern
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and
satisfaction of liabilities in the normal course of business. As shown in the accompanying financial statements, the Company has
suffered recurring losses and used significant cash in support of its operating activities and the Company’s cash position
is not sufficient to support the Company’s operations. Research and development of the Company’s brachytherapy product
line has been funded with proceeds from the sale of equity and debt securities as well as a series of grants. The Company requires
funding of approximately $2 million annually to maintain current operating activities.
The
Company has completed its reverse stock split which was approved by FINRA and went effective on June 28, 2019.
The
Company’s stock offering under Regulation A+ was qualified by the Securities and Exchange Commission (“SEC”)
on June 3, 2020 and have issued the first tranche of shares under the Regulation A+ on June 10, 2020. The intent is to raise up
to $1,800,000 over the next 12-18 months, which may be completed in separate closings.
The
Company intends to use the proceeds generated from the sale of shares under Regulation A+ as follows:
For
the animal therapy market:
●
Fund
the effort to communicate the benefits of IsoPet ® to the veterinary community and the pet parents.
●
Conduct
additional clinical studies to generate more data for the veterinary community
●
Subsidize
some IsoPet ® therapies, if necessary, to ensure that all viable candidates are treated.
●
Assist
a new regional clinic with their license and certification training.
For
the human market:
●
Enhance
the pedigree of the Quality Management System.
●
Complete
the previously defined pre-clinical testing and additional testing on an animal model closely aligned with our revised indication
for use. Report the results to the FDA in a pre-submission meeting.
●
Use
the feedback from that meeting to write the IDE (Investigational Device Exemption), which is required to initiate clinical
trials.
F- 8
The
Company received $497,880 which were deposited into the Company’s accounts between April and June 2020. Following the clearance
of the Regulation A+ offering by the SEC on June 3, 2020, the common shares for these proceeds were issued. In addition, the Company
exchanged their outstanding convertible notes payable of $525,000, $27,536 in accrued interest and $98,508 in an exchange premium
stipulated in the note agreements into shares of common stock. In addition, the Company raised $1,138,800 in the Regulation A+
from November 30, 2020 through December 3, 2020 and issued 42,177,778 shares of common stock and sold 19,200,000 warrants for
$19,200 in these offerings.
Research
and development of the Company’s brachytherapy product line has been funded with proceeds from the sale of equity and debt
securities. The Company requires funding of approximately $2 million annually to maintain current operating activities. Over the
next 12 to 24 months, the Company believes it will cost approximately $9 million to: (1) fund the FDA approval process to conduct
human clinical trials, (2) conduct Phase I, pilot, clinical trials, (3) activate several regional clinics to administer IsoPet ®
across the county, (4) create an independent production center within the current production site to create a template for
future international manufacturing, and (5) initiate regulatory approval processes outside of the United States.
The
continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional resources
and personnel. The principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24
months will be the FDA’s classification of the Company’s brachytherapy products as Class II or Class III devices (or
otherwise) and any requirements for additional studies which may possibly include clinical studies. Thereafter, the principal
variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and
the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those
products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic
transactions such as licensing and partnership agreements or additional capital raises.
Following
receipt of required regulatory approvals and financing, in the U.S., the Company intends to outsource material aspects of manufacturing,
distribution, sales and marketing. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships
to facilitate its global commercialization strategy.
In
the longer-term, subject to the Company receiving adequate funding, regulatory approval for RadioGel™ and other brachytherapy
products, and thereafter being able to successfully commercialize its brachytherapy products, the Company intends to consider
resuming research efforts with respect to other products and technologies intended to help improve the diagnosis and treatment
of cancer and other illnesses.
Based
on the Company’s financial history since inception, the Company’s independent registered public accounting firm has
expressed substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue,
nominal cash, and has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company
will be required to delay the implementation of its business strategy and may not be able to continue operations.
The
Company has been impacted from the effects of COVID-19. The Company’s headquarters are in Northeast Washington however there
focus of the animal therapy market has been the Northwestern sector of the United States, the initial epicenter of the COVID-19
outbreak in the United States. In addition to a slow down in the marketing of the services, the volatility of the stock market
has contributed to a lack of funds that ordinarily may have been available to the Company. The Company is hopeful that by the
end of the third quarter of 2021, they will be allowed to continue their marketing to the animal therapy market and attempt
to increase the exposure to their product and generate revenue accordingly.
F- 9
As
of December 31, 2020, the Company has $903,704 cash on hand. There are currently commitments to vendors for products and services
purchased that will necessitate liquidation of the Company if it is unable to raise additional capital. The current level of cash
is not enough to cover the fixed and variable obligations of the Company.
Assuming
the Company is successful in the Company’s sales/development effort, it believes that it will be able to raise additional
funds through strategic agreements or the sale of the Company’s stock to either current or new stockholders. There is no
guarantee that the Company will be able to raise additional funds or to do so at an advantageous price.
The
financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might
be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern
is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain
profitability. The Company plans to seek additional funding to maintain its operations through debt and equity financing and to
improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements
to the cost structure. There is no assurance that the Company will be successful in its efforts to raise additional working capital
or achieve profitable operations. The financial statements do not include any adjustments that might result from the outcome of
this uncertainty.
NOTE
2: SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use
of Estimates
The
preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities
at the date of financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates the
Company considers include criteria for stock-based compensation expense, and valuation allowances on deferred tax assets. Actual
results could differ from those estimates.
Financial
Statement Reclassification
Certain
account balances from prior periods have been reclassified in these audited financial statements so as to conform to current period
classifications.
Cash
Equivalents
For
the purposes of the statement of cash flows, the Company considers all highly liquid debt instruments purchased with an original
maturity of three months or less to be cash equivalents.
The Company occasionally maintains cash
balances in excess of the FDIC insured limit. The Company does not consider this risk to be material.
F- 10
Fair
Value of Financial Instruments
Fair
value of financial instruments requires disclosure of the fair value information, whether or not recognized in the balance sheet,
where it is practicable to estimate that value. As of December 31, 2020 and 2019, the balances reported for cash, prepaid expenses,
accounts receivable, accounts payable, and accrued expenses, approximate the fair value because of their short maturities.
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. Accounting Standards Codification (“ ASC ”) Topic 820 established
a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority
to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority
to unobservable inputs (level 3 measurements). These tiers include:
Level
1, defined as observable inputs such as quoted prices for identical instruments in active markets;
Level
2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted
prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not
active; and
Level
3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions,
such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are
unobservable.
The
Company measures certain financial instruments including options and warrants issued during the period at fair value on a recurring
basis.
Derivative
Liabilities and Beneficial Conversion Feature
The
Company evaluates its convertible debt, options, warrants or other contracts, if any, to determine if those contracts or embedded
components of those contracts qualify as derivatives to be separately accounted for in accordance with ASC Topic 815, Accounting
for Derivative Instruments and Hedging Activities (“ ASC 815 ”) as well as related interpretations of this standard
and Accounting Standards Update 2017-11, which was adopted by the Company effective January 1, 2018. In accordance with this standard,
derivative instruments are recognized as either assets or liabilities in the balance sheet and are measured at fair values with
gains or losses recognized in earnings. Embedded derivatives that are not clearly and closely related to the host contract are
bifurcated and are recognized at fair value with changes in fair value recognized as either a gain or loss in earnings.
The
result of this accounting treatment is that the fair value of the derivative instrument is marked-to-market each balance sheet
date and with the change in fair value recognized in the statement of operations as other income or expense.
Upon
conversion, exercise or cancellation of a derivative instrument, the instrument is marked to fair value at the date of conversion,
exercise or cancellation than that the related fair value is removed from the books. Gains or losses on debt extinguishment are
recognized in the statement of operations upon conversion, exercise or cancellation of a derivative instrument after any shares
issued in such a transaction are recorded at market value.
The
classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is
re-assessed at the end of each reporting period. Equity instruments that are initially classified as equity that become subject
to reclassification are reclassified to liability at the fair value of the instrument on the reclassification date. Instruments
that become a derivative after inception are recognized as a derivative on the date they become a derivative with the offsetting
entry recorded in earnings.
The
Company determines the fair value of derivative instruments and hybrid instruments, considering all of the rights and
obligations of each instrument, based on available market data using a binomial model, adjusted for the effect of dilution,
because it embodies all of the requisite assumptions (including trading volatility, estimated terms, dilution and risk-free
rates) necessary to fair value these instruments. For instruments in default with no remaining time to maturity the Company
uses a one-year term for their years to maturity estimate unless a sooner conversion date can be estimated or is known.
Estimating fair values of derivative financial instruments requires the development of significant and subjective estimates
that may, and are likely to, change over the duration of the instrument with related changes in internal and external market
factors. In addition, option-based techniques (such as Black-Scholes model) are highly volatile and sensitive to changes in
the trading market price of our common stock.
F- 11
The
Company accounts for the beneficial conversion feature on its convertible instruments in accordance with ASC 470-20. The Beneficial
Conversion Feature (“BCF”) is normally characterized as the convertible portion or feature that provides a rate of
conversion that is below market value or in the money when issued. The Company records a BCF when these criteria exist, when issued.
BCFs that are contingent upon the occurrence of a future event are recorded when the contingency is resolved.
To
determine the effective conversion price, the Company first allocates the proceeds received to the convertible instrument, and
then use those allocated proceeds to determine the effective conversion price. The intrinsic value of the conversion option should
be measured using the effective conversion price for the convertible instrument on the proceeds allocated to that instrument.
The
accounting for a BCF requires that the BCF be recognized by allocating the intrinsic value of the conversion option to additional
paid in capital, resulting in a discount to the convertible instrument. This discount should be accreted from the date on which
the BCF is first recognized through the earliest conversion date for instruments that do not have a stated redemption date.
Fixed
Assets
Fixed
assets are carried at the lower of cost or net realizable value. Production equipment with a cost of $2,500 or greater and other
fixed assets with a cost of $1,500 or greater are capitalized. Major betterments that extend the useful lives of assets are also
capitalized. Normal maintenance and repairs are charged to expense as incurred. When assets are sold or otherwise disposed of,
the cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized in operations.
Depreciation
is computed using the straight-line method over the following estimated useful lives:
Production
equipment:
3
to 7 years
Office
equipment:
2
to 5 years
Furniture
and fixtures:
2
to 5 years
Leasehold
improvements and capital lease assets are amortized over the shorter of the life of the lease or the estimated life of the asset.
Management
of the Company reviews the net carrying value of all of its equipment on an asset by asset basis whenever events or changes in
circumstances indicate that its carrying amount may not be recoverable. These reviews consider the net realizable value of each
asset, as measured in accordance with the preceding paragraph, to determine whether impairment in value has occurred, and the
need for any asset impairment write-down.
License
Fees
License
fees are stated at cost, less accumulated amortization. Amortization of license fees is computed using the straight-line method
over the estimated economic useful life of the assets.
Effective
March 2012, the Company entered into an exclusive license agreement with Battelle Memorial Institute regarding the use of its
patented RadioGel™ technology. This license agreement originally called for a $17,500 nonrefundable license fee and a royalty
based on a percent of gross sales for licensed products sold; the license agreement also contains a minimum royalty amount to
be paid each year starting with 2013. The license agreement was most recently amended on December 20, 2018, and pursuant to the
amendment the maintenance fee schedule was updated for minimum royalties, as well as the increase in royalties from one percent
(1%) to two percent (2%), then on October 8, 2019 to reduce the fee back to one percent (1%).
F- 12
Future
minimum royalties for the years ended December 31 are noted below:
Minimum
Royalties per
Calendar Year
Calendar Year
2021
$ 10,000
2022
4,000
Total
$ 14,000
The
Company periodically reviews the carrying values of capitalized license fees and any impairments are recognized when the expected
future operating cash flows to be derived from such assets are less than their carrying value.
The
2021 fee was paid in December 2020.
Patents
and Intellectual Property
While
patents are being developed or pending, they are not being amortized. Management has determined that the economic life of the
patents to be ten years and amortization, over such 10-year period and on a straight-line basis will begin once the patents have
been issued and the Company begins utilization of the patents through production and sales, resulting in revenues.
The
Company evaluates the recoverability of intangible assets, including patents and intellectual property on a continual basis. Several
factors are used to evaluate intangibles, including, but not limited to, management’s plans for future operations, recent
operating results and projected and expected undiscounted future cash flows.
There
have been no such capitalized costs in the years ended December 31, 2020 and 2019, respectively. However, a patent
was filed on July 1, 2019 (No. 1811.191) filed by Michael Korenko and David Swanberg and assigned to the Company based on the
Company’s proprietary particle manufacturing process. The timing of this filing was important given the Company’s
plans to make IsoPet® commercially available, which it did on or about July 9, 2019. This additional patent protection will
strengthen the Company’s competitive position. It is the Company’s intention to further extend this patent protection
to several key countries within one year, as permitted under international patent laws and treaties.
Revenue
Recognition
In
May 2014, the Financial Accounting Standards Board (“F ASB ”) issued Accounting Standard Update (“ ASU ”)
No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue
recognition to be used across all industries and requires additional disclosures. The updated guidance introduces a five-step
model to achieve its core principal of the entity recognizing revenue to depict the transfer of goods or services to customers
at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.
The Company adopted the updated guidance effective January 1, 2018 using the full retrospective method.
Under
ASC 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to preform respective
obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for
the goods transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration
is probable. The adoption of ASC 606 did not have an impact on the Company’s operations or cash flows.
F- 13
The
Company recognized revenue as they (i) identified the contracts with ach customer; (ii) identified the performance obligation
in each contract; (iii) determined the transaction price in each contract; (iv) were able to allocate the transaction price to
the performance obligations in the contract; and (v) recognized revenue upon the satisfaction of the performance obligation. Upon
the sales of the product to complete the procedures on the animals, the Company recognized revenue as that was considered the
performance obligation.
All
revenue generated during the years ended December 31, 2020 and 2019 related to sales of product.
Loss
Per Share
The Company accounts for its loss per common
share by replacing primary and fully diluted earnings per share with basic and diluted earnings per share. Basic loss per share
is computed by dividing loss available to common stockholders (the numerator) by the weighted-average number of common shares
outstanding (the denominator) for the period, and does not include the impact of any potentially dilutive common stock equivalents
since the impact would be anti-dilutive. The computation of diluted earnings per share is similar to basic earnings per share,
except that the denominator is increased to include the number of additional common shares that would have been outstanding if
potentially dilutive common shares had been issued. For the given periods of loss, of the periods ended in the years ended
December 31, 2020 and 2019, the basic earnings per share equals the diluted earnings per share.
The
following represent common stock equivalents that could be dilutive in the future as of December 31, 2020 and 2019, which include
the following:
December 31, 2020
December 31, 2019
Convertible debt
1,252,456
10,914,782
Preferred stock
12,998,195
27,372,515
Common stock options
28,885,461
34,524,580
Common stock warrants
32,064,375
31,286,847
Total potential dilutive securities
75,190,487
104,098,724
Research
and Development Costs
Research
and developments costs, including salaries, research materials, administrative expenses and contractor fees, are charged to operations
as incurred. The cost of equipment used in research and development activities which has alternative uses is capitalized as part
of fixed assets and not treated as an expense in the period acquired. Depreciation of capitalized equipment used to perform research
and development is classified as research and development expense in the year computed.
The
Company incurred $84,668 and $67,584 research and development costs for the years ended December 31, 2020 and 2019, respectively,
all of which were recorded in the Company’s operating expenses noted on the statements of operations for the years then
ended.
Advertising
and Marketing Costs
Advertising
and marketing costs are expensed as incurred except for the cost of tradeshows which are deferred until the tradeshow occurs.
During the years ended December 31, 2020 and 2019, the Company incurred $6,182 and $0 in advertising and marketing costs which
are included in general and administrative expenses.
F- 14
Contingencies
In
the ordinary course of business, the Company is involved in legal proceedings involving contractual and employment relationships,
product liability claims, patent rights, and a variety of other matters. The Company records contingent liabilities resulting
from asserted and unasserted claims against it, when it is probable that a liability has been incurred and the amount of the loss
is reasonably estimable. The Company discloses contingent liabilities when there is a reasonable possibility that the ultimate
loss will exceed the recorded liability. Estimated probable losses require analysis of multiple factors, in some cases including
judgments about the potential actions of third-party claimants and courts. Therefore, actual losses in any future period are inherently
uncertain. The Company has entered into various agreements that require them to pay certain fees to consultants and/or employees
that have been fully accrued for as of December 31, 2020 and 2019.
Income
Taxes
To
address accounting for uncertainty in tax positions, the Company clarifies the accounting for income taxes by prescribing a minimum
recognition threshold that a tax position is required to meet before being recognized in the financial statements. The Company
also provides guidance on de-recognition, measurement, classification, interest, and penalties, accounting in interim periods,
disclosure and transition.
The
Company files income tax returns in the U.S. federal jurisdiction. The Company did not have any tax expense for the years ended
December 31, 2020 and 2019. The Company did not have any deferred tax liability or asset on its balance sheet on December 31,
2020 and 2019.
Interest
costs and penalties related to income taxes, if any, will be classified as interest expense and general and administrative costs,
respectively, in the Company’s financial statements. For the years ended December 31, 2020 and 2019, the Company did not
recognize any interest or penalty expense related to income taxes. The Company believes that it is not reasonably possible for
the amounts of unrecognized tax benefits to significantly increase or decrease within the next twelve months.
Stock-Based
Compensation
The
Company recognizes compensation costs under FASB ASC Topic 718, Compensation – Stock Compensation and ASU 2018-07. Companies
are required to measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and
recognize the costs in the financial statements over the period during which employees are required to provide services. Share
based compensation arrangements include stock options, restricted share plans, performance-based awards, share appreciation rights
and employee share purchase plans. As such, compensation cost is measured on the date of grant at their fair value. Such compensation
amounts, if any, are amortized over the respective vesting periods of the option grant.
F- 15
In
May 2017, the FASB issued ASU 2017-09, “Compensation - Stock Compensation.” The update provides guidance about which
changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in ASC Topic
718. An entity shall account for the effects of a modification described in ASC paragraphs 718-20-35-3 through 35-9, unless all
the following are met: (1) The fair value of the modified award is the same as the fair value of the original award immediately
before the original award is modified; (2) The vesting conditions of the modified award are the same as the vesting conditions
of the original award immediately before the original award is modified; and (3) The classification of the modified award as an
equity instrument or a liability instrument is the same as the classification of the original award immediately before the original
award is modified. The provisions of this update become effective for annual periods and interim periods within those annual periods
beginning after December 15, 2017. The Company’s adoption of this guidance on January 1, 2018 did not have a material impact
on the Company’s results of operations, financial position and related disclosures.
In
June 2018, the FASB issued ASU No. 2018-07 “Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based
Payment Accounting.” These amendments expand the scope of Topic 718, Compensation - Stock Compensation (which currently
only includes share-based payments to employees) to include share-based payments issued to nonemployees for goods or services.
Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned. The ASU supersedes
Subtopic 505-50, Equity - Equity-Based Payments to Non-Employees. The guidance is effective for public companies for fiscal years,
and interim fiscal periods within those fiscal years, beginning after December 15, 2018. Early adoption is permitted, but no earlier
than a company’s adoption date of Topic 606, Revenue from Contracts with Customers. The adoption of this standard did not
have a material impact on its financial statements. The Company has determined that no amounts had to be revalued upon adoption
of this amendment.
Recent
Accounting Pronouncements
In
August, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own
Equity (Subtopic 815-40), Accounting for Convertible Instruments and Contract’s in an Entity’s Own Equity. The ASU
simplifies accounting for convertible instruments by removing major separation models required under current GAAP. Consequently,
more convertible debt instruments will be reported as a single liability instrument with no separate accounting for embedded conversion
features. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope
exception, which will permit more equity contracts to qualify for it. The ASU simplifies the diluted net income per share calculation
in certain areas. The ASU is effective for annual and interim periods beginning after December 31, 2021, and early adoption is
permitted for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. The Company is currently
evaluating the impact that this new guidance will have on its financial statements.
The
Company does not discuss recent pronouncements that are not anticipated to have an impact on or are unrelated to its financial
condition, results of operations, cash flows or disclosures.
NOTE
3: FIXED ASSETS
Fixed
assets consist of the following at December 31, 2020 and 2019:
December 31, 2020
December 31, 2019
Production equipment
$ -
$ -
Less accumulated depreciation
-
-
$ -
$ -
There
is no depreciation expense for the years ended December 31, 2020 and 2019.
In
June 2019, the Company sold the one piece of equipment still held for $0. The basis of this piece of equipment was also $0, resulting
in no gain or loss on the sale.
F- 16
NOTE
4: RELATED PARTY TRANSACTIONS
Related
Party Convertible Notes Payable
As
of December 31, 2020 and 2019, the Company had the following related party convertible notes outstanding:
2020
2019
September 2019 $15,000 Note, 8% interest, due January 2020
$ -
$ 15,000
-
-
Total Convertible Notes Payable, Net
$ -
$ 15,000
Less: Debt Discount
-
(500 )
$ -
$ 14,500
The
Company from time to time receives non-interest bearing advancers from its Chief Executive Officer that are due on demand. During
the year ended December 31, 2019, the Company received $20,000 in advances and repaid $5,000 of these and had $15,000 outstanding
at September 24, 2019. On September 24, 2019, these advances were converted into a convertible note at 8% interest which matures
January 15, 2020. Interest on this note for the period ended December 31, 2019 amounted to $321, and this amount is accrued at
December 31, 2019. The Chief Executive Officer received 150,000 warrants when the advances were converted into this convertible
note payable. The Company recognized a discount on the convertible note of $3,721 as a result of the warrants which are being
amortized over the life of the note through January 15, 2020. The Company is in default of this note. As a result of the default,
the interest rate charged was changed to 12.5% through conversion of this note in April 2020.
Interest
expense for the years ended December 31, 2020 and 2019 on the related party convertible notes payable amounted to $298 and $321,
respectively.
Related
Party Notes Payable
As
of December 31, 2020 and 2019, the Company had the following related party notes outstanding:
2020
2019
January 2019 $60,000 Note, 8% interest, due January 2020
$ 60,000
$ 60,000
March 2019 $48,000 Note, 8% interest, due March 2020
48,000
48,000
April 2019 $29,000 Note, 8% interest, due April 2020
29,000
29,000
July 2019 $50,000 Note 8% interest, due July 2020
50,000
50,000
November 2019 $50,000 Note 8% interest, due November 2020
50,000
50,000
Total Related Party Notes Payable, Net
$ 237,000
$ 237,000
On
January 24, 2019 the Company entered into a note payable with a trust related to one of the Company’s directors in the amount
of $60,000. The note is for a one-year period which was to mature January 24, 2020 and bears interest at an annual rate of 8.00%.
The Company is in default of this note.
On
March 27, 2019 the Company entered into a note payable with a trust related to one of our directors in the amount of $48,000.
The note is for a one-year period maturing March 27, 2020 and bears interest at an annual rate of 8%. The Company is in default
of this note. On April 29, 2019 the Company entered into a note payable with a trust related to one of our directors in the amount
of $29,000. The Company is in default of this note. On July 5, 2019 the Company entered into a note payable with a trust related
to one of our directors in the amount of $50,000. The note is for a one-year period maturing July 5, 2020 and bears interest at
an annual rate of 8%. The Company is in default of this note. On November 25, 2019 the Company entered into a note payable with
a trust related to one of our directors in the amount of $50,000. The note is for a one-year period maturing November 25, 2020
and bears interest at an annual rate of 8%. The Company is in default of this note. Interest expense for these notes for the years
ended December 31, 2020 and 2019 was $18,960 and $11,307, respectively and accrued interest at December 31, 2020 is $30,267.
The
Company borrowed $107,000 in the year ended December 31, 2020 from its CEO and repaid these amounts in full.
F- 17
Related
Party Payables
The
Company periodically receives advances for operating funds from related parties or has related parties make payments on the Company’s
behalf. As a result of these activities the Company had related party payables of $32,110 and $32,110 as of December 31, 2020
and 2019, respectively.
Preferred
and Common Shares Issued to Officers and Directors
The
Company’s Chairman converted the Series B Convertible Preferred Shares into Series C Convertible Preferred Shares and as
of April 2020, the 385,302 shares that are issued in the Series C Convertible Preferred Stock are all to the Chairman.
In
April 2020, effective March 31, 2020, the Company converted the $15,000 convertible note payable along with $619 in accrued interest
and an exchange premium of $3,124 into 694,178 shares of common stock. This was part of the Regulation A+. These shares were issued
on June 10, 2020 following the qualification of the Regulation A+.
The
Company’s Chief Executive Officer exercised 2,500,000 stock options for $60,000 in December 2020.
NOTE
5: CONVERTIBLE NOTES PAYABLE
As
of December 31, 2020 and 2019, the Company had the following convertible notes outstanding:
2020
2019
July and August 2012 $1,060,000 Notes convertible into common stock at $4.60 per share, 12% interest, due December 2013 and January 2014
$ 45,000
$ 45,000
May 2019 $60,000 Note convertible into common shares at $0.04 per share, 8% interest, due October 30, 2019
-
60,000
July 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
50,000
September 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
50,000
September 2019 $38,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
38,000
September 2019 $25,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
25,000
September 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
50,000
September 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
50,000
September 2019 $37,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
37,000
December 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due March 31, 2020
-
50,000
November 2020 $50,000 Note convertible into common shares at $0.04, 6% interest, due May 30, 2021
50,000
-
Penalties on notes in default
12,418
10,618
Total Convertible Notes Payable, Net
$ 107,418
$ 465,618
Less: BCF Discount
-
(6,187 )
Less: Debt Discount
-
(24,545 )
$ 107,418
$ 434,886
F- 18
Interest
expense for the years ended December 31, 2020 and 2019 on the convertible notes payable amounted to $21,394 and $16,563, respectively.
The
Company entered into a $50,000 convertible promissory note dated May 31, 2019, that was to mature October 30, 2019. The convertible
promissory note bears interest at a rate of 8%, The convertible promissory note is convertible into shares of common stock at
a price of $0.032 per share. Upon the closing of an equity financing pursuant to an effective registration statement with gross
proceeds to the Company totaling at least $250,000 exclusive of any exchanges (“Qualified Financing”), the outstanding
principal amount of this convertible promissory note together with all accrued and unpaid interest shall be exchanged into such
securities as are issued in the Qualified Financing at a rate of 1.20. Upon an exchange, the Payee shall be granted all rights
afforded to an investor in the Qualified Financing. The $10,000 contingent exchange amount is classified as original issue discount
and will be amortized over the life of the convertible promissory note. The convertible promissory noteholder received 625,000
warrants at an exercise price of $0.04 per share, that have a term of two years. The warrants were valued at $12,592 and represent
a debt discount, which were amortized over the life of the convertible promissory note.
The
Company entered into $300,000 in convertible promissory notes in July and September 2019, that were to mature January 15, 2020.
The convertible promissory notes bear interest at a rate of 8%, The convertible promissory notes are convertible into shares of
common stock at a price of $0.04 per share. Upon the closing of an equity financing pursuant to an effective registration statement
with gross proceeds to the Company totaling at least $250,000 exclusive of any exchanges (“Qualified Financing”),
the outstanding principal amount of this convertible promissory notes together with all accrued and unpaid interest shall be exchanged
into such securities as are issued in the Qualified Financing at a rate of 1.20. Upon an exchange, the Payee shall be granted
all rights afforded to an investor in the Qualified Financing. The convertible promissory noteholders received 3,000,000 warrants
at an exercise price ranging between $0.06 and $0.08 per share (amended to $0.045 per share), that have a term of two years. The
warrants were valued at $91,716 and represent a debt discount, which will be amortized over the life of the convertible promissory
notes. In addition, the Company recognized a beneficial conversion feature discount to the notes of $59,957 that is being amortized
over the life of the notes.
Prior
to the conversion of these notes, the Company was in default of these notes. As a result of the default, the interest rate charged
was changed to 12.5% up through the conversion of these notes.
The
Company entered into $50,000 in a convertible promissory note on December 31, 2019, that matures March 31, 2020. The convertible
promissory notes bear interest at a rate of 8%, The convertible promissory note is convertible into shares of common stock at
a price of $0.04 per share. Upon the closing of an equity financing pursuant to an effective registration statement with gross
proceeds to the Company totaling at least $250,000 exclusive of any exchanges (“Qualified Financing”), the outstanding
principal amount of this convertible promissory notes together with all accrued and unpaid interest shall be exchanged into such
securities as are issued in the Qualified Financing at a rate of 1.20. Upon an exchange, the Payee shall be granted all rights
afforded to an investor in the Qualified Financing. The convertible promissory noteholders received 625,000 warrants at an exercise
price of $0.06 per share (amended to $0.045 per share), that have a term of two years. The warrants were valued at $14,299 and
represent a debt discount, which will be amortized over the life of the convertible promissory note. This note was converted effective
March 31, 2020. These shares were issued on June 10, 2020 following the qualification of the Regulation A+.
The
Company issued a convertible note in January 2020 in the amount of $100,000 to an accredited investor. The note bears interest
at 8% per annum and was to mature March 31, 2020. The Company granted 1,250,000 warrants with an exercise price of $0.06 per share
and a term of two years with this note and amended 1,312,500 previously issued warrants held by the investor to provide for a
$.06 exercise price and an expiration date of March 31, 2022, the note was converted in June 2020.
F- 19
The
Company entered into a $50,000 convertible promissory note on November 30, 2020, that matures May 30, 2021. The convertible promissory
notes bear interest at a rate of 6%, The convertible promissory note is convertible into shares of common stock at a price of
$0.04 per share. Upon the closing of an equity financing pursuant to an effective registration statement with gross proceeds to
the Company totaling at least $350,000 exclusive of any exchanges (“Qualified Financing”), the outstanding principal
amount of this convertible promissory notes together with all accrued and unpaid interest shall be exchanged into such securities
as are issued in the Qualified Financing at a rate of 1.20. Upon an exchange, the Payee shall be granted all rights afforded to
an investor in the Qualified Financing. The Company along with the noteholder agreed to exchange 1,867,500 warrants into
933,750 common shares. These shares were issued in December 2020.
NOTE
6: PROMISSORY NOTES PAYABLE
As
of December 31, 2020 and 2019, the Company had the following promissory notes outstanding:
2020
2019
February 2019, two promissory notes for $50,000 each (total of $100,000), maturing August 2019, extended to February 2020, at 8.00% interest (originally) and now 15% interest and extended to August 20, 2020
$ -
$ 100,000
Debt discount
(- )
-
Total Promissory Notes Payable, Net
$ -
$ 100,000
The
Company issued two separate promissory notes on February 20, 2019 at $50,000 each (total of $100,000) that were to mature on August
20, 2019 and accrued interest at 8.00% per annum. In connection with the promissory notes, the Company issued warrants to purchase
1,250,000 shares of common stock. The Company recorded the relative fair value of the warrants as a debt discount of $28,721 and
amortized the discount over the life of the note (6 months). Amortization of debt discount for the year ended December 31, 2019
was $28,721 and is recorded as interest expense on the statement of operations for the year ended December 31, 2019.
On
August 20, 2019, the two noteholders agreed to extend these notes another six-months to February 20, 2020, then amended again
for six-months and the notes were to mature August 20, 2020. In consideration for the extension, the note holders received 750,000
warrants (375,000 each) and the interest rate on the notes increased from 8% to 15% per annum. The interest expense on these notes
for the years ended December 31, 2020 and 2019 amounted to $8,032 and $9,410.
The
Company repaid $50,000 of these notes plus $13,442 in accrued interest in July 2020, and settled the remaining $50,000 into 1,851,852
shares of common stock effective July 14, 2020.
F- 20
NOTE
7: INCOME TAXES
Deferred
taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences and operating
loss and tax credit carry-forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences
are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced
by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred
tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates
on the date of enactment.
Net
deferred tax assets consist of the following components as of December 31, 2020 and 2019:
December 31, 2020
December 31, 2019
Deferred tax assets:
Net operating loss carryover
$ 6,080,000
$ 5,890,000
Interest expense
-
15,000
Related party accrual
6,400
23,400
Capital Loss Carryover
3,400
3,400
Deferred tax liabilities
Depreciation
(- )
(2,100 )
Valuation allowance
(6,089,800 )
(5,929,700 )
Net deferred tax asset
$ -
$ -
The
income tax provision differs from the amount of income tax determined by applying the U.S. Federal income tax rate to pretax income
from continuing operations for the years ended December 31, 2020 and 2019 due to the following:
December 31, 2020
December 31, 2019
Book income (loss)
$ (201,000 )
$ (338,100 )
Forgiveness of debt
(600 )
(7,200 )
Depreciation
(1,100 )
(1,100 )
Interest expense
-
15,000
Related party accrual
4,000
21,100
Stock for services
-
2,600
Options expense
500
134,000
Non-cash interest expense
5,900
39,900
Valuation allowance
192,300
133,800
Income tax expense
$ -
$ -
F- 21
At
December 31, 2020, the Company had net operating loss carryforwards of approximately $28,960,300.
Topic
740 provides guidance on the accounting for uncertainty in income taxes recognized in a company’s financial statements.
Topic 740 requires a company to determine whether it is more likely than not that a tax position will be sustained upon examination
based upon the technical merits of the position. If the more-likely-than-not threshold is met, a company must measure the tax
position to determine the amount to recognize in the financial statements. At the adoption date of January 1, 2007, the Company
had no unrecognized tax benefit, which would affect the effective tax rate if recognized.
The
Company includes interest and penalties arising from the underpayment of income taxes in the statements of operations in the provision
for income taxes. As of December 31, 2020, the Company had no accrued interest or penalties related to uncertain tax positions.
The
Company files income tax returns in the U.S. federal jurisdiction. The Company is located in the state of Washington and Washington
state does not require the filing of income taxes. With few exceptions, the Company is no longer subject to U.S. federal, state
and local, or non-U.S. income tax examinations by tax authorities for years before 2017.
NOTE
8: STOCKHOLDERS’ DEFICIT
Common
Stock
The
Company has 950,000,000 shares of common stock authorized, with a par value of $0.001, and as of December 31, 2020 and December
31, 2019, the Company has 292,278,591 and 184,845,821 shares issued and outstanding, respectively.
On
March 28, 2019, the Company’s board of directors approved a reverse 1-for-8 stock split, and a decrease in the authorized
shares from 2,000,000,000 to 950,000,000. The reverse stock split went effective by FINRA on June 28, 2019.
Preferred
Stock
As
of December 31, 2020 and 2019, the Company has 20,000,000 shares of Preferred stock authorized with a par value of $0.001. The
Company’s Board of Directors is authorized to provide for the issuance of shares of preferred stock in one or more series,
fix or alter the designations, preferences, rights, qualifications, limitations or restrictions of the shares of each series,
including the dividend rights, dividend rates, conversion rights, voting rights, term of redemption including sinking fund provisions,
redemption price or prices, liquidation preferences and the number of shares constituting any series or designations of such series
without further vote or action by the shareholders. The issuance of preferred stock may have the effect of delaying, deferring
or preventing a change in control of management without further action by the shareholders and may adversely affect the voting
and other rights of the holders of common stock. The issuance of preferred stock with voting and conversion rights may adversely
affect the voting power of the holders of common stock, including the loss of voting control to others.
On
October 8, 2018 the Company created out of the shares of Preferred Stock, par value $0.001 per share, of the Company, as authorized
in Article IV of the Company’s Certificate of Incorporation, a series of Preferred Stock of the Company, to be named “Series
B Convertible Preferred Stock,” consisting of Five Million (5,000,000) shares.
On
March 27, 2019 the Company created out of the shares of Preferred Stock, par value $0.001 per share, of the Company, as authorized
in Article IV of the Company’s Certificate of Incorporation, a series of Preferred Stock of the Company, to be named “Series
C Convertible Preferred Stock,” consisting of Five Million (5,000,000) shares.
F- 22
Series
A Convertible Preferred Stock (“Series A Convertible Preferred”)
In
June 2015, the Series A Certificate of Designation was filed with the Delaware Secretary of State to designate 2.5 million shares
of our preferred stock as Series A Convertible Preferred. Effective March 31, 2016, the Company amended the Certificate of Designations,
Preferences and Rights of Series A Convertible Preferred of the Registrant, increasing the maximum number of shares of Series
A Convertible Preferred from 2,500,000 shares to 5,000,000 shares. The following summarizes the current rights and preferences
of the Series A Convertible Preferred:
Liquidation
Preference . The Series A Convertible Preferred has a liquidation preference of $5.00 per share.
Dividends .
Shares of Series A Convertible Preferred do not have any separate dividend rights.
Conversion .
Subject to certain limitations set forth in the Series A Certificate of Designation, each share of Series A Convertible Preferred
is convertible, at the option of the holder, into that number of shares of common stock (the “ Series A Conversion Shares ”)
equal to the liquidation preference thereof, divided by Conversion Price (as such term is defined in the Series A Certificate
of Designation), currently $4.00.
In
the event the Company completes an equity or equity-based public offering, registered with the SEC, resulting in gross proceeds
to the Company totaling at least $5.0 million, all issued and outstanding shares of Series A Convertible Preferred at that time
will automatically convert into Series A Conversion Shares.
Redemption .
Subject to certain conditions set forth in the Series A Certificate of Designation, in the event of a Change of Control (defined
in the Series A Certificate of Designation as the time at which as a third party not affiliated with the Company or any holders
of the Series A Convertible Preferred shall have acquired, in one or a series of related transactions, equity securities of the
Company representing more than fifty percent 50% of the outstanding voting securities of the Company), the Company, at its option,
will have the right to redeem all or a portion of the outstanding Series A Convertible Preferred in cash at a price per share
of Series A Convertible Preferred equal to 100% of the Liquidation Preference.
Voting
Rights . Holders of Series A Convertible Preferred are entitled to vote on all matters, together with the holders of common
stock, and have the equivalent of five (5) votes for every Series A Conversion Share issuable upon conversion of such holder’s
outstanding shares of Series A Convertible Preferred. However, the Series A Conversion Shares, when issued, will have all the
same voting rights as other issued and outstanding common stock of the Company, and none of the rights of the Series A Convertible
Preferred.
Liquidation .
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “ Liquidation ”),
the holders of Series A Convertible Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the
Company an amount equal to the liquidation preference of the Series A Convertible Preferred before any distribution or payment
shall be made to the holders of any junior securities, and if the assets of the Company is insufficient to pay in full such amounts,
then the entire assets to be distributed to the holders of the Series A Convertible Preferred shall be ratably distributed among
the holders in accordance with the respective amounts that would be payable on such shares if all amounts payable thereon were
paid in full.
Certain
Price and Share Adjustments .
a)
Stock Dividends and Stock Splits . If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions
payable in shares of common stock on shares of common stock or any other common stock equivalents; (ii) subdivides outstanding
shares of common stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding
shares of common stock into a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the common
stock, any shares of capital stock of the Company, then the conversion price shall be adjusted accordingly.
b) Merger
or Reorganization . If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or
merger in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of
Series A Preferred shall be convertible into the kind and amount of securities, cash or other property that a holder of the
number of shares of common stock issuable upon conversion of one share of Series A Convertible Preferred prior to any such
merger or reorganization would have been entitled to receive pursuant to such transaction.
F- 23
Series
B Convertible Preferred Stock (“Series B Convertible Preferred”)
In
October 2018, the Series B Certificate of Designation was filed with the Delaware Secretary of State to designate 5.0 million
shares of our preferred stock as Series B Convertible Preferred. The following summarizes the current rights and preferences of
the Series B Convertible Preferred:
Liquidation
Preference . The Series B Convertible Preferred has a liquidation preference of $1.00 per share.
Dividends .
Shares of Series B Convertible Preferred do not have any separate dividend rights.
Conversion .
Subject to certain limitations set forth in the Series B Certificate of Designation, each share of Series B Convertible Preferred
is convertible, at the option of the holder, into that number of shares of common stock (the “ Series B Conversion Shares ”)
equal to the liquidation preference thereof, divided by Conversion Price (as such term is defined in the Series B Certificate
of Designation), currently $0.08.
Redemption .
Subject to certain conditions set forth in the Series B Certificate of Designation, in the event of a Change of Control (defined
in the Series B Certificate of Designation as the time at which as a third party not affiliated with the Company or any holders
of the Series B Convertible Preferred shall have acquired, in one or a series of related transactions, equity securities of the
Company representing more than fifty percent 50% of the outstanding voting securities of the Company), the Company, at its option,
will have the right to redeem all or a portion of the outstanding Series B Convertible Preferred in cash at a price per share
of Series B Convertible Preferred equal to 100% of the Liquidation Preference.
Voting
Rights . Holders of Series B Convertible Preferred are entitled to vote on all matters, together with the holders of common
stock, and have the equivalent of two (2) votes for every Series B Conversion Share issuable upon conversion of such holder’s
outstanding shares of Series B Convertible Preferred. However, the Series B Conversion Shares, when issued, will have all the
same voting rights as other issued and outstanding common stock of the Company, and none of the rights of the Series A Convertible
Preferred.
Liquidation .
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “ Liquidation ”),
the holders of Series B Convertible Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the
Company an amount equal to the liquidation preference of the Series B Convertible Preferred before any distribution or payment
shall be made to the holders of any junior securities, and if the assets of the Company is insufficient to pay in full such amounts,
then the entire assets to be distributed to the holders of the Series B Convertible Preferred shall be ratably distributed among
the holders in accordance with the respective amounts that would be payable on such shares if all amounts payable thereon were
paid in full.
Certain
Price and Share Adjustments .
a)
Stock Dividends and Stock Splits . If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions
payable in shares of common stock on shares of common stock or any other common stock equivalents; (ii) subdivides outstanding
shares of common stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding
shares of common stock into a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the common
stock, any shares of capital stock of the Company, then the conversion price shall be adjusted accordingly.
b)
Merger or Reorganization . If the Company is involved in any reorganization, recapitalization, reclassification, consolidation
or merger in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series
B Convertible Preferred shall be convertible into the kind and amount of securities, cash or other property that a holder of the
number of shares of common stock issuable upon conversion of one share of Series B Convertible Preferred prior to any such merger
or reorganization would have been entitled to receive pursuant to such transaction.
F- 24
Series
C Convertible Preferred Stock (“Series C Convertible Preferred”)
In
March 2019, the Series C Certificate of Designation was filed with the Delaware Secretary of State to designate 5.0 million shares
of our preferred stock as Series C Convertible Preferred. The following summarizes the current rights and preferences of the Series
C Convertible Preferred:
Liquidation
Preference . The Series C Convertible Preferred has a liquidation preference of $1.00 per share.
Dividends .
Shares of Series C Convertible Preferred do not have any separate dividend rights.
Conversion .
Subject to certain limitations set forth in the Series C Certificate of Designation, each share of Series C Convertible Preferred
is convertible, at the option of the holder, into that number of shares of common stock (the “ Series C Conversion Shares ”)
equal to the liquidation preference thereof, divided by Conversion Price (as such term is defined in the Series C Certificate
of Designation), currently $0.08.
The
Series C Convertible Preferred will only be convertible at any time after the date that the Company shall have amended its Certificate
of Incorporation to increase the number of shares of common stock authorized for issuance thereunder or effect a reverse stock
split of the outstanding shares of common stock by a sufficient amount to permit the conversion of all Series C Convertible Preferred
into shares of common stock (“ Authorized Share Approval ”) (such date, the “ Initial Convertibility
Date ”), each share of Series C Convertible Preferred shall be convertible into validly issued, fully paid and non-assessable
shares of Common Stock on the terms and conditions set forth in the Series C Certificate of Designation under the definition “ Conversion
Rights ”.
Redemption .
Subject to certain conditions set forth in the Series C Certificate of Designation, in the event of a Change of Control (defined
in the Series C Certificate of Designation as the time at which as a third party not affiliated with the Company or any holders
of the Series C Convertible Preferred shall have acquired, in one or a series of related transactions, equity securities of the
Company representing more than fifty percent 50% of the outstanding voting securities of the Company), the Company, at its option,
will have the right to redeem all or a portion of the outstanding Series B Convertible Preferred in cash at a price per share
of Series C Convertible Preferred equal to 100% of the Liquidation Preference.
Voting
Rights . Holders of Series C Convertible Preferred are entitled to vote on all matters, together with the holders of common
stock, and have the equivalent of thirty-two (32) votes for every Series C Conversion Share issuable upon conversion of such holder’s
outstanding shares of Series C Convertible Preferred. However, the Series C Conversion Shares, when issued, will have all the
same voting rights as other issued and outstanding common stock of the Company, and none of the rights of the Series C Convertible
Preferred.
Liquidation .
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “ Liquidation ”),
the holders of Series C Convertible Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the
Company an amount equal to the liquidation preference of the Series C Convertible Preferred before any distribution or payment
shall be made to the holders of any junior securities, and if the assets of the Company is insufficient to pay in full such amounts,
then the entire assets to be distributed to the holders of the Series C Convertible Preferred shall be ratably distributed among
the holders in accordance with the respective amounts that would be payable on such shares if all amounts payable thereon were
paid in full.
Certain
Price and Share Adjustments .
a)
Stock Dividends and Stock Splits . If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions
payable in shares of common stock on shares of common stock or any other common stock equivalents; (ii) subdivides outstanding
shares of common stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding
shares of common stock into a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the common
stock, any shares of capital stock of the Company, then the conversion price shall be adjusted accordingly.
F- 25
b)
Merger or Reorganization . If the Company is involved in any reorganization, recapitalization, reclassification, consolidation
or merger in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series
C Convertible Preferred shall be convertible into the kind and amount of securities, cash or other property that a holder of the
number of shares of common stock issuable upon conversion of one share of Series C Convertible Preferred prior to any such merger
or reorganization would have been entitled to receive pursuant to such transaction.
Common
and Preferred Stock Issuances - 2020
The
Company in January 2020 paid $50,000 to redeem 100,000 shares of Series B Convertible Preferred Stock. The redemption price was
agreed to by the investor.
In
January 2020, the Company converted 435,990 shares of Series C Convertible Preferred stock into 5,449,875 shares of common stock.
In
March through June 2020, the Company entered into agreements to issue 18,440,000 shares of common stock conditioned upon the qualification
of the offer and sale of such shares under Regulation A+ for $497,880. Additionally, the Company agreed to issue 9,220,000 warrants
with a term of two years and an exercise price of $.045 for a purchase price of $8,143. These shares were issued in June 2020
and July 2020 following the qualification of the Regulation A+.
In
March through June 2020, certain holders of convertible promissory notes entered into agreements to exchange certain notes totaling
$651,044, including $525,000 in principal amount, $27,536 in accrued interest and an exchange premium as provided for in the note
agreements of $98,508 into 21,770,668 shares of common stock effective upon the qualification of the offer and sale of such shares
under Regulation A+. In connection with the holder’s agreement to enter into the exchange, the Company issued 2,200,000
warrants with a two-year term and an exercise price of $0.045 per share and amend 4,400,000 previously issued warrants to provide
for a $.045 exercise price and an expiration date of March 31, 2022. These shares were issued on June 10, 2020 following the qualification
of the Regulation A+.
During
the three months ended September 30, 2020, the Company issued 1,851,852 shares of common stock to settle $50,000 in promissory
notes.
Between
November 30 and December 2, 2020, the Company issued 42,177,778 shares of common stock along with 19,200,000 warrants under the
Regulation A+ for cash proceeds of $1,138,800 for the common stock and the warrants were purchased for $19,200.
On
November 30, 2020, the Company issued 933,750 shares of common stock in exchange for 1,867,500 warrants in accordance with a convertible
promissory note.
On
December 2, 2020, holders of Series A Preferred stock redeemed 381,635 shares of Series A Preferred stock for $13,650. The Company
canceled these certificates simultaneous to the redemption.
On
December 3, 2020, a Series B Preferred holder converted 276,592 Series B shares into 3,457,400 common shares, and on December
29, 2020 this Series B Preferred holder converted 300,000 Series B shares into 3,750,000 common shares.
On
December 10, 2020, the Chief Executive Officer exercised 2,500,000 stock options into common shares valued at $60,000.
Between
December 14, 2020 and December 28, 2020, the Company issued 4,759,435 shares of common stock in the cashless exercise of 6,860,000
warrants.
Common
and Preferred Stock Issuances - 2019
In
January 2019, the Company received $100,000 in gross proceeds resulting from the issuance to accredited investors of 1,250,000
shares of common stock, 100,000 shares of Series B Convertible Preferred and warrants to purchase 1,250,000 shares of common stock.
The
Company issued 18,390,225 shares of common stock in consideration for the conversion of 1,471,218 shares of Series B Convertible
Preferred.
The
Company issued 821,292 shares of Series C Convertible Preferred in exchange for 821,292 shares of Series B Convertible Preferred.
The
Company issued 1,062,500 shares of common stock in a settlement of accounts payable valued at $43,900. This includes 500,000 shares
to the Company’s former CEO in settlement of that litigation (see Note 9).
The
Company issued 312,500 shares of common stock for services rendered in connection with the raising of debt instruments valued
at $12,500.
The
Company issued 385.000 shares of common stock in conversion of vested restricted stock units.
Common
Stock Options
The
Company recognizes in the financial statements compensation related to all stock-based awards, including stock options and warrants,
based on their estimated grant-date fair value. The Company has estimated expected forfeitures and is recognizing compensation
expense only for those awards expected to vest. All compensation is recognized by the time the award vests.
F- 26
The
following schedule summarizes the changes in the Company’s stock options:
Weighted
Weighted
Options Outstanding
Average
Average
Number
Exercise
Remaining
Aggregate
Exercise
Of
Price
Contractual
Intrinsic
Price
Shares
Per Share
Life
Value
Per Share
Balance at December 31, 2018
11,318,021
$ 0.11-120.00
3.91 years
$ -
$ 0.24
Options granted
23,252,809
$ 0.024-0.04
-
$ -
Options exercised
-
$ -
-
$ -
Options expired
(46,250 )
$ -
-
$ -
Balance at December 31, 2019
34,524,580
$ 0.024-120.00
6.49 years
$ 277,973
$ 0.08
Options granted
-
$ -
-
$ -
Options exercised
(2,500,000 )
$ -
-
$ -
Options expired
(3,139,119 )
$ -
-
$ -
Balance at December 31, 2020
28,885,461
$ 0.024-120.00
5.57 years
$ 1,661,429
$ 0.05
Exercisable at December 31, 2020
28,789,836
$ 0.024-120.00
5.56 years
$ 1,653,636
$ 0.05
In
June 2019, the Company issued 382,500 stock options to consultants that vest through June 30, 2020. The grant date of these options
was June 17, 2019, the date of board approval. On June 21, 2019, 46,250 stock options expired that were issued June 21, 2016.
There was $6,529 expensed in 2019 and $2,176 remaining to be expensed through June 30, 2020 for these options.
The
Company has granted 21,000,000 stock options under the Company’s 2015 Omnibus Securities and Incentive Plan to Dr. Korenko.
The granting of the stock options occurs 10 days after the approval of the Company’s recent 1 for 8 reverse stock split
that occurred on June 28, 2018. The vesting of the options are as follows: (i) 50% vested in equal amounts at the end of each
of the two successive calendar quarters (25% for each of the quarters September 30, 2019, and December 31, 2019); (ii) 25% upon
the Company filing a patent (completed on July 1, 2019); and (iii) 25% upon the first commercial sale of IsoPet ® .
The first commercial sale occurred in July 2019. The value of these options in the aggregate is $585,144.
In
September 2019, the Company granted 1,000,000 stock options in a settlement agreement for past due legal fees. The options have
a ten-year life and vest immediately. These options were valued at $33,829 which offset accounts payable. The Company recognized
a gain of $34,106 on this transaction which is included in the net (gain) loss on debt extinguishment in the statement of operations
for the year ended December 31, 2019.
In
September 2019, the Company granted 500,000 stock options to a consultant for services rendered. The options have a ten-year life
and vest immediately. These options were valued at $16,915.
In
December 2019, the Company granted 370,309 stock options to consultants for accounts payable. The options have a ten-year life
and vest immediately. These options were valued at $14,812.
On
December 10, 2020, the Chief Executive Officer exercised 2,500,000 stock options into common shares valued at $60,000.
During
the years ending December 31, 2020 and 2019, the Company recognized $2,176 and $608,588, respectively, worth of stock based compensation
related to the vesting of it stock options.
F- 27
Common
Stock Warrants
The
following schedule summarizes the changes in the Company’s common stock warrants:
Weighted
Weighted
Warrants
Outstanding
Average
Average
Number
Exercise
Remaining
Aggregate
Exercise
Of
Price
Contractual
Intrinsic
Price
Shares
Per
Share
Life
Value
Per
Share
Balance
at December 31, 2018
23,052,472
$
0.08-80.00
1.77
years
$
-
$
0.08
Warrants
granted
8,234,375
$
-
-
$
Warrants
exercised
-
$
-
-
$
Warrants
expired/cancelled
-
$
-
-
$
Balance
at December 31, 2019
31,286,847
$
0.08-80.00
0.97
years
$
-
$
0.10
Warrants
granted
31,870,000
$
0.045-0.06
-
$
Warrants
exercised/exchanged
(8,727,500
)
$
-
-
$
Warrants
expired/cancelled
(22,364,972
)
$
-
-
$
Balance
at December 31, 2020
32,064,375
$
0.04-80.00
1.65
years
$
1,614,567
$
0.06
Exercisable
at December 31, 2020
32,064,375
$
0.04-80.00
1.65
years
$
1,614,567
$
0.06
Changes
to these inputs could produce a significantly higher or lower fair value measurement. The fair value of each option/warrant is
estimated using the Black-Scholes valuation model. The following assumptions were used for the years ended December 31, 2020 and
2019:
Year
Ended
Year
Ended
December
31,
2020
December
31,
2019
Expected term
2
- 5 years
2
- 5 years
Expected volatility
109
- 147 %
144
- 295 %
Expected dividend yield
-
-
Risk-free interest rate
0.20
- 0.58 %
0.58
– 0.81 %
For
the year ended December 31, 2019, the Company granted 1,250,000 warrants in the issuance of common and preferred shares issued
for cash to accredited investors, 5,650,000 warrants in the issuance of promissory notes (recorded as a debt discount valued at
$151,048), 750,000 warrants for the extension of promissory notes, recorded as interest expense valued at $25,656, 500,000 warrants
for settlement of accounts payable valued at $18,500 (see Note 9) and 84,375 warrants issued for consulting services valued at
$3,792.
The
Company issued a convertible note in the amount of $100,000 to an accredited investor. The note bears interest at 8% per annum
and matures March 31, 2020. The Company granted 1,250,000 warrants with an exercise price of $0.06 per share and a term of two
years with this note and amended 1,312,500 previously issued warrants held by the investor to provide for a $.06 exercise price
and an expiration date of March 31, 2022. This issuance resulted in a debt discount of $28,482.
In
March through June 2020, the Company entered into agreements to issue 18,440,000 shares of common stock conditioned upon the qualification
of the offer and sale of such shares under Regulation A+ for $497,880. Additionally, the Company agreed to issue 9,220,000 warrants
with a term of two years and an exercise price of $.045 for a purchase price of $8,143. These shares were issued in June 2020
and July 2020 following the qualification of the Regulation A+.
In
March through June 2020, certain holders of convertible promissory notes entered into agreements to exchange certain notes totaling
$651,044, including $525,000 in principal amount, $27,536 in accrued interest and an exchange premium as provided for in the note
agreements of $98,508 into 21,770,668 shares of common stock effective upon the qualification of the offer and sale of such shares
under Regulation A+. In connection with the holder’s agreement to enter into the exchange, the Company issued 2,200,000
warrants with a two-year term and an exercise price of $0.045 per share and amend 4,400,000 previously issued warrants to provide
for a $.045 exercise price and an expiration date of March 31, 2022. These shares were issued on June 10, 2020 following the qualification
of the Regulation A+. The issuance of the warrants resulted in $77,883 in additional warrant expense.
Between
November 30, 2020 and December 2, 2020 the Company sold 19,200,000 warrants for $19,200. These warrants have a two-year term and
have an exercise price of $0.06 per share.
On
November 30, 2020, the Company exchanged 1,867,500 warrants into 933,750 shares of common stock, and between December 14, 2020
and December 28, 2020, there were cashless exercises of 6,860,000 warrants into 4,759,435 shares of common stock.
In
the Company’s quarter ended December 31, 2020, 22,364,972 warrants expired.
Restricted
Stock Units
The
following schedule summarizes the changes in the Company’s restricted stock units:
Weighted
Number
Average
Of
Grant Date
Shares
Fair Value
Balance at December 31, 2018
262,500
$ 0.59
RSU’s granted
-
$ -
RSU’s vested
-
$ -
RSU’s forfeited
-
$ -
Balance at December 31, 2019
262,500
$ 0.59
RSU’s granted
-
$ -
RSU’s vested
-
$ -
RSU’s forfeited
-
$ -
Balance at December 31, 2020
262,500
$ 0.59
F- 28
During
the years ended December 31, 2020 and 2019, the Company recognized $0 and $0 worth of expense related to the vesting of its RSU’s,
respectively. As of December 31, 2020, the Company had $155,400 worth of expense yet to be recognized for RSU’s not yet
vested.
NOTE
9: LEGAL MATTERS
The
Company may, from time to time, be involved in various legal proceedings incidental to the conduct of our business. Historically,
the outcome of all such legal proceedings has not, in the aggregate, had a material adverse effect on our business, financial
condition, results of operations or liquidity. Other than as set forth below, there are no additional material pending or threatened
legal proceedings at this time.
On
January 28, 2019, James Katzaroff, (“ Plaintiff ”) the Company’s former Chief Executive Officer filed a
lawsuit in the Superior Court in the State of Washington in and for the County of Benton against the Company and its current and
former directors, alleging a default of the Separation Agreement and General Release (“ Release ”) that the Company
entered into with Plaintiff on July 21, 2017 (the “ Complaint ”). The Company has made required payments under
the Release.
On
November 25, 2019, the Company and its current and former directors entered into a Settlement Agreement with the Plaintiff. Under
the terms of the Settlement Agreement, the Company has agreed to issue 500,000 shares of common stock and 500,000 warrants to
the Plaintiff, make an initial payment of $33,503 by December 4, 2019 and beginning on December 16, 2019, the Company will make
payments of $10,000 per month for 10 months in full satisfaction of the Separation Agreement and General Release originally entered
into on July 21, 2017. The Company has paid this liability in full as of September 11, 2020.
NOTE
10: COMMITMENT
On
June 4, 2019, the Company entered into an Executive Employment Agreement (“Employment Agreement”) with Dr. Michael
K. Korenko, the Company’s Chief Executive Officer. The employment term under the Employment Agreement commenced with an
effective date of June 11, 2019 and expires on December 31, 2020, and December 31 of each successive year if the Employment Agreement
is extended, unless terminated earlier as set forth in the Employment Agreement. The Company on December 31, 2020 extended this
agreement through December 31, 2021.
Under
the terms of the Employment Agreement, the Company shall pay to Dr. Korenko a base compensation of $180,000. Additionally,
in December 2020, Dr. Korenko satisfied the conditions to have his deferred compensation as discussed in the Employment Agreement
paid to him.
NOTE
11: CONCENTRATIONS OF CREDIT AND OTHER RISKS
Accounts
Receivable
The
Company had one customer that represented 100% of the Company’s total revenues for the years ended December 31, 2020 and
2019. The customer that represented 100% of the Company’s total revenue as of December 31, 2020 and 2019 had no net accounts
receivable balances.
F- 29
The
loss of a significant customer representing the percentage of total revenue would have a temporary adverse effect on the Company’s
revenue, which would continue until the Company located new customers to replace them.
The
Company routinely assesses the financial strength of its customers and provides an allowance for doubtful accounts as necessary.
As of December 31, 2020 and 2019, the Company had no allowance or bad debt expense recorded.
Product
Purchases
Some
of the products the Company might market and components thereof are currently available only from a limited number of suppliers
including the source for the main component in the Company’s products, Y-90 which is only derived from one source. Failure
to obtain deliveries from this source could have a material adverse effect on the Company’s ability to operate.
NOTE
12: SUBSEQUENT EVENTS
In
January 2021, the Company issued 1,259,250 shares of common stock in conversion of a convertible note payable of $50,000 and accrued
interest of $370. This conversion resulted in a loss on conversion of $176,295.
In
January 2021, the Company issued 3,423,968 shares of common stock in the cashless exercise of 4,875,000 warrants.
In March 2021, the Company received $1,360,000
as part of their amended Regulation A+ at $0.08 (17,000,000 shares), along with the sale of 8,487,500 two-year warrants at a strike
price of $0.10 per share for $8,238.
F- 30
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.