What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2026-03-31 compared with 2025-03-24 · 98 added, 70 removed, 411 unchanged (29% of the section changed)

39 unchanged sentences

in an accumulated deficit of $88,427,246 and $85,361,229 as of December 31, 2025 and 2024, respectively, including net losses of $3,066,017

and $2,894,753 for the years ended December 31, 2024 and 2023.

Historically, the Company has relied upon investor funds to maintain its

operations and develop its business.

The Company needs to raise additional capital from investors for working capital as well as business

expansion, and there is no assurance that additional investor funds will be available on terms acceptable to the Company, or at all.

If the Company is unable to unable to obtain additional financing to meet its working capital requirements, the Company likely would

cease operations.

Company requires funding of approximately $3.5 million per year for Selling and General Administration costs and to fund its ongoing

Over the next 36 months, the Company believes it will cost approximately $10 million to:

(1) conduct human clinical trials;

(2) activate several regional clinics to administer IsoPet ® across the county;

(3) create an alternate manufacturing center

based on a template for future international manufacturing.

principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the FDA’s

classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise) and any requirements for

additional studies, which may possibly include clinical studies.

Thereafter, the principal variables in the amount of the Company’s

spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with

third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the United States

of America (“ U.S.

”, or the “ United States ”) and elsewhere.

The Company intends to fund its activities

through strategic transactions such as licensing and partnership agreements or additional capital raises.

and $2,910,448 for the years ended December 31, 2025 and 2024, respectively.

Historically, the Company has relied upon investor funds

to maintain its operations and develop its business.

The Company needs to raise additional capital from investors for working capital

as well as business expansion, and there is no assurance that additional investor funds will be available on terms acceptable to the

Company, or at all.

If the Company is unable to unable to obtain additional financing to meet its working capital requirements, the Company

likely would cease operations.

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.

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.

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.

geopolitical events, including the inherent instability and volatility in global capital markets, as well as the lack of liquidity in

22 unchanged sentences

radionuclide therapy Y-90 RadioGel™ device.

Company has been working with the FDA to obtain clearance for its precision radionuclide therapy Y-90 RadioGel TM device, but

no assurances have been received.

On December 23, 2014, the Company announced that it submitted a de novo application to the FDA

for marketing clearance for its patented Y-90 RadioGel TM device pursuant to Section 513(f)(2) of the U.S.

Food, Drug and Cosmetic

Act (the “ Act ”).

Company has repeatedly attempted to gain FDA approval for the IDE and obtain clearance for its precision radionuclide therapy Y-90 RadioGel TM

device, but no assurances have been received.

next attempt to submit an IDE request is targeted to be submitted in the near future buttressed by additional animal and human therapy

communicated using the recommend format of a well-respected FDA advisor.

December 23, 2014, the Company announced that it submitted a de novo application to the FDA for marketing clearance for its patented

Y-90 RadioGel TM device pursuant to Section 513(f)(2) of the U.S.

Food, Drug and Cosmetic Act (the “ Act ”).

In June 2015, the FDA notified the Company the de novo application was not granted.

2014, the FDA found the same device under Section 510(k) of the Act not substantially equivalent and concluded that the device is classified

by statute as a Class III medical device, unless the device is reclassified.

The Company is seeking reclassification of the product to

If the Company is successful in seeking reconsideration of the Company’s de novo application, as a regulatory

matter, the device could be on an easier and faster path to market in the United States.

However, there would still be the requirements

to complete the in vitro and in vivo testing, and then some human clinical trials.

That testing date is submitted in a de novo pre-market

application and if accepted we could then go to market.

As a practical matter, the Company would still need to secure funding and commercial

arrangements before marketing could commence.

If the de novo application is declined and if the Company obtains funding to permit

it to continue operations, the Company will explore steps toward seeking approval for the device as a Class III medical device.

the time and cost of seeking approval as a Class III medical device is materially greater than the time and cost of seeking approval

as a Class II medical device.

If the Company seeks approval as a Class III device, human clinical trials will be necessary.

human trials for Class III products are larger, of longer duration and costlier than those for Class II devices.

In February 2014, the FDA found the same device

under Section 510(k) of the Act not substantially equivalent and concluded that the device is classified by statute as a Class III medical

device, unless the device is reclassified.

The Company is seeking reclassification of the product to Class II.

If the Company is successful

in seeking reconsideration of the Company’s de novo application, as a regulatory matter, the device could be on an easier

and faster path to market in the United States.

However, there would still be the requirements to complete the in vitro and in vivo testing,

and then some human clinical trials.

That testing date is submitted in a de novo pre-market application and if accepted we could then

go to market.

As a practical matter, the Company would still need to secure funding and commercial arrangements before marketing could

If the de novo application is declined and if the Company obtains funding to permit it to continue operations, the Company

will explore steps toward seeking approval for the device as a Class III medical device.

Generally, the time and cost of seeking approval

as a Class III medical device is materially greater than the time and cost of seeking approval as a Class II medical device.

If the Company

seeks approval as a Class III device, human clinical trials will be necessary.

Generally, human trials for Class III products are larger,

of longer duration and costlier than those for Class II devices.

will be additional cost and time to reach marketing clearance or approval.

30 unchanged sentences

Korenko has been working with two internal candidates with the potential to seamlessly assume authority.

David Swanberg and Brad Weeks, current active consultants to the Company with broad responsivities, have been identified as high potential

David Swanberg, Chief Operating Officer of the Company, and Brad Weeks, President of the Company, have been identified as high potential

candidates to succeed Dr.

Korenko or to assume senior positions, although no formal arrangement has been reached.

The Company Board would

make the final appointment.

See “ Directors, Executive Officers and Significant Consultants” on page 36.

19 unchanged sentences

The Company had $68,379 and $27,995

in operating revenues, net of discounts, for the years ended December 31, 2024 and 2023, respectively, as we have commenced sales of

in operating revenues, net of discounts, and the years ended December 31, 2025 and 2024, respectively

of the Company’s competitors have greater resources and experience than the Company has.

39 unchanged sentences

Company relies on a sole manufacturing contact with IsoTherapeutics.

IsoTherapeutics

is our sole particle manufacturing contractor.

Vivos now has alternate suppliers for its hydrogel and is actively engaged is selecting

an alternate supplier for the particle production.

Both domestic and internation candidates are being assessed.

Company currently relies on a single contract manufacturer in Texas (previously IsoTherapeutics, acquired by Telix Pharmaceuticals in

April 2024) for the production of RadioGel® and IsoPet®, including the yttrium-90 (Y-90) phosphate particles and their integration

with sterile hydrogel to create individual patient doses.

This arrangement has been identified as a risk factor in prior corporate filings

due to potential single-source vulnerabilities.

mitigate these risks and support scalable growth, the Company is actively diversifying its manufacturing base.

For the domestic side,

Vivos has signed a contract for production space at the Applied Process Engineering Laboratory (APEL) in Richland, Washington, where

the Company will serve as the manufacturer of record.

Equipment has been ordered, installation is underway, and licensing applications

have been submitted to enable operational readiness.

international production, the Company is in ongoing discussions with experienced radiopharmaceutical contract manufacturers in India,

aligned with the activities of Vivos Scientific India LLP (VSIL), to establish a second facility.

These efforts aim to reduce shipping

costs, improve logistical efficiency, and expand global market access for both RadioGel® (human) and IsoPet® (veterinary) therapies.

Company’s strategic target is to have one domestic production facility (with Vivos as manufacturer of record) and one international

production facility operational in 2026.

Production with the existing Texas contract manufacturer will continue through Q2 2026 to ensure

continuity during the transition.

parallel, the Company has secured alternate suppliers for the hydrogel polymer component (PrecisionGel™), including Akina, Inc.

(engaged in 2021 and expanding to supply sterilized hydrogel) and SciPoly.

For particle production, Vivos is actively assessing both

domestic and international candidates to develop additional alternatives beyond the current arrangement.

These diversification steps—announced

in the February 17, 2026, press release—address sole-source dependencies, accommodate increasing demand (particularly in the IsoPet®

division), and support broader commercialization following regulatory advancements.

Company will rely heavily on a limited number of suppliers for the foreseeable future.

93 unchanged sentences

the Company’s disclosure controls and procedures were ineffective as of December 31, 2025 and 2024.

The Company needs to hire additional

qualified accounting personnel to resolve this material weakness.

The Company also will need to expend any additional resources and efforts

that may be necessary to establish and to maintain the effectiveness of the Company’s internal control over financial reporting

and disclosure controls and procedures.

The Company has engaged the

services of both internal accounting and tax providers to resolve this material weakness.

The Company also will need to expend any additional

resources and efforts that may be necessary to establish and to maintain the effectiveness of the Company’s internal control over

financial reporting and disclosure controls and procedures.

Company’s patented or other technologies may infringe on other patents, which may expose us to costly litigation.

57 unchanged sentences

Company had 455,494,238 shares of common stock outstanding as of December 31, 2025.

The Company also had outstanding on that date

dilutive securities consisting of preferred stock, restricted stock units, options, and warrants (collectively, “ Common

Stock Equivalents ”) that if they had been exercised and converted in full on December 31, 2024, would have resulted in the

issuance of up to 43,852,379 additional shares of common stock.

The issuance of shares upon the exercise of the Common Stock

Equivalents may result in substantial dilution to each stockholder by reducing that stockholder’s percentage ownership of the

Company’s total outstanding shares of common stock.

The issuance of some or all those warrants and any exercise of those

warrants will have the effect of further diluting the percentage ownership of the Company’s other stockholders.

The Company also had outstanding on that date dilutive

securities consisting of preferred stock, restricted stock units, options, and warrants (collectively, “ Common Stock Equivalents ”)

that if they had been exercised and converted in full on December 31, 2025, would have resulted in the issuance of up to 81,927,379 additional

shares of common stock.

The issuance of shares upon the exercise of the Common Stock Equivalents may result in substantial dilution to

each stockholder by reducing that stockholder’s percentage ownership of the Company’s total outstanding shares of common

The issuance of some or all those warrants and any exercise of those warrants will have the effect of further diluting the percentage

ownership of the Company’s other stockholders.

sales of the Company’s securities, including sales following exercise or conversion of derivative securities, or the perception

96 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors