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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-K
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended December 31, 2024
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ________ to _________
Commission
file number: 0-53497
VIVOS
INC
(Exact
name of registrant as specified in its charter)
Delaware |
|
80-0138937 |
(State
or other jurisdiction of |
|
(I.R.S.
Employer |
incorporation
or organization) |
|
Identification
No.) |
1030
N Center Parkway
Kennewick,
Washington 99352
(Address
of principal executive offices) (Zip Code)
(509)
222-2222
Registrant’s
telephone number, including area code
Securities
registered pursuant to Section 12(b) of the Act:
None
Securities
registered pursuant to Section 12(g) of the Act:
Common
Stock, $0.001 Par Value
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
Accelerated Filer |
☐ |
Accelerated
Filer |
☐ |
Non-Accelerated
Filer |
☒ |
Smaller
Reporting Company |
☒ |
|
|
Emerging
growth company |
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Ex- change Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The
aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which
the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s
most recently completed second fiscal quarter was approximately $78,824,965. Shares of common stock held by each executive officer and
director and by each person who owns 10% or more of the outstanding common stock of the registrant have been excluded in that such persons
may be deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes.
Without acknowledging that any individual director of registrant is an affiliate, all directors have been included as affiliates with
respect to shares owned by them.
As
of March 7, 2025, there were 453,373,806 shares of the registrant’s common stock outstanding, 2,071,007 shares of
the registrant’s Series A Convertible Preferred Stock outstanding, 363 of the registrant’s Series B Convertible Preferred
Stock outstanding and 385,302 of the registrant’s Series C Convertible Preferred Stock outstanding.
VIVOS
INC
Report
on Form 10-K
TABLE
OF CONTENTS
PART
I
FORWARD
LOOKING STATEMENTS
Except
for statements of historical fact, certain information described in this Annual Report on Form 10-K (“Annual Report”)
contains “forward-looking statements” that involve substantial risks and uncertainties. You can identify these statements
by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“intend,” “may,” “should,” “will,” “would” or similar words. The statements
that contain these or similar words should be read carefully because these statements discuss the Company’s future expectations,
including its expectations of its future results of operations or financial position, or state other “forward-looking” information.
Vivos Inc. believes that it is important to communicate its future expectations to its investors. However, there may be events in the
future that the Company is not able to accurately predict or to control. Further, the Company urges you to be cautious of the forward-looking
statements which are contained in this Annual Report because they involve risks, uncertainties and other factors affecting its operations,
market growth, service, products, and licenses. The risk factors in the section captioned “Risk Factors” in Item 1A of the
Company’s Annual Report, as well as other cautionary language in this Annual Report, describe such risks, uncertainties and events
that may cause the Company’s actual results and achievements, whether expressed or implied, to differ materially from the expectations
the Company describes in its forward-looking statements. The occurrence of any of the events described as risk factors could have a material
adverse effect on the Company’s business, results of operations and financial position.
ITEM
1. BUSINESS.
Vivos
Inc. (the “Company,” “we,” “us,” “our”) is a radiation oncology
medical device company engaged in the development of its yttrium-90 (“Y-90”) based precision radionuclide therapy
device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide TherapyTM.
A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories,
universities, and private corporations, lead the Company’s development efforts. The Company’s overall vision is to globally
empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments
for cancer.
In
2013, the United States Food and Drug Administration (“FDA”) issued the determination that RadioGel™ is a device
for human therapy for non-resectable cancers in humans. This should result in a faster path than a drug for final approval.
In
January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGelTM should be classified as
a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company believes
that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas, but
rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals. We expect the
result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet®
for the treatment of solid tumors in animals. The FDA does not have premarket authority over devices with a veterinary classification,
and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance
with all applicable laws and regulations.
Based
on the FDA’s recommendation, RadioGelTM is being marketed as “IsoPet®” for use by veterinarians
to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet®”
name. IsoPet® and RadioGelTM are used synonymously throughout this document. The only distinction between IsoPet®
and RadioGelTM is the FDA’s recommendation that we use “IsoPet®” for veterinarian usage,
and reserve “RadioGelTM” for human therapy. Historically, the Company’s primary focus was on the development
and marketing of Isopet® for animal therapy, through the Company’s IsoPet® Solutions division. Over
the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device
Exemption and to obtain approval for clinical trials in India.
The
Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement of
university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of the technology
in private clinics. In January 2025 the Company restructured and aligned its internal resources and focused effort to align with animal
therapy, human therapy, and recently other applications of its patented technologies.
The
Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet®/RadioGelTM
testing and therapy. Washington State University treated five cats for feline sarcoma and served to develop the procedures which
are incorporated in our label. They concluded that the product was safe and effective in killing cancer cells. Colorado State University
demonstrated the CT and PET-CT imaging of IsoPet®. The University of Missouri conducted an animal study to treat canine
sarcoma. Johns Hopkins University completed a study on VX2 Tumors in Rabbits. Every study confirmed that the Y-90 stayed at the injection
site with insignificant distribution outside that boundary.
Commencing
in July 2019, the Company recognized its first commercial sale of IsoPet®. A veterinarian from Alaska brought his cat with a re-occurrent
spindle cell sarcoma tumor on his face. The cat had previously received external beam therapy, but now the tumor was growing rapidly.
He was given a high dose of 400Gy with heavy therapy at the margins.
The
Company anticipates that any near-term profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet®)
and related services, and from certifying veterinary clinics to administer IsoPet Therapy. Until recently the Company certified clinics
at its own expense, but the demand has increased to the point that starting in 2025 the Company billed its first clinic for the certification
process.
The
plan is to incorporate the data assembled from our work with Isopet® in animal therapy to support the Company’s
efforts in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell RadioGel™
as a Class II medical device. RadioGel™ is an injectable particle-gel for Precision Radionuclide Therapy radiation treatment of
cancerous tumors in people and animals. RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature
and then gels when reaching body temperature after injection into a tumor. In the gel are small, less than two microns, Y-90 phosphate
particles. Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local radiation
dose. The radiation is beta, consisting of high-speed electrons. These electrons only travel a short distance so the device can deliver
high radiation to the tumor with minimal dose to the surrounding tissue. Optimally, patients can go home immediately following treatment
without the risk of radiation exposure to family members. Since Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its
original value after ten days.
In
2021 the Company modified its Indication for Use from skin cancer to cancerous tissue or solid tumors pathologically associated with
locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic
lymph nodes or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require post-surgical
remnant ablation (for example, after prior incomplete radioiodine therapy). Papillary thyroid carcinoma belongs to the general class
of head and neck tumors for which tumors are accessible by intraoperative direct needle injection. The Company’s Medical Advisory
Board felt that demonstrating efficacy in clinical trials with this new indication provided a more efficient pathway to regulatory clearance.
In
December 2023, the Food and Drug Administration granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device
pursuant to the FDA’s Breakthrough Devices Program. This gave the company access to the “sprint” rapid review process
for IDE comments. For the last several months the company has been taking advantage of that program to resoled detailed FDA questions
on a variety of topics.
In
early 2025 the Company began actively pursuing human clinical trials in India. This involved successful step-by-step implementation of
several requirements, including location of a respected lead investigator at a respected hospital; regulatory approvals (securing clearances
from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health
& Family Welfare, and the Company was issued the Clinical Trial Registry-India (CTRI) number required for publishing results); logistical
coordination (acquired liability insurance, expanded the treatment institution’s radioactive material license to include RadioGel®,
and established robust international shipping protocols and an alternate contingency shipping path for the Yttrium-90 (Y-90)-based product);
protocol development (finalized the Clinical Trial Protocol, incorporating Mayo Clinic study designs and feedback from FDA pre-submission
discussions); operational readiness (re-validated RadioGel® manufacturing at IsoTherapeutics to ensure compliance with
Quality Management System standards and FDA sterility and validation recommendations); administrative preparations (signed agreements
with the Ethics Committee and treatment institution while confirming trademark and patent protections in the region); and training and
certification (conducted comprehensive certification training for the treatment team). Failure on any step would have terminated the effort.
In
December 2024 the Company conducted an important offset strategic meeting to ensure that its entire key internal and external team was
alighted to its strategic plans. Attendees included all our current internal team members, our senior health physics volunteer, the members
of the Medical Advisory Board and the Veterinary Medicine Advisory Board, lead Investigator for the proposed Mayo Clinic clinical trial,
lead investigator for the clinical trial in India, and our patent attorney. The primary objective was to re-assess our business direction,
to select the next target series of indications for Use, to ensure that we have developed the optimum precision Radionuclide TherapyTM
approach for each cancer type, including the isotope, the delivery technique, and the dose, and to ensure that our current and
future patents protect these directions. It also discussed the domestic and internation plans.
The
Company decided to explore the viability of harvesting its technology for other business opportunities as a separate “division.”
The Company is working with Akina, on these initiatives. The current efforts are on the Peltier Chiller technology and the hydrogel.
To prevent the Company from being distracted from its primary focus of treating cancer, if viable, Akina would probably also be the principal
distributor. Alternatively, each business sector can be spun off as separate business activities to an interested party.
Controlled
Laboratory Chilling - As Akina explained, it is easy to purchase many laboratory devices to control heating, but there are limited or
no options for controlled cooling, which is a common laboratory requirement usually involving ice baths. The Company is now testing a
prototype universal laboratory cooling device.
Hydrogel
– the Company spent years on refining the development of its hydrogel, in which gelation initiates just above room temperature
and is completed as it warms to body temperature. It is currently investing in quantifying and controlling the hydrogel resorption characteristics.
There has been sufficient spontaneous interest in this component to warrant a serious business case assessment. The Company just trademarked
the name Precision GelTM and, in addition to its current hydrogel patent, has filed a new provisional patent in January 2025
to cover retention, transport, and release of a broad range of agents. These agents include radioactive and non-radioactive materials,
solid particles, including nano-particles, large molecules, small molecules, including liquids, cells, and viruses. A MOU has been drafted
to interface with potential clients including licensing and exclusive material contracting. Initial meetings are scheduled in the first
quarter of 2025 with potential clients to assess the business viability.
Intellectual
Property
Our
original license agreement with Battelle National Laboratory (the “Battelle License”) reached its end of life in 2022.
We have expanded our proprietary knowledge, as well as our trademark and patent protection, in anticipation of the Battelle License reaching
the end of its term during the past several years.
Our
trademark protection, which usually is extended to 17 countries, has been expanding continuously as summarized below:
We
own applications/registrations for the following and should mark as noted below:
|
○ |
ISOPET® |
|
○ |
RADIOGEL® |
|
○ |
ALPHA-GELTM |
|
○ |
BETA-GELTM |
|
○ |
GAMMA-GELTM |
|
○ |
PRECISION
RADIONUCLIDE THERAPYTM |
|
○ |
PRECISIONGELTM |
Similarly,
we have systematically filed provisional and utility patents that cover our key components, hydrogel and the yttrium phosphate
particles, and our injection system in the US office and more than ten others covering approximately 63 counties.
In
January 2025 we filed an additional provisional patent on the control, transport, and delivery of PrecisionGel.
IsoPet
Regional Clinics
Vista
Veterinary Hospital (“Vista”) was selected as the pilot private clinic to initiate commercial sales of IsoPet®.
It is good management practice to implement and learn from a pilot program before spreading to regional clinics across the country. Vista
is in the Tri-Cities Washington area was convenient for interactions with key personnel of the Company.
Vista
has done well in several audits by the Washington State Department of Health. The Company worked closely with the Washington State Department
of Health to refine and improve the radioactive material license by adding several detailed procedures, which will benefit future regional
clinics. In addition, a second veterinarian has been certified.
The
testing at the universities and at Vista have demonstrated that IsoPet® is effective on killing cancer tissue near the
injections. It is most effective in early cases before the cancer has begun to spread. Later stage cancers are more difficult to treat
since the tendrils from the primary cancer site are not well defined or imaged and therefore can lead to recurrence.
Johns
Hopkins University Veterinary Clinical Trials Network (“Johns Hopkins”), is now an Isopet® regional
clinic. They have the required radioactive material license and have completed their training certification for Isopet®.
This important relationship will also help meet our objective of obtaining high quality data on a range of cancers that can be published
in leading journals. These publications are the optimal way to increase awareness of Isopet®, and to gain broader acceptance
from the veterinarian/oncology community. Johns Hopkins just completed the VX2 Tumor therapy animal study in rabbits and is writing a
report for publication. The study further demonstrated the safety of RadioGel®, generating the activity decay curves that
show that the hydrogel remains at the injection site. This study also: (1) demonstrated the validity of the Instructions for Use; (2)
the validity of the Injection Guidance Table; and (3) provided a basis for refining the techniques for treating small human cancerous
lymph nodes.
RadioGel’s
classification as a breakthrough device was positively influenced by the safety and effectiveness of many animal therapies.
We
expanded the number of IsoPet Certified clinic from 4 in 2023 to 13 by the end of 2024:
|
● |
Vista
Veterinary Hospital – Kennewick, WA |
|
● |
University
of Missouri – Columbia, MO |
|
● |
Johns
Hopkins University – Baltimore, MD |
|
● |
New
England Equine Practice – Patterson, NY |
|
● |
Myhre
Equine Clinic, Rochester, NH |
|
● |
University
of Wisconsin School of Veterinary Medicine, Madison, W |
|
● |
Brazos
Valley Equine Hospital, Navasota, TX |
|
● |
Indian
Creek Veterinary Hospital, Fort Wayne, IN |
|
● |
Hopkinton
Animal Hospital - Hopkinton, N |
|
● |
NorthStar
VETS Veterinary Emergency Trauma & Specialty Center, Robbinsville, NJ |
|
● |
Animal
Emergency & Specialty Center of Knoxville, Knoxville, TN |
|
● |
Sumner
Veterinary Hospital, Sumner, WA |
|
● |
The
University of Illinois College of Veterinary Medicine, Urbana, IL |
We
now treat feline, canine, equine, and exotic animals.
We
are targeting to open approximately ten more clinics in 2025.
The
Company worked closely with FX Masse to assist the clinics with licensing. They developed nine certification training modules for use
in potential regional clinics. These modules are necessary to satisfy the radioactive material handling licenses.
During
2024, the Company saw the development of three new websites to elevate the online presence and brand identity. These included a corporate
website and dedicated sites for its two divisions, RadioGel® and IsoPet®, tailored to their unique audiences.
Each site featured user-friendly designs, informative content, and engaging blogs to educate visitors and build industry authority. Marketing
Materials were created that effectively communicated our innovative cancer treatment Precision Radionuclide Therapy™.
Our
team managed a booth at six conferences. LeeAnna Binder toured the country discussing IsoPet therapy with several clinics in a specially modified IsoPet van. To amplify visibility, our marketing team managed and maintained an
active presence on social media platforms, including Facebook, Instagram, X, and LinkedIn, with consistent, engaging posts to
connect with our target audience. This comprehensive approach enhanced brand recognition, drove traffic to our websites, and
supported business growth.
In
2024, IsoPet Division transitioned from data collection to commercialization, utilizing our extensive data to refine our offerings. By
collaborating closely with certified clinics, we have recalibrated our pricing to make our services more affordable for pet patients.
As we enter 2025, with plans to expand our clinic network across strategic US regions, we are excited about enhancing pet care nationwide.
With increasing patient volumes, we are also aligning with our production team to establish a more defined ordering schedule. This strategy
will help synchronize patient bookings with product availability, ultimately reducing production costs and making IsoPet’s solutions
even more accessible.
Our
objectives are to open several more regional clinics over the next three years, and to participate in a minimum of four conferences annually
to spread the word about IsoPet® in the veterinarian community for treating tumors in small animals and horses. Our Veterinary
Medicine Steering Board provides advice on obtaining new pet patients.
FDA
Regulatory Status- Recent Developments
Human
Therapy
In
November 2020 the Company submitted a request for a Breakthrough Device Designation. Ultimately, this was denied, but the FDA acknowledged,
“The FDA does believe that RadioGel™ meets criterion #2a: Device represents breakthrough technology. Your device does
meet this criterion because it is a novel application of a precision radionuclide therapy device outside of the liver.” More
importantly, the process resulted in a rapid review of our existing data and approach. It led to a redirection of our efforts on writing
the Investigational Device Exemptions (“IDEs”) and saved the Company much time in the review of that future application.
Based
on advice from the FDA the Company scheduled a Pre-Submission meeting on November 30, 2021 to discuss a draft of an IDE for Early Feasibility
Medical Device Clinical Studies, including certain First in Human (“FIH”) Studies. Using this process results in more
rapid feedback to prepare the final IDE.
The
FDA was supportive and had suggested this Q-Submission path for rapid turnaround and dialog. The Mayo Clinic physicians did an excellent
job presenting the need for Radiogel™ to treat recurrent thyroid cancer and to answer a range of questions from the
new FDA review team. The FDA provided many helpful suggestions on a range of subjects from labeling to dosimetry to the Mayo Clinic protocol
for clinical testing, and the need for some additional specific testing. They suggested having another Q-Sub Review and conference call
dedicated to the details of the dosimetry calculations.
In
May of 2022 the Company held another pre-submission meeting with the FDA. They concurred with our dosimetry techniques and requested
one more animal test to confirm that the Y-90 stays at the injection site. We participated in another pre-submission meeting to discuss
this new animal test of VX-2 tumors in rabbits at Johns Hopkins. We have a meeting scheduled with the FDA in October to obtain their
feedback on our new animal test plan.
We
held another pre-submission meeting with the FDA on October 17, 2022 to obtain detailed feedback on the proposed VX-2/Rabbit Animal Test
Plan and to submit the Risk Management Report (“RMR”). The RMR analyzed all hypothetical scenarios and concluded that
RadioGel is inherently safe.
We
participated in pre-submission meetings with the FDA on April 10, 2023, and September 29, 2023, to discuss the preliminary results of
the VX2 tumor animal study and to obtain feedback on the genotoxicity protocol.
After
providing addition information to the FDA on December 18, 2023, the FDA classified us as a Breakthrough device to our proposed Indication
for Use.
Since
September 2024 the company has been engaged in the sprint process to discuss several FDA comments in detail. There will continue through
February 2024, at which time we will re-submit the request for an IDE. In parallel, the Company is working with the Mayo Clinic’s
principal investigators to improve the clinical trial protocol for their Institutional Review Board.
The
Medical Advisory Board (“MAB”) selected 18 applications for RadioGel™, each of which meet the criteria described
above. This large number confirms the wide applicability of the device and defines the path for future business growth. The Company’s
application establishes a single Indication for Use - treatment of cancerous tissue or solid tumors pathologically associated with locoregional
papillary thyroid carcinoma and recurrent papillary thyroid carcinoma.
We
anticipate that this initial application will facilitate each subsequent application for additional Indications for Use. After the second
Indication for Use, our objective is to apply for a broad Indication for Use which we would target to obtain approval to treat all solid
tumors
Radiogel™
Device Designation:
In
2014, the Company submitted a presubmission (Q130140) to obtain FDA feedback about the proposed product. The FDA requested that the Company
file a request for designation with the Office of Combination Products (RFD130051), which led to the determination that RadioGel™
is a device for human therapy for non-resectable cancers, which must be reviewed and ultimately regulated by the Center for Devices and
Radiological Health (“CDRH”). The Company then submitted a 510(k) notice for RadioGel™ (K133368), which was
found Not Substantially Equivalent due to the lack of a suitable predicate, and RadioGel™ was assigned to the Class III product
code NAW (microspheres). Class III products or devices are generally the highest risk devices and are therefore subject to the highest
level of regulatory review, control, and oversight. Class III products or devices must typically be approved by FDA before they are marketed.
Class II devices represent lower risk products or devices than Class III and require fewer regulatory controls to provide reasonable
assurance of the device’s safety and effectiveness. In contrast, Class I products and devices are deemed to be lower risk than
Class I or II, and are therefore subject to the least regulatory controls.
A
pre-submission meeting (Q140496) was held with the FDA on June 17, 2014, during which the FDA maintained that RadioGel™ should
be considered a Class III device and therefore subject to pre-market approval. On December 29, 2014, the Company submitted a de novo
petition for RadioGel™ (DEN140043). The de novo petition was denied by the FDA on June 1, 2015, with the FDA providing
numerous comments and questions. On September 29, 2015, the Company submitted a follow-up pre-submission informational meeting request
with the FDA (Q151569). This meeting took place on November 9, 2015, at which time the FDA indicated acceptance of the Company’s
applied dosimetry methods and clarified the FDA’s outstanding questions regarding RadioGel™. Following the November 2015
pre-submission meeting, the Company prepared a new pre-submission package to obtain FDA feedback on the proposed testing methods, intended
to address the concerns raised by the FDA staff and to address the suitability of RadioGel™ for de novo reclassification.
This pre-submission package was presented to the FDA in a meeting on August 29, 2017. During the August 2017 meeting, the FDA clarified
their position on the remaining pre-clinical testing needed for RadioGel™. Specifically, the FDA addressed proposed dosimetry calculating
techniques, dosimetry distribution between injections, hydrogel viscoelastic properties, and the details of the Company’s proposed
animal testing.
Financing
and Strategy
The
Company requires funding of approximately $3.5 million per year for Selling and General Administration costs and to fund its ongoing
initiatives. Over the next 36 months, the Company believes it will cost approximately $10 million to: (1) conduct human clinical trials;
(2) activate several regional clinics to administer IsoPet® across the county; (3) create an alternate manufacturing center
based on a template for future international manufacturing.
The
principal variables in the timing and amount of spending depends on the speed of FDA approval for clinical trials. The currently approved
1-A Reg A provided a basis for obtaining most of the required investment, assuming there are willing investors. The Company intends to
reduce its funding requirement via generating income from sales in the animal sector.
Outside
of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.
Based
on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed
substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and
has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to
delay the implementation of its business strategy and may not be able to continue operations.
As
of December 31, 2024, the Company has $2,212,548 cash on hand. There are currently commitments to vendors for products and services purchased.
To continue the development of the Company’s products, the current level of cash may not be enough to cover the fixed and variable
obligations of the Company. The company has been utilizing the previously authorized Reg A as the principal vehicle to obtain funding
and intends to continue to bring in the funding necessary to support the projected activities through 2027. There is no guarantee that
the Company will be able to raise additional funds or to do so at an advantageous price.
Product
Features
The
Company’s RadioGel™ device has the following product features:
|
● |
Beta
particles only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the nearby normal
tissues. In medical terms Y-90 beta emitter has a high efficacy rate; |
|
|
|
|
● |
Benefitting
from the short penetration distance, the patient can go home immediately with no fear of exposure to family members, and there is
a greatly reduced radiation risk to the doctor. A simple plastic tube around the syringe, gloves and safety glasses are all that
is required. Other gamma emitting products require much more protection; |
|
|
|
|
● |
A
2.7-day half-life means that only 5% of the radiation remains after ten days. This is in contrast to the industry-standard gamma
irradiation product, which has a half-life of 17 days; |
|
|
|
|
● |
The
short half-life also means that any medical waste can be stored for thirty days then disposed as normal hospital waste; |
|
|
|
|
● |
RadioGel™
can be administered with small diameter needles (27-gauge) so there is minimal damage to the normal tissue. This contrasts with the
injection of metal seeds, which does considerable damage; and |
|
|
|
|
● |
After
about 120 days the gel resorbs by a normal biological cycle, called the Krebs Cycle. The only remaining evidence of the treatment
are phosphate particles so small in diameter that it requires a high-resolution microscope to find them. This contrasts with permanent
presence of metal seeds. |
Steps
from Production to Therapy
Device
Production
During
the next two years, the Company intends to continue to outsource material aspects of manufacturing and distribution. As future product
volume increases, the Company will reassess its make-buy decision on manufacturing and will analyze the cost/benefit of a centrally located
facility.
Production
of the Hydrogel
RadioGel™
is manufactured with a proprietary process under ventilated sterile hood by following strict Good Management Practices (“GMP”)
procedures. It is made in large batches that are frozen for up to three months. When the product is ready to ship, a small quantity of
the gel is dissolved in a sterile saline solution. It is then passed through an ultra-fine filter to ensure sterility.
Production
of the Yttrium-90 Phosphate Particles
The
Y-90 particles are produced with simple ingredients via a proprietary process, again following strict GMP procedures. They are then mixed
into a phosphate-buffered saline solution. They can be produced in large batches for several shipments. The number of particles per shipment
is determined by the dose prescribed by the doctor.
Pre-Mixing
– Ready to Use (“RTU”)
The
Company now pre-mixes the particle solution and the hydrogel and places the RTU IsoPet® in standard size vials. This innovation is
cost effective and reduces the probability of any accidental spills or biological contamination at the therapy sites. It also simplified
the certification training for new regional clinics.
Shipment
The
vials are shipped inside the specially designed plastic shipping pigs via FedEx or UPS, all following the proper protocols.
At
the User
The
quantities and activities are in the information on the product label.
The
specific injection technique described on the Instructions for Use. For small tumors, one centimeter in diameter or less, the cancer
is treated with a single injection. For larger tumors, the cancer is treated with a series of small injections from the same syringe
or multiple syringes.
Principal
Markets
The
Company is currently pursuing two synergistic business sectors, medical and veterinary, each of which are summarized below.
Medical
Sector
RadioGel™
is currently fully developed, requiring only FDA approval before commercialization.
Building
on the FDA’s ruling of RadioGel™ as a device, the Company incorporated the FDA suggestions and has invested in
the pre-clinical testing required for IDE submittal. This included two years of effort on biocompatibility testing. The last remaining
animal test has been completed, and the Company is engaged in the detailed sprint revie process.
Clinical
trials have just initiated in India. It is anticipated that these data will help accelerate FDA approval in the USA.
Veterinary
Sector
There
are approximately 150 million pet dogs and cats in the United States. Nearly one-half of dogs and one-third of cats are diagnosed with
cancer at some point in their lifetime. The Veterinary Oncology & Hematology Center in Norwalk, Connecticut, reports that cancer
is the number one natural cause of death in older cats and dogs, accounting for nearly 50 percent of pet deaths each year. The American
Veterinary Medical Association reports that half of the dogs ten years or older will die because of cancer. The National Cancer Institute
reports that about six million dogs are diagnosed with cancer each year, translating to more than 16,000 a day.
The
Company’s IsoPet® operating division focuses on the veterinary oncology market Richard Weller DVM, DACVIM, is now
the Chairman of the Veterinary Medicine Advisory Board. In addition, John E. Hendrich, PhD, DVM is a new member.
Development
of the product and application techniques and animal testing is allowed under FDA regulation. Commercial sales of RadioGelTM for
animals requires confirmation by the FDA Center for Veterinary Medicine (“CVM”). In January 2018, the Center for Veterinary
Medicine Product Classification Group, the entity within the CVM that is responsible for determining the classification of a product,
ruled that RadioGelTM should be classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.
Additionally,
after a legal review, the Company believes that the device classification obtained from the FDA Center for Veterinary Medicine is not
limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers, including all or
most all solid tumors in animals. We expect the result of such classification and label approval will be that no additional regulatory
approvals are necessary for the use of RadioGelTM for the treatment of solid tumors in animals. The FDA does not have premarket
authority over devices with a veterinary classification, and the manufacturers are responsible for assuring that the product is safe,
effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.
The
Company currently intends to utilize university veterinary hospitals for therapy development, given that veterinary hospitals offer superior
and plentiful veterinarians and students, many animal patients, radioactive material handling licenses, and are respected by private
veterinary centers and hospitals.
Competitors
The
Company competes in a market characterized by technological innovation, extensive research efforts, and significant competition.
The
pharmaceutical and biotechnology industries are intensely competitive and subject to rapid and significant technological changes. Several
companies are pursuing the development of pharmaceuticals and products that target the same diseases and conditions that our products
target. We cannot predict with accuracy the timing or impact of the introduction of potentially competitive products or their possible
effect on our sales. Certain potentially competitive products to our products may be in various stages of development. Also, there may
be many ongoing studies with currently marketed products and other developmental products, which may yield new data that could adversely
impact the use of our products in their current and potential future Indications for Use. The introduction of competitive products could
significantly reduce our sales, which, in turn would adversely impact our financial and operating results.
There
are a wide variety of cancer treatments approved and marketed in the U.S. and globally. General categories of treatment include surgery,
chemotherapy, radiation therapy and immunotherapy. These products have a diverse set of success rates and side effects. The Company’s
Radiogel™ precision radionuclide therapy product would generally compete with brachytherapy devices currently marketed in the U.S.
and globally. The traditional iodine-125 (“I-125”) and palladium-103 (“Pd-103”) technologies are
well entrenched with powerful market players. The industry-standard I-125-based therapy was developed by Oncura, which is a unit of General
Electric Healthcare. Additionally, C.R. Bard, a major industry player competes in the I-125 marketplace. These market competitors are
also involved in the distribution of Pd-103 based products. Cs-131 brachytherapy products are marketed by GT MedTech. Several Y-90 therapies
have been FDA approved including SIR-Spheres by Sirtex, TheraSphere by Biocompatibles UK.
Raw
Materials
The
Company currently subcontracts the manufacturing of RadioGelTM at IsoTherapeutics. Eckert and Ziegler is the sole supplier
of the Y-90 used by IsoTherapeutics to manufacture the Company’s RadioGel™. The Company obtains supplies, hardware,
handling equipment and packaging from several different U.S. suppliers. Eckert and Ziegler previously provided Y-90 to the USA from Germany,
but we now receive the material from their Massachusetts operations.
In
2024 IsoTherapeutics was acquired by Telix. That has stimulated Vivos to accelerate its efforts to develop an additional manufacturing
contractor. Our objective is to develop more than one alternative to manufacture our components by 2026.
During
2021, the Company engaged Akina, Inc. as an alternate supplier of its hydrogel polymer component. We have now expanded to include SciPoly
as another alternate polymer supplier. We are completing the actions to expand Akina’s role to be the supplier of sterilized hydrogel,
PrecisionGelTM.
Customers
The
Company anticipates that potential customers for our potential precision radionuclide therapy products likely would include those
institutions and individuals that currently purchase brachytherapy products or other oncology treatment products. We anticipate that
the veterinarian and medical communities will recognize the Precision Radionuclide TherapyTM as the best option for
treating many solid tumors.
Government
Regulation
The
Company’s present and future intended activities in the development, manufacturing, and sale of cancer therapy products, including
RadioGel™, are subject to extensive laws, regulations, regulatory approvals, and guidelines. Within the United States,
the Company’s therapeutic radiological devices must comply with the U.S. Federal Food, Drug and Cosmetic Act, which is enforced
by FDA. The Company is also required to adhere to applicable FDA Quality System Regulations, also known as the Good Manufacturing Practices,
which include extensive record keeping and periodic inspections of manufacturing facilities.
In
the United States, the FDA regulates, among other things, new product clearances and approvals to establish the safety and efficacy of
these products. We are also subject to other federal and state laws and regulations, including the Occupational Safety and Health Act
and the Environmental Protection Act.
The
Federal Food, Drug, and Cosmetic Act and other federal statutes and regulations govern or influence the research, testing, manufacture,
safety, labeling, storage, record keeping, approval, distribution, use, reporting, advertising, and promotion of such products. Noncompliance
with applicable requirements can result in civil penalties, recall, injunction or seizure of products, refusal of the government to approve
or clear product approval applications, disqualification from sponsoring or conducting clinical investigations, preventing us from entering
government supply contracts, withdrawal of previously approved applications, and criminal prosecution.
In
the United States, medical devices are classified into three different categories over which the FDA applies increasing levels of regulation:
Class I, Class II, and Class III. Most Class I devices are exempt from premarket notification 510(k); most Class II devices require premarket
notification 510(k); and most Class III devices require premarket approval. RadioGel™ is currently classified as a Class
III device.
Approval
of new Class III medical devices is a lengthy procedure and can take several years and require the expenditure of significant resources.
There is a shorter FDA review and clearance process for Class II medical devices, the premarket notification or 510(k) process, whereby
a company can market certain Class II medical devices that can be shown to be substantially equivalent to other legally marketed devices.
As
a registered medical device manufacturer with the FDA, we are subject to inspection to ensure compliance with FDA’s current Good
Manufacturing Practices, or cGMP. These regulations require that we and any of our contract manufacturers design, manufacture, and service
products, and maintain documents in a prescribed manner with respect to manufacturing, testing, distribution, storage, design control,
and service activities. Modifications or enhancements that could significantly affect the safety or effectiveness of a device or that
constitute a major change to the intended use of the device require a new 510(k) premarket notification for any significant product modification.
The
Medical Device Reporting regulation requires that we provide information to the FDA on deaths or serious injuries alleged to be associated
with the use of our devices, as well as product malfunctions that are likely to cause or contribute to death or serious injury if the
malfunction were to recur. Labeling and promotional activities are regulated by the FDA and, in some circumstances, by the Federal Trade
Commission.
As
a medical device manufacturer, we are also subject to laws and regulations administered by governmental entities at the federal, state,
and local levels. For example, our facility is licensed as a medical device manufacturing facility in the State of Washington and is
subject to periodic state regulatory inspections. Our customers are also subject to a wide variety of laws and regulations that could
affect the nature and scope of their relationships with us.
In
the United States, as a manufacturer of medical devices and devices utilizing radioactive byproduct material, we are subject to extensive
regulation by not only federal governmental authorities, such as the FDA and FAA, but also by state and local governmental authorities,
such as the Washington State Department of Health, to ensure such devices are safe and effective. In Washington State, the Department
of Health, by agreement with the federal Nuclear Regulatory Commission (“NRC”), regulates the possession, use, and
disposal of radioactive byproduct material as well as the manufacture of radioactive sealed sources to ensure compliance with state and
federal laws and regulations. RadioGel™ constitutes both medical devices and radioactive sealed sources and are subject
to these regulations.
Moreover,
our use, management, and disposal of certain radioactive substances and wastes are subject to regulation by several federal and state
agencies depending on the nature of the substance or waste material. We believe that we follow all federal and state regulations for
this purpose.
Environmental
Regulation
Our
business does not require us to comply with any extraordinary environmental regulations. Our RadioGel™ product is manufactured
in an independently owned and operated facility. Any environmental effects or contamination event that could result would be from the
shipping company during shipment and misuse by the treatment facility upon arrival.
Human
Capital
Since
2017, the Company has followed the cost-effective model of having had one full-time employee, the CEO. The Company utilizes several independent
contractors to assist with its operations. This includes key positions, such as acting CFO and Quality Assurance Manager. The Company
does not have a collective bargaining agreement with any of its personnel and believes its relations with its personnel are good. This
enables the Company to operate on very low overhead, for cost-effective utilization of its investment and to manage our work scope like
projects.
Available
Information
The
Company prepares and files annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and certain other
information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information
regarding issuers that file electronically with the SEC at http://www.sec.gov. Moreover, the Company maintains a website at http://www.RadioGel.com
that contains important information about the Company, including biographies of key management personnel, as well as information about
the Company’s business. This information is publicly available and is updated regularly. The content on any website referred to
in this Offering Circular is not incorporated by reference into this Offering Circular, unless (and only to the extent) expressly so
stated herein.
ITEM
1A. RISK FACTORS.
Investing
in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information
in this Annual Report, including our financial statements and the related notes and “Management’s Discussion and Analysis
of Financial Condition and Results of Operations,” before deciding whether to invest in our securities. The occurrence of any of
the events or developments described below could harm our business, financial condition, operating results, and growth prospects. In
such an event, the market price of our common stock could decline, and you may lose all or part of your investment. Additional risks
and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.
RISKS
ASSOCIATED WITH THE COMPANY’S BUSINESS
Our
independent registered public accounting firms’ reports on its financial statements questions the Company’s ability to continue
as a going concern.
The
Company’s independent registered public accounting firms’ reports on the Company’s financial statements for the years
ended December 31, 2024 and 2023 express substantial doubt about the Company’s ability to continue as a going concern. The reports
include an explanatory paragraph stating that the Company has suffered recurring losses, used significant cash in support of its operating
activities and based on its current operating levels, require additional capital or restructuring to sustain its operation for the foreseeable
future. There is no assurance that the Company will be able to obtain sufficient additional capital to continue its operations and to
alleviate doubt about its ability to continue as a going concern. If the Company obtains additional financing, such funds may not be
available on favorable terms and likely would entail considerable dilution to existing shareholders. Any debt financing, if available,
may involve restrictive covenants that restrict its ability to conduct its business. It is extremely remote that the Company could obtain
any financing on any basis that did not result in considerable dilution for shareholders. Inclusion of a “going concern qualification”
in the report of its independent accountants or in any future report may have a negative impact on our ability to obtain debt or equity
financing and may adversely impact our stock price.
A
combination of our current financial condition and the United States Food and Drug Administration’s (“FDA”) determinations
to date regarding Radiogel™ raise material concerns about ability to continue as a going concern.
The
Company will not be able to continue as a going concern unless the Company obtains financing. Depending upon the amount of financing,
if any, the Company can obtain, the Company may not receive adequate funds to continue the approval process for RadioGel™ or other
precision radionuclide therapy products with the FDA, which would disrupt our business operations or derail our business strategy, and
materially and adversely affect our business, financial condition, and results of operations.
The
Company has generated operating losses since inception, which are expected to continue, and has increasing cash requirements, which it
may be unable to satisfy.
The
Company has generated material operating losses since inception. The Company has had recurring net losses since inception which has resulted
in an accumulated deficit of $85,361,229 and $82,450,781 as of December 31, 2024 and 2023, respectively, including net losses of $2,910,448
and $2,894,753 for the years ended December 31, 2024 and 2023. Historically, the Company has relied upon investor funds to maintain its
operations and develop its business. The Company needs to raise additional capital from investors for working capital as well as business
expansion, and there is no assurance that additional investor funds will be available on terms acceptable to the Company, or at all.
If the Company is unable to unable to obtain additional financing to meet its working capital requirements, the Company likely would
cease operations.
The
Company requires funding of approximately $3.5 million per year for Selling and General Administration costs and to fund its ongoing
initiatives. Over the next 36 months, the Company believes it will cost approximately $10 million to: (1) conduct human clinical trials;
(2) activate several regional clinics to administer IsoPet® across the county; (3) create an alternate manufacturing center
based on a template for future international manufacturing.
The
principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the FDA’s
classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise) and any requirements for
additional studies, which may possibly include clinical studies. Thereafter, the principal variables in the amount of the Company’s
spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with
third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the United States
of America (“U.S.”, or the “United States”) and elsewhere. The Company intends to fund its activities
through strategic transactions such as licensing and partnership agreements or additional capital raises.
Recent
geopolitical events, including the inherent instability and volatility in global capital markets, as well as the lack of liquidity in
the capital markets, could also impact the Company’s ability to obtain financing and its ability to execute its business plan.
Recent
economic events, the inherent instability in global capital markets, as well as the lack of liquidity in the capital markets, could adversely
impact the Company’s ability to obtain financing and its ability to execute its business plan, which would materially and adversely
affect our business and operations.
The
Company has a limited operating history, which may make it difficult to evaluate its business and prospects.
The
Company has a limited operating history upon which one can base an evaluation of its business and prospects. As a company in the development
stage, there are substantial risks, uncertainties, expenses, and difficulties to which its business is subject. To address these risks
and uncertainties, the Company must do the following:
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successfully
develop and execute the business strategy; |
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respond
to competitive developments; and |
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attract,
integrate, retain, and motivate qualified personnel. |
There
is no assurance that the Company will achieve or maintain profitable operations or that the Company will obtain or maintain adequate
working capital to meet its obligations as they become due. The Company cannot be certain that its business strategy will be successfully
developed and implemented or that the Company will successfully address the risks that face its business. If the Company does not successfully
address these risks, its business, prospects, financial condition, and results of operations could be materially and adversely affected.
The
Company’s products are regulated and require appropriate clearances and approvals to be marketed in the U.S. and globally.
There
is no assurance the FDA or other global regulatory authorities will grant the Company permission to market the Company’s precision
radionuclide therapy Y-90 RadioGel™ device.
The
Company has been working with the FDA to obtain clearance for its precision radionuclide therapy Y-90 RadioGelTM device, but
no assurances have been received. On December 23, 2014, the Company announced that it submitted a de novo application to the FDA
for marketing clearance for its patented Y-90 RadioGelTM device pursuant to Section 513(f)(2) of the U.S. Food, Drug and Cosmetic
Act (the “Act”). In June 2015, the FDA notified the Company the de novo application was not granted. In February
2014, the FDA found the same device under Section 510(k) of the Act not substantially equivalent and concluded that the device is classified
by statute as a Class III medical device, unless the device is reclassified. The Company is seeking reclassification of the product to
Class II. If the Company is successful in seeking reconsideration of the Company’s de novo application, as a regulatory
matter, the device could be on an easier and faster path to market in the United States. However, there would still be the requirements
to complete the in vitro and in vivo testing, and then some human clinical trials. That testing date is submitted in a de novo pre-market
application and if accepted we could then go to market. As a practical matter, the Company would still need to secure funding and commercial
arrangements before marketing could commence. If the de novo application is declined and if the Company obtains funding to permit
it to continue operations, the Company will explore steps toward seeking approval for the device as a Class III medical device. Generally,
the time and cost of seeking approval as a Class III medical device is materially greater than the time and cost of seeking approval
as a Class II medical device. If the Company seeks approval as a Class III device, human clinical trials will be necessary. Generally,
human trials for Class III products are larger, of longer duration and costlier than those for Class II devices.
There
will be additional cost and time to reach marketing clearance or approval. Unless the Company obtains sufficient funding, it will be
unable to undertake such activities. There can be no assurance that the product will be approved as either a Class II or Class III device
by the FDA even if additional data is provided. There can be no assurance that the Company will receive FDA approval, or if it does,
the timing thereof.
If
the Company is successful in increasing the size of its organization, the Company may experience difficulties in managing growth.
The
Company is a small organization with a minimal number of employees. If the Company is successful, it may experience a period of significant
expansion in headcount, facilities, infrastructure and overhead and further expansion may be required to address potential growth and
market opportunities. Any such future growth will impose significant added responsibilities on members of management, including the need
to improve the Company’s operational and financial systems and to identify, recruit, maintain and integrate additional managers.
The Company’s future financial performance and its ability to compete effectively will depend, in part, on the ability to manage
any future growth effectively.
The
Company’s business is dependent upon the continued services of the Company’s Chief Executive Officer, Michael Korenko. Should
the Company lose the services of Dr. Korenko, the Company’s operations will be negatively impacted.
The
Company’s business is dependent upon the expertise of its Chief Executive Officer, Michael Korenko. Dr. Korenko is essential to
the Company’s operations. Accordingly, an investor must rely on Dr. Korenko’s management decisions that will continue to
control the Company’s business affairs. The Company does not maintain life insurance on Dr. Korenko’s life. The loss of the
services of Dr. Korenko would have a material adverse effect upon the Company’s business.
To
mitigate this risk Dr. Korenko has been working with two internal candidates with the potential to seamlessly assume authority. Both
David Swanberg and Brad Weeks, current active consultants to the Company with broad responsivities, have been identified as high potential
candidates to succeed Dr. Korenko or to assume senior positions, although no formal arrangement has been reached. The Company Board would
make the final appointment. See “Directors, Executive Officers and Significant Consultants” on page 29.
The
Company is heavily dependent on consultants for many of the services necessary to continue operations. The loss of any of these consultants
could have a material adverse effect on the Company’s business, results of operations and financial condition.
The
Company’s success is heavily dependent on the continued active participation of certain consultants and collaborating scientists.
Loss of the services of any one or more of its consultants could have a material adverse effect upon the Company’s business, results
of operations and financial condition.
If
the Company is unable to hire and retain additional qualified personnel, the business and financial condition may suffer.
The
Company’s success and achievement of its growth plans depend on its ability to recruit, hire, train and retain highly qualified
technical, scientific, regulatory, and managerial employees, consultants, and advisors. Competition for qualified personnel among pharmaceutical
and biotechnology companies is intense, and an inability to attract and motivate additional highly skilled personnel required for the
expansion of the Company’s activities, or the loss of any such persons, could have a material adverse effect on its business, results
of operations and financial condition.
The
Company’s revenues have historically been derived from sales made to a small number of customers. The Company has discontinued
prior operations related to its core business. To succeed, we will need to recommence our operations and achieve sales to a materially
larger number of customers.
The
Company’s revenues relate to their commercializing of its products and procedures performed. The Company had $27,995 and $19,500
in operating revenues, net of discounts, for the years ended December 31, 2024 and 2023, respectively, as we have commenced sales of
IsoPet®.
Many
of the Company’s competitors have greater resources and experience than the Company has.
Many
of the Company’s competitors have greater financial resources, longer history, broader experience, greater name recognition, and
more substantial operations than the Company has, and they represent substantial long-term competition for us. The Company’s competitors
may be able to devote more financial and human resources than the Company can to research, new product development, regulatory approvals,
and marketing and sales. The Company’s competitors may develop or market products that are viewed by customers as more effective
or more economical than the Company’s products. There is no assurance that the Company will be able to compete effectively against
current and future competitors, and such competitive pressures may adversely affect the Company’s business and results of operations.
The
Company’s future revenues depend upon acceptance of its current and future products in the markets in which they compete.
The
Company’s future revenues depend upon receipt of financing, regulatory approval and the successful production, marketing, and sales
of the various isotopes the Company might market in the future. The rate and level of market acceptance of each of these products, if
any, may vary depending on the perception by physicians and other members of the healthcare community of its safety and efficacy as compared
to that of any competing products; the clinical outcomes of any patients treated; the effectiveness of its sales and marketing efforts
in the United States, Europe, Far East, Middle East, and Russia; any unfavorable publicity concerning its products or similar products;
the price of the Company’s products relative to other products or competing treatments; any decrease in current reimbursement rates
from the Centers for Medicare and Medicaid Services or third-party payers; regulatory developments related to the manufacture or continued
use of its products; availability of sufficient supplies to either purchase or manufacture its products; its ability to produce sufficient
quantities of its products; and the ability of physicians to properly utilize its products and avoid excessive levels of radiation to
patients. Any material adverse developments with respect to the commercialization of any such products may adversely affect revenues
and may cause the Company to continue to incur losses in the future.
The
Company currently relies on a single supplier for Y-90 particles, and that supplier is the only supplier in the United States. An inability
to procure Y-90 particles will materially harm the Company’s business.
There
is only one supplier of Y-90 particles in the United States, requiring us to rely entirely on this supplier to provide the Y-90 particles
needed to produce RadioGelTM. If we are unable to obtain a sufficient supply of Y-90 particles, we will not be able to proceed
with our development of RadioGelTM and our business would be materially harmed.
Eckert
and Ziegler is the sole supplier of the Y-90 particles used by IsoTherapeutics and is the only supplier of Y-90 particles in the United
States. In the event Eckert & Ziegler is unable to satisfy our supply requirements or stope producing Y-90 particles, we will be
unable to continue with development of RadioGel™ and our business would be materially harmed.
The
Company relies on a sole manufacturing contact with IsoTherapeutics.
IsoTherapeutics
is our sole particle manufacturing contractor. Vivos now has alternate suppliers for its hydrogel and is actively engaged is selecting
an alternate supplier for the particle production. Both domestic and internation candidates are being assessed.
The
Company will rely heavily on a limited number of suppliers for the foreseeable future.
Some
of the products the Company might market, and components thereof, are currently available only from a limited number of suppliers, several
of which are international suppliers. Failure to obtain deliveries from these sources would have a material adverse effect on the Company’s
ability to operate.
The
Company may incur material losses and costs because of product liability claims that may be brought against it.
The
Company faces an inherent business risk of exposure to product liability claims if products supplied by the Company fail to perform as
expected or such products result, or is alleged to result, in bodily injury. Any such claims may also result in adverse publicity, which
could damage the Company’s reputation by raising questions about the safety and efficacy of its products and could interfere with
its efforts to market its products. A successful product liability claim against the Company more than its available insurance coverage
or established reserves may have a material adverse effect on its business. Although the Company currently maintains liability insurance
in amounts it believes are commercially reasonable, any product liability the Company may incur may exceed its insurance coverage.
The
Company is subject to the risk that certain third parties may mishandle the Company’s products.
If
the Company markets products, the Company likely will rely on third parties, such as commercial air courier companies, to deliver the
products, and on other third parties to package the products in certain specialized packaging forms requested by customers. The Company
thus would be subject to the risk that these third parties may mishandle its product, which could result in material adverse effects,
particularly given the radioactive nature of some of the products.
The
Company is subject to uncertainties regarding reimbursement for use of its products.
Hospitals
and freestanding clinics may be less likely to purchase the Company’s products if they cannot be assured of receiving favorable
reimbursement for treatments using its products from third-party payers, such as Medicare and private health insurance plans. Third-party
payers are increasingly challenging the pricing of certain medical services or devices, and there is no assurance that they will reimburse
the Company’s customers at levels sufficient for it to maintain favorable sales and price levels for the Company’s products.
There is no uniform policy on reimbursement among third-party payers, and there is no assurance that the Company’s products will
continue to qualify for reimbursement from all third-party payers or that reimbursement rates will not be reduced. A reduction in or
elimination of third-party reimbursement for treatments using the Company’s products would likely have a material adverse effect
on the Company’s revenues.
The
Company’s future growth is largely dependent upon its ability to develop new technologies that achieve market acceptance with appropriate
margins.
The
Company’s business operates in global markets that are characterized by rapidly changing technologies and evolving industry standards.
Accordingly, future growth rates depend upon several factors, including the Company’s ability to (i) identify emerging technological
trends in the Company’s target end-markets, (ii) develop and maintain competitive products, (iii) enhance the Company’s products
by adding innovative features that differentiate the Company’s products from those of its competitors, and (iv) develop, manufacture,
and bring products to market quickly and cost-effectively. The Company’s ability to develop new products based on technological
innovation can affect the Company’s competitive position and requires the investment of significant resources. These development
efforts divert resources from other potential investments in the Company’s business, and they may not lead to the development of
new technologies or products on a timely basis or that meet the needs of the Company’s customers as fully as competitive offerings.
In addition, the markets for the Company’s products may not develop or grow as it currently anticipates. The failure of the Company’s
technologies or products to gain market acceptance due to more attractive offerings by the Company’s competitors could significantly
reduce the Company’s revenues and adversely affect the Company’s competitive standing and prospects.
The
Company may rely on third parties to represent it locally in the marketing and sales of its products in international markets and its
revenue may depend on the efforts and results of those third parties.
The
Company’s future success may depend, in part, on its ability to enter and maintain collaborative relationships with one or more
third parties, the collaborator’s strategic interest in the Company’s products and the Company’s products under development,
and the collaborator’s ability to successfully market and sell any such products.
The
Company intends to pursue collaborative arrangements regarding the marketing and sales of its products; however, it may not be able to
establish or maintain such collaborative arrangements, or if it is able to do so, the Company’s collaborators may not be effective
in marketing and selling its products. To the extent that the Company decides not to, or is unable to, enter collaborative arrangements
with respect to the sales and marketing of its products, significant capital expenditures, management resources and time will be required
to establish and develop an in-house marketing and sales force with technical expertise. To the extent that the Company depends on third
parties for marketing and distribution, any revenues received by the Company will depend upon the efforts and results of such third parties,
which may or may not be successful.
The
Company may pursue strategic acquisitions that may have an adverse impact on its business.
Executing
the Company’s business strategy may involve pursuing and consummating strategic transactions to acquire complementary businesses
or technologies. In pursuing these strategic transactions, even if the Company does not consummate them, or in consummating such transactions
and integrating the acquired business or technology, the Company may expend significant financial and management resources and incur
other significant costs and expenses. There is no assurance that any strategic transactions will result in additional revenues or other
strategic benefits for the Company’s business. The Company may issue shares of the Company’s stock as consideration for acquisitions,
joint ventures or other strategic transactions, and the use of stock as purchase consideration could dilute the interests of its current
stockholders. In addition, the Company may obtain debt financing in connection with an acquisition. Any such debt financing may involve
restrictive covenants relating to capital-raising activities and other financial and operational matters, which may make it more difficult
for the Company to obtain additional capital and pursue business opportunities, including potential acquisitions. In addition, such debt
financing may impair the Company’s ability to obtain future additional financing for working capital, capital expenditures, acquisitions,
general corporate or other purposes, and a substantial portion of cash flows, if any, from the Company’s operations may be dedicated
to interest payments and debt repayment, thereby reducing the funds available to the Company for other purposes.
The
Company will need to hire additional qualified accounting personnel in order to remediate a material weakness in its internal control
over financial accounting, and the Company will need to expend any additional resources and efforts that may be necessary to establish
and to maintain the effectiveness of its internal control over financial reporting and its disclosure controls and procedures.
As
a public company, the Company is subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, and the Sarbanes-Oxley
Act of 2002. The Company’s management is required to evaluate and disclose its assessment of the effectiveness of the Company’s
internal control over financial reporting as of each year-end, including disclosing any “material weakness” in the Company’s
internal control over financial reporting. A material weakness is a control deficiency, or combination of control deficiencies, that
results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented
or detected. As a result of its assessment, management has determined that there is a material weakness due to the lack of segregation
of duties and, due to this material weakness, management concluded that, as of December 31, 2024 and 2023, the Company’s internal
control over financial reporting was ineffective. This material weakness has the potential of adversely impacting the Company’s
financial reporting process and the Company’s financial reports. Because of this material weakness, management also concluded that
the Company’s disclosure controls and procedures were ineffective as of December 31, 2024 and 2023. The Company needs to hire additional
qualified accounting personnel to resolve this material weakness. The Company also will need to expend any additional resources and efforts
that may be necessary to establish and to maintain the effectiveness of the Company’s internal control over financial reporting
and disclosure controls and procedures.
The
Company’s patented or other technologies may infringe on other patents, which may expose us to costly litigation.
It
is possible that the Company’s patented or other technologies may infringe on patents or other rights owned by others. The Company
may have to alter its products or processes, pay licensing fees, defend infringement actions or challenge the validity of the patents
in court, or cease activities altogether because of patent rights of third parties, thereby causing additional unexpected costs and delays
to the Company. Patent litigation is costly and time consuming, and the Company may not have sufficient resources to pursue such litigation.
If the Company does not obtain a license under such patents, if it is found liable for infringement, or if it is not able to have such
patents declared invalid, the Company may be liable for significant money damages, may encounter significant delays in bringing products
to market or may be precluded from participating in the manufacture, use or sale of products or methods of treatment requiring such licenses.
Protecting
the Company’s intellectual property is critical to its innovation efforts.
The
Company owns or has a license to use several U.S. and foreign patents and patent applications, trademarks, and copyrights. The Company’s
intellectual property rights may be challenged, invalidated, or infringed upon by third parties, or it may be unable to maintain, renew
or enter new licenses of third party proprietary intellectual property on commercially reasonable terms. In some non-U.S. countries,
laws affecting intellectual property are uncertain in their application, which can adversely affect the scope or enforceability of the
Company’s patents and other intellectual property rights. Any of these events or factors could diminish or cause the Company to
lose the competitive advantages associated with the Company’s intellectual property, subject the Company to judgments, penalties,
and significant litigation costs, or temporarily or permanently disrupt its sales and marketing of the affected products or services.
The
Company may not be able to protect its trade secrets and other unpatented proprietary technology, which could give competitors an advantage.
The
Company relies upon trade secrets and other unpatented proprietary technology. The Company may not be able to adequately protect its
rights about such unpatented proprietary technology, or competitors may independently develop substantially equivalent technology. The
Company seeks to protect trade secrets and proprietary knowledge, in part through confidentiality agreements with its employees, consultants,
advisors and collaborators. Nevertheless, these agreements may not effectively prevent disclosure of the Company’s confidential
information and may not provide the Company with an adequate remedy in the event of unauthorized disclosure of such information, and
as result the Company’s competitors could gain a competitive advantage.
The
Company is subject to extensive government regulation in jurisdictions around the world in which it does business. Regulations address,
among other things, environmental compliance, import/export restrictions, healthcare services, taxes and financial reporting, and those
regulations can significantly increase the cost of doing business, which in turn can negatively impact operations, financial results,
and cash flow.
If
the Company is successful in developing manufacturing capability, the Company will be subject to extensive government regulation and
intervention both in the U.S. and in all foreign jurisdictions in which it conducts business. Compliance with applicable laws and regulations
will result in higher capital expenditures and operating costs, and changes to current regulations with which the Company complies can
necessitate further capital expenditures and increases in operating costs to enable continued compliance. Additionally, from time to
time, the Company may be involved in proceedings under certain of these laws and regulations. Foreign operations are subject to political
instabilities, restrictions on funds transfers, import/export restrictions, and currency fluctuation.
RISKS
RELATED TO THE COMPANY’S COMMON STOCK
The
Company’s common stock is currently quoted on the OTCQB Marketplace. Failure to develop or maintain a more active trading market
may negatively affect the value of the Company’s common stock, may deter some potential investors from purchasing the Company’s
common stock or other equity securities, and may make it difficult or impossible for stockholders to sell their shares of common stock.
The
Company’s average daily volume of shares traded for the years ended December 31, 2024 and 2023 was 1,268,973 and 512,332, respectively.
Failure to develop or maintain an active trading market may negatively affect the value of the Company’s common stock, may make
some potential investors unwilling to purchase the Company’s common stock or equity securities that are convertible into or exercisable
for the Company’s common stock, and may make it difficult or impossible for the Company’s stockholders to sell their shares
of common stock and recover any part of their investment.
The
Company’s outstanding securities, the stock or other securities that it may become obligated to issue under existing agreements,
and certain provisions of those securities, may cause immediate and substantial dilution to existing stockholders and may make it more
difficult to raise additional equity capital.
The
Company had 440,873,806 shares of common stock outstanding as of December 31, 2024. The Company also had outstanding on that date
dilutive securities consisting of preferred stock, restricted stock units, options, and warrants (collectively, “Common
Stock Equivalents”) that if they had been exercised and converted in full on December 31, 2024, would have resulted in the
issuance of up to 43,852,379 additional shares of common stock. The issuance of shares upon the exercise of the Common Stock
Equivalents may result in substantial dilution to each stockholder by reducing that stockholder’s percentage ownership of the
Company’s total outstanding shares of common stock. The issuance of some or all those warrants and any exercise of those
warrants will have the effect of further diluting the percentage ownership of the Company’s other stockholders.
Future
sales of the Company’s securities, including sales following exercise or conversion of derivative securities, or the perception
that such sales may occur, may depress the price of common stock, and could encourage short sales.
The
sale or availability for sale of substantial amounts of the Company’s shares in the public market, including shares issuable upon
exercise of the Common Stock Equivalents, or the perception that such sales may occur, may adversely affect the market price of the Company’s
common stock. Any decline in the price of the Company’s common stock may encourage short sales, which could place further downward
pressure on the price of the Company’s common stock.
The
Company’s stock price is likely to be volatile.
For
the year ended December 31, 2024, the reported low closing price for the Company’s common stock was $0.049 per share, and the reported
high closing price was $0.255 per share. For the year ended December 31, 2023, the reported low closing price for the Company’s
common stock was $0.0412 per share, and the reported high closing price was $0.1195 per share. There is generally significant volatility
in the market prices, as well as limited liquidity, of securities of early-stage companies, particularly early-stage medical product
companies. Contributing to this volatility are various events that can affect the Company’s stock price in a positive or negative
manner. These events include, but are not limited to: governmental approvals, refusals to approve, regulations or other actions; market
acceptance and sales growth of the Company’s products; litigation involving the Company or the Company’s industry; developments
or disputes concerning the Company’s patents or other proprietary rights; changes in the structure of healthcare payment systems;
departure of key personnel; future sales of its securities; fluctuations in its financial results or those of companies that are perceived
to be similar to us; investors’ general perception of us; and general economic, industry and market conditions. If any of these
events occur, it could cause the Company’s stock price to fall, and any of these events may cause the Company’s stock price
to be volatile.
The
Company’s common stock is subject to the “Penny Stock” rules of the SEC and the trading market in its securities is
limited, which makes transactions in its common stock cumbersome and may reduce the value of an investment in the Company’s stock.
The
SEC has adopted Rule 3a51-1, which establishes the definition of a “penny stock,” for the purposes relevant to us, as any
equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, subject
to certain exceptions. For any transaction involving a penny stock, unless exempt, Rule 15g-9 requires that a broker or dealer approve
a person’s account for transactions in penny stocks and that the broker or dealer receive from the investor a written agreement
to the transaction, setting forth the identity and quantity of the penny stock to be purchased.
To
approve a person’s account for transactions in penny stocks, the broker or dealer must obtain financial information and investment
experience and objectives of the person and must make a reasonable determination that the transactions in penny stocks are suitable for
that person and that the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of
transactions in penny stocks.
The
broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to
the penny stock market, which sets forth the basis on which the broker or dealer made the suitability determination, and that the broker
or dealer received a signed, written agreement from the investor prior to the transaction.
Generally,
brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more
difficult for investors to dispose of the Company’s common stock and may cause a decline in the market value of its stock.
Disclosure
also must be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions
payable to both the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies
available to an investor in cases of fraud in penny stock transactions. Finally, monthly statements must be sent disclosing recent price
information for the penny stock held in the account and information on the limited market in penny stocks.
As
a result of the Company issuing preferred stock, the rights of holders of the Company’s common stock and the value of the Company’s
common stock may be adversely affected.
The
Company’s Board of Directors is authorized to issue classes or series of preferred stock, without any action on the part of the
stockholders. The Company’s Board of Directors also has the power, without stockholder approval, to set the terms of any such classes
or series of preferred stock, including voting rights, dividend rights and preferences over the common stock with respect to dividends
or upon the liquidation, dissolution, or winding-up of its business, and other terms. The Company has issued preferred stock that has
a preference over the common stock with respect to the payment of dividends or upon liquidation, dissolution, or winding-up, and with
respect to voting rights. In accordance with that and with the issuance of preferred stock, our common stockholders voting rights have
been diluted and it is possible that the rights of holders of the common stock or the value of the common stock have been adversely affected.
The
Company does not expect to pay any dividends on common stock for the foreseeable future.
The
Company has not paid any cash dividends on its common stock to date and does not anticipate it will pay cash dividends on its common
stock in the foreseeable future. Accordingly, stockholders must be prepared to rely on sales of their common stock after price appreciation
to earn an investment return, which may never occur. Any determination to pay dividends in the future will be made at the discretion
of the Company’s board of directors and will depend on the Company’s results of operations, financial conditions, contractual
restrictions, restrictions imposed by applicable law, and other factors that the Company’s board deems relevant.
GENERAL
RISK FACTORS
Volatility
in raw material and energy costs, interruption in ordinary sources of supply, and an inability to recover from unanticipated increases
in energy and raw material costs could result in lost sales or could increase significantly the cost of doing business.
Market
and economic conditions affecting the costs of raw materials, utilities, energy costs, and infrastructure required to provide for the
delivery of the Company’s products and services are beyond the Company’s control. Any disruption or halt in supplies, or
rapid escalations in costs, could adversely affect the Company’s ability to manufacture products or to competitively price the
Company’s products in the marketplace. To date, the ultimate impact of energy costs increases has been mitigated through price
increases or offset through improved process efficiencies; however, continuing escalation of energy costs could have a negative impact
upon the Company’s business and financial performance.
General
economic conditions in markets in which the Company does business can impact the demand for the Company’s goods and services. Decreased
demand for the Company’s products and services could have a negative impact on its financial performance and cash flow.
Demand
for the Company’s products and services, in part, depends on the general economic conditions affecting the countries and industries
in which the Company does business. A downturn in economic conditions in a country or industry that the Company serves may adversely
affect the demand for the Company’s products and services, in turn negatively impacting the Company’s operations and financial
results. Further, changes in demand for the Company’s products and services can magnify the impact of economic cycles on the Company’s
businesses. Unanticipated contract terminations by customers can negatively impact operations, financial results and cash flow. The Company’s
earnings, cash flow and financial position are exposed to financial market risks worldwide, including interest rate and currency exchange
rate fluctuations and exchange rate controls. Fluctuations in domestic and world financial markets could adversely affect interest rates
and impact the Company’s ability to obtain credit or attract investors.
ITEM
1B. UNRESOLVED STAFF COMMENTS.
This
item is not applicable to the Company because the Company is a smaller reporting company as defined by Rule 12b-2 under the Securities
Exchange Act of 1934.
ITEM
1C. CYBERSECURITY
Risk
Management and Strategy
Our
cybersecurity policies, standards, processes, and practices are based on applicable laws and regulations and informed by industry standards
and industry-recognized practices. Our strategy to assess, identify, and manage material cybersecurity risks is through a comprehensive,
cross-functional approach that is focused on preserving the confidentiality, security, and availability of our information systems and
data. We implement security measures and processes to identify, prevent, and mitigate cybersecurity threats and to effectively respond
to cybersecurity incidents when they occur. Our cyber risk management includes: (1) enterprise risk management to identify top cybersecurity
risks; (2) vulnerability management to identify software vulnerabilities and risks related to compute infrastructure; (3) vendor risk
management to identify risks related to third parties and business partners, which includes pre-engagement review, use of contractual
security provisions, and continued monitoring, as applicable; (4) privacy risk management to identify privacy risks in our product and
platforms and ensure regulatory compliance; (5) security monitoring to analyze and assess threat activity in real time; and (6) security
incident response to investigate, respond to, and mitigate cyber threats. We regularly engage third parties to identify risks in our
underlying software and infrastructure, to provide threat intelligence, and to assist in triaging, identifying, and responding to cyber
threats.
In
2024, we were part of an elaborate phishing scam that resulted in a loss and as a result we enabled additional cybersecurity
procedures to ensure this does not occur again, and established new checking accounts to mitigate any further losses. Other than
this one incident, we
did not identify any cybersecurity threats that have materially affected or are reasonably likely to materially affect our business
strategy, results of operations, or financial condition. However, despite our efforts, we cannot eliminate all risks from
cybersecurity threats, or provide assurances that we have not experienced undetected cybersecurity
incidents.
Governance
Our
Board of Directors maintains oversight of risks from cybersecurity threats by meeting with and receiving periodic updates from our Chief
Executive Officer, who is assigned oversight of cybersecurity risks. Our Chief Executive Officer is responsible for ensuring that management
has processes in place designed to identify and evaluate cybersecurity risks to which the Company is exposed and to implement processes
and programs to manage cybersecurity risks and mitigate cybersecurity incidents.
ITEM
2. PROPERTIES.
The
Company is headquartered in Kennewick, Washington. Our Chief Executive Officer currently works from his home office in virtual communication
with key personnel. Cadwell Laboratories, which is controlled by Carl Cadwell, a director of the Company, provides office space to management
on an as-needed basis until such time as the Company leases permanent office space. Management believes that the Company’s sites
are adequate to support the business and suitable for present purposes, and the properties and equipment have been well maintained.
ITEM
3. LEGAL PROCEEDINGS.
The
Company may, from time to time, be involved in various legal proceedings incidental to the conduct of our business. Historically, the
outcome of all such legal proceedings has not, in the aggregate, had a material adverse effect on our business, financial condition,
results of operations or liquidity. There are no material pending or threatened legal proceedings at this time.
ITEM
4. MINE SAFETY DISCLOSURES.
Not
applicable.
PART
II
ITEM
5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Market
Information
The
Company’s common stock is traded on the OTCQB Marketplace under the symbol “RDGL.” The following table sets forth,
in U.S. dollars, the high and low closing prices for each of the calendar quarters indicated, as reported by the OTCQB Marketplace, for
the past two fiscal years. Such OTCQB Marketplace quotations reflect inter-dealer prices, without markup, markdown or commissions and,
particularly because our common stock is traded infrequently, may not necessarily represent actual transactions or a liquid trading market.
|
High | |
Low |
2024 |
| |
|
Quarter ended December 31 |
|
$ | 0 .1766 | | |
$ | 0.0707 | |
Quarter ended September 30 |
|
$ | 0.1925 | | |
$ | 0.085 | |
Quarter ended June 30 |
|
$ | 0.248 | | |
$ | 0.078 | |
Quarter ended March 31 |
|
$ | 0.076 | | |
$ | 0.05 | |
|
|
| | | |
| | |
2023 |
|
| | | |
| | |
Quarter ended December 31 |
|
$ | 0.085 | | |
$ | 0.0412 | |
Quarter ended September 30 |
|
$ | 0.08 | | |
$ | 0.0481 | |
Quarter ended June 30 |
|
$ | 0.1195 | | |
$ | 0.0491 | |
Quarter ended March 31 |
|
$ | 0.0738 | | |
$ | 0.0431 | |
Holders
As
of March 7, 2025, we had 453,373,806
shares of common stock, par value $0.001 per share, issued and outstanding, which were held by approximately 232 shareholders of
record. Our transfer agent is Pacific Stock Transfer, 6725 Via Austi Pkwy, Suite 300, Las Vegas, NV 89119.
Securities
Authorized for Issuance Under Equity Compensation Plans
The
following table sets forth information as of December 31, 2024 with respect to the Company’s equity compensation plans previously
approved by stockholders and equity compensation plans not previously approved by stockholders.
| |
Equity
Compensation Plan Information |
Plan
Category | |
Number
of securities to be issued upon exercise of outstanding options, warrants and rights | |
| |
Weighted-average
exercise price of outstanding options, warrants and rights | |
| |
Number
of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) |
| |
(a) | |
| |
(b) | |
| |
(c) |
Equity compensation plans approved by stockholders | |
25,777,500 | |
| |
$ | |
| 0.09 | |
| |
32,836,047 |
Equity compensation plans not approved by stockholders | |
34,115,309 | |
| |
$ | |
| 0.07 | |
| |
- |
Total | |
34,115,309 | (1) |
| |
$ | |
| 0.07 | (1) |
| |
- |
(1) |
In
addition to the 2015 Plan (defined below), the Company has individual compensation arrangements under which equity securities are
authorized for issuance in exchange for consideration in the form of goods or services of certain individuals. |
2015
Omnibus Securities and Incentive Plan
In
October 2015, our Board of Directors and stockholders approved the adoption of the 2015 Omnibus Securities and Incentive Plan (the “2015
Plan”). The 2015 Plan authorizes a pre-determined number of shares of common stock for issuance to all employees of the Company
or any subsidiary of the Company, any non-employee director, consultants and independent contractors of the Company or any subsidiary,
and any joint venture partners (including, without limitation, officers, directors and partners thereof) of the Company or any subsidiary.
The aggregate number of shares that may be issued under the Plan shall not exceed twenty percent (20%) of the issued and outstanding
shares of common stock on an as converted primary basis on a rolling basis. For calculation purposes, the As Converted Primary Shares
(as defined in the 2015 Plan) shall include all shares of common stock and all shares of common stock issuable upon the conversion of
outstanding preferred stock and other convertible securities, but shall not include any shares of common stock issuable upon the exercise
of options, warrants and other convertible securities issued pursuant to the 2015 Plan. As of December 31, 2024, the Converted Primary
Shares calculation results in 32,836,047 aggregate shares that may be issued under the 2015 Plan. The 2015 Plan is administered by the
Company’s Compensation Committee, who may issue awards in the form of stock options and/or restricted stock awards. Effective December
31, 2024, an aggregate total of 88,174,761 restricted stock units (“RSUs”) under the 2015 Plan were authorized, but
as of March 7, 2025, an aggregate total of 56,050,000 RSUs had been issued.
Recent
Sales of Unregistered Securities
Below
is a description of all unregistered securities issued by the Company during and subsequent to the quarter ended December 31, 2024, through
the date of this report. Each of the issuances identified below were issued in transactions exempt from registration under the Securities
Act of 1933, as amended, in reliance on Section 3(a)(9) and/or 4(2) thereof.
Issuances
During the Quarter Ended December 31, 2024
Between
November 12 and 14, 2024, the Company completed the sale of 11,950,000 shares of common stock pursuant to its Regulation A+ offering,
conducted under the Company’s offering statement on Form 1-A, originally filed with the SEC on June 28, 2024 (File No. 024-12456)
(the “Offering Statement”), qualified by the SEC on July 16, 2024, as supplemented from time to time (the “Regulation
A+ Offering”).
On
November 20, 2024, 122,500 shares of common stock were issued to consultants for the sale of common shares pursuant to the Regulation
A+, and on December 31, 2024, the Company issued 42,049 common shares to consultants of the Company pursuant to their agreement.
In
December 2024, the Company issued 8,416,554 common shares in the exercise of warrants.
On
October 14, 2024, 250,000 shares of common stock were issued in connection with the vesting of restricted stock units.
On
December 16, 2024, 200,000 shares of Series B Preferred shares were converted into 2,500,000 shares of common stock.
Issuances
Subsequent to December 31, 2024
On
February 6, 2025, there has been 12,500,000 shares of common stock issued under the Regulation A+.
ITEM
6. [RESERVED]
ITEM
7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The
following discussion and analysis is intended as a review of significant factors affecting the Company’s financial condition and
results of operations for the periods indicated. The discussion should be read in conjunction with the Company’s financial statements
and the notes presented herein. In addition to historical information, the following Management’s Discussion and Analysis of Financial
Condition and Results of Operations contains forward-looking statements that involve risks and uncertainties. The Company’s actual
results could differ significantly from those anticipated in these forward-looking statements as a result of the risk factors set forth
above in Item 1A and other factors discussed in this Annual Report.
Results
of Operations
Comparison
for the Year Ended December 31, 2024 and December 31, 2023
The
following table sets forth information from our statements of operations for the years ended December 31, 2024 and 2023:
| |
Year
Ended December 31, 2024 | | |
Year
Ended December 31, 2023 | |
Revenues | |
$ | 27,995 | | |
$ | 19,500 | |
Cost of goods sold | |
| (30,979 | ) | |
| (25,536 | ) |
Gross loss | |
| (2,984 | ) | |
| (6,036 | |
Operating expense | |
| (2,601,400 | ) | |
| (2,787,110 | ) |
Operating loss | |
| (2,604,384 | ) | |
| (2,793,146 | ) |
Non-operating expense | |
| (306,064 | ) | |
| (101,607 | ) |
Net loss | |
$ | (2,910,448 | ) | |
$ | (2,894,753 | ) |
Revenues
and Cost of Goods Sold
Revenue
was $27,995 and $19,500 for the years ended December 31, 2024 and 2023, respectively. All revenue recognized in the year ended December
31, 2023 relate to the procedures performed with respect to the IsoPet® therapies. All revenue except $4,995 in 2024 relate
to the procedures performed with respect to the IsoPet® therapies. The $4,995 relates to a new license fee charged by
the Company to clinics for certification to perform these therapies. These revenues are recognized upon the certification being completed.
Management
does not anticipate that the Company will generate sufficient revenue to sustain operations until such time as the Company secures multiple
revenue-generating arrangements with respect to RadioGel™ and/or any of our other brachytherapy technologies.
Operating
Expense
Operating
expense for the years ended December 31, 2024 and 2023, respectively, consisted of the following:
| |
Year
Ended December 31, 2024 | | |
Year
Ended December 31, 2023 | |
Professional fees, including
stock-based compensation | |
$ | 1,682,350 | | |
$ | 1,606,923 | |
Payroll expense | |
| 352,597 | | |
| 281,716 | |
Research and development expense | |
| 324,629 | | |
| 732,698 | |
General and administrative
expense | |
| 241,824 | | |
| 165,773 | |
Total operating expense | |
$ | 2,601,400 | | |
$ | 2,787,110 | |
Operating
expense for the years ended December 31, 2024 and 2023 was $2,601,400 and $2,787,110, respectively. The decrease in operating expense
from 2023 to 2024 can be attributed to the increase in professional fees ($1,606,923 for the year ended December 31, 2023 compared to
$1,682,350 for the year ended December 31, 2024) as the Company utilized more services due to amending the offering statement on Form
1-A (the “Offering Statement”) for the Company’s offering being made pursuant to Regulation A+ (the “Regulation
A+ Offering”), and the fees incurred for the consultants engaged in 2024, including: stock-based compensation; the increase
in general and administrative expense ($165,773 for the year ended December 31, 2023 compared to $241,824 for the year ended December
31, 2024); the decrease in research and development expense ($732,698 for the year ended December 31, 2023 compared to $324,629 for the
year ended December 31, 2024) as the Company ramped up the development of their products with the recent raising of capital in 2023;
and, an increase in payroll expense ($281,716 for the year ended December 31, 2023 compared to $352,597 for the year ended December 31,
2024) related to our Chief Executive Officer’s employment contract taking effect.
Non-Operating
Expense
Non-operating
expense for the years ended December 31, 2024 and 2023, respectively, consisted of the following:
| |
Years
Ended December 31, 2024 | | |
Years
Ended December 31, 2023 | |
Interest income | |
$ | 74,936 | | |
$ | 49,577 | |
Loss on issuance of
shares and exchange of warrants | |
| (381,000 | ) | |
| (151,184 | ) |
| |
| | | |
| | |
Non-operating expense | |
$ | 306,064 | | |
$ | (101,607 | ) |
Non-operating
income (expense) for the year ended December 31, 2023 varied from the year ended December 31, 2024. In 2023, we recognized a loss on
issuance of shares of $151,184 and interest earned on our bank accounts of $49,577. In 2024, we recognized a loss on the exchange of
warrants of $381,000, and incurred interest income of $74,936 related to our cash position in our bank accounts.
Net
Loss
Our
net loss for the years ended December 31, 2024 and 2023 was $(2,910,448) and $(2,894,753), respectively.
Liquidity
and Capital Resources
At
December 31, 2024, the Company had working capital of $2,147,247, compared to working capital of $1,365,120 at December 31, 2023. During
the year ended December 31, 2024, the Company experienced negative cash flows from operations of $1,684,039 and realized $2,304,300 of
cash flows from financing activities. As of December 31, 2024, the Company did not have any commitments for capital expenditures. During
the year ended December 31, 2023, the Company experienced negative cash flows from operations of $1,293,023 and realized $1,179,245 of
cash flows from financing activities. As of December 31, 2023, the Company did not have any commitments for capital expenditures.
Cash
used in operating activities was primarily a result of the Company’s non-cash items, such as loss from operations, loss on
exchange of warrants, loss on conversion of debt and share based compensation. Cash provided from financing activities increased
from $1,179,245 for the year ended December 31, 2023 to $2,304,300 for the year ended December 31, 2024. In 2023, the Company raised
$1,179,245 from sales of common stock. In 2024, the Company raised $2,284,950 from sales of common stock and warrants.
The
Company has generated material operating losses since inception. The Company had a net loss of $2,894,753 for the year ended December
31, 2023, and a net loss of $2,910,448 for the year ended December 31, 2024. The Company expects to continue to experience net operating
losses for the foreseeable future. Historically, the Company has relied upon investor funds to maintain its operations and develop the
Company’s business. The Company anticipates raising additional capital within the next twelve months for working capital as well
as business expansion, although the Company can provide no assurance that additional capital will be available on terms acceptable to
the Company, if at all. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have
to curtail its business or cease all operations.
The
Company requires funding of at least $3.5 million per year to maintain current operating activities. Over the next 36 months, the Company
believes it will cost approximately $10 million to: (1) fund the FDA approval process to conduct human clinical trials; (2) conduct Phase
I, pilot, and clinical trials; (3) activate several regional clinics to administer IsoPet® across the county; (4) create
an independent production center within the current production site to create a template for future international manufacturing; and
(5) initiate regulatory approval processes outside of the United States.
The
principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the FDA’s
classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise) and any requirements for
additional studies, which may possibly include clinical studies. Thereafter, the principal variables in the amount of the Company’s
spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with
third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the U.S. and
elsewhere. The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements or
additional capital raises.
Recent
geopolitical events, including the inherent instability and volatility in global capital markets, as well as the lack of liquidity in
the capital markets, could also impact the Company’s ability to obtain financing and its ability to execute its business plan.
Our
Chief Executive Officer currently works from his home office in virtual communication with key personnel. Cadwell Laboratories, which
is controlled by Carl Cadwell, a director of the Company, provides office space to management on an as-needed basis until such time as
the Company leases permanent office space.
Off-Balance
Sheet Arrangements
The
Company does not have any off-balance sheet arrangements that are reasonably likely to have a current or future effect on the Company’s
financial condition, revenues, results of operations, liquidity, or capital expenditures.
Critical
Accounting Policies
Use
of Estimates
The
preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at
the date of financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates the Company
considers include criteria for stock-based compensation expense, and valuation allowances on deferred tax assets. Actual results could
differ from those estimates.
Revenue
Recognition
In
May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”)
No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue recognition
to be used across all industries and requires additional disclosures. The updated guidance introduces a five-step model to achieve its
core principle of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects
the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company adopted the updated
guidance effective January 1, 2018 using the full retrospective method.
Under
the FASB’s Accounting Standards Codification (“ASC”) Topic 606, to recognize revenue, the Company is required
to identify an approved contract with commitments to preform respective obligations, identify rights of each party in the transaction
regarding goods to be transferred, identify the payment terms for the goods transferred, verify that the contract has commercial substance
and verify that collection of substantially all consideration is probable.
The
Company recognized revenue as they (i) identified the contracts with each customer; (ii) identified the performance obligation in each
contract; (iii) determined the transaction price in each contract; (iv) were able to allocate the transaction price to the performance
obligations in the contract; and (v) recognized revenue upon the satisfaction of the performance obligation. Upon the sales of the product
to complete the procedures on the animals, the Company recognized revenue as that was considered the performance obligation.
The
Company in 2024 also implemented a license program for clinics that pay for certification to perform these therapies. These revenues
are recognized upon the certification being completed. During the year ended December 31, 2024, $4,995 of the revenue relates to this
certification.
Fair
Value of Financial Instruments
The
Company adopted ASC Topic 820 (“Fair Value Measurements”) as of January 1, 2008 for financial instruments measured as fair
value on a recurring basis. ASC Topic 820 defines fair value, established a framework for measuring fair value in accordance with accounting
principles generally accepted in the United States and expands disclosures about fair value measurements.
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. ASC Topic 820 established a three-tier fair value hierarchy which prioritizes the inputs
used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets
or liabilities (level 1 measurements) and the lowest priority to unobservable inputs (level 3 measurements). These tiers include:
|
- |
Level
1, defined as observable inputs such as quoted prices for identical instruments in active markets; |
|
|
|
|
- |
Level
2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted
prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active;
and |
|
|
|
|
- |
Level
3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions,
such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. |
Stock-Based
Compensation
The
Company recognizes compensation costs under FASB ASC Topic 718, Compensation – Stock Compensation, and ASU No. 2018-07 –
Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. Companies are required
to measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs
in the financial statements over the period during which employees are required to provide services. Share based compensation arrangements
include stock options, restricted share plans, performance-based awards, share appreciation rights and employee share purchase plans.
As such, compensation cost is measured on the date of grant at their fair value. Such compensation amounts, if any, are amortized over
the respective vesting periods of the option grant.
ITEM
7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
This
item is not applicable to the Company because the Company is a smaller reporting company as defined by Rule 12b-2 under the Securities
Exchange Act of 1934.
ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
All
financial information required by this Item is included on the pages immediately following the Index to Financial Statements appearing
on page F-1 and is hereby incorporated by reference.
ITEM
9. Changes in and Disagreements with Accountants on Accounting and Financial
Disclosure.
None
ITEM
9A. CONTROLS AND PROCEDURES.
Disclosure
Controls and Procedures
Based
on an evaluation as of the date of the end of the period covered by this report, the Company’s Chief Executive Officer and Interim
Chief Financial Officer conducted an evaluation of the effectiveness of the design and operation of the Company’s disclosure controls
and procedures, as required by Rule 13a-15 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Based on that evaluation, the Company’s Chief Executive Officer and Interim Chief Financial Officer concluded that, because of
the disclosed material weaknesses in the Company’s internal control over financial reporting, the Company’s disclosure controls
and procedures were ineffective as of the end of the period covered by this report to ensure that information required to be disclosed
by the Company in the reports that the Company files or submits under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified by the SEC’s rules and forms.
Disclosure
controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in the
Company’s reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported, within the time periods
specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed in the Company’s reports filed under the Exchange Act is accumulated
and communicated to management, including the Company’s Chief Executive Officer and the Company’s Interim Chief Financial
Officer, to allow timely decisions regarding required disclosure.
Management’s
Annual Report on Internal Control Over Financial Reporting
Management
is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Exchange Act Rule 13a-15(f).
Management conducted an evaluation of the effectiveness of the internal control over financial reporting as of December 31, 2024, using
the criteria established in Internal Control – Integrated Framework (2013 framework) issued by the Committee of Sponsoring
Organizations of the Treadway Commission (“COSO”). Because of its inherent limitations, internal control over financial
reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject
to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies
or procedures may deteriorate.
A
material weakness is a control deficiency, or combination of control deficiencies, that results in more than a remote likelihood that
a material misstatement of the annual or interim financial statements will not be prevented or detected. As a result of management’s
assessment, management has determined that there are material weaknesses due to the lack of segregation of duties and, due to the limited
resources based on the size of the Company. Due to the material weaknesses management concluded that as of December 31, 2024, the Company’s
internal control over financial reporting was ineffective. In order to address and resolve the weaknesses, the Company will endeavor
to locate and appoint additional qualified personnel to the board of directors and pertinent officer positions as the Company’s
financial means allow. To date, the Company’s limited financial resources have not allowed the Company to hire the additional personnel
necessary to address the material weaknesses.
Management’s
Annual Report on Internal Control Over Financial Reporting
This
annual report does not include an attestation report of the Company’s registered public accounting firm regarding internal control
over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting
firm pursuant to temporary rules of the Securities and Exchange Commission that permit the Company to provide only management’s
report in this Annual Report.
Changes
in Internal Control Over Financial Reporting
There
have been no changes in the Company’s internal control over financial reporting that occurred during the Company’s last fiscal
quarter (the Company’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely
to materially affect, the Company’s internal control over financial reporting.
The
term “internal control over financial reporting” is defined as a process designed by, or under the supervision of, the registrant’s
principal executive and principal financial officers, or persons performing similar functions, and effected by the registrant’s
board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes
those policies and procedures that:
(a) |
Pertain
to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets
of the registrant; |
|
|
(b) |
Provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with
generally accepted accounting principles, and that receipts and expenditures of the registrant are being made only in accordance
with authorizations of management and directors of the registrant; and |
|
|
(c) |
Provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the registrant’s
assets that could have a material effect on the financial statements. |
ITEM
9B. OTHER INFORMATION.
During
the quarter ended December 31, 2024, none of our directors or executive officers adopted or terminated a Rule 10b5-1 trading plan or
a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K).
Item
9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not
applicable.
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE.
The
Company’s current directors and executive officers are as follows:
NAME |
|
AGE |
|
POSITION |
Michael
K. Korenko |
|
79 |
|
President,
Chief Executive Officer, and Director |
Michael
Pollack |
|
58 |
|
Interim
Chief Financial Officer |
Carlton
M. Cadwell |
|
80 |
|
Chairman
of the Board and Secretary |
Term
of Office
All
the Company’s directors hold office until the next annual meeting of the stockholders or until their successors is elected and
qualified. The Company’s executive officers are appointed by the Company’s board of directors and hold office until their
resignation, removal, death or retirement.
Background
and Business Experience
The
business experience during the past five years of each of the Company’s directors and executive officers is as follows:
Dr.
Michael K. Korenko, President and Chief Executive Officer of the Company since December 2016, and a member of the Board of Directors
since August 2017, joined the Company as an Advisor to the Board of the Company during 2009 and served as member of the Board from May
2009 to March 2010. Dr. Korenko has also served on the Hanford Advisory Board since 2009. Dr. Korenko served as Business Development
Manager for Curtiss-Wright from 2006 to 2009, as Chief Operating Officer for Curtiss-Wright from 2000 to 2005 and was Executive Vice
President of Closure for Safe Sites of Colorado at Rocky Flats from 1994 to 2000. Dr. Korenko served as Vice President of Westinghouse
from 1987 to 1994 and was responsible for the 300 and 400 areas, including the Fast Flux Testing Facility (“FFTF”)
and all engineering, safety analysis, and projects for the Hanford site.
Dr.
Korenko is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development
Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager
of the Year. Dr. Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a
White House Fellow for the Department of Defense, reporting to Secretary Cap Weinberger with a dual assignment at the Office of Science
and Technology.
Dr.
Korenko brings to the Board over seven years’ experience working with and advising various small businesses, including companies
involved in turnarounds. Dr. Korenko has also been involved as an advisor to the Company since 2009 in the development of medical isotopes.
Dr.
Korenko was selected as President and CEO of Advanced Medical Isotopes (Vivos Inc) on December 14, 2016. Since then, has been credited
with turning around the financial health and reputation of the Company, completing the product development, obtaining the device classification
for animal therapy, and breakthrough classification for the target indication for use, and for setting the stage to obtaining IDE approval
for human therapy.
Carlton
M. Cadwell, Chairman of the Board and Secretary since December 2016, joined the Company as a director in 2006. Dr. Cadwell
brings over 30 years of experience in business management, strategic planning, and implementation. He co-founded Cadwell Laboratories,
Inc. in 1979 and has served as its President since its inception. Cadwell Laboratories, Inc. is a major international provider of neurodiagnostic
medical devices. After receiving his bachelor’s degree from the University of Oregon in 1966 and a doctoral degree from the University
of Washington in 1970, he began his career serving in the United States Army as a dentist for three years. From 1973 to 1980, Dr. Cadwell
practiced dentistry in private practice and since has started several businesses.
Mr.
Cadwell brings to the Board over ten years of service on the Board and over forty-five years of experience as a successful entrepreneur,
as well as medical expertise.
Michael
Pollack CPA, the Interim Chief Financial Officer, joined the Company as interim Chief Financial Officer in December 2018. Mr.
Pollack has been a partner in a certified public accounting firm for the past fifteen years and specializes in accounting and auditing
for small public companies. Mr. Pollack has approximately 30 years of experience in public accounting and consulting to over 100 publicly
traded and 250 private companies. Mr. Pollack has also held CFO and Controller positions in an array of industries. Mr. Pollack graduated
from the University of Maryland with a Bachelor of Arts in Economics. Mr. Pollack is a member of the American Institute of Certified
Public Accountants, as well as licensed to practice in New Jersey, and New York.
Significant
Consultants
David
J. Swanberg, M.S., P.E. Mr. Swanberg has over 30 years’ experience in radiochemical processing, medical isotope production,
nuclear waste management, materials science, regulatory affairs, and project management. Mr. Swanberg has worked in diverse organizations
ranging from small start-up businesses to corporations with multi-billion-dollar annual revenues. From 2005 to 2008, he served as Executive
Vice President of Operations and as a member of the Board of Directors for IsoRay Medical Inc. from 2005 to 2008 managing day-to-day
operations, R&D, and new product development. Mr. Swanberg was a co-founder of IsoRay and led the initial Cs-131 brachytherapy seed
product development, FDA 510(k) submission/clearance, and NRC Sealed Source review and registration. Mr. Swanberg led the radiation dosimetry
evaluations to meet American Association of Physicists in Medicine guidelines and is a current member of the AAPM. Mr. Swanberg and participated
in several capital financing rounds totaling over $30.0 million. Mr. Swanberg also served as Assistant General Manager of IsoRay LLC
from 2000 to 2003, and in additionally in key management roles as IsoRay transitioned from IsoRay LLC to IsoRay Medical, Inc. Mr. Swanberg
holds a BA in Chemistry from Bethel University (MN) and an MS in Chemical Engineering from Montana State University. Mr. Swanberg has
numerous technical publications and holds several patents.
Brad
Weeks is the Business Development Manager for Vivos Inc. and both divisions IsoPet®
and RadioGel®. Brad holds a Master of Business Administration (MBA) with a focus on Technology Management. He brings a unique blend
of experience in service and support, regulatory affairs, quality management systems, and sales operations. Brad possesses diverse experience
across the semiconductor and medical device industries. He is co-lead of the animal sector and has earned deep respect for his leadership
skills.
Fredrick
Swindler is the Quality Assurance Manager for Vivos Inc. Fred provides expertise in quality assurance and regulatory affairs
in the medical device industry specific emphasis in development and auditing of quality systems as well as product submissions. Fred
holds an MBA and brings over 55 years of extensive experience to the Company.
Medical
and Veterinarian Advisory Boards
Dr.
Barry D. Pressman MD, FACR - Chairman Medical Advisory Board. Dr. Pressman is Professor and Chairman of the S. Mark Taper Foundation
Imaging Centre and Department, and Chief of the Section of Neuroradiology and Head and Neck Radiology at Cedars-Sinai Medical Center,
located in Los Angeles, California.
Dr.
Pressman is a past President of The American College of Radiology, the Western Neuroradiological Society, as well as past President of
the California Radiological Society. Currently he is a member of the American Society of Neuroradiology and the American Society of Pediatric
Neuroradiology.
Dr.
Pressman earned his medical degree Cum Laude from Harvard Medical School after graduating Summa Cum Laude from Dartmouth College. After
a surgical internship at Harvard’s Peter Bent Brigham Hospital in Boston, he completed a diagnostic radiology residency at Columbia-Presbyterian
Medical Center in New York and a Neuroradiology fellowship at George Washington University Hospital. During this period, he wrote many
original papers for Computer Tomography (CT).
Dr.
Albert S. DeNittis MD, MS, FCPP - Medical Advisory Board. Dr. Albert S. DeNittis is currently is the Chief of Radiation Oncology
at Lankenau Medical Center and Clinical Professor at Lankenau Institute for Medical Research in Wynnewood, Pennsylvania, and the Director
of Radiation Oncology at Brodesseur Cancer Center in New Jersey. He is also the Principal Investigator and in charge of a grant awarded
by the NIH for its National Cancer Oncology Research Program (NCORP) at Main Line Health. Dr. DeNittis’ practice experience includes
image-guided radiosurgery, stereotactic body radiation therapy (SBRT), intensity modulated radiation therapy (IMRT), image guided radiation
therapy (IGRT), high-dose rate (HDR) precision radionuclide therapy, cranial and extracranial stereotactic radiosurgery, respiratory
gating, and Cyberknife.
Dr.
DeNittis has served on numerous regional, national and government committees related to key issues in Dr. DeNittis earned a BA and a
MS at Rutgers University and a MD from the Robert Wood Johnson Medical School at the University of Medicine and Dentistry of New Jersey.
He completed postdoctoral training internships and residency at the Department of Radiation Oncology at the Hospital of the University
of Pennsylvania. Dr. DeNittis is board certified by the American Board of Radiology and Licensed in New Jersey and Pennsylvania.
Dr.
Beau Toskich, MD, FCPP - Medical Advisory Board. Dr. Toskich is currently Mayo Clinic Senior Associate Consultant,
Vascular and Interventional Radiology, Mayo Clinic, Florida Campus, Board Certified Diagnostic Radiology, Vascular and Interventional
Radiology, and Nuclear Regulatory Commission Authorized User
Dr.
Richard Weller, DVM, DACVIM (Internal Medicine; Oncology) DipMS - Veterinary Medicine Advisory Board Chairman. Prior to his retirement
in 2014, Dr. Weller was a Senior Program Manager in the Radiation Biology Group of the Biological Sciences Division at Pacific Northwest
National Laboratory (PNNL), where he was involved in the development of RadioGel. A 1973 graduate of Washington State University. Dr.
Weller has extensive experience in designing and executing clinical studies, treatment planning, mechanisms of carcinogenesis, radiation
biology, targeted delivery systems for chemotherapeutic and radio-therapeutic agents, bio-markers of disease, and comparative oncology;
as well as over 30 years of experience developing and using animal models, including the use of spontaneous tumors in companion animals,
for bio-medical applications.
Dr.
Weller is board-certified by the American College of Veterinary Internal Medicine in Internal Medicine (1980) and Oncology (1987), Past
Chairperson of the Organizing Committee for the Specialty of Veterinary Medical Oncology, Past Chairperson of the Board of Regents of
the American College of Veterinary Internal Medicine, Past President of the Board of Regents of the American College of Veterinary Internal
Medicine, Past President of the Specialty of Oncology, and a Charter Member of the Veterinary Cancer Society which he served as Treasurer
for 16 years. He is an Honorary Professor of the Institute of Veterinary Medicine in Kyiv, Ukraine. Dr. Weller has lectured and trained
veterinarians worldwide and has authored or co-authored over 250 articles, technical reports, book chapters, and presentations in his
fields of expertise.
Dr.
John Heindrick, DVM - Veterinary Medicine Advisory Board Member – Dr. Heindrick is a recently retired co-owner of
VCA Ventana Animal Hospital in Albuquerque NM. He brings practical experience in veterinary medicine and has accompanied us at our conference
booths.
Section
16(a) Beneficial Ownership Reporting Compliance
Section
16(a) of the Securities Exchange Act of 1934 requires the Company’s executive officers, directors and persons who own more than
10% of the Company’s common stock to file with the SEC initial reports of beneficial ownership on Form 3, changes in beneficial
ownership on Form 4, and an annual statement of beneficial ownership on Form 5. Such executive officers, directors and greater than 10%
stockholders are required by SEC rules to furnish the Company with copies of all such forms that they have filed.
Based
solely on its review of such forms filed with the SEC and received by the Company and representations from certain reporting persons,
the Company believes that all reports required to be filed by each of each of its executive officers, directors and 10% stockholders
were filed during the year ended December 31, 2024 and that such reports were timely.
Code
of Ethics
The
Company’s Board of Directors has not adopted a code of ethics that applies to the principal executive officer, principal financial
officer, principal accounting officer or controller, or persons performing similar functions, because of the Company’s limited
number of executive officers and employees that would be covered by such a code and the Company’s limited financial resources.
The Company anticipates that it will adopt a code of ethics after it increases the number of executive officers and employees and obtain
additional financial resources.
Audit
Committee and Audit Committee Financial Expert
As
of the date of this Offering Circular, the Company has not established an audit committee, and therefore, the Company’s full board
of directors performs the functions that customarily would be undertaken by an audit committee. The Company’s Board of Directors
during 2024 and 2023 was comprised of two directors, one of whom the Company had determined satisfied the general independence standards
of the NASDAQ listing requirements.
The
Company’s Board of Directors has determined that none of its current members qualifies as an “audit committee financial expert,”
as defined by the rules of the SEC. In the future, the Company intends to establish board committees and to appoint such persons to those
committees as are necessary to meet the corporate governance requirements imposed by a national securities exchange, although it is not
required to comply with such requirements until the Company elects to seek listing on a national securities exchange.
Board
of Directors; Attendance at Meetings
The
Board held no meetings and acted by unanimous written consent two times during the year ended December 31, 2024. The Board
held no meetings and acted by unanimous written consent two times during the year ended December 31, 2023. We have no formal policy with
respect to the attendance of Board members at annual meetings of shareholders but encourage all incumbent directors and director nominees
to attend each annual meeting of shareholders.
ITEM
11. EXECUTIVE COMPENSATION.
Summary
Compensation Table
The
following table sets forth the compensation paid to the Company’s Chief Executive Officer and those executive officers that earned
more than $100,000 during the year ended December 31, 2024 (collectively, the “Named Executive Officers”):
Name
and Principal Position (1) | |
Year | | |
Salary
($) | | |
Bonus
($) | | |
Stock
Awards ($) | | |
Option
Awards ($)(2) | | |
Total
($) | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Dr. Michael K. Korenko | |
| 2024 | | |
$ | 295,500 | | |
$ | 40,000 | | |
$ | - | | |
$ | - | | |
$ | 335,500 | |
CEO, President, and Director | |
| 2023 | | |
$ | 236,391 | | |
$ | 30,000 | | |
$ | - | | |
$ | - | | |
$ | 266,391 | |
|
(1) |
Michael
Pollack began serving as the Company’s Interim Chief Financial Officer in December 2018 and was paid no compensation directly
in 2023 or 2024. Accordingly, he has not been included in this table. |
|
|
|
|
(2) |
The
amounts in this column represent the grant date fair value of stock option awards, computed in accordance with FASB ASC Topic 718. |
Narrative
Disclosure to Summary Compensation Table
Dr.
Michael K. Korenko. On October 24, 2018, Mr. Korenko entered into an employment agreement with the Company (the “Old Employment
Agreement”), which was scheduled to terminate on December 31, 2019. On June 4, 2019, the Company entered into an Executive
Employment Agreement (“Employment Agreement”) with Dr. Michael K. Korenko, the Company’s Chief Executive Officer.
The employment term under the Employment Agreement commenced with an effective date of June 11, 2019 and expires on December 31, 2020,
and December 31 of each successive year if the Employment Agreement is extended, unless terminated earlier as set forth in the Employment
Agreement. The Company on December 31, 2020 extended this agreement through December 31, 2021 while renegotiating terms of a new Employment
Agreement. On May 3, 2021, the Company and the Chief Executive Officer agreed the terms of a new Employment Agreement with an effective
date of January 1, 2021 that has a term of three years and expired December 31, 2023. The Company renewed the Employment Agreement for
a term of two years expiring December 31, 2025.
Under
the terms of the Employment Agreement effective January 1, 2024, the Company shall pay to Dr. Korenko a base compensation of $295,500.
In addition, there is a discretionary bonus to be earned in the amount of $10,000 per quarter upon the satisfaction of conditions to
be determined by the Board of Directors of the Company. In addition, the Company granted Dr. Korenko 20,000,000 restricted stock units
on January 1, 2024 that vest over the two-year period.
Outstanding
Equity Awards at Fiscal Year-End Table
The
following table sets forth all outstanding equity awards held by the Company’s Named Executive Officers as of the end of last fiscal
year.
|
|
Option
Awards |
Name |
|
Number
of Securities Underlying Unexercised Options(#) Exercisable |
|
Number
of Securities Underlying Unexercised Options (#) Unexercisable |
|
Option
Exercise Price ($) |
|
Option
Exercise Date |
NONE |
|
|
|
|
|
|
|
|
Compensation
of Directors
During
the year ended December 31, 2024, the Company’s non-employee directors were not paid any compensation.
The
following table sets forth, for each of the Company’s non-employee directors who served during 2024, the aggregate number of stock
awards and the aggregate number of stock option awards that were outstanding as of December 31, 2024:
Name | |
| Outstanding Stock Awards
(#) | | |
| Outstanding Stock Options
(#) | |
Carlton M. Cadwell | |
| - | | |
| - | |
There
are no employment contracts or compensatory plans or arrangements with respect to any director that would result in payments by the Company
to such person because of his or her resignation as a director or any change in control of the Company.
Compensation
Committee Interlocks and Insider Participation
None
of our officers currently serves, or has served during the last completed fiscal year, on the compensation committee or board of directors
of any other entity that has one or more officers serving as a member of our Board of Directors.
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
Beneficial
Ownership of the Company’s Common Stock
The
following table sets forth, as of March 7, 2025, the number of shares of common stock beneficially owned by the following persons:
(i) all persons the Company knows to be beneficial owners of at least 5% of the Company’s common stock, (ii) the Company’s
current directors, (iii) the Company’s current executive officers; and (iv) all current directors and executive officers as a group.
As
of March 7, 2025, there were 453,373,806 shares of common stock outstanding and up to 43,852,379 shares issuable upon exercise of
common stock equivalents, assuming exercise and conversion occurred as of that date, for a total of 497,226,185 shares.
Name
and Address of Beneficial Owner(1) | |
Amount
and Nature of Beneficial Ownership(2) | | |
Percent
of Class | | |
| |
Cadwell Family Irrevocable Trust | |
| 26,912 | | |
| * | | |
| % | |
| |
| | | |
| | | |
| | |
Carlton M. Cadwell (3) | |
| 15,406,979 | | |
| 3 | | |
| % | |
| |
| | | |
| | | |
| | |
Michael K. Korenko (4) | |
| 15,435,090 | | |
| 3 | | |
| % | |
| |
| | | |
| | | |
| | |
Michael Pollack | |
| 16,000 | | |
| * | | |
| | |
| |
| | | |
| | | |
| | |
All Current Directors
and Executive Officers as a group (3 individuals) | |
| 30,334,981 | | |
| 6 | | |
| % | |
*
Less than 1%
(1) |
The
address of each of the beneficial owners above is c/o Vivos Inc, 1030 N Center Parkway, Kennewick, WA 99352, except that the address
of the Cadwell Family Irrevocable Trust (the “Cadwell Trust”) is 909 North Kellogg Street, Kennewick, WA 99336. |
|
|
(2) |
In
determining beneficial ownership of the Company’s common stock as of a given date, the number of shares shown includes shares
of common stock which may be acquired upon exercise of the common stock equivalents within 60 days of that date. In determining the
percent of common stock owned by a person or entity on March [●], 2025, (a) the numerator is the number of shares of the class
beneficially owned by such person or entity, including shares which may be acquired within 60 days on exercise of the common stock
equivalents, and (b) the denominator is the sum of (i) the total shares of common stock outstanding on March [●], 2025, and
(ii) the total number of shares that the beneficial owner may acquire upon conversion of the common stock equivalents. Subject to
community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose of its
shares, except that under the terms of the Cadwell Trust, Dr. Cadwell does not have or share voting or investment power over the
shares beneficially owned by the Cadwell Trust. |
|
|
(3) |
Includes
1,136,137 shares issuable upon conversion of Series A Preferred; and 4,816,275 shares issuable upon conversion of Series C Preferred,
and 2,316,830 shares of common stock issued to AMIC Gift, LLC, an LLC controlled by Carlton and his wife. |
|
|
(4) |
Includes
5,000,000 shares issuable for vested RSUs. |
Beneficial
Ownership of the Company’s Series A Convertible Preferred Stock
As
of March 7, 2025, there were 2,071,007 shares of Series A Preferred issued and outstanding, convertible into 2,588,758 shares
of the Company’s common stock.
The
following table sets forth, as of March 7, 2025, the number of shares of Series A Preferred beneficially owned by the following
persons: (i) all persons the Company known to be beneficial owners of at least 5% of the Company’s Series A Preferred, (ii) the
Company’s current directors, (iii) the Company’s current executive officers, and (iv) all current directors and executive
officers as a group.
Name
and Address of Beneficial Owner (1) | |
Amount
and Nature of Beneficial Ownership (2) | | |
Percent
of Class | |
Cadwell Family Irrevocable Trust | |
| 148,309 | | |
| 7.16 | % |
| |
| | | |
| | |
Carlton M. Cadwell | |
| 908,910 | | |
| 43.89 | % |
| |
| | | |
| | |
All
Current Directors and Executive Officers as a group (2 individuals)(3) | |
| 1,057,219 | | |
| 51.05 | % |
| |
| | | |
| | |
Major Shareholder(s): | |
| | | |
| | |
| |
| | | |
| | |
L. Bruce Jolliff | |
| 197,979 | | |
| 9.56 | % |
| |
| | | |
| | |
Stoel Rives | |
| 133,333 | | |
| 6.44 | % |
(1) |
The
address of each of the beneficial owners above is c/o Vivos Inc, 1030 N Center Parkway, Kennewick, WA 99352, except that the address
of (i) the Cadwell Family Irrevocable Trust (the “Cadwell Trust”) is 909 North Kellogg Street, Kennewick, WA 99336;
(ii) L. Bruce Jolliff is 206 N 41st St. Unit 1, Yakima, WA 98901; and (iii) Stoel Rives is One Union Square, 600 University Street,
Suite 3600, Seattle, WA 98101. |
|
|
(2) |
Subject
to community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose of
its shares, except that Dr. Cadwell under the terms of the Cadwell Trust does not have or share voting or investment power over the
Series A Convertible Preferred beneficially owned by the Cadwell Trust. |
|
|
(3) |
Neither
Michael Korenko, the Company’s Chief Executive Officer, nor Michael Pollack, the Company’s Interim Chief Financial Officer,
hold any Company Series A Convertible Preferred, and therefore have been omitted from this table. |
Beneficial
Ownership of the Company’s Series B Convertible Preferred Stock
As
of March 7, 2025, there were 363 shares of Series B Preferred issued and outstanding, convertible into 4.538 shares of the Company’s
common stock.
The
following table sets forth, as of March [●], 2025, the number of shares of Series B Preferred beneficially owned by the following
persons: (i) all persons the Company known to be beneficial owners of at least 5% of the Company’s Series B Preferred, (ii) the
Company’s current directors, (iii) the Company’s current executive officers, and (iv) all current directors and executive
officers as a group.
Name
and Address of Beneficial Owner (1) | |
Amount
and Nature of Beneficial Ownership (2) | | |
Percent
of Class | |
All Current
Directors and Executive Officers as a group (3 individuals) | |
| - | | |
| * | % |
| |
| | | |
| | |
Major Shareholder(s): | |
| | | |
| | |
| |
| | | |
| | |
Firstfire Global Opportunities
Fund(1) | |
| 363 | | |
| 100 | % |
*
Less than 1%
(1) |
None
of the Company’s directors and executive officers hold any shares of the Company’s Series B Convertible Preferred, and
they have therefore been omitted from this table. The address of the beneficial owners is as follows: (i) Firstfire Global Opportunities
Fund. |
|
|
(2) |
Subject
to community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose of
its shares. |
|
|
Beneficial
Ownership of the Company’s Series C Convertible Preferred Stock
As
of March 7, 2025, there were 385,302 shares of Series C Preferred issued and outstanding, convertible into 4,816,275 shares of
the Company’s common stock.
The
following table sets forth, as of March 7, 2025, the number of shares of Series C Preferred beneficially owned by the following
persons: (i) all persons the Company known to be beneficial owners of at least 5% of the Company’s Series C Preferred, (ii) the
Company’s current directors, (iii) the Company’s current executive officers, and (iv) all current directors and executive
officers as a group.
Name
and Address of Beneficial Owner (1) | |
Amount
and Nature of Beneficial Ownership (2) | | |
Percent
of Class | |
Carlton M. Cadwell | |
| 385,302 | | |
| 100 | % |
All
Current Directors and Executive Officers as a group (3 individuals) (3) | |
| 385,302 | | |
| 100 | % |
(1) |
The
address of each of the beneficial owners above is c/o Vivos Inc, 1030 N Center Parkway, Kennewick, WA 99352. |
|
|
(2) |
Subject
to community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose of
its shares, except that Dr. Cadwell under the terms of the Cadwell Trust does not have or share voting or investment power over the
Series C Preferred beneficially owned by the Cadwell Trust. |
|
|
(3) |
Neither
Michael Korenko, the Company’s Chief Executive Officer, nor Michael Pollack, the Company’s Interim Chief Financial Officer,
hold any shares of the Company’s Series C Preferred, and have therefore been omitted from this table. |
Changes
in Control
The
Company does not know of any arrangements, including any pledges of the Company’s securities that may result in a change in control
of the Company.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
Indebtedness
from Related Parties
There
has been no indebtedness from related parties for the years ended December 31, 2024 and 2023, except for a brief period in December 2024
in the amount of $40,949.
Independent
Directors
The
Company’s common stock is traded on the OTCQB Marketplace, which does not impose any independence requirements on the Board of
Directors or the board committees of the companies whose stock is traded on that market. The Company has decided to adopt the independence
standards of the Nasdaq listing rules in determining whether the Company’s directors are independent. Generally, under those rules
a director does not qualify as an independent director if the director or a member of the director’s immediate family has had in
the past three years certain relationships or affiliations with the Company, the Company’s auditors, or other companies that do
business with the Company. The Company’s Board of Directors has determined that Mr. Cadwell is qualified as an independent director
under those Nasdaq rules, and accordingly, would have been qualified under those rules to serve on a compensation committee or a nominating
committee, if the Company had established such committees of the Company’s Board of Directors. Dr. Korenko is not an independent
director due to his employment by the Company as an executive officer.
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
Audit
Fees
The
aggregate fees incurred by the Company’s principal accountant for the audit of the Company’s annual financial statements,
review of financial statements included in the quarterly reports and other fees that are normally provided by the accountant in connection
with statutory and regulatory filings or engagements for the years ended December 31, 2024 and 2023 were $38,500 and $40,500, respectively,
all of which was paid to Fruci & Associates II, PLLC.
Audit
Related Fees
The
aggregate fees billed for professional services that are reasonably related to the performance of the audit or review of the Company’s
financial statements but are not reported “Audit Fees” for the years ended December 31, 2024 and 2023 in the amounts of $4,500
and $4,500, respectively. All services performed by the Company’s Registered Public Accounting Firm, Fruci & Associates II,
PLLC have been pre-approved by the Company’s Board of Directors.
Tax
Fees
The
aggregate fees billed for professional services rendered by principal accountant for tax compliance, tax advice and tax planning during
the years ended December 31, 2024 and 2023 were $3,850 and $3,500, respectively, all of which was paid to Fruci & Associates
II, PLLC.
All
Other Fees
Other
fees billed for products or services provided by the Company’s principal accountant during the years ended December 31, 2024 and
2023. There were no fees incurred to Fruci & Associates II, PLLC related to all other fees.
PART
IV
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
(a)
Documents filed as part of this Report.
1. |
Financial
Statements. The Vivos Inc. Balance Sheets as of December 31, 2024 and 2023, the Statements of Operations for the years
ended December 31, 2024 and 2023, the Statements of Changes in Stockholders’ Equity for the years ended December 31, 2024
and 2023, and the Statements of Cash Flows for the years ended December 31, 2024 and 2023, together with the notes thereto and the
reports of Fruci & Associates II, PLLC as required by Item 8 are included in this 2024 Annual Report on Form 10-K as set forth
in Item 8 above. |
|
|
2. |
Financial
Statement Schedules. All financial statement schedules have been omitted since they are either not required or not applicable,
or because the information required is included in the financial statements or the notes thereto. |
|
|
3. |
Exhibits.
The following exhibits are either filed as a part hereof or are incorporated by reference. Exhibit numbers correspond to the numbering
system in Item 601 of Regulation S-K. |
Exhibit
Number |
|
Description |
3.1 |
|
Certificate
of Incorporation of Savage Mountain Sports Corporation, dated January 11, 2000 (incorporated by reference to Exhibit 3.1 to the Company’s
Registration Statement on Form 10-12G (File No. 000-53497) filed on November 12, 2008). |
3.2 |
|
By-Laws
(incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497) filed
on November 12, 2008). |
3.3 |
|
Certificate
of Amendment of Certificate of Incorporation changing the name of the Company to Advanced Medical Isotope Corporation, dated May
23, 2006 (incorporated by reference to Exhibit 3.5 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497)
filed on November 12, 2008). |
3.4 |
|
Certificate
of Amendment of Certificate of Incorporation increasing authorized capital dated September 26, 2006 (incorporated by reference to
Exhibit 3.6 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497) filed on November 12, 2008). |
3.5 |
|
Certificate
of Amendment to the Certificate of Incorporation increasing authorized common stock and authorizing preferred stock, dated May 18,
2011 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on May 18, 2011). |
3.6 |
|
Certificate
of Amendment to the Certificate of Incorporation authorizing a series of Preferred Stock to be named “Series A Convertible
Preferred Stock”, consisting of 2,500,000 shares, which series shall have specific designations, powers, preferences and relative
and other special rights, qualifications, limitations and restrictions as outlined in the Certificate of Designations, filed June
30, 2015 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on July 7, 2015). |
3.7 |
|
Certificate
of Amendment to the Certificate of Incorporation increasing the authorized series of “Series A Convertible Preferred Stock”
to 5,000,000 shares, filed March 31, 2016 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form
8-K filed on April 7, 2016). |
3.8 |
|
Certificate
of Amendment to the Certificate of Incorporation authorizing a series of Preferred Stock to be named “Series B Convertible
Preferred Stock”, consisting of 5,000,000 shares, which series shall have specific designations, powers, preferences and relative
and other special rights, qualifications, limitations and restrictions as outlined in the Certificate of Designations, filed October
10, 2018 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on October 17, 2018). |
3.9 |
|
Certificate
of Designations, Preferences and Rights of Series C Convertible Preferred Stock of Vivos Inc., dated March 27, 2019 (incorporated
by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed on April 2, 2019). |
3.10 |
|
Certificate
of Amendment to its Certificate of Incorporation of Vivos Inc., as amended, effecting a 1-for-8 reverse split, dated June 26, 2019
(incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 2, 2019). |
4.1 |
|
Form
of Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on October 17, 2018). |
4.2 |
|
Form
of Series A Warrant (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 11,
2022). |
4.3 |
|
Form
of Series B Warrant (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on July 11,
2022). |
4.4 |
|
Form
of Series C Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on December
27, 2023). |
10.1 |
|
Agreement
and Plan of Reorganization, dated as of December 15, 1998, by and among HHH Entertainment, Inc. and Earth Sports Products, Inc. (incorporated
by reference to Exhibit 10.1 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497) filed on November
12, 2008). |
10.2 |
|
Agreement
and Plan of Merger of HHH Entertainment, Inc. and Savage Mountain Sports Corporation, dated as of January 6, 2000 (incorporated by
reference to Exhibit 10.2 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497), filed on November 12,
2008). |
10.3 |
|
Agreement
and Plan of Acquisition by and between Neu-Hope Technologies, Inc., UTEK Corporation and Advanced Medical Isotope Corporation, dated
September 22, 2006 (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form 10-12G (File
No. 000-53497), filed on November 12, 2008). |
10.4 |
|
Agreement
and Plan of Acquisition by and between Isonics Corporation and Advanced Medical Isotope Corporation dated June 13, 2007 (incorporated
by reference to Exhibit 10.6 to the Company’s Registration Statement on Form 10-12G (File No. 000-53497), filed on November
12, 2008). |
10.5 |
|
Form
of Non-Statutory Stock Option Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form
8-K filed on March 15, 2012). |
10.6 |
|
Promissory
Note dated December 16, 2008 between Advanced Medical Isotope Corporation and Carlton M. Cadwell (incorporated by reference to Exhibit
10.11 to the Company’s Annual Report on Form 10-K filed on March 3, 2012). |
10.7 |
|
2015
Omnibus Securities and Incentive Plan (incorporated by reference to Exhibit 10.12 to the Company’s Annual Report on Form 10-K,
filed May 25, 2016). |
10.8 |
|
Washington
State University Sub-Award Agreement for the period December 15, 2017 through January 31, 2018.(incorporated by reference to Exhibit
10.13 to the Company’s Annual report on Form 10-K, filed April 2, 2018). |
10.9 |
|
The
Curators of the University of Missouri Sponsored Research Contract for the period November 1, 2017 through October 31, 2018. (incorporated
by reference to Exhibit 10.14 to the Company’s Annual report on Form 10-K, filed April 2, 2018). |
10.10 |
|
Form
of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed
on October 17, 2018). |
10.11 |
|
Employment
Agreement between Vivos Inc. and Michael Korenko, dated May 3, 2021 (incorporated by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed on May 7, 2021. |
10.12 |
|
Amended
and Restated Employment Agreement between Vivos Inc. and Michael Korenko. Dated December 19, 2023, with a deemed effective date of
January 1, 2024 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed March 25, 2024). |
10.13 |
|
Form
of Series C Warrant Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed on December 27, 2023). |
10.14 |
|
Form
of Warrant Exchange Agreement (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed
on December 27, 2023. |
23* |
|
Consent of Independent Registered Public Accounting Firm |
31.1* |
|
Certification of Chief Executive Officer pursuant to Sec. 302 of the Sarbanes-Oxley Act of 2002 (4) |
31.2* |
|
Certification of Chief Financial Officer pursuant to Sec. 302 of the Sarbanes-Oxley Act of 2002 (4) |
32.1* |
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 (4) |
101.INS* |
|
Inline
XBRL Instance Document |
101.SCH* |
|
Inline
XBRL Taxonomy Extension Schema |
101.CAL* |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase |
101.DEF* |
|
Inline
XBRL Taxonomy Extension Definition Linkbase |
101.LAB* |
|
Inline
XBRL Taxonomy Extension Label Linkbase |
101.PRE* |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase |
104 |
|
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
*
Filed herewith.
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
|
VIVOS
INC. |
|
|
|
Date:
March 24, 2025 |
By: |
/s/
Michael K. Korenko |
|
Name: |
Michael
K. Korenko |
|
Title: |
Chief
Executive Officer |
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the dates indicated.
Date:
March 24, 2025 |
By: |
/s/
Michael K. Korenko |
|
Name: |
Michael
K. Korenko |
|
Title: |
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
Date:
March 24, 2025 |
By: |
/s/
Michael Pollack |
|
Name: |
Michael
Pollack |
|
Title: |
Interim
Chief Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
|
|
|
Date:
March 24, 2025 |
By: |
/s/
Carlton M. Cadwell |
|
Name: |
Carlton
M. Cadwell |
|
Title: |
Secretary
and Chairman of the Board |
Vivos
Inc.
Index
to Financial Statements
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To
the Board of Directors and Shareholders of Vivos, Inc.
Opinion
on the Financial Statements
We
have audited the accompanying balance sheets of Vivos, Inc. (“the Company”) as of December 31, 2024 and 2023, and the related
statements of operations, changes in stockholders’ equity, and cash flows for each of the years in the two-year period ended December
31, 2024, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present
fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023 and the results of its operations
and its cash flows for each of the years in the two-year period ended December 31, 2024, in conformity with accounting principles generally
accepted in the United States of America.
Going
Concern
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note
1 to the financial statements, the Company has a history of net losses, and negative cash flows from operations. These factors, among
others, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard
to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome
of this uncertainty.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits,
we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits
provide a reasonable basis for our opinion.
Critical
Audit Matters
Critical
audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be
communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and
(2) involved our especially challenging, subjective, or complex judgments. We determined that there were no critical audit matters.

Fruci & Associates II, PLLC – PCAOB ID #05525
We have served as the Company’s auditor since 2016.
Spokane, Washington
March 24, 2025
VIVOS
INC
BALANCE
SHEETS
DECEMBER
31, 2024 AND 2023
| |
DECEMBER 31, | | |
DECEMBER 31, | |
| |
2024 | | |
2023 | |
ASSETS | |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash | |
$ | 2,212,548 | | |
$ | 1,592,287 | |
Accounts receivable | |
| 10,326 | | |
| 7,000 | |
Prepaid expenses | |
| 10,582 | | |
| 10,837 | |
| |
| | | |
| | |
Total Current Assets | |
| 2,233,456 | | |
| 1,610,124 | |
| |
| | | |
| | |
| |
| | | |
| | |
TOTAL ASSETS | |
$ | 2,233,456 | | |
$ | 1,610,124 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
LIABILITIES | |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 86,209 | | |
$ | 245,004 | |
| |
| | | |
| | |
Total Current Liabilities | |
| 86,209 | | |
| 245,004 | |
| |
| | | |
| | |
Total Liabilities | |
| 86,209 | | |
| 245,004 | |
| |
| | | |
| | |
Commitments and contingencies | |
| - | | |
| - | |
| |
| | | |
| | |
STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Preferred stock, par value, $0.001, 20,000,000 shares authorized, Series A
Convertible Preferred, 5,000,000 shares authorized, 2,071,007 shares issued and outstanding, respectively | |
| 2,071 | | |
| 2,071 | |
Additional paid in capital - Series A Convertible preferred stock | |
| 8,842,458 | | |
| 8,842,458 | |
Series B Convertible Preferred, 5,000,000 shares authorized, 363 and 200,363 shares
issued and outstanding, respectively | |
| - | | |
| 200 | |
Additional paid in capital - Series B Convertible preferred stock | |
| 4,538 | | |
| 290,956 | |
Series C Convertible Preferred, 5,000,000 shares authorized, 385,302 shares issued and outstanding, respectively | |
| 385 | | |
| 385 | |
Preferred stock, value | |
| 385 | | |
| 385 | |
Additional paid in capital - Series C Convertible preferred stock | |
| 500,507 | | |
| 500,507 | |
Additional paid in capital | |
| 500,507 | | |
| 500,507 | |
Common stock, par value, $0.001, 950,000,000 shares authorized, 440,873,806 and
387,894,033 issued and outstanding, respectively | |
| 440,874 | | |
| 387,894 | |
Additional paid in capital - common stock | |
| 77,719,143 | | |
| 73,791,430 | |
Subscriptions receivable | |
| (1,500 | ) | |
| - | |
Accumulated deficit | |
| (85,361,229 | ) | |
| (82,450,781 | ) |
| |
| | | |
| | |
Total Stockholders’ Equity | |
| 2,147,247 | | |
| 1,365,120 | |
| |
| | | |
| | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 2,233,456 | | |
$ | 1,610,124 | |
The
accompanying notes are an integral part of these financial statements.
VIVOS
INC
STATEMENTS
OF OPERATIONS
FOR
THE YEARS ENDED DECEMBER 31, 2024 AND 2023
| |
DECEMBER
31, | | |
DECEMBER
31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Revenues,
net | |
$ | 27,995 | | |
$ | 19,500 | |
Cost
of Goods Sold | |
| (30,979 | ) | |
| (25,536 | ) |
| |
| | | |
| | |
Gross
loss | |
| (2,984 | ) | |
| (6,036 | ) |
| |
| | | |
| | |
OPERATING
EXPENSES | |
| | | |
| | |
Professional
fees, including stock-based compensation | |
| 1,682,350 | | |
| 1,606,923 | |
Payroll
expenses | |
| 352,597 | | |
| 281,716 | |
Research
and development | |
| 324,629 | | |
| 732,698 | |
General
and administrative expenses | |
| 241,824 | | |
| 165,773 | |
| |
| | | |
| | |
Total
Operating Expenses | |
| 2,601,400 | | |
| 2,787,110 | |
| |
| | | |
| | |
OPERATING
LOSS | |
| (2,604,384 | ) | |
| (2,793,146 | ) |
| |
| | | |
| | |
NON-OPERATING
INCOME (EXPENSE) | |
| | | |
| | |
Interest
income | |
| 74,936 | | |
| 49,577 | |
Loss
on issuance of shares and exchange of warrants | |
| (381,000 | ) | |
| (151,184 | ) |
| |
| | | |
| | |
Total
Non-Operating Expenses | |
| (306,064 | ) | |
| (101,607 | ) |
| |
| | | |
| | |
| |
| | | |
| | |
Provision
for income taxes | |
| - | | |
| - | |
| |
| | | |
| | |
NET
LOSS | |
$ | (2,910,448 | ) | |
$ | (2,894,753 | ) |
| |
| | | |
| | |
| |
| | | |
| | |
Net
loss per share - basic and diluted | |
$ | (0.01 | ) | |
$ | (0.01 | ) |
| |
| | | |
| | |
Weighted
average common shares outstanding | |
| 409,673,533 | | |
| 368,805,214 | |
The
accompanying notes are an integral part of these financial statements.
VIVOS
INC
STATEMENT
OF CHANGES IN STOCKHOLDERS’ EQUITY
FOR
THE YEARS ENDED DECEMBER 31, 2024 AND 2023
| |
Shares | | |
Amount | | |
Preferred | | |
Shares | | |
Amount | | |
Preferred | | |
Shares | | |
Amount | | |
Preferred | | |
Shares | | |
Amount | | |
Common | | |
Receivable | | |
Deficit | | |
Total | |
| |
| | |
| | |
Additional | | |
| | |
| | |
Additional | | |
| | |
Additional | | |
| | |
| | |
| | |
| | |
| |
| |
| | |
| | |
Paid-In | | |
| | |
| | |
Paid-In | | |
|
| | |
Paid-In | | |
| | |
Additional | | |
| | |
| | |
| |
| |
Series
A Preferred | | |
Capital
- Series A | | |
Series
B Preferred | | |
Capital
- Series B | | |
Series
C Preferred | | |
Capital
- Series C | | |
Common
Stock | | |
Paid-In
Capital - | | |
Subscription | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Preferred | | |
Shares | | |
Amount | | |
Preferred | | |
Shares | | |
Amount | | |
Preferred | | |
Shares | | |
Amount | | |
Common | | |
Receivable | | |
Deficit | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance
- December 31, 2022 | |
| 2,071,007 | | |
$ | 2,071 | | |
$ | 8,842,458 | | |
| 200,363 | | |
$ | 200 | | |
$ | 290,956 | | |
| 385,302 | | |
$ | 385 | | |
$ | 500,507 | | |
| 362,541,528 | | |
$ | 362,541 | | |
$ | 71,217,954 | | |
$ | - | | |
$ | (79,556,028 | ) | |
$ | 1,661,044 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock
issued for: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Cash | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 16,132,000 | | |
| 16,132 | | |
| 1,144,316 | | |
| - | | |
| - | | |
| 1,160,448 | |
Accounts
payable | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 500,000 | | |
| 500 | | |
| 27,950 | | |
| - | | |
| - | | |
| 28,450 | |
RSUs | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 4,000,000 | | |
| 4,000 | | |
| (4,000 | ) | |
| - | | |
| - | | |
| - | |
Warrant
exercises and exchanges | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 4,720,505 | | |
| 4,721 | | |
| 146,463 | | |
| - | | |
| - | | |
| 151,184 | |
Warrants
purchased for cash | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 18,797 | | |
| - | | |
| - | | |
| 18,797 | |
RSUs
granted to consultants that have vested | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,239,950 | | |
| - | | |
| - | | |
| 1,239,950 | |
Net
loss for the year | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,894,753 | ) | |
| (2,894,753 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance
- December 31, 2023 | |
| 2,071,007 | | |
| 2,071 | | |
| 8,842,458 | | |
| 200,363 | | |
| 200 | | |
| 290,956 | | |
| 385,302 | | |
| 385 | | |
| 500,507 | | |
| 387,894,033 | | |
| 387,894 | | |
| 73,791,430 | | |
| - | | |
| (82,450,781 | ) | |
| 1,365,120 | |
Balance
| |
| 2,071,007 | | |
| 2,071 | | |
| 8,842,458 | | |
| 200,363 | | |
| 200 | | |
| 290,956 | | |
| 385,302 | | |
| 385 | | |
| 500,507 | | |
| 387,894,033 | | |
| 387,894 | | |
| 73,791,430 | | |
| - | | |
| (82,450,781 | ) | |
| 1,365,120 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock
issued for: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Cash | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 24,950,000 | | |
| 24,950 | | |
| 2,241,050 | | |
| - | | |
| - | | |
| 2,266,000 | |
Services | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 605,801 | | |
| 606 | | |
| 88,319 | | |
| - | | |
| - | | |
| 88,925 | |
Exercise
of warrants (cash and cashless) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 25,336,472 | | |
| 25,336 | | |
| 376,514 | | |
| (1,500 | ) | |
| - | | |
| 400,350 | |
Conversion
of preferred stock to common stock | |
| - | | |
| - | | |
| - | | |
| (200,000 | ) | |
| (200 | ) | |
| (286,418 | ) | |
| - | | |
| - | | |
| - | | |
| 2,500,000 | | |
| 2,500 | | |
| 284,118 | | |
| - | | |
| - | | |
| - | |
Vested
RSUs | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 750,000 | | |
| 750 | | |
| (750 | ) | |
| - | | |
| - | | |
| - | |
Adjustment
for vested RSUs | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,162,500 | ) | |
| (1,162 | ) | |
| 1,162 | | |
| - | | |
| - | | |
| - | |
Warrants
purchased for cash | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 18,950 | | |
| - | | |
| - | | |
| 18,950 | |
RSUs
granted to consultants that have vested | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 918,350 | | |
| - | | |
| - | | |
| 918,350 | |
Net
loss for the year | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,910,448 | ) | |
| (2,910,448 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance
- December 31, 2024 | |
| 2,071,007 | | |
$ | 2,071 | | |
$ | 8,842,458 | | |
| 363 | | |
$ | - | | |
$ | 4,538 | | |
| 385,302 | | |
$ | 385 | | |
$ | 500,507 | | |
| 440,873,806 | | |
$ | 440,874 | | |
$ | 77,719,143 | | |
$ | (1,500 | ) | |
$ | (85,361,229 | ) | |
$ | 2,147,247 | |
Balance
| |
| 2,071,007 | | |
$ | 2,071 | | |
$ | 8,842,458 | | |
| 363 | | |
$ | - | | |
$ | 4,538 | | |
| 385,302 | | |
$ | 385 | | |
$ | 500,507 | | |
| 440,873,806 | | |
$ | 440,874 | | |
$ | 77,719,143 | | |
$ | (1,500 | ) | |
$ | (85,361,229 | ) | |
$ | 2,147,247 | |
The
accompanying notes are an integral part of these financial statements.
VIVOS
INC
STATEMENTS
OF CASH FLOWS
FOR
THE YEARS ENDED DECEMBER 31, 2024 AND 2023
| |
2024 | | |
2023 | |
CASH FLOW FROM OPERTING ACTIVIITES | |
| | | |
| | |
Net loss | |
$ | (2,910,448 | ) | |
$ | (2,894,753 | ) |
Adjustments to reconcile net loss to net cash used in operating activities | |
| | | |
| | |
Common stock, stock options and warrants for services | |
| 88,925 | | |
| - | |
RSUs issued for services | |
| 918,350 | | |
| 1,239,950 | |
Loss on issuance of shares and warrants | |
| 381,000 | | |
| 151,184 | |
Changes in assets and liabilities | |
| | | |
| | |
Accounts receivable | |
| (3,326 | ) | |
| 4,000 | |
Prepaid expenses and other assets | |
| 255 | | |
| 14,834 | |
Accounts payable and accrued expenses | |
| (158,795 | ) | |
| 191,762 | |
Total adjustments | |
| 1,226,409 | | |
| 1,601,730 | |
| |
| | | |
| | |
Net cash used in operating activities | |
| (1,684,039 | ) | |
| (1,293,023 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITES | |
| | | |
| | |
Proceeds from short-term advances from related party | |
| 40,949 | | |
| - | |
Payments of related party notes | |
| (40,949 | ) | |
| - | |
Exercise of warrants | |
| 19,350 | | |
| - | |
Proceeds from common stock and warrants | |
| 2,284,950 | | |
| 1,179,245 | |
Net cash provided by financing activities | |
| 2,304,300 | | |
| 1,179,245 | |
| |
| | | |
| | |
NET INCREASE (DECREASE) IN CASH | |
| 620,261 | | |
| (113,778 | ) |
| |
| | | |
| | |
CASH- BEGINNING OF YEAR | |
| 1,592,287 | | |
| 1,706,065 | |
| |
| | | |
| | |
CASH - END OF YEAR | |
$ | 2,212,548 | | |
$ | 1,592,287 | |
| |
| | | |
| | |
CASH PAID DURING THE YEAR FOR: | |
| | | |
| | |
Interest expense | |
$ | - | | |
$ | - | |
| |
| | | |
| | |
Income taxes | |
$ | - | | |
$ | - | |
| |
| | | |
| | |
SUPPLEMENTAL INFORMATION - NON-CASH INVESTING AND FINANCING ACTIVITIES: | |
| | | |
| | |
| |
| | | |
| | |
Common stock issued in cashless exercise of warrants | |
$ | 23,251 | | |
$ | 4,721 | |
RSUs vested into common stock | |
$ | 750 | | |
$ | 4,000 | |
Accounts payable converted into shares of common stock | |
$ | - | | |
$ | 28,450 | |
The
accompanying notes are an integral part of these financial statements.
VIVOS
INC.
NOTES
TO FINANCIAL STATEMENTS
DECEMBER
31, 2024 AND 2023
NOTE
1: BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
Business
Overview
Vivos
Inc. (the “Company,” “we,” “us,” “our”) is a radiation oncology
medical device company engaged in the development of its yttrium-90 (“Y-90”) based precision radionuclide therapy
device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide TherapyTM.
A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories,
universities, and private corporations, lead the Company’s development efforts. The Company’s overall vision is to globally
empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments
for cancer.
In
2013, the United States Food and Drug Administration (“FDA”) issued the determination that RadioGel™ is a device
for human therapy for non-resectable cancers in humans. This should result in a faster path than a drug for final approval.
In
January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGelTM should be classified as
a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company believes
that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas, but
rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals. We expect the
result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet®
for the treatment of solid tumors in animals. The FDA does not have premarket authority over devices with a veterinary classification,
and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance
with all applicable laws and regulations.
Based
on the FDA’s recommendation, RadioGelTM is being marketed as “IsoPet®” for use by veterinarians
to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet®”
name. IsoPet® and RadioGelTM are used synonymously throughout this document. The only distinction between IsoPet®
and RadioGelTM is the FDA’s recommendation that we use “IsoPet®” for veterinarian usage,
and reserve “RadioGelTM” for human therapy. Historically, the Company’s primary focus was on the development
and marketing of Isopet® for animal therapy, through the Company’s IsoPet® Solutions division. Over
the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device
Exemption and to obtain approval for clinical trials in India.
The
Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement of
university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of the technology
in private clinics. In January 2025 the Company restructured and aligned its internal resources and focused effort to align with animal
therapy, human therapy, and recently other applications of its patented technologies.
The
Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet®/RadioGelTM
testing and therapy. Washington State University treated five cats for feline sarcoma and served to develop the procedures which
are incorporated in our label. They concluded that the product was safe and effective in killing cancer cells. Colorado State University
demonstrated the CT and PET-CT imaging of IsoPet®. The University of Missouri conducted an animal study to treat canine
sarcoma. Johns Hopkins University completed a study on VX2 Tumors in Rabbits. Every study confirmed that the Y-90 stayed at the injection
site with insignificant distribution outside that boundary.
Commencing
in July 2019, the Company recognized its first commercial sale of IsoPet®. A veterinarian from Alaska brought his cat with a re-occurrent
spindle cell sarcoma tumor on his face. The cat had previously received external beam therapy, but now the tumor was growing rapidly.
He was given a high dose of 400Gy with heavy therapy at the margins.
The
Company anticipates that any near-term profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet®)
and related services, and from certifying veterinary clinics to administer IsoPet Therapy. Until recently the Company certified clinics
at its own expense, but the demand has increased to the point that starting in 2025 the Company billed its first clinic for the certification
process.
The
plan is to incorporate the data assembled from our work with Isopet® in animal therapy to support the Company’s
efforts in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell RadioGel™
as a Class II medical device. RadioGel™ is an injectable particle-gel for Precision Radionuclide Therapy radiation treatment of
cancerous tumors in people and animals. RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature
and then gels when reaching body temperature after injection into a tumor. In the gel are small, less than two microns, Y-90 phosphate
particles. Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local radiation
dose. The radiation is beta, consisting of high-speed electrons. These electrons only travel a short distance so the device can deliver
high radiation to the tumor with minimal dose to the surrounding tissue. Optimally, patients can go home immediately following treatment
without the risk of radiation exposure to family members. Since Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its
original value after ten days.
In
2021 the Company modified its Indication for Use from skin cancer to cancerous tissue or solid tumors pathologically associated with
locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic
lymph nodes or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require post-surgical
remnant ablation (for example, after prior incomplete radioiodine therapy). Papillary thyroid carcinoma belongs to the general class
of head and neck tumors for which tumors are accessible by intraoperative direct needle injection. The Company’s Medical Advisory
Board felt that demonstrating efficacy in clinical trials with this new indication provided a more efficient pathway to regulatory clearance.
In
December 2023, the Food and Drug Administration granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device
pursuant to the FDA’s Breakthrough Devices Program. This gave the company access to the “sprint” rapid review process
for IDE comments. For the last several months the company has been taking advantage of that program to resoled detailed FDA questions
on a variety of topics.
In
early 2025 the Company began actively pursuing human clinical trials in India. This involved successful step-by-step implementation of
several requirements, including location of a respected lead investigator at a respected hospital; regulatory approvals (securing clearances
from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health
& Family Welfare, and the Company was issued the Clinical Trial Registry-India (CTRI) number required for publishing results); logistical
coordination (acquired liability insurance, expanded the treatment institution’s radioactive material license to include RadioGel®,
and established robust international shipping protocols and an alternate contingency shipping path for the Yttrium-90 (Y-90)-based product);
protocol development (finalized the Clinical Trial Protocol, incorporating Mayo Clinic study designs and feedback from FDA pre-submission
discussions); operational readiness (re-validated RadioGel® manufacturing at IsoTherapeutics to ensure compliance with
Quality Management System standards and FDA sterility and validation recommendations); administrative preparations (signed agreements
with the Ethics Committee and treatment institution while confirming trademark and patent protections in the region); and training and
certification (conducted comprehensive certification training for the treatment team). Failure on any step would have terminated the effort.
In
December 2024 the Company conducted an important offset strategic meeting to ensure that its entire key internal and external team was
alighted to its strategic plans. Attendees included all our current internal team members, our senior health physics volunteer, the members
of the Medical Advisory Board and the Veterinary Medicine Advisory Board, lead Investigator for the proposed Mayo Clinic clinical trial,
lead investigator for the clinical trial in India, and our patent attorney. The primary objective was to re-assess our business direction,
to select the next target series of indications for Use, to ensure that we have developed the optimum precision Radionuclide TherapyTM
approach for each cancer type, including the isotope, the delivery technique, and the dose, and to ensure that our current and
future patents protect these directions. It also discussed the domestic and internation plans.
The
Company decided to explore the viability of harvesting its technology for other business opportunities as a separate “division.”
The Company is working with Akina, on these initiatives. The current efforts are on the Peltier Chiller technology and the hydrogel.
To prevent the Company from being distracted from its primary focus of treating cancer, if viable, Akina would probably also be the principal
distributor. Alternatively, each business sector can be spun off as separate business activities to an interested party.
Controlled
Laboratory Chilling - As Akina explained, it is easy to purchase many laboratory devices to control heating, but there are limited or
no options for controlled cooling, which is a common laboratory requirement usually involving ice baths. The Company is now testing a
prototype universal laboratory cooling device.
Hydrogel
– the Company spent years on refining the development of its hydrogel, in which gelation initiates just above room temperature
and is completed as it warms to body temperature. It is currently investing in quantifying and controlling the hydrogel resorption characteristics.
There has been sufficient spontaneous interest in this component to warrant a serious business case assessment. The Company just trademarked
the name Precision GelTM and, in addition to its current hydrogel patent, has filed a new provisional patent in January 2025
to cover retention, transport, and release of a broad range of agents. These agents include radioactive and non-radioactive materials,
solid particles, including nano-particles, large molecules, small molecules, including liquids, cells, and viruses. A MOU has been drafted
to interface with potential clients including licensing and exclusive material contracting. Initial meetings are scheduled in the first
quarter of 2025 with potential clients to assess the business viability.
Intellectual
Property
Our
original license agreement with Battelle National Laboratory (the “Battelle License”) reached its end of life in 2022.
We have expanded our proprietary knowledge, as well as our trademark and patent protection, in anticipation of the Battelle License reaching
the end of its term during the past several years.
Our
trademark protection, which usually is extended to 17 countries, has been expanding continuously as summarized below:
We
own applications/registrations for the following and should mark as noted below:
| ○ | ISOPET® |
| ○ | RADIOGEL® |
| ○ | ALPHA-GELTM |
| ○ | BETA-GELTM |
| ○ | GAMMA-GELTM |
| ○ | PRECISION
RADIONUCLIDE THERAPYTM |
| ○ | PRECISIONGELTM |
Similarly,
we have systematically filed provisional and utility patents that cover our key components, hydrogel and the yttrium phosphate
particles, and our injection system in the US office and more than ten others covering approximately 63 counties.
In
January 2025 we filed an additional provisional patent on the control, transport, and delivery of PrecisionGel.
Going
Concern
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the normal course of business. As shown in the accompanying financial statements, the Company has suffered recurring
losses and used significant cash in support of its operating activities and the Company’s cash position is not sufficient to support
the Company’s operations. Research and development of the Company’s brachytherapy product line has been funded with proceeds
from the sale of equity and debt securities as well as a series of grants. The Company requires funding of approximately $2.5 million
annually to maintain current operating activities.
Financing
and Strategy
In
November 2019, the SEC qualified the Company’s offering of its Common Stock, under Regulation A of Section 3(6) of the Securities
Act of 1933, as amended (the “Securities Act”) (“Regulation A”), which offering was and amended
from time to time thereafter (the “2019 Regulation A+ Offering”). In September 2021, the SEC qualified the Company’s
offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (together with the 2019 Regulation
A+ Offering, the “Prior Regulation A+ Offerings”). During the year ended December 31, 2023, $1,179,245 was raised
through the sale of 16,132,000 shares of common stock and the private placement of 18,797,000 warrants. During the year ended December
31, 2024, the Company raised $2,266,000 through the issuance of 24,950,000 shares of common stock. The Company’s Prior Regulation
A Offerings undertaken pursuant to Regulation A+ have raised approximately $7,250,000 from the sale of shares of common stock.
On
July 17, 2024, the SEC qualified the Company’s offering under Regulation A to offer up to $60,000,000 shares of its Common Stock
(the “July 2024 Regulation A+ Offering”).
The
Company is using the proceeds generated from the Prior Regulation A+ Offering and the July 2024 Regulation A+ Offering as follows:
Research
and development of the Company’s brachytherapy product line has been funded with proceeds from the sale of equity and debt securities.
The Company may require additional funding of approximately $5
million annually to maintain current operating
activities. Over
the next 12 to 48 months, the Company believes it will cost approximately $9 million to: (1) fund the FDA approval process to conduct
human clinical trials; (2) conduct Phase I, pilot, and clinical trials; (3) activate several regional clinics to administer IsoPet®
across the county; (4) create an independent production center within the current production site to create a template for future
international manufacturing; and (5) initiate regulatory approval processes outside of the United States. The proceeds to be raised from
the Regulation A+ Offerings will be used to continue to fund this development.
The
continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional resources and personnel.
The principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the FDA’s
classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise), and any requirements for
additional studies (which may possibly include clinical studies). Thereafter, the principal variables in the amount of the Company’s
spending and its financing requirements would be: (1) the timing of any approvals; (2) the nature of the Company’s arrangements
with third parties for manufacturing, sales, distribution, and licensing of those products; and (3) the products’ success in the
U.S. and elsewhere. The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements,
as well as proceeds to be raised from the Regulation A+ Offerings.
Following
receipt of required regulatory approvals and necessary financing to fund our working capital requirements, the Company intends to outsource
material aspects of manufacturing, distribution, sales, and marketing for operations within the U.S. Outside of the U.S., the Company
intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.
Long-term,
the Company intends to consider resuming research efforts with respect to other products and technologies intended to help improve the
diagnosis and treatment of cancer and other illnesses. These long-term goals are subject to the Company: (1) receiving adequate funding;
(2) receiving regulatory approval for RadioGel™ and other brachytherapy products; and (3) being able to successfully
commercialize its brachytherapy products.
Based
on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed
substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and
has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to
delay the implementation of its business strategy and may not be able to continue operations.
The
Company’s headquarters are in Northeast Washington, however, our focus on the animal therapy market has been the Northwestern sector
of the U.S. The Company continues its marketing efforts on the animal therapy market and our attempts to increase the exposure to our
product, and generate revenue accordingly.
As
of December 31, 2024, the Company had $2,212,548 cash on hand. There are currently commitments to vendors for products and services purchased.
To continue the development of the Company’s products, the current level of cash will not be enough to cover the fixed and variable
obligations of the Company.
The
Company anticipates using the proceeds from the July 2024 Regulation A+ Offering as follows:
For
the animal therapy market:
|
● |
Expand
communication on our website, the Company’s social media presence, conferences, and journals, each intended to increase the
number of certified clinics for small animal and equine therapy and to increase the number of patients. |
|
● |
Subsidize
some IsoPet® therapies, if necessary, to ensure that all viable candidates are treated; and. |
|
● |
Assist
a new regional clinic with their license and certification training. |
For
the human market:
|
● |
Enhance
the pedigree of the Quality Management System. |
|
● |
Begin
automation of product manufacturing. |
|
● |
Fund
liability insurance for human clinical studies; and. |
|
● |
Fund
human clinical studies in the US. |
Research
and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity
and debt securities, including from the Prior Regulation A+ Offerings. The Company requires additional funding of approximately $2.5
million annually to maintain operating activities.
Over
the next 36 months, the Company believes it will cost approximately $8.0 to $9.0 million to: (1) fund the FDA approval process to conduct
human clinical trials; (2) conduct Phase I, pilot, clinical trials; (3) activate several regional clinics to administer IsoPet®
across the U.S.; (4) create an independent production center within the current production site to create a template for future
international manufacturing; and (5) initiate regulatory approval processes outside of the United States. The
proceeds raised from the Prior Regulation A+ Offerings were used to fund this development and proceeds from the July 2024 Regulation
A+ Offering will be used to continue such development efforts.
The
continued deployment of the precision radionuclide therapy products and a worldwide regulatory approval effort will require additional
resources and personnel. The principal variables in the timing and amount of spending for the precision radionuclide therapy products
in the next 12 to 24 months will be the FDA’s classification of the Company’s precision radionuclide therapy products as
Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies.
Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing
of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing
of those products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic
transactions such as licensing and partnership agreements or from proceeds raised from the Prior Regulation A+ Offering and from the
July 2024 Regulation A+ Offering.
The
Company intends to expand the indications for use in phases: first, for lymph nodes associated with thyroid cancer, secondly, cancerous
lung nodules, and finally, all non-sectable solid tumors. It is anticipated that the medical community may begin to use RadioGel off-label,
we will support but will not encourage that practice.
Following
receipt of required regulatory approvals and financing, in the U.S., the Company intends to outsource material aspects of manufacturing,
distribution, sales and marketing. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate
its global commercialization strategy.
Long-term,
the Company intends to consider resuming research efforts with respect to other products and technologies, such as Gamma Gel and Alpha
Gel intended to help improve the diagnosis and treatment of cancer and other illnesses. These long-term goals are subject to the Company:
(1) receiving adequate funding; (2) receiving regulatory approval for RadioGel™ and other precision radionuclide therapy
products; and (3) being able to successfully commercialize its precision radionuclide therapy products.
Based
on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed
substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and
has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to
delay the implementation of its business strategy and may not be able to continue operations.
The
Company’s headquarters are in the State of Washington., The initial focus of the animal therapy market has been the Northwestern
sector of the United States. The Company has initiated marketing efforts to the animal therapy market in other regions of the United
States, attempting to increase the exposure to our product and increase revenue opportunities.
There
are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products,
the current level of cash will not be enough to cover the fixed and variable obligations of the Company. The Company has focused on operating
on minimum overhead, including using a virtual office for the last several years and retaining experienced industry consultants available
on an as needed basis. This has helped focus the capital received from the Company’s Regulation A+ Offerings on activities that
enhance our objectives.
There
is no guarantee that the Company will be able to raise additional funds or to do so on terms advantageous to the Company’s stockholders.
The
financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary
should the Company be unable to continue as a going concern. The Company’s continuation as a going concern is dependent upon its
ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain profitability. The Company
plans to seek additional funding to maintain its operations through debt and equity financing and to improve operating performance through
a focus on strategic products and increased efficiencies in business processes and improvements to the cost structure. There can be no
assurance that the Company will be successful in its efforts to raise additional working capital or achieve profitable operations. The
financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Use
of Estimates
The
preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at
the date of financial statements and the reported amount of revenue and expense during the reporting period. Estimates the Company considers
include criteria for stock-based compensation expense, and valuation allowances on deferred tax assets. Actual results could differ from
those estimates.
Cash
Equivalents
For
the purposes of the statement of cash flows, the Company considers all highly liquid debt instruments purchased with an original maturity
of three months or less to be cash equivalents.
The
Company occasionally maintains cash balances in excess of the FDIC insured limit. The Company does not consider this risk to be material.
Fair
Value of Financial Instruments
Fair
value of financial instruments requires disclosure of the fair value information, whether or not recognized in the balance sheet, where
it is practicable to estimate that value. As of December 31, 2024 and 2023, the balances reported for cash, prepaid expense,
accounts receivable, accounts payable, and accrued expense, approximate the fair value because of their short maturities.
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. Accounting Standards Codification (“ASC”) Topic 820 established a three-tier
fair value hierarchy which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted
quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs
(level 3 measurements). These tiers include:
Level
1, defined as observable inputs such as quoted prices for identical instruments in active markets;
Level
2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices
for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and
Level
3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions,
such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
The
Company measures certain financial instruments including options and warrants issued during the period at fair value on a recurring basis.
Patents
and Intellectual Property
While
patents are being developed or pending, they are not being amortized. Management has determined that the economic life of the patents
to be ten years and amortization, over such 10-year period and on a straight-line basis will begin once the patents have been issued
and the Company begins utilization of the patents through production and sales, resulting in revenues.
The
Company evaluates the recoverability of intangible assets, including patents and intellectual property on a continual basis. Several
factors are used to evaluate intangibles, including, but not limited to, management’s plans for future operations, recent operating
results and projected and expected undiscounted future cash flows.
There
have been no such capitalized costs in the years ended December 31, 2024 and 2023, respectively. However, a patent was
filed on July 1, 2019 (No. 1811.191) filed by Michael Korenko and David Swanberg and assigned to the Company based on the Company’s
proprietary particle manufacturing process. The timing of this filing was important given the Company’s plans to make IsoPet®
commercially available, which it did on or about July 9, 2019. This additional patent protection will strengthen the Company’s
competitive position. It is the Company’s intention to further extend this patent protection to several key countries within one
year, as permitted under international patent laws and treaties.
Revenue
Recognition
In
May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”)
No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue recognition
to be used across all industries and requires additional disclosures. The guidance introduces a five-step model to achieve its core principal
of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration
to which the entity expects to be entitled in exchange for those goods or services. The Company adopted the updated guidance effective
January 1, 2018 using the full retrospective method.
Under
ASC 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to perform respective
obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for the goods
transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration is probable.
The adoption of ASC 606 did not have an impact on the Company’s operations or cash flows.
The
Company recognized revenue as they (i) identified the contracts with each customer; (ii) identified the performance obligation in each
contract; (iii) determined the transaction price in each contract; (iv) were able to allocate the transaction price to the performance
obligations in the contract; and (v) recognized revenue upon the satisfaction of the performance obligation. Upon the sales of the product
to complete the procedures on the animals, the Company recognized revenue as that was considered the performance obligation.
The
Company in 2024 also implemented a license program for clinics that pay for certification to perform these therapies. These revenues
are recognized upon the certification being completed. During 2024, $4,995 of the revenue relates to this certification.
Loss
Per Share
The
Company accounts for its loss per common share by replacing primary and fully diluted earnings per share with basic and diluted earnings
per share. Basic loss per share is computed by dividing loss available to common stockholders (the numerator) by the weighted-average
number of common shares outstanding (the denominator) for the period, and does not include the impact of any potentially dilutive Common
Stock equivalents since the impact would be anti-dilutive. The computation of diluted earnings per share is similar to basic earnings
per share, except that the denominator is increased to include the number of additional common shares that would have been outstanding
if potentially dilutive common shares had been issued. For the given periods of loss, of the periods ended in the years ended December
31, 2024 and 2023, the basic earnings per share equals the diluted earnings per share.
The
following represent Common Stock equivalents that could be dilutive in the future as December 31, 2024 and 2023, which include the following:
SCHEDULE
OF DILUTIVE EARNINGS PER SHARE
| |
December 31,
2024 | | |
December 31,
2023 | |
Preferred stock | |
| 7,409,570 | | |
| 9,909,570 | |
Restricted stock units | |
| 22,725,000 | | |
| 1,450,000 | |
Common stock options | |
| 2,252,809 | | |
| 2,252,809 | |
Common stock warrants | |
| 11,465,000 | | |
| 26,134,000 | |
Total potential dilutive securities | |
| 43,852,379 | | |
| 39,746,379 | |
Research
and Development Costs
Research
and developments costs, including salaries, research materials, administrative expense and contractor fees, are charged to operations
as incurred. The cost of equipment used in research and development activities which has alternative uses is capitalized as part of fixed
assets and not treated as an expense in the period acquired. Depreciation of capitalized equipment used to perform research and development
is classified as research and development expense in the year computed.
The
Company incurred $324,629 and $732,698 in research and development costs for the years ended December 31, 2024 and 2023, respectively,
all of which were recorded in the Company’s operating expense noted on the statements of operations for the periods then ended.
Advertising
and Marketing Costs
Advertising
and marketing costs are expensed as incurred except for the cost of tradeshows which are deferred until the tradeshow occurs. During
the years ended December 31, 2024 and 2023, the Company incurred nominal advertising and marketing costs.
Contingencies
In
the ordinary course of business, the Company is involved in legal proceedings involving contractual and employment relationships, product
liability claims, patent rights, and a variety of other matters. The Company records contingent liabilities resulting from asserted and
unasserted claims against it, when it is probable that a liability has been incurred and the amount of the loss is reasonably estimable.
The Company discloses contingent liabilities when there is a reasonable possibility that the ultimate loss will exceed the recorded liability.
Estimated probable losses require analysis of multiple factors, in some cases including judgments about the potential actions of third-party
claimants and courts. Therefore, actual losses in any future period are inherently uncertain. The Company has entered into various agreements
that require them to pay certain fees to consultants and/or employees that have been fully accrued for as of December 31, 2024 and 2023.
Income
Taxes
To
address accounting for uncertainty in tax positions, the Company clarifies the accounting for income taxes by prescribing a minimum recognition
threshold that a tax position is required to meet before being recognized in the financial statements. The Company also provides guidance
on de-recognition, measurement, classification, interest, and penalties, accounting in interim periods, disclosure and transition.
The
Company files income tax returns in the U.S. federal jurisdiction. The Company did not have any tax expense for the years ended December
31, 2024 and 2023. The Company did not have any deferred tax liability or asset on its balance sheets as of December 31, 2024 and 2023.
Interest
costs and penalties related to income taxes, if any, will be classified as interest expense and general and administrative costs, respectively,
in the Company’s financial statements. For the years ended December 31, 2024 and 2023, the Company did not recognize any interest
or penalty expense related to income taxes. The Company believes that it is not reasonably possible for the amounts of unrecognized tax
benefits to significantly increase or decrease within the next twelve months.
Stock-Based
Compensation
The
Company recognizes compensation costs under FASB ASC Topic 718, Compensation – Stock Compensation and ASU 2018-07. Companies are
required to measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize
the costs in the financial statements over the period during which employees are required to provide services. Share based compensation
arrangements include stock options, restricted share plans, performance-based awards, share appreciation rights and employee share purchase
plans. As such, compensation cost is measured on the date of grant at their fair value. Such compensation amounts, if any, are amortized
over the respective vesting periods of the option grant.
Recent
Accounting Pronouncements
The
Company does not discuss recent pronouncements that are not anticipated to have an impact on or are unrelated to its financial condition,
results of operations, cash flows or disclosures.
In November 2023, the Financial Accounting Standards Board issued Accounting Standards Update 2023-07 (“ASU
2023-07”). ASU 2023-07 improves segment reporting disclosures for public companies. ASU 2023-07 requires more detailed information
about reportable segments and expenses including the requirement to disclose qualitative information about factors used to identify reportable
segments and quantitative information about profit and loss measures and significant expense categories. ASU 2023-07 was effective for
public companies in fiscal years beginning after December 15, 2023. The Company has not yet begun generating significant revenue from its planned principal operations and operates as
a single reportable segment. The chief operating decision maker is the Company’s chief executive officer who assesses performance
based on total expenses, cash flows, and progress made in the Company’s ongoing development efforts. All of the Company’s
long-lived assets are located in the United States. The Company analyzed ASU 2023-07 and determined that the required
information is presented within the consolidated financial statements and footnote disclosures herein. The Company does not believe that
ASU 2023-07 will have a material impact on the consolidated financial statements.
NOTE
2: RELATED PARTY TRANSACTIONS
In
September 2023, our Chief Executive Officer advanced $10,000 to the Company, which amount was repaid October 4, 2023. In December 2024,
our Chief Executive Officer advanced $40,949 to the Company, which amount was repaid within ten days.
NOTE
3: STOCKHOLDERS’ EQUITY
Common
Stock
The
Company has authorized 950,000,000 shares of Common Stock. As of December 31, 2024 and 2023, there are 440,873,806 and 387,894,033 shares
of Common Stock issued and outstanding, respectively.
Preferred
Stock
The
Company has authorized 20,000,000 shares of Preferred Stock. There are currently three series of Preferred Stock outstanding; Series
A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series C Convertible Preferred Stock. The Company’s Board
of Directors is authorized to provide for the issuance of shares of Preferred Stock in one or more series, fix or alter the designations,
preferences, rights, qualifications, limitations or restrictions of the shares of each series, including the dividend rights, dividend
rates, conversion rights, voting rights, term of redemption including sinking fund provisions, redemption price or prices, liquidation
preferences and the number of shares constituting any series or designations of such series without further vote or action by the shareholders.
The issuance of Preferred Stock may have the effect of delaying, deferring, or preventing a change in control of management without further
action by the shareholders and may adversely affect the voting and other rights of the holders of Common Stock. The issuance of Preferred
Stock with voting and conversion rights may adversely affect the voting power of the holders of Common Stock, including the loss of voting
control to others.
Series
A Convertible Preferred Stock
On
June 30, 2015, a certificate of designations was filed with the Delaware Secretary of State to designate 2,500,000 shares of the Company’s
Preferred Stock as Series A Convertible Preferred Stock, par value $0.001 per share (“Series A Preferred”) (the “Series
A COD”). Effective March 31, 2016, the Company amended the Series A COD, increasing the maximum number of shares of Series
A Preferred from 2,500,000 shares to 5,000,000 shares. As of December 31, 2024 and 2023, there are 2,071,007 shares of Series A Preferred
issued and outstanding, respectively.
The
following summarizes the current rights and preferences of the Series A Preferred:
Liquidation
Preference. The Series A Preferred has a liquidation preference of $5.00 per share.
Dividends.
Shares of Series A Preferred do not have any separate dividend rights.
Conversion.
Subject to certain limitations set forth in the Series A COD, each share of Series A Preferred is convertible, at the option of the holder,
into that number of shares of Common Stock (the “Series A Conversion Shares”) equal to the liquidation preference
thereof, divided by Conversion Price (as such term is defined in the Series A COD), currently $4.00.
In
the event the Company completes an equity or equity-based public offering, registered with the SEC, resulting in gross proceeds to the
Company totaling at least $5.0 million, all issued and outstanding shares of Series A Preferred at that time will automatically convert
into Series A Conversion Shares.
Redemption.
Subject to certain conditions set forth in the Series A COD, in the event of a Change of Control (defined in the Series A COD), or at
such time as a third party not affiliated with the Company or any holders of the Series A Preferred shall have acquired, in one or a
series of related transactions, equity securities of the Company representing more than fifty percent (50%) of the outstanding voting
securities of the Company), the Company, at its option, will have the right to redeem all or a portion of the outstanding Series A Preferred
in cash at a price per share of Series A Preferred equal to 100% of the Liquidation Preference.
Voting
Rights. Holders of Series A Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
equivalent of five votes for every Series A Conversion Share issuable upon conversion of such holder’s outstanding shares of Series
A Preferred. However, the Series A Conversion Shares, when issued, will have all the same voting rights as other issued and outstanding
Common Stock of the Company, and none of the rights of the Series A Preferred.
Liquidation.
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”),
the holders of Series A Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company an amount
equal to the liquidation preference of the Series A Preferred before any distribution or payment shall be made to the holders of any
junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
to the holders of the Series A Preferred shall be ratably distributed among the holders in accordance with the respective amounts that
would be payable on such shares if all amounts payable thereon were paid in full.
Certain
Price and Share Adjustments.
a)
Stock Dividends and Stock Splits. If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions payable
in shares of Common Stock on shares of Common Stock or any other Common Stock equivalents; (ii) subdivides outstanding shares of Common
Stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into
a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock
of the Company, then the conversion price shall be adjusted accordingly.
b)
Merger or Reorganization. If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or merger
in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series A Preferred
shall be convertible into the kind and amount of securities, cash or other property that a holder of the number of shares of Common Stock
issuable upon conversion of one share of Series A Preferred prior to any such merger or reorganization would have been entitled to receive
pursuant to such transaction.
Series
B Convertible Preferred Stock
On
October 10, 2018, a certificate of designation was filed with the Delaware Secretary of State to designate 5,000,000 shares of our Preferred
Stock as Series B Convertible Preferred Stock, par value $0.001 per share (“Series B Preferred”) (the “Series
B COD”). As of December 31, 2024 and 2023, there are 363 and 200,363 shares of Series B Preferred issued and outstanding, respectively.
The
following summarizes the current rights and preferences of the Series B Preferred:
Liquidation
Preference. The Series B Preferred has a liquidation preference of $1.00 per share.
Dividends.
Shares of Series B Preferred do not have any separate dividend rights.
Conversion.
Subject to certain limitations set forth in the Series B COD, each share of Series B Convertible is convertible, at the option of the
holder, into that number of shares of Common Stock (the “Series B Conversion Shares”) equal to the liquidation preference
thereof, divided by the Conversion Price (as such term is defined in the Series B COD), currently $0.08.
Redemption.
Subject to certain conditions set forth in the Series B COD, in the event of a Change of Control (defined in the Series B COD), or at
such as a third party not affiliated with the Company or any holders of the Series B Convertible shall have acquired, in one or a series
of related transactions, equity securities of the Company representing more than fifty percent (50%) of the outstanding voting securities
of the Company), the Company, at its option, will have the right to redeem all or a portion of the outstanding Series B Preferred in
cash at a price per share of Series B Preferred equal to 100% of the Liquidation Preference.
Voting
Rights. Holders of Series B Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
equivalent of two votes for every Series B Conversion Share issuable upon conversion of such holder’s outstanding shares of Series
B Preferred. However, the Series B Conversion Shares, when issued, will have the same voting rights as other issued and outstanding shares
of Common Stock of the Company, and none of the rights of the Series A Preferred.
Liquidation.
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”),
the holders of Series B Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company an amount
equal to the liquidation preference of the Series B Preferred before any distribution or payment shall be made to the holders of any
junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
to the holders of the Series B Preferred shall be ratably distributed among the holders in accordance with the respective amounts that
would be payable on such shares if all amounts payable thereon were paid in full.
Certain
Price and Share Adjustments.
a)
Stock Dividends and Stock Splits. If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions payable
in shares of Common Stock on shares of Common Stock or any other Common Stock equivalents; (ii) subdivides outstanding shares of Common
Stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into
a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock
of the Company, then the conversion price shall be adjusted accordingly.
b)
Merger or Reorganization. If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or merger
in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series B Preferred
shall be convertible into the kind and amount of securities, cash or other property that a holder of the number of shares of Common Stock
issuable upon conversion of one share of Series B Preferred prior to any such merger or reorganization would have been entitled to receive
pursuant to such transaction.
On
December 16, 2024, there was 200,000 Series B Preferred shares converted into 2,500,000 common shares.
Series
C Convertible Preferred Stock
On
March 27, 2019, a certificate of designation was filed with the Delaware Secretary of State to designate 5,000,000 shares of our Preferred
Stock as Series C Convertible Preferred Stock, par value $0.001 per share (“Series C Preferred”) (the “Series
C COD”). As of December 31, 2024 and 2023, there were 385,302 shares of Series C Preferred issued and outstanding, respectively.
The
following summarizes the current rights and preferences of the Series C Preferred:
Liquidation
Preference. The Series C Preferred has a liquidation preference of $1.00 per share.
Dividends.
Shares of Series C Preferred do not have any separate dividend rights.
Conversion.
Subject to certain limitations set forth in the Series C COD, each share of Series C Preferred is convertible, at the option of the holder,
into that number of shares of Common Stock (the “Series C Conversion Shares”) equal to the liquidation preference
thereof, divided by Conversion Price (as such term is defined in the Series C COD), currently $0.08.
The
Series C Preferred will only be convertible at any time after the date that the Company shall have amended its Certificate of Incorporation
to increase the number of shares of Common Stock authorized for issuance thereunder or effect a reverse stock split of the outstanding
shares of Common Stock by a sufficient amount to permit the conversion of all Series C Preferred into shares of Common Stock (“Authorized
Share Approval”) (such date, the “Initial Convertibility Date”), each share of Series C Preferred shall
be convertible into validly issued, fully paid and non-assessable shares of Common Stock on the terms and conditions set forth in the
Series C COD under the definition “Conversion Rights”.
Redemption.
Subject to certain conditions set forth in the Series C COD, in the event of a Change of Control (defined in the Series C COD), or at
such time as a third party not affiliated with the Company or any holders of the Series C Preferred shall have acquired, in one or a
series of related transactions, equity securities of the Company representing more than fifty percent (50%) of the outstanding voting
securities of the Company), the Company, at its option, will have the right to redeem all or a portion of the outstanding Series C Preferred
in cash at a price per share of Series C Preferred equal to 100% of the Liquidation Preference.
Voting
Rights. Holders of Series C Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
equivalent of thirty-two votes for every Series C Conversion Share issuable upon conversion of such holder’s outstanding shares
of Series C Preferred. However, the Series C Conversion Shares, when issued, will have the same voting rights as other issued and outstanding
shares of Common Stock of the Company, and none of the rights of the Series C Preferred.
Liquidation.
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”),
the holders of Series C Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company an amount
equal to the liquidation preference of the Series C Preferred before any distribution or payment shall be made to the holders of any
junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
to the holders of the Series C Preferred shall be ratably distributed among the holders in accordance with the respective amounts that
would be payable on such shares if all amounts payable thereon were paid in full.
Certain
Price and Share Adjustments.
a)
Stock Dividends and Stock Splits. If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions payable
in shares of Common Stock on shares of Common Stock or any other Common Stock equivalents; (ii) subdivides outstanding shares of Common
Stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into
a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock
of the Company, then the conversion price shall be adjusted accordingly.
b)
Merger or Reorganization. If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or merger
in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series C Preferred
shall be convertible into the kind and amount of securities, cash or other property that a holder of the number of shares of Common Stock
issuable upon conversion of one share of Series C Preferred prior to any such merger or reorganization would have been entitled to receive
pursuant to such transaction.
Common
and Preferred Stock Issuances
Common
and Preferred Stock Issuances - 2024
The
Company issued 24,950,000 shares of Common Stock pursuant to the Regulation A+ Offerings for cash proceeds of $2,266,000.
The
Company issued 605,801 shares of Common Stock for services rendered valued at $88,925.
The
Company issued 20,336,472 shares of Common Stock in the cashless exercise of 28,619,000 warrants.
The
Company issued 5,000,000
shares of Common Stock in the exchange of 5,000,000
warrants and recognized a loss on the exchange of $381,000
which is included in the exercise of warrants in the consolidated statement of changes in stockholders’s equity.
There
were 200,000 Series B Preferred shares converted into 2,500,000 common shares.
The
Company settled 750,000 RSUs for Common Stock.
The
Company adjusted their common shares for vested RSUs in prior periods that were cancelled.
Common
and Preferred Stock Issuances – 2023
In
April 2023, the Company issued 8,000,000 shares of Common Stock, 2,665,000 Series A warrants and 8,000,000 Series B warrants in their
Regulation A+ Offerings for $640,000. The Company sold the warrants for $10,665.
In October
2023, the Company issued 2,221,505 shares of common stock in a cashless exercise of warrants to purchase 2,132,000 shares of common stock.
In December
2023, the Company issued: (1) 500,000 shares of common stock in settlement of accounts payable of $28,450; (2) 8,132,000 shares of common
stock and 8,132,000 warrants pursuant to the Offering Statement for the Regulation A+ Offering for an aggregate total of $528,580; (3)
2,499,000 shares of common stock in a cashless exercise of warrants to purchase 4,998,000 shares of common stock and issued new warrants
to purchase 10,002,000 shares of common stock; and (4) issued 4,000,000 shares of common stock for 4,00,000 vested restricted stock units,
for which the Company recognized a loss of $151,184 on this exchange of vested restricted stock units for shares of common stock.
NOTE
4: COMMON STOCK OPTIONS, WARRANTS AND RESTRICTED STOCK UNITS
Common
Stock Options
The
Company recognizes in the financial statements compensation related to all stock-based awards, including stock options and warrants,
based on their estimated grant-date fair value. The Company has estimated expected forfeitures and is recognizing compensation expense
only for those awards expected to vest. All compensation is recognized by the time the award vests.
The
following schedule summarizes the changes in the Company’s stock options:
SCHEDULE
OF CHANGES IN STOCK OPTION
| |
Options
Outstanding | | |
Weighted
Average Remaining | | |
| | |
Weighted
Average | |
| |
Number
Of Shares | | |
Exercise
Price Per Share | | |
Contractual
Life | | |
Aggregate
Intrinsic Value | | |
Exercise
Price Per Share | |
Year Ended December
31, 2024 | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Outstanding at January 1, 2024 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 5.70
years | | |
$ | 78,886 | | |
$ | 0.04 | |
Granted | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Exercised | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Expired/cancelled | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Outstanding at December
31, 2024 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 4.70
years | | |
$ | 174,855 | | |
$ | 0.04 | |
Exercisable at December
31, 2024 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 4.70
years | | |
$ | 174,855 | | |
$ | 0.04 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Year Ended December
31, 2023 | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Outstanding at January 1, 2023 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 6.70
years | | |
$ | 16,032 | | |
$ | 0.04 | |
Granted | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Exercised | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Expired/cancelled | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Outstanding at December
31, 2023 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 5.70
years | | |
$ | 78,886 | | |
$ | 0.04 | |
Exercisable at December
31, 2023 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 5.70
years | | |
$ | 78,886 | | |
$ | 0.04 | |
During
the years ended December 31, 2024 and 2023, the Company recognized $0 of stock-based compensation expense related to the vesting of stock
options.
Common
Stock Warrants
The
following schedule summarizes the changes in the Company’s stock warrants:
SCHEDULE
OF CHANGES IN STOCK WARRANTS
| |
Warrants
Outstanding | | |
Weighted
Average Remaining | | |
| | |
Weighted
Average | |
| |
Number
Of Shares | | |
Exercise
Price Per Share | | |
Contractual
Life | | |
Aggregate
Intrinsic Value | | |
Exercise
Price Per Share | |
Years Ended
December 31, 2024 | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Outstanding at January 1, 2024 | |
| 26,134,000 | | |
$ | 0.06-0.10 | | |
| 3.54
years | | |
$ | - | | |
$ | 0.0827 | |
Granted | |
| 18,950,000 | | |
$ | 0.075 | | |
| - | | |
$ | - | | |
$ | - | |
Redeemed | |
| (500,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Exercised | |
| (28,619,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Exchanged | |
| (5,000,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Outstanding at December 31, 2024 | |
| 11,465,000 | | |
$ | 0.13 | | |
| 3
years | | |
$ | 123,690 | | |
$ | 0.13 | |
Exercisable at December 31, 2024 | |
| 11,465,000 | | |
$ | 0.13 | | |
| 3
years | | |
$ | 123,690 | | |
$ | 0.13 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Years Ended
December 31, 2023 | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Outstanding at January 1, 2023 | |
| 26,737,500 | | |
$ | 0.06-0.10 | | |
| 1.52
years | | |
$ | - | | |
$ | 0.09 | |
Granted | |
| 28,799,000 | | |
$ | 0.0827 | | |
| - | | |
$ | - | | |
$ | - | |
Redeemed | |
| (500,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Exercised | |
| (7,663,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Exchanged | |
| (10,002,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Expired/cancelled | |
| (11,237,500 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Outstanding at December 31, 2023 | |
| 26,134,000 | | |
$ | 0.06-0.10 | | |
| 3.54
years | | |
$ | - | | |
$ | 0.0827 | |
Exercisable at December 31, 2023 | |
| 26,134,000 | | |
$ | 0.06-0.10 | | |
| 3.54
years | | |
$ | - | | |
$ | 0.0827 | |
Changes
to these inputs could produce a significantly higher or lower fair value measurement. The fair value of each option/warrant is estimated
using the Black-Scholes valuation model. The following assumptions were used for the periods as follows:
SCHEDULE
OF ASSUMPTIONS USED IN FAIR VALUE MEASUREMENT
|
|
|
Year
Ended |
|
|
|
Years
Ended |
|
|
|
|
December
31, 2024 |
|
|
|
December
31, 2023 |
|
Expected
term |
|
|
- |
|
|
|
- |
|
Expected
volatility |
|
|
- |
% |
|
|
- |
% |
Expected
dividend yield |
|
|
- |
|
|
|
- |
|
Risk-free
interest rate |
|
|
- |
% |
|
|
- |
% |
The
Company granted 10,665,000 warrants in their Reg A+ funding in April 2023, with an exercise price of $0.0775 and a three-year term.
The
Company granted 2,000,000 warrants in their Regulation A+ Offering in January 2024, with an exercise price of $0.075 and a three-year
term and 5,000,000 warrants with the same terms on April 1, 2024.
In
November 2024, the Company sold 11,950,000 warrants, 30% of which expire December 31, 2024 at an exercise price of $0.01 and 70% of which
expire December 31, 2027 at an exercise price of $0.15 for $11,950 under Regulation D.
In
2024, the Company issued 25,336,468 shares of Common Stock in the exercise of 33,619,000 warrants and received $19,350.
Restricted
Stock Units
The
following schedule summarizes the changes in the Company’s restricted stock units:
SCHEDULE
OF CHANGES IN RESTRICTED STOCK UNITS
| |
Number
Of Shares | | |
Weighted
Average Grant Date Fair Value | |
Year Ended December
31, 2024 | |
| | | |
| | |
| |
| | | |
| | |
Outstanding at January 1, 2024 | |
| 1,450,000 | | |
$ | 0.09 | |
Granted | |
| 21,850,000 | | |
$ | 0.08 | |
Vested | |
| (11,475,000 | ) | |
$ | - | |
Forfeited | |
| - | | |
$ | - | |
Outstanding at December 31, 2024 | |
| 11,825,000 | | |
$ | 0.08 | |
| |
| | | |
| | |
Year Ended December
31, 2023 | |
| | | |
| | |
| |
| | | |
| | |
Outstanding at January 1, 2023 | |
| 10,262,500 | | |
$ | 0.08 | |
Granted | |
| 6,900,000 | | |
$ | 0.068 | |
Vested | |
| (15,450,000 | ) | |
$ | - | |
Forfeited | |
| (262,500 | ) | |
$ | - | |
Outstanding at December
31, 2023 | |
| 1,450,000 | | |
$ | 0.09 | |
During
the years ended December 31, 2024 and 2023, the Company recognized $918,350 and $1,239,950 in expense related to the vesting of its restricted
stock units. As of December 31, 2024, the Company had $923,855 worth of expense yet to be recognized for restricted stock units not yet
vested.
On
January 1, 2024, the Company granted 20,000,000
restricted stock units to its Chief Executive Officer as part of his new employment agreement that vest in four equal installments
over a two-year
period beginning February 1, 2024. In May 2024, the Company granted 1,050,000
restricted stock units to consultants that vest through December 31, 2025. In November 2024, the Company granted 800,000 restricted
stock units that vest in May 2025. During the year ended December 31, 2024, 11,475,000
of these restricted stock units vested.
On May 1,
2023, the Company granted 2,900,000 RSUs to consultants, with 25% of such RSUs vesting immediately, 25% vest on December 31, 2023, 25%
vest on December 31, 2024 and the remaining 25% vest on December 31, 2025. These RSUs are valued at $263,900.
On August
4, 2023, the Chief Executive Officer rescinded 1,012,500 of which 750,000 had vested in prior years, of his fully vested RSUs.
In December
2023, the Company granted 4,000,000 immediately vested RSUs to a consultant, for which the RSUs are valued at $208,000.
NOTE
5: COMMITMENT
On
June 4, 2019, the Company entered into an Executive Employment Agreement (“Employment Agreement”) with Dr. Michael
K. Korenko, the Company’s Chief Executive Officer. The employment term under the Employment Agreement commenced with an effective
date of June 11, 2019 and expires on December 31, 2020, and December 31 of each successive year if the Employment Agreement is extended,
unless terminated earlier as set forth in the Employment Agreement. On December 31, 2020, the Company extended the Employment Agreement
through December 31, 2021 while renegotiating terms of a new Employment Agreement. On May 3, 2021, the Company and the Chief Executive
Officer agreed the terms of a new Employment Agreement with an effective date of January 1, 2021 that has a term of three years and expired
December 31, 2023. The Company renewed the Employment Agreement for a term of two years expiring December 31, 2025.
Under
the terms of the Employment Agreement effective January 1, 2024, the Company shall pay to Dr. Korenko a base compensation of $295,500.
In addition, there is a discretionary bonus to be earned in the amount of $10,000 per quarter upon the satisfaction of conditions to
be determined by the Board of Directors of the Company. In addition, the Company granted Dr. Korenko 20,000,000 restricted stock units
on January 1, 2024 that vest over the two year period.
NOTE
6: INCOME TAXES
Deferred
taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences and operating
loss and tax credit carry-forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences
are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a
valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets
will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of
enactment.
Net
deferred tax assets consist of the following components as of December 31, 2024 and 2023:
SCHEDULE
OF NET DEFERRED TAX ASSETS
| |
December
31,
2024 | | |
December
31,
2023 | |
Deferred tax assets: | |
| | | |
| | |
Net operating loss carryover | |
$ | 7,260,000 | | |
$ | 6,840,000 | |
Capital Loss Carryover | |
| 3,400 | | |
| 3,400 | |
Valuation allowance | |
| (7,263,400 | ) | |
| (6,843,400 | ) |
Net deferred tax asset | |
$ | - | | |
$ | - | |
The
income tax provision differs from the amount of income tax determined by applying the U.S. Federal income tax rate to pretax income from
continuing operations for the years ended December 31, 2024 and 2023 due to the following:
SCHEDULE
OF FEDERAL INCOME TAX RATE
| |
December
31,
2024 | | |
December
31,
2023 | |
Book income (loss) | |
$ | (611,200 | ) | |
$ | (607,900 | ) |
Depreciation | |
| (1,100 | ) | |
| (1,100 | ) |
Stock for services | |
| 192,900 | | |
| 260,400 | |
Other non-deductible expense | |
| - | | |
| 6,300 | |
Valuation allowance | |
| 419,400 | | |
| 342,300 | |
Income tax expense | |
$ | - | | |
$ | - | |
At
December 31, 2024, the Company had net operating loss carryforwards of approximately $34,581,700.
ASC
Topic 740 – Income Taxes (“ASC 740”) provides guidance on the accounting for uncertainty in income taxes recognized
in a company’s financial statements. ASC 740 requires a company to determine whether it is more likely than not that a tax position
will be sustained upon examination based upon the technical merits of the position. If the more-likely-than-not threshold is met, a company
must measure the tax position to determine the amount to recognize in the financial statements. At the adoption date of January 1, 2007,
the Company had no unrecognized tax benefit, which would affect the effective tax rate if recognized.
The
Company includes interest and penalties arising from the underpayment of income taxes in the statements of operations in the provision
for income taxes. As of December 31, 2024, the Company had no accrued interest or penalties related to uncertain tax positions.
The
Company files income tax returns in the U.S. federal jurisdiction. The Company is located in the state of Washington and Washington state
does not require the filing of income taxes. With few exceptions, the Company is no longer subject to U.S. federal, state and local,
or non-U.S. income tax examinations by tax authorities for years before 2017.
NOTE
7: SUBSEQUENT EVENTS
The Company has evaluated subsequent events through the date of this report and noted the following:
On
February 6, 2025, there has been 12,500,000 shares of common stock issued under the Regulation A+.
Exhibit
23

CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We
consent to the incorporation by reference in the Post-Qualification Amendment #2 to the Offering Statement on Form 1-A (File No. 024-11627)
of our audit report dated March 24, 2025, with respect to the balance sheets of Vivos, Inc. as of December 31, 2024 and 2023, and the
related statements of operations, changes in stockholders’ equity, and cash flows for each of the years in the two-year period
ended December 31, 2024. Our report relating to those financial statements includes an emphasis of matter paragraph regarding substantial
doubt as to the Company’s ability to continue as a going concern.
We
also consent to the reference to us under the heading “Experts” in such Amendment #2 to the Offering Statement.
 |
|
Fruci
& Associates II, PLLC – PCAOB ID #05525 |
|
Spokane,
Washington |
|
March 24, 2025 |
|
EXHIBIT
31.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER
PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Michael K. Korenko, certify that:
1.
I have reviewed this annual report on Form 10-K of VIVOS INC;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
March 24, 2025
/s/
Michael K. Korenko |
|
Michael
K. Korenko |
|
Chief
Executive Officer |
|
(Principal
Executive Officer) |
|
EXHIBIT
31.2
CERTIFICATION
OF INTERIM CHIEF FINANCIAL OFFICER
PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Michael Pollack, certify that:
1.
I have reviewed this annual report on Form 10-K of VIVOS INC;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
March 24, 2025
/s/
Michael Pollack |
|
Michael
Pollack |
|
Interim
Chief Financial Officer |
|
(Interim
Principal Financial Officer) |
|
EXHIBIT
32.1
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the accompanying annual report of VIVOS INC (the “Company”) on Form 10-K for the year ended December
31, 2024 (the “Report”), the undersigned, Michael K. Korenko, Chief Executive Officer of the Company, and Michael
Pollack, Interim Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, that:
(1)
The Report fully complies with the requirements of section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as
amended; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
Date:
March 24, 2025
/s/
Michael K. Korenko |
|
Name:
Michael K. Korenko |
|
Title:
Chief Executive Officer |
|
|
|
/s/
Michael Pollack |
|
Name:
Michael Pollack |
|
Title:
Interim Chief Financial Officer |
|
v3.25.1
Cover - USD ($)
|
12 Months Ended |
|
|
Dec. 31, 2024 |
Mar. 07, 2025 |
Jun. 30, 2024 |
Cover [Abstract] |
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Document Fiscal Year Focus |
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|
|
|
Current Fiscal Year End Date |
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|
|
|
Entity File Number |
0-53497
|
|
|
Entity Registrant Name |
VIVOS
INC
|
|
|
Entity Central Index Key |
0001449349
|
|
|
Entity Tax Identification Number |
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DE
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1030
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Kennewick
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WA
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99352
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222-2222
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v3.25.1
Balance Sheets - USD ($)
|
Dec. 31, 2024 |
Dec. 31, 2023 |
Current Assets: |
|
|
Cash |
$ 2,212,548
|
$ 1,592,287
|
Accounts receivable |
10,326
|
7,000
|
Prepaid expenses |
10,582
|
10,837
|
Total Current Assets |
2,233,456
|
1,610,124
|
TOTAL ASSETS |
2,233,456
|
1,610,124
|
Current Liabilities: |
|
|
Accounts payable and accrued expenses |
86,209
|
245,004
|
Total Current Liabilities |
86,209
|
245,004
|
Total Liabilities |
86,209
|
245,004
|
Commitments and contingencies |
|
|
STOCKHOLDERS’ EQUITY |
|
|
Common stock, par value, $0.001, 950,000,000 shares authorized, 440,873,806 and 387,894,033 issued and outstanding, respectively |
440,874
|
387,894
|
Additional paid in capital - common stock |
77,719,143
|
73,791,430
|
Subscriptions receivable |
(1,500)
|
|
Accumulated deficit |
(85,361,229)
|
(82,450,781)
|
Total Stockholders’ Equity |
2,147,247
|
1,365,120
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
2,233,456
|
1,610,124
|
Series A Convertible Preferred Stock [Member] |
|
|
STOCKHOLDERS’ EQUITY |
|
|
Preferred stock, value |
2,071
|
2,071
|
Additional paid in capital |
8,842,458
|
8,842,458
|
Series B Convertible Preferred Stock [Member] |
|
|
STOCKHOLDERS’ EQUITY |
|
|
Preferred stock, value |
|
200
|
Additional paid in capital |
4,538
|
290,956
|
Series C Convertible Preferred Stock [Member] |
|
|
STOCKHOLDERS’ EQUITY |
|
|
Preferred stock, value |
385
|
385
|
Additional paid in capital |
$ 500,507
|
$ 500,507
|
X |
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v3.25.1
Balance Sheets (Parenthetical) - $ / shares
|
Dec. 31, 2024 |
Dec. 31, 2023 |
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
20,000,000
|
20,000,000
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
950,000,000
|
950,000,000
|
Common stock, shares issued |
440,873,806
|
387,894,033
|
Common stock, shares outstanding |
440,873,806
|
387,894,033
|
Series A Convertible Preferred Stock [Member] |
|
|
Preferred stock, shares authorized |
5,000,000
|
5,000,000
|
Preferred stock, shares issued |
2,071,007
|
2,071,007
|
Preferred stock, shares outstanding |
2,071,007
|
2,071,007
|
Series B Convertible Preferred Stock [Member] |
|
|
Preferred stock, shares authorized |
5,000,000
|
5,000,000
|
Preferred stock, shares issued |
363
|
200,363
|
Preferred stock, shares outstanding |
363
|
200,363
|
Series C Convertible Preferred Stock [Member] |
|
|
Preferred stock, shares authorized |
5,000,000
|
5,000,000
|
Preferred stock, shares issued |
385,302
|
385,302
|
Preferred stock, shares outstanding |
385,302
|
385,302
|
X |
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v3.25.1
Statements of Operations - USD ($)
|
12 Months Ended |
Dec. 31, 2024 |
Dec. 31, 2023 |
Income Statement [Abstract] |
|
|
Revenues, net |
$ 27,995
|
$ 19,500
|
Cost of Goods Sold |
(30,979)
|
(25,536)
|
Gross loss |
(2,984)
|
(6,036)
|
OPERATING EXPENSES |
|
|
Professional fees, including stock-based compensation |
1,682,350
|
1,606,923
|
Payroll expenses |
352,597
|
281,716
|
Research and development |
324,629
|
732,698
|
General and administrative expenses |
241,824
|
165,773
|
Total Operating Expenses |
2,601,400
|
2,787,110
|
OPERATING LOSS |
(2,604,384)
|
(2,793,146)
|
NON-OPERATING INCOME (EXPENSE) |
|
|
Interest income |
74,936
|
49,577
|
Loss on issuance of shares and exchange of warrants |
(381,000)
|
(151,184)
|
Total Non-Operating Expenses |
(306,064)
|
(101,607)
|
NET LOSS BEFORE PROVISION FOR INCOME TAXES |
(2,910,448)
|
(2,894,753)
|
Provision for income taxes |
|
|
NET LOSS |
$ (2,910,448)
|
$ (2,894,753)
|
Net loss per share - basic |
$ (0.01)
|
$ (0.01)
|
Net loss per share - diluted |
$ (0.01)
|
$ (0.01)
|
Weighted average common shares outstanding - basic |
409,673,533
|
368,805,214
|
Weighted average common shares outstanding - diluted |
409,673,533
|
368,805,214
|
X |
- DefinitionThe aggregate costs related to goods produced and sold and services rendered by an entity during the reporting period. This excludes costs incurred during the reporting period related to financial services rendered and other revenue generating activities.
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v3.25.1
Statement of Changes in Stockholders' Equity - USD ($)
|
Preferred Stock [Member]
Series A Preferred Stock [Member]
|
Preferred Stock [Member]
Additional Paid-In Capital - Series A Preferred [Member]
|
Preferred Stock [Member]
Series B Preferred Stock [Member]
|
Preferred Stock [Member]
Additional Paid-In Capital - Series B Preferred [Member]
|
Preferred Stock [Member]
Series C Preferred Stock [Member]
|
Preferred Stock [Member]
Additional Paid-In Capital - Series C Preferred [Member]
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Subscription Receivable [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 2,071
|
$ 8,842,458
|
$ 200
|
$ 290,956
|
$ 385
|
$ 500,507
|
$ 362,541
|
$ 71,217,954
|
|
$ (79,556,028)
|
$ 1,661,044
|
Balance, shares at Dec. 31, 2022 |
2,071,007
|
|
200,363
|
|
385,302
|
|
362,541,528
|
|
|
|
|
Cash |
|
|
|
|
|
|
$ 16,132
|
1,144,316
|
|
|
1,160,448
|
Cash, shares |
|
|
|
|
|
|
16,132,000
|
|
|
|
|
Accounts payable |
|
|
|
|
|
|
$ 500
|
27,950
|
|
|
28,450
|
Accounts payable, shares |
|
|
|
|
|
|
500,000
|
|
|
|
|
Vested RSUs |
|
|
|
|
|
|
$ 4,000
|
(4,000)
|
|
|
|
Vested RSUs, shares |
|
|
|
|
|
|
4,000,000
|
|
|
|
|
Warrant exercises and exchanges |
|
|
|
|
|
|
$ 4,721
|
146,463
|
|
|
151,184
|
Warrant exercises and exchanges, shares |
|
|
|
|
|
|
4,720,505
|
|
|
|
|
Warrants purchased for cash |
|
|
|
|
|
|
|
18,797
|
|
|
18,797
|
RSUs granted to consultants that have vested |
|
|
|
|
|
|
|
1,239,950
|
|
|
1,239,950
|
Net loss for the year |
|
|
|
|
|
|
|
|
|
(2,894,753)
|
(2,894,753)
|
Balance at Dec. 31, 2023 |
$ 2,071
|
8,842,458
|
$ 200
|
290,956
|
$ 385
|
500,507
|
$ 387,894
|
73,791,430
|
|
(82,450,781)
|
1,365,120
|
Balance, shares at Dec. 31, 2023 |
2,071,007
|
|
200,363
|
|
385,302
|
|
387,894,033
|
|
|
|
|
Cash |
|
|
|
|
|
|
$ 24,950
|
2,241,050
|
|
|
$ 2,266,000
|
Cash, shares |
|
|
|
|
|
|
24,950,000
|
|
|
|
24,950,000
|
Vested RSUs |
|
|
|
|
|
|
$ 750
|
(750)
|
|
|
|
Vested RSUs, shares |
|
|
|
|
|
|
750,000
|
|
|
|
|
Warrants purchased for cash |
|
|
|
|
|
|
|
18,950
|
|
|
18,950
|
RSUs granted to consultants that have vested |
|
|
|
|
|
|
|
918,350
|
|
|
918,350
|
Net loss for the year |
|
|
|
|
|
|
|
|
|
(2,910,448)
|
(2,910,448)
|
Services |
|
|
|
|
|
|
$ 606
|
88,319
|
|
|
$ 88,925
|
Services, shares |
|
|
|
|
|
|
605,801
|
|
|
|
605,801
|
Exercise of warrants (cash and cashless) |
|
|
|
|
|
|
$ 25,336
|
376,514
|
(1,500)
|
|
$ 400,350
|
Exercise of warrants (cash and cashless), shares |
|
|
|
|
|
|
25,336,472
|
|
|
|
|
Conversion of preferred stock to common stock |
|
|
$ (200)
|
(286,418)
|
|
|
$ 2,500
|
284,118
|
|
|
|
Conversion of preferred stock to common stock, shares |
|
|
(200,000)
|
|
|
|
2,500,000
|
|
|
|
|
Adjustment for vested RSUs |
|
|
|
|
|
|
$ (1,162)
|
1,162
|
|
|
|
Adjustment for vested RSUs, shares |
|
|
|
|
|
|
(1,162,500)
|
|
|
|
|
Balance at Dec. 31, 2024 |
$ 2,071
|
$ 8,842,458
|
|
$ 4,538
|
$ 385
|
$ 500,507
|
$ 440,874
|
$ 77,719,143
|
$ (1,500)
|
$ (85,361,229)
|
$ 2,147,247
|
Balance, shares at Dec. 31, 2024 |
2,071,007
|
|
363
|
|
385,302
|
|
440,873,806
|
|
|
|
|
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v3.25.1
Statements of Cash Flows - USD ($)
|
12 Months Ended |
Dec. 31, 2024 |
Dec. 31, 2023 |
CASH FLOW FROM OPERTING ACTIVIITES |
|
|
Net loss |
$ (2,910,448)
|
$ (2,894,753)
|
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
Common stock, stock options and warrants for services |
88,925
|
|
RSUs issued for services |
918,350
|
1,239,950
|
Loss on issuance of shares and warrants |
381,000
|
151,184
|
Changes in assets and liabilities |
|
|
Accounts receivable |
(3,326)
|
4,000
|
Prepaid expenses and other assets |
255
|
14,834
|
Accounts payable and accrued expenses |
(158,795)
|
191,762
|
Total adjustments |
1,226,409
|
1,601,730
|
Net cash used in operating activities |
(1,684,039)
|
(1,293,023)
|
CASH FLOWS FROM FINANCING ACTIVITES |
|
|
Proceeds from short-term advances from related party |
40,949
|
|
Payments of related party notes |
(40,949)
|
|
Exercise of warrants |
19,350
|
|
Proceeds from common stock and warrants |
2,284,950
|
1,179,245
|
Net cash provided by financing activities |
2,304,300
|
1,179,245
|
NET INCREASE (DECREASE) IN CASH |
620,261
|
(113,778)
|
CASH- BEGINNING OF YEAR |
1,592,287
|
1,706,065
|
CASH - END OF YEAR |
2,212,548
|
1,592,287
|
CASH PAID DURING THE YEAR FOR: |
|
|
Interest expense |
|
|
Income taxes |
|
|
SUPPLEMENTAL INFORMATION - NON-CASH INVESTING AND FINANCING ACTIVITIES: |
|
|
Common stock issued in cashless exercise of warrants |
23,251
|
4,721
|
RSUs vested into common stock |
750
|
4,000
|
Accounts payable converted into shares of common stock |
|
$ 28,450
|
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v3.25.1
Cybersecurity Risk Management and Strategy Disclosure
|
12 Months Ended |
Dec. 31, 2024 |
Cybersecurity Risk Management, Strategy, and Governance [Abstract] |
|
Cybersecurity Risk Management Processes for Assessing, Identifying, and Managing Threats [Text Block] |
Our
cybersecurity policies, standards, processes, and practices are based on applicable laws and regulations and informed by industry standards
and industry-recognized practices. Our strategy to assess, identify, and manage material cybersecurity risks is through a comprehensive,
cross-functional approach that is focused on preserving the confidentiality, security, and availability of our information systems and
data. We implement security measures and processes to identify, prevent, and mitigate cybersecurity threats and to effectively respond
to cybersecurity incidents when they occur. Our cyber risk management includes: (1) enterprise risk management to identify top cybersecurity
risks; (2) vulnerability management to identify software vulnerabilities and risks related to compute infrastructure; (3) vendor risk
management to identify risks related to third parties and business partners, which includes pre-engagement review, use of contractual
security provisions, and continued monitoring, as applicable; (4) privacy risk management to identify privacy risks in our product and
platforms and ensure regulatory compliance; (5) security monitoring to analyze and assess threat activity in real time; and (6) security
incident response to investigate, respond to, and mitigate cyber threats. We regularly engage third parties to identify risks in our
underlying software and infrastructure, to provide threat intelligence, and to assist in triaging, identifying, and responding to cyber
threats.
In
2024, we were part of an elaborate phishing scam that resulted in a loss and as a result we enabled additional cybersecurity
procedures to ensure this does not occur again, and established new checking accounts to mitigate any further losses. Other than
this one incident, we
did not identify any cybersecurity threats that have materially affected or are reasonably likely to materially affect our business
strategy, results of operations, or financial condition. However, despite our efforts, we cannot eliminate all risks from
cybersecurity threats, or provide assurances that we have not experienced undetected cybersecurity
incidents.
|
Cybersecurity Risk Management Processes Integrated [Flag] |
true
|
Cybersecurity Risk Management Third Party Engaged [Flag] |
true
|
Cybersecurity Risk Materially Affected or Reasonably Likely to Materially Affect Registrant [Flag] |
false
|
Cybersecurity Risk Role of Management [Text Block] |
Our
Board of Directors maintains oversight of risks from cybersecurity threats by meeting with and receiving periodic updates from our Chief
Executive Officer, who is assigned oversight of cybersecurity risks. Our Chief Executive Officer is responsible for ensuring that management
has processes in place designed to identify and evaluate cybersecurity risks to which the Company is exposed and to implement processes
and programs to manage cybersecurity risks and mitigate cybersecurity incidents.
|
Cybersecurity Risk Management Positions or Committees Responsible [Flag] |
true
|
Cybersecurity Risk Process for Informing Management or Committees Responsible [Text Block] |
Our Chief Executive Officer is responsible for ensuring that management
has processes in place designed to identify and evaluate cybersecurity risks to which the Company is exposed and to implement processes
and programs to manage cybersecurity risks and mitigate cybersecurity incidents
|
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v3.25.1
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
|
12 Months Ended |
Dec. 31, 2024 |
Accounting Policies [Abstract] |
|
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES |
NOTE
1: BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
Business
Overview
Vivos
Inc. (the “Company,” “we,” “us,” “our”) is a radiation oncology
medical device company engaged in the development of its yttrium-90 (“Y-90”) based precision radionuclide therapy
device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide TherapyTM.
A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories,
universities, and private corporations, lead the Company’s development efforts. The Company’s overall vision is to globally
empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments
for cancer.
In
2013, the United States Food and Drug Administration (“FDA”) issued the determination that RadioGel™ is a device
for human therapy for non-resectable cancers in humans. This should result in a faster path than a drug for final approval.
In
January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGelTM should be classified as
a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company believes
that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas, but
rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals. We expect the
result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet®
for the treatment of solid tumors in animals. The FDA does not have premarket authority over devices with a veterinary classification,
and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance
with all applicable laws and regulations.
Based
on the FDA’s recommendation, RadioGelTM is being marketed as “IsoPet®” for use by veterinarians
to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet®”
name. IsoPet® and RadioGelTM are used synonymously throughout this document. The only distinction between IsoPet®
and RadioGelTM is the FDA’s recommendation that we use “IsoPet®” for veterinarian usage,
and reserve “RadioGelTM” for human therapy. Historically, the Company’s primary focus was on the development
and marketing of Isopet® for animal therapy, through the Company’s IsoPet® Solutions division. Over
the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device
Exemption and to obtain approval for clinical trials in India.
The
Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement of
university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of the technology
in private clinics. In January 2025 the Company restructured and aligned its internal resources and focused effort to align with animal
therapy, human therapy, and recently other applications of its patented technologies.
The
Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet®/RadioGelTM
testing and therapy. Washington State University treated five cats for feline sarcoma and served to develop the procedures which
are incorporated in our label. They concluded that the product was safe and effective in killing cancer cells. Colorado State University
demonstrated the CT and PET-CT imaging of IsoPet®. The University of Missouri conducted an animal study to treat canine
sarcoma. Johns Hopkins University completed a study on VX2 Tumors in Rabbits. Every study confirmed that the Y-90 stayed at the injection
site with insignificant distribution outside that boundary.
Commencing
in July 2019, the Company recognized its first commercial sale of IsoPet®. A veterinarian from Alaska brought his cat with a re-occurrent
spindle cell sarcoma tumor on his face. The cat had previously received external beam therapy, but now the tumor was growing rapidly.
He was given a high dose of 400Gy with heavy therapy at the margins.
The
Company anticipates that any near-term profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet®)
and related services, and from certifying veterinary clinics to administer IsoPet Therapy. Until recently the Company certified clinics
at its own expense, but the demand has increased to the point that starting in 2025 the Company billed its first clinic for the certification
process.
The
plan is to incorporate the data assembled from our work with Isopet® in animal therapy to support the Company’s
efforts in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell RadioGel™
as a Class II medical device. RadioGel™ is an injectable particle-gel for Precision Radionuclide Therapy radiation treatment of
cancerous tumors in people and animals. RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature
and then gels when reaching body temperature after injection into a tumor. In the gel are small, less than two microns, Y-90 phosphate
particles. Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local radiation
dose. The radiation is beta, consisting of high-speed electrons. These electrons only travel a short distance so the device can deliver
high radiation to the tumor with minimal dose to the surrounding tissue. Optimally, patients can go home immediately following treatment
without the risk of radiation exposure to family members. Since Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its
original value after ten days.
In
2021 the Company modified its Indication for Use from skin cancer to cancerous tissue or solid tumors pathologically associated with
locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic
lymph nodes or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require post-surgical
remnant ablation (for example, after prior incomplete radioiodine therapy). Papillary thyroid carcinoma belongs to the general class
of head and neck tumors for which tumors are accessible by intraoperative direct needle injection. The Company’s Medical Advisory
Board felt that demonstrating efficacy in clinical trials with this new indication provided a more efficient pathway to regulatory clearance.
In
December 2023, the Food and Drug Administration granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device
pursuant to the FDA’s Breakthrough Devices Program. This gave the company access to the “sprint” rapid review process
for IDE comments. For the last several months the company has been taking advantage of that program to resoled detailed FDA questions
on a variety of topics.
In
early 2025 the Company began actively pursuing human clinical trials in India. This involved successful step-by-step implementation of
several requirements, including location of a respected lead investigator at a respected hospital; regulatory approvals (securing clearances
from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health
& Family Welfare, and the Company was issued the Clinical Trial Registry-India (CTRI) number required for publishing results); logistical
coordination (acquired liability insurance, expanded the treatment institution’s radioactive material license to include RadioGel®,
and established robust international shipping protocols and an alternate contingency shipping path for the Yttrium-90 (Y-90)-based product);
protocol development (finalized the Clinical Trial Protocol, incorporating Mayo Clinic study designs and feedback from FDA pre-submission
discussions); operational readiness (re-validated RadioGel® manufacturing at IsoTherapeutics to ensure compliance with
Quality Management System standards and FDA sterility and validation recommendations); administrative preparations (signed agreements
with the Ethics Committee and treatment institution while confirming trademark and patent protections in the region); and training and
certification (conducted comprehensive certification training for the treatment team). Failure on any step would have terminated the effort.
In
December 2024 the Company conducted an important offset strategic meeting to ensure that its entire key internal and external team was
alighted to its strategic plans. Attendees included all our current internal team members, our senior health physics volunteer, the members
of the Medical Advisory Board and the Veterinary Medicine Advisory Board, lead Investigator for the proposed Mayo Clinic clinical trial,
lead investigator for the clinical trial in India, and our patent attorney. The primary objective was to re-assess our business direction,
to select the next target series of indications for Use, to ensure that we have developed the optimum precision Radionuclide TherapyTM
approach for each cancer type, including the isotope, the delivery technique, and the dose, and to ensure that our current and
future patents protect these directions. It also discussed the domestic and internation plans.
The
Company decided to explore the viability of harvesting its technology for other business opportunities as a separate “division.”
The Company is working with Akina, on these initiatives. The current efforts are on the Peltier Chiller technology and the hydrogel.
To prevent the Company from being distracted from its primary focus of treating cancer, if viable, Akina would probably also be the principal
distributor. Alternatively, each business sector can be spun off as separate business activities to an interested party.
Controlled
Laboratory Chilling - As Akina explained, it is easy to purchase many laboratory devices to control heating, but there are limited or
no options for controlled cooling, which is a common laboratory requirement usually involving ice baths. The Company is now testing a
prototype universal laboratory cooling device.
Hydrogel
– the Company spent years on refining the development of its hydrogel, in which gelation initiates just above room temperature
and is completed as it warms to body temperature. It is currently investing in quantifying and controlling the hydrogel resorption characteristics.
There has been sufficient spontaneous interest in this component to warrant a serious business case assessment. The Company just trademarked
the name Precision GelTM and, in addition to its current hydrogel patent, has filed a new provisional patent in January 2025
to cover retention, transport, and release of a broad range of agents. These agents include radioactive and non-radioactive materials,
solid particles, including nano-particles, large molecules, small molecules, including liquids, cells, and viruses. A MOU has been drafted
to interface with potential clients including licensing and exclusive material contracting. Initial meetings are scheduled in the first
quarter of 2025 with potential clients to assess the business viability.
Intellectual
Property
Our
original license agreement with Battelle National Laboratory (the “Battelle License”) reached its end of life in 2022.
We have expanded our proprietary knowledge, as well as our trademark and patent protection, in anticipation of the Battelle License reaching
the end of its term during the past several years.
Our
trademark protection, which usually is extended to 17 countries, has been expanding continuously as summarized below:
We
own applications/registrations for the following and should mark as noted below:
| ○ | ISOPET® |
| ○ | RADIOGEL® |
| ○ | ALPHA-GELTM |
| ○ | BETA-GELTM |
| ○ | GAMMA-GELTM |
| ○ | PRECISION
RADIONUCLIDE THERAPYTM |
| ○ | PRECISIONGELTM |
Similarly,
we have systematically filed provisional and utility patents that cover our key components, hydrogel and the yttrium phosphate
particles, and our injection system in the US office and more than ten others covering approximately 63 counties.
In
January 2025 we filed an additional provisional patent on the control, transport, and delivery of PrecisionGel.
Going
Concern
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the normal course of business. As shown in the accompanying financial statements, the Company has suffered recurring
losses and used significant cash in support of its operating activities and the Company’s cash position is not sufficient to support
the Company’s operations. Research and development of the Company’s brachytherapy product line has been funded with proceeds
from the sale of equity and debt securities as well as a series of grants. The Company requires funding of approximately $2.5 million
annually to maintain current operating activities.
Financing
and Strategy
In
November 2019, the SEC qualified the Company’s offering of its Common Stock, under Regulation A of Section 3(6) of the Securities
Act of 1933, as amended (the “Securities Act”) (“Regulation A”), which offering was and amended
from time to time thereafter (the “2019 Regulation A+ Offering”). In September 2021, the SEC qualified the Company’s
offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (together with the 2019 Regulation
A+ Offering, the “Prior Regulation A+ Offerings”). During the year ended December 31, 2023, $1,179,245 was raised
through the sale of 16,132,000 shares of common stock and the private placement of 18,797,000 warrants. During the year ended December
31, 2024, the Company raised $2,266,000 through the issuance of 24,950,000 shares of common stock. The Company’s Prior Regulation
A Offerings undertaken pursuant to Regulation A+ have raised approximately $7,250,000 from the sale of shares of common stock.
On
July 17, 2024, the SEC qualified the Company’s offering under Regulation A to offer up to $60,000,000 shares of its Common Stock
(the “July 2024 Regulation A+ Offering”).
The
Company is using the proceeds generated from the Prior Regulation A+ Offering and the July 2024 Regulation A+ Offering as follows:
Research
and development of the Company’s brachytherapy product line has been funded with proceeds from the sale of equity and debt securities.
The Company may require additional funding of approximately $5
million annually to maintain current operating
activities. Over
the next 12 to 48 months, the Company believes it will cost approximately $9 million to: (1) fund the FDA approval process to conduct
human clinical trials; (2) conduct Phase I, pilot, and clinical trials; (3) activate several regional clinics to administer IsoPet®
across the county; (4) create an independent production center within the current production site to create a template for future
international manufacturing; and (5) initiate regulatory approval processes outside of the United States. The proceeds to be raised from
the Regulation A+ Offerings will be used to continue to fund this development.
The
continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional resources and personnel.
The principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the FDA’s
classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise), and any requirements for
additional studies (which may possibly include clinical studies). Thereafter, the principal variables in the amount of the Company’s
spending and its financing requirements would be: (1) the timing of any approvals; (2) the nature of the Company’s arrangements
with third parties for manufacturing, sales, distribution, and licensing of those products; and (3) the products’ success in the
U.S. and elsewhere. The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements,
as well as proceeds to be raised from the Regulation A+ Offerings.
Following
receipt of required regulatory approvals and necessary financing to fund our working capital requirements, the Company intends to outsource
material aspects of manufacturing, distribution, sales, and marketing for operations within the U.S. Outside of the U.S., the Company
intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.
Long-term,
the Company intends to consider resuming research efforts with respect to other products and technologies intended to help improve the
diagnosis and treatment of cancer and other illnesses. These long-term goals are subject to the Company: (1) receiving adequate funding;
(2) receiving regulatory approval for RadioGel™ and other brachytherapy products; and (3) being able to successfully
commercialize its brachytherapy products.
Based
on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed
substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and
has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to
delay the implementation of its business strategy and may not be able to continue operations.
The
Company’s headquarters are in Northeast Washington, however, our focus on the animal therapy market has been the Northwestern sector
of the U.S. The Company continues its marketing efforts on the animal therapy market and our attempts to increase the exposure to our
product, and generate revenue accordingly.
As
of December 31, 2024, the Company had $2,212,548 cash on hand. There are currently commitments to vendors for products and services purchased.
To continue the development of the Company’s products, the current level of cash will not be enough to cover the fixed and variable
obligations of the Company.
The
Company anticipates using the proceeds from the July 2024 Regulation A+ Offering as follows:
For
the animal therapy market:
|
● |
Expand
communication on our website, the Company’s social media presence, conferences, and journals, each intended to increase the
number of certified clinics for small animal and equine therapy and to increase the number of patients. |
|
● |
Subsidize
some IsoPet® therapies, if necessary, to ensure that all viable candidates are treated; and. |
|
● |
Assist
a new regional clinic with their license and certification training. |
For
the human market:
|
● |
Enhance
the pedigree of the Quality Management System. |
|
● |
Begin
automation of product manufacturing. |
|
● |
Fund
liability insurance for human clinical studies; and. |
|
● |
Fund
human clinical studies in the US. |
Research
and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity
and debt securities, including from the Prior Regulation A+ Offerings. The Company requires additional funding of approximately $2.5
million annually to maintain operating activities.
Over
the next 36 months, the Company believes it will cost approximately $8.0 to $9.0 million to: (1) fund the FDA approval process to conduct
human clinical trials; (2) conduct Phase I, pilot, clinical trials; (3) activate several regional clinics to administer IsoPet®
across the U.S.; (4) create an independent production center within the current production site to create a template for future
international manufacturing; and (5) initiate regulatory approval processes outside of the United States. The
proceeds raised from the Prior Regulation A+ Offerings were used to fund this development and proceeds from the July 2024 Regulation
A+ Offering will be used to continue such development efforts.
The
continued deployment of the precision radionuclide therapy products and a worldwide regulatory approval effort will require additional
resources and personnel. The principal variables in the timing and amount of spending for the precision radionuclide therapy products
in the next 12 to 24 months will be the FDA’s classification of the Company’s precision radionuclide therapy products as
Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies.
Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing
of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing
of those products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic
transactions such as licensing and partnership agreements or from proceeds raised from the Prior Regulation A+ Offering and from the
July 2024 Regulation A+ Offering.
The
Company intends to expand the indications for use in phases: first, for lymph nodes associated with thyroid cancer, secondly, cancerous
lung nodules, and finally, all non-sectable solid tumors. It is anticipated that the medical community may begin to use RadioGel off-label,
we will support but will not encourage that practice.
Following
receipt of required regulatory approvals and financing, in the U.S., the Company intends to outsource material aspects of manufacturing,
distribution, sales and marketing. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate
its global commercialization strategy.
Long-term,
the Company intends to consider resuming research efforts with respect to other products and technologies, such as Gamma Gel and Alpha
Gel intended to help improve the diagnosis and treatment of cancer and other illnesses. These long-term goals are subject to the Company:
(1) receiving adequate funding; (2) receiving regulatory approval for RadioGel™ and other precision radionuclide therapy
products; and (3) being able to successfully commercialize its precision radionuclide therapy products.
Based
on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed
substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and
has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to
delay the implementation of its business strategy and may not be able to continue operations.
The
Company’s headquarters are in the State of Washington., The initial focus of the animal therapy market has been the Northwestern
sector of the United States. The Company has initiated marketing efforts to the animal therapy market in other regions of the United
States, attempting to increase the exposure to our product and increase revenue opportunities.
There
are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products,
the current level of cash will not be enough to cover the fixed and variable obligations of the Company. The Company has focused on operating
on minimum overhead, including using a virtual office for the last several years and retaining experienced industry consultants available
on an as needed basis. This has helped focus the capital received from the Company’s Regulation A+ Offerings on activities that
enhance our objectives.
There
is no guarantee that the Company will be able to raise additional funds or to do so on terms advantageous to the Company’s stockholders.
The
financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary
should the Company be unable to continue as a going concern. The Company’s continuation as a going concern is dependent upon its
ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain profitability. The Company
plans to seek additional funding to maintain its operations through debt and equity financing and to improve operating performance through
a focus on strategic products and increased efficiencies in business processes and improvements to the cost structure. There can be no
assurance that the Company will be successful in its efforts to raise additional working capital or achieve profitable operations. The
financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Use
of Estimates
The
preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at
the date of financial statements and the reported amount of revenue and expense during the reporting period. Estimates the Company considers
include criteria for stock-based compensation expense, and valuation allowances on deferred tax assets. Actual results could differ from
those estimates.
Cash
Equivalents
For
the purposes of the statement of cash flows, the Company considers all highly liquid debt instruments purchased with an original maturity
of three months or less to be cash equivalents.
The
Company occasionally maintains cash balances in excess of the FDIC insured limit. The Company does not consider this risk to be material.
Fair
Value of Financial Instruments
Fair
value of financial instruments requires disclosure of the fair value information, whether or not recognized in the balance sheet, where
it is practicable to estimate that value. As of December 31, 2024 and 2023, the balances reported for cash, prepaid expense,
accounts receivable, accounts payable, and accrued expense, approximate the fair value because of their short maturities.
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. Accounting Standards Codification (“ASC”) Topic 820 established a three-tier
fair value hierarchy which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted
quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs
(level 3 measurements). These tiers include:
Level
1, defined as observable inputs such as quoted prices for identical instruments in active markets;
Level
2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices
for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and
Level
3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions,
such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
The
Company measures certain financial instruments including options and warrants issued during the period at fair value on a recurring basis.
Patents
and Intellectual Property
While
patents are being developed or pending, they are not being amortized. Management has determined that the economic life of the patents
to be ten years and amortization, over such 10-year period and on a straight-line basis will begin once the patents have been issued
and the Company begins utilization of the patents through production and sales, resulting in revenues.
The
Company evaluates the recoverability of intangible assets, including patents and intellectual property on a continual basis. Several
factors are used to evaluate intangibles, including, but not limited to, management’s plans for future operations, recent operating
results and projected and expected undiscounted future cash flows.
There
have been no such capitalized costs in the years ended December 31, 2024 and 2023, respectively. However, a patent was
filed on July 1, 2019 (No. 1811.191) filed by Michael Korenko and David Swanberg and assigned to the Company based on the Company’s
proprietary particle manufacturing process. The timing of this filing was important given the Company’s plans to make IsoPet®
commercially available, which it did on or about July 9, 2019. This additional patent protection will strengthen the Company’s
competitive position. It is the Company’s intention to further extend this patent protection to several key countries within one
year, as permitted under international patent laws and treaties.
Revenue
Recognition
In
May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”)
No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue recognition
to be used across all industries and requires additional disclosures. The guidance introduces a five-step model to achieve its core principal
of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration
to which the entity expects to be entitled in exchange for those goods or services. The Company adopted the updated guidance effective
January 1, 2018 using the full retrospective method.
Under
ASC 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to perform respective
obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for the goods
transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration is probable.
The adoption of ASC 606 did not have an impact on the Company’s operations or cash flows.
The
Company recognized revenue as they (i) identified the contracts with each customer; (ii) identified the performance obligation in each
contract; (iii) determined the transaction price in each contract; (iv) were able to allocate the transaction price to the performance
obligations in the contract; and (v) recognized revenue upon the satisfaction of the performance obligation. Upon the sales of the product
to complete the procedures on the animals, the Company recognized revenue as that was considered the performance obligation.
The
Company in 2024 also implemented a license program for clinics that pay for certification to perform these therapies. These revenues
are recognized upon the certification being completed. During 2024, $4,995 of the revenue relates to this certification.
Loss
Per Share
The
Company accounts for its loss per common share by replacing primary and fully diluted earnings per share with basic and diluted earnings
per share. Basic loss per share is computed by dividing loss available to common stockholders (the numerator) by the weighted-average
number of common shares outstanding (the denominator) for the period, and does not include the impact of any potentially dilutive Common
Stock equivalents since the impact would be anti-dilutive. The computation of diluted earnings per share is similar to basic earnings
per share, except that the denominator is increased to include the number of additional common shares that would have been outstanding
if potentially dilutive common shares had been issued. For the given periods of loss, of the periods ended in the years ended December
31, 2024 and 2023, the basic earnings per share equals the diluted earnings per share.
The
following represent Common Stock equivalents that could be dilutive in the future as December 31, 2024 and 2023, which include the following:
SCHEDULE
OF DILUTIVE EARNINGS PER SHARE
| |
December 31,
2024 | | |
December 31,
2023 | |
Preferred stock | |
| 7,409,570 | | |
| 9,909,570 | |
Restricted stock units | |
| 22,725,000 | | |
| 1,450,000 | |
Common stock options | |
| 2,252,809 | | |
| 2,252,809 | |
Common stock warrants | |
| 11,465,000 | | |
| 26,134,000 | |
Total potential dilutive securities | |
| 43,852,379 | | |
| 39,746,379 | |
Research
and Development Costs
Research
and developments costs, including salaries, research materials, administrative expense and contractor fees, are charged to operations
as incurred. The cost of equipment used in research and development activities which has alternative uses is capitalized as part of fixed
assets and not treated as an expense in the period acquired. Depreciation of capitalized equipment used to perform research and development
is classified as research and development expense in the year computed.
The
Company incurred $324,629 and $732,698 in research and development costs for the years ended December 31, 2024 and 2023, respectively,
all of which were recorded in the Company’s operating expense noted on the statements of operations for the periods then ended.
Advertising
and Marketing Costs
Advertising
and marketing costs are expensed as incurred except for the cost of tradeshows which are deferred until the tradeshow occurs. During
the years ended December 31, 2024 and 2023, the Company incurred nominal advertising and marketing costs.
Contingencies
In
the ordinary course of business, the Company is involved in legal proceedings involving contractual and employment relationships, product
liability claims, patent rights, and a variety of other matters. The Company records contingent liabilities resulting from asserted and
unasserted claims against it, when it is probable that a liability has been incurred and the amount of the loss is reasonably estimable.
The Company discloses contingent liabilities when there is a reasonable possibility that the ultimate loss will exceed the recorded liability.
Estimated probable losses require analysis of multiple factors, in some cases including judgments about the potential actions of third-party
claimants and courts. Therefore, actual losses in any future period are inherently uncertain. The Company has entered into various agreements
that require them to pay certain fees to consultants and/or employees that have been fully accrued for as of December 31, 2024 and 2023.
Income
Taxes
To
address accounting for uncertainty in tax positions, the Company clarifies the accounting for income taxes by prescribing a minimum recognition
threshold that a tax position is required to meet before being recognized in the financial statements. The Company also provides guidance
on de-recognition, measurement, classification, interest, and penalties, accounting in interim periods, disclosure and transition.
The
Company files income tax returns in the U.S. federal jurisdiction. The Company did not have any tax expense for the years ended December
31, 2024 and 2023. The Company did not have any deferred tax liability or asset on its balance sheets as of December 31, 2024 and 2023.
Interest
costs and penalties related to income taxes, if any, will be classified as interest expense and general and administrative costs, respectively,
in the Company’s financial statements. For the years ended December 31, 2024 and 2023, the Company did not recognize any interest
or penalty expense related to income taxes. The Company believes that it is not reasonably possible for the amounts of unrecognized tax
benefits to significantly increase or decrease within the next twelve months.
Stock-Based
Compensation
The
Company recognizes compensation costs under FASB ASC Topic 718, Compensation – Stock Compensation and ASU 2018-07. Companies are
required to measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize
the costs in the financial statements over the period during which employees are required to provide services. Share based compensation
arrangements include stock options, restricted share plans, performance-based awards, share appreciation rights and employee share purchase
plans. As such, compensation cost is measured on the date of grant at their fair value. Such compensation amounts, if any, are amortized
over the respective vesting periods of the option grant.
Recent
Accounting Pronouncements
The
Company does not discuss recent pronouncements that are not anticipated to have an impact on or are unrelated to its financial condition,
results of operations, cash flows or disclosures.
In November 2023, the Financial Accounting Standards Board issued Accounting Standards Update 2023-07 (“ASU
2023-07”). ASU 2023-07 improves segment reporting disclosures for public companies. ASU 2023-07 requires more detailed information
about reportable segments and expenses including the requirement to disclose qualitative information about factors used to identify reportable
segments and quantitative information about profit and loss measures and significant expense categories. ASU 2023-07 was effective for
public companies in fiscal years beginning after December 15, 2023. The Company has not yet begun generating significant revenue from its planned principal operations and operates as
a single reportable segment. The chief operating decision maker is the Company’s chief executive officer who assesses performance
based on total expenses, cash flows, and progress made in the Company’s ongoing development efforts. All of the Company’s
long-lived assets are located in the United States. The Company analyzed ASU 2023-07 and determined that the required
information is presented within the consolidated financial statements and footnote disclosures herein. The Company does not believe that
ASU 2023-07 will have a material impact on the consolidated financial statements.
|
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v3.25.1
RELATED PARTY TRANSACTIONS
|
12 Months Ended |
Dec. 31, 2024 |
Related Party Transactions [Abstract] |
|
RELATED PARTY TRANSACTIONS |
NOTE
2: RELATED PARTY TRANSACTIONS
In
September 2023, our Chief Executive Officer advanced $10,000 to the Company, which amount was repaid October 4, 2023. In December 2024,
our Chief Executive Officer advanced $40,949 to the Company, which amount was repaid within ten days.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.25.1
STOCKHOLDERS’ EQUITY
|
12 Months Ended |
Dec. 31, 2024 |
Equity [Abstract] |
|
STOCKHOLDERS’ EQUITY |
NOTE
3: STOCKHOLDERS’ EQUITY
Common
Stock
The
Company has authorized 950,000,000 shares of Common Stock. As of December 31, 2024 and 2023, there are 440,873,806 and 387,894,033 shares
of Common Stock issued and outstanding, respectively.
Preferred
Stock
The
Company has authorized 20,000,000 shares of Preferred Stock. There are currently three series of Preferred Stock outstanding; Series
A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series C Convertible Preferred Stock. The Company’s Board
of Directors is authorized to provide for the issuance of shares of Preferred Stock in one or more series, fix or alter the designations,
preferences, rights, qualifications, limitations or restrictions of the shares of each series, including the dividend rights, dividend
rates, conversion rights, voting rights, term of redemption including sinking fund provisions, redemption price or prices, liquidation
preferences and the number of shares constituting any series or designations of such series without further vote or action by the shareholders.
The issuance of Preferred Stock may have the effect of delaying, deferring, or preventing a change in control of management without further
action by the shareholders and may adversely affect the voting and other rights of the holders of Common Stock. The issuance of Preferred
Stock with voting and conversion rights may adversely affect the voting power of the holders of Common Stock, including the loss of voting
control to others.
Series
A Convertible Preferred Stock
On
June 30, 2015, a certificate of designations was filed with the Delaware Secretary of State to designate 2,500,000 shares of the Company’s
Preferred Stock as Series A Convertible Preferred Stock, par value $0.001 per share (“Series A Preferred”) (the “Series
A COD”). Effective March 31, 2016, the Company amended the Series A COD, increasing the maximum number of shares of Series
A Preferred from 2,500,000 shares to 5,000,000 shares. As of December 31, 2024 and 2023, there are 2,071,007 shares of Series A Preferred
issued and outstanding, respectively.
The
following summarizes the current rights and preferences of the Series A Preferred:
Liquidation
Preference. The Series A Preferred has a liquidation preference of $5.00 per share.
Dividends.
Shares of Series A Preferred do not have any separate dividend rights.
Conversion.
Subject to certain limitations set forth in the Series A COD, each share of Series A Preferred is convertible, at the option of the holder,
into that number of shares of Common Stock (the “Series A Conversion Shares”) equal to the liquidation preference
thereof, divided by Conversion Price (as such term is defined in the Series A COD), currently $4.00.
In
the event the Company completes an equity or equity-based public offering, registered with the SEC, resulting in gross proceeds to the
Company totaling at least $5.0 million, all issued and outstanding shares of Series A Preferred at that time will automatically convert
into Series A Conversion Shares.
Redemption.
Subject to certain conditions set forth in the Series A COD, in the event of a Change of Control (defined in the Series A COD), or at
such time as a third party not affiliated with the Company or any holders of the Series A Preferred shall have acquired, in one or a
series of related transactions, equity securities of the Company representing more than fifty percent (50%) of the outstanding voting
securities of the Company), the Company, at its option, will have the right to redeem all or a portion of the outstanding Series A Preferred
in cash at a price per share of Series A Preferred equal to 100% of the Liquidation Preference.
Voting
Rights. Holders of Series A Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
equivalent of five votes for every Series A Conversion Share issuable upon conversion of such holder’s outstanding shares of Series
A Preferred. However, the Series A Conversion Shares, when issued, will have all the same voting rights as other issued and outstanding
Common Stock of the Company, and none of the rights of the Series A Preferred.
Liquidation.
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”),
the holders of Series A Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company an amount
equal to the liquidation preference of the Series A Preferred before any distribution or payment shall be made to the holders of any
junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
to the holders of the Series A Preferred shall be ratably distributed among the holders in accordance with the respective amounts that
would be payable on such shares if all amounts payable thereon were paid in full.
Certain
Price and Share Adjustments.
a)
Stock Dividends and Stock Splits. If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions payable
in shares of Common Stock on shares of Common Stock or any other Common Stock equivalents; (ii) subdivides outstanding shares of Common
Stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into
a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock
of the Company, then the conversion price shall be adjusted accordingly.
b)
Merger or Reorganization. If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or merger
in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series A Preferred
shall be convertible into the kind and amount of securities, cash or other property that a holder of the number of shares of Common Stock
issuable upon conversion of one share of Series A Preferred prior to any such merger or reorganization would have been entitled to receive
pursuant to such transaction.
Series
B Convertible Preferred Stock
On
October 10, 2018, a certificate of designation was filed with the Delaware Secretary of State to designate 5,000,000 shares of our Preferred
Stock as Series B Convertible Preferred Stock, par value $0.001 per share (“Series B Preferred”) (the “Series
B COD”). As of December 31, 2024 and 2023, there are 363 and 200,363 shares of Series B Preferred issued and outstanding, respectively.
The
following summarizes the current rights and preferences of the Series B Preferred:
Liquidation
Preference. The Series B Preferred has a liquidation preference of $1.00 per share.
Dividends.
Shares of Series B Preferred do not have any separate dividend rights.
Conversion.
Subject to certain limitations set forth in the Series B COD, each share of Series B Convertible is convertible, at the option of the
holder, into that number of shares of Common Stock (the “Series B Conversion Shares”) equal to the liquidation preference
thereof, divided by the Conversion Price (as such term is defined in the Series B COD), currently $0.08.
Redemption.
Subject to certain conditions set forth in the Series B COD, in the event of a Change of Control (defined in the Series B COD), or at
such as a third party not affiliated with the Company or any holders of the Series B Convertible shall have acquired, in one or a series
of related transactions, equity securities of the Company representing more than fifty percent (50%) of the outstanding voting securities
of the Company), the Company, at its option, will have the right to redeem all or a portion of the outstanding Series B Preferred in
cash at a price per share of Series B Preferred equal to 100% of the Liquidation Preference.
Voting
Rights. Holders of Series B Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
equivalent of two votes for every Series B Conversion Share issuable upon conversion of such holder’s outstanding shares of Series
B Preferred. However, the Series B Conversion Shares, when issued, will have the same voting rights as other issued and outstanding shares
of Common Stock of the Company, and none of the rights of the Series A Preferred.
Liquidation.
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”),
the holders of Series B Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company an amount
equal to the liquidation preference of the Series B Preferred before any distribution or payment shall be made to the holders of any
junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
to the holders of the Series B Preferred shall be ratably distributed among the holders in accordance with the respective amounts that
would be payable on such shares if all amounts payable thereon were paid in full.
Certain
Price and Share Adjustments.
a)
Stock Dividends and Stock Splits. If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions payable
in shares of Common Stock on shares of Common Stock or any other Common Stock equivalents; (ii) subdivides outstanding shares of Common
Stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into
a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock
of the Company, then the conversion price shall be adjusted accordingly.
b)
Merger or Reorganization. If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or merger
in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series B Preferred
shall be convertible into the kind and amount of securities, cash or other property that a holder of the number of shares of Common Stock
issuable upon conversion of one share of Series B Preferred prior to any such merger or reorganization would have been entitled to receive
pursuant to such transaction.
On
December 16, 2024, there was 200,000 Series B Preferred shares converted into 2,500,000 common shares.
Series
C Convertible Preferred Stock
On
March 27, 2019, a certificate of designation was filed with the Delaware Secretary of State to designate 5,000,000 shares of our Preferred
Stock as Series C Convertible Preferred Stock, par value $0.001 per share (“Series C Preferred”) (the “Series
C COD”). As of December 31, 2024 and 2023, there were 385,302 shares of Series C Preferred issued and outstanding, respectively.
The
following summarizes the current rights and preferences of the Series C Preferred:
Liquidation
Preference. The Series C Preferred has a liquidation preference of $1.00 per share.
Dividends.
Shares of Series C Preferred do not have any separate dividend rights.
Conversion.
Subject to certain limitations set forth in the Series C COD, each share of Series C Preferred is convertible, at the option of the holder,
into that number of shares of Common Stock (the “Series C Conversion Shares”) equal to the liquidation preference
thereof, divided by Conversion Price (as such term is defined in the Series C COD), currently $0.08.
The
Series C Preferred will only be convertible at any time after the date that the Company shall have amended its Certificate of Incorporation
to increase the number of shares of Common Stock authorized for issuance thereunder or effect a reverse stock split of the outstanding
shares of Common Stock by a sufficient amount to permit the conversion of all Series C Preferred into shares of Common Stock (“Authorized
Share Approval”) (such date, the “Initial Convertibility Date”), each share of Series C Preferred shall
be convertible into validly issued, fully paid and non-assessable shares of Common Stock on the terms and conditions set forth in the
Series C COD under the definition “Conversion Rights”.
Redemption.
Subject to certain conditions set forth in the Series C COD, in the event of a Change of Control (defined in the Series C COD), or at
such time as a third party not affiliated with the Company or any holders of the Series C Preferred shall have acquired, in one or a
series of related transactions, equity securities of the Company representing more than fifty percent (50%) of the outstanding voting
securities of the Company), the Company, at its option, will have the right to redeem all or a portion of the outstanding Series C Preferred
in cash at a price per share of Series C Preferred equal to 100% of the Liquidation Preference.
Voting
Rights. Holders of Series C Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
equivalent of thirty-two votes for every Series C Conversion Share issuable upon conversion of such holder’s outstanding shares
of Series C Preferred. However, the Series C Conversion Shares, when issued, will have the same voting rights as other issued and outstanding
shares of Common Stock of the Company, and none of the rights of the Series C Preferred.
Liquidation.
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”),
the holders of Series C Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company an amount
equal to the liquidation preference of the Series C Preferred before any distribution or payment shall be made to the holders of any
junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
to the holders of the Series C Preferred shall be ratably distributed among the holders in accordance with the respective amounts that
would be payable on such shares if all amounts payable thereon were paid in full.
Certain
Price and Share Adjustments.
a)
Stock Dividends and Stock Splits. If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions payable
in shares of Common Stock on shares of Common Stock or any other Common Stock equivalents; (ii) subdivides outstanding shares of Common
Stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into
a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock
of the Company, then the conversion price shall be adjusted accordingly.
b)
Merger or Reorganization. If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or merger
in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series C Preferred
shall be convertible into the kind and amount of securities, cash or other property that a holder of the number of shares of Common Stock
issuable upon conversion of one share of Series C Preferred prior to any such merger or reorganization would have been entitled to receive
pursuant to such transaction.
Common
and Preferred Stock Issuances
Common
and Preferred Stock Issuances - 2024
The
Company issued 24,950,000 shares of Common Stock pursuant to the Regulation A+ Offerings for cash proceeds of $2,266,000.
The
Company issued 605,801 shares of Common Stock for services rendered valued at $88,925.
The
Company issued 20,336,472 shares of Common Stock in the cashless exercise of 28,619,000 warrants.
The
Company issued 5,000,000
shares of Common Stock in the exchange of 5,000,000
warrants and recognized a loss on the exchange of $381,000
which is included in the exercise of warrants in the consolidated statement of changes in stockholders’s equity.
There
were 200,000 Series B Preferred shares converted into 2,500,000 common shares.
The
Company settled 750,000 RSUs for Common Stock.
The
Company adjusted their common shares for vested RSUs in prior periods that were cancelled.
Common
and Preferred Stock Issuances – 2023
In
April 2023, the Company issued 8,000,000 shares of Common Stock, 2,665,000 Series A warrants and 8,000,000 Series B warrants in their
Regulation A+ Offerings for $640,000. The Company sold the warrants for $10,665.
In October
2023, the Company issued 2,221,505 shares of common stock in a cashless exercise of warrants to purchase 2,132,000 shares of common stock.
In December
2023, the Company issued: (1) 500,000 shares of common stock in settlement of accounts payable of $28,450; (2) 8,132,000 shares of common
stock and 8,132,000 warrants pursuant to the Offering Statement for the Regulation A+ Offering for an aggregate total of $528,580; (3)
2,499,000 shares of common stock in a cashless exercise of warrants to purchase 4,998,000 shares of common stock and issued new warrants
to purchase 10,002,000 shares of common stock; and (4) issued 4,000,000 shares of common stock for 4,00,000 vested restricted stock units,
for which the Company recognized a loss of $151,184 on this exchange of vested restricted stock units for shares of common stock.
|
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- DefinitionThe entire disclosure for equity.
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v3.25.1
COMMON STOCK OPTIONS, WARRANTS AND RESTRICTED STOCK UNITS
|
12 Months Ended |
Dec. 31, 2024 |
Equity [Abstract] |
|
COMMON STOCK OPTIONS, WARRANTS AND RESTRICTED STOCK UNITS |
NOTE
4: COMMON STOCK OPTIONS, WARRANTS AND RESTRICTED STOCK UNITS
Common
Stock Options
The
Company recognizes in the financial statements compensation related to all stock-based awards, including stock options and warrants,
based on their estimated grant-date fair value. The Company has estimated expected forfeitures and is recognizing compensation expense
only for those awards expected to vest. All compensation is recognized by the time the award vests.
The
following schedule summarizes the changes in the Company’s stock options:
SCHEDULE
OF CHANGES IN STOCK OPTION
| |
Options
Outstanding | | |
Weighted
Average Remaining | | |
| | |
Weighted
Average | |
| |
Number
Of Shares | | |
Exercise
Price Per Share | | |
Contractual
Life | | |
Aggregate
Intrinsic Value | | |
Exercise
Price Per Share | |
Year Ended December
31, 2024 | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Outstanding at January 1, 2024 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 5.70
years | | |
$ | 78,886 | | |
$ | 0.04 | |
Granted | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Exercised | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Expired/cancelled | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Outstanding at December
31, 2024 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 4.70
years | | |
$ | 174,855 | | |
$ | 0.04 | |
Exercisable at December
31, 2024 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 4.70
years | | |
$ | 174,855 | | |
$ | 0.04 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Year Ended December
31, 2023 | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Outstanding at January 1, 2023 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 6.70
years | | |
$ | 16,032 | | |
$ | 0.04 | |
Granted | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Exercised | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Expired/cancelled | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Outstanding at December
31, 2023 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 5.70
years | | |
$ | 78,886 | | |
$ | 0.04 | |
Exercisable at December
31, 2023 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 5.70
years | | |
$ | 78,886 | | |
$ | 0.04 | |
During
the years ended December 31, 2024 and 2023, the Company recognized $0 of stock-based compensation expense related to the vesting of stock
options.
Common
Stock Warrants
The
following schedule summarizes the changes in the Company’s stock warrants:
SCHEDULE
OF CHANGES IN STOCK WARRANTS
| |
Warrants
Outstanding | | |
Weighted
Average Remaining | | |
| | |
Weighted
Average | |
| |
Number
Of Shares | | |
Exercise
Price Per Share | | |
Contractual
Life | | |
Aggregate
Intrinsic Value | | |
Exercise
Price Per Share | |
Years Ended
December 31, 2024 | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Outstanding at January 1, 2024 | |
| 26,134,000 | | |
$ | 0.06-0.10 | | |
| 3.54
years | | |
$ | - | | |
$ | 0.0827 | |
Granted | |
| 18,950,000 | | |
$ | 0.075 | | |
| - | | |
$ | - | | |
$ | - | |
Redeemed | |
| (500,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Exercised | |
| (28,619,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Exchanged | |
| (5,000,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Outstanding at December 31, 2024 | |
| 11,465,000 | | |
$ | 0.13 | | |
| 3
years | | |
$ | 123,690 | | |
$ | 0.13 | |
Exercisable at December 31, 2024 | |
| 11,465,000 | | |
$ | 0.13 | | |
| 3
years | | |
$ | 123,690 | | |
$ | 0.13 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Years Ended
December 31, 2023 | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Outstanding at January 1, 2023 | |
| 26,737,500 | | |
$ | 0.06-0.10 | | |
| 1.52
years | | |
$ | - | | |
$ | 0.09 | |
Granted | |
| 28,799,000 | | |
$ | 0.0827 | | |
| - | | |
$ | - | | |
$ | - | |
Redeemed | |
| (500,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Exercised | |
| (7,663,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Exchanged | |
| (10,002,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Expired/cancelled | |
| (11,237,500 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Outstanding at December 31, 2023 | |
| 26,134,000 | | |
$ | 0.06-0.10 | | |
| 3.54
years | | |
$ | - | | |
$ | 0.0827 | |
Exercisable at December 31, 2023 | |
| 26,134,000 | | |
$ | 0.06-0.10 | | |
| 3.54
years | | |
$ | - | | |
$ | 0.0827 | |
Changes
to these inputs could produce a significantly higher or lower fair value measurement. The fair value of each option/warrant is estimated
using the Black-Scholes valuation model. The following assumptions were used for the periods as follows:
SCHEDULE
OF ASSUMPTIONS USED IN FAIR VALUE MEASUREMENT
|
|
|
Year
Ended |
|
|
|
Years
Ended |
|
|
|
|
December
31, 2024 |
|
|
|
December
31, 2023 |
|
Expected
term |
|
|
- |
|
|
|
- |
|
Expected
volatility |
|
|
- |
% |
|
|
- |
% |
Expected
dividend yield |
|
|
- |
|
|
|
- |
|
Risk-free
interest rate |
|
|
- |
% |
|
|
- |
% |
The
Company granted 10,665,000 warrants in their Reg A+ funding in April 2023, with an exercise price of $0.0775 and a three-year term.
The
Company granted 2,000,000 warrants in their Regulation A+ Offering in January 2024, with an exercise price of $0.075 and a three-year
term and 5,000,000 warrants with the same terms on April 1, 2024.
In
November 2024, the Company sold 11,950,000 warrants, 30% of which expire December 31, 2024 at an exercise price of $0.01 and 70% of which
expire December 31, 2027 at an exercise price of $0.15 for $11,950 under Regulation D.
In
2024, the Company issued 25,336,468 shares of Common Stock in the exercise of 33,619,000 warrants and received $19,350.
Restricted
Stock Units
The
following schedule summarizes the changes in the Company’s restricted stock units:
SCHEDULE
OF CHANGES IN RESTRICTED STOCK UNITS
| |
Number
Of Shares | | |
Weighted
Average Grant Date Fair Value | |
Year Ended December
31, 2024 | |
| | | |
| | |
| |
| | | |
| | |
Outstanding at January 1, 2024 | |
| 1,450,000 | | |
$ | 0.09 | |
Granted | |
| 21,850,000 | | |
$ | 0.08 | |
Vested | |
| (11,475,000 | ) | |
$ | - | |
Forfeited | |
| - | | |
$ | - | |
Outstanding at December 31, 2024 | |
| 11,825,000 | | |
$ | 0.08 | |
| |
| | | |
| | |
Year Ended December
31, 2023 | |
| | | |
| | |
| |
| | | |
| | |
Outstanding at January 1, 2023 | |
| 10,262,500 | | |
$ | 0.08 | |
Granted | |
| 6,900,000 | | |
$ | 0.068 | |
Vested | |
| (15,450,000 | ) | |
$ | - | |
Forfeited | |
| (262,500 | ) | |
$ | - | |
Outstanding at December
31, 2023 | |
| 1,450,000 | | |
$ | 0.09 | |
During
the years ended December 31, 2024 and 2023, the Company recognized $918,350 and $1,239,950 in expense related to the vesting of its restricted
stock units. As of December 31, 2024, the Company had $923,855 worth of expense yet to be recognized for restricted stock units not yet
vested.
On
January 1, 2024, the Company granted 20,000,000
restricted stock units to its Chief Executive Officer as part of his new employment agreement that vest in four equal installments
over a two-year
period beginning February 1, 2024. In May 2024, the Company granted 1,050,000
restricted stock units to consultants that vest through December 31, 2025. In November 2024, the Company granted 800,000 restricted
stock units that vest in May 2025. During the year ended December 31, 2024, 11,475,000
of these restricted stock units vested.
On May 1,
2023, the Company granted 2,900,000 RSUs to consultants, with 25% of such RSUs vesting immediately, 25% vest on December 31, 2023, 25%
vest on December 31, 2024 and the remaining 25% vest on December 31, 2025. These RSUs are valued at $263,900.
On August
4, 2023, the Chief Executive Officer rescinded 1,012,500 of which 750,000 had vested in prior years, of his fully vested RSUs.
In December
2023, the Company granted 4,000,000 immediately vested RSUs to a consultant, for which the RSUs are valued at $208,000.
|
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- DefinitionThe entire disclosure for shareholders' equity and share-based payment arrangement. Includes, but is not limited to, disclosure of policy and terms of share-based payment arrangement, deferred compensation arrangement, and employee stock purchase plan (ESPP).
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v3.25.1
COMMITMENT
|
12 Months Ended |
Dec. 31, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENT |
NOTE
5: COMMITMENT
On
June 4, 2019, the Company entered into an Executive Employment Agreement (“Employment Agreement”) with Dr. Michael
K. Korenko, the Company’s Chief Executive Officer. The employment term under the Employment Agreement commenced with an effective
date of June 11, 2019 and expires on December 31, 2020, and December 31 of each successive year if the Employment Agreement is extended,
unless terminated earlier as set forth in the Employment Agreement. On December 31, 2020, the Company extended the Employment Agreement
through December 31, 2021 while renegotiating terms of a new Employment Agreement. On May 3, 2021, the Company and the Chief Executive
Officer agreed the terms of a new Employment Agreement with an effective date of January 1, 2021 that has a term of three years and expired
December 31, 2023. The Company renewed the Employment Agreement for a term of two years expiring December 31, 2025.
Under
the terms of the Employment Agreement effective January 1, 2024, the Company shall pay to Dr. Korenko a base compensation of $295,500.
In addition, there is a discretionary bonus to be earned in the amount of $10,000 per quarter upon the satisfaction of conditions to
be determined by the Board of Directors of the Company. In addition, the Company granted Dr. Korenko 20,000,000 restricted stock units
on January 1, 2024 that vest over the two year period.
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v3.25.1
INCOME TAXES
|
12 Months Ended |
Dec. 31, 2024 |
Income Tax Disclosure [Abstract] |
|
INCOME TAXES |
NOTE
6: INCOME TAXES
Deferred
taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences and operating
loss and tax credit carry-forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences
are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a
valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets
will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of
enactment.
Net
deferred tax assets consist of the following components as of December 31, 2024 and 2023:
SCHEDULE
OF NET DEFERRED TAX ASSETS
| |
December
31,
2024 | | |
December
31,
2023 | |
Deferred tax assets: | |
| | | |
| | |
Net operating loss carryover | |
$ | 7,260,000 | | |
$ | 6,840,000 | |
Capital Loss Carryover | |
| 3,400 | | |
| 3,400 | |
Valuation allowance | |
| (7,263,400 | ) | |
| (6,843,400 | ) |
Net deferred tax asset | |
$ | - | | |
$ | - | |
The
income tax provision differs from the amount of income tax determined by applying the U.S. Federal income tax rate to pretax income from
continuing operations for the years ended December 31, 2024 and 2023 due to the following:
SCHEDULE
OF FEDERAL INCOME TAX RATE
| |
December
31,
2024 | | |
December
31,
2023 | |
Book income (loss) | |
$ | (611,200 | ) | |
$ | (607,900 | ) |
Depreciation | |
| (1,100 | ) | |
| (1,100 | ) |
Stock for services | |
| 192,900 | | |
| 260,400 | |
Other non-deductible expense | |
| - | | |
| 6,300 | |
Valuation allowance | |
| 419,400 | | |
| 342,300 | |
Income tax expense | |
$ | - | | |
$ | - | |
At
December 31, 2024, the Company had net operating loss carryforwards of approximately $34,581,700.
ASC
Topic 740 – Income Taxes (“ASC 740”) provides guidance on the accounting for uncertainty in income taxes recognized
in a company’s financial statements. ASC 740 requires a company to determine whether it is more likely than not that a tax position
will be sustained upon examination based upon the technical merits of the position. If the more-likely-than-not threshold is met, a company
must measure the tax position to determine the amount to recognize in the financial statements. At the adoption date of January 1, 2007,
the Company had no unrecognized tax benefit, which would affect the effective tax rate if recognized.
The
Company includes interest and penalties arising from the underpayment of income taxes in the statements of operations in the provision
for income taxes. As of December 31, 2024, the Company had no accrued interest or penalties related to uncertain tax positions.
The
Company files income tax returns in the U.S. federal jurisdiction. The Company is located in the state of Washington and Washington state
does not require the filing of income taxes. With few exceptions, the Company is no longer subject to U.S. federal, state and local,
or non-U.S. income tax examinations by tax authorities for years before 2017.
|
X |
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v3.25.1
SUBSEQUENT EVENTS
|
12 Months Ended |
Dec. 31, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
7: SUBSEQUENT EVENTS
The Company has evaluated subsequent events through the date of this report and noted the following:
On
February 6, 2025, there has been 12,500,000 shares of common stock issued under the Regulation A+.
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v3.25.1
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
12 Months Ended |
Dec. 31, 2024 |
Accounting Policies [Abstract] |
|
Business Overview |
Business
Overview
Vivos
Inc. (the “Company,” “we,” “us,” “our”) is a radiation oncology
medical device company engaged in the development of its yttrium-90 (“Y-90”) based precision radionuclide therapy
device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide TherapyTM.
A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories,
universities, and private corporations, lead the Company’s development efforts. The Company’s overall vision is to globally
empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments
for cancer.
In
2013, the United States Food and Drug Administration (“FDA”) issued the determination that RadioGel™ is a device
for human therapy for non-resectable cancers in humans. This should result in a faster path than a drug for final approval.
In
January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGelTM should be classified as
a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company believes
that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas, but
rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals. We expect the
result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet®
for the treatment of solid tumors in animals. The FDA does not have premarket authority over devices with a veterinary classification,
and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance
with all applicable laws and regulations.
Based
on the FDA’s recommendation, RadioGelTM is being marketed as “IsoPet®” for use by veterinarians
to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet®”
name. IsoPet® and RadioGelTM are used synonymously throughout this document. The only distinction between IsoPet®
and RadioGelTM is the FDA’s recommendation that we use “IsoPet®” for veterinarian usage,
and reserve “RadioGelTM” for human therapy. Historically, the Company’s primary focus was on the development
and marketing of Isopet® for animal therapy, through the Company’s IsoPet® Solutions division. Over
the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device
Exemption and to obtain approval for clinical trials in India.
The
Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement of
university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of the technology
in private clinics. In January 2025 the Company restructured and aligned its internal resources and focused effort to align with animal
therapy, human therapy, and recently other applications of its patented technologies.
The
Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet®/RadioGelTM
testing and therapy. Washington State University treated five cats for feline sarcoma and served to develop the procedures which
are incorporated in our label. They concluded that the product was safe and effective in killing cancer cells. Colorado State University
demonstrated the CT and PET-CT imaging of IsoPet®. The University of Missouri conducted an animal study to treat canine
sarcoma. Johns Hopkins University completed a study on VX2 Tumors in Rabbits. Every study confirmed that the Y-90 stayed at the injection
site with insignificant distribution outside that boundary.
Commencing
in July 2019, the Company recognized its first commercial sale of IsoPet®. A veterinarian from Alaska brought his cat with a re-occurrent
spindle cell sarcoma tumor on his face. The cat had previously received external beam therapy, but now the tumor was growing rapidly.
He was given a high dose of 400Gy with heavy therapy at the margins.
The
Company anticipates that any near-term profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet®)
and related services, and from certifying veterinary clinics to administer IsoPet Therapy. Until recently the Company certified clinics
at its own expense, but the demand has increased to the point that starting in 2025 the Company billed its first clinic for the certification
process.
The
plan is to incorporate the data assembled from our work with Isopet® in animal therapy to support the Company’s
efforts in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell RadioGel™
as a Class II medical device. RadioGel™ is an injectable particle-gel for Precision Radionuclide Therapy radiation treatment of
cancerous tumors in people and animals. RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature
and then gels when reaching body temperature after injection into a tumor. In the gel are small, less than two microns, Y-90 phosphate
particles. Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local radiation
dose. The radiation is beta, consisting of high-speed electrons. These electrons only travel a short distance so the device can deliver
high radiation to the tumor with minimal dose to the surrounding tissue. Optimally, patients can go home immediately following treatment
without the risk of radiation exposure to family members. Since Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its
original value after ten days.
In
2021 the Company modified its Indication for Use from skin cancer to cancerous tissue or solid tumors pathologically associated with
locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic
lymph nodes or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require post-surgical
remnant ablation (for example, after prior incomplete radioiodine therapy). Papillary thyroid carcinoma belongs to the general class
of head and neck tumors for which tumors are accessible by intraoperative direct needle injection. The Company’s Medical Advisory
Board felt that demonstrating efficacy in clinical trials with this new indication provided a more efficient pathway to regulatory clearance.
In
December 2023, the Food and Drug Administration granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device
pursuant to the FDA’s Breakthrough Devices Program. This gave the company access to the “sprint” rapid review process
for IDE comments. For the last several months the company has been taking advantage of that program to resoled detailed FDA questions
on a variety of topics.
In
early 2025 the Company began actively pursuing human clinical trials in India. This involved successful step-by-step implementation of
several requirements, including location of a respected lead investigator at a respected hospital; regulatory approvals (securing clearances
from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health
& Family Welfare, and the Company was issued the Clinical Trial Registry-India (CTRI) number required for publishing results); logistical
coordination (acquired liability insurance, expanded the treatment institution’s radioactive material license to include RadioGel®,
and established robust international shipping protocols and an alternate contingency shipping path for the Yttrium-90 (Y-90)-based product);
protocol development (finalized the Clinical Trial Protocol, incorporating Mayo Clinic study designs and feedback from FDA pre-submission
discussions); operational readiness (re-validated RadioGel® manufacturing at IsoTherapeutics to ensure compliance with
Quality Management System standards and FDA sterility and validation recommendations); administrative preparations (signed agreements
with the Ethics Committee and treatment institution while confirming trademark and patent protections in the region); and training and
certification (conducted comprehensive certification training for the treatment team). Failure on any step would have terminated the effort.
In
December 2024 the Company conducted an important offset strategic meeting to ensure that its entire key internal and external team was
alighted to its strategic plans. Attendees included all our current internal team members, our senior health physics volunteer, the members
of the Medical Advisory Board and the Veterinary Medicine Advisory Board, lead Investigator for the proposed Mayo Clinic clinical trial,
lead investigator for the clinical trial in India, and our patent attorney. The primary objective was to re-assess our business direction,
to select the next target series of indications for Use, to ensure that we have developed the optimum precision Radionuclide TherapyTM
approach for each cancer type, including the isotope, the delivery technique, and the dose, and to ensure that our current and
future patents protect these directions. It also discussed the domestic and internation plans.
The
Company decided to explore the viability of harvesting its technology for other business opportunities as a separate “division.”
The Company is working with Akina, on these initiatives. The current efforts are on the Peltier Chiller technology and the hydrogel.
To prevent the Company from being distracted from its primary focus of treating cancer, if viable, Akina would probably also be the principal
distributor. Alternatively, each business sector can be spun off as separate business activities to an interested party.
Controlled
Laboratory Chilling - As Akina explained, it is easy to purchase many laboratory devices to control heating, but there are limited or
no options for controlled cooling, which is a common laboratory requirement usually involving ice baths. The Company is now testing a
prototype universal laboratory cooling device.
Hydrogel
– the Company spent years on refining the development of its hydrogel, in which gelation initiates just above room temperature
and is completed as it warms to body temperature. It is currently investing in quantifying and controlling the hydrogel resorption characteristics.
There has been sufficient spontaneous interest in this component to warrant a serious business case assessment. The Company just trademarked
the name Precision GelTM and, in addition to its current hydrogel patent, has filed a new provisional patent in January 2025
to cover retention, transport, and release of a broad range of agents. These agents include radioactive and non-radioactive materials,
solid particles, including nano-particles, large molecules, small molecules, including liquids, cells, and viruses. A MOU has been drafted
to interface with potential clients including licensing and exclusive material contracting. Initial meetings are scheduled in the first
quarter of 2025 with potential clients to assess the business viability.
|
Intellectual Property |
Intellectual
Property
Our
original license agreement with Battelle National Laboratory (the “Battelle License”) reached its end of life in 2022.
We have expanded our proprietary knowledge, as well as our trademark and patent protection, in anticipation of the Battelle License reaching
the end of its term during the past several years.
Our
trademark protection, which usually is extended to 17 countries, has been expanding continuously as summarized below:
We
own applications/registrations for the following and should mark as noted below:
| ○ | ISOPET® |
| ○ | RADIOGEL® |
| ○ | ALPHA-GELTM |
| ○ | BETA-GELTM |
| ○ | GAMMA-GELTM |
| ○ | PRECISION
RADIONUCLIDE THERAPYTM |
| ○ | PRECISIONGELTM |
Similarly,
we have systematically filed provisional and utility patents that cover our key components, hydrogel and the yttrium phosphate
particles, and our injection system in the US office and more than ten others covering approximately 63 counties.
In
January 2025 we filed an additional provisional patent on the control, transport, and delivery of PrecisionGel.
|
Going Concern |
Going
Concern
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the normal course of business. As shown in the accompanying financial statements, the Company has suffered recurring
losses and used significant cash in support of its operating activities and the Company’s cash position is not sufficient to support
the Company’s operations. Research and development of the Company’s brachytherapy product line has been funded with proceeds
from the sale of equity and debt securities as well as a series of grants. The Company requires funding of approximately $2.5 million
annually to maintain current operating activities.
|
Financing and Strategy |
Financing
and Strategy
In
November 2019, the SEC qualified the Company’s offering of its Common Stock, under Regulation A of Section 3(6) of the Securities
Act of 1933, as amended (the “Securities Act”) (“Regulation A”), which offering was and amended
from time to time thereafter (the “2019 Regulation A+ Offering”). In September 2021, the SEC qualified the Company’s
offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (together with the 2019 Regulation
A+ Offering, the “Prior Regulation A+ Offerings”). During the year ended December 31, 2023, $1,179,245 was raised
through the sale of 16,132,000 shares of common stock and the private placement of 18,797,000 warrants. During the year ended December
31, 2024, the Company raised $2,266,000 through the issuance of 24,950,000 shares of common stock. The Company’s Prior Regulation
A Offerings undertaken pursuant to Regulation A+ have raised approximately $7,250,000 from the sale of shares of common stock.
On
July 17, 2024, the SEC qualified the Company’s offering under Regulation A to offer up to $60,000,000 shares of its Common Stock
(the “July 2024 Regulation A+ Offering”).
The
Company is using the proceeds generated from the Prior Regulation A+ Offering and the July 2024 Regulation A+ Offering as follows:
Research
and development of the Company’s brachytherapy product line has been funded with proceeds from the sale of equity and debt securities.
The Company may require additional funding of approximately $5
million annually to maintain current operating
activities. Over
the next 12 to 48 months, the Company believes it will cost approximately $9 million to: (1) fund the FDA approval process to conduct
human clinical trials; (2) conduct Phase I, pilot, and clinical trials; (3) activate several regional clinics to administer IsoPet®
across the county; (4) create an independent production center within the current production site to create a template for future
international manufacturing; and (5) initiate regulatory approval processes outside of the United States. The proceeds to be raised from
the Regulation A+ Offerings will be used to continue to fund this development.
The
continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional resources and personnel.
The principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the FDA’s
classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise), and any requirements for
additional studies (which may possibly include clinical studies). Thereafter, the principal variables in the amount of the Company’s
spending and its financing requirements would be: (1) the timing of any approvals; (2) the nature of the Company’s arrangements
with third parties for manufacturing, sales, distribution, and licensing of those products; and (3) the products’ success in the
U.S. and elsewhere. The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements,
as well as proceeds to be raised from the Regulation A+ Offerings.
Following
receipt of required regulatory approvals and necessary financing to fund our working capital requirements, the Company intends to outsource
material aspects of manufacturing, distribution, sales, and marketing for operations within the U.S. Outside of the U.S., the Company
intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.
Long-term,
the Company intends to consider resuming research efforts with respect to other products and technologies intended to help improve the
diagnosis and treatment of cancer and other illnesses. These long-term goals are subject to the Company: (1) receiving adequate funding;
(2) receiving regulatory approval for RadioGel™ and other brachytherapy products; and (3) being able to successfully
commercialize its brachytherapy products.
Based
on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed
substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and
has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to
delay the implementation of its business strategy and may not be able to continue operations.
The
Company’s headquarters are in Northeast Washington, however, our focus on the animal therapy market has been the Northwestern sector
of the U.S. The Company continues its marketing efforts on the animal therapy market and our attempts to increase the exposure to our
product, and generate revenue accordingly.
As
of December 31, 2024, the Company had $2,212,548 cash on hand. There are currently commitments to vendors for products and services purchased.
To continue the development of the Company’s products, the current level of cash will not be enough to cover the fixed and variable
obligations of the Company.
The
Company anticipates using the proceeds from the July 2024 Regulation A+ Offering as follows:
For
the animal therapy market:
|
● |
Expand
communication on our website, the Company’s social media presence, conferences, and journals, each intended to increase the
number of certified clinics for small animal and equine therapy and to increase the number of patients. |
|
● |
Subsidize
some IsoPet® therapies, if necessary, to ensure that all viable candidates are treated; and. |
|
● |
Assist
a new regional clinic with their license and certification training. |
For
the human market:
|
● |
Enhance
the pedigree of the Quality Management System. |
|
● |
Begin
automation of product manufacturing. |
|
● |
Fund
liability insurance for human clinical studies; and. |
|
● |
Fund
human clinical studies in the US. |
Research
and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity
and debt securities, including from the Prior Regulation A+ Offerings. The Company requires additional funding of approximately $2.5
million annually to maintain operating activities.
Over
the next 36 months, the Company believes it will cost approximately $8.0 to $9.0 million to: (1) fund the FDA approval process to conduct
human clinical trials; (2) conduct Phase I, pilot, clinical trials; (3) activate several regional clinics to administer IsoPet®
across the U.S.; (4) create an independent production center within the current production site to create a template for future
international manufacturing; and (5) initiate regulatory approval processes outside of the United States. The
proceeds raised from the Prior Regulation A+ Offerings were used to fund this development and proceeds from the July 2024 Regulation
A+ Offering will be used to continue such development efforts.
The
continued deployment of the precision radionuclide therapy products and a worldwide regulatory approval effort will require additional
resources and personnel. The principal variables in the timing and amount of spending for the precision radionuclide therapy products
in the next 12 to 24 months will be the FDA’s classification of the Company’s precision radionuclide therapy products as
Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies.
Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing
of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing
of those products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic
transactions such as licensing and partnership agreements or from proceeds raised from the Prior Regulation A+ Offering and from the
July 2024 Regulation A+ Offering.
The
Company intends to expand the indications for use in phases: first, for lymph nodes associated with thyroid cancer, secondly, cancerous
lung nodules, and finally, all non-sectable solid tumors. It is anticipated that the medical community may begin to use RadioGel off-label,
we will support but will not encourage that practice.
Following
receipt of required regulatory approvals and financing, in the U.S., the Company intends to outsource material aspects of manufacturing,
distribution, sales and marketing. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate
its global commercialization strategy.
Long-term,
the Company intends to consider resuming research efforts with respect to other products and technologies, such as Gamma Gel and Alpha
Gel intended to help improve the diagnosis and treatment of cancer and other illnesses. These long-term goals are subject to the Company:
(1) receiving adequate funding; (2) receiving regulatory approval for RadioGel™ and other precision radionuclide therapy
products; and (3) being able to successfully commercialize its precision radionuclide therapy products.
Based
on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed
substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and
has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to
delay the implementation of its business strategy and may not be able to continue operations.
The
Company’s headquarters are in the State of Washington., The initial focus of the animal therapy market has been the Northwestern
sector of the United States. The Company has initiated marketing efforts to the animal therapy market in other regions of the United
States, attempting to increase the exposure to our product and increase revenue opportunities.
There
are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products,
the current level of cash will not be enough to cover the fixed and variable obligations of the Company. The Company has focused on operating
on minimum overhead, including using a virtual office for the last several years and retaining experienced industry consultants available
on an as needed basis. This has helped focus the capital received from the Company’s Regulation A+ Offerings on activities that
enhance our objectives.
There
is no guarantee that the Company will be able to raise additional funds or to do so on terms advantageous to the Company’s stockholders.
The
financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary
should the Company be unable to continue as a going concern. The Company’s continuation as a going concern is dependent upon its
ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain profitability. The Company
plans to seek additional funding to maintain its operations through debt and equity financing and to improve operating performance through
a focus on strategic products and increased efficiencies in business processes and improvements to the cost structure. There can be no
assurance that the Company will be successful in its efforts to raise additional working capital or achieve profitable operations. The
financial statements do not include any adjustments that might result from the outcome of this uncertainty.
|
Use of Estimates |
Use
of Estimates
The
preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at
the date of financial statements and the reported amount of revenue and expense during the reporting period. Estimates the Company considers
include criteria for stock-based compensation expense, and valuation allowances on deferred tax assets. Actual results could differ from
those estimates.
|
Cash Equivalents |
Cash
Equivalents
For
the purposes of the statement of cash flows, the Company considers all highly liquid debt instruments purchased with an original maturity
of three months or less to be cash equivalents.
The
Company occasionally maintains cash balances in excess of the FDIC insured limit. The Company does not consider this risk to be material.
|
Fair Value of Financial Instruments |
Fair
Value of Financial Instruments
Fair
value of financial instruments requires disclosure of the fair value information, whether or not recognized in the balance sheet, where
it is practicable to estimate that value. As of December 31, 2024 and 2023, the balances reported for cash, prepaid expense,
accounts receivable, accounts payable, and accrued expense, approximate the fair value because of their short maturities.
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. Accounting Standards Codification (“ASC”) Topic 820 established a three-tier
fair value hierarchy which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted
quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs
(level 3 measurements). These tiers include:
Level
1, defined as observable inputs such as quoted prices for identical instruments in active markets;
Level
2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices
for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and
Level
3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions,
such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
The
Company measures certain financial instruments including options and warrants issued during the period at fair value on a recurring basis.
|
Patents and Intellectual Property |
Patents
and Intellectual Property
While
patents are being developed or pending, they are not being amortized. Management has determined that the economic life of the patents
to be ten years and amortization, over such 10-year period and on a straight-line basis will begin once the patents have been issued
and the Company begins utilization of the patents through production and sales, resulting in revenues.
The
Company evaluates the recoverability of intangible assets, including patents and intellectual property on a continual basis. Several
factors are used to evaluate intangibles, including, but not limited to, management’s plans for future operations, recent operating
results and projected and expected undiscounted future cash flows.
There
have been no such capitalized costs in the years ended December 31, 2024 and 2023, respectively. However, a patent was
filed on July 1, 2019 (No. 1811.191) filed by Michael Korenko and David Swanberg and assigned to the Company based on the Company’s
proprietary particle manufacturing process. The timing of this filing was important given the Company’s plans to make IsoPet®
commercially available, which it did on or about July 9, 2019. This additional patent protection will strengthen the Company’s
competitive position. It is the Company’s intention to further extend this patent protection to several key countries within one
year, as permitted under international patent laws and treaties.
|
Revenue Recognition |
Revenue
Recognition
In
May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”)
No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue recognition
to be used across all industries and requires additional disclosures. The guidance introduces a five-step model to achieve its core principal
of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration
to which the entity expects to be entitled in exchange for those goods or services. The Company adopted the updated guidance effective
January 1, 2018 using the full retrospective method.
Under
ASC 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to perform respective
obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for the goods
transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration is probable.
The adoption of ASC 606 did not have an impact on the Company’s operations or cash flows.
The
Company recognized revenue as they (i) identified the contracts with each customer; (ii) identified the performance obligation in each
contract; (iii) determined the transaction price in each contract; (iv) were able to allocate the transaction price to the performance
obligations in the contract; and (v) recognized revenue upon the satisfaction of the performance obligation. Upon the sales of the product
to complete the procedures on the animals, the Company recognized revenue as that was considered the performance obligation.
The
Company in 2024 also implemented a license program for clinics that pay for certification to perform these therapies. These revenues
are recognized upon the certification being completed. During 2024, $4,995 of the revenue relates to this certification.
|
Loss Per Share |
Loss
Per Share
The
Company accounts for its loss per common share by replacing primary and fully diluted earnings per share with basic and diluted earnings
per share. Basic loss per share is computed by dividing loss available to common stockholders (the numerator) by the weighted-average
number of common shares outstanding (the denominator) for the period, and does not include the impact of any potentially dilutive Common
Stock equivalents since the impact would be anti-dilutive. The computation of diluted earnings per share is similar to basic earnings
per share, except that the denominator is increased to include the number of additional common shares that would have been outstanding
if potentially dilutive common shares had been issued. For the given periods of loss, of the periods ended in the years ended December
31, 2024 and 2023, the basic earnings per share equals the diluted earnings per share.
The
following represent Common Stock equivalents that could be dilutive in the future as December 31, 2024 and 2023, which include the following:
SCHEDULE
OF DILUTIVE EARNINGS PER SHARE
| |
December 31,
2024 | | |
December 31,
2023 | |
Preferred stock | |
| 7,409,570 | | |
| 9,909,570 | |
Restricted stock units | |
| 22,725,000 | | |
| 1,450,000 | |
Common stock options | |
| 2,252,809 | | |
| 2,252,809 | |
Common stock warrants | |
| 11,465,000 | | |
| 26,134,000 | |
Total potential dilutive securities | |
| 43,852,379 | | |
| 39,746,379 | |
|
Research and Development Costs |
Research
and Development Costs
Research
and developments costs, including salaries, research materials, administrative expense and contractor fees, are charged to operations
as incurred. The cost of equipment used in research and development activities which has alternative uses is capitalized as part of fixed
assets and not treated as an expense in the period acquired. Depreciation of capitalized equipment used to perform research and development
is classified as research and development expense in the year computed.
The
Company incurred $324,629 and $732,698 in research and development costs for the years ended December 31, 2024 and 2023, respectively,
all of which were recorded in the Company’s operating expense noted on the statements of operations for the periods then ended.
|
Advertising and Marketing Costs |
Advertising
and Marketing Costs
Advertising
and marketing costs are expensed as incurred except for the cost of tradeshows which are deferred until the tradeshow occurs. During
the years ended December 31, 2024 and 2023, the Company incurred nominal advertising and marketing costs.
|
Contingencies |
Contingencies
In
the ordinary course of business, the Company is involved in legal proceedings involving contractual and employment relationships, product
liability claims, patent rights, and a variety of other matters. The Company records contingent liabilities resulting from asserted and
unasserted claims against it, when it is probable that a liability has been incurred and the amount of the loss is reasonably estimable.
The Company discloses contingent liabilities when there is a reasonable possibility that the ultimate loss will exceed the recorded liability.
Estimated probable losses require analysis of multiple factors, in some cases including judgments about the potential actions of third-party
claimants and courts. Therefore, actual losses in any future period are inherently uncertain. The Company has entered into various agreements
that require them to pay certain fees to consultants and/or employees that have been fully accrued for as of December 31, 2024 and 2023.
|
Income Taxes |
Income
Taxes
To
address accounting for uncertainty in tax positions, the Company clarifies the accounting for income taxes by prescribing a minimum recognition
threshold that a tax position is required to meet before being recognized in the financial statements. The Company also provides guidance
on de-recognition, measurement, classification, interest, and penalties, accounting in interim periods, disclosure and transition.
The
Company files income tax returns in the U.S. federal jurisdiction. The Company did not have any tax expense for the years ended December
31, 2024 and 2023. The Company did not have any deferred tax liability or asset on its balance sheets as of December 31, 2024 and 2023.
Interest
costs and penalties related to income taxes, if any, will be classified as interest expense and general and administrative costs, respectively,
in the Company’s financial statements. For the years ended December 31, 2024 and 2023, the Company did not recognize any interest
or penalty expense related to income taxes. The Company believes that it is not reasonably possible for the amounts of unrecognized tax
benefits to significantly increase or decrease within the next twelve months.
|
Stock-Based Compensation |
Stock-Based
Compensation
The
Company recognizes compensation costs under FASB ASC Topic 718, Compensation – Stock Compensation and ASU 2018-07. Companies are
required to measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize
the costs in the financial statements over the period during which employees are required to provide services. Share based compensation
arrangements include stock options, restricted share plans, performance-based awards, share appreciation rights and employee share purchase
plans. As such, compensation cost is measured on the date of grant at their fair value. Such compensation amounts, if any, are amortized
over the respective vesting periods of the option grant.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
The
Company does not discuss recent pronouncements that are not anticipated to have an impact on or are unrelated to its financial condition,
results of operations, cash flows or disclosures.
In November 2023, the Financial Accounting Standards Board issued Accounting Standards Update 2023-07 (“ASU
2023-07”). ASU 2023-07 improves segment reporting disclosures for public companies. ASU 2023-07 requires more detailed information
about reportable segments and expenses including the requirement to disclose qualitative information about factors used to identify reportable
segments and quantitative information about profit and loss measures and significant expense categories. ASU 2023-07 was effective for
public companies in fiscal years beginning after December 15, 2023. The Company has not yet begun generating significant revenue from its planned principal operations and operates as
a single reportable segment. The chief operating decision maker is the Company’s chief executive officer who assesses performance
based on total expenses, cash flows, and progress made in the Company’s ongoing development efforts. All of the Company’s
long-lived assets are located in the United States. The Company analyzed ASU 2023-07 and determined that the required
information is presented within the consolidated financial statements and footnote disclosures herein. The Company does not believe that
ASU 2023-07 will have a material impact on the consolidated financial statements.
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v3.25.1
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
12 Months Ended |
Dec. 31, 2024 |
Accounting Policies [Abstract] |
|
SCHEDULE OF DILUTIVE EARNINGS PER SHARE |
The
following represent Common Stock equivalents that could be dilutive in the future as December 31, 2024 and 2023, which include the following:
SCHEDULE
OF DILUTIVE EARNINGS PER SHARE
| |
December 31,
2024 | | |
December 31,
2023 | |
Preferred stock | |
| 7,409,570 | | |
| 9,909,570 | |
Restricted stock units | |
| 22,725,000 | | |
| 1,450,000 | |
Common stock options | |
| 2,252,809 | | |
| 2,252,809 | |
Common stock warrants | |
| 11,465,000 | | |
| 26,134,000 | |
Total potential dilutive securities | |
| 43,852,379 | | |
| 39,746,379 | |
|
X |
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v3.25.1
COMMON STOCK OPTIONS, WARRANTS AND RESTRICTED STOCK UNITS (Tables)
|
12 Months Ended |
Dec. 31, 2024 |
Equity [Abstract] |
|
SCHEDULE OF CHANGES IN STOCK OPTION |
The
following schedule summarizes the changes in the Company’s stock options:
SCHEDULE
OF CHANGES IN STOCK OPTION
| |
Options
Outstanding | | |
Weighted
Average Remaining | | |
| | |
Weighted
Average | |
| |
Number
Of Shares | | |
Exercise
Price Per Share | | |
Contractual
Life | | |
Aggregate
Intrinsic Value | | |
Exercise
Price Per Share | |
Year Ended December
31, 2024 | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Outstanding at January 1, 2024 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 5.70
years | | |
$ | 78,886 | | |
$ | 0.04 | |
Granted | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Exercised | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Expired/cancelled | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Outstanding at December
31, 2024 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 4.70
years | | |
$ | 174,855 | | |
$ | 0.04 | |
Exercisable at December
31, 2024 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 4.70
years | | |
$ | 174,855 | | |
$ | 0.04 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Year Ended December
31, 2023 | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Outstanding at January 1, 2023 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 6.70
years | | |
$ | 16,032 | | |
$ | 0.04 | |
Granted | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Exercised | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Expired/cancelled | |
| - | | |
$ | - | | |
| - | | |
| | | |
$ | - | |
Outstanding at December
31, 2023 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 5.70
years | | |
$ | 78,886 | | |
$ | 0.04 | |
Exercisable at December
31, 2023 | |
| 2,252,809 | | |
$ | 0.024-0.04 | | |
| 5.70
years | | |
$ | 78,886 | | |
$ | 0.04 | |
|
SCHEDULE OF CHANGES IN STOCK WARRANTS |
The
following schedule summarizes the changes in the Company’s stock warrants:
SCHEDULE
OF CHANGES IN STOCK WARRANTS
| |
Warrants
Outstanding | | |
Weighted
Average Remaining | | |
| | |
Weighted
Average | |
| |
Number
Of Shares | | |
Exercise
Price Per Share | | |
Contractual
Life | | |
Aggregate
Intrinsic Value | | |
Exercise
Price Per Share | |
Years Ended
December 31, 2024 | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Outstanding at January 1, 2024 | |
| 26,134,000 | | |
$ | 0.06-0.10 | | |
| 3.54
years | | |
$ | - | | |
$ | 0.0827 | |
Granted | |
| 18,950,000 | | |
$ | 0.075 | | |
| - | | |
$ | - | | |
$ | - | |
Redeemed | |
| (500,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Exercised | |
| (28,619,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Exchanged | |
| (5,000,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Outstanding at December 31, 2024 | |
| 11,465,000 | | |
$ | 0.13 | | |
| 3
years | | |
$ | 123,690 | | |
$ | 0.13 | |
Exercisable at December 31, 2024 | |
| 11,465,000 | | |
$ | 0.13 | | |
| 3
years | | |
$ | 123,690 | | |
$ | 0.13 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Years Ended
December 31, 2023 | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Outstanding at January 1, 2023 | |
| 26,737,500 | | |
$ | 0.06-0.10 | | |
| 1.52
years | | |
$ | - | | |
$ | 0.09 | |
Granted | |
| 28,799,000 | | |
$ | 0.0827 | | |
| - | | |
$ | - | | |
$ | - | |
Redeemed | |
| (500,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Exercised | |
| (7,663,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Exchanged | |
| (10,002,000 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Expired/cancelled | |
| (11,237,500 | ) | |
$ | - | | |
| - | | |
$ | - | | |
$ | - | |
Outstanding at December 31, 2023 | |
| 26,134,000 | | |
$ | 0.06-0.10 | | |
| 3.54
years | | |
$ | - | | |
$ | 0.0827 | |
Exercisable at December 31, 2023 | |
| 26,134,000 | | |
$ | 0.06-0.10 | | |
| 3.54
years | | |
$ | - | | |
$ | 0.0827 | |
|
SCHEDULE OF ASSUMPTIONS USED IN FAIR VALUE MEASUREMENT |
SCHEDULE
OF ASSUMPTIONS USED IN FAIR VALUE MEASUREMENT
|
|
|
Year
Ended |
|
|
|
Years
Ended |
|
|
|
|
December
31, 2024 |
|
|
|
December
31, 2023 |
|
Expected
term |
|
|
- |
|
|
|
- |
|
Expected
volatility |
|
|
- |
% |
|
|
- |
% |
Expected
dividend yield |
|
|
- |
|
|
|
- |
|
Risk-free
interest rate |
|
|
- |
% |
|
|
- |
% |
|
SCHEDULE OF CHANGES IN RESTRICTED STOCK UNITS |
The
following schedule summarizes the changes in the Company’s restricted stock units:
SCHEDULE
OF CHANGES IN RESTRICTED STOCK UNITS
| |
Number
Of Shares | | |
Weighted
Average Grant Date Fair Value | |
Year Ended December
31, 2024 | |
| | | |
| | |
| |
| | | |
| | |
Outstanding at January 1, 2024 | |
| 1,450,000 | | |
$ | 0.09 | |
Granted | |
| 21,850,000 | | |
$ | 0.08 | |
Vested | |
| (11,475,000 | ) | |
$ | - | |
Forfeited | |
| - | | |
$ | - | |
Outstanding at December 31, 2024 | |
| 11,825,000 | | |
$ | 0.08 | |
| |
| | | |
| | |
Year Ended December
31, 2023 | |
| | | |
| | |
| |
| | | |
| | |
Outstanding at January 1, 2023 | |
| 10,262,500 | | |
$ | 0.08 | |
Granted | |
| 6,900,000 | | |
$ | 0.068 | |
Vested | |
| (15,450,000 | ) | |
$ | - | |
Forfeited | |
| (262,500 | ) | |
$ | - | |
Outstanding at December
31, 2023 | |
| 1,450,000 | | |
$ | 0.09 | |
|
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v3.25.1
INCOME TAXES (Tables)
|
12 Months Ended |
Dec. 31, 2024 |
Income Tax Disclosure [Abstract] |
|
SCHEDULE OF NET DEFERRED TAX ASSETS |
Net
deferred tax assets consist of the following components as of December 31, 2024 and 2023:
SCHEDULE
OF NET DEFERRED TAX ASSETS
| |
December
31,
2024 | | |
December
31,
2023 | |
Deferred tax assets: | |
| | | |
| | |
Net operating loss carryover | |
$ | 7,260,000 | | |
$ | 6,840,000 | |
Capital Loss Carryover | |
| 3,400 | | |
| 3,400 | |
Valuation allowance | |
| (7,263,400 | ) | |
| (6,843,400 | ) |
Net deferred tax asset | |
$ | - | | |
$ | - | |
|
SCHEDULE OF FEDERAL INCOME TAX RATE |
The
income tax provision differs from the amount of income tax determined by applying the U.S. Federal income tax rate to pretax income from
continuing operations for the years ended December 31, 2024 and 2023 due to the following:
SCHEDULE
OF FEDERAL INCOME TAX RATE
| |
December
31,
2024 | | |
December
31,
2023 | |
Book income (loss) | |
$ | (611,200 | ) | |
$ | (607,900 | ) |
Depreciation | |
| (1,100 | ) | |
| (1,100 | ) |
Stock for services | |
| 192,900 | | |
| 260,400 | |
Other non-deductible expense | |
| - | | |
| 6,300 | |
Valuation allowance | |
| 419,400 | | |
| 342,300 | |
Income tax expense | |
$ | - | | |
$ | - | |
|
X |
- DefinitionTabular disclosure of the federal tax basis of investment holdings. This item captures the aggregate cost of securities, aggregate gross unrealized appreciation for all securities in which there is an excess of value over tax cost, aggregate gross unrealized depreciation for all securities in which there is an excess of tax cost over value, net unrealized appreciation (depreciation), and an explanation of the differences between tax and book.
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v3.25.1
SCHEDULE OF DILUTIVE EARNINGS PER SHARE (Details) - shares
|
12 Months Ended |
Dec. 31, 2024 |
Dec. 31, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total potential dilutive securities |
43,852,379
|
39,746,379
|
Preferred Stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total potential dilutive securities |
7,409,570
|
9,909,570
|
Restricted Stock Units (RSUs) [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total potential dilutive securities |
22,725,000
|
1,450,000
|
Equity Option [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total potential dilutive securities |
2,252,809
|
2,252,809
|
Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total potential dilutive securities |
11,465,000
|
26,134,000
|
X |
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v3.25.1
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
|
1 Months Ended |
12 Months Ended |
Jul. 17, 2024 |
Dec. 31, 2023 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
|
|
Current operating activities |
|
|
$ 2,500,000
|
|
Sale of common stock |
|
|
7,250,000
|
|
Current operating activities |
|
|
(1,684,039)
|
$ (1,293,023)
|
Cash on hand |
|
|
$ 2,212,548
|
|
Economic life of the patent |
|
|
10 years
|
|
Revenue relates to certification |
|
|
$ 4,995
|
|
Research and development costs |
|
|
324,629
|
$ 732,698
|
Brachytherapy Product Line [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Current operating activities |
|
|
$ 5,000,000
|
|
Offering term |
|
|
Over
the next 12 to 48 months, the Company believes it will cost approximately $9 million to: (1) fund the FDA approval process to conduct
human clinical trials; (2) conduct Phase I, pilot, and clinical trials; (3) activate several regional clinics to administer IsoPet®
across the county; (4) create an independent production center within the current production site to create a template for future
international manufacturing; and (5) initiate regulatory approval processes outside of the United States. The proceeds to be raised from
the Regulation A+ Offerings will be used to continue to fund this development.
|
|
Radionuclide Therapy Product Line [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Current operating activities |
|
|
$ 2,500,000
|
|
Offering term |
|
|
Over
the next 36 months, the Company believes it will cost approximately $8.0 to $9.0 million to: (1) fund the FDA approval process to conduct
human clinical trials; (2) conduct Phase I, pilot, clinical trials; (3) activate several regional clinics to administer IsoPet®
across the U.S.; (4) create an independent production center within the current production site to create a template for future
international manufacturing; and (5) initiate regulatory approval processes outside of the United States.
|
|
Warrant [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Number of common stock shares issued, shares |
|
4,998,000
|
|
|
Number of warrants issued |
|
18,797,000
|
|
18,797,000
|
Common Stock [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Number of common stock shares issued, value |
|
|
$ 2,266,000
|
|
Number of common stock shares issued, shares |
|
2,499,000
|
24,950,000
|
|
Common Stock [Member] | Maximum [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Number of common stock shares issued, value |
$ 60,000,000
|
|
|
|
Private Placement [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Number of common stock shares issued, value |
|
|
|
$ 1,179,245
|
Number of common stock shares issued, shares |
|
|
|
16,132,000
|
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v3.25.1
SCHEDULE OF CHANGES IN STOCK OPTION (Details) - USD ($)
|
12 Months Ended |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Exercise Price Per Share Outstanding, Beginning Balance |
2,252,809
|
2,252,809
|
|
Weighted Average Remaining Contractual Life, Outstanding |
4 years 8 months 12 days
|
5 years 8 months 12 days
|
6 years 8 months 12 days
|
Aggregate Intrinsic Value Outstanding, Beginning |
$ 78,886
|
$ 16,032
|
|
Weighted Average Exercise Price Per Share Outstanding, Beginning |
$ 0.04
|
$ 0.04
|
|
Number of Options, Granted |
|
|
|
Exercise Price Per Share, Granted |
|
|
|
Weighted Average Exercise Price Per Share Options, Granted |
|
|
|
Number of Options, Exercised |
|
|
|
Exercise Price Per Share, Exercised |
|
|
|
Weighted Average Exercise Price Per Share Options, Exercised |
|
|
|
Number of Options, Expired/cancelled |
|
|
|
Exercise Price Per Share, Expired/cancelled |
|
|
|
Weighted Average Exercise Price Per Share Options, Expired/cancelled |
|
|
|
Number of Options Outstanding, Ending Balance |
2,252,809
|
2,252,809
|
2,252,809
|
Aggregate Intrinsic Value Outstanding, Ending |
$ 174,855
|
$ 78,886
|
$ 16,032
|
Weighted Average Exercise Price Per Share Outstanding, Ending |
$ 0.04
|
$ 0.04
|
$ 0.04
|
Number of Options, Exercisable |
2,252,809
|
2,252,809
|
|
Weighted Average Remaining Contractual Life, Exercisable |
4 years 8 months 12 days
|
5 years 8 months 12 days
|
|
Aggregate Intrinsic Value, Exercisable |
$ 174,855
|
$ 78,886
|
|
Weighted Average Exercise Price Per Share, Exercisable |
$ 0.04
|
$ 0.04
|
|
Minimum [Member] |
|
|
|
Exercise Price Per Share Outstanding, Beginning Balance |
0.024
|
0.024
|
|
Exercise Price Per Share Outstanding, Ending |
0.024
|
0.024
|
0.024
|
Exercise Price Per Share, Exercisable |
0.024
|
0.024
|
|
Maximum [Member] |
|
|
|
Exercise Price Per Share Outstanding, Beginning Balance |
0.04
|
0.04
|
|
Exercise Price Per Share Outstanding, Ending |
0.04
|
0.04
|
$ 0.04
|
Exercise Price Per Share, Exercisable |
$ 0.04
|
$ 0.04
|
|
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v3.25.1
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($)
|
|
|
|
|
1 Months Ended |
12 Months Ended |
|
|
Dec. 16, 2024 |
Mar. 27, 2019 |
Oct. 10, 2018 |
Jun. 30, 2015 |
Dec. 31, 2023 |
Oct. 31, 2023 |
Apr. 30, 2023 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Mar. 31, 2016 |
Mar. 30, 2016 |
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares authorized |
|
|
|
|
950,000,000
|
|
|
950,000,000
|
950,000,000
|
|
|
Common stock, shares issued |
|
|
|
|
387,894,033
|
|
|
440,873,806
|
387,894,033
|
|
|
Common stock, shares outstanding |
|
|
|
|
387,894,033
|
|
|
440,873,806
|
387,894,033
|
|
|
Preferred stock, shares authorized |
|
|
|
|
20,000,000
|
|
|
20,000,000
|
20,000,000
|
|
|
Preferred stock, par value |
|
|
|
|
$ 0.001
|
|
|
$ 0.001
|
$ 0.001
|
|
|
Number of shares issued |
|
|
|
|
|
|
|
24,950,000
|
|
|
|
Proceeds from issuance of common stock |
|
|
|
|
|
|
|
$ 2,266,000
|
|
|
|
Issued for services, shares |
|
|
|
|
|
|
|
605,801
|
|
|
|
Issued for services, value |
|
|
|
|
|
|
|
$ 88,925
|
|
|
|
Number of shares issued, value on accounts payable |
|
|
|
|
|
|
|
$ 2,266,000
|
$ 1,160,448
|
|
|
Accounts Payable [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
500,000
|
|
|
|
|
|
|
Number of shares issued, value on accounts payable |
|
|
|
|
$ 28,450
|
|
|
|
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Issued for common stock RSU |
|
|
|
|
|
|
|
750,000
|
|
|
|
Restricted Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares vested |
|
|
|
|
400,000
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Shares issued |
2,500,000
|
|
|
|
|
|
|
2,500,000
|
|
|
|
Number of shares issued |
|
|
|
|
8,132,000
|
2,221,505
|
8,000,000
|
24,950,000
|
16,132,000
|
|
|
Issued for services, shares |
|
|
|
|
|
|
|
605,801
|
|
|
|
Issued for services, value |
|
|
|
|
|
|
|
$ 606
|
|
|
|
Issued for common stock warrant exercise |
|
|
|
|
|
|
|
20,336,472
|
|
|
|
Issued for common stock RSU |
|
|
|
|
|
|
|
750,000
|
4,000,000
|
|
|
Number of shares issued, value on accounts payable |
|
|
|
|
|
|
$ 640,000
|
$ 24,950
|
$ 16,132
|
|
|
Proceeds from issuance of warrants |
|
|
|
|
|
|
$ 10,665
|
|
|
|
|
Warrants exercise shares |
|
|
|
|
|
|
|
33,619,000
|
|
|
|
Common stock additional offering |
|
|
|
|
$ 528,580
|
|
|
|
$ 528,580
|
|
|
Securities in cashless exchange |
|
|
|
|
2,499,000
|
|
|
24,950,000
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
8,132,000
|
|
|
|
|
|
|
Issued for common stock warrant exercise |
|
|
|
|
|
|
|
5,000,000
|
|
|
|
Issued for cashless exercise, warrants |
|
|
|
|
|
|
|
28,619,000
|
|
|
|
Stock exchange of warrants |
|
|
|
|
|
|
|
5,000,000
|
|
|
|
Recognized loss exchange |
|
|
|
|
|
|
|
$ 381,000
|
|
|
|
Warrants exercise shares |
|
|
|
|
|
2,132,000
|
|
|
|
|
|
Securities in cashless exchange |
|
|
|
|
4,998,000
|
|
|
|
|
|
|
Gain loss on exchange |
|
|
|
|
$ 151,184
|
|
|
|
|
|
|
New Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Securities in cashless exchange |
|
|
|
|
10,002,000
|
|
|
|
|
|
|
Series A Convertible Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
|
2,500,000
|
5,000,000
|
|
|
5,000,000
|
5,000,000
|
5,000,000
|
2,500,000
|
Preferred stock, par value |
|
|
|
$ 0.001
|
|
|
|
|
|
|
|
Preferred stock, shares issued |
|
|
|
|
2,071,007
|
|
|
2,071,007
|
2,071,007
|
|
|
Preferred stock, shares outstanding |
|
|
|
|
2,071,007
|
|
|
2,071,007
|
2,071,007
|
|
|
Preferred stock, liquidation preference per share |
|
|
|
5.00
|
|
|
|
|
|
|
|
Conversion price per share |
|
|
|
$ 4.00
|
|
|
|
|
|
|
|
Gross proceeds from preferred stock |
|
|
|
$ 5,000,000.0
|
|
|
|
|
|
|
|
Preferred stock redemption, description |
|
|
|
Subject to certain conditions set forth in the Series A COD, in the event of a Change of Control (defined in the Series A COD), or at
such time as a third party not affiliated with the Company or any holders of the Series A Preferred shall have acquired, in one or a
series of related transactions, equity securities of the Company representing more than fifty percent (50%) of the outstanding voting
securities of the Company), the Company, at its option, will have the right to redeem all or a portion of the outstanding Series A Preferred
in cash at a price per share of Series A Preferred equal to 100% of the Liquidation Preference.
|
|
|
|
|
|
|
|
Redemption percentage |
|
|
|
100.00%
|
|
|
|
|
|
|
|
Voting percentage |
|
|
|
Holders of Series A Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
equivalent of five votes for every Series A Conversion Share issuable upon conversion of such holder’s outstanding shares of Series
A Preferred. However, the Series A Conversion Shares, when issued, will have all the same voting rights as other issued and outstanding
Common Stock of the Company, and none of the rights of the Series A Preferred.
|
|
|
|
|
|
|
|
Series B Convertible Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
5,000,000
|
|
5,000,000
|
|
|
5,000,000
|
5,000,000
|
|
|
Preferred stock, par value |
|
|
$ 0.001
|
|
|
|
|
|
|
|
|
Preferred stock, shares issued |
|
|
|
|
200,363
|
|
|
363
|
200,363
|
|
|
Preferred stock, shares outstanding |
|
|
|
|
200,363
|
|
|
363
|
200,363
|
|
|
Preferred stock, liquidation preference per share |
|
|
1.00
|
|
|
|
|
|
|
|
|
Conversion price per share |
|
|
$ 0.08
|
|
|
|
|
|
|
|
|
Preferred stock redemption, description |
|
|
Subject to certain conditions set forth in the Series B COD, in the event of a Change of Control (defined in the Series B COD), or at
such as a third party not affiliated with the Company or any holders of the Series B Convertible shall have acquired, in one or a series
of related transactions, equity securities of the Company representing more than fifty percent (50%) of the outstanding voting securities
of the Company), the Company, at its option, will have the right to redeem all or a portion of the outstanding Series B Preferred in
cash at a price per share of Series B Preferred equal to 100% of the Liquidation Preference.
|
|
|
|
|
|
|
|
|
Redemption percentage |
|
|
100.00%
|
|
|
|
|
|
|
|
|
Voting percentage |
|
|
Holders of Series B Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
equivalent of two votes for every Series B Conversion Share issuable upon conversion of such holder’s outstanding shares of Series
B Preferred. However, the Series B Conversion Shares, when issued, will have the same voting rights as other issued and outstanding shares
of Common Stock of the Company, and none of the rights of the Series A Preferred.
|
|
|
|
|
|
|
|
|
Shares converted |
200,000
|
|
|
|
|
|
|
200,000
|
|
|
|
Series C Convertible Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
5,000,000
|
|
|
5,000,000
|
|
|
5,000,000
|
5,000,000
|
|
|
Preferred stock, par value |
|
$ 0.001
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares issued |
|
|
|
|
385,302
|
|
|
385,302
|
385,302
|
|
|
Preferred stock, shares outstanding |
|
|
|
|
385,302
|
|
|
385,302
|
385,302
|
|
|
Preferred stock, liquidation preference per share |
|
1.00
|
|
|
|
|
|
|
|
|
|
Conversion price per share |
|
$ 0.08
|
|
|
|
|
|
|
|
|
|
Preferred stock redemption, description |
|
Subject to certain conditions set forth in the Series C COD, in the event of a Change of Control (defined in the Series C COD), or at
such time as a third party not affiliated with the Company or any holders of the Series C Preferred shall have acquired, in one or a
series of related transactions, equity securities of the Company representing more than fifty percent (50%) of the outstanding voting
securities of the Company), the Company, at its option, will have the right to redeem all or a portion of the outstanding Series C Preferred
in cash at a price per share of Series C Preferred equal to 100% of the Liquidation Preference.
|
|
|
|
|
|
|
|
|
|
Redemption percentage |
|
100.00%
|
|
|
|
|
|
|
|
|
|
Voting percentage |
|
Holders of Series C Preferred are entitled to vote on all matters, together with the holders of Common Stock, and have the
equivalent of thirty-two votes for every Series C Conversion Share issuable upon conversion of such holder’s outstanding shares
of Series C Preferred. However, the Series C Conversion Shares, when issued, will have the same voting rights as other issued and outstanding
shares of Common Stock of the Company, and none of the rights of the Series C Preferred.
|
|
|
|
|
|
|
|
|
|
Series A Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
|
2,665,000
|
|
|
|
|
Series B Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
|
8,000,000
|
|
|
|
|
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v3.25.1
SCHEDULE OF CHANGES IN STOCK WARRANTS (Details) - Warrant [Member] - USD ($)
|
|
1 Months Ended |
12 Months Ended |
Apr. 01, 2024 |
Nov. 30, 2024 |
Jan. 31, 2024 |
Apr. 30, 2023 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Number of Warrants Outstanding, Beginning |
|
|
26,134,000
|
|
26,134,000
|
26,737,500
|
|
Weighted Average Remaining Contractual Life Warrants Outstanding, Ending |
|
|
|
|
3 years
|
3 years 6 months 14 days
|
1 year 6 months 7 days
|
Aggregate Intrinsic Value Warrants, Beginning |
|
|
|
|
|
|
|
Weighted Average Exercise Price Per Share Warrants, Beginning |
|
|
$ 0.0827
|
|
$ 0.0827
|
$ 0.09
|
|
Number of Warrants, Granted |
5,000,000
|
|
2,000,000
|
10,665,000
|
18,950,000
|
28,799,000
|
|
Exercise Price Per Share Warrants, Granted |
|
$ 0.01
|
$ 0.075
|
$ 0.0775
|
$ 0.075
|
$ 0.0827
|
|
Weighted Average Exercise Price Per Share Warrants, Granted |
|
|
|
|
|
|
|
Number of Warrants, Redeemed |
|
|
|
|
|
(500,000)
|
|
Exercise Price Per Share Warrants, Exercised |
|
|
|
|
|
|
|
Number of Warrants, Exercised |
|
|
|
|
(28,619,000)
|
(7,663,000)
|
|
Number of Warrants, Expired/cancelled |
|
|
|
|
(5,000,000)
|
(11,237,500)
|
|
Exercise Price Per Share Warrants, Expired/cancelled |
|
|
|
|
|
|
|
Number of Warrants Outstanding, Ending |
|
|
|
|
11,465,000
|
26,134,000
|
26,737,500
|
Exercise Price Per Share Warrants Outstanding, Ending |
|
|
|
|
$ 0.13
|
|
|
Aggregate Intrinsic Value Warrants, Ending |
|
|
|
|
$ 123,690
|
|
|
Weighted Average Exercise Price Per Share Warrants, Ending |
|
|
|
|
$ 0.13
|
$ 0.0827
|
|
Number of Warrants, Exercisable |
|
|
|
|
11,465,000
|
26,134,000
|
|
Exercise Price Per Share Warrants, Exercisable |
|
|
|
|
$ 0.13
|
|
|
Weighted Average Remaining Contractual Life Warrants, Exercisable |
|
|
|
|
3 years
|
3 years 6 months 14 days
|
|
Aggregate Intrinsic Value Warrants, Exercisable |
|
|
|
|
$ 123,690
|
|
|
Weighted Average Exercise Price Per Share Warrants, Exercisable |
|
|
|
|
$ 0.13
|
$ 0.0827
|
$ 0.09
|
Number of Warrants, Exchanged |
|
|
|
|
|
(10,002,000)
|
|
Exercise Price Per Share Warrants, Exchanged |
|
|
|
|
|
|
|
Minimum [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Exercise Price Per Share Warrants Outstanding, Beginning |
|
|
0.06
|
|
0.06
|
0.06
|
|
Exercise Price Per Share Warrants Outstanding, Ending |
|
|
|
|
|
0.06
|
0.06
|
Exercise Price Per Share Warrants, Exercisable |
|
|
|
|
|
0.06
|
|
Maximum [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Exercise Price Per Share Warrants Outstanding, Beginning |
|
|
$ 0.10
|
|
$ 0.10
|
0.10
|
|
Exercise Price Per Share Warrants Outstanding, Ending |
|
|
|
|
|
0.10
|
$ 0.10
|
Exercise Price Per Share Warrants, Exercisable |
|
|
|
|
|
$ 0.10
|
|
X |
- DefinitionWeighted Average Exercise Price Per Share Exercise Price Warrants Granted.
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v3.25.1
SCHEDULE OF CHANGES IN RESTRICTED STOCK UNITS (Details) - Restricted Stock Units [Member] - $ / shares
|
12 Months Ended |
Dec. 31, 2024 |
Dec. 31, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Number of Shares, RSU's, Beginning |
1,450,000
|
10,262,500
|
Weighted Average Grant Date Fair Value, RSU's, Beginning |
$ 0.09
|
$ 0.08
|
Number of Shares, RSU's, Granted |
21,850,000
|
6,900,000
|
Weighted Average Grant Date Fair Value, RSU's, Granted |
$ 0.08
|
$ 0.068
|
Number of Shares, RSU's, Vested |
(11,475,000)
|
(15,450,000)
|
Weighted Average Grant Date Fair Value, RSU's, Vested |
|
|
Number of Shares, RSU's, Forfeited |
|
(262,500)
|
Weighted Average Grant Date Fair Value, RSU's, Forfeited |
|
|
Number of Shares, RSU's, Ending balance |
11,825,000
|
1,450,000
|
Weighted Average Grant Date Fair Value, RSU's, Ending |
$ 0.08
|
$ 0.09
|
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- DefinitionThe number of equity-based payment instruments, excluding stock (or unit) options, that were forfeited during the reporting period.
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v3.25.1
COMMON STOCK OPTIONS, WARRANTS AND RESTRICTED STOCK UNITS (Details Narrative) - USD ($)
|
|
|
|
|
|
|
|
|
1 Months Ended |
9 Months Ended |
12 Months Ended |
Dec. 31, 2025 |
Dec. 31, 2024 |
Nov. 30, 2024 |
Apr. 01, 2024 |
Jan. 01, 2024 |
Dec. 31, 2023 |
Aug. 04, 2023 |
May 01, 2023 |
Nov. 30, 2024 |
May 31, 2024 |
Jan. 31, 2024 |
Dec. 31, 2023 |
Apr. 30, 2023 |
Sep. 30, 2024 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from warrant exercise |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 19,350
|
|
Restricted stock expense vesting |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
918,350
|
1,239,950
|
Restricted stock expenses yet to be recognized |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
923,855
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from warrant exercise |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 19,350
|
|
Issued for common stock warrant exercise |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,336,468
|
|
Number of Shares, warrants granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,619,000
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 0
|
$ 0
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of warrants, granted |
|
|
|
5,000,000
|
|
|
|
|
|
|
2,000,000
|
|
10,665,000
|
|
18,950,000
|
28,799,000
|
Exercise price per share warrants granted |
|
|
|
|
|
|
|
|
$ 0.01
|
|
$ 0.075
|
|
$ 0.0775
|
|
$ 0.075
|
$ 0.0827
|
Weighted average remaining contractual term |
|
|
|
|
|
|
|
|
|
|
3 years
|
|
3 years
|
|
|
|
Proceeds from warrant exercise |
|
|
|
|
|
|
|
|
$ 11,950
|
|
|
|
|
|
|
|
Number of Shares, warrants granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28,619,000
|
7,663,000
|
Warrant [Member] | Expire in December 31, 2024 [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of warrants, granted |
|
|
|
|
|
|
|
|
11,950,000
|
|
|
|
|
|
|
|
Warrants expiration percentage |
|
|
|
|
|
|
|
|
30.00%
|
|
|
|
|
|
|
|
Warrant [Member] | Expire in December 27, 2027 [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price per share warrants granted |
|
|
$ 0.15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants expiration percentage |
|
|
|
|
|
|
|
|
70.00%
|
|
|
|
|
|
|
|
Restricted Stock Units [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of restricted shares unit granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,850,000
|
6,900,000
|
Restricted stock units vested |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,475,000
|
15,450,000
|
Restricted Stock Units [Member] | Chief Executive Officer [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of restricted shares unit granted |
|
|
|
|
20,000,000
|
|
|
|
|
|
|
|
|
|
|
|
Vest period |
|
|
|
|
2 years
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock units vested |
|
|
|
|
|
|
|
|
|
|
|
|
|
11,475,000
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of restricted shares unit granted |
|
|
|
|
|
|
|
2,900,000
|
|
|
|
4,000,000
|
|
|
|
|
Number of shares issued |
25.00%
|
25.00%
|
|
|
|
25.00%
|
|
25.00%
|
|
|
|
|
|
|
|
|
Restricted stock vested, value |
|
|
|
|
|
|
|
$ 263,900
|
|
|
|
|
|
|
|
|
Number of restricted shares unit granted, value |
|
|
|
|
|
|
|
|
|
|
|
$ 208,000
|
|
|
|
|
Restricted Stock Units (RSUs) [Member] | Chief Executive Officer [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock units vested |
|
|
|
|
|
|
1,012,500
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested, Number of Shares |
|
|
|
|
|
|
750,000
|
|
|
|
|
|
|
|
|
|
Restricted Stock Units (RSUs) [Member] | Consultants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of restricted shares unit granted |
|
|
|
|
|
|
|
|
|
1,050,000
|
|
|
|
|
|
|
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v3.25.1
COMMITMENT (Details Narrative) - Dr. Michael K. Korenko [Member] - USD ($)
|
Jan. 01, 2024 |
Jun. 04, 2019 |
Employment Agreement [Member] |
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
Agreement term description |
|
The employment term under the Employment Agreement commenced with an effective
date of June 11, 2019 and expires on December 31, 2020, and December 31 of each successive year if the Employment Agreement is extended,
unless terminated earlier as set forth in the Employment Agreement. On December 31, 2020, the Company extended the Employment Agreement
through December 31, 2021 while renegotiating terms of a new Employment Agreement. On May 3, 2021, the Company and the Chief Executive
Officer agreed the terms of a new Employment Agreement with an effective date of January 1, 2021 that has a term of three years and expired
December 31, 2023. The Company renewed the Employment Agreement for a term of two years expiring December 31, 2025.
|
Compensation amount |
$ 295,500
|
|
Discretionary bonus |
$ 10,000
|
|
Vest period |
2 years
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
Granted restricted stock units |
20,000,000
|
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v3.25.1
SCHEDULE OF NET DEFERRED TAX ASSETS (Details) - USD ($)
|
Dec. 31, 2024 |
Dec. 31, 2023 |
Deferred tax assets: |
|
|
Net operating loss carryover |
$ 7,260,000
|
$ 6,840,000
|
Capital Loss Carryover |
3,400
|
3,400
|
Valuation allowance |
(7,263,400)
|
(6,843,400)
|
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|
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v3.25.1
SCHEDULE OF FEDERAL INCOME TAX RATE (Details) - USD ($)
|
12 Months Ended |
Dec. 31, 2024 |
Dec. 31, 2023 |
Income Tax Disclosure [Abstract] |
|
|
Book income (loss) |
$ (611,200)
|
$ (607,900)
|
Depreciation |
(1,100)
|
(1,100)
|
Stock for services |
192,900
|
260,400
|
Other non-deductible expense |
|
6,300
|
Valuation allowance |
419,400
|
342,300
|
Income tax expense |
|
|
v3.25.1
X |
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