UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR
THE QUARTERLY PERIOD ENDED: March 31, 2026
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 000-53497
VIVOS
INC
(Exact
name of registrant as specified in its charter)
Delaware
80-0138937
(State
or other jurisdiction
of
incorporation or organization)
(I.R.S.
Employer
Identification
No.)
1030
N Center Parkway ,
Kennewick ,
WA 99336
(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
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. (Check one):
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 company 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 Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of May 14, 2026, there were 493,890,608 shares of the registrant’s common stock outstanding.
TABLE
OF CONTENTS
Page
PART I – FINANCIAL INFORMATION
Item 1.
Financial Statements
3
Condensed Consolidated Balance Sheets as of March 31, 2026 (unaudited) and December 31, 2025
3
Condensed Consolidated Statements of Operations for the Three Months ended March 31, 2026 and 2025 (unaudited)
4
Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three Months ended March 31, 2026 and 2025 (unaudited)
5
Condensed Consolidated Statements of Cash Flow for the Three Months ended March 31, 2026 and 2025 (unaudited)
6
Notes to Condensed Consolidated Financial Statements (unaudited)
7
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
24
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
44
Item 4.
Controls and Procedures
44
PART II – OTHER INFORMATION
Item 1.
Legal Proceedings
45
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
45
Item 6.
Exhibits
45
SIGNATURES
46
2
PART
I – FINANCIAL INFORMATION
VIVOS
INC
CONDENSED
CONSOLIDATED BALANCE SHEETS
MARCH
31, 2026 (UNAUDITED) AND DECEMBER 31, 2025
MARCH 31,
DECEMBER 31,
2026
2025
(UNAUDITED)
ASSETS
Current Assets:
Cash
$ 2,525,782
$ 1,558,525
Accounts receivable
7,668
22,331
Inventory
56,863
57,257
Prepaid expenses
9,073
12,956
Total Current Assets
2,599,386
1,651,069
Fixed assets, net
244,055
102,811
Other Assets:
Right of use assets
104,064
110,703
Other assets
3,000
3,000
Total Other Assets
107,064
113,703
TOTAL ASSETS
$ 2,950,505
$ 1,867,583
LIABILITIES AND STOCKHOLDERS’ EQUITY
LIABILITIES
Current Liabilities:
Accounts payable and accrued expenses
$ 143,602
$ 92,472
Current portion of lease liability
28,135
25,420
Total Current Liabilities
171,737
117,892
Non-current Liabilities:
Lease liability, net of current portion
81,458
88,851
Total Non-current Liabilities
81,458
88,851
Total Liabilities
253,195
206,743
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 shares issued and outstanding,
respectively
-
-
Additional paid in capital - Series B Convertible preferred stock
4,538
4,538
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, 482,840,608 and 455,494,238 issued and
outstanding, respectively
482,841
455,494
Additional paid in capital - common stock
82,476,601
80,282,633
Accumulated deficit
( 89,612,091 )
( 88,427,246 )
Total Stockholders’ Equity
2,697,310
1,660,840
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 2,950,505
$ 1,867,583
The accompanying notes are an integral part of these
condensed consolidated financial statements.
3
VIVOS
INC
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
FOR
THE THREE MONTHS ENDED MARCH 31, 2026 AND 2025
MARCH 31,
MARCH 31,
2026
2025
Revenues, net
$ 36,068
$ 26,748
Cost of Goods Sold
44,086
35,831
Gross loss
( 8,018 )
( 9,083 )
OPERATING EXPENSES
Professional fees, including stock-based compensation
285,432
588,268
Payroll expenses
155,434
94,697
Research and development
37,923
119,281
General and administrative expenses
58,685
52,203
Total Operating Expenses
537,474
854,449
OPERATING LOSS
( 545,492 )
( 863,532 )
NON-OPERATING INCOME
Interest income
12,275
28,836
Loss on issuance of shares and warrant exchange
( 651,628 )
-
Total Non-Operating Income
( 639,353 )
28,836
NET LOSS BEFORE PROVISION FOR INCOME TAXES
( 1,184,845 )
( 834,696 )
Provision for income taxes
-
-
NET LOSS
$ ( 1,184,845 )
$ ( 834,696 )
Net loss per share - basic and diluted
$ ( 0.00 )
$ ( 0.00 )
Weighted average common shares outstanding
462,160,317
448,234,917
The accompanying notes are an integral part of these
condensed consolidated financial statements.
4
VIVOS
INC
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (UNAUDITED)
FOR
THE THREE MONTHS ENDED MARCH 31, 2026 AND 2025
Series A Preferred
Additional Paid-In
Capital -Series A
Series B Preferred
Additional Paid-In
Capital - Series B
Series C Preferred
Additional Paid-In
Capital - Series C
Common Stock
Additional Paid-In
Capital -
Subscription
Accumulated
Shares
Amount
Preferred
Shares
Amount
Preferred
Shares
Amount
Preferred
Shares
Amount
Common
Receivable
Deficit
Total
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
Stock issued for:
Cash
-
-
-
-
-
-
-
-
-
12,500,000
12,500
1,487,500
-
-
1,500,000
Services
-
-
-
-
-
-
-
-
-
38,422
38
4,650
-
-
4,688
Exercise
of warrants (cash and cashless)
-
-
-
-
-
-
-
-
-
-
-
-
( 1,500 )
-
( 1,500 )
Warrants purchased for cash
-
-
-
-
-
-
-
-
-
-
-
6,250
-
-
6,250
RSUs granted to consultants
that have vested
-
-
-
-
-
-
-
-
-
-
-
361,500
-
-
361,500
Net loss for the period
-
-
-
-
-
-
-
-
-
-
-
-
-
( 834,696 )
( 834,696 )
Balance - March 31, 2025
2,071,007
$ 2,071
$ 8,842,458
363
$ -
$ 4,538
385,302
$ 385
$ 500,507
453,412,228
$ 453,412
$ 79,579,043
$ ( 3,000 )
$ ( 86,195,925 )
$ 3,183,489
Balance - December 31, 2025
2,071,007
$ 2,071
$ 8,842,458
363
$ -
$ 4,538
385,302
$ 385
$ 500,507
455,494,238
$ 455,494
$ 80,282,633
$ -
$ ( 88,427,246 )
$ 1,660,840
Balance
2,071,007
$ 2,071
$ 8,842,458
363
$ -
$ 4,538
385,302
$ 385
$ 500,507
455,494,238
$ 455,494
$ 80,282,633
$ -
$ ( 88,427,246 )
$ 1,660,840
Stock issued for:
Cash
-
-
-
-
-
-
-
-
-
19,200,000
19,200
1,516,800
-
-
1,536,000
Services
-
-
-
-
-
-
-
-
-
196,370
197
16,490
-
-
16,687
Exercise/Exchange
of warrants (cash and cashless)
-
-
-
-
-
-
-
-
-
7,950,000
7,950
643,678
-
-
651,628
Vested
RSUs
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Warrants purchased for cash
-
-
-
-
-
-
-
-
-
-
-
17,000
-
-
17,000
RSUs granted to consultants
that have vested
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Net loss for the period
-
-
-
-
-
-
-
-
-
-
-
-
-
( 1,184,845 )
( 1,184,845 )
Balance - March 31, 2026
2,071,007
$ 2,071
$ 8,842,458
363
$ -
$ 4,538
385,302
$ 385
$ 500,507
482,840,608
$ 482,841
$ 82,476,601
$ -
$ ( 89,612,091 )
$ 2,697,310
Balance
2,071,007
$ 2,071
$ 8,842,458
363
$ -
$ 4,538
385,302
$ 385
$ 500,507
482,840,608
$ 482,841
$ 82,476,601
$ -
$ ( 89,612,091 )
$ 2,697,310
The
accompanying notes are an integral part of these condensed consolidated financial statements.
.
5
VIVOS
INC
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
FOR
THE THREE MONTHS ENDED MARCH 31, 2026 AND 2025
2026
2025
CASH FLOW FROM OPERTING ACTIVIITES
Net loss
$ ( 1,184,845 )
$ ( 834,696 )
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation
9,961
-
Common stock, stock options and warrants for services
16,687
4,688
RSUs issued for services
-
361,500
Loss on issuance of shares and warrant exchange
651,628
-
Changes in assets and liabilities
Accounts receivable
14,663
1,622
Inventory
394
( 21,198 )
Prepaid expenses and other assets
3,883
3,717
Accounts payable and accrued expenses
51,129
29,169
Operating lease expense
6,639
-
Total adjustments
754,984
379,498
Net cash used in operating activities
( 429,861 )
( 455,198 )
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of fixed assets
( 151,205 )
-
Net cash (used in) investing activities
( 151,205 )
-
CASH FLOWS FROM FINANCING ACTIVITES
Payments of lease liability
( 4,677 )
-
Exercise of warrants
-
1,500
Proceeds from common stock and warrants
1,553,000
1,506,250
Net cash provided by financing activities
1,548,323
1,507,750
NET INCREASE IN CASH
967,257
1,052,552
CASH - BEGINNING OF PERIOD
1,558,525
2,212,548
CASH - END OF PERIOD
$ 2,525,782
$ 3,265,100
CASH PAID DURING THE PERIOD FOR:
Interest expense
$ -
$ -
Income taxes
$ -
$ -
The accompanying notes are an integral part of these
condensed consolidated financial statements.
6
VIVOS
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
1: BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
The
accompanying condensed financial statements of Vivos Inc. (the “ Company ”) have been prepared without audit, pursuant
to the rules and regulations of the Securities and Exchange Commission (“ SEC ”). Certain information and disclosures
required by accounting principles generally accepted in the United States have been condensed or omitted pursuant to such rules and regulations.
These condensed financial statements reflect all adjustments that, in the opinion of management, are necessary to present fairly the
results of operations of the Company for the period presented. The results of operations for the three months ended March 31, 2026, are
not necessarily indicative of the results that may be expected for any future period or the fiscal year ending December 31, 2026 and
should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the
SEC on March 31, 2026.
Vivos
Inc. (the “ Company ,” “ we ,” “ us ,” “ our ”) is a radiation oncology
medical device company engaged in the development of its yttrium-90 (“ Y-90 ”) based precision radionuclide therapy
device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide Therapy™. A prominent
team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories, universities,
and private corporations, lead the Company’s development efforts. The Company’s overall vision is to globally empower physicians,
medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments for cancer.
In
2013, the United States Food and Drug Administration (“ FDA ”) issued the determination that RadioGel™ is a device
for human therapy for non-resectable cancers in humans. This should result in a faster path than a drug for final approval.
In
January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel™ should be classified as a device
for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company believes that
the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas, but rather
may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals. We expect the result
of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet ®
for the treatment of solid tumors in animals. The FDA does not have premarket authority over devices with a veterinary classification,
and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance
with all applicable laws and regulations.
Based
on the FDA’s recommendation, RadioGel™ is being marketed as “IsoPet ® ” for use by veterinarians
to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet ® ”
name. IsoPet ® and RadioGel™ are used synonymously throughout this document. The only distinction between IsoPet ®
and RadioGel™ is the FDA’s recommendation that we use “IsoPet ® ” for veterinarian usage,
and reserve “RadioGel™” 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.
7
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.
We
refer you to Item 2– Management’s Discussion and Analysis of Financial Condition and Results of Operations of this
Form 10-Q for more information about our business.
On
September 17, 2025, the Board of Directors of the Company approved the creation of Vivos Scientific India LLP (“Vivos India”
or the “LLP”), a wholly owned separate legal entity in India. Vivos India expands the Company’s strategic initiatives,
with the objective of establishing a manufacturing center, expanding human therapies and pursuing commercialization of therapies in India.
In addition, we will generate additional human trial data to support our process with the Food and Drug Administration (“FDA”).
Vivos India was established on October 1, 2025 (deemed to have commenced on October 15, 2025). Pursuant to the LLP dated as of November
18, 2025, ownership of Vivos India is held jointly by Michael Korenko the Company’s CEO, and Sandip Bali, a consultant of the Company
based in India. Since the Company will by the sole source of funding for Vivos India and the Company will control the activities of Vivos
India, the Company has consolidated this entity as a variable interest entity in accordance with ASC 810. Additionally, the business
of the LLP is the research and development of the patents held by the Company in India pursuant to the Product Transfer and License Deed
entered into November 18, 2025. It is not anticipated that this entity will incur revenues in the near term.
On
November 18, 2025, the Company and Vivos India entered into a Product Transfer and License Deed whereby the Company will grant Vivos
India an exclusive license and product transfer to develop, seek regulatory approvals, import, market, distribute, and commercialize
the Products in India, subject to the terms and conditions of the Deed. In accordance with this agreement, any inventions, improvements,
data or know-how developed by Vivos India in connection with the Company’s products shall be promptly disclosed in writing and
are hereby irrevocably assigned to the Company.
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 and thus raises significant doubt about the Company’s ability to continue as a going concern. 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 $ 3 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 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 (the “ 2021 Regulation A
Offering ”). 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 ” and, together with the 2019 Regulation A+ Offering
and the 2021 Regulation A Offering, the “ Regulation A+ Offerings ”). The Company filed with the SEC an offering statement
on Form 1-A (including a preliminary offering circular dated February 13, 2026, amended March 4, 2026) under Regulation A for the offering
of up to $ 75.0 million of shares of its Common Stock, which offering was qualified by the SEC as of March 5, 2026 (the “2026 Regulation
A+ Offering” and, together with the 2019 Regulation A+ Offering, 2021 Regulation A Offering, and July 2024 Regulation A+ Offering,
the “Regulation A+ Offerings”).
8
During
the year ended December 31, 2023, we raised $ 1,179,245 through the sale of 16,132,000 shares of Common Stock through the Regulation A+
Offerings and concurrent private placements of 18,797,000 warrants. During the year ended December 31, 2024, $ 2,266,000 was raised through
the issuance of 24,950,000 shares of Common Stock through the Regulation A+ Offerings. During the year ended December 31, 2025, $ 1,500,000
was raised through the issuance of 12,500,000 shares of Common Stock through the Regulation A+ Offerings and $ 6,250 through a concurrent
private placement of 6,250,000 warrants.
In
March and April 2026, the Company raised $ 2,203,800
through the sale of 27,200,000
shares of Common Stock through the Regulation A+ Offering and concurrent private placement of 27,800,000
warrants.
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: (i) receiving adequate funding;
(ii) receiving regulatory approval for RadioGel ™ and other brachytherapy products; and (iii) 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 March 31, 2026, the Company had $ 2,525,782 of 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 is insufficient to cover the fixed and variable
obligations of the Company.
The
Company anticipates using additional proceeds from the March 2026 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 certain 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;
●
Construct and validate
two new production facilities; and
●
Fund human clinical studies
in the US and India.
9
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 $ 3.0
million annually to maintain operating activities. Over
the next 36 months, the Company believes it will require approximately $9.0 million in additional capital to: (i) fund the FDA approval
process to conduct human clinical trials; (ii) conduct Phase I, pilot, clinical trials; (iii) activate several regional clinics to administer
IsoPet ® across the U.S.; (iv) create an independent production center within the current production site to create a template
for future international manufacturing; and (v) initiate regulatory approval processes outside of the U.S. The
proceeds raised from the 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 Regulation A+ Offerings.
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.
Consolidation
The
Company has a relationship with Vivos India, which is considered a variable interest entity (VIE) under the guidance in ASC 810, Consolidations.
A VIE is an entity in which the equity investors do not have sufficient equity investment at risk or lack the characteristics of a controlling
financial interest. The Company evaluates the interests in such entities to determine whether it is the primary beneficiary and therefore
required to consolidate the VIE in its financial statements.
The
Company has determined that it is the primary beneficiary of Vivos India because it has both (i) the power to direct the activities that
most significantly impact the VIE’s economic performance, and (ii) the obligation to absorb losses or the right to receive benefits
that could potentially be significant to the VIE. Accordingly, the assets, liabilities, and results of operations of Vivos India will
be included in the Company’s consolidated financial statements. All intercompany activity will be eliminated in consolidation.
As of March 31, 2026, the Company is still waiting on regulatory approval in India to commence operations.
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.
Financial
Statement Reclassification
Certain
account balances from prior periods have been reclassified in these financial statements so as to conform to current period classifications.
There were no changes to the net loss as a result of these reclassifications.
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.
10
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 March 31, 2026 and December 31, 2025, 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.
Fixed
Assets
Fixed
assets are recorded at cost. Expenditures for renewals and improvements that significantly add to the productive capacity or extend the
useful life of an asset are capitalized. Expenditures for maintenance and repairs are expensed as incurred. When equipment is retired
or sold, the cost and related accumulated depreciation are eliminated from the balance sheet accounts and the resultant gain or loss
is reflected in income.
Depreciation
is provided using the straight-line method, based on useful lives of the assets which is five years .
The
Company reviews the carrying value of its fixed assets for impairment whenever events and circumstances indicate that the carrying value
of an asset may not be recoverable from the estimated future cash flows expected to result from its use and eventual disposition. In
cases where undiscounted expected future cash flows are less than the carrying value, an impairment loss is recognized equal to an amount
by which the carrying value exceeds the fair value of assets. The factors considered by management in performing this assessment include
current operating results, trends and prospects, the manner in which the property is used, and the effects of obsolescence, demand, competition,
and other economic factors.
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.
11
The
Company evaluates the recoverability of intangible assets, including patents and intellectual property on a continual basis. Several
factors are used to evaluate intangibles, including, but not limited to, management’s plans for future operations, recent operating
results and projected and expected undiscounted future cash flows.
There
have been no such capitalized costs in the periods ended March 31, 2026 and December 31, 2025, respectively. However, a patent was filed
by Michael Korenko and David Swanberg on July 1, 2019 (No. 1811.191) 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. In addition, due to a pricing discount from the manufacturer, the Company sold
to two of their customers the hydrogel vials that are used in the treatments. This practice is not likely to be continued in future periods.
The
following table disaggregates the Company’s revenue by major source for the three months ended March 31, 2026 and 2025:
SCHEDULE OF DISAGGREGATION OF REVENUE
2026
2025
Three Months Ended March 31,
2026
2025
Revenue:
Services - Treatments
$ -
$ 66,195
IsoPet
70,980
-
Certification
-
29,983
Freight
2,100
-
Polymer
3,168
-
Discount - Services
-
( 59,435 )
Discount - IsoPet
( 40,180 )
-
Discount - Certifications
-
( 9,995 )
Total
$ 36,068
$ 26,748
12
Inventory
Since
the Company is selling a tangible good (IsoPet, which is considered a medical device) for the use in treatments, this is considered inventory
as it is awaiting consumption into the final product. Inventory is valued at the lower of cost or net realizable value. Management evaluates
quantities on hand and physical condition as these characteristics may be impacted by anticipated customer demand for current products.
Inventory as of March 31, 2026 amounts to $ 56,863 . The Company did not hold inventory until February 2025.
The
Company purchases materials from two vendors that each ship to a third vendor who assembles the materials into a finished product which
is then shipped to the clinics for use in the treatments being performed. This vendor who completes the process is charged a fixed fee
which is directly charged to cost of sales. The only inventory not maintained by the Company is held at the vendor who assembles the
product.
There
have been no write-downs of inventory as of March 31, 2026, and the Company evaluates the inventory monthly for obsolescence. The Company
from time to time will write-off items for spoilage when the need arises in the normal course of business.
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 holders of our Common Stock (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 March 31, 2026 and 2025, 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 March 31, 2026 and December 31, 2025, which include
the following:
SCHEDULE OF DILUTIVE EARNINGS PER SHARE
March 31, 2026
December 31, 2025
Preferred stock
7,409,570
7,409,570
Restricted stock units
56,150,000
56,150,000
Common stock options
2,252,809
2,252,809
Common stock warrants
25,165,000
16,115,000
Total potential dilutive securities
90,977,379
81,927,379
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 $ 37,923 and $ 119,281 in research and development costs for the three months ended March 31, 2026 and 2025, respectively,
all of which were recorded in the Company’s operating expense noted on the statements of operations for the periods then ended.
13
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 three months ended March 31, 2026 and 2025, 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 March 31, 2026 and December
31, 2025.
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 periods ended March
31, 2026 and 2025. The Company did not have any deferred tax liability or asset on its balance sheets as of March 31, 2026 and December
31, 2025.
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 periods ended March 31, 2026 and 2025, 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.
In
December 2023, the Financial Accounting Standards Board issued ASU 2023-09, which requires enhanced disclosures related to the effective
tax rate reconciliation and income taxes paid. The guidance is intended to improve transparency regarding the nature and magnitude of
factors contributing to differences between the statutory tax rate and the effective tax rate, as well as cash taxes paid by jurisdiction.
The
Company adopted this standard effective January 1, 2025 on a prospective basis. The adoption did not have a material impact on the Company’s
consolidated financial position, results of operations, or cash flows, as the amendments are disclosure-only in nature. Prior-period
amounts have been recast to conform to the current-period presentation, where applicable.
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.
14
Segment
Reporting
The
Company follows Financial Accounting Standards Board issued Accounting Standards Update 2023-07 (“ASU 2023-07”) for
its segment reporting. 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. The Company has not yet begun generating significant revenue from its planned principal
operations and operates as a single reportable segment. The revenue associated with the services that the clinics perform by way of treatments
and the licensure of these clinics are not considered two distinct segments for the periods ended March 31, 2026 and 2025, respectively.
The benefit the clinics get by being licensed will assist in increased revenues associated with the treatments being administered. 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. With the formation of the VIE, Vivos India, and the fact
that this is consolidated for financial reporting purposes, the activities of Vivos India are a defined segment for geographical purposes.
As of March 31, 2026, the Company is still waiting on regulatory approval in India to commence operations. All of the Company’s
long-lived assets as of March 31, 2026 are located in the United States.
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.
NOTE
2: RELATED PARTY TRANSACTIONS
In
February 2026, our Chief Executive Officer advanced $ 5,350 to the Company, which amount was repaid within six days.
NOTE
3: FIXED ASSETS
As
of March 31, 2026 and December 31, 2025, the Company has the following fixed assets:
SCHEDULE OF FIXED ASSETS
March 31, 2026
December 31, 2025
Production equipment – 5 year-life
$ 252,404
$ 101,199
Office equipment – 5 year-life
1,986
1,986
Accumulated depreciation
( 10,335 )
( 374 )
Fixed assets, net
$ 244,055
$ 102,811
Depreciation
expense for the three months ended March 31, 2026 and 2025 was $ 9,961 and $ 0 .
NOTE
4: STOCKHOLDERS’ EQUITY
Common
Stock
The
Company has authorized 950,000,000 shares of Common Stock. As of March 31, 2026 and December 31, 2025, there are 482,840,608 and 455,494,238
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.
15
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 March 31, 2026 and December 31, 2025, 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.
16
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 March 31, 2026 and December 31, 2025, there are 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.
17
(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, 200,000 Series B Preferred shares were converted into 2,500,000 shares of Common Stock. There were no conversions
in 2026 and 2025.
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 March 31, 2026 and December 31, 2025, 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.
18
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 – Three Months Ended March 31, 2026
In
January 2026, the Company issued 44,118 shares of Common Stock for services valued at $ 3,000 .
In
March 2026, the Company issued 19,200,000 shares of Common Stock pursuant to the Regulation A+ Offering, and 17,000,000 warrants for
cash proceeds of $ 1,553,000 .
In
March 2026, the Company issued 7,950,000 shares of Common Stock in exchange of 7,950,000 warrants. The Company recognized a loss of $ 651,628
in the exchange.
In
March 2026, the Company issued 152,252 shares of Common Stock for services valued at $ 13,687 .
Common
and Preferred Stock Issuances – Three Months Ended March 31, 2025
In
January 2025, the Company received $ 1,500 from warrants exercised in December 2024.
In
February 2025, the Company issued 12,500,000 shares of Common Stock pursuant to the Regulation A+ Offering, and 6,250,000 warrants for
cash proceeds of $ 1,506,250 .
In
March 2025, the Company issued 38,422 shares of Common Stock for services rendered valued at $ 4,688 .
NOTE
5: 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.
19
The
following schedule summarizes the changes in the Company’s stock options:
SCHEDULE OF CHANGES IN STOCK OPTION
Options Outstanding
Weighted Average
Weighted Average
Number Of Shares
Exercise Price Per Share
Remaining
Contractual Life
Aggregate Intrinsic Value
Exercise Price Per Share
Three Months Ended March 31, 2025
Outstanding at January 1, 2025
2,252,809
$ 0.024 - 0.04
4.70 years
$ 174,855
$ 0.04
Granted
-
$ -
-
$ -
Exercised
-
$ -
-
$ -
Expired/cancelled
-
$ -
-
$ -
Outstanding at March 31, 2025
2,252,809
$ 0.024 - 0.04
4.45 years
$ 190,850
$ 0.04
Exercisable at March 31, 2025
2,252,809
$ 0.024 - 0.04
4.45 years
$ 190,850
$ 0.04
Three Months Ended March 31, 2026
Outstanding at January 1, 2026
2,252,809
$ 0.024 - 0.04
3.70 years
$ 71,226
$ 0.04
Granted
-
$ -
-
$ -
Exercised
-
$ -
-
$ -
Expired/cancelled
-
$ -
-
$ -
Outstanding at March 31, 2026
2,252,809
$ 0.024 - 0.04
3.45 years
$ 118,535
$ 0.04
Exercisable at March 31, 2026
2,252,809
$ 0.024 - 0.04
3.45 years
$ 118,535
$ 0.04
During
the three months ended March 31, 2026 and 2025, 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
Weighted
Average
Number
Of Shares
Exercise
Price Per Share
Remaining
Contractual
Life
Aggregate
Intrinsic Value
Exercise
Price Per Share
Three Months
Ended March 31, 2025
Outstanding at January 1, 2025
11,465,000
$ 0.13
3
years
$ 123,690
$ 0.0827
Granted
6,250,000
$ 0.15
-
$ -
$ -
Redeemed
-
-
-
-
-
Exercised
-
$ -
-
$ -
$ -
Exchanged
-
$ -
-
$ -
$ -
Expired/cancelled
-
-
-
-
Outstanding at March 31, 2025
17,715,000
$ 0.075 - 0.15
2.93
years
$ 145,700
$ 0.13
Exercisable at March 31, 2025
17,715,000
$ 0.075 - 0.15
2.93
years
$ 145,700
$ 0.13
Three Months
Ended March 31, 2026
Outstanding at January 1, 2026
16,115,000
$ 0.075 - 0.15
2.20
years
$ -
$ 0.143
Granted
17,000,000
$ 0.075
-
$ -
$ -
Redeemed
-
$ -
-
$ -
$ -
Exercised
-
$ -
-
$ -
$ -
Exchanged
( 7,950,000 )
$ -
-
$ -
$ -
Expired/cancelled
-
$ -
-
$ -
$ -
Outstanding at March 31, 2026
25,165,000
$ 0.075 - 0.15
3.22
years
$ 297,255
$ 0.0905
Exercisable at March 31, 2026
25,165,000
$ 0.075 - 0.15
3.22
years
$ 297,255
$ 0.0905
20
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
Three Months Ended
Three Months Ended
March 31, 2026
March 31, 2025
Expected term
0 -
0 -
Expected volatility
- %
- %
Expected dividend yield
-
-
Risk-free interest rate
- %
- %
The
Company granted 6,250,000 warrants in February 2025, with an exercise price of $ 0.15 that expire June 30, 2028 .
The
Company granted 17,000,000 warrants in March 2026, with an exercise price of $ 0.075 that expire December 31, 2029 . The Company exchanged
7,950,000 warrants into 7,950,000 shares of Common Stock, and repriced 1,450,000 warrants from $ 0.15 to $ 0.075 and extended the expiration
date to December 31, 2029 . The Company recorded a loss of $ 651,628 in these exchanges.
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
Three Months Ended March 31, 2025
Outstanding at January 1, 2025
11,825,000
$ 0.09
Granted
-
$ 0.08
Vested
( 5,000,000 )
$ -
Forfeited
-
$ -
Outstanding at March 31, 2025
6,825,000
$ 0.08
Three Months Ended December 31, 2026
Outstanding at January 1, 2026
900,000
$ 0.09
Granted
-
$ -
Vested
-
$ -
Forfeited
-
$ -
Outstanding at December 31, 2026
900,000
$ 0.09
During
the three months ended March 31, 2026 and 2025, the Company recognized $ 0 and $ 361,500 in expense related to the vesting of its restricted
stock units. As of March 31, 2026, the Company had $ 121,170 worth of expense yet to be recognized for restricted stock units not yet
vested.
21
During
the three months ended March 31, 2025, 5,000,000 restricted stock units vested. The Company’s Omnibus Plan expired on December
31, 2025 and they are in process of forming a new plan, subject to shareholder approval. On January 1, 2026, the Company entered into
a new employment agreement with their CEO that provides for a grant of 20,000,000 RSUs. These RSUs have not been issued as of the date
of this report as the new Omnibus plan is yet to be approved.
NOTE
6: LEASES
The
Company has adopted ASU No. 2016-02, Leases (Topic 842) and as such accounted for our leases in terms of the right of use assets
and offsetting lease liability obligations under this pronouncement. The Company had had only short-term leases through entering into
a long-term lease agreement on November 1, 2025. The Company recorded these amounts at present value, in accordance with the standard,
using a discount rate of 4.5 %. The right of use asset is composed of the sum of all lease payments, at present value, and is amortized
straight line over the life of the expected lease term. For the expected term of the lease the Company used the initial terms of 48 months.
Upon the election by the Company to extend the lease for additional years, that election will be treated as a lease modification and
the lease will be reviewed for re-measurement.
The
Company has chosen to implement this standard using the modified retrospective model approach with a cumulative-effect adjustment, which
does not require the Company to adjust the comparative periods presented when transitioning to the new guidance. The Company has also
elected to utilize the transition related practical expedients permitted by the new standard. The modified retrospective approach provides
a method for recording existing leases at adoption and in comparative periods that approximates the results of a modified retrospective
approach. Adoption of the new standard did not result in an adjustment to retained earnings for the Company.
As
of March 31, 2026, the value of the unamortized lease right of use asset was $ 104,064 . As of March 31, 2026, the Company’s lease
liability was $ 109,593 .
SCHEDULE OF OPERATING LEASE MATURITY
Maturity of lease liability for the operating lease for the period ended March 31,
2027
$ 32,505
2028
$ 33,460
2029
$ 33,460
2030
$ 19,518
Imputed interest
$ ( 9,350 )
Total lease liability
$ 109,593
Disclosed as:
Current portion
$ 28,135
Non-current portion
$ 81,458
SCHEDULE OF LESSEE RIGHT OF USE OF ASSET AMORTIZATION
Amortization of the right of use asset for the period ended March 31, 2027
$ 27,280
2028
$ 28,607
2029
$ 30,004
2030
$ 18,173
Total
$ 104,064
22
Total
Lease Cost
Individual
components of the total lease cost incurred by the Company is as follows:
SCHEDULE OF LEASE COST
Three Months ended
March 31, 2026
Three Months ended
March 31, 2025
Operating lease expense
$ 6,638
$ -
NOTE
7: CONCENTRATIONS
Five
and three customers accounted for all of the revenues, with two and three customers accounting for more than 10% of total revenue. As
of March 31, 2026 and December 31, 2025, three and six customers represented 100 % of the Company’s accounts receivable, of which
three and three customers represented greater than 10% of the total outstanding.
NOTE
8: 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. On December 19, 2023, the Company renewed the Employment Agreement for a term of two years expiring December 31, 2025.
The Company entered into a new Employment Agreement effective January 1, 2026.
Under
the terms of the Employment Agreement effective January 1, 2026, the Company shall pay to Dr. Korenko a base compensation of 325,000 .
In addition, Dr. Korenko is entitled to a discretionary bonus to be earned in the amount of $ 12,000
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, 2026 that vest over the 2 two-year period. These restricted stock units have not been issued as
of yet as the Company is working on a new Omnibus plant to be approved by the shareholders.
NOTE
9: SUBSEQUENT EVENTS
The
Company has evaluated subsequent events through the date of this report and there were no items noted to be disclosed except for the
items below.
In
April 2026, the Company issued 250,000 shares of Common Stock as a signing bonus for a consultant.
In
April 2026, the Company issued 8,000,000 shares of Common Stock pursuant to the Regulation A+ Offering, and 10,800,000 warrants for cash
proceeds of $ 650,800 .
In April 2026, the Company issued
2,800,000 shares of Common Stock in exchange of 2,800,000 warrants.
23
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Except
for statements of historical fact, certain information described in this Quarterly Report on Form 10-Q (“Quarterly 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 Quarterly 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 on Form 10-K, filed with the SEC on March 30, 2026, as well as other cautionary language in this Quarterly
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.
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 devices. This includes RadioGel®
Precision Radionuclide Therapy™ (Human Division) for treating solid tumors and positive surgical margins in humans and IsoPet®
(Animal Division) for treating solid tumors in animals. The Company also sells PLGA-g-PEG polymers and PrecisionGel™, a hydrogel
polymer platform for delivering active pharmaceutical ingredients and therapeutic agents. 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, veterinarians,
and patients by providing them with new isotope technologies and advanced polymer solutions that offer safe and effective treatments
for cancer in both humans and animals.
In
2013, the United States Food and Drug Administration (“ FDA ”) issued the determination that RadioGel ®
is a device for human therapy for non-resectable cancers in humans. This should result in a faster path than a drug for final approval.
In
January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel® (now marketed as IsoPet® for
veterinary use) should be classified as a medical device for animal therapy, initially specified for feline sarcomas and canine soft
tissue sarcomas. Additionally, after legal review, the Company believes that this device classification from the FDA Center for Veterinary
Medicine is not strictly limited to canine and feline sarcomas but may extend to a broader population of veterinary cancers, including
all or most solid tumors in animals. As veterinary medical devices do not require premarket approval or notification (such as 510(k)
or PMA) for commercial distribution in the United States, IsoPet® is authorized for marketing and commercial distribution following
this classification, provided the product is safe, effective, properly labeled, and compliant with applicable laws and regulations. The
FDA does not exercise premarket authority over veterinary devices, and manufacturers bear responsibility for ensuring ongoing compliance.
This classification enables the commercial distribution of IsoPet® for treating solid tumors in animals.
Based
on the FDA’s recommendation, RadioGel ® is being marketed as “IsoPet ® ” for use by veterinarians
to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet ® ”
name. IsoPet ® and RadioGel ® are used synonymously throughout this document. The only distinction between
IsoPet ® and RadioGel ® is the FDA’s recommendation that we use “IsoPet ® ”
for veterinarian usage, and reserve “RadioGel ® ” 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 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 efforts to align with animal
therapy, human therapy, and recently other applications of its patented technologies.
The
Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet ® /RadioGel™
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.
24
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 Company has transitioned to “Volume Pricing” to stimulate broader interest
and adoption. With significant growth achieved in 2025—including a reported 1,200% year-over-year increase in administered therapies
and expansion of the certified clinic network—the Animal Therapy Division (IsoPet®) is positioned to reach breakeven status
in 2026, supported by ongoing profitability-focused initiatives, continued clinic expansion, and improved operational efficiency.
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.
On
September 17, 2025, the Board of Directors of the Company approved the creation of Vivos Scientific India LLP (“VSIL”), a
wholly owned separate legal entity in India. Vivos India was formally established in September 2025 (with incorporation completed and
government approvals finalized shortly thereafter), expanding the Company’s strategic initiatives in the region. The primary objectives
include establishing the Company’s first international manufacturing center for RadioGel® and IsoPet®, advancing expanded
human therapy demonstrations and clinical trials (including ongoing patient treatments initiated in December 2024 and progress toward
DCGI regulatory clearance for larger-scale trials), pursuing commercialization of therapies for both humans and animals in India, and
generating additional human trial data to support the Company’s regulatory processes with the U.S. Food and Drug Administration
(FDA), such as the planned Investigational Device Exemption (IDE) submission in early 2026. As of February 2026, discussions continue
with experienced radiopharmaceutical contract manufacturers in India to support the establishment of this international production facility,
with a target for operational status by the end of 2026 to reduce shipping costs, enhance logistical efficiency, and facilitate broader
global access to the Company’s precision radionuclide therapies.
In
the third quarter ended September 30, 2025, the Company strengthened its leadership team to support accelerating growth in both the U.S.
and international markets by appointing Brad Allan Weeks as President (effective September 1, 2025) and David J. Swanberg as Chief Operating
Officer (effective September 15, 2025). These appointments reflect the Company’s strategic response to rapid expansion, particularly
in the IsoPet® Animal Therapy Division—which achieved a reported 1,200% year-over-year increase in administered therapies from
2024 to 2025—and ongoing advancements in RadioGel® human therapy development, including progress toward FDA Investigational
Device Exemption (IDE) submission and the establishment of Vivos Scientific India LLP in September 2025. The new executive roles are
designed to enhance operational efficiency, scale commercial activities, drive clinic certifications and therapy adoption, and position
the Company for sustained growth and potential profitability in the Animal Therapy Division by 2026.
25
Strategic
Initiatives
●
IDE
- In December 2023, the FDA granted RadioGel® Precision Radionuclide Therapy™ the designation as a Breakthrough Device
pursuant to the FDA’s Breakthrough Devices Program, thereby giving the Company access to the “sprint” rapid review
process for IDE comments. For the first two quarters of 2025, the Company took advantage of the process to resolve detailed FDA
questions on a variety of topics. On August 13, 2025, the FDA rejected the Company’s IDE based on cited deficiencies. Based on
the FDA recommendations, the Company used the pre-submission process to respond to the FDA’s comments. On October 14, 2025,
the Company submitted the pre-submission document dedicated to sterility. This document incorporated the new E-Beam sterilization
process.
Over
the past several years, the Company has engaged extensively with the FDA, successfully addressing feedback from more than 40 individual
reviewers—many comments stemming from frequent review team changes within the Agency. Vivos has provided comprehensive data
and finalized the key technical parameters related to demonstrating precision delivery of RadioGel ® to the treatment
area and ensuring minimal exposure to non-target tissues.
In
a key strategic move, Vivos has engaged one of the top regulatory experts in the field of brachytherapy and combination radiotherapy
devices, with deep experience guiding such products through the FDA’s Center for Devices and Radiological Health (CDRH). This
expert’s prior role at the FDA and proven track record of successful IDE approvals for Class III implantable radiation device,
several reviewed by the same branch overseeing RadioGel ® , have provided invaluable guidance.
With
this expert’s analysis of FDA feedback patterns, the Company is bolstering its IDE submission by:
1.
Fully addressing all outstanding
FDA concerns and adopting a submission format and structure proven effective by regulatory experts for similar devices.
2.
Incorporating additional
information from clinical human data that has become available since the Company’s last IDE submission, further strengthening
the evidence package.
3.
Reformatting and summarizing
pre-clinical data in a manner that more directly and effectively addresses the remaining FDA concerns.
4.
Leveraging extensive veterinary
clinical data from IsoPet ® commercial use: Integrating comprehensive treatment outcomes from over 100 safely administered
therapies across diverse tumor types and species, with zero reportable serious adverse events attributable to the product, to provide
additional real-world safety and efficacy evidence supporting the Precision Radionuclide Therapy™ platform.
5.
Highlighting specialized
equine ocular applications: Including detailed case data on successful treatments of ocular squamous cell carcinoma in horses (with
injections near or into the cornea), showing no major side effects in adjacent critical structures, to further demonstrate the therapy’s
precision, minimal invasiveness, and favorable risk profile in challenging anatomical locations.
These
enhancements maintain the intended use while maximizing the submission’s clarity, completeness, and alignment with Agency expectations.
These recommendations required substantial effort to incorporate into our next submission.
●
Commercialization
of Human Therapy in India - The Company is actively pursuing an expanded permit from the Drugs Controller General of India (DCGI)
to continue treating the initial cohort of up to 30 patients focused on head and neck cancers (including cancerous lymph nodes) and
to initiate larger-scale clinical trials supporting potential commercial applications in India. This next phase would involve a second
hospital site with a new principal investigator, incorporating an enhanced protocol that aligns with prior FDA feedback—such
as post-treatment whole-body PET examinations for broader safety validation and efficacy assessment across additional tumor locations.
26
In
September 2025, the Company established Vivos Scientific India LLP (VSIL), a wholly owned subsidiary in India, to accelerate developmental
testing, support regulatory processes (including DCGI clearances), expand human and animal therapy demonstrations, and lay the groundwork
for the Company’s first international manufacturing center for RadioGel® and IsoPet®. The entity has secured its Certificate
of Incorporation and completed key foundational steps (e.g., name reservation, digital signatures, and LLP Agreement filing), with
headquarters in Mumbai, supported by an Indian Advisory Board. As of February 2026, VSIL is operational and advancing these initiatives,
though full business activation and manufacturing setup remain in progress pending additional regulatory and logistical milestones.
This subsidiary strengthens the Company’s long-term commitment to India as a key hub for clinical advancement, data generation
to bolster the U.S. FDA pathway (e.g., IDE support), and eventual commercialization in both human oncology and veterinary applications.
●
Animal
Therapy in India – In the second quarter of 2025, the Company sponsored a highly successful “Pets in the Park”
event in Mumbai, featuring a renowned speaker to raise awareness about pet cancer and introduce IsoPet® therapy. The event generated
overwhelming positive response and demonstrated strong interest in initiating animal therapy in India. Building on this momentum,
the Company has established solid contacts with interested veterinary clinics and key stakeholders in the region.
The
establishment of Vivos Scientific India LLP (VSIL) in September 2025 further supports these efforts by providing a dedicated local
entity to advance developmental testing, pursue regulatory pathways for veterinary applications (complementing ongoing human therapy
progress with the DCGI), and explore commercialization opportunities for IsoPet® in India. A local production site in India—targeted
as part of the Company’s international manufacturing expansion, with one facility anticipated to become operational by the
end of 2026—would significantly enhance cost-effectiveness by reducing shipping expenses, improving supply chain logistics,
and enabling broader, more affordable access to IsoPet® Precision Radionuclide Therapy™ for veterinary use in the Indian
market and beyond. This aligns with the Company’s global strategy to expand the IsoPet® division, which has already seen
substantial growth in the U.S. (including a reported 1,200% year-over-year increase in administered therapies from 2024 to 2025),
and positions India as a promising hub for both animal and human applications of the platform.
●
Alternate
Production Facilities – Previous corporate filings have highlighted risk factors associated with the Company’s reliance
on a single production site. For the past two years, the Company has actively assessed alternate facilities to mitigate this risk
and support scalable growth.
In
a significant step announced on February 17, 2026, Vivos Inc. is advancing plans to diversify its manufacturing base. The Company’s
strategic target is to establish one domestic production facility—where Vivos will serve as the manufacturer of record—and
one international production facility, both operational in 2026. These facilities will produce the yttrium-90 (Y-90) phosphate particles
and mix them with sterile hydrogel to create individual patient doses for RadioGel® (human applications) and IsoPet® (veterinary
applications).
For
the domestic site, Vivos has signed a contract for production space at the Applied Process Engineering Laboratory (APEL) in Richland,
Washington. Equipment has been ordered, installation is underway, and licensing applications have been submitted to support operational
readiness. The international facility is being pursued through ongoing discussions with experienced radiopharmaceutical contract
manufacturers in India, aligned with the establishment and activities of Vivos Scientific India LLP (VSIL), to reduce shipping costs,
enhance logistical efficiency, and expand access to global markets.
The
Company will continue production with its existing contract manufacturer through Q2 2026, ensuring continuity during the transition
to these new facilities. This multi-site approach is expected to address previous single-source vulnerabilities, improve supply chain
resilience, accommodate higher production volumes as demand grows (particularly in the IsoPet® division, which reported substantial
therapy increases in 2025), and support the Company’s broader commercialization and regulatory goals for both human and animal
therapies.
27
●
Future Indications for
Use and Alternate Isotopes – In December 2024, the Company conducted an offsite strategic meeting with our key technical
staff, both our Medical and Veterinary Advisory Boards, our principal investigators from Mayo Clinic and India, and the Chairman
of our Board. The objective was to determine our next target indications for use and to ensure that Y-90 was the best therapeutic
isotope to treat these cancers.
Over
time we intend to expand the indications for use to include all lymph nodes, lung cancer, childhood brain cancer, eyelid cancer,
and finally all solid tumors. Our health physics experts reviewed the benefits of every available isotope, with respect to the target
range of potential indication for use.
This
strategic group confirmed that our current isotope, Y-90 was effective for all the targeted indications for use. However, we also
decided to explore P-32, Lu-177, and Ac-225.
○
P-32 is not as energetic
as Y-90; however, we could modify the concentration, as it has a longer half-life, which could prove to be an advantage for international
shipments.
○
While Lu-177 is relatively
low-energy, we could adjust the concentration, as it has a lower penetration distance, which might be an advantage in therapies near
critical structures since that would result in a higher therapeutic ratio.
○
Ac-225 has a very low penetration
distance, but it would be distributed homogeneously in our hydrogel. This could be an advantage in treating brain tumors and bone
cancer due to its extremely low alpha penetration.
Recent
successful therapies of equine ocular tumors without damaging the eye and human therapy on cancerous nodes directly on the trachea without
damaging that organ, confirm the use of Y-90 and may impact the business case of development of alternate isotopes.
Our
trademarks include BetaGel and AlphaGel and our provisional patents cover the isotopes P-32, Lu-177, and Ac-225. Depending on the business
case conclusions, over the next three years we intend to conduct laboratory testing and then animal and finally human studies in India.
●
The
Company is exploring the viability of leveraging its technology to develop other businesses unrelated to the Company’s principal
business of cancer treatment. Each business opportunity could generate income to support our primary objectives or potentially be
spun off as a separate business activity to an interested party. To date the focus has been on:
PrecisionGel
– The Company spent years refining the development of its hydrogel, in which gelation initiates at room temperature and is
completed as it warms to body temperature. The Company is currently investing in quantifying and controlling the hydrogel resorption
and agent dispersal characteristics. There has been enough interest in this component to warrant a serious business case assessment.
The Company has trademarked
the name Precision Gel™ and, in addition to its current hydrogel patent, filed a new provisional patent in January 2025. In
2026 Akina and Vivos will release a publication to summarize years of development on our hydrogel, including rheology, resorption
characteristics, concentration and composition control, and agent release data, including retention, transport, and release of a
broad range of agents. It is anticipated that this publication will be beneficial to marketing Precision Gel.
In
the second quarter of 2025, we signed a contract with Akina, Inc to sell this polymer. It is now in their catalog. The Company has
had recent sales to universities and pharmaceutical companies; we anticipate this will be a slow growing but solid market. The priority
remains IDE approval.
Duncan Chiller
– Akina encouraged Vivos to leverage our Peltier Chiller technology to develop a general laboratory equipment device for non-water
localized chilling. An elementary device demonstrated proof of concept. A prototype will be produced at APEL for testing at and eventual
distribution by Akina.
28
Intellectual
Property
The
Company’s original license agreement with Battelle National Laboratory (the “Battelle License”) reached its end of
life in 2022. In anticipation of this expiration, Vivos has significantly expanded its proprietary knowledge base, along with robust
trademark and patent protections, over the past several years. The Company no longer relies on the Battelle license for any core intellectual
or proprietary technology, having developed and secured independent advancements in its Precision Radionuclide Therapy™ (PRnT™)
platform.
Trademark
Protection continues to expand globally, now covering registrations and applications in 17 countries (with ongoing efforts to broaden
this footprint):
The
Company owns applications/registrations for the following key marks:
○
ISOPET®
○
RADIOGEL®
○
ALPHA-GEL™
○
BETA-GEL™
○
GAMMA-GEL™
○
PRECISION RADIONUCLIDE
THERAPY™
○
PRECISIONGEL™
○
Peltier Chlller ©
○
Duncan Chiller™
Patent
Portfolio has been systematically strengthened through provisional and utility patent filings covering critical components of the platform,
including the hydrogel formulation, yttrium-90 phosphate particles, injection/delivery systems, and related methods. These protections
are pursued in the United States and in more than ten additional patent offices, encompassing approximately 63 countries.
Key
recent milestones include:
●
In January 2025, the Company
filed an additional provisional patent related to PrecisionGel™.
●
On September 3, 2025, a
provisional patent (No. 63/873,014) was filed for sterile thermogels using electron beam sterilization, enhancing manufacturing processes
for the hydrogel component.
●
On January 13, 2026, the
United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 12,521,452 B2, titled “Radiotherapy Gel and Method
of Preparing the Same.” This patent protects critical advancements in the proprietary PRnT™ platform, including the integration
of biodegradable, thermosensitive PLGA-g-PEG hydrogel with yttrium-90 particles for targeted beta radiation delivery into solid tumors
while minimizing exposure to surrounding healthy tissue. It underpins the flagship products RadioGel® (human applications) and
IsoPet® (veterinary use).
●
Concurrently, PRECISIONGEL™
trademark approvals advanced, with publication in the U.S. and New Zealand.
●
Additionally, the Company
filed a new patent application in early 2026 to further protect and expand the PrecisionGel™ hydrogel technology, including
its use for timed-release delivery of various therapeutic agents (e.g., anti-cancer drugs and gene therapies) beyond radionuclide
applications.
These
developments—highlighted in the Company’s January 28, 2026, press release—materially enhance Vivos’ intellectual
property position, support ongoing clinical and regulatory progress (including FDA IDE efforts and international expansion via Vivos
Scientific India LLP (VSIL)), enable broader global commercialization, and position the Company for potential strategic partnerships
and licensing opportunities. The comprehensive IP portfolio, including four years of developmental data, validated Quality Management
System documentation, and worldwide protections, provides a strong foundation for the Precision Radionuclide Therapy™ platform
in both human and veterinary oncology.
29
Financing
and Strategy
In
March 2026, the Company filed with the SEC an offering statement on Form 1-A (including a preliminary offering circular dated February
13, 2026, amended March 4, 2026) under Regulation A for the offering of up to $75.0 million of shares of its Common Stock, which offering
was qualified by the SEC as of March 5, 2026 (the “2026 Regulation A+ Offering” and, together with the 2019 Regulation A+
Offering, 2021 Regulation A Offering, and July 2024 Regulation A+ Offering, the “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 through the Regulation
A+ Offerings and concurrent private placements of 18,797,000 warrants. During the year ended December 31, 2024, $2,266,000 was raised
through the issuance of 24,950,000 shares of Common Stock through the Regulation A+ Offerings. During the year ended December 31, 2025,
$1,500,000 was raised through the issuance of 12,500,000 shares of Common Stock through the Regulation A+ Offerings and $6,250 through
a concurrent private placement of 6,250,000 warrants.
In
March and April 2026, the Company raised $2,203,800 through the sale of 27,200,000 shares of Common Stock through the Regulation A+ Offering
and concurrent private placement of 27,800,000 warrants.
Cumulative
proceeds from these offerings have supported critical advancements, including Breakthrough Device designation (December 2023), ongoing
IDE resubmission preparations (with strengthened submission planned by end of Q1 or April 2026), international human therapy data generation
in India, manufacturing diversification (new domestic facility at APEL in Richland, WA, and international site discussions aligned with
Vivos Scientific India LLP (VSIL)), leadership enhancements, intellectual property expansion (e.g., U.S. Patent No. 12,521,452 B2 issued
January 13, 2026, and additional provisional filings), and substantial growth in the IsoPet® Animal Therapy Division (1,200% year-over-year
increase in administered therapies from 2024 to 2025).
Upon
successful qualification, the 2026 Regulation A+ Offering would provide expanded capacity for equity fundraising to further advance RadioGel®
human therapy development (including IDE submission and potential approval for clinical trials), scale IsoPet® commercialization
(targeting breakeven in the Animal Therapy Division in 2026), support VSIL initiatives for local manufacturing and clinical trials in
India, mitigate single-site production risks through multi-facility operations (targeted for 2026 readiness), and pursue broader global
access to the Precision Radionuclide Therapy™ platform in both human and veterinary oncology. The Company continues to monitor
cash needs closely and explore additional financing avenues as it progresses toward regulatory milestones and operational profitability.
Following
receipt of required regulatory approvals (including potential FDA IDE clearance for human trials) and necessary financing to support
working capital and expansion, the Company plans to transition to greater operational control over key aspects of its supply chain. In
the U.S., Vivos is establishing Company-managed production facilities (with Vivos as the manufacturer of record) to produce Y-90 particles,
hydrogel mixtures, and patient doses, while continuing to leverage select contract manufacturing during the transition period through
Q2 2026. This approach aims to enhance supply chain resilience, reduce dependencies, and accommodate growing demand in both RadioGel®
(human) and IsoPet® (veterinary) applications. For international markets, the Company is pursuing direct commercialization pathways
through subsidiaries such as Vivos Scientific India LLP (VSIL), including local manufacturing and regulatory advancement in India, while
remaining open to strategic licensing arrangements, partnerships, or collaborations to accelerate global access and market penetration
for its Precision Radionuclide Therapy™ platform.
Long-term,
the Company intends to consider resuming research on additional products and technologies to improve cancer diagnosis and treatment (e.g.,
expanded PRnT™ indications or PrecisionGel™ applications for other therapeutics). These goals depend on:
(i)
securing adequate funding
(e.g., via the pending 2026 Regulation A+ Offering or other sources);
30
(ii)
obtaining regulatory approvals
for RadioGel® and related brachytherapy products (e.g., FDA IDE clearance, with submission planned by end of Q1/April 2026);
and
(iii)
successfully commercializing
current products (RadioGel® for humans and IsoPet® for veterinary use), including scaling adoption and operationalizing new
manufacturing facilities in 2026.
Based
on the Company’s financial history since inception, the independent registered public accounting firm has expressed substantial
doubt about the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and accumulated
significant deficits. Without sufficient additional capital, the Company may need to delay its business strategy or may be unable to
continue operations. Management continues to pursue fundraising (including the 2026 Regulation A+ Offering), cost controls, and key milestones—such
as IsoPet® growth and potential breakeven in the Animal Therapy Division in 2026—to address liquidity challenges.
The
Company’s corporate headquarters are located in Kennewick, Washington (Suite N288, 1030 N. Center Parkway, Kennewick, WA 99336),
in the Tri-Cities region of Southeast Washington. The Company continues its marketing efforts in the IsoPet® animal therapy market,
with a focus on expanding nationwide adoption across the U.S. Following substantial growth in 2025—including a reported 1,200%
year-over-year increase in administered therapies, expansion to 17 certified clinics, and a sharp rise in inbound inquiries from veterinarians
and pet owners—the Company is implementing profitability-focused initiatives starting in Q1 2026. These include ongoing clinic
certifications (now billing clinics for the process), volume pricing to stimulate broader interest, and efforts to increase exposure,
generate revenue, and scale the network of certified veterinary treatment centers nationwide. This national expansion builds on the therapy’s
proven safety and efficacy (over 100 treatments with zero reportable serious adverse events) and supports the goal of achieving breakeven
status in the Animal Therapy Division in 2026.
As
of March 31, 2026, the Company had $2,525,782 in 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 be insufficient to cover the fixed and variable
obligations of the Company.
The
Company anticipates allocating proceeds from the Regulation A+ Offerings (including the pending 2026 Regulation A+ Offering) primarily
to advance its core Precision Radionuclide Therapy™ (PRnT™) platform across both veterinary and human applications, while
supporting operational growth, regulatory progress, and manufacturing enhancements.
For
the Animal Therapy Market (IsoPet®):
●
Increase marketing and
outreach via the Company website, social media, conferences, and publications to grow the number of certified veterinary clinics
(for small animals and equine therapy) and expand patient treatments.
●
Support controlled IsoPet®
studies by providing complimentary products in exchange for data and publications on specific cancers, ensuring broader treatment
access for viable candidates.
●
Assist new regional clinics
with licensing, certification training, and therapy demonstrations (including margin therapy applications).
●
Transition to volume pricing
to drive broader adoption and revenue growth.
For
the Human Market (RadioGel®):
●
Expand and diversify production
sites (including the new domestic facility in Richland, WA, and international site discussions aligned with Vivos Scientific India
LLP (VSIL)) to mitigate single-source risks and scale capacity.
●
Strengthen the Quality
Management System pedigree for regulatory compliance.
●
Initiate automation in
product manufacturing processes.
●
Secure liability insurance
for human clinical studies.
●
Fund human clinical studies
and trials in the U.S. (post-IDE approval) and India (ongoing demonstrations and expanded DCGI-permitted trials).
●
Establish and operationalize
Vivos Scientific India LLP (VSIL) to support local manufacturing, regulatory advancement, and commercialization in India.
31
These
allocations align with the Company’s priorities of achieving breakeven in the Animal Therapy Division in 2026, securing FDA IDE
clearance (with resubmission targeted for end of Q1/April 2026), diversifying manufacturing (targeting operational facilities in 2026),
and generating additional clinical data to support global commercialization of RadioGel® and IsoPet®. Actual use may vary based
on regulatory timelines, funding levels, and strategic opportunities.
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 Regulation A+ Offerings. The Company requires additional funding of approximately $3.0 million
annually to maintain operating activities. Over the next 36 months, the Company believes it will require approximately $9.0 million in
additional capital to: (i) fund the FDA approval process to conduct human clinical trials; (ii) conduct Phase I, pilot, clinical trials;
(iii) activate several regional clinics to administer IsoPet ® across the U.S.; (iv) create an independent production center
within the current production site to create a template for future international manufacturing; and (v) initiate regulatory approval
processes outside of the United States. The proceeds raised from the Regulation A+ Offerings were used to fund this development and will
be used to continue such development efforts.
The
continued deployment of 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 Regulation A+ Offerings.
The
Company has vendor commitments for products and services, and current cash levels are insufficient to cover fixed and variable obligations
or sustain ongoing product development. To minimize overhead, the Company has operated with a virtual office for several years and retained
experienced industry consultants on an as-needed basis, allowing Regulation A+ Offering proceeds to focus on strategic objectives such
as regulatory advancement, manufacturing diversification, and therapy commercialization.
There
is no guarantee that the Company will secure additional funds or do so on favorable terms to stockholders.
The
financial statements do not include adjustments for the recoverability and classification of liabilities that might be necessary if the
Company cannot continue as a going concern. Continuation as a going concern depends on generating sufficient cash flow to meet obligations
timely and ultimately achieving profitability. The independent registered public accounting firm has expressed substantial doubt about
the Company’s ability to continue as a going concern due to limited revenue, nominal cash, and accumulated deficits since inception.
Management plans to pursue additional funding through debt and equity financing (including the pending 2026 Regulation A+ Offering),
enhance operating performance via strategic focus on core products, process efficiencies, and cost structure improvements. There can
be no assurance of success in raising working capital or achieving profitable operations, and the financial statements include no adjustments
for outcomes of this uncertainty.
IsoPet
Animal Division
The
Company selected Vista Veterinary Hospital in Kennewick, Washington (Tri-Cities area), as the pilot private clinic for initiating commercial
IsoPet® sales. This location facilitated close collaboration with Company personnel to refine processes, serving as a model before
national expansion. Vista has successfully passed multiple audits by the Washington State Department of Health, with the Company working
closely alongside the Department to enhance the radioactive material license by incorporating detailed procedures that benefit future
clinics. A second veterinarian at Vista has also been certified.
32
Clinical
experience at universities and Vista demonstrates IsoPet®’s effectiveness in ablating cancer tissue near injection sites, performing
best in early-stage tumors before metastasis. Later-stage cancers are more challenging due to poorly defined tendrils, increasing recurrence
risk.
Johns
Hopkins University Veterinary Clinical Trials Network (Baltimore, MD) is now a certified IsoPet® regional clinic, holding the required
radioactive material license and completing training. This partnership supports high-quality data collection across cancer types for
publication in leading journals, boosting awareness and acceptance in the veterinary oncology community. Johns Hopkins recently completed
a VX2 tumor study in rabbits, confirming IsoPet® (and by extension RadioGel®) safety, with hydrogel retention at the injection
site, activity decay curves, validation of Instructions for Use and Injection Guidance Table, and insights for refining human lymph node
treatments.
Animal
therapy safety and efficacy data from IsoPet® contributed positively to RadioGel®’s Breakthrough Device designation.
As
of December 31, 2025, the Company has 17 certified regional clinics nationwide, treating feline, canine, equine, and exotic animals:
1.
Vista Veterinary Hospital
– Kennewick WA – (Drs. Michelle Meyer and Jeffrey Goebel)
2.
University of Missouri
– Columbia MO – (Dr. Charle Maitz)
3.
Johns Hopkins University
– Baltimore MD – (Dr. Rebecca Krimins)
4.
Indian Creek Veterinary
Hospital - Fort Wayne IN – (Dr. Kevin Cawood)
5.
Hopkinton Animal Hospital
- Weare NH – (Dr. Michael Dutton retiring, Dr. Jordan Gange)
6.
NorthStar VETS - Robbinsville,
NJ - (Dr. Diana Sanchez)
7.
Animal Emergency &
Specialty Center of Knoxville, Knoxville, NJ (Dr. Jeffrey Phillips)
8.
Sumner Veterinary Hospital,
Sumner, WA (Dr. Vanessa Rizzo)
9.
New England Equine Practice
– Patterson NY – (Dr. Bill Bradley)
10.
Myhre Equine Clinic –
Rochester NH – (Dr. Michael Myhre)
11.
University of Wisconsin
School of Veterinary Medicine - (Dr. Kayla Le)
12.
University of Illinois
College of Veterinary Medicine, Urbana, IL (Dr, Kimberly Selting)
13.
Brazos Equine Hospital,
Navasota, TX (Dr. Ben Buchanan)
14.
University of Florida Large
Animal Hospital (Dr. Diego De Gasperid)
15.
Capital Veterinary Specialists
(Drs. Kevin Drygas, Carl Jehn)
16.
University of Florida Small
Animal Hospital (Dr. Gutti, Dr. Takada)
17.
Sun City Veterinary Surgical
Center, El Paso, TX (Dr. Silverman)
In
2024, three new dedicated websites were launched: the corporate site and separate ones for RadioGel® (human) and IsoPet® (veterinary),
featuring user-friendly designs, educational content, and blogs to build authority. Marketing materials effectively highlight Precision
Radionuclide Therapy™.
During
2025, the IsoPet® division achieved a reported 1,200% year-over-year increase in administered therapies, with over 100 safe treatments
(zero serious adverse events). The team staffed booths at six conferences, and LeeAnna Binder conducted nationwide outreach via a modified
IsoPet® van. Active social media management on Facebook, Instagram, X, and LinkedIn drove engagement and website traffic.
The
division shifted from data collection to commercialization in 2024–2025, refining pricing for affordability, aligning production
with patient bookings to reduce costs, and implementing volume pricing. Starting Q1 2026, profitability initiatives include billing clinics
for certification and continued network expansion.
Objectives
include adding several more regional clinics in 2026 (with interested parties in the pipeline) and participating in at least four conferences
annually to promote IsoPet® for small animal and equine tumors. The Veterinary Medicine Steering Board advises patient acquisition
strategies. This nationwide growth supports the goal of breakeven in the Animal Therapy Division in 2026.
33
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.
In
July 2025 we applied for FDA IDE with an application approval containing new India human therapy data. In FDA August 2025 the FDA declined
approval based on their detailed questions/concerns. In November 2025 we participated in a Pre-Submission meeting focused on sterilization
to address their comments confirming completion of container closure integrity testing and to introduce the Agency to the Company’s
enhanced Electron Beam (E-Beam) sterilization process for the RadioGel hydrogel to determine their reaction and recommendations.
To
maximize the probability of IDE approval on the next submission, in October 2025 the Company engaged one of the leading regulatory experts
in the field of brachytherapy and combination radiotherapy devices. This expert has over 25 years of direct experience guiding such products
through the FDA’s Center for Devices and Radiological Health (CDRH), including prior senior roles within the FDA’s Office
of Device Evaluation. He has a proven track record of leading successful IDE approvals for multiple Class III implantable radiation devices,
several of which were reviewed by the same Interventional Radiology and Oncology branch currently assigned to RadioGel®. His in-depth
knowledge of this review team’s expectations, historical precedents, and common deficiency patterns has been instrumental in shaping
the Company’s regulatory strategy.
34
Currently,
the IDE is in preparation under this expert’s guidance. The Company is positioned to incorporate final FDA input and submit the
complete IDE application in the near term (targeted by the end of the first quarter or in April 2026). This expert’s proven ability
to present complex IDE data in a format that this specific review panel can easily digest and understand has strengthened the submission,
alongside integration of newly available human clinical data, reformatted pre-clinical information, and leveraging veterinary outcomes
from IsoPet® (over 100 therapies with zero reportable serious adverse events). The Company remains encouraged by the constructive
ongoing dialogue with the FDA and is strongly positioned for IDE approval to advance human clinical trials.
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.
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;
35
●
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
2025 the Company decided to expand its manufacturing capabilities and to target for on domestic and one international production center.
Several candidates were assessed.
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. An alternate process
of E-Beam sterilization was developed and verified. Limited GDA recommended testing will be conducted next year to obtain FDA approval
for human therapy.
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.
36
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, and the Company is engaged in the detailed
sprint revie process. It has recently utilized the pre-submission process and the expertise of a well-respected advisor.
Clinical
trials have initiated in India. It is anticipated that these data, when it is restructured and expanded, will help accelerate FDA approval
in the USA. We have applied for the regulatory approval to complete the remaining designated patients.
Veterinary
Sector
The
United States is home to approximately 163.6 million pet dogs and cats (with recent 2025 estimates from the American Veterinary Medical
Association (the “ AVMA ”) indicating about 87.3 million dogs and 76.3 million cats). Cancer remains a leading health
concern for these pets: roughly half of dogs over age 10 and a significant portion of older cats develop cancer, which is the number
one natural cause of death in senior dogs and cats, accounting for nearly 50% of pet deaths in many cases. The National Cancer Institute
and veterinary sources estimate that about 6 million dogs are diagnosed with cancer each year (more than 16,000 per day), with similar
high incidence in cats.
Product
development, application techniques, and animal testing for IsoPet® (the veterinary branding of the yttrium-90 based therapy) are
permitted under FDA regulations. For commercial sales in animals, the FDA’s Center for Veterinary Medicine (CVM) provides classification
guidance. In January 2018, the CVM Product Classification Group ruled that RadioGel® (now marketed as IsoPet® for veterinary
use) is classified as a medical device for animal therapy, initially for feline sarcomas and canine soft tissue sarcomas.
Following
legal review, the Company believes this device classification is not strictly limited to those specific sarcomas but can extend to a
broader range of veterinary cancers, including most or all solid tumors in animals. As veterinary medical devices do not require premarket
approval, notification (e.g., 510(k)), or other premarket authorization from the FDA for commercial distribution in the United States,
IsoPet® is authorized for marketing and use following this classification—provided the product is safe, effective, properly
labeled, and compliant with all applicable laws and regulations. The FDA exercises no premarket authority over veterinary devices, placing
responsibility on manufacturers to ensure ongoing compliance. This classification enables the commercial distribution of IsoPet®
for treating solid tumors in animals without additional regulatory approvals.
The
IsoPet® division reported a 1,200% year-over-year increase in administered therapies from 2024 to 2025, as stated in the Company’s
December 22, 2025, press release. This growth reflects accelerating nationwide adoption among veterinarians and pet owners seeking a
precise, minimally invasive, and cost-effective alternative to conventional radiation or surgery for solid tumors.
In
recent months, the Company has observed a significant increase in inbound inquiries from veterinarians and pet owners regarding access
to IsoPet® therapy, indicating growing awareness and demand for this targeted Precision Radionuclide Therapy™ platform. Starting
in Q1 2026, the division is implementing profitability-focused initiatives, including billing clinics for certification training, applying
volume pricing to encourage broader adoption, refining production scheduling for efficiency, and continuing to expand the network of
certified clinics.
37
To
date, over 100 IsoPet® treatments have been safely administered across dogs, cats, horses, and exotic animals, with zero reportable
serious adverse events attributable to the product. This veterinary clinical data supports ongoing commercialization efforts in the Animal
Therapy Division and provides supporting safety and efficacy evidence for the shared yttrium-90 platform in the RadioGel® human program
(including contributions to the Breakthrough Device designation and the pending IDE resubmission).
With
17 certified clinics operational as of December 31, 2025, and additional interested sites in the pipeline, the Company is positioned
to continue building on this momentum through scaled adoption, operational efficiencies, and strategic outreach (such as conferences,
social media, and publications from case studies). These efforts support the target of achieving breakeven in the Animal Therapy Division
in 2026.
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 RadioGel® (and IsoPet®) to its contract manufacturer in Texas (previously
IsoTherapeutics, acquired by Telix Pharmaceuticals in April 2024). This acquisition prompted the Company to accelerate plans for manufacturing
diversification to reduce dependency on a single provider and enhance supply chain resilience.
Eckert
& Ziegler serves as the sole supplier of yttrium-90 (Y-90), now sourced from their Massachusetts operations (previously from Germany).
The Company procures additional supplies, hardware, handling equipment, and packaging from various U.S. suppliers.
To
address single-source risks, the Company is advancing toward multiple production alternatives targeted for 2026 operational status:
●
One domestic facility where
Vivos will act as the manufacturer of record (contract signed for space at the Applied Process Engineering Laboratory (APEL) in Richland,
Washington; equipment ordered, installation underway, and licensing applications submitted).
●
One international facility
(ongoing discussions with experienced radiopharmaceutical contract manufacturers in India, aligned with Vivos Scientific India LLP
(VSIL) activities to reduce shipping costs and support global access).
38
The
Company will continue production with the existing Texas contract manufacturer through Q2 2026 to ensure continuity during the transition.
For
the hydrogel polymer component (PrecisionGel™), the Company engaged Akina, Inc. as an alternate supplier in 2021. Efforts are underway
to further expand Akina’s role to supply sterilized hydrogel (PrecisionGel™), supporting manufacturing scalability and compliance
needs for both RadioGel® (human) and IsoPet® (veterinary) applications.
These
initiatives—detailed in the February 17, 2026, press release on manufacturing diversification—align with the Company’s
strategy to mitigate supply chain vulnerabilities, accommodate growing demand (particularly in the IsoPet® division), and facilitate
broader commercialization following regulatory progress (e.g., pending IDE resubmission).
Customers
The
Company anticipates that potential customers for its Precision Radionuclide Therapy™ (PRnT™) products—RadioGel®
for human applications and IsoPet® for veterinary use—will primarily include institutions and individuals already utilizing
brachytherapy or other oncology treatments. For the veterinary market (IsoPet®), this encompasses certified veterinary clinics, university
veterinary hospitals, specialty animal oncology centers, and private practices treating small animals (dogs and cats), equine patients
(horses), and exotic species. Adoption has accelerated nationwide, with 17 certified regional clinics operational as of December 31,
2025, including academic institutions like the University of Florida (both small and large animal hospitals), Johns Hopkins University
Veterinary Clinical Trials Network, University of Missouri, University of Wisconsin, University of Illinois, and private facilities such
as Vista Veterinary Hospital, NorthStar VETS, and Sun City Veterinary Surgical Center. These clinics serve pet owners seeking minimally
invasive, targeted alternatives to traditional surgery or external radiation for solid tumors.
For
human applications (RadioGel®), potential customers would include hospitals, oncology centers, interventional radiologists, and medical
professionals treating non-resectable solid tumors, particularly in challenging anatomical locations. The therapy’s precision—delivering
localized beta radiation via direct injection while minimizing exposure to healthy tissue—positions it as a compelling option for
institutions focused on advanced radiotherapy.
The
veterinary and medical communities are expected to recognize Precision Radionuclide Therapy™ as an effective treatment for many
solid tumors, supported by real-world veterinary data (over 100 safe treatments with zero reportable serious adverse events) and ongoing
human demonstrations in India. Growing inbound inquiries from veterinarians, pet owners, and medical professionals, along with clinic
expansions, publications from case studies, and marketing efforts (e.g., conferences, social media, and dedicated websites), are driving
broader awareness and demand across both markets. The Company’s strategy emphasizes direct sales to certified clinics (veterinary)
and eventual partnerships or institutional adoption (human), with scalability enhanced by manufacturing diversification targeted for
2026.
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.
39
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.
Vivos
Inc has applied to Washington state for the manufacturing license to produce IsoPet and RadioGel.
40
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.
Future
operations in APEL have minimal environmental risk and are covered by liability insurance.
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.
In
September 2025 the Company’s brought on a full-time President to assist the CEO in managing the Company which includes expansion
both domestically and internationally.
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 Annual Report is not incorporated by reference into this Annual Report, unless (and only to the extent) expressly so stated herein.
Results
of Operations
Comparison
of the Three months Ended March 31, 2026 and 2025
The
following table sets forth information from our statements of operations for the three months ended March 31, 2026 and 2025:
Three Months Ended
March 31, 2026
Three Months Ended
March 31, 2025
Revenues
$ 36,068
$ 26,748
Cost of goods sold
44,086
35,831
Gross (loss) income
(8,018 )
(9,083 )
Operating expense
(537,474 )
(854,449 )
Operating loss
(545,492 )
(863,532 )
Non-operating income (expense)
(639,353 )
28,836
Net loss
$ (1,184,845 )
$ (834,696 )
Revenues
and Cost of Goods Sold
Revenue
was $36,068 and $26,748 for the three months ended March 31, 2026 and 2025, respectively. All revenue recognized in the three months
ended March 31, 2026 and 2025 relate to the procedures performed with respect to the IsoPet ® therapies, sales of IsoPet ® and
freight.
41
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.
Commencing
in 2025, the Company had started ordering Hydrogel to use in more than one treatment. This is anticipated to increase the number of treatments
that can be handled in a particular clinic monthly. As a result, we have inventory built up that when used will increase our cost of
goods sold over time.
Operating
Expenses
Operating
expense for the three months ended March 31, 2026 and 2025, respectively consists of the following:
Three months ended
March 31, 2026
Three months ended
March 31, 2025
Professional fees, including stock-based compensation
$ 285,432
$ 588,268
Payroll expense
155,434
94,697
Research and development
37,923
119,281
General and administrative expense
58,685
52,203
Total operating expense
$ 537,474
$ 854,449
Operating
expense for the three months ended March 31, 2026 and 2025 was $537,474 and $854,449, respectively. The decrease in operating expense
from 2025 to 2026 can be attributed to the decrease in professional fees ($588,268 for the three months ended March 31, 2025 versus $285,432
for the three months ended March 31, 2026) related to the fees incurred for the consultants engaged in 2026 versus 2025 and the decrease
in the value of the vested RSUs; the increase in general and administrative expense ($52,203 for the three months ended March 31, 2025
versus $58,685 for the three months ended March 31, 2026); the decrease in research and development ($119,281 for the three months ended
March 31, 2025 versus $37,923 for the three months ended March 31, 2026) as the Company continued to ramp up the development of their
products in 2025 in India as well as the US including research studies as well as continuing the steps necessary to be accepted by the
FDA, and an increase in payroll expense ($94,697 for the three months ended March 31, 2025 versus $155,434 for the three months ended
March 31, 2026) related to the CEOs employment contract and bonus, as well as the President’s payroll in 2026.
Non-Operating
Income (Expense)
Non-operating
income (expense) for the three months ended March 31, 2026 and 2025 were as follows:
Three months ended
March 31, 2026
Three months ended
March 31, 2025
Interest income
$ 12,275
$ 28,836
Loss on exchange of warrants
(651,628 )
-
Non-operating income (expense)
$ (639,353 )
$ 28,836
Non-operating
income (expense) for the three months ended March 31, 2026 and 2025 related to interest earned on the Company’s cash accounts,
and in 2026, the loss on exchange of warrants.
42
Net
Loss
Our
net loss for the three months ended March 31, 2026 and 2025 was $(1,184,845) and $(834,696), respectively.
Liquidity
and Capital Resources
At
March 31, 2026, the Company had working capital of $2,427,649, as compared to working capital of $1,533,177 at December 31, 2025. As
of March 31, 2026, the Company did not have any commitments for capital expenditures.
Net
cash used in operating activities for the three months ended March 31, 2026 and 2025, was $429,861 and $455,198, respectively. Cash used
in operating activities was primarily related to the Company’s net loss from operations, stock-based compensation, the loss on
exchange of warrants as well as the changes in accounts receivable, inventory, prepaid expense, and accounts payable. During the three
months ended March 31, 2026 and 2025, there was no cash used in investing activities except for the purchases of fixed assets in 2026
of $151,205. Net cash provided by financing activities for the three months ended March 31, 2026 and 2025 was $1,548,323 and $1,507,750,
respectively, consisting of proceeds from the sales of Common Stock and warrants as part of our Regulation A+ Offerings and payments
of lease obligations.
The
Company has generated material operating losses since inception. The Company had a net loss of $1,184,845 for the three months ended
March 31, 2026 as compared to a net loss of $834,696 for the three months ended March 31, 2025. 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 $3.0 million per year to maintain current operating activities. Over the next 36 months, the Company
believes it will require approximately $9.0 million in additional capital to: (i) fund the FDA approval process to conduct human clinical
trials; (ii) conduct Phase I, pilot, and clinical trials; (iii) activate several regional clinics to administer IsoPet ® across
the county; (iv) create an independent production center within the current production site to create a template for future international
manufacturing; and (v) 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.
Accounting
Policies and Estimates
The
preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the United
States of America requires management to make estimates and assumptions that affect the amounts reported in the unaudited condensed financial
statements and accompanying notes. Management bases its estimates on historical experience and on various other assumptions that are
believed to be reasonable under the circumstances. Actual results could differ from these estimates under different assumptions or conditions.
During the period ended March 31, 2026, we believe there have been no significant changes to the items disclosed as significant accounting
policies in management’s notes to the financial statements in our annual report on Form 10-K for the year ended December 31, 2025,
filed on March 31, 2026.
43
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.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
This
item is not applicable to us because we are a smaller reporting company as defined by Rule 12b-2 under the Securities Exchange Act of
1934.
Item
4. Controls and Procedures.
Disclosure
Controls and Procedures
Based
on an evaluation as of the date of the end of the period covered by this report, the Company’s Chief Executive Officer and Interim
Chief Financial Officer conducted an evaluation of the effectiveness of the design and operation of the Company’s disclosure controls
and procedures, as required by Exchange Act Rule 13a-15. Based on that evaluation, the Company’s Chief Executive Officer and Interim
Chief Financial Officer concluded that, because of material weakness related to proper segregation of duties, 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.
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 period ended March 31,
2026 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.
44
PART
II
Item
1. 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.
Item
2. Unregistered Sales of Equity Securities
From
January 1, 2026 through March 31, 2026, the Company issued:
19,200,000
shares of Common Stock in their Regulation A+ Offering, and 17,000,000 warrants in the amount of $1,553,000.
196,370
shares of Common Stock for services rendered valued at $16,687.
7,950,000
shares of Common Stock in exchange of warrants.
Item
6. Exhibits.
Exhibit
Number
Description
31.1
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes – Oxley Act of 2002
31.2
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes – Oxley Act of 2002
32.1
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350
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 (embedded within the Inline XBRL document)
45
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Vivos Inc.
Date: May 14, 2026
By:
/s/
Michael Korenko
Name:
Michael K. Korenko
Title:
Chief Executive Officer
(Principal Executive Officer)
Date: May 14, 2026
By:
/s/
Michael Pollack
Name:
Michael Pollack
Title:
Interim Chief Financial
Officer
(Interim Principal Financial
and Accounting Officer)
46
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.