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 Rule 13a-15 of the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”).
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.
27
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, 2024, 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, 2024, 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.
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.
During
the quarter ended December 31, 2024, none of our directors or executive officers adopted or terminated a Rule 10b5-1 trading plan or
a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K).
Item
9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not
applicable.
28
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
79
President,
Chief Executive Officer, and Director
Michael
Pollack
58
Interim
Chief Financial Officer
Carlton
M. Cadwell
80
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.
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 with a dual assignment at the Office of Science
and Technology.
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.
Dr.
Korenko was selected as President and CEO of Advanced Medical Isotopes (Vivos Inc) on December 14, 2016. Since then, has been credited
with turning around the financial health and reputation of the Company, completing the product development, obtaining the device classification
for animal therapy, and breakthrough classification for the target indication for use, and for setting the stage to obtaining IDE approval
for human therapy.
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.
29
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.
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.
Brad
Weeks is the Business Development Manager for Vivos Inc. and both divisions IsoPet®
and RadioGel®. Brad holds a Master of Business Administration (MBA) with a focus on Technology Management. He brings a unique blend
of experience in service and support, regulatory affairs, quality management systems, and sales operations. Brad possesses diverse experience
across the semiconductor and medical device industries. He is co-lead of the animal sector and has earned deep respect for his leadership
skills.
Fredrick
Swindler is the Quality Assurance Manager for Vivos Inc. Fred provides expertise in quality assurance and regulatory affairs
in the medical device industry specific emphasis in development and auditing of quality systems as well as product submissions. Fred
holds an MBA and brings over 55 years of extensive experience to the Company.
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.
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) precision radionuclide therapy, 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.
30
Dr.
Beau Toskich, MD , FCPP - Medical Advisory Board . Dr. Toskich is currently Mayo Clinic Senior Associate Consultant,
Vascular and Interventional Radiology, Mayo Clinic, Florida Campus, Board Certified Diagnostic Radiology, Vascular and Interventional
Radiology, and Nuclear Regulatory Commission Authorized User
Dr.
Richard Weller, DVM, DACVIM (Internal Medicine; Oncology) DipMS - Veterinary Medicine Advisory Board Chairman . 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.
Dr.
John Heindrick, DVM - Veterinary Medicine Advisory Board Member – Dr. Heindrick is a recently retired co-owner of
VCA Ventana Animal Hospital in Albuquerque NM. He brings practical experience in veterinary medicine and has accompanied us at our conference
booths.
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, 2024 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 Offering Circular, 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 2024 and 2023 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.
31
Board
of Directors; Attendance at Meetings
The
Board held no meetings and acted by unanimous written consent two times during the year ended December 31, 2024. The Board
held no meetings and acted by unanimous written consent two times during the year ended December 31, 2023. 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
more than $100,000 during the year ended December 31, 2024 (collectively, the “Named Executive Officers ”):
Name
and Principal Position (1)
Year
Salary
($)
Bonus
($)
Stock
Awards ($)
Option
Awards
($) (2)
Total
($)
Dr. Michael K. Korenko
2024
$ 295,500
$ 40,000
$ -
$ -
$ 335,500
CEO, President, and Director
2023
$ 236,391
$ 30,000
$ -
$ -
$ 266,391
(1)
Michael
Pollack began serving as the Company’s Interim Chief Financial Officer in December 2018 and was paid no compensation directly
in 2023 or 2024. 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.
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, 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 while renegotiating terms of a new Employment
Agreement. On May 3, 2021, the Company and the Chief Executive Officer agreed the terms of a new Employment Agreement with an effective
date of January 1, 2021 that has a term of three years and expired December 31, 2023. The Company renewed the Employment Agreement for
a term of two years expiring December 31, 2025.
Under
the terms of the Employment Agreement effective January 1, 2024, the Company shall pay to Dr. Korenko a base compensation of $295,500.
In addition, there is a discretionary bonus to be earned in the amount of $10,000 per quarter upon the satisfaction of conditions to
be determined by the Board of Directors of the Company. In addition, the Company granted Dr. Korenko 20,000,000 restricted stock units
on January 1, 2024 that vest over the two-year period.
Outstanding
Equity Awards at Fiscal Year-End Table
The
following table sets forth all outstanding equity awards held by the Company’s Named Executive Officers as of the end of last fiscal
year.
Option
Awards
Name
Number
of Securities Underlying Unexercised Options(#) Exercisable
Number
of Securities Underlying Unexercised Options (#) Unexercisable
Option
Exercise Price ($)
Option
Exercise Date
NONE
32
Compensation
of Directors
During
the year ended December 31, 2024, 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 2024, the aggregate number of stock
awards and the aggregate number of stock option awards that were outstanding as of December 31, 2024:
Name
Outstanding
Stock
Awards
(#)
Outstanding
Stock
Options
(#)
Carlton M. Cadwell
-
-
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.
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 7, 2025, 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 7, 2025, there were 453,373,806 shares of common stock outstanding and up to 43,852,379 shares issuable upon exercise of
common stock equivalents, assuming exercise and conversion occurred as of that date, for a total of 497,226,185 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)
15,406,979
3
%
Michael K. Korenko (4)
15,435,090
3
%
Michael Pollack
16,000
*
All Current Directors
and Executive Officers as a group (3 individuals)
30,334,981
6
%
*
Less than 1%
33
(1)
The
address of each of the beneficial owners above is c/o Vivos Inc, 1030 N Center Parkway, Kennewick, WA 99352, 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 [●], 2025, (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 [●], 2025, 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,
and 2,316,830 shares of common stock issued to AMIC Gift, LLC, an LLC controlled by Carlton and his wife.
(4)
Includes
5,000,000 shares issuable for vested RSUs.
Beneficial
Ownership of the Company’s Series A Convertible Preferred Stock
As
of March 7, 2025, there were 2,071,007 shares of Series A Preferred issued and outstanding, convertible into 2,588,758 shares
of the Company’s common stock.
The
following table sets forth, as of March 7, 2025, 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
7.16 %
Carlton M. Cadwell
908,910
43.89 %
All
Current Directors and Executive Officers as a group (2 individuals) (3)
1,057,219
51.05 %
Major Shareholder(s):
L. Bruce Jolliff
197,979
9.56 %
Stoel Rives
133,333
6.44 %
(1)
The
address of each of the beneficial owners above is c/o Vivos Inc, 1030 N Center Parkway, Kennewick, WA 99352, except that the address
of (i) the Cadwell Family Irrevocable Trust (the “ Cadwell Trust ”) is 909 North Kellogg Street, Kennewick, WA 99336;
(ii) L. Bruce Jolliff is 206 N 41st St. Unit 1, Yakima, WA 98901; and (iii) 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)
Neither
Michael Korenko, the Company’s Chief Executive Officer, nor Michael Pollack, the Company’s Interim Chief Financial Officer,
hold any Company Series A Convertible Preferred, and therefore have been omitted from this table.
34
Beneficial
Ownership of the Company’s Series B Convertible Preferred Stock
As
of March 7, 2025, there were 363 shares of Series B Preferred issued and outstanding, convertible into 4.538 shares of the Company’s
common stock.
The
following table sets forth, as of March [●], 2025, 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):
Firstfire Global Opportunities
Fund (1)
363
100 %
*
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 the beneficial owners is as follows: (i) Firstfire Global Opportunities
Fund.
(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.
Beneficial
Ownership of the Company’s Series C Convertible Preferred Stock
As
of March 7, 2025, 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 7, 2025, 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 %
(1)
The
address of each of the beneficial owners above is c/o Vivos Inc, 1030 N Center Parkway, Kennewick, WA 99352.
(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 have therefore been omitted from this table.
35
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
There
has been no indebtedness from related parties for the years ended December 31, 2024 and 2023, except for a brief period in December 2024
in the amount of $40,949.
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, 2024 and 2023 were $38,500 and $40,500, 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, 2024 and 2023 in the amounts of $4,500
and $4,500, 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.
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, 2024 and 2023 were $3,850 and $3,500, 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, 2024 and
2023. There were no fees incurred to Fruci & Associates II, PLLC related to all other fees.
36
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, 2024 and 2023, the Statements of Operations for the years
ended December 31, 2024 and 2023, the Statements of Changes in Stockholders’ Equity for the years ended December 31, 2024
and 2023, and the Statements of Cash Flows for the years ended December 31, 2024 and 2023, together with the notes thereto and the
reports of Fruci & Associates II, PLLC as required by Item 8 are included in this 2024 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).
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).
3.9
Certificate
of Designations, Preferences and Rights of Series C Convertible Preferred Stock of Vivos Inc., dated March 27, 2019 (incorporated
by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed on April 2, 2019).
3.10
Certificate
of Amendment to its Certificate of Incorporation of Vivos Inc., as amended, effecting a 1-for-8 reverse split, dated June 26, 2019
(incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 2, 2019).
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).
4.2
Form
of Series A Warrant (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 11,
2022).
4.3
Form
of Series B Warrant (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on July 11,
2022).
4.4
Form
of Series C Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on December
27, 2023).
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 between Vivos Inc. and Michael Korenko, dated May 3, 2021 (incorporated by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed on May 7, 2021.
10.12
Amended
and Restated Employment Agreement between Vivos Inc. and Michael Korenko. Dated December 19, 2023, with a deemed effective date of
January 1, 2024 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed March 25, 2024).
10.13
Form
of Series C Warrant Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed on December 27, 2023).
10.14
Form
of Warrant Exchange Agreement (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed
on December 27, 2023.
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*
Inline
XBRL Instance Document
101.SCH*
Inline
XBRL Taxonomy Extension Schema
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase
104
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
*
Filed herewith.
37
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, 2025
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, 2025
By:
/s/
Michael K. Korenko
Name:
Michael
K. Korenko
Title:
Chief
Executive Officer
(Principal
Executive Officer)
Date:
March 24, 2025
By:
/s/
Michael Pollack
Name:
Michael
Pollack
Title:
Interim
Chief Financial Officer
(Principal
Financial and Accounting Officer)
Date:
March 24, 2025
By:
/s/
Carlton M. Cadwell
Name:
Carlton
M. Cadwell
Title:
Secretary
and Chairman of the Board
38
Vivos
Inc.
Index
to Financial Statements
Pages
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 5525 )
F-1
Financial
Statements:
Balance Sheets as of December 31, 2024 and 2023
F-2
Statements of Operations for the years ended December 31, 2024 and 2023
F-3
Statement of Changes in Stockholders’ Equity for the years ended December 31, 2024 and 2023
F-4
Statements of Cash Flow for the years ended December 31, 2024 and 2023
F-5
Notes to Financial Statements
F-6
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, 2024 and 2023, and the related
statements of operations, changes in stockholders’ equity, and cash flows for each of the years in the two-year period ended December
31, 2024, 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, 2024 and 2023 and the results of its operations
and its cash flows for each of the years in the two-year period ended December 31, 2024, 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 a history of net losses, and negative cash flows from operations. These factors, among
others, 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
Critical
audit matters 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. We determined that there were no critical audit matters.
Fruci & Associates II, PLLC – PCAOB ID #05525
We have served as the Company’s auditor since 2016.
Spokane, Washington
March 24, 2025
F- 1
VIVOS
INC
BALANCE
SHEETS
DECEMBER
31, 2024 AND 2023
DECEMBER 31,
DECEMBER 31,
2024
2023
ASSETS
Current Assets:
Cash
$ 2,212,548
$ 1,592,287
Accounts receivable
10,326
7,000
Prepaid expenses
10,582
10,837
Total Current Assets
2,233,456
1,610,124
TOTAL ASSETS
$ 2,233,456
$ 1,610,124
LIABILITIES AND STOCKHOLDERS’ EQUITY
LIABILITIES
Current Liabilities:
Accounts payable and accrued expenses
$ 86,209
$ 245,004
Total Current Liabilities
86,209
245,004
Total Liabilities
86,209
245,004
Commitments and contingencies
-
-
STOCKHOLDERS’ EQUITY
Preferred stock, par value, $ 0.001 , 20,000,000 shares authorized, Series A
Convertible Preferred, 5,000,000 shares authorized, 2,071,007 shares issued and outstanding, respectively
2,071
2,071
Additional paid in capital - Series A Convertible preferred stock
8,842,458
8,842,458
Series B Convertible Preferred, 5,000,000 shares authorized, 363 and 200,363 shares
issued and outstanding, respectively
-
200
Additional paid in capital - Series B Convertible preferred stock
4,538
290,956
Series C Convertible Preferred, 5,000,000 shares authorized, 385,302 shares issued and outstanding, respectively
385
385
Preferred stock, value
385
385
Additional paid in capital - Series C Convertible preferred stock
500,507
500,507
Additional paid in capital
500,507
500,507
Common stock, par value, $ 0.001 , 950,000,000 shares authorized, 440,873,806 and
387,894,033 issued and outstanding, respectively
440,874
387,894
Additional paid in capital - common stock
77,719,143
73,791,430
Subscriptions receivable
( 1,500 )
-
Accumulated deficit
( 85,361,229 )
( 82,450,781 )
Total Stockholders’ Equity
2,147,247
1,365,120
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 2,233,456
$ 1,610,124
The
accompanying notes are an integral part of these financial statements.
F- 2
VIVOS
INC
STATEMENTS
OF OPERATIONS
FOR
THE YEARS ENDED DECEMBER 31, 2024 AND 2023
DECEMBER
31,
DECEMBER
31,
2024
2023
Revenues,
net
$ 27,995
$ 19,500
Cost
of Goods Sold
( 30,979 )
( 25,536 )
Gross
loss
( 2,984 )
( 6,036 )
OPERATING
EXPENSES
Professional
fees, including stock-based compensation
1,682,350
1,606,923
Payroll
expenses
352,597
281,716
Research
and development
324,629
732,698
General
and administrative expenses
241,824
165,773
Total
Operating Expenses
2,601,400
2,787,110
OPERATING
LOSS
( 2,604,384 )
( 2,793,146 )
NON-OPERATING
INCOME (EXPENSE)
Interest
income
74,936
49,577
Loss
on issuance of shares and exchange of warrants
( 381,000 )
( 151,184 )
Total
Non-Operating Expenses
( 306,064 )
( 101,607 )
NET
LOSS BEFORE PROVISION FOR INCOME TAXES
( 2,910,448 )
( 2,894,753 )
Provision
for income taxes
-
-
NET
LOSS
$ ( 2,910,448 )
$ ( 2,894,753 )
Net
loss per share - basic and diluted
$ ( 0.01 )
$ ( 0.01 )
Weighted
average common shares outstanding
409,673,533
368,805,214
The
accompanying notes are an integral part of these financial statements.
F- 3
VIVOS
INC
STATEMENT
OF CHANGES IN STOCKHOLDERS’ EQUITY
FOR
THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Shares
Amount
Preferred
Shares
Amount
Preferred
Shares
Amount
Preferred
Shares
Amount
Common
Receivable
Deficit
Total
Additional
Additional
Additional
Paid-In
Paid-In
Paid-In
Additional
Series
A Preferred
Capital
- Series A
Series
B Preferred
Capital
- Series B
Series
C Preferred
Capital
- Series C
Common
Stock
Paid-In
Capital -
Subscription
Accumulated
Shares
Amount
Preferred
Shares
Amount
Preferred
Shares
Amount
Preferred
Shares
Amount
Common
Receivable
Deficit
Total
Balance
- December 31, 2022
2,071,007
$ 2,071
$ 8,842,458
200,363
$ 200
$ 290,956
385,302
$ 385
$ 500,507
362,541,528
$ 362,541
$ 71,217,954
$ -
$ ( 79,556,028 )
$ 1,661,044
Stock
issued for:
Cash
-
-
-
-
-
-
-
-
-
16,132,000
16,132
1,144,316
-
-
1,160,448
Accounts
payable
-
-
-
-
-
-
-
-
-
500,000
500
27,950
-
-
28,450
RSUs
-
-
-
-
-
-
-
-
-
4,000,000
4,000
( 4,000 )
-
-
-
Warrant
exercises and exchanges
-
-
-
-
-
-
-
-
-
4,720,505
4,721
146,463
-
-
151,184
Warrants
purchased for cash
-
-
-
-
-
-
-
-
-
-
-
18,797
-
-
18,797
RSUs
granted to consultants that have vested
-
-
-
-
-
-
-
-
-
-
-
1,239,950
-
-
1,239,950
Net
loss for the year
-
-
-
-
-
-
-
-
-
-
-
-
-
( 2,894,753 )
( 2,894,753 )
Balance
- December 31, 2023
2,071,007
2,071
8,842,458
200,363
200
290,956
385,302
385
500,507
387,894,033
387,894
73,791,430
-
( 82,450,781 )
1,365,120
Balance
2,071,007
2,071
8,842,458
200,363
200
290,956
385,302
385
500,507
387,894,033
387,894
73,791,430
-
( 82,450,781 )
1,365,120
Stock
issued for:
Cash
-
-
-
-
-
-
-
-
-
24,950,000
24,950
2,241,050
-
-
2,266,000
Services
-
-
-
-
-
-
-
-
-
605,801
606
88,319
-
-
88,925
Exercise
of warrants (cash and cashless)
-
-
-
-
-
-
-
-
-
25,336,472
25,336
376,514
( 1,500 )
-
400,350
Conversion
of preferred stock to common stock
-
-
-
( 200,000 )
( 200 )
( 286,418 )
-
-
-
2,500,000
2,500
284,118
-
-
-
Vested
RSUs
-
-
-
-
-
-
-
-
-
750,000
750
( 750 )
-
-
-
Adjustment
for vested RSUs
-
-
-
-
-
-
-
-
-
( 1,162,500 )
( 1,162 )
1,162
-
-
-
Warrants
purchased for cash
-
-
-
-
-
-
-
-
-
-
-
18,950
-
-
18,950
RSUs
granted to consultants that have vested
-
-
-
-
-
-
-
-
-
-
-
918,350
-
-
918,350
Net
loss for the year
-
-
-
-
-
-
-
-
-
-
-
-
-
( 2,910,448 )
( 2,910,448 )
Balance
- December 31, 2024
2,071,007
$ 2,071
$ 8,842,458
363
$ -
$ 4,538
385,302
$ 385
$ 500,507
440,873,806
$ 440,874
$ 77,719,143
$ ( 1,500 )
$ ( 85,361,229 )
$ 2,147,247
Balance
2,071,007
$ 2,071
$ 8,842,458
363
$ -
$ 4,538
385,302
$ 385
$ 500,507
440,873,806
$ 440,874
$ 77,719,143
$ ( 1,500 )
$ ( 85,361,229 )
$ 2,147,247
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, 2024 AND 2023
2024
2023
CASH FLOW FROM OPERTING ACTIVIITES
Net loss
$ ( 2,910,448 )
$ ( 2,894,753 )
Adjustments to reconcile net loss to net cash used in operating activities
Common stock, stock options and warrants for services
88,925
-
RSUs issued for services
918,350
1,239,950
Loss on issuance of shares and warrants
381,000
151,184
Changes in assets and liabilities
Accounts receivable
( 3,326 )
4,000
Prepaid expenses and other assets
255
14,834
Accounts payable and accrued expenses
( 158,795 )
191,762
Total adjustments
1,226,409
1,601,730
Net cash used in operating activities
( 1,684,039 )
( 1,293,023 )
CASH FLOWS FROM FINANCING ACTIVITES
Proceeds from short-term advances from related party
40,949
-
Payments of related party notes
( 40,949 )
-
Exercise of warrants
19,350
-
Proceeds from common stock and warrants
2,284,950
1,179,245
Net cash provided by financing activities
2,304,300
1,179,245
NET INCREASE (DECREASE) IN CASH
620,261
( 113,778 )
CASH- BEGINNING OF YEAR
1,592,287
1,706,065
CASH - END OF YEAR
$ 2,212,548
$ 1,592,287
CASH PAID DURING THE YEAR FOR:
Interest expense
$ -
$ -
Income taxes
$ -
$ -
SUPPLEMENTAL INFORMATION - NON-CASH INVESTING AND FINANCING ACTIVITIES:
Common stock issued in cashless exercise of warrants
$ 23,251
$ 4,721
RSUs vested into common stock
$ 750
$ 4,000
Accounts payable converted into shares of common stock
$ -
$ 28,450
The
accompanying notes are an integral part of these financial statements.
F- 5
VIVOS
INC.
NOTES
TO FINANCIAL STATEMENTS
DECEMBER
31, 2024 AND 2023
NOTE
1: BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
Business
Overview
Vivos
Inc. (the “ Company ,” “ we ,” “ us ,” “ our ”) is a radiation oncology
medical device company engaged in the development of its yttrium-90 (“ Y-90 ”) based precision radionuclide therapy
device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide Therapy TM .
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
2013, the United States Food and Drug Administration (“ FDA ”) issued the determination that RadioGel™ is a device
for human therapy for non-resectable cancers in humans. This should result in a faster path than a drug for final approval.
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 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 is being 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. Historically, the Company’s primary focus was on the development
and marketing of Isopet ® for animal therapy, through the Company’s IsoPet ® Solutions division. Over
the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device
Exemption and to obtain approval for clinical trials in India.
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. In January 2025 the Company restructured and aligned its internal resources and focused effort to align with animal
therapy, human therapy, and recently other applications of its patented technologies.
The
Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet ® /RadioGel TM
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 ® . The University of Missouri conducted an animal study to treat canine
sarcoma. Johns Hopkins University completed a study on VX2 Tumors in Rabbits. Every study confirmed that the Y-90 stayed at the injection
site with insignificant distribution outside that boundary.
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.
The
Company anticipates that any near-term profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet ® )
and related services, and from certifying veterinary clinics to administer IsoPet Therapy. Until recently the Company certified clinics
at its own expense, but the demand has increased to the point that starting in 2025 the Company billed its first clinic for the certification
process.
F- 6
The
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 Precision Radionuclide Therapy 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, Y-90 phosphate
particles. 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.
In
2021 the Company modified its Indication for Use from skin cancer 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 with this new indication provided a more efficient pathway to regulatory clearance.
In
December 2023, the Food and Drug Administration granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device
pursuant to the FDA’s Breakthrough Devices Program. This gave the company access to the “sprint” rapid review process
for IDE comments. For the last several months the company has been taking advantage of that program to resoled detailed FDA questions
on a variety of topics.
In
early 2025 the Company began actively pursuing human clinical trials in India. This involved successful step-by-step implementation of
several requirements, including location of a respected lead investigator at a respected hospital; regulatory approvals (securing clearances
from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health
& Family Welfare, and the Company was issued the Clinical Trial Registry-India (CTRI) number required for publishing results); logistical
coordination (acquired liability insurance, expanded the treatment institution’s radioactive material license to include RadioGel ® ,
and established robust international shipping protocols and an alternate contingency shipping path for the Yttrium-90 (Y-90)-based product);
protocol development (finalized the Clinical Trial Protocol, incorporating Mayo Clinic study designs and feedback from FDA pre-submission
discussions); operational readiness (re-validated RadioGel ® manufacturing at IsoTherapeutics to ensure compliance with
Quality Management System standards and FDA sterility and validation recommendations); administrative preparations (signed agreements
with the Ethics Committee and treatment institution while confirming trademark and patent protections in the region); and training and
certification (conducted comprehensive certification training for the treatment team). Failure on any step would have terminated the effort.
In
December 2024 the Company conducted an important offset strategic meeting to ensure that its entire key internal and external team was
alighted to its strategic plans. Attendees included all our current internal team members, our senior health physics volunteer, the members
of the Medical Advisory Board and the Veterinary Medicine Advisory Board, lead Investigator for the proposed Mayo Clinic clinical trial,
lead investigator for the clinical trial in India, and our patent attorney. The primary objective was to re-assess our business direction,
to select the next target series of indications for Use, to ensure that we have developed the optimum precision Radionuclide Therapy TM
approach for each cancer type, including the isotope, the delivery technique, and the dose, and to ensure that our current and
future patents protect these directions. It also discussed the domestic and internation plans.
The
Company decided to explore the viability of harvesting its technology for other business opportunities as a separate “division.”
The Company is working with Akina, on these initiatives. The current efforts are on the Peltier Chiller technology and the hydrogel.
To prevent the Company from being distracted from its primary focus of treating cancer, if viable, Akina would probably also be the principal
distributor. Alternatively, each business sector can be spun off as separate business activities to an interested party.
Controlled
Laboratory Chilling - As Akina explained, it is easy to purchase many laboratory devices to control heating, but there are limited or
no options for controlled cooling, which is a common laboratory requirement usually involving ice baths. The Company is now testing a
prototype universal laboratory cooling device.
F- 7
Hydrogel
– the Company spent years on refining the development of its hydrogel, in which gelation initiates just above room temperature
and is completed as it warms to body temperature. It is currently investing in quantifying and controlling the hydrogel resorption characteristics.
There has been sufficient spontaneous interest in this component to warrant a serious business case assessment. The Company just trademarked
the name Precision Gel TM and, in addition to its current hydrogel patent, has filed a new provisional patent in January 2025
to cover retention, transport, and release of a broad range of agents. These agents include radioactive and non-radioactive materials,
solid particles, including nano-particles, large molecules, small molecules, including liquids, cells, and viruses. A MOU has been drafted
to interface with potential clients including licensing and exclusive material contracting. Initial meetings are scheduled in the first
quarter of 2025 with potential clients to assess the business viability.
Intellectual
Property
Our
original license agreement with Battelle National Laboratory (the “ Battelle License ”) reached its end of life in 2022.
We have expanded our proprietary knowledge, as well as our trademark and patent protection, in anticipation of the Battelle License reaching
the end of its term during the past several years.
Our
trademark protection, which usually is extended to 17 countries, has been expanding continuously as summarized below:
We
own applications/registrations for the following and should mark as noted below:
○ ISOPET®
○ RADIOGEL®
○ ALPHA-GEL TM
○ BETA-GEL TM
○ GAMMA-GEL TM
○ PRECISION
RADIONUCLIDE THERAPY TM
○ PRECISIONGEL TM
Similarly,
we have systematically filed provisional and utility patents that cover our key components, hydrogel and the yttrium phosphate
particles, and our injection system in the US office and more than ten others covering approximately 63 counties.
In
January 2025 we filed an additional provisional patent on the control, transport, and delivery of PrecisionGel.
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 $ 2.5 million
annually to maintain current operating activities.
Financing
and Strategy
In
November 2019, the SEC qualified the Company’s offering of its Common Stock, under Regulation A of Section 3(6) of the Securities
Act of 1933, as amended (the “ Securities Act ”) (“ Regulation A ”), which offering was and amended
from time to time thereafter (the “ 2019 Regulation A+ Offering ”). In September 2021, the SEC qualified the Company’s
offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (together with the 2019 Regulation
A+ Offering, the “ Prior Regulation A+ Offerings ”). During the year ended December 31, 2023, $ 1,179,245 was raised
through the sale of 16,132,000 shares of common stock and the private placement of 18,797,000 warrants. During the year ended December
31, 2024, the Company raised $ 2,266,000 through the issuance of 24,950,000 shares of common stock. The Company’s Prior Regulation
A Offerings undertaken pursuant to Regulation A+ have raised approximately $ 7,250,000 from the sale of shares of common stock.
On
July 17, 2024, the SEC qualified the Company’s offering under Regulation A to offer up to $ 60,000,000 shares of its Common Stock
(the “ July 2024 Regulation A+ Offering ”).
The
Company is using the proceeds generated from the Prior Regulation A+ Offering and the July 2024 Regulation A+ Offering as follows:
F- 8
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 may require additional funding of approximately $ 5
million annually to maintain current operating
activities. Over
the next 12 to 48 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, and 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 proceeds to be raised from
the Regulation A+ Offerings will be used to continue to fund this development.
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: (1) the timing of any approvals; (2) the nature of the Company’s arrangements
with third parties for manufacturing, sales, distribution, and licensing of those products; and (3) 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,
as well as proceeds to be raised from the Regulation A+ Offerings.
Following
receipt of required regulatory approvals and necessary financing to fund our working capital requirements, the Company intends to outsource
material aspects of manufacturing, distribution, sales, and marketing for operations within the U.S. Outside of the U.S., the Company
intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.
Long-term,
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. These long-term goals are subject to the Company: (1) receiving adequate funding;
(2) receiving regulatory approval for RadioGel ™ and other brachytherapy products; and (3) being able to successfully
commercialize its brachytherapy products.
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’s headquarters are in Northeast Washington, however, our focus on the animal therapy market has been the Northwestern sector
of the U.S. The Company continues its marketing efforts on the animal therapy market and our attempts to increase the exposure to our
product, and generate revenue accordingly.
As
of December 31, 2024, the Company had $ 2,212,548 cash on hand. There are currently commitments to vendors for products and services purchased.
To continue the development of the Company’s products, the current level of cash will not be enough to cover the fixed and variable
obligations of the Company.
The
Company anticipates using the proceeds from the July 2024 Regulation A+ Offering as follows:
For
the animal therapy market:
●
Expand
communication on our website, the Company’s social media presence, conferences, and journals, each intended to increase the
number of certified clinics for small animal and equine therapy and to increase the number of patients.
●
Subsidize
some IsoPet ® therapies, if necessary, to ensure that all viable candidates are treated; and.
●
Assist
a new regional clinic with their license and certification training.
F- 9
For
the human market:
●
Enhance
the pedigree of the Quality Management System.
●
Begin
automation of product manufacturing.
●
Fund
liability insurance for human clinical studies; and.
●
Fund
human clinical studies in the US.
Research
and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity
and debt securities, including from the Prior Regulation A+ Offerings. The Company requires additional funding of approximately $ 2.5
million annually to maintain operating activities.
Over
the next 36 months, the Company believes it will cost approximately $8.0 to $9.0 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 U.S.; (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
proceeds raised from the Prior Regulation A+ Offerings were used to fund this development and proceeds from the July 2024 Regulation
A+ Offering will be used to continue such development efforts.
The
continued deployment of the precision radionuclide therapy 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 precision radionuclide therapy products
in the next 12 to 24 months will be the FDA’s classification of the Company’s precision radionuclide therapy 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 from proceeds raised from the Prior Regulation A+ Offering and from the
July 2024 Regulation A+ Offering.
The
Company intends to expand the indications for use in phases: first, for lymph nodes associated with thyroid cancer, secondly, cancerous
lung nodules, and finally, all non-sectable solid tumors. It is anticipated that the medical community may begin to use RadioGel off-label,
we will support but will not encourage that practice.
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.
Long-term,
the Company intends to consider resuming research efforts with respect to other products and technologies, such as Gamma Gel and Alpha
Gel intended to help improve the diagnosis and treatment of cancer and other illnesses. These long-term goals are subject to the Company:
(1) receiving adequate funding; (2) receiving regulatory approval for RadioGel ™ and other precision radionuclide therapy
products; and (3) being able to successfully commercialize its precision radionuclide therapy products.
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’s headquarters are in the State of Washington., The initial focus of the animal therapy market has been the Northwestern
sector of the United States. The Company has initiated marketing efforts to the animal therapy market in other regions of the United
States, attempting to increase the exposure to our product and increase revenue opportunities.
There
are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products,
the current level of cash will not be enough to cover the fixed and variable obligations of the Company. The Company has focused on operating
on minimum overhead, including using a virtual office for the last several years and retaining experienced industry consultants available
on an as needed basis. This has helped focus the capital received from the Company’s Regulation A+ Offerings on activities that
enhance our objectives.
There
is no guarantee that the Company will be able to raise additional funds or to do so on terms advantageous to the Company’s stockholders.
F- 10
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 can be 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.
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 amount of revenue and expense 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.
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.
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, 2024 and 2023, the balances reported for cash, prepaid expense,
accounts receivable, accounts payable, and accrued expense, 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.
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.
F- 11
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, 2024 and 2023, 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 (“ FASB ”) 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 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 perform 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.
The
Company recognized revenue as they (i) identified the contracts with each 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.
The
Company in 2024 also implemented a license program for clinics that pay for certification to perform these therapies. These revenues
are recognized upon the certification being completed. During 2024, $ 4,995 of the revenue relates to this certification.
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, 2024 and 2023, 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 December 31, 2024 and 2023, which include the following:
SCHEDULE
OF DILUTIVE EARNINGS PER SHARE
December 31,
2024
December 31,
2023
Preferred stock
7,409,570
9,909,570
Restricted stock units
22,725,000
1,450,000
Common stock options
2,252,809
2,252,809
Common stock warrants
11,465,000
26,134,000
Total potential dilutive securities
43,852,379
39,746,379
F- 12
Research
and Development Costs
Research
and developments costs, including salaries, research materials, administrative expense 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 $ 324,629 and $ 732,698 in research and development costs for the years ended December 31, 2024 and 2023, respectively,
all of which were recorded in the Company’s operating expense noted on the statements of operations for the periods 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, 2024 and 2023, the Company incurred nominal advertising and marketing costs.
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, 2024 and 2023.
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, 2024 and 2023. The Company did not have any deferred tax liability or asset on its balance sheets as of December 31, 2024 and 2023.
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, 2024 and 2023, 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- 13
Recent
Accounting Pronouncements
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.
In November 2023, the Financial Accounting Standards Board issued Accounting Standards Update 2023-07 (“ASU
2023-07”). ASU 2023-07 improves segment reporting disclosures for public companies. ASU 2023-07 requires more detailed information
about reportable segments and expenses including the requirement to disclose qualitative information about factors used to identify reportable
segments and quantitative information about profit and loss measures and significant expense categories. ASU 2023-07 was effective for
public companies in fiscal years beginning after December 15, 2023. The Company has not yet begun generating significant revenue from its planned principal operations and operates as
a single reportable segment. The chief operating decision maker is the Company’s chief executive officer who assesses performance
based on total expenses, cash flows, and progress made in the Company’s ongoing development efforts. All of the Company’s
long-lived assets are located in the United States. The Company analyzed ASU 2023-07 and determined that the required
information is presented within the consolidated financial statements and footnote disclosures herein. The Company does not believe that
ASU 2023-07 will have a material impact on the consolidated financial statements.
NOTE
2: RELATED PARTY TRANSACTIONS
In
September 2023, our Chief Executive Officer advanced $ 10,000 to the Company, which amount was repaid October 4, 2023. In December 2024,
our Chief Executive Officer advanced $ 40,949 to the Company, which amount was repaid within ten days.
NOTE
3: STOCKHOLDERS’ EQUITY
Common
Stock
The
Company has authorized 950,000,000 shares of Common Stock. As of December 31, 2024 and 2023, there are 440,873,806 and 387,894,033 shares
of Common Stock issued and outstanding, respectively.
Preferred
Stock
The
Company has authorized 20,000,000 shares of Preferred Stock. There are currently three series of Preferred Stock outstanding; Series
A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series C Convertible Preferred Stock. 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.
Series
A Convertible Preferred Stock
On
June 30, 2015, a certificate of designations was filed with the Delaware Secretary of State to designate 2,500,000 shares of the Company’s
Preferred Stock as Series A Convertible Preferred Stock, par value $ 0.001 per share (“ Series A Preferred ”) (the “ Series
A COD ”). Effective March 31, 2016, the Company amended the Series A COD, increasing the maximum number of shares of Series
A Preferred from 2,500,000 shares to 5,000,000 shares. As of December 31, 2024 and 2023, there are 2,071,007 shares of Series A Preferred
issued and outstanding, respectively.
The
following summarizes the current rights and preferences of the Series A Preferred:
Liquidation
Preference . The Series A Preferred has a liquidation preference of $ 5.00 per share.
Dividends .
Shares of Series A Preferred do not have any separate dividend rights.
Conversion .
Subject to certain limitations set forth in the Series A COD, each share of Series A 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 COD), 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 Preferred at that time will automatically convert
into Series A Conversion Shares.
Redemption .
Subject to certain conditions set forth in the Series A COD, in the event of a Change of Control (defined in the Series A COD), or at
such time as a third party not affiliated with the Company or any holders of the Series A 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 Preferred
in cash at a price per share of Series A Preferred equal to 100 % of the Liquidation Preference.
F- 14
Voting
Rights . Holders of Series A Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
equivalent of five votes for every Series A Conversion Share issuable upon conversion of such holder’s outstanding shares of Series
A 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 Preferred.
Liquidation .
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “ Liquidation ”),
the holders of Series A 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 Preferred before any distribution or payment shall be made to the holders of any
junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
to the holders of the Series A 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 Preferred prior to any such merger or reorganization would have been entitled to receive
pursuant to such transaction.
Series
B Convertible Preferred Stock
On
October 10, 2018, a certificate of designation was filed with the Delaware Secretary of State to designate 5,000,000 shares of our Preferred
Stock as Series B Convertible Preferred Stock, par value $ 0.001 per share (“ Series B Preferred ”) (the “ Series
B COD ”). As of December 31, 2024 and 2023, there are 363 and 200,363 shares of Series B Preferred issued and outstanding, respectively.
The
following summarizes the current rights and preferences of the Series B Preferred:
Liquidation
Preference . The Series B Preferred has a liquidation preference of $ 1.00 per share.
Dividends .
Shares of Series B Preferred do not have any separate dividend rights.
Conversion .
Subject to certain limitations set forth in the Series B COD, each share of Series B Convertible 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 the Conversion Price (as such term is defined in the Series B COD), currently $ 0.08 .
Redemption .
Subject to certain conditions set forth in the Series B COD, in the event of a Change of Control (defined in the Series B COD), or at
such as a third party not affiliated with the Company or any holders of the Series B Convertible 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 Preferred in
cash at a price per share of Series B Preferred equal to 100 % of the Liquidation Preference.
Voting
Rights . Holders of Series B Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
equivalent of two votes for every Series B Conversion Share issuable upon conversion of such holder’s outstanding shares of Series
B Preferred. However, the Series B Conversion Shares, when issued, will have the same voting rights as other issued and outstanding shares
of Common Stock of the Company, and none of the rights of the Series A Preferred.
F- 15
Liquidation .
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “ Liquidation ”),
the holders of Series B 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 Preferred before any distribution or payment shall be made to the holders of any
junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
to the holders of the Series B 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 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 Preferred prior to any such merger or reorganization would have been entitled to receive
pursuant to such transaction.
On
December 16, 2024, there was 200,000 Series B Preferred shares converted into 2,500,000 common shares.
Series
C Convertible Preferred Stock
On
March 27, 2019, a certificate of designation was filed with the Delaware Secretary of State to designate 5,000,000 shares of our Preferred
Stock as Series C Convertible Preferred Stock, par value $ 0.001 per share (“ Series C Preferred ”) (the “ Series
C COD ”). As of December 31, 2024 and 2023, there were 385,302 shares of Series C Preferred issued and outstanding, respectively.
The
following summarizes the current rights and preferences of the Series C Preferred:
Liquidation
Preference . The Series C Preferred has a liquidation preference of $ 1.00 per share.
Dividends .
Shares of Series C Preferred do not have any separate dividend rights.
Conversion .
Subject to certain limitations set forth in the Series C COD, each share of Series C 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 COD), currently $ 0.08 .
The
Series C 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 Preferred into shares of Common Stock (“ Authorized
Share Approval ”) (such date, the “ Initial Convertibility Date ”), each share of Series C 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 COD under the definition “ Conversion Rights ”.
Redemption .
Subject to certain conditions set forth in the Series C COD, in the event of a Change of Control (defined in the Series C COD), or at
such time as a third party not affiliated with the Company or any holders of the Series C 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 C Preferred
in cash at a price per share of Series C Preferred equal to 100 % of the Liquidation Preference.
F- 16
Voting
Rights . Holders of Series C Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
equivalent of thirty-two votes for every Series C Conversion Share issuable upon conversion of such holder’s outstanding shares
of Series C Preferred. However, the Series C Conversion Shares, when issued, will have the same voting rights as other issued and outstanding
shares of Common Stock of the Company, and none of the rights of the Series C Preferred.
Liquidation .
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “ Liquidation ”),
the holders of Series C 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 Preferred before any distribution or payment shall be made to the holders of any
junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
to the holders of the Series C 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 C 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 Preferred prior to any such merger or reorganization would have been entitled to receive
pursuant to such transaction.
Common
and Preferred Stock Issuances
Common
and Preferred Stock Issuances - 2024
The
Company issued 24,950,000 shares of Common Stock pursuant to the Regulation A+ Offerings for cash proceeds of $ 2,266,000 .
The
Company issued 605,801 shares of Common Stock for services rendered valued at $ 88,925 .
The
Company issued 20,336,472 shares of Common Stock in the cashless exercise of 28,619,000 warrants.
The
Company issued 5,000,000
shares of Common Stock in the exchange of 5,000,000
warrants and recognized a loss on the exchange of $ 381,000
which is included in the exercise of warrants in the consolidated statement of changes in stockholders’s equity.
There
were 200,000 Series B Preferred shares converted into 2,500,000 common shares.
The
Company settled 750,000 RSUs for Common Stock.
The
Company adjusted their common shares for vested RSUs in prior periods that were cancelled.
Common
and Preferred Stock Issuances – 2023
In
April 2023, the Company issued 8,000,000 shares of Common Stock, 2,665,000 Series A warrants and 8,000,000 Series B warrants in their
Regulation A+ Offerings for $ 640,000 . The Company sold the warrants for $ 10,665 .
In October
2023, the Company issued 2,221,505 shares of common stock in a cashless exercise of warrants to purchase 2,132,000 shares of common stock.
In December
2023, the Company issued: (1) 500,000 shares of common stock in settlement of accounts payable of $ 28,450 ; (2) 8,132,000 shares of common
stock and 8,132,000 warrants pursuant to the Offering Statement for the Regulation A+ Offering for an aggregate total of $ 528,580 ; (3)
2,499,000 shares of common stock in a cashless exercise of warrants to purchase 4,998,000 shares of common stock and issued new warrants
to purchase 10,002,000 shares of common stock; and (4) issued 4,000,000 shares of common stock for 4,00,000 vested restricted stock units,
for which the Company recognized a loss of $ 151,184 on this exchange of vested restricted stock units for shares of common stock.
NOTE
4: COMMON STOCK OPTIONS, WARRANTS AND 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- 17
The
following schedule summarizes the changes in the Company’s stock options:
SCHEDULE
OF CHANGES IN STOCK OPTION
Options
Outstanding
Weighted
Average
Remaining
Weighted
Average
Number
Of
Shares
Exercise
Price
Per Share
Contractual
Life
Aggregate
Intrinsic Value
Exercise
Price
Per Share
Year Ended December
31, 2024
Outstanding at January 1, 2024
2,252,809
$ 0.024 - 0.04
5.70
years
$ 78,886
$ 0.04
Granted
-
$ -
-
$ -
Exercised
-
$ -
-
$ -
Expired/cancelled
-
$ -
-
$ -
Outstanding at December
31, 2024
2,252,809
$ 0.024 - 0.04
4.70
years
$ 174,855
$ 0.04
Exercisable at December
31, 2024
2,252,809
$ 0.024 - 0.04
4.70
years
$ 174,855
$ 0.04
Year Ended December
31, 2023
Outstanding at January 1, 2023
2,252,809
$ 0.024 - 0.04
6.70
years
$ 16,032
$ 0.04
Granted
-
$ -
-
$ -
Exercised
-
$ -
-
$ -
Expired/cancelled
-
$ -
-
$ -
Outstanding at December
31, 2023
2,252,809
$ 0.024 - 0.04
5.70
years
$ 78,886
$ 0.04
Exercisable at December
31, 2023
2,252,809
$ 0.024 - 0.04
5.70
years
$ 78,886
$ 0.04
During
the years ended December 31, 2024 and 2023, the Company recognized $ 0 of stock-based compensation expense related to the vesting of stock
options.
Common
Stock Warrants
The
following schedule summarizes the changes in the Company’s stock warrants:
SCHEDULE
OF CHANGES IN STOCK WARRANTS
Warrants
Outstanding
Weighted
Average
Remaining
Weighted
Average
Number
Of
Shares
Exercise
Price
Per Share
Contractual
Life
Aggregate
Intrinsic Value
Exercise
Price
Per Share
Years Ended
December 31, 2024
Outstanding at January 1, 2024
26,134,000
$ 0.06 - 0.10
3.54
years
$ -
$ 0.0827
Granted
18,950,000
$ 0.075
-
$ -
$ -
Redeemed
( 500,000 )
$ -
-
$ -
$ -
Exercised
( 28,619,000 )
$ -
-
$ -
$ -
Exchanged
( 5,000,000 )
$ -
-
$ -
$ -
Outstanding at December 31, 2024
11,465,000
$ 0.13
3
years
$ 123,690
$ 0.13
Exercisable at December 31, 2024
11,465,000
$ 0.13
3
years
$ 123,690
$ 0.13
Years Ended
December 31, 2023
Outstanding at January 1, 2023
26,737,500
$ 0.06 - 0.10
1.52
years
$ -
$ 0.09
Granted
28,799,000
$ 0.0827
-
$ -
$ -
Redeemed
( 500,000 )
$ -
-
$ -
$ -
Exercised
( 7,663,000 )
$ -
-
$ -
$ -
Exchanged
( 10,002,000 )
$ -
-
$ -
$ -
Expired/cancelled
( 11,237,500 )
$ -
-
$ -
$ -
Outstanding at December 31, 2023
26,134,000
$ 0.06 - 0.10
3.54
years
$ -
$ 0.0827
Exercisable at December 31, 2023
26,134,000
$ 0.06 - 0.10
3.54
years
$ -
$ 0.0827
F- 18
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 periods as follows:
SCHEDULE
OF ASSUMPTIONS USED IN FAIR VALUE MEASUREMENT
Year
Ended
Years
Ended
December
31, 2024
December
31, 2023
Expected
term
-
-
Expected
volatility
-
%
-
%
Expected
dividend yield
-
-
Risk-free
interest rate
-
%
-
%
The
Company granted 10,665,000 warrants in their Reg A+ funding in April 2023, with an exercise price of $ 0.0775 and a three-year term.
The
Company granted 2,000,000 warrants in their Regulation A+ Offering in January 2024, with an exercise price of $ 0.075 and a three-year
term and 5,000,000 warrants with the same terms on April 1, 2024.
In
November 2024, the Company sold 11,950,000 warrants, 30 % of which expire December 31, 2024 at an exercise price of $ 0.01 and 70 % of which
expire December 31, 2027 at an exercise price of $ 0.15 for $ 11,950 under Regulation D.
In
2024, the Company issued 25,336,468 shares of Common Stock in the exercise of 33,619,000 warrants and received $ 19,350 .
Restricted
Stock Units
The
following schedule summarizes the changes in the Company’s restricted stock units:
SCHEDULE
OF CHANGES IN RESTRICTED STOCK UNITS
Number
Of Shares
Weighted
Average
Grant Date Fair Value
Year Ended December
31, 2024
Outstanding at January 1, 2024
1,450,000
$ 0.09
Granted
21,850,000
$ 0.08
Vested
( 11,475,000 )
$ -
Forfeited
-
$ -
Outstanding at December 31, 2024
11,825,000
$ 0.08
Year Ended December
31, 2023
Outstanding at January 1, 2023
10,262,500
$ 0.08
Granted
6,900,000
$ 0.068
Vested
( 15,450,000 )
$ -
Forfeited
( 262,500 )
$ -
Outstanding at December
31, 2023
1,450,000
$ 0.09
F- 19
During
the years ended December 31, 2024 and 2023, the Company recognized $ 918,350 and $ 1,239,950 in expense related to the vesting of its restricted
stock units. As of December 31, 2024, the Company had $ 923,855 worth of expense yet to be recognized for restricted stock units not yet
vested.
On
January 1, 2024, the Company granted 20,000,000
restricted stock units to its Chief Executive Officer as part of his new employment agreement that vest in four equal installments
over a two-year
period beginning February 1, 2024. In May 2024, the Company granted 1,050,000
restricted stock units to consultants that vest through December 31, 2025. In November 2024, the Company granted 800,000 restricted
stock units that vest in May 2025. During the year ended December 31, 2024, 11,475,000
of these restricted stock units vested.
On May 1,
2023, the Company granted 2,900,000 RSUs to consultants, with 25 % of such RSUs vesting immediately, 25 % vest on December 31, 2023, 25 %
vest on December 31, 2024 and the remaining 25 % vest on December 31, 2025. These RSUs are valued at $ 263,900 .
On August
4, 2023, the Chief Executive Officer rescinded 1,012,500 of which 750,000 had vested in prior years, of his fully vested RSUs.
In December
2023, the Company granted 4,000,000 immediately vested RSUs to a consultant, for which the RSUs are valued at $ 208,000 .
NOTE
5: 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. On December 31, 2020, the Company extended the Employment Agreement
through December 31, 2021 while renegotiating terms of a new Employment Agreement. On May 3, 2021, the Company and the Chief Executive
Officer agreed the terms of a new Employment Agreement with an effective date of January 1, 2021 that has a term of three years and expired
December 31, 2023. The Company renewed the Employment Agreement for a term of two years expiring December 31, 2025.
Under
the terms of the Employment Agreement effective January 1, 2024, the Company shall pay to Dr. Korenko a base compensation of $ 295,500 .
In addition, there is a discretionary bonus to be earned in the amount of $ 10,000 per quarter upon the satisfaction of conditions to
be determined by the Board of Directors of the Company. In addition, the Company granted Dr. Korenko 20,000,000 restricted stock units
on January 1, 2024 that vest over the two year period.
NOTE
6: 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, 2024 and 2023:
SCHEDULE
OF NET DEFERRED TAX ASSETS
December
31,
2024
December
31,
2023
Deferred tax assets:
Net operating loss carryover
$ 7,260,000
$ 6,840,000
Capital Loss Carryover
3,400
3,400
Valuation allowance
( 7,263,400 )
( 6,843,400 )
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, 2024 and 2023 due to the following:
SCHEDULE
OF FEDERAL INCOME TAX RATE
December
31,
2024
December
31,
2023
Book income (loss)
$ ( 611,200 )
$ ( 607,900 )
Depreciation
( 1,100 )
( 1,100 )
Stock for services
192,900
260,400
Other non-deductible expense
-
6,300
Valuation allowance
419,400
342,300
Income tax expense
$ -
$ -
At
December 31, 2024, the Company had net operating loss carryforwards of approximately $ 34,581,700 .
ASC
Topic 740 – Income Taxes (“ ASC 740 ”) provides guidance on the accounting for uncertainty in income taxes recognized
in a company’s financial statements. ASC 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, 2024, 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
7: SUBSEQUENT EVENTS
The Company has evaluated subsequent events through the date of this report and noted the following:
On
February 6, 2025, there has been 12,500,000 shares of common stock issued under the Regulation A+.
F- 20
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.