1 unchanged sentence
Controls and Procedures
−Removed: Based on an evaluation as of the date of the end of the period covered
−Removed: by this report, the Company’s Chief Executive Officer and Interim Chief Financial Officer conducted an evaluation of the effectiveness
−Removed: of the design and operation of the Company’s disclosure controls and procedures, as required by Rule 13a-15 of the Securities Exchange
−Removed: Act of 1934, as amended (the “ Exchange Act ”).
−Removed: Based on that evaluation, the Company’s Chief Executive Officer
−Removed: and Interim Chief Financial Officer concluded that, because of the disclosed material weaknesses in the Company’s internal control
−Removed: over financial reporting, the Company’s disclosure controls and procedures were ineffective as of the end of the period covered
−Removed: by this report to ensure that information required to be disclosed by the Company in the reports that the Company files or submits under
−Removed: the Exchange Act is recorded, processed, summarized and reported within the time periods specified by the SEC’s rules and forms.
+Added: 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
+Added: Chief Financial Officer conducted an evaluation of the effectiveness of the design and operation of the Company’s disclosure controls
+Added: and procedures, as required by Rule 13a-15 of the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”).
+Added: Based on that evaluation, the Company’s Chief Executive Officer and Interim Chief Financial Officer concluded that, because of
+Added: the disclosed material weaknesses in the Company’s internal control over financial reporting, the Company’s disclosure controls
+Added: and procedures were ineffective as of the end of the period covered by this report to ensure that information required to be disclosed
+Added: by the Company in the reports that the Company files or submits under the Exchange Act is recorded, processed, summarized and reported
+Added: within the time periods specified by the SEC’s rules and forms.
controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in the
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OTHER INFORMATION.
−Removed: the quarter ended December 31, 2023, none of our directors or executive officers adopted or terminated a Rule 10b5-1 trading plan or a
−Removed: non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K).
−Removed: DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT
−Removed: Not applicable.
+Added: the quarter ended December 31, 2024, none of our directors or executive officers adopted or terminated a Rule 10b5-1 trading plan or
+Added: a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K).
+Added: DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE.
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Korenko served as Vice President of Westinghouse
−Removed: from 1987 to 1994 and was responsible for the 300 and 400 areas, including the Fast Flux Testing Facility (“ FFTF ”) and all
−Removed: engineering, safety analysis, and projects for the Hanford site.
+Added: from 1987 to 1994 and was responsible for the 300 and 400 areas, including the Fast Flux Testing Facility (“ FFTF ”)
+Added: and all engineering, safety analysis, and projects for the Hanford site.
Korenko is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development
2 unchanged sentences
Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a
−Removed: White House Fellow for the Department of Defense, reporting to Secretary Cap Weinberger.
+Added: White House Fellow for the Department of Defense, reporting to Secretary Cap Weinberger with a dual assignment at the Office of Science
+Added: and Technology.
Korenko brings to the Board over seven years’ experience working with and advising various small businesses, including companies
4 unchanged sentences
with turning around the financial health and reputation of the Company, completing the product development, obtaining the device classification
−Removed: for animal therapy, and for setting the stage to obtaining IDE approval for human therapy.
+Added: for animal therapy, and breakthrough classification for the target indication for use, and for setting the stage to obtaining IDE approval
+Added: for human therapy.
Cadwell , Chairman of the Board and Secretary since December 2016, joined the Company as a director in 2006.
21 unchanged sentences
Public Accountants, as well as licensed to practice in New Jersey, and New York.
−Removed: Identification
−Removed: of Significant Consultants
Swanberg, M.S., P.E.
17 unchanged sentences
numerous technical publications and holds several patents.
+Added: Weeks is the Business Development Manager for Vivos Inc.
+Added: and both divisions IsoPet®
+Added: and RadioGel®.
+Added: Brad holds a Master of Business Administration (MBA) with a focus on Technology Management.
+Added: He brings a unique blend
+Added: of experience in service and support, regulatory affairs, quality management systems, and sales operations.
+Added: Brad possesses diverse experience
+Added: across the semiconductor and medical device industries.
+Added: He is co-lead of the animal sector and has earned deep respect for his leadership
+Added: Swindler is the Quality Assurance Manager for Vivos Inc.
+Added: Fred provides expertise in quality assurance and regulatory affairs
+Added: in the medical device industry specific emphasis in development and auditing of quality systems as well as product submissions.
+Added: holds an MBA and brings over 55 years of extensive experience to the Company.
and Veterinarian Advisory Boards
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image-guided radiosurgery, stereotactic body radiation therapy (SBRT), intensity modulated radiation therapy (IMRT), image guided radiation
−Removed: therapy (IGRT), high-dose rate (HDR) brachytherapy, cranial and extracranial stereotactic radiosurgery, respiratory gating, and Cyberknife.
+Added: therapy (IGRT), high-dose rate (HDR) precision radionuclide therapy, cranial and extracranial stereotactic radiosurgery, respiratory
+Added: gating, and Cyberknife.
DeNittis has served on numerous regional, national and government committees related to key issues in Dr.
46 unchanged sentences
Committee and Audit Committee Financial Expert
−Removed: of the date of this report, the Company has not established an audit committee, and therefore, the Company’s full board of directors
−Removed: performs the functions that customarily would be undertaken by an audit committee.
−Removed: The Company’s Board of Directors during 2023
−Removed: and 2022 was comprised of two directors, one of whom the Company had determined satisfied the general independence standards of the NASDAQ
−Removed: listing requirements.
+Added: of the date of this Offering Circular, the Company has not established an audit committee, and therefore, the Company’s full board
+Added: of directors performs the functions that customarily would be undertaken by an audit committee.
+Added: The Company’s Board of Directors
+Added: during 2024 and 2023 was comprised of two directors, one of whom the Company had determined satisfied the general independence standards
+Added: of the NASDAQ listing requirements.
Company’s Board of Directors has determined that none of its current members qualifies as an “audit committee financial expert,”
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Attendance at Meetings
−Removed: The Board held no meetings and acted by unanimous written consent two
−Removed: times during the year ended December 31, 2023.
−Removed: In 2022, we conducted no meetings of the Board of Directors, and the Board of Directors
−Removed: acted by unanimous written consent two times.
−Removed: We have no formal policy with respect to the attendance of Board members at annual meetings
−Removed: of shareholders but encourage all incumbent directors and director nominees to attend each annual meeting of shareholders.
+Added: Board held no meetings and acted by unanimous written consent two times during the year ended December 31, 2024.
+Added: held no meetings and acted by unanimous written consent two times during the year ended December 31, 2023.
+Added: We have no formal policy with
+Added: respect to the attendance of Board members at annual meetings of shareholders but encourage all incumbent directors and director nominees
+Added: to attend each annual meeting of shareholders.
EXECUTIVE COMPENSATION.
Compensation Table
−Removed: following table sets forth the compensation paid to the Company’s Chief Executive Officer and those executive officers that
−Removed: earned in excess of $100,000 during the year ended December 31, 2023 (collectively, the “Named Executive Officers ”):
+Added: following table sets forth the compensation paid to the Company’s Chief Executive Officer and those executive officers that earned
+Added: more than $100,000 during the year ended December 31, 2024 (collectively, the “Named Executive Officers ”):
and Principal Position (1)
−Removed: President and Director
+Added: CEO, President, and Director
Pollack began serving as the Company’s Interim Chief Financial Officer in December 2018 and was paid no compensation directly
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Agreement” ), which was scheduled to terminate on December 31, 2019.
−Removed: On June 4, 2019, Mr.
−Removed: Korenko and the Company entered into
−Removed: a new employment agreement, effective June 11, 2019, which shall terminate on December 31, 2020 and December 31 of subsequent years (the
−Removed: “ Termination Date” ) if the agreement is extended pursuant to its terms.
−Removed: Under the terms of his employment agreement,
−Removed: the Company may terminate Dr.
−Removed: Korenko’s employment either with or without cause prior to the Termination Date, but in the event
−Removed: of a termination without cause, Dr.
−Removed: Korenko shall be entitled to receive monthly payments of his base salary for a period of six months
−Removed: thereafter, all of Dr.
−Removed: Korenko’s outstanding options, if any, shall vest, and Dr.
−Removed: Korenko shall be entitled to receive all past
−Removed: due compensation within three weeks of the date of termination.
−Removed: Company shall pay to Dr.
−Removed: Korenko an annual base compensation of $180,000, which is payable in equal monthly intervals.
−Removed: Of the $180,000
−Removed: in annual base salary, $60,000 of annual pay shall be deferred and accrued until the Company’s cash balance exceeds $1,000,000,
−Removed: which occurred in December 2020.
−Removed: Korenko’s employment agreement provides that he shall receive a stock option grant issued
−Removed: under the Company’s 2015 Omnibus Securities and Incentive Plan in an amount equal to 21 million options ten days after the Company’s
−Removed: 1-for-8 reverse split, which was consummated in late June 2019.
−Removed: The options shall have a seven-year term, shall be exercisable at a price
−Removed: of $0.024 per share, and shall vest as follows:
−Removed: 50% shall vest in equal amounts at the end of each quarter for the two quarters after
−Removed: grant date, 25% shall vest upon the Company filing for a patent, and the remaining 25% shall vest upon the first commercial sale of IsoPet.
−Removed: In December 2020, Mr.
−Removed: Korenko exercised 2,500,000 of these options for $60,000.
−Removed: Company paid bonuses to certain employees based on their performance, the Company’s need to retain such employees, and funds available.
−Removed: All bonus payments were approved by the Company’s Board of Directors.
−Removed: June 4, 2019, the Company entered into an Executive Employment Agreement (“Employment Agreement”) with Dr.
−Removed: the Company’s Chief Executive Officer.
−Removed: The employment term under the Employment Agreement commenced with an effective date of June
−Removed: 11, 2019 and expires on December 31, 2020, and December 31 of each successive year if the Employment Agreement is extended, unless terminated
−Removed: earlier as set forth in the Employment Agreement.
−Removed: The Company on December 31, 2020 extended this agreement through December 31, 2021
−Removed: while renegotiating terms of a new Employment Agreement.
−Removed: On May 3, 2021, the Company and the Chief Executive Officer agreed the terms
−Removed: 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.
−Removed: The Company renewed the Employment Agreement for a term of two years expiring December 31, 2025.
+Added: On June 4, 2019, the Company entered into an Executive
+Added: Employment Agreement (“ Employment Agreement ”) with Dr.
+Added: Korenko, the Company’s Chief Executive Officer.
+Added: The employment term under the Employment Agreement commenced with an effective date of June 11, 2019 and expires on December 31, 2020,
+Added: and December 31 of each successive year if the Employment Agreement is extended, unless terminated earlier as set forth in the Employment
+Added: The Company on December 31, 2020 extended this agreement through December 31, 2021 while renegotiating terms of a new Employment
+Added: On May 3, 2021, the Company and the Chief Executive Officer agreed the terms of a new Employment Agreement with an effective
+Added: date of January 1, 2021 that has a term of three years and expired December 31, 2023.
+Added: The Company renewed the Employment Agreement for
+Added: a term of two years expiring December 31, 2025.
the terms of the Employment Agreement effective January 1, 2024, the Company shall pay to Dr.
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awards and the aggregate number of stock option awards that were outstanding as of December 31, 2024:
−Removed: June 2016, the Company granted to Mr.
−Removed: Cadwell options to purchase 12,500 shares of common stock at an exercise price of $8.00 per share,
−Removed: which options expired June 21, 2019.
−Removed: These options had a grant date fair value of $34,771, which amounts were calculated in accordance
−Removed: with ASC Topic 718.
−Removed: Additionally,
−Removed: the Company granted warrants to purchase 6,425,503 shares of Company common stock to Carlton Cadwell in 2018 as a result of the Path
−Removed: Forward Agreements and conversion of his advances to the Company.
−Removed: These warrants expired in October 2020.
are no employment contracts or compensatory plans or arrangements with respect to any director that would result in payments by the Company
6 unchanged sentences
following table sets forth, as of March 7, 2025, the number of shares of common stock beneficially owned by the following persons:
−Removed: all persons the Company knows to be beneficial owners of at least 5% of the Company’s common stock, (ii) the Company’s current
−Removed: directors, (iii) the Company’s current executive officers, and (iv) all current directors and executive officers as a group.
−Removed: of March 18, 2024, there were 389,894,033 shares of common stock outstanding and up to 56,746,379 shares issuable upon exercise of common
−Removed: stock equivalents, assuming exercise and conversion occurred as of that date, for a total of 446,640,412 shares.
+Added: (i) all persons the Company knows to be beneficial owners of at least 5% of the Company’s common stock, (ii) the Company’s
+Added: current directors, (iii) the Company’s current executive officers;
+Added: and (iv) all current directors and executive officers as a group.
+Added: 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
+Added: common stock equivalents, assuming exercise and conversion occurred as of that date, for a total of 497,226,185 shares.
and Address of Beneficial Owner (1)
and Nature of Beneficial Ownership (2)
−Removed: Family Irrevocable Trust
−Removed: Current Directors and Executive Officers as a group (3 individuals)
−Removed: address of each of the beneficial owners above is c/o Vivos Inc, 719 Jadwin Avenue, Richland, WA 99336, except that the address of
−Removed: the Cadwell Family Irrevocable Trust (the “ Cadwell Trust” ) is 909 North Kellogg Street, Kennewick, WA 99336.
+Added: Cadwell Family Irrevocable Trust
+Added: Michael Pollack
+Added: All Current Directors
+Added: and Executive Officers as a group (3 individuals)
+Added: address of each of the beneficial owners above is c/o Vivos Inc, 1030 N Center Parkway, Kennewick, WA 99352, except that the address
+Added: of the Cadwell Family Irrevocable Trust (the “ Cadwell Trust” ) is 909 North Kellogg Street, Kennewick, WA 99336.
determining beneficial ownership of the Company’s common stock as of a given date, the number of shares shown includes shares
1 unchanged sentence
In determining the
−Removed: percent of common stock owned by a person or entity on March 1, 2023, (a) the numerator is the number of shares of the class beneficially
−Removed: owned by such person or entity, including shares which may be acquired within 60 days on exercise of the common stock equivalents,
−Removed: and (b) the denominator is the sum of (i) the total shares of common stock outstanding on March 1, 2023, and (ii) the total number
−Removed: of shares that the beneficial owner may acquire upon conversion of the common stock equivalents.
−Removed: Subject to community property laws
−Removed: where applicable, the Company believes that each beneficial owner has sole power to vote and dispose of its shares, except that under
−Removed: the terms of the Cadwell Trust, Dr.
−Removed: Cadwell does not have or share voting or investment power over the shares beneficially owned
−Removed: by the Cadwell Trust.
+Added: percent of common stock owned by a person or entity on March [●], 2025, (a) the numerator is the number of shares of the class
+Added: beneficially owned by such person or entity, including shares which may be acquired within 60 days on exercise of the common stock
+Added: equivalents, and (b) the denominator is the sum of (i) the total shares of common stock outstanding on March [●], 2025, and
+Added: (ii) the total number of shares that the beneficial owner may acquire upon conversion of the common stock equivalents.
+Added: community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose of its
+Added: shares, except that under the terms of the Cadwell Trust, Dr.
+Added: Cadwell does not have or share voting or investment power over the
+Added: shares beneficially owned by the Cadwell Trust.
1,136,137 shares issuable upon conversion of Series A Preferred;
3 unchanged sentences
Ownership of the Company’s Series A Convertible Preferred Stock
−Removed: of March 18, 2024, there were 2,071,007 shares of Series A Preferred issued and outstanding, convertible into 2,588,758 shares of the
−Removed: Company’s common stock.
−Removed: following table sets forth, as of March 18, 2024, the number of shares of Series A Preferred beneficially owned by the following persons:
−Removed: (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
−Removed: current directors, (iii) the Company’s current executive officers, and (iv) all current directors and executive officers as a group.
−Removed: Name and Address of Beneficial Owner (1)
−Removed: Amount and Nature of Beneficial Ownership (2)
−Removed: Percent of Class
+Added: of March 7, 2025, there were 2,071,007 shares of Series A Preferred issued and outstanding, convertible into 2,588,758 shares
+Added: of the Company’s common stock.
+Added: following table sets forth, as of March 7, 2025, the number of shares of Series A Preferred beneficially owned by the following
+Added: (i) all persons the Company known to be beneficial owners of at least 5% of the Company’s Series A Preferred, (ii) the
+Added: Company’s current directors, (iii) the Company’s current executive officers, and (iv) all current directors and executive
+Added: officers as a group.
+Added: and Address of Beneficial Owner (1)
+Added: and Nature of Beneficial Ownership (2)
Cadwell Family Irrevocable Trust
−Removed: All Current Directors and Executive Officers as a group (2 individuals) (3)
+Added: Current Directors and Executive Officers as a group (2 individuals) (3)
Major Shareholder(s):
Bruce Jolliff
−Removed: address of each of the beneficial owners above is c/o Vivos Inc, 719 Jadwin Avenue, Richland, WA 99336, except that the address of
−Removed: (i) the Cadwell Family Irrevocable Trust (the “ Cadwell Trust ”) is 909 North Kellogg Street, Kennewick, WA 99336;
+Added: address of each of the beneficial owners above is c/o Vivos Inc, 1030 N Center Parkway, Kennewick, WA 99352, except that the address
+Added: of (i) the Cadwell Family Irrevocable Trust (the “ Cadwell Trust ”) is 909 North Kellogg Street, Kennewick, WA 99336;
Bruce Jolliff is 206 N 41st St.
6 unchanged sentences
Series A Convertible Preferred beneficially owned by the Cadwell Trust.
−Removed: Neither Michael Korenko, the Company’s Chief Executive Officer, nor Michael Pollack, the Company’s
−Removed: Interim Chief Financial Officer, hold any Company Series A Convertible Preferred, and therefore have been omitted from this table.
+Added: Michael Korenko, the Company’s Chief Executive Officer, nor Michael Pollack, the Company’s Interim Chief Financial Officer,
+Added: hold any Company Series A Convertible Preferred, and therefore have been omitted from this table.
Ownership of the Company’s Series B Convertible Preferred Stock
−Removed: of March 1 8, 2024, there were 200,363 shares of Series B Preferred issued and outstanding, convertible
−Removed: into 2,504.538 shares of the Company’s common stock.
−Removed: following table sets forth, as of March 18, 2024, the number of shares of Series B Preferred beneficially owned by the following persons:
−Removed: (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
−Removed: current directors, (iii) the Company’s current executive officers, and (iv) all current directors and executive officers as a group.
−Removed: Name and Address of Beneficial Owner (1)
−Removed: Amount and Nature of Beneficial Ownership (2)
−Removed: Percent of Class
−Removed: All Current Directors and Executive Officers as a group (3 individuals)
+Added: of March 7, 2025, there were 363 shares of Series B Preferred issued and outstanding, convertible into 4.538 shares of the Company’s
+Added: common stock.
+Added: following table sets forth, as of March [●], 2025, the number of shares of Series B Preferred beneficially owned by the following
+Added: (i) all persons the Company known to be beneficial owners of at least 5% of the Company’s Series B Preferred, (ii) the
+Added: Company’s current directors, (iii) the Company’s current executive officers, and (iv) all current directors and executive
+Added: officers as a group.
+Added: and Address of Beneficial Owner (1)
+Added: and Nature of Beneficial Ownership (2)
+Added: Directors and Executive Officers as a group (3 individuals)
Major Shareholder(s):
−Removed: Jason Adelman (3)
+Added: Firstfire Global Opportunities
of the Company’s directors and executive officers hold any shares of the Company’s Series B Convertible Preferred, and
1 unchanged sentence
The address of the beneficial owners is as follows:
−Removed: (i) Jason Adelman (JTA Resources
−Removed: is 40 East 66th St., New York, NY 10065.
+Added: (i) Firstfire Global Opportunities
to community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose of
−Removed: 200,000 shares of Series B Preferred held by JTA Resources LLC.
Ownership of the Company’s Series C Convertible Preferred Stock
−Removed: of March 18, 2024, there were 385,302 shares of Series C Preferred issued and outstanding, convertible into 4,816,275 shares of the Company’s
−Removed: common stock.
−Removed: following table sets forth, as of March 18, 2024, the number of shares of Series C Preferred beneficially owned by the following persons:
−Removed: (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
−Removed: current directors, (iii) the Company’s current executive officers, and (iv) all current directors and executive officers as a group.
−Removed: Name and Address of Beneficial Owner (1)
−Removed: Amount and Nature of Beneficial Ownership (2)
−Removed: Percent of Class
−Removed: All Current Directors and Executive Officers as a group (3 individuals) (3)
−Removed: address of each of the beneficial owners above is c/o Vivos Inc, 719 Jadwin Avenue, Richland, WA 99336.,
+Added: of March 7, 2025, there were 385,302 shares of Series C Preferred issued and outstanding, convertible into 4,816,275 shares of
+Added: the Company’s common stock.
+Added: following table sets forth, as of March 7, 2025, the number of shares of Series C Preferred beneficially owned by the following
+Added: (i) all persons the Company known to be beneficial owners of at least 5% of the Company’s Series C Preferred, (ii) the
+Added: Company’s current directors, (iii) the Company’s current executive officers, and (iv) all current directors and executive
+Added: officers as a group.
+Added: and Address of Beneficial Owner (1)
+Added: and Nature of Beneficial Ownership (2)
+Added: Current Directors and Executive Officers as a group (3 individuals) (3)
+Added: address of each of the beneficial owners above is c/o Vivos Inc, 1030 N Center Parkway, Kennewick, WA 99352.
to community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose of
8 unchanged sentences
from Related Parties
−Removed: has been no indebtedness from related parties for the years ended December 31, 2023 and 2022.
+Added: has been no indebtedness from related parties for the years ended December 31, 2024 and 2023, except for a brief period in December 2024
+Added: in the amount of $40,949.
Company’s common stock is traded on the OTCQB Marketplace, which does not impose any independence requirements on the Board of
20 unchanged sentences
and $4,500, respectively.
−Removed: All services performed by the Company’s Registered Public Accounting Firm, Fruci & Associates II, PLLC
−Removed: have been pre-approved by the Company’s Board of Directors.
+Added: All services performed by the Company’s Registered Public Accounting Firm, Fruci & Associates II,
+Added: PLLC have been pre-approved by the Company’s Board of Directors.
aggregate fees billed for professional services rendered by principal accountant for tax compliance, tax advice and tax planning during
−Removed: the years ended December 31, 2023 and 2022 were $3,500 and $3,250, respectively, all of which was paid to Fruci & Associates II,
+Added: the years ended December 31, 2024 and 2023 were $3,850 and $3,500, respectively, all of which was paid to Fruci & Associates
fees billed for products or services provided by the Company’s principal accountant during the years ended December 31, 2024 and
4 unchanged sentences
Balance Sheets as of December 31, 2024 and 2023, the Statements of Operations for the years
−Removed: ended December 31, 2023 and 2022, the Statements of Changes in Stockholders’ Deficit for the years ended December 31, 2023
+Added: 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
7 unchanged sentences
system in Item 601 of Regulation S-K.
−Removed: 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.
−Removed: 000-53497) filed on November 12, 2008).
−Removed: By-Laws (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form 10-12G (File No.
+Added: of Incorporation of Savage Mountain Sports Corporation, dated January 11, 2000 (incorporated by reference to Exhibit 3.1 to the Company’s
+Added: Registration Statement on Form 10-12G (File No.
000-53497) filed on November 12, 2008).
−Removed: 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.
+Added: (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form 10-12G (File No.
+Added: 000-53497) filed
+Added: on November 12, 2008).
+Added: of Amendment of Certificate of Incorporation changing the name of the Company to Advanced Medical Isotope Corporation, dated May
+Added: 23, 2006 (incorporated by reference to Exhibit 3.5 to the Company’s Registration Statement on Form 10-12G (File No.
filed on November 12, 2008).
−Removed: 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.
+Added: of Amendment of Certificate of Incorporation increasing authorized capital dated September 26, 2006 (incorporated by reference to
+Added: Exhibit 3.6 to the Company’s Registration Statement on Form 10-12G (File No.
000-53497) filed on November 12, 2008).
−Removed: 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).
−Removed: 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).
−Removed: 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).
−Removed: 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).
−Removed: 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).
−Removed: 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).
−Removed: 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).
−Removed: 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).
−Removed: 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).
−Removed: 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).
−Removed: Agreement and Plan of Reorganization, dated as of December 15, 1998, by and among HHH Entertainment, Inc.
+Added: of Amendment to the Certificate of Incorporation increasing authorized common stock and authorizing preferred stock, dated May 18,
+Added: 2011 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on May 18, 2011).
+Added: of Amendment to the Certificate of Incorporation authorizing a series of Preferred Stock to be named “Series A Convertible
+Added: Preferred Stock”, consisting of 2,500,000 shares, which series shall have specific designations, powers, preferences and relative
+Added: and other special rights, qualifications, limitations and restrictions as outlined in the Certificate of Designations, filed June
+Added: 30, 2015 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on July 7, 2015).
+Added: of Amendment to the Certificate of Incorporation increasing the authorized series of “Series A Convertible Preferred Stock”
+Added: to 5,000,000 shares, filed March 31, 2016 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form
+Added: 8-K filed on April 7, 2016).
+Added: of Amendment to the Certificate of Incorporation authorizing a series of Preferred Stock to be named “Series B Convertible
+Added: Preferred Stock”, consisting of 5,000,000 shares, which series shall have specific designations, powers, preferences and relative
+Added: and other special rights, qualifications, limitations and restrictions as outlined in the Certificate of Designations, filed October
+Added: 10, 2018 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on October 17, 2018).
+Added: of Designations, Preferences and Rights of Series C Convertible Preferred Stock of Vivos Inc., dated March 27, 2019 (incorporated
+Added: by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed on April 2, 2019).
+Added: of Amendment to its Certificate of Incorporation of Vivos Inc., as amended, effecting a 1-for-8 reverse split, dated June 26, 2019
+Added: (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 2, 2019).
+Added: of Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on October 17, 2018).
+Added: 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,
+Added: 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,
+Added: of Series C Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on December
+Added: and Plan of Reorganization, dated as of December 15, 1998, by and among HHH Entertainment, Inc.
and Earth Sports Products, Inc.
−Removed: (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form 10-12G (File No.
+Added: (incorporated
+Added: by reference to Exhibit 10.1 to the Company’s Registration Statement on Form 10-12G (File No.
000-53497) filed on November
−Removed: Agreement and Plan of Merger of HHH Entertainment, Inc.
−Removed: 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.
+Added: and Plan of Merger of HHH Entertainment, Inc.
+Added: and Savage Mountain Sports Corporation, dated as of January 6, 2000 (incorporated by
+Added: reference to Exhibit 10.2 to the Company’s Registration Statement on Form 10-12G (File No.
000-53497), filed on November 12,
−Removed: 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.
+Added: and Plan of Acquisition by and between Neu-Hope Technologies, Inc., UTEK Corporation and Advanced Medical Isotope Corporation, dated
+Added: September 22, 2006 (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form 10-12G (File
000-53497), filed on November 12, 2008).
−Removed: 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.
+Added: and Plan of Acquisition by and between Isonics Corporation and Advanced Medical Isotope Corporation dated June 13, 2007 (incorporated
+Added: by reference to Exhibit 10.6 to the Company’s Registration Statement on Form 10-12G (File No.
000-53497), filed on November
−Removed: 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).
−Removed: Promissory Note dated December 16, 2008 between Advanced Medical Isotope Corporation and Carlton M.
−Removed: Cadwell (incorporated by reference to Exhibit 10.11 to the Company’s Annual Report on Form 10-K filed on March 3, 2012).
−Removed: 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).
−Removed: 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).
−Removed: The Curators of the University of Missouri Sponsored Research Contract for the period November 1, 2017 through October 31, 2018.
−Removed: (incorporated by reference to Exhibit 10.14 to the Company’s Annual report on Form 10-K, filed April 2, 2018).
−Removed: 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).
−Removed: Employment Agreement between Vivos Inc.
−Removed: 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.
−Removed: Amended and Restated Employment Agreement between Vivos Inc.
+Added: of Non-Statutory Stock Option Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form
+Added: 8-K filed on March 15, 2012).
+Added: Note dated December 16, 2008 between Advanced Medical Isotope Corporation and Carlton M.
+Added: Cadwell (incorporated by reference to Exhibit
+Added: 10.11 to the Company’s Annual Report on Form 10-K filed on March 3, 2012).
+Added: Omnibus Securities and Incentive Plan (incorporated by reference to Exhibit 10.12 to the Company’s Annual Report on Form 10-K,
+Added: filed May 25, 2016).
+Added: State University Sub-Award Agreement for the period December 15, 2017 through January 31, 2018.(incorporated by reference to Exhibit
+Added: 10.13 to the Company’s Annual report on Form 10-K, filed April 2, 2018).
+Added: Curators of the University of Missouri Sponsored Research Contract for the period November 1, 2017 through October 31, 2018.
+Added: (incorporated
+Added: by reference to Exhibit 10.14 to the Company’s Annual report on Form 10-K, filed April 2, 2018).
+Added: of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed
+Added: on October 17, 2018).
+Added: Agreement between Vivos Inc.
+Added: and Michael Korenko, dated May 3, 2021 (incorporated by reference to Exhibit 10.1 to the Company’s
+Added: Current Report on Form 8-K filed on May 7, 2021.
+Added: and Restated Employment Agreement between Vivos Inc.
and Michael Korenko.
−Removed: Dated December 19, 2023, with a deemed effective date of January 1, 2024
−Removed: 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).
−Removed: 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.
+Added: Dated December 19, 2023, with a deemed effective date of
+Added: January 1, 2024 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed March 25, 2024).
+Added: of Series C Warrant Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K
+Added: filed on December 27, 2023).
+Added: of Warrant Exchange Agreement (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed
+Added: on December 27, 2023.
Consent of Independent Registered Public Accounting Firm
47 unchanged sentences
accompanying financial statements have been prepared assuming that the Company will continue as a going concern.
−Removed: As discussed in
−Removed: Note 1 to the financial statements, the Company has recurring losses and used significant cash in support of its operating
−Removed: activities and the Company’s cash position is not sufficient to support the Company’s operations.
+Added: As discussed in Note
+Added: 1 to the financial statements, the Company has a history of net losses, and negative cash flows from operations.
These factors, among
2 unchanged sentences
to these matters are also described in Note 1.
−Removed: The financial statements do not include any adjustments that might result from the
−Removed: outcome of this uncertainty.
+Added: The financial statements do not include any adjustments that might result from the outcome
+Added: of this uncertainty.
financial statements are the responsibility of the Company’s management.
22 unchanged sentences
Audit Matters
−Removed: critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated
−Removed: or required to be communicated to the audit committee and that:
−Removed: (1) relate to accounts or disclosures that are material to the financial
−Removed: statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of critical audit matters
−Removed: does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit
−Removed: matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
−Removed: Transactions (Notes 3 and 4 to the financial statements)
−Removed: of the Critical Audit Matter
−Removed: Company’s evaluation of common shares issuances, including in exchange for stock warrants involved complexity and judgement in
−Removed: applying the relevant accounting standards when auditing management’s conclusions on the classification and recognition of warrants
−Removed: on issuance and on exercise and equity transactions upon issuance.
−Removed: the Critical Audit Matter Was Addressed in the Audit
−Removed: principal audit procedures to evaluate management’s calculation and recording of common share issuances included the following:
−Removed: We evaluated the appropriateness and consistency of management’s methods and assumptions used in the identification, recognition,
−Removed: measurement, and disclosure of equity-based securities issuances during the year, including the classification with respect to the terms
−Removed: and in considering applicable generally accepted accounting standards.
−Removed: We read the applicable agreements and compared to key terms to management’s analysis of the transaction, and we evaluated,
−Removed: and tested the reasonableness of management’s calculation utilized in the determination of common shares issued, including exchange for
−Removed: stock warrants.
−Removed: We evaluated whether management had appropriately considered new information that could significantly change the measurement or
−Removed: disclosure of common shares issued including exchange for stock warrants, and evaluated the disclosures related to the financial statement
−Removed: impacts of the transactions.
−Removed: reviewed current and subsequent period accounting records and third-party documentation to identify unrecorded equity transactions.
+Added: audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be
+Added: communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and
+Added: (2) involved our especially challenging, subjective, or complex judgments.
+Added: We determined that there were no critical audit matters.
Fruci & Associates II, PLLC – PCAOB ID #05525
−Removed: have served as the Company’s auditor since 2016.
−Removed: & Associates II, PLLC
+Added: We have served as the Company’s auditor since 2016.
+Added: Spokane, Washington
+Added: March 24, 2025
31, 2024 AND 2023
−Removed: DECEMBER 31, 2023
−Removed: DECEMBER 31, 2022
Current Assets:
Accounts receivable
−Removed: Prepaid expense
+Added: Prepaid expenses
Total Current Assets
1 unchanged sentence
Current Liabilities:
−Removed: Accounts payable and accrued expense
+Added: Accounts payable and accrued expenses
Total Current Liabilities
2 unchanged sentences
STOCKHOLDERS’ EQUITY
−Removed: 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
+Added: Preferred stock, par value, $ 0.001 , 20,000,000 shares authorized, Series A
+Added: Convertible Preferred, 5,000,000 shares authorized, 2,071,007 shares issued and outstanding, respectively
Additional paid in capital - Series A Convertible preferred stock
−Removed: Series B Convertible Preferred, 5,000,000 shares authorized, 200,363 shares issued and outstanding, respectively
+Added: Series B Convertible Preferred, 5,000,000 shares authorized, 363 and 200,363 shares
+Added: issued and outstanding, respectively
Additional paid in capital - Series B Convertible preferred stock
Series C Convertible Preferred, 5,000,000 shares authorized, 385,302 shares issued and outstanding, respectively
+Added: Preferred stock, value
Additional paid in capital - Series C Convertible preferred stock
Additional paid in capital
−Removed: Common stock, par value, $ 0.001 , 950,000,000 shares authorized, 387,894,033 and 362,541,528 issued and outstanding, respectively
+Added: Common stock, par value, $ 0.001 , 950,000,000 shares authorized, 440,873,806 and
+Added: 387,894,033 issued and outstanding, respectively
Additional paid in capital - common stock
+Added: Subscriptions receivable
Accumulated deficit
6 unchanged sentences
THE YEARS ENDED DECEMBER 31, 2024 AND 2023
−Removed: DECEMBER 31, 2023
−Removed: DECEMBER 31, 2022
−Removed: Revenues, net
−Removed: Cost of Goods Sold
−Removed: Gross (loss) profit
−Removed: OPERATING EXPENSE
−Removed: Professional fees, including stock-based compensation
−Removed: Payroll expense
−Removed: Research and development expense
−Removed: General and administrative expense
−Removed: Total Operating Expenses
−Removed: OPERATING LOSS
+Added: of Goods Sold
+Added: fees, including stock-based compensation
+Added: and development
+Added: and administrative expenses
+Added: Operating Expenses
( 2,604,384 )
( 2,793,146 )
−Removed: NON-OPERATING INCOME (EXPENSE)
−Removed: Interest income
−Removed: Loss on issuance of shares
−Removed: Gain on debt extinguishment
−Removed: Total Non-Operating Income (Expense)
−Removed: NET LOSS BEFORE PROVISION FOR INCOME TAXES
+Added: NON-OPERATING
+Added: INCOME (EXPENSE)
+Added: on issuance of shares and exchange of warrants
+Added: Non-Operating Expenses
+Added: LOSS BEFORE PROVISION FOR INCOME TAXES
( 2,910,448 )
( 2,894,753 )
−Removed: Provision for income taxes
+Added: for income taxes
$ ( 2,910,448 )
$ ( 2,894,753 )
−Removed: Net loss per share - basic and diluted
−Removed: Weighted average common shares outstanding
+Added: loss per share - basic and diluted
+Added: average common shares outstanding
accompanying notes are an integral part of these financial statements.
1 unchanged sentence
THE YEARS ENDED DECEMBER 31, 2024 AND 2023
−Removed: Series A Preferred
−Removed: Series B Preferred
−Removed: Series C Preferred
−Removed: Balance - December 31, 2021
+Added: - December 31, 2022
$ ( 79,556,028 )
−Removed: Stock issued for:
−Removed: Accounts payable
−Removed: Fractional adjustment
−Removed: Warrant exercises
−Removed: Warrants purchased for cash
−Removed: RSUs granted to consultants that have vested
−Removed: Net loss for the year
+Added: exercises and exchanges
+Added: purchased for cash
+Added: granted to consultants that have vested
+Added: loss for the year
( 2,894,753 )
( 2,894,753 )
−Removed: Balance - December 31, 2022
+Added: - December 31, 2023
( 82,450,781 )
−Removed: Balance - December 31, 2022
( 82,450,781 )
+Added: of warrants (cash and cashless)
+Added: of preferred stock to common stock
+Added: for vested RSUs
( 1,162,500 )
−Removed: Stock issued for:
−Removed: Accounts payable
−Removed: Warrant exercises and exchanges
−Removed: Warrants purchased for cash
−Removed: RSUs granted to consultants that have vested
−Removed: Net loss for the year
+Added: purchased for cash
+Added: granted to consultants that have vested
+Added: loss for the year
( 2,910,448 )
( 2,910,448 )
−Removed: Balance - December 31, 2023
+Added: - December 31, 2024
$ ( 85,361,229 )
9 unchanged sentences
RSUs issued for services
−Removed: Loss on issuance of shares
−Removed: (Gain) on conversion of debt
+Added: Loss on issuance of shares and warrants
Changes in assets and liabilities
Accounts receivable
−Removed: Prepaid expense and other assets
−Removed: Accounts payable and accrued expense
+Added: Prepaid expenses and other assets
+Added: Accounts payable and accrued expenses
Total adjustments
3 unchanged sentences
CASH FLOWS FROM FINANCING ACTIVITES
+Added: Proceeds from short-term advances from related party
+Added: Payments of related party notes
+Added: Exercise of warrants
Proceeds from common stock and warrants
Net cash provided by financing activities
−Removed: NET (DECREASE) INCREASE IN CASH
+Added: NET INCREASE (DECREASE) IN CASH
CASH- BEGINNING OF YEAR
CASH - END OF YEAR
−Removed: CASH PAID DURING THE PERIOD FOR:
+Added: CASH PAID DURING THE YEAR FOR:
Interest expense
7 unchanged sentences
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
−Removed: Company was incorporated under the laws of Delaware on December 23, 1994 as Savage Mountain Sports Corporation (“ SMSC ”).
−Removed: On September 6, 2006, the Company changed its name to Advanced Medical Isotope Corporation, and on December 28, 2017, the Company began
−Removed: operating as Vivos Inc.
−Removed: The Company has authorized capital of 950,000,000 shares of common stock, $ 0.001 par value per share, and 20,000,000
−Removed: shares of preferred stock, $ 0.001 par value per share.
−Removed: principal place of business is located at 719 Jadwin Avenue, Richland, WA 99352.
−Removed: Our telephone number is (509) 736-4000.
−Removed: Our corporate
−Removed: website address is http://www.radiogel.com.
−Removed: Our common stock is currently quoted on the OTC Pink Marketplace under the symbol “RDGL.”
−Removed: Company is a radiation oncology medical device company engaged in the development of its yttrium-90 (“ Y-90 ”)
−Removed: based brachytherapy device, RadioGel ™ , for the treatment of non-resectable tumors.
−Removed: A prominent team of
−Removed: radiochemists, scientists and engineers, collaborating with strategic partners, including national laboratories, universities and
−Removed: private corporations, lead the Company’s development efforts.
−Removed: The Company’s overall vision is to globally empower
−Removed: physicians, medical researchers and patients by providing them with new isotope technologies that offer safe and effective
−Removed: treatments for cancer.
−Removed: January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel ™ should be classified
−Removed: as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.
+Added: (the “ Company ,” “ we ,” “ us ,” “ our ”) is a radiation oncology
+Added: medical device company engaged in the development of its yttrium-90 (“ Y-90 ”) based precision radionuclide therapy
+Added: device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide Therapy TM .
+Added: A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories,
+Added: universities, and private corporations, lead the Company’s development efforts.
+Added: The Company’s overall vision is to globally
+Added: empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments
+Added: 2013, the United States Food and Drug Administration (“ FDA ”) issued the determination that RadioGel™ is a device
+Added: for human therapy for non-resectable cancers in humans.
+Added: This should result in a faster path than a drug for final approval.
+Added: January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel TM should be classified as
+Added: a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.
Additionally, after a legal review, the Company believes
−Removed: that the device classification obtained from the Food and Drug Administration (“ FDA ”) Center for Veterinary Medicine
−Removed: is not limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers, including
−Removed: all or most solid tumors in animals.
−Removed: We expect the result of such classification and label review will be that no additional regulatory
−Removed: approvals are necessary for the use of IsoPet ® for the treatment of solid tumors in animals.
−Removed: The FDA does not have premarket
−Removed: authority over devices with a veterinary classification, and the manufacturers are responsible for assuring that the product is safe,
−Removed: effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.
−Removed: on the FDA’s recommendation, RadioGel ™ will be marketed as “IsoPet ® ” for use by veterinarians
+Added: that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas, but
+Added: rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals.
+Added: We expect the
+Added: result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet ®
+Added: for the treatment of solid tumors in animals.
+Added: The FDA does not have premarket authority over devices with a veterinary classification,
+Added: and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance
+Added: with all applicable laws and regulations.
+Added: 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 ® ”
−Removed: IsoPet ® and RadioGel ™ are used synonymously throughout this document.
−Removed: The only distinction between
−Removed: IsoPet ® and RadioGel ™ is the FDA’s recommendation that we use “IsoPet ® ”
−Removed: for veterinarian usage, and reserve “RadioGel ™” for human therapy.
−Removed: Based on these developments, the Company
−Removed: has shifted its primary focus to the development and marketing of Isopet ® for animal therapy, through the Company’s
−Removed: IsoPet ® Solutions division.
−Removed: Company’s IsoPet ® Solutions division was established in May 2016 to focus on the veterinary oncology market, namely
−Removed: engagement of university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of
−Removed: the technology in private clinics.
−Removed: The Company has worked with three different university veterinarian hospitals on IsoPet ®
+Added: IsoPet ® and RadioGel TM are used synonymously throughout this document.
+Added: The only distinction between IsoPet ®
+Added: and RadioGel TM is the FDA’s recommendation that we use “IsoPet ® ” for veterinarian usage,
+Added: and reserve “RadioGel TM” for human therapy.
+Added: Historically, the Company’s primary focus was on the development
+Added: and marketing of Isopet ® for animal therapy, through the Company’s IsoPet ® Solutions division.
+Added: the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device
+Added: Exemption and to obtain approval for clinical trials in India.
+Added: Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement of
+Added: university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of the technology
+Added: in private clinics.
+Added: In January 2025 the Company restructured and aligned its internal resources and focused effort to align with animal
+Added: therapy, human therapy, and recently other applications of its patented technologies.
+Added: Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet ® /RadioGel TM
testing and therapy.
4 unchanged sentences
demonstrated the CT and PET-CT imaging of IsoPet ® .
−Removed: A contract was signed with University of Missouri to treat canine sarcomas
−Removed: and equine sarcoids starting in November 2017.
−Removed: dogs were treated for canine soft tissue sarcoma.
−Removed: Response evaluation criteria in solid tumors (“ RECIST ”) is a set
−Removed: of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during
−Removed: The criteria were published by an international collaboration including the European Organisation for Research and Treatment
−Removed: of Cancer (“ EORTC ”), National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical
−Removed: Trials Group.
−Removed: testing at the University of Missouri met its objective to demonstrate the safety of IsoPet ® .
−Removed: Using its advanced CT and
−Removed: PET equipment it was able to demonstrate that the dose calculations were accurate and that the injections perfused into the cell interstices
−Removed: and did not stay concentrated in a bolus.
−Removed: This results in a more homogeneous dose distribution.
−Removed: There was insignificant spread of Y-90
−Removed: outside the points of injection demonstrating the effectiveness of the particles and the gel to localize the radiation with no spreading
−Removed: to the blood or other organs nor to urine or fecal material.
−Removed: This confirms that IsoPet ® is safe for same day therapy.
−Removed: effectiveness of IsoPet ® for life extension was not the prime objective, but it resulted in valuable insights.
−Removed: cases one is still cancer-free but the others eventually recurred since there was not a strong focus on treating the margins.
−Removed: The University
−Removed: of Missouri has agreed to become a regional center to administer IsoPet ® therapy and will incorporate the improvements
−Removed: suggested by the testing program.
−Removed: The Company anticipates that future profits, if any, will be derived
−Removed: from direct sales of RadioGel ™ (under the name IsoPet ® ) and related services, and from licensing to private
−Removed: medical and veterinary clinics in the United States of America (the “ USA ”, or, the “ U.S.
−Removed: ”) and internationally.
−Removed: The Company intends to report the results from the IsoPet ® Solutions division as a separate operating segment in accordance
−Removed: with generally accepted accounting principles (“ GAAP ”).
−Removed: Commencing in July 2019, the Company recognized its first commercial
−Removed: sale of IsoPet ® .
−Removed: A veterinarian from Alaska brought his cat with a re-occurrent spindle cell sarcoma tumor on his face.
+Added: The University of Missouri conducted an animal study to treat canine
+Added: Johns Hopkins University completed a study on VX2 Tumors in Rabbits.
+Added: Every study confirmed that the Y-90 stayed at the injection
+Added: site with insignificant distribution outside that boundary.
+Added: in July 2019, the Company recognized its first commercial sale of IsoPet®.
+Added: A veterinarian from Alaska brought his cat with a re-occurrent
+Added: spindle cell sarcoma tumor on his face.
The cat had previously received external beam therapy, but now the tumor was growing rapidly.
−Removed: He was given a high dose of 400 Gray with
−Removed: heavy therapy at the margins.
−Removed: This sale met the revenue recognition requirements under Financial Accounting Standards Board (“ FASB ”)
−Removed: Accounting Standards Codification (“ ASC ”) Topic 606 – Revenue from Contracts with Customers (“ ASC 606 ”)
−Removed: as the performance obligation was satisfied.
−Removed: The Company completed sales for an additional four animals that received the IsoPet ®
−Removed: Our plan is to incorporate the data assembled from our work with Isopet ®
−Removed: in animal therapy to support the Company’s efforts in the development of our RadioGel ™ device candidate, including
−Removed: obtaining approval from the FDA to market and sell RadioGel ™ as a Class II medical device.
−Removed: is an injectable particle-gel for brachytherapy radiation treatment of cancerous tumors in people and animals.
−Removed: is comprised of a hydrogel, or a substance that is liquid at room temperature and then gels when reaching body temperature after injection
−Removed: into a tumor.
−Removed: In the gel are small particles, less than two microns, of Y-90.
−Removed: Once injected, these inert particles are locked in place
−Removed: inside the tumor by the gel, delivering a very high local radiation dose.
+Added: He was given a high dose of 400Gy with heavy therapy at the margins.
+Added: Company anticipates that any near-term profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet ® )
+Added: and related services, and from certifying veterinary clinics to administer IsoPet Therapy.
+Added: Until recently the Company certified clinics
+Added: 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
+Added: plan is to incorporate the data assembled from our work with Isopet ® in animal therapy to support the Company’s
+Added: efforts in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell RadioGel™
+Added: as a Class II medical device.
+Added: RadioGel™ is an injectable particle-gel for Precision Radionuclide Therapy radiation treatment of
+Added: cancerous tumors in people and animals.
+Added: RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature
+Added: and then gels when reaching body temperature after injection into a tumor.
+Added: In the gel are small, less than two microns, Y-90 phosphate
+Added: Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local radiation
The radiation is beta, consisting of high-speed electrons.
−Removed: electrons only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the surrounding tissue.
−Removed: Optimally, patients can go home immediately following treatment without the risk of radiation exposure to family members.
−Removed: Since Y-90 has
−Removed: a half-life of 2.7 days, the radioactivity drops to 5% of its original value after ten days.
−Removed: the Company modified its Indication for Use from skin cancel to cancerous tissue or solid tumors pathologically associated with locoregional
−Removed: papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic lymph nodes
−Removed: or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require post-surgical
+Added: These electrons only travel a short distance so the device can deliver
+Added: high radiation to the tumor with minimal dose to the surrounding tissue.
+Added: Optimally, patients can go home immediately following treatment
+Added: without the risk of radiation exposure to family members.
+Added: Since Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its
+Added: original value after ten days.
+Added: 2021 the Company modified its Indication for Use from skin cancer to cancerous tissue or solid tumors pathologically associated with
+Added: locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic
+Added: 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).
2 unchanged sentences
The Company’s Medical Advisory
−Removed: Board felt that demonstrating efficacy in clinical trials was much easier with this new indication.
−Removed: Our original license with Battelle National Laboratory (the “ Battelle
−Removed: License ”) reached its end of life in 2022.
−Removed: During the past several years, we have expanded our proprietary knowledge, as well
−Removed: as our trademark and patent protection, in anticipation of the Battelle License reaching the end of its term.
−Removed: Our RadioGel TM trademark protection is in 17 countries.
−Removed: We have expanded our trademark protection from RadioGel TM to now include IsoPet ® .
−Removed: We obtained the International
−Removed: Certificate of Registration for ISOPET, which is the first step to file in several countries .
−Removed: have filed for trademark protection for the term Precision Radionuclide Therapy TM.
−Removed: We believe this term will be increasingly
−Removed: Company received the Patent Cooperation Treaty (“ PCT ”) International Search Report on our patent application (No.1811.191).
−Removed: Seven of our claims were immediately ruled as having novelty, inventive step and industrial applicability.
−Removed: This gives us the basis to
−Removed: extend for many years the patent protection for our proprietary Y-90 phosphate particles utilized in Isopet ® and Radiogel™.
−Removed: Our patent team filed our particle patent in more than ten patent offices
−Removed: that collectively cover 63 countries throughout the world.
−Removed: We filed a continuation-in-part applications number 1774054 in the USA to expand
−Removed: the claims on our particle patent.
−Removed: Patent office recently gave us the Notice of Allowance for our patent to produce our yttrium
−Removed: phosphate microparticles, U.S.
−Removed: Patent Application Serial No:
−Removed: We also filed an amendment to correct the wording on our claims
−Removed: at make them consistent with the USE claims.
−Removed: European Patent Application NO.
−Removed: 20 834 229.5;
−Removed: filed a hydrogel utility patent in the USA (16309:17/943,311) and internationally (16389:PCT/US22/4374) based on the last 18 months
−Removed: of development work to optimize our hydrogel component.
−Removed: These include reducing the polymer production time and increasing the output
−Removed: by a factor of three.
−Removed: We have also further reduced the level of trace contaminants to be well below the FDA guidelines.
−Removed: filed a provisional patent (Serial Number 63436562) to protect our innovative improvements in our shipping container, our vial shield,
−Removed: our syringe shield, and our Peltier chiller.
−Removed: Our objectives were to reduce shipping costs, decrease radiation exposure, and enhance sterility.
−Removed: These devices will be preferentially used at Mayo Clinics for human clinical studies at and our IsoPet regional treatment centers.
−Removed: Company filed a utility patent in Q4 2023 for this therapy support equipment.
−Removed: We anticipate that Precision Radionuclide Therapy will become increasingly
−Removed: important in the future and expand to other isotope and other indications for use.
−Removed: Therefore, we filed an alternate particle utility patent
−Removed: (Serial number 18/152,137).
−Removed: We will focus our near-term effort on the Y-90 therapy, which we believe is the best beta emitter;
−Removed: we leveraged our hydrogel utility patent to incorporate other promising isotopes and compounds for a range of future applications.
−Removed: includes gamma and alpha particle emitters.
+Added: Board felt that demonstrating efficacy in clinical trials with this new indication provided a more efficient pathway to regulatory clearance.
+Added: December 2023, the Food and Drug Administration granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device
+Added: pursuant to the FDA’s Breakthrough Devices Program.
+Added: This gave the company access to the “sprint” rapid review process
+Added: for IDE comments.
+Added: For the last several months the company has been taking advantage of that program to resoled detailed FDA questions
+Added: on a variety of topics.
+Added: early 2025 the Company began actively pursuing human clinical trials in India.
+Added: This involved successful step-by-step implementation of
+Added: several requirements, including location of a respected lead investigator at a respected hospital;
+Added: regulatory approvals (securing clearances
+Added: from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health
+Added: & Family Welfare, and the Company was issued the Clinical Trial Registry-India (CTRI) number required for publishing results);
+Added: coordination (acquired liability insurance, expanded the treatment institution’s radioactive material license to include RadioGel ® ,
+Added: and established robust international shipping protocols and an alternate contingency shipping path for the Yttrium-90 (Y-90)-based product);
+Added: protocol development (finalized the Clinical Trial Protocol, incorporating Mayo Clinic study designs and feedback from FDA pre-submission
+Added: discussions);
+Added: operational readiness (re-validated RadioGel ® manufacturing at IsoTherapeutics to ensure compliance with
+Added: Quality Management System standards and FDA sterility and validation recommendations);
+Added: administrative preparations (signed agreements
+Added: with the Ethics Committee and treatment institution while confirming trademark and patent protections in the region);
+Added: and training and
+Added: certification (conducted comprehensive certification training for the treatment team).
+Added: Failure on any step would have terminated the effort.
+Added: December 2024 the Company conducted an important offset strategic meeting to ensure that its entire key internal and external team was
+Added: alighted to its strategic plans.
+Added: Attendees included all our current internal team members, our senior health physics volunteer, the members
+Added: of the Medical Advisory Board and the Veterinary Medicine Advisory Board, lead Investigator for the proposed Mayo Clinic clinical trial,
+Added: lead investigator for the clinical trial in India, and our patent attorney.
+Added: The primary objective was to re-assess our business direction,
+Added: to select the next target series of indications for Use, to ensure that we have developed the optimum precision Radionuclide Therapy TM
+Added: approach for each cancer type, including the isotope, the delivery technique, and the dose, and to ensure that our current and
+Added: future patents protect these directions.
+Added: It also discussed the domestic and internation plans.
+Added: Company decided to explore the viability of harvesting its technology for other business opportunities as a separate “division.”
+Added: The Company is working with Akina, on these initiatives.
+Added: The current efforts are on the Peltier Chiller technology and the hydrogel.
+Added: To prevent the Company from being distracted from its primary focus of treating cancer, if viable, Akina would probably also be the principal
+Added: Alternatively, each business sector can be spun off as separate business activities to an interested party.
+Added: Laboratory Chilling - As Akina explained, it is easy to purchase many laboratory devices to control heating, but there are limited or
+Added: no options for controlled cooling, which is a common laboratory requirement usually involving ice baths.
+Added: The Company is now testing a
+Added: prototype universal laboratory cooling device.
+Added: – the Company spent years on refining the development of its hydrogel, in which gelation initiates just above room temperature
+Added: and is completed as it warms to body temperature.
+Added: It is currently investing in quantifying and controlling the hydrogel resorption characteristics.
+Added: There has been sufficient spontaneous interest in this component to warrant a serious business case assessment.
+Added: The Company just trademarked
+Added: the name Precision Gel TM and, in addition to its current hydrogel patent, has filed a new provisional patent in January 2025
+Added: to cover retention, transport, and release of a broad range of agents.
+Added: These agents include radioactive and non-radioactive materials,
+Added: solid particles, including nano-particles, large molecules, small molecules, including liquids, cells, and viruses.
+Added: A MOU has been drafted
+Added: to interface with potential clients including licensing and exclusive material contracting.
+Added: Initial meetings are scheduled in the first
+Added: quarter of 2025 with potential clients to assess the business viability.
+Added: original license agreement with Battelle National Laboratory (the “ Battelle License ”) reached its end of life in 2022.
+Added: We have expanded our proprietary knowledge, as well as our trademark and patent protection, in anticipation of the Battelle License reaching
+Added: the end of its term during the past several years.
+Added: trademark protection, which usually is extended to 17 countries, has been expanding continuously as summarized below:
+Added: own applications/registrations for the following and should mark as noted below:
+Added: ○ ALPHA-GEL TM
+Added: ○ BETA-GEL TM
+Added: ○ GAMMA-GEL TM
+Added: RADIONUCLIDE THERAPY TM
+Added: ○ PRECISIONGEL TM
+Added: we have systematically filed provisional and utility patents that cover our key components, hydrogel and the yttrium phosphate
+Added: particles, and our injection system in the US office and more than ten others covering approximately 63 counties.
+Added: January 2025 we filed an additional provisional patent on the control, transport, and delivery of PrecisionGel.
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
7 unchanged sentences
annually to maintain current operating activities.
−Removed: Company completed its reverse stock split which was approved by FINRA and went effective on June 28, 2019.
−Removed: Company’s stock offering under Regulation A+ was qualified by the Securities and Exchange Commission (“ SEC ”)
−Removed: on June 3, 2020.
−Removed: A second Regulation A+ offering was qualified by the SEC on September 15, 2021, pursuant to the Company’s offering
−Removed: statement on Form 1-A (File No.
−Removed: 024-11627) (the “ Offering Statement ”) to raise capital by selling 50,000,000
−Removed: shares at a price of $ 0.10
−Removed: per share, for a maximum offering of $ 5,000,000
−Removed: (the “ Regulation A+ Offering ”).
−Removed: In July 2022, the Company amended the Offering Statement, which the Company raised $ 1,200,000
−Removed: per share ( 15,000,000
−Removed: shares) and sold 20,000,000
−Removed: warrants for $ 20,000 .
−Removed: An amendment to the Offering Statement was filed and qualified in October 2022, to raise the remaining $ 3,800,000
−Removed: of the original offering amount of $ 5,000,000
−Removed: at a price of $ 0.08 per share.
−Removed: A further amendment
−Removed: to the Offering Statement was filed and qualified in December 2023, as supplemented, to raise the remaining $ 3,200,000 at an offering
−Removed: price of $ 0.064 per share.
−Removed: During 2023, $ 1,179,245
−Removed: was raised through the issuance of 16,132,000
−Removed: shares of common stock and warrants to purchase
−Removed: shares of common stock.
−Removed: The Company’s offerings undertaken pursuant to Regulation A+
−Removed: have raised approximately $ 6,000,000 from the sale of shares.
−Removed: The Company is using the proceeds generated
−Removed: the animal therapy market:
−Removed: the effort to communicate the benefits of IsoPet® to the veterinary community and the pet parents.
−Removed: additional clinical studies to generate more data for the veterinary community
−Removed: some IsoPet ® therapies, if necessary, to ensure that all viable candidates are treated.
−Removed: new regional clinics with their license and certification training.
−Removed: the human market:
−Removed: the pedigree of the Quality Management System.
−Removed: the previously defined pre-clinical testing and additional testing on an animal model closely aligned with our revised indication
−Removed: Report the results to the FDA in a pre-submission meeting.
−Removed: Use the feedback from that meeting to write the (Investigational Device
−Removed: Exemption (“ IDE ”), which is required to initiate clinical trials.
+Added: November 2019, the SEC qualified the Company’s offering of its Common Stock, under Regulation A of Section 3(6) of the Securities
+Added: Act of 1933, as amended (the “ Securities Act ”) (“ Regulation A ”), which offering was and amended
+Added: from time to time thereafter (the “ 2019 Regulation A+ Offering ”).
+Added: In September 2021, the SEC qualified the Company’s
+Added: offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (together with the 2019 Regulation
+Added: A+ Offering, the “ Prior Regulation A+ Offerings ”).
+Added: During the year ended December 31, 2023, $ 1,179,245 was raised
+Added: through the sale of 16,132,000 shares of common stock and the private placement of 18,797,000 warrants.
+Added: During the year ended December
+Added: 31, 2024, the Company raised $ 2,266,000 through the issuance of 24,950,000 shares of common stock.
+Added: The Company’s Prior Regulation
+Added: A Offerings undertaken pursuant to Regulation A+ have raised approximately $ 7,250,000 from the sale of shares of common stock.
+Added: 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
+Added: (the “ July 2024 Regulation A+ Offering ”).
+Added: Company is using the proceeds generated from the Prior Regulation A+ Offering and the July 2024 Regulation A+ Offering as follows:
and development of the Company’s brachytherapy product line has been funded with proceeds from the sale of equity and debt securities.
1 unchanged sentence
million annually to maintain current operating
−Removed: Over the next 12 to 48 months, the Company believes
−Removed: it will cost approximately $9 million to:
−Removed: (1) fund the FDA approval process to conduct human clinical trials;
+Added: the next 12 to 48 months, the Company believes it will cost approximately $9 million to:
+Added: (1) fund the FDA approval process to conduct
+Added: human clinical trials;
(2) conduct Phase I, pilot, and clinical trials;
−Removed: (3) activate several regional clinics to administer IsoPet ® across the
−Removed: (4) create an independent production center within the current production site to create a template for future international manufacturing;
+Added: (3) activate several regional clinics to administer IsoPet ®
+Added: across the county;
+Added: (4) create an independent production center within the current production site to create a template for future
+Added: international manufacturing;
and (5) initiate regulatory approval processes outside of the United States.
−Removed: The proceeds to be raised from the Regulation A+ Offering
−Removed: will be used to continue to fund this development.
−Removed: The continued deployment of the brachytherapy products and a worldwide
−Removed: regulatory approval effort will require additional resources and personnel.
−Removed: The principal variables in the timing and amount of spending
−Removed: for the brachytherapy products in the next 12 to 24 months will be the FDA’s classification of the Company’s brachytherapy
−Removed: products as Class II or Class III devices (or otherwise), and any requirements for additional studies (which may possibly include clinical
−Removed: Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be:
+Added: The proceeds to be raised from
+Added: the Regulation A+ Offerings will be used to continue to fund this development.
+Added: continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional resources and personnel.
+Added: 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
+Added: classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise), and any requirements for
+Added: additional studies (which may possibly include clinical studies).
+Added: Thereafter, the principal variables in the amount of the Company’s
+Added: spending and its financing requirements would be:
(1) the timing of any approvals;
−Removed: (2) the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution
−Removed: and licensing of those products;
−Removed: and (3) the products’ success in the U.S.
+Added: (2) the nature of the Company’s arrangements
+Added: with third parties for manufacturing, sales, distribution, and licensing of those products;
+Added: and (3) the products’ success in the
and elsewhere.
−Removed: The Company intends to fund its activities
−Removed: through strategic transactions such as licensing and partnership agreements, as well as proceeds to be raised from the Regulation A+ Offering.
−Removed: Following receipt of required regulatory approvals and necessary financing
−Removed: to fund our working capital requirements, the Company intends to outsource material aspects of manufacturing, distribution, sales and
−Removed: marketing for operations within the U.S..
−Removed: Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships
−Removed: to facilitate its global commercialization strategy.
−Removed: Long-term, the Company intends to consider resuming research efforts with respect to other products and technologies
−Removed: intended to help improve the diagnosis and treatment of cancer and other illnesses.
+Added: The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements,
+Added: as well as proceeds to be raised from the Regulation A+ Offerings.
+Added: receipt of required regulatory approvals and necessary financing to fund our working capital requirements, the Company intends to outsource
+Added: material aspects of manufacturing, distribution, sales, and marketing for operations within the U.S.
+Added: Outside of the U.S., the Company
+Added: intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.
+Added: the Company intends to consider resuming research efforts with respect to other products and technologies intended to help improve the
+Added: diagnosis and treatment of cancer and other illnesses.
These long-term goals are subject to the Company:
(1) receiving adequate funding;
−Removed: (2) receiving regulatory approval for RadioGel TM and other brachytherapy products;
−Removed: being able to successfully commercialize its brachytherapy products.
+Added: (2) receiving regulatory approval for RadioGel ™ and other brachytherapy products;
+Added: and (3) being able to successfully
+Added: commercialize its brachytherapy products.
on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed
4 unchanged sentences
delay the implementation of its business strategy and may not be able to continue operations.
−Removed: The Company’s headquarters are in Northeast
−Removed: Washington however there focus of the animal therapy market has been the Northwestern sector of the United States.
−Removed: The Company continues
−Removed: their marketing to the animal therapy market and attempt to increase the exposure to their product and generate revenue accordingly.
−Removed: of December 31, 2023, the Company has $ 1,592,287 cash on hand.
+Added: Company’s headquarters are in Northeast Washington, however, our focus on the animal therapy market has been the Northwestern sector
+Added: The Company continues its marketing efforts on the animal therapy market and our attempts to increase the exposure to our
+Added: product, and generate revenue accordingly.
+Added: of December 31, 2024, the Company had $ 2,212,548 cash on hand.
There are currently commitments to vendors for products and services purchased.
−Removed: To continue the development of the Company’s products, the current level of cash may not be enough to cover the fixed and variable
+Added: 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.
−Removed: is no guarantee that the Company will be able to raise additional funds or to do so at an advantageous price.
+Added: Company anticipates using the proceeds from the July 2024 Regulation A+ Offering as follows:
+Added: the animal therapy market:
+Added: communication on our website, the Company’s social media presence, conferences, and journals, each intended to increase the
+Added: number of certified clinics for small animal and equine therapy and to increase the number of patients.
+Added: some IsoPet ® therapies, if necessary, to ensure that all viable candidates are treated;
+Added: a new regional clinic with their license and certification training.
+Added: the human market:
+Added: the pedigree of the Quality Management System.
+Added: automation of product manufacturing.
+Added: liability insurance for human clinical studies;
+Added: human clinical studies in the US.
+Added: and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity
+Added: and debt securities, including from the Prior Regulation A+ Offerings.
+Added: The Company requires additional funding of approximately $ 2.5
+Added: million annually to maintain operating activities.
+Added: the next 36 months, the Company believes it will cost approximately $8.0 to $9.0 million to:
+Added: (1) fund the FDA approval process to conduct
+Added: human clinical trials;
+Added: (2) conduct Phase I, pilot, clinical trials;
+Added: (3) activate several regional clinics to administer IsoPet ®
+Added: across the U.S.;
+Added: (4) create an independent production center within the current production site to create a template for future
+Added: international manufacturing;
+Added: and (5) initiate regulatory approval processes outside of the United States.
+Added: proceeds raised from the Prior Regulation A+ Offerings were used to fund this development and proceeds from the July 2024 Regulation
+Added: A+ Offering will be used to continue such development efforts.
+Added: continued deployment of the precision radionuclide therapy products and a worldwide regulatory approval effort will require additional
+Added: resources and personnel.
+Added: The principal variables in the timing and amount of spending for the precision radionuclide therapy products
+Added: in the next 12 to 24 months will be the FDA’s classification of the Company’s precision radionuclide therapy products as
+Added: Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies.
+Added: Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing
+Added: of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing
+Added: of those products and the products’ success in the U.S.
+Added: and elsewhere.
+Added: The Company intends to fund its activities through strategic
+Added: transactions such as licensing and partnership agreements or from proceeds raised from the Prior Regulation A+ Offering and from the
+Added: July 2024 Regulation A+ Offering.
+Added: Company intends to expand the indications for use in phases:
+Added: first, for lymph nodes associated with thyroid cancer, secondly, cancerous
+Added: lung nodules, and finally, all non-sectable solid tumors.
+Added: It is anticipated that the medical community may begin to use RadioGel off-label,
+Added: we will support but will not encourage that practice.
+Added: receipt of required regulatory approvals and financing, in the U.S., the Company intends to outsource material aspects of manufacturing,
+Added: distribution, sales and marketing.
+Added: Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate
+Added: its global commercialization strategy.
+Added: the Company intends to consider resuming research efforts with respect to other products and technologies, such as Gamma Gel and Alpha
+Added: Gel intended to help improve the diagnosis and treatment of cancer and other illnesses.
+Added: These long-term goals are subject to the Company:
+Added: (1) receiving adequate funding;
+Added: (2) receiving regulatory approval for RadioGel ™ and other precision radionuclide therapy
+Added: and (3) being able to successfully commercialize its precision radionuclide therapy products.
+Added: on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed
+Added: substantial doubt as to the Company’s ability to continue as a going concern.
+Added: The Company has limited revenue, nominal cash, and
+Added: has accumulated deficits since inception.
+Added: If the Company cannot obtain sufficient additional capital, the Company will be required to
+Added: delay the implementation of its business strategy and may not be able to continue operations.
+Added: Company’s headquarters are in the State of Washington., The initial focus of the animal therapy market has been the Northwestern
+Added: sector of the United States.
+Added: The Company has initiated marketing efforts to the animal therapy market in other regions of the United
+Added: States, attempting to increase the exposure to our product and increase revenue opportunities.
+Added: are currently commitments to vendors for products and services purchased.
+Added: To continue the development of the Company’s products,
+Added: the current level of cash will not be enough to cover the fixed and variable obligations of the Company.
+Added: The Company has focused on operating
+Added: on minimum overhead, including using a virtual office for the last several years and retaining experienced industry consultants available
+Added: on an as needed basis.
+Added: This has helped focus the capital received from the Company’s Regulation A+ Offerings on activities that
+Added: enhance our objectives.
+Added: 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.
financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary
4 unchanged sentences
a focus on strategic products and increased efficiencies in business processes and improvements to the cost structure.
−Removed: There is no assurance
−Removed: that the Company will be successful in its efforts to raise additional working capital or achieve profitable operations.
−Removed: The financial
−Removed: statements do not include any adjustments that might result from the outcome of this uncertainty.
+Added: There can be no
+Added: assurance that the Company will be successful in its efforts to raise additional working capital or achieve profitable operations.
+Added: financial statements do not include any adjustments that might result from the outcome of this uncertainty.
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
−Removed: the date of financial statements and the reported amounts of revenues and expenses during the reporting period.
−Removed: Estimates the Company
−Removed: considers include criteria for stock-based compensation expense, and valuation allowances on deferred tax assets.
−Removed: Actual results could
−Removed: differ from those estimates.
−Removed: Statement Reclassification
−Removed: account balances from prior periods have been reclassified in these financial statements so as to conform to current period classifications.
+Added: the date of financial statements and the reported amount of revenue and expense during the reporting period.
+Added: Estimates the Company considers
+Added: include criteria for stock-based compensation expense, and valuation allowances on deferred tax assets.
+Added: Actual results could differ from
+Added: those estimates.
the purposes of the statement of cash flows, the Company considers all highly liquid debt instruments purchased with an original maturity
5 unchanged sentences
it is practicable to estimate that value.
−Removed: As of December 31, 2023 and 2022, the balances reported for cash, prepaid expenses, accounts
−Removed: receivable, accounts payable, and accrued expenses, approximate the fair value because of their short maturities.
−Removed: Fair value is defined as the price that would be received to sell an
−Removed: asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
−Removed: ASC Topic 820- Fair
−Removed: Value Measurement, established a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value.
−Removed: The hierarchy
−Removed: gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and
−Removed: the lowest priority to unobservable inputs (level 3 measurements).
+Added: As of December 31, 2024 and 2023, the balances reported for cash, prepaid expense,
+Added: accounts receivable, accounts payable, and accrued expense, approximate the fair value because of their short maturities.
+Added: 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
+Added: market participants at the measurement date.
+Added: Accounting Standards Codification (“ ASC ”) Topic 820 established a three-tier
+Added: fair value hierarchy which prioritizes the inputs used in measuring fair value.
+Added: The hierarchy gives the highest priority to unadjusted
+Added: quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs
+Added: (level 3 measurements).
These tiers include:
−Removed: Level 1, defined as
−Removed: observable inputs such as quoted prices for identical instruments in active markets;
−Removed: Level 2, defined as inputs
−Removed: other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar
−Removed: instruments in active markets or quoted prices for identical or similar instruments in markets that are not active;
−Removed: Level 3, defined as
−Removed: unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as
−Removed: valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are
−Removed: unobservable.
+Added: 1, defined as observable inputs such as quoted prices for identical instruments in active markets;
+Added: 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices
+Added: for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active;
+Added: 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions,
+Added: such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
Company measures certain financial instruments including options and warrants issued during the period at fair value on a recurring basis.
8 unchanged sentences
have been no such capitalized costs in the years ended December 31, 2024 and 2023, respectively.
−Removed: However, a patent was filed on July
−Removed: 1811.191) by Michael Korenko and David Swanberg and assigned to the Company based on the Company’s proprietary
−Removed: particle manufacturing process.
+Added: However, a patent was
+Added: filed on July 1, 2019 (No.
+Added: 1811.191) filed by Michael Korenko and David Swanberg and assigned to the Company based on the Company’s
+Added: proprietary particle manufacturing process.
The timing of this filing was important given the Company’s plans to make IsoPet ®
4 unchanged sentences
year, as permitted under international patent laws and treaties.
−Removed: In May 2014, the FASB issued Accounting Standard Update (“ ASU ”)
+Added: May 2014, the Financial Accounting Standards Board (“ FASB ”) issued Accounting Standard Update (“ ASU ”)
2014-09, Revenue from Contracts with Customers (Topic 606).
1 unchanged sentence
to be used across all industries and requires additional disclosures.
−Removed: The updated guidance introduces a five-step model to achieve its
−Removed: core principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects
−Removed: the consideration to which the entity expects to be entitled in exchange for those goods or services.
−Removed: The Company adopted the updated
−Removed: guidance effective January 1, 2018 using the full retrospective method.
−Removed: ASC 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to preform respective
+Added: The guidance introduces a five-step model to achieve its core principal
+Added: of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration
+Added: to which the entity expects to be entitled in exchange for those goods or services.
+Added: The Company adopted the updated guidance effective
+Added: January 1, 2018 using the full retrospective method.
+Added: 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.
+Added: The adoption of ASC 606 did not have an impact on the Company’s operations or cash flows.
Company recognized revenue as they (i) identified the contracts with each customer;
6 unchanged sentences
to complete the procedures on the animals, the Company recognized revenue as that was considered the performance obligation.
−Removed: revenue recognized in the years ended December 31, 2023 and 2022 relate to the procedures performed with respect to the IsoPet ®
+Added: Company in 2024 also implemented a license program for clinics that pay for certification to perform these therapies.
+Added: These revenues
+Added: are recognized upon the certification being completed.
+Added: During 2024, $ 4,995 of the revenue relates to this certification.
Company accounts for its loss per common share by replacing primary and fully diluted earnings per share with basic and diluted earnings
7 unchanged sentences
31, 2024 and 2023, the basic earnings per share equals the diluted earnings per share.
−Removed: following represent common stock equivalents that could be dilutive in the future as of December 31, 2023 and 2022, which include the
+Added: following represent Common Stock equivalents that could be dilutive in the future as December 31, 2024 and 2023, which include the following:
OF DILUTIVE EARNINGS PER SHARE
−Removed: December 31, 2023
−Removed: December 31, 2022
Preferred stock
4 unchanged sentences
and Development Costs
−Removed: and developments costs, including salaries, research materials, administrative costs and contractor fees, are charged to operations
+Added: and developments costs, including salaries, research materials, administrative expense and contractor fees, are charged to operations
The cost of equipment used in research and development activities which has alternative uses is capitalized as part of fixed
26 unchanged sentences
31, 2024 and 2023.
−Removed: The Company did not have any deferred tax liability or asset on its balance sheets on December 31, 2023 and 2022.
+Added: The Company did not have any deferred tax liability or asset on its balance sheets as of December 31, 2024 and 2023.
costs and penalties related to income taxes, if any, will be classified as interest expense and general and administrative costs, respectively,
16 unchanged sentences
results of operations, cash flows or disclosures.
+Added: In November 2023, the Financial Accounting Standards Board issued Accounting Standards Update 2023-07 (“ASU
+Added: ASU 2023-07 improves segment reporting disclosures for public companies.
+Added: ASU 2023-07 requires more detailed information
+Added: about reportable segments and expenses including the requirement to disclose qualitative information about factors used to identify reportable
+Added: segments and quantitative information about profit and loss measures and significant expense categories.
+Added: ASU 2023-07 was effective for
+Added: public companies in fiscal years beginning after December 15, 2023.
+Added: The Company has not yet begun generating significant revenue from its planned principal operations and operates as
+Added: a single reportable segment.
+Added: The chief operating decision maker is the Company’s chief executive officer who assesses performance
+Added: based on total expenses, cash flows, and progress made in the Company’s ongoing development efforts.
+Added: All of the Company’s
+Added: long-lived assets are located in the United States.
+Added: The Company analyzed ASU 2023-07 and determined that the required
+Added: information is presented within the consolidated financial statements and footnote disclosures herein.
+Added: The Company does not believe that
+Added: ASU 2023-07 will have a material impact on the consolidated financial statements.
RELATED PARTY TRANSACTIONS
−Removed: and Common Shares Issued to Officers and Directors
−Removed: March 2022, the Chief Executive Officer exercised 75,000 warrants in a cashless exercise into 22,266 shares of common stock, and was
−Removed: issued 76,250 shares of common stock valued at $ 4,880 for services rendered.
−Removed: September 2023, the CEO advanced $ 10,000 to the Company which was repaid October 4, 2023.
+Added: September 2023, our Chief Executive Officer advanced $ 10,000 to the Company, which amount was repaid October 4, 2023.
+Added: In December 2024,
+Added: our Chief Executive Officer advanced $ 40,949 to the Company, which amount was repaid within ten days.
STOCKHOLDERS’ EQUITY
−Removed: Company has 950,000,000 shares of common stock authorized, with a par value of $ 0.001 , and as of December 31, 2023 and December 31, 2022,
−Removed: the Company has 387,894,033 and 362,541,528 shares issued and outstanding, respectively.
−Removed: of December 31, 2023 and 2022, the Company has 20,000,000 shares of Preferred stock authorized with a par value of $ 0.001 .
−Removed: The Company’s
−Removed: 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,
+Added: Company has authorized 950,000,000 shares of Common Stock.
+Added: As of December 31, 2024 and 2023, there are 440,873,806 and 387,894,033 shares
+Added: of Common Stock issued and outstanding, respectively.
+Added: Company has authorized 20,000,000 shares of Preferred Stock.
+Added: There are currently three series of Preferred Stock outstanding;
+Added: A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series C Convertible Preferred Stock.
+Added: The Company’s Board
+Added: 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
6 unchanged sentences
control to others.
−Removed: October 8, 2018 the Company created out of the shares of Preferred Stock, par value $ 0.001 per share, of the Company, as authorized in
−Removed: Article IV of the Company’s Certificate of Incorporation, a series of Preferred Stock of the Company, to be named “Series
−Removed: B Convertible Preferred Stock,” consisting of Five Million (5,000,000) shares.
−Removed: March 27, 2019 the Company created out of the shares of Preferred Stock, par value $ 0.001 per share, of the Company, as authorized in
−Removed: Article IV of the Company’s Certificate of Incorporation, a series of Preferred Stock of the Company, to be named “Series
−Removed: C Convertible Preferred Stock,” consisting of Five Million ( 5,000,000 ) shares.
−Removed: A Convertible Preferred Stock (“Series A Convertible Preferred”)
−Removed: June 2015, the Series A Certificate of Designation was filed with the Delaware Secretary of State to designate 2.5 million shares of
−Removed: our preferred stock as Series A Convertible Preferred.
−Removed: Effective March 31, 2016, the Company amended the Certificate of Designations,
−Removed: Preferences and Rights of Series A Convertible Preferred of the Registrant, increasing the maximum number of shares of Series A Convertible
−Removed: Preferred from 2,500,000 shares to 5,000,000 shares.
−Removed: The following summarizes the current rights and preferences of the Series A Convertible
−Removed: The Series A Convertible Preferred has a liquidation preference of $ 5.00 per share.
−Removed: Shares of Series A Convertible Preferred do not have any separate dividend rights.
−Removed: Subject to certain limitations set forth in the Series A Certificate of Designation, each share of Series A Convertible Preferred is
−Removed: convertible, at the option of the holder, into that number of shares of common stock (the “ Series A Conversion Shares ”)
−Removed: equal to the liquidation preference thereof, divided by Conversion Price (as such term is defined in the Series A Certificate of Designation),
−Removed: currently $ 4.00 .
+Added: A Convertible Preferred Stock
+Added: 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
+Added: Preferred Stock as Series A Convertible Preferred Stock, par value $ 0.001 per share (“ Series A Preferred ”) (the “ Series
+Added: Effective March 31, 2016, the Company amended the Series A COD, increasing the maximum number of shares of Series
+Added: A Preferred from 2,500,000 shares to 5,000,000 shares.
+Added: As of December 31, 2024 and 2023, there are 2,071,007 shares of Series A Preferred
+Added: issued and outstanding, respectively.
+Added: following summarizes the current rights and preferences of the Series A Preferred:
+Added: The Series A Preferred has a liquidation preference of $ 5.00 per share.
+Added: Shares of Series A Preferred do not have any separate dividend rights.
+Added: 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,
+Added: into that number of shares of Common Stock (the “ Series A Conversion Shares ”) equal to the liquidation preference
+Added: thereof, divided by Conversion Price (as such term is defined in the Series A COD), currently $ 4.00 .
the event the Company completes an equity or equity-based public offering, registered with the SEC, resulting in gross proceeds to the
−Removed: Company totaling at least $ 5.0 million, all issued and outstanding shares of Series A Convertible Preferred at that time will automatically
−Removed: convert into Series A Conversion Shares.
−Removed: Subject to certain conditions set forth in the Series A Certificate of Designation, in the event of a Change of Control (defined in the
−Removed: Series A Certificate of Designation as the time at which as a third party not affiliated with the Company or any holders of the Series
−Removed: A Convertible Preferred shall have acquired, in one or a series of related transactions, equity securities of the Company representing
−Removed: more than fifty percent 50% of the outstanding voting securities of the Company), the Company, at its option, will have the right to
−Removed: redeem all or a portion of the outstanding Series A Convertible Preferred in cash at a price per share of Series A Convertible Preferred
−Removed: equal to 100 % of the Liquidation Preference .
−Removed: Holders of Series A Convertible Preferred are entitled to vote on all matters, together with the holders of common stock,
−Removed: and have the equivalent of five votes for every Series A Conversion Share issuable upon conversion of such holder’s outstanding
−Removed: shares of Series A Convertible Preferred.
−Removed: However, the Series A Conversion Shares, when issued, will have all the same voting rights
−Removed: as other issued and outstanding common stock of the Company, and none of the rights of the Series A Convertible Preferred .
+Added: Company totaling at least $ 5.0 million, all issued and outstanding shares of Series A Preferred at that time will automatically convert
+Added: into Series A Conversion Shares.
+Added: 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
+Added: 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
+Added: series of related transactions, equity securities of the Company representing more than fifty percent (50%) of the outstanding voting
+Added: 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
+Added: in cash at a price per share of Series A Preferred equal to 100 % of the Liquidation Preference.
+Added: Holders of Series A Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
+Added: equivalent of five votes for every Series A Conversion Share issuable upon conversion of such holder’s outstanding shares of Series
+Added: However, the Series A Conversion Shares, when issued, will have all the same voting rights as other issued and outstanding
+Added: 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 ”),
−Removed: the holders of Series A Convertible Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company
−Removed: an amount equal to the liquidation preference of the Series A Convertible Preferred before any distribution or payment shall be made
−Removed: to the holders of any junior securities, and if the assets of the Company is insufficient to pay in full such amounts, then the entire
−Removed: assets to be distributed to the holders of the Series A Convertible Preferred shall be ratably distributed among the holders in accordance
−Removed: with the respective amounts that would be payable on such shares if all amounts payable thereon were paid in full.
+Added: the holders of Series A Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company an amount
+Added: equal to the liquidation preference of the Series A Preferred before any distribution or payment shall be made to the holders of any
+Added: junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
+Added: to the holders of the Series A Preferred shall be ratably distributed among the holders in accordance with the respective amounts that
+Added: would be payable on such shares if all amounts payable thereon were paid in full.
Price and Share Adjustments .
Stock Dividends and Stock Splits.
−Removed: If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions
−Removed: payable in shares of common stock on shares of common stock or any other common stock equivalents;
−Removed: (ii) subdivides outstanding shares
−Removed: of common stock into a larger number of shares;
−Removed: (iii) combines (including by way of a reverse stock split) outstanding shares of common
−Removed: stock into a smaller number of shares;
−Removed: or (iv) issues, in the event of a reclassification of shares of the common stock, any shares of
−Removed: capital stock of the Company, then the conversion price shall be adjusted accordingly.
+Added: If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions payable
+Added: in shares of Common Stock on shares of Common Stock or any other Common Stock equivalents;
+Added: (ii) subdivides outstanding shares of Common
+Added: Stock into a larger number of shares;
+Added: (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into
+Added: a smaller number of shares;
+Added: or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock
+Added: of the Company, then the conversion price shall be adjusted accordingly.
Merger or Reorganization.
−Removed: If the Company is involved in any reorganization, recapitalization, reclassification, consolidation
−Removed: or merger in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series A
−Removed: Preferred shall be convertible into the kind and amount of securities, cash or other property that a holder of the number of shares of
−Removed: common stock issuable upon conversion of one share of Series A Convertible Preferred prior to any such merger or reorganization would
−Removed: have been entitled to receive pursuant to such transaction.
−Removed: B Convertible Preferred Stock (“Series B Convertible Preferred”)
−Removed: October 2018, the Series B Certificate of Designation was filed with the Delaware Secretary of State to designate 5.0 million shares
−Removed: of our preferred stock as Series B Convertible Preferred.
−Removed: The following summarizes the current rights and preferences of the Series B
−Removed: Convertible Preferred:
−Removed: The Series B Convertible Preferred has a liquidation preference of $ 1.00 per share.
−Removed: Shares of Series B Convertible Preferred do not have any separate dividend rights.
−Removed: Subject to certain limitations set forth in the Series B Certificate of Designation, each share of Series B Convertible Preferred is
−Removed: convertible, at the option of the holder, into that number of shares of common stock (the “ Series B Conversion Shares ”)
−Removed: equal to the liquidation preference thereof, divided by Conversion Price (as such term is defined in the Series B Certificate of Designation),
−Removed: currently $ 0.08 .
−Removed: Subject to certain conditions set forth in the Series B Certificate of Designation, in the event of a Change of Control (defined in the
−Removed: Series B Certificate of Designation as the time at which as a third party not affiliated with the Company or any holders of the Series
−Removed: B Convertible Preferred shall have acquired, in one or a series of related transactions, equity securities of the Company representing
−Removed: more than fifty percent 50% of the outstanding voting securities of the Company), the Company, at its option, will have the right to
−Removed: redeem all or a portion of the outstanding Series B Convertible Preferred in cash at a price per share of Series B Convertible Preferred
−Removed: equal to 100 % of the Liquidation Preference .
−Removed: Holders of Series B Convertible Preferred are entitled to vote on all matters, together with the holders of common stock,
−Removed: and have the equivalent of two votes for every Series B Conversion Share issuable upon conversion of such holder’s outstanding
−Removed: shares of Series B Convertible Preferred.
−Removed: However, the Series B Conversion Shares, when issued, will have all the same voting rights
−Removed: as other issued and outstanding common stock of the Company, and none of the rights of the Series A Convertible Preferred .
+Added: If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or merger
+Added: in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series A Preferred
+Added: 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
+Added: issuable upon conversion of one share of Series A Preferred prior to any such merger or reorganization would have been entitled to receive
+Added: pursuant to such transaction.
+Added: B Convertible Preferred Stock
+Added: October 10, 2018, a certificate of designation was filed with the Delaware Secretary of State to designate 5,000,000 shares of our Preferred
+Added: Stock as Series B Convertible Preferred Stock, par value $ 0.001 per share (“ Series B Preferred ”) (the “ Series
+Added: As of December 31, 2024 and 2023, there are 363 and 200,363 shares of Series B Preferred issued and outstanding, respectively.
+Added: following summarizes the current rights and preferences of the Series B Preferred:
+Added: The Series B Preferred has a liquidation preference of $ 1.00 per share.
+Added: Shares of Series B Preferred do not have any separate dividend rights.
+Added: Subject to certain limitations set forth in the Series B COD, each share of Series B Convertible is convertible, at the option of the
+Added: holder, into that number of shares of Common Stock (the “ Series B Conversion Shares ”) equal to the liquidation preference
+Added: thereof, divided by the Conversion Price (as such term is defined in the Series B COD), currently $ 0.08 .
+Added: 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
+Added: 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
+Added: of related transactions, equity securities of the Company representing more than fifty percent (50%) of the outstanding voting securities
+Added: 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
+Added: cash at a price per share of Series B Preferred equal to 100 % of the Liquidation Preference.
+Added: Holders of Series B Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
+Added: equivalent of two votes for every Series B Conversion Share issuable upon conversion of such holder’s outstanding shares of Series
+Added: However, the Series B Conversion Shares, when issued, will have the same voting rights as other issued and outstanding shares
+Added: of 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 ”),
−Removed: the holders of Series B Convertible Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company
−Removed: an amount equal to the liquidation preference of the Series B Convertible Preferred before any distribution or payment shall be made
−Removed: to the holders of any junior securities, and if the assets of the Company is insufficient to pay in full such amounts, then the entire
−Removed: assets to be distributed to the holders of the Series B Convertible Preferred shall be ratably distributed among the holders in accordance
−Removed: with the respective amounts that would be payable on such shares if all amounts payable thereon were paid in full.
+Added: the holders of Series B Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company an amount
+Added: equal to the liquidation preference of the Series B Preferred before any distribution or payment shall be made to the holders of any
+Added: junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
+Added: to the holders of the Series B Preferred shall be ratably distributed among the holders in accordance with the respective amounts that
+Added: would be payable on such shares if all amounts payable thereon were paid in full.
Price and Share Adjustments .
Stock Dividends and Stock Splits.
−Removed: If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions
−Removed: payable in shares of common stock on shares of common stock or any other common stock equivalents;
−Removed: (ii) subdivides outstanding shares
−Removed: of common stock into a larger number of shares;
−Removed: (iii) combines (including by way of a reverse stock split) outstanding shares of common
−Removed: stock into a smaller number of shares;
−Removed: or (iv) issues, in the event of a reclassification of shares of the common stock, any shares of
−Removed: capital stock of the Company, then the conversion price shall be adjusted accordingly.
+Added: If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions payable
+Added: in shares of Common Stock on shares of Common Stock or any other Common Stock equivalents;
+Added: (ii) subdivides outstanding shares of Common
+Added: Stock into a larger number of shares;
+Added: (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into
+Added: a smaller number of shares;
+Added: or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock
+Added: of the Company, then the conversion price shall be adjusted accordingly.
Merger or Reorganization.
−Removed: If the Company is involved in any reorganization, recapitalization, reclassification, consolidation
−Removed: or merger in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series B
−Removed: Convertible Preferred shall be convertible into the kind and amount of securities, cash or other property that a holder of the number
−Removed: of shares of common stock issuable upon conversion of one share of Series B Convertible Preferred prior to any such merger or reorganization
−Removed: would have been entitled to receive pursuant to such transaction.
−Removed: C Convertible Preferred Stock (“Series C Convertible Preferred”)
−Removed: March 2019, the Series C Certificate of Designation was filed with the Delaware Secretary of State to designate 5.0 million shares of
−Removed: our preferred stock as Series C Convertible Preferred.
−Removed: The following summarizes the current rights and preferences of the Series C Convertible
−Removed: The Series C Convertible Preferred has a liquidation preference of $ 1.00 per share.
−Removed: Shares of Series C Convertible Preferred do not have any separate dividend rights.
−Removed: Subject to certain limitations set forth in the Series C Certificate of Designation, each share of Series C Convertible Preferred is
−Removed: convertible, at the option of the holder, into that number of shares of common stock (the “ Series C Conversion Shares ”)
−Removed: equal to the liquidation preference thereof, divided by Conversion Price (as such term is defined in the Series C Certificate of Designation),
−Removed: currently $ 0.08 .
−Removed: Series C Convertible Preferred will only be convertible at any time after the date that the Company shall have amended its Certificate
−Removed: of Incorporation to increase the number of shares of common stock authorized for issuance thereunder or effect a reverse stock split
−Removed: of the outstanding shares of common stock by a sufficient amount to permit the conversion of all Series C Convertible Preferred into
−Removed: shares of common stock (“ Authorized Share Approval ”) (such date, the “ Initial Convertibility Date ”),
−Removed: each share of Series C Convertible Preferred shall be convertible into validly issued, fully paid and non-assessable shares of Common
−Removed: Stock on the terms and conditions set forth in the Series C Certificate of Designation under the definition “ Conversion Rights ”.
−Removed: Subject to certain conditions set forth in the Series C Certificate of Designation, in the event of a Change of Control (defined in the
−Removed: Series C Certificate of Designation as the time at which as a third party not affiliated with the Company or any holders of the Series
−Removed: C Convertible Preferred shall have acquired, in one or a series of related transactions, equity securities of the Company representing
−Removed: more than fifty percent 50% of the outstanding voting securities of the Company), the Company, at its option, will have the right to
−Removed: redeem all or a portion of the outstanding Series C Convertible Preferred in cash at a price per share of Series C Convertible Preferred
−Removed: equal to 100 % of the Liquidation Preference .
−Removed: Holders of Series C Convertible Preferred are entitled to vote on all matters, together with the holders of common stock,
−Removed: and have the equivalent of 32 votes for every Series C Conversion Share issuable upon conversion of such holder’s
−Removed: outstanding shares of Series C Convertible Preferred.
−Removed: However, the Series C Conversion Shares, when issued, will have all the same voting
−Removed: rights as other issued and outstanding common stock of the Company, and none of the rights of the Series C Convertible Preferred.
+Added: If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or merger
+Added: in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series B Preferred
+Added: 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
+Added: issuable upon conversion of one share of Series B Preferred prior to any such merger or reorganization would have been entitled to receive
+Added: pursuant to such transaction.
+Added: December 16, 2024, there was 200,000 Series B Preferred shares converted into 2,500,000 common shares.
+Added: C Convertible Preferred Stock
+Added: March 27, 2019, a certificate of designation was filed with the Delaware Secretary of State to designate 5,000,000 shares of our Preferred
+Added: Stock as Series C Convertible Preferred Stock, par value $ 0.001 per share (“ Series C Preferred ”) (the “ Series
+Added: As of December 31, 2024 and 2023, there were 385,302 shares of Series C Preferred issued and outstanding, respectively.
+Added: following summarizes the current rights and preferences of the Series C Preferred:
+Added: The Series C Preferred has a liquidation preference of $ 1.00 per share.
+Added: Shares of Series C Preferred do not have any separate dividend rights.
+Added: 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,
+Added: into that number of shares of Common Stock (the “ Series C Conversion Shares ”) equal to the liquidation preference
+Added: thereof, divided by Conversion Price (as such term is defined in the Series C COD), currently $ 0.08 .
+Added: Series C Preferred will only be convertible at any time after the date that the Company shall have amended its Certificate of Incorporation
+Added: to increase the number of shares of Common Stock authorized for issuance thereunder or effect a reverse stock split of the outstanding
+Added: shares of Common Stock by a sufficient amount to permit the conversion of all Series C Preferred into shares of Common Stock (“ Authorized
+Added: Share Approval ”) (such date, the “ Initial Convertibility Date ”), each share of Series C Preferred shall
+Added: be convertible into validly issued, fully paid and non-assessable shares of Common Stock on the terms and conditions set forth in the
+Added: Series C COD under the definition “ Conversion Rights ”.
+Added: 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
+Added: 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
+Added: series of related transactions, equity securities of the Company representing more than fifty percent (50%) of the outstanding voting
+Added: 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
+Added: in cash at a price per share of Series C Preferred equal to 100 % of the Liquidation Preference.
+Added: Holders of Series C Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
+Added: equivalent of thirty-two votes for every Series C Conversion Share issuable upon conversion of such holder’s outstanding shares
+Added: of Series C Preferred.
+Added: However, the Series C Conversion Shares, when issued, will have the same voting rights as other issued and outstanding
+Added: 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 ”),
−Removed: the holders of Series C Convertible Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company
−Removed: an amount equal to the liquidation preference of the Series C Convertible Preferred before any distribution or payment shall be made
−Removed: to the holders of any junior securities, and if the assets of the Company is insufficient to pay in full such amounts, then the entire
−Removed: assets to be distributed to the holders of the Series C Convertible Preferred shall be ratably distributed among the holders in accordance
−Removed: with the respective amounts that would be payable on such shares if all amounts payable thereon were paid in full.
+Added: the holders of Series C Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company an amount
+Added: equal to the liquidation preference of the Series C Preferred before any distribution or payment shall be made to the holders of any
+Added: junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
+Added: to the holders of the Series C Preferred shall be ratably distributed among the holders in accordance with the respective amounts that
+Added: would be payable on such shares if all amounts payable thereon were paid in full.
Price and Share Adjustments .
Stock Dividends and Stock Splits.
−Removed: If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions
−Removed: payable in shares of common stock on shares of common stock or any other common stock equivalents;
−Removed: (ii) subdivides outstanding shares
−Removed: of common stock into a larger number of shares;
−Removed: (iii) combines (including by way of a reverse stock split) outstanding shares of common
−Removed: stock into a smaller number of shares;
−Removed: or (iv) issues, in the event of a reclassification of shares of the common stock, any shares of
−Removed: capital stock of the Company, then the conversion price shall be adjusted accordingly.
+Added: If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions payable
+Added: in shares of Common Stock on shares of Common Stock or any other Common Stock equivalents;
+Added: (ii) subdivides outstanding shares of Common
+Added: Stock into a larger number of shares;
+Added: (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into
+Added: a smaller number of shares;
+Added: or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock
+Added: of the Company, then the conversion price shall be adjusted accordingly.
Merger or Reorganization.
−Removed: If the Company is involved in any reorganization, recapitalization, reclassification, consolidation
−Removed: or merger in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series C
−Removed: Convertible Preferred shall be convertible into the kind and amount of securities, cash or other property that a holder of the number
−Removed: of shares of common stock issuable upon conversion of one share of Series C Convertible Preferred prior to any such merger or reorganization
−Removed: would have been entitled to receive pursuant to such transaction.
+Added: If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or merger
+Added: in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series C Preferred
+Added: 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
+Added: issuable upon conversion of one share of Series C Preferred prior to any such merger or reorganization would have been entitled to receive
+Added: pursuant to such transaction.
and Preferred Stock Issuances
−Removed: April 2023, the Company issued 8,000,000
−Removed: shares of common stock, warrants to purchase 2,665,000
−Removed: shares of A Convertible Preferred, and warrants to purchase 8,000,000
−Removed: shares of Series B Convertible Preferred, pursuant to our Offering Statement for our Regulation A+ Offering, for aggregate
−Removed: proceeds of $ 640,000 .
−Removed: The Company sold the warrants to purchase shares of Series A Convertible Preferred and Series B Convertible Preferred for $ 10,665 .
−Removed: October 2023, the Company issued 2,221,505
−Removed: shares of common stock in a cashless exercise of warrants to purchase 2,132,000
−Removed: shares of common stock.
−Removed: December 2023, the Company issued:
−Removed: shares of common stock in settlement of accounts payable of $ 28,450 ;
−Removed: (2) 8,132,000
−Removed: shares of common stock and 8,132,000
−Removed: warrants pursuant to the Offering Statement for the Regulation A+ Offering for an aggregate total of $ 528,580 ;
−Removed: (3) 2,499,000
−Removed: 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;
−Removed: and (4) issued 4,000,000
−Removed: shares of common stock for 4,00,000
−Removed: vested restricted stock units, for which the Company recognized a loss
−Removed: on this exchange of vested restricted stock units for shares of common
and Preferred Stock Issuances - 2024
−Removed: March 2022, the Company issued 299,577 shares
−Removed: of common stock in the cashless exercise of warrants to purchase 825,000 shares of common stock, and issued 76,250 shares
−Removed: of common stock to its Chief Executive Officer for services rendered valued at $ 4,880 .
−Removed: In June 2022, there was a fractional adjustment recorded for 90 shares
−Removed: of common stock.
−Removed: July 7, 2022, the Company sold 15,000,000
−Removed: shares of common stock under the Regulation A+ Offering for cash proceeds of $ 1,200,000 , and sold warrants to purchase 20,000,000
−Removed: shares of common stock for cash proceeds of $ 20,000 .
−Removed: September 2022, the Company issued 984,840
−Removed: shares of common stock valued at $ 49,242
−Removed: in settlement of accounts payable.
+Added: Company issued 24,950,000 shares of Common Stock pursuant to the Regulation A+ Offerings for cash proceeds of $ 2,266,000 .
+Added: Company issued 605,801 shares of Common Stock for services rendered valued at $ 88,925 .
+Added: Company issued 20,336,472 shares of Common Stock in the cashless exercise of 28,619,000 warrants.
+Added: Company issued 5,000,000
+Added: shares of Common Stock in the exchange of 5,000,000
+Added: warrants and recognized a loss on the exchange of $ 381,000
+Added: which is included in the exercise of warrants in the consolidated statement of changes in stockholders’s equity.
+Added: were 200,000 Series B Preferred shares converted into 2,500,000 common shares.
+Added: Company settled 750,000 RSUs for Common Stock.
+Added: Company adjusted their common shares for vested RSUs in prior periods that were cancelled.
+Added: and Preferred Stock Issuances – 2023
+Added: 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
+Added: Regulation A+ Offerings for $ 640,000 .
+Added: The Company sold the warrants for $ 10,665 .
+Added: 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.
+Added: 2023, the Company issued:
+Added: (1) 500,000 shares of common stock in settlement of accounts payable of $ 28,450 ;
+Added: (2) 8,132,000 shares of common
+Added: stock and 8,132,000 warrants pursuant to the Offering Statement for the Regulation A+ Offering for an aggregate total of $ 528,580 ;
+Added: 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
+Added: to purchase 10,002,000 shares of common stock;
+Added: and (4) issued 4,000,000 shares of common stock for 4,00,000 vested restricted stock units,
+Added: for which the Company recognized a loss of $ 151,184 on this exchange of vested restricted stock units for shares of common stock.
COMMON STOCK OPTIONS, WARRANTS AND RESTRICTED STOCK UNITS
7 unchanged sentences
OF CHANGES IN STOCK OPTION
−Removed: at December 31, 2021
+Added: Intrinsic Value
+Added: Year Ended December
+Added: Outstanding at January 1, 2024
$ 0.024 - 0.04
−Removed: expired/canceled
−Removed: at December 31, 2022
+Added: Expired/cancelled
+Added: Outstanding at December
$ 0.024 - 0.04
−Removed: at December 31, 2022
+Added: Exercisable at December
$ 0.024 - 0.04
−Removed: at December 31, 2022
+Added: Year Ended December
+Added: Outstanding at January 1, 2023
$ 0.024 - 0.04
−Removed: expired/canceled
−Removed: at December 31, 2023
+Added: Expired/cancelled
+Added: Outstanding at December
$ 0.024 - 0.04
−Removed: at December 31, 2023
+Added: Exercisable at December
$ 0.024 - 0.04
−Removed: the years ended December 31, 2023 and 2022, the Company recognized $ 0 and $ 0 , respectively, worth of stock based compensation related
−Removed: to the vesting of it stock options.
+Added: the years ended December 31, 2024 and 2023, the Company recognized $ 0 of stock-based compensation expense related to the vesting of stock
Stock Warrants
1 unchanged sentence
OF CHANGES IN STOCK WARRANTS
−Removed: Warrants Outstanding
−Removed: Balance at December 31, 2021
−Removed: $ 0.04 - 0.10
−Removed: Warrants granted
−Removed: $ 0.01 – 0.08
−Removed: Warrants exercised
+Added: Intrinsic Value
+Added: December 31, 2024
+Added: Outstanding at January 1, 2024
$ 0.06 - 0.10
−Removed: Warrants expired/cancelled
( 28,619,000 )
−Removed: Balance at December 31, 2022
( 5,000,000 )
+Added: Outstanding at December 31, 2024
Exercisable at December 31, 2024
+Added: December 31, 2023
+Added: Outstanding at January 1, 2023
$ 0.06 - 0.10
−Removed: Warrants granted
−Removed: Warrants redeemed
−Removed: Warrants exercised
( 7,663,000 )
−Removed: Warrants exchanged
( 10,002,000 )
−Removed: Warrants expired/cancelled
+Added: Expired/cancelled
( 11,237,500 )
−Removed: Balance at December 31, 2023
+Added: Outstanding at December 31, 2023
$ 0.06 - 0.10
4 unchanged sentences
using the Black-Scholes valuation model.
−Removed: In the years ended 2023 and 2022 all warrants issued were issued pursuant to the Regulation A+ Offering, and are included in equity.
−Removed: The following assumptions
−Removed: were used for the periods as follows:
+Added: The following assumptions were used for the periods as follows:
OF ASSUMPTIONS USED IN FAIR VALUE MEASUREMENT
−Removed: December 31, 2023
−Removed: December 31, 2022
−Removed: Expected term
−Removed: Expected volatility
−Removed: Expected dividend yield
−Removed: Risk-free interest rate
−Removed: April and December 2023, the Company sold warrants to purchase 18,797,000
−Removed: shares of Common Stock in the Regulation A+ Offering for cash proceeds of $ 18,797 .
−Removed: In addition during the year ended December 31 2023:
−Removed: (1) warrants to purchase 10,002,000
−Removed: shares of common stock were issued when the Company exchanged warrants to purchase 10,002,000
−Removed: shares of common stock and issued 2,499,000
−Removed: shares of common stock;
−Removed: (2) warrants to purchase 7,663,000
−Removed: shares of common stock were exercised or expired;
−Removed: (3) warrants to purchase 11,237,500
−Removed: shares of common stock expired;
−Removed: and (4) warrants to purchase 500,000
−Removed: shares of common stock were redeemed.
−Removed: March 2022 the Company issued 299,577
−Removed: shares of common stock in the cashless exercise of warrants to purchase 825,000
−Removed: shares of common stock.
−Removed: In June 2022, warrants to purchase 1,000,000
−Removed: shares of common stock expired.
−Removed: July 7, 2022, the Company sold 15,000,000
−Removed: shares under the Regulation A+ Offering for $ 1,200,000
−Removed: , and warrants to purchase 20,000,000
−Removed: shares of common stock for $ 20,000 .
−Removed: following schedule summarizes the changes in the Company’s restricted stock units (“ RSUs ”):
+Added: dividend yield
+Added: interest rate
+Added: 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.
+Added: 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
+Added: term and 5,000,000 warrants with the same terms on April 1, 2024.
+Added: 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
+Added: expire December 31, 2027 at an exercise price of $ 0.15 for $ 11,950 under Regulation D.
+Added: 2024, the Company issued 25,336,468 shares of Common Stock in the exercise of 33,619,000 warrants and received $ 19,350 .
+Added: following schedule summarizes the changes in the Company’s restricted stock units:
OF CHANGES IN RESTRICTED STOCK UNITS
−Removed: Weighted Average
−Removed: Balance at December 31, 2021
−Removed: RSU’s granted
+Added: Grant Date Fair Value
+Added: Year Ended December
+Added: Outstanding at January 1, 2024
( 11,475,000 )
−Removed: RSU’s forfeited
−Removed: Balance at December 31, 2022
−Removed: RSUs forfeited
+Added: Outstanding at December 31, 2024
+Added: Year Ended December
+Added: Outstanding at January 1, 2023
( 15,450,000 )
−Removed: Balance at December 31, 2023
−Removed: the years ended December 31, 2023 and 2022, the Company recognized $ 1,239,950 and $ 1,389,700 worth of expense related to the vesting
−Removed: of its RSU’s.
−Removed: As of December 31, 2023, the Company had $ 131,950 worth of expense yet to be recognized for RSU’s not yet vested.
−Removed: February 3, 2022 and May 3, 2022, 10,000,000 of the RSUs valued at $ 900,000 to the Chief Executive Officer vested.
−Removed: On June 1, 2022, 100,000 RSUs were granted
−Removed: to a consultant valued at $ 8,200 that vested immediately.
−Removed: May 1, 2023, the Company granted 2,900,000
−Removed: RSUs to consultants, with 25 %
−Removed: of such RSUs vesting immediately, 25 %
−Removed: vest on December 31, 2023, 25 %
−Removed: vest on December 31, 2024 and the remaining 25 %
−Removed: vest on December 31, 2025.
+Added: Outstanding at December
+Added: 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
+Added: As of December 31, 2024, the Company had $ 923,855 worth of expense yet to be recognized for restricted stock units not yet
+Added: January 1, 2024, the Company granted 20,000,000
+Added: restricted stock units to its Chief Executive Officer as part of his new employment agreement that vest in four equal installments
+Added: over a two-year
+Added: period beginning February 1, 2024.
+Added: In May 2024, the Company granted 1,050,000
+Added: restricted stock units to consultants that vest through December 31, 2025.
+Added: In November 2024, the Company granted 800,000 restricted
+Added: stock units that vest in May 2025.
+Added: During the year ended December 31, 2024, 11,475,000
+Added: of these restricted stock units vested.
+Added: 2023, the Company granted 2,900,000 RSUs to consultants, with 25 % of such RSUs vesting immediately, 25 % vest on December 31, 2023, 25 %
+Added: vest on December 31, 2024 and the remaining 25 % vest on December 31, 2025.
These RSUs are valued at $ 263,900 .
−Removed: 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.
−Removed: December 2023, the Company granted 4,000,000 immediately vested RSUs to a consultant, for which the RSUs are valued at $ 208,000 .
+Added: 4, 2023, the Chief Executive Officer rescinded 1,012,500 of which 750,000 had vested in prior years, of his fully vested RSUs.
+Added: 2023, the Company granted 4,000,000 immediately vested RSUs to a consultant, for which the RSUs are valued at $ 208,000 .
June 4, 2019, the Company entered into an Executive Employment Agreement (“ Employment Agreement ”) with Dr.
Korenko, the Company’s Chief Executive Officer.
−Removed: employment term under the Employment Agreement commenced with an effective date of June 11, 2019 and expires on December 31, 2020, and
−Removed: December 31 of each successive year if the Employment Agreement is extended, unless terminated earlier as set forth in the Employment
−Removed: The Company on December 31, 2020 extended this agreement through December 31, 2021 while renegotiating terms of a new Employment
−Removed: On May 3, 2021, the Company and the Chief Executive Officer agreed the terms of a new Employment Agreement with an effective
−Removed: date of January 1, 2021 that has a term of three years and expired December 31, 2023.
−Removed: The Company renewed the Employment Agreement for
−Removed: a term of two years expiring December 31, 2025 .
+Added: The employment term under the Employment Agreement commenced with an effective
+Added: date of June 11, 2019 and expires on December 31, 2020, and December 31 of each successive year if the Employment Agreement is extended,
+Added: unless terminated earlier as set forth in the Employment Agreement.
+Added: On December 31, 2020, the Company extended the Employment Agreement
+Added: through December 31, 2021 while renegotiating terms of a new Employment Agreement.
+Added: On May 3, 2021, the Company and the Chief Executive
+Added: 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
+Added: December 31, 2023.
+Added: The Company renewed the Employment Agreement for a term of two years expiring December 31, 2025.
the terms of the Employment Agreement effective January 1, 2024, the Company shall pay to Dr.
14 unchanged sentences
deferred tax assets consist of the following components as of December 31, 2024 and 2023:
−Removed: SCHEDULE OF NET DEFERRED TAX ASSETS
−Removed: December 31, 2023
−Removed: December 31, 2022
+Added: OF NET DEFERRED TAX ASSETS
Deferred tax assets:
8 unchanged sentences
continuing operations for the years ended December 31, 2024 and 2023 due to the following:
−Removed: SCHEDULE OF FEDERAL INCOME TAX RATE
−Removed: December 31, 2023
−Removed: December 31, 2022
+Added: OF FEDERAL INCOME TAX RATE
Book income (loss)
1 unchanged sentence
$ ( 607,900 )
−Removed: Forgiveness of debt
−Removed: Related party accrual
Stock for services
3 unchanged sentences
December 31, 2024, the Company had net operating loss carryforwards of approximately $ 34,581,700 .
−Removed: ASC Topic 740 – Income Taxes (“ ASC 740 ”) provides guidance on the accounting for uncertainty
−Removed: in income taxes recognized in a company’s financial statements.
−Removed: ASC 740 requires a company to determine whether it is more likely
−Removed: than not that a tax position will be sustained upon examination based upon the technical merits of the position.
−Removed: If the more-likely-than-not
−Removed: threshold is met, a company must measure the tax position to determine the amount to recognize in the financial statements.
−Removed: At the adoption
−Removed: date of January 1, 2007, the Company had no unrecognized tax benefit, which would affect the effective tax rate if recognized.
+Added: Topic 740 – Income Taxes (“ ASC 740 ”) provides guidance on the accounting for uncertainty in income taxes recognized
+Added: in a company’s financial statements.
+Added: ASC 740 requires a company to determine whether it is more likely than not that a tax position
+Added: will be sustained upon examination based upon the technical merits of the position.
+Added: If the more-likely-than-not threshold is met, a company
+Added: must measure the tax position to determine the amount to recognize in the financial statements.
+Added: At the adoption date of January 1, 2007,
+Added: the Company had no unrecognized tax benefit, which would affect the effective tax rate if recognized.
Company includes interest and penalties arising from the underpayment of income taxes in the statements of operations in the provision
9 unchanged sentences
SUBSEQUENT EVENTS
−Removed: January 1, 2024 through the date of filing, the Company issued 2,000,000
−Removed: shares of common stock and warrants to purchase 2,000,000
−Removed: shares of common stock pursuant to the Regulation A+ Offering for cash proceeds of $ 128,000 .
−Removed: The Chief Executive Officer entered into the Employment Agreement with
−Removed: the Company for two years and received 20,000,000 RSUs that vest over the two year term of the Employment Agreement.
+Added: The Company has evaluated subsequent events through the date of this report and noted the following:
+Added: February 6, 2025, there has been 12,500,000 shares of common stock issued under the Regulation A+.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.